QIAGEN Receives FDA Emergency Use Authorization for NeuMoDx Multiplex Test Expanding COVID-19 Portfolio

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GERMANTOWN, Md. & HILDEN, Germany–(BUSINESS WIRE)– QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the Emergency Use Authorization by the U.S. FDA for the NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 VantageAssay that will help healthcare professionals quickly identify and differentiate individuals suspected by a healthcare provider of respiratory viral infection consistent with COVID-19.

As restrictions are eased and social distancing measures are reduced, respiratory viral infections are likely to increase. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2, influenza or RSV can be similar. This makes it essential to correctly identify them in order to treat and manage patients accordingly, especially in the COVID-19 pandemic. This polymerase chain reaction (PCR) multiplex test will be an important tool now and in upcoming winter seasons for simultaneous qualitative detection and differentiation of influenzas A and B, respiratory syncytial virus (RSV) and SARS-CoV-2 infections within 80 minutes.

QIAGEN launched the NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Test in the European Union and other markets that accept CE-IVD in November 2020 and will now begin commercialization of the test in the U.S.

QIAGEN’s new respiratory test takes advantage of the NeuMoDx 96 and NeuMoDx 288 molecular systems’ automated three-step workflow. Coupled with additional system features ­­– like processing capacity, true random access, and continuous loading of samples, reagents and consumables while the system is running – the NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 VantageAssay will be a powerful diagnostic tool for the flu season and COVID-19 pandemic.

“The authorization of this new test will become a pivotal tool for the detection and differentiation of SARS-CoV-2 from influenza like illnesses, or ILls,” said Jean-Pascal Viola, Senior Vice President, Head of the Molecular Diagnostics Business Area and Corporate Business Development at QIAGEN. “This test will play an important role in differentiating between ILI’s while the burden of COVID-19 continues. With its ease of use and true random access, the NeuMoDx will help laboratories maintain throughput for this increased testing volume while continuing routine testing. Also, with the continued ramp up of our manufacturing capacity, the NeuMoDx will be ready to answer the needs of molecular diagnostic laboratories for 2021 and beyond.”

The new 4-plex test joins a growing menu of assays on the NeuMoDx platform, which includes tests for blood-borne viruses, sexual and reproductive health, transplant and immunocompromised disease areas. More tests are in development and expected to launch in the coming months, including VZV, adenovirus and others.

QIAGEN fully acquired NeuMoDx in September 2020 and made it one of its five growth drivers for the company to continue growing on a standalone basis – the others being Sample Prep, QIAcuity, QFT and QIAstat-Dx. The NeuMoDx™ Flu A-B/RSV/ SARS-CoV-2 VantageTest strengthens QIAGEN’s footprint in PCR, the gold standard in coronavirus testing.

QIAGEN has a broad portfolio of testing and research solutions for COVID-19, ranging from fast singleplex and multiplex PCR tests to fast syndromic solutions (QIAstat-Dx), providing customers with a broad variety of PCR-based testing options. Furthermore, the portfolio includes RNA extraction kits and instruments as well as testing components and enzymes used by third parties for their own PCR test kits. QIAGEN’s COVID-19 portfolio also includes the QIAreach Antibody and Antigen tests, as well as SARS-CoV-2 T-Cell tests based on the QuantiFERON IGRA technology. In October 2020, the company also launched QIAprep&amp which streamlines PCR workflows by integrating sample preparation and real-time PCR detection into a single kit. QIAGEN also provides NGS solutions for research into mutations of COVID-19, dPCR solutions for wastewater testing and bioinformatics with QDI.

Further information on QIAGEN’s response to the coronavirus outbreak can be found here.

For more information on the NeuMoDx platform and NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Test,please visit http://qiagen.com/NeuMoDx

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of December 31, 2020, QIAGEN employed more than 5,600 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.

Forward-Looking Statement

Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN’s products, collaborations markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN’s products (including fluctuations due to general economic conditions, the level and timing of customers’ funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN’s products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors’ products; market acceptance of QIAGEN’s new products and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).

TCR² Therapeutics Establishes Commercial-Scale Cell Therapy Manufacturing Facility

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Mar 29, 2021
  • 85,000 square foot state-of-the-art facility being built in Rockville, Maryland
  • Accelerates TCR2’s commercial-scale manufacturing timelines with production anticipated in 2023
  • Aaron Vernon hired as Vice President of Technical Operations

CAMBRIDGE, Mass., March 29, 2021 (GLOBE NEWSWIRE) — TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell therapy company with a pipeline of novel T cell therapies for patients suffering from cancer, today announced that it has signed a long-term, full-building lease with Alexandria Real Estate Equities, Inc. (NYSE: ARE) for an existing 85,000 square foot cell therapy manufacturing facility in Rockville, Maryland which is ready for Current Good Manufacturing Practice (cGMP) build-out. The site will support clinical and commercial production of gavo-cel with a capacity to treat several thousand cancer patients annually. The facility is expected to accelerate the Company’s commercial-scale manufacturing timelines with production anticipated in 2023.

“After observing the consistent early clinical benefit and manageable safety profile experienced by patients treated with gavo-cel, we committed to securing a dedicated U.S. manufacturing facility as the first step in building a regional network to supply cancer patients with our therapies,” said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. “Leasing an existing manufacturing footprint is a substantial milestone for TCR2, saving us valuable time and capital so that we can be ready for commercial production in 2023. Our new state-of-the-art facility will allow us to directly leverage our cell therapy process development expertise and control our end-to-end production supply chain. We are very pleased to be building a world-class cell therapy production facility for gavo-cel that will bring new hope to cancer patients suffering from solid tumors.”

The 85,000 square foot facility constructed by Alexandria Real Estate Equities will provide space for commercial and clinical manufacturing, quality control laboratories and offices upon completion. TCR2 is designing the state-of-the-art cell therapy facility to utilize semi-automated and functionally closed systems which aim to provide cGMP manufacturing while optimizing the reliability of our cell therapy products and reducing manufacturing costs and vein-to-vein time. The flexible layout will allow production of gavo-cel and other emerging cell therapies in the TRuC-T cell pipeline.

“The hiring of Aaron Vernon to head technical operations for the Company comes at the right time as we expand our manufacturing capabilities in anticipation of commercial production. His prior leadership roles in building out commercial operations as well as his specific expertise in global supply chain management will offer vital insights to TCR2 as we continue to execute upon our clinical strategy for gavo-cel,” added Dr. Menzel.

Aaron Vernon joins TCR2 as Vice President of Technical Operations. Most recently, he held senior positions including Vice President of Global Technical Operations and Vice President of Engineering & Supply Chain at Autolus Therapeutics, a clinical stage autologous CAR-T cell therapy company, where he held numerous responsibilities including manufacturing capacity expansion and overseeing internal and external manufacturing of plasmid, vector and cell therapy products. Previously, Aaron was Vice President of Global Supply Chain and Manufacturing at Sucampo Pharmaceuticals. Earlier in his career, served in various engineering and manufacturing operations roles at AstraZeneca, MedImmune and Johnson & Johnson.

About TCR2 Therapeutics

TCR2 Therapeutics Inc. is a clinical-stage cell therapy company developing a pipeline of novel T cell therapies for patients suffering from solid tumors or hematological malignancies. TCR2’s proprietary T cell receptor (TCR) Fusion Construct T cells (TRuC®-T cells) specifically recognize and kill cancer cells by harnessing signaling from the entire TCR, independent of human leukocyte antigens (HLA). In preclinical studies, TRuC-T cells have demonstrated superior anti-tumor activity compared to chimeric antigen receptor T cells (CAR-T cells), while secreting lower levels of cytokine release. The Company’s lead TRuC-T cell product candidate targeting solid tumors, gavo-cel, is currently being studied in a Phase 1/2 clinical trial to treat patients with mesothelin-positive non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma, and cholangiocarcinoma. The Company’s lead TRuC-T cell product candidate targeting hematological malignancies, TC-110, is currently being studied in a Phase 1/2 clinical trial to treat patients with CD19-positive adult acute lymphoblastic leukemia (aALL) and with aggressive or indolent non-Hodgkin lymphoma (NHL). For more information about TCR2, please visit www.tcr2.com.

Forward-looking Statements

This press release contains forward-looking statements and information within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as “may,” “will,” “could”, “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “seeks,” “endeavor,” “potential,” “continue” or the negative of such words or other similar expressions can be used to identify forward-looking statements. These forward-looking statements include, but are not limited to, express or implied statements regarding the therapeutic potential of gavo-cel, timing for interim updates for the Company’s clinical trials and announcement of additional preclinical data, timing for the certification and operation of our manufacturing facilities, including the new facility in Rockville, Maryland, manufacturing timing and capacity for clinical trials and commercial operations, increased clinical trial demand, timing of future IND filings and clinical development plans, the development of the Company’s TRuC-T cells, their potential characteristics, applications and clinical utility, and the potential therapeutic applications of the Company’s TRuC-T cell platform.

The expressed or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical studies and in the availability and timing of data from ongoing clinical studies; whether interim results from a clinical trial will be predictive of the final results of the trial; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials; the expected timing of submissions for regulatory approval or review by governmental authorities, including review under accelerated approval processes; orphan drug designation eligibility; regulatory approvals to conduct trials or to market products; TCR2’s ability to maintain sufficient manufacturing capabilities to support its research, development and commercialization efforts, including TCR2’s ability to secure additional manufacturing facilities; whether TCR2‘s cash resources will be sufficient to fund TCR2‘s foreseeable and unforeseeable operating expenses and capital expenditure requirements, the impact of the COVID-19 pandemic on TCR2’s ongoing operations; and other risks set forth under the caption “Risk Factors” in TCR2’s most recent Annual Report on Form 10-K, most recent Quarterly Report on Form 10-Q and its other filings with the Securities and Exchange Commission. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although TCR2 believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur.

Moreover, except as required by law, neither TCR2 nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

Investor and Media Contact:

Carl Mauch
Director, Investor Relations and Corporate Communications
TCR2 Therapeutics Inc.
(617) 949-5667
carl.mauch@tcr2.com 

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Six Montgomery County Companies Benefit from Bio Lab Pilot Project Grants

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MCEDC awards almost $100,000 to early growth-stage biotech companies to help with small wet lab buildout

Rockville, Md. — The Montgomery County Economic Development Corporation (MCEDC) awarded a total of $96,430 to six small life science companies as part of its recently completed Bio Lab Pilot Project. The project was launched in 2019 to assist local growth-stage life science companies with their wet lab and infrastructure needs. Applicants seeking financial help to build out small wet lab space less than 5,000 SF were encouraged to apply for $10 per SF of lab fit out costs, up to $30,000 per company. Project funding was provided by MCEDC and the Maryland Department of Commerce.

The six local companies receiving grants to support new or repurposed lab space are:

  • APCBIO INNOVATIONS, WHICH DEVELOPS SEVERAL DRUG CANDIDATES TO TREAT RESPIRATORY DISEASES;
  • APPLIED BIOMIMETIC, WHICH USES POLYMER TECHNOLOGY AND PROTEIN SCIENCE TO MANUFACTURE HIGH-PERFORMANCE MEMBRANES;
  • BIOINNOVATISE, WHICH PROVIDES A VARIETY OF CONTRACT BIOMOLECULAR SERVICES RELATED TO DNA SEQUENCING;
  • CODEX BIOSOLUTIONS, WHICH PRODUCES CELL-BASED ASSAY PRODUCTS INCLUDING ACTONE CELL LINES, ASSAY KITS AND PRODUCTS FOR TOXICITY STUDIES;
  • NEOMICS PHARMACEUTICALS, WHICH HAS AN R&D PIPELINE THAT INCLUDES TCR-T CELL THERAPY TO TREAT SOLID TUMORS; AND
  • RISE THERAPEUTICS, WHICH DEVELOPS NOVEL DRUGS TARGETING INTESTINAL MICROBIOME-ASSOCIATED IMMUNE PATHWAYS WITH ORAL BIOLOGICAL THERAPIES.

Successful applicants to the Bio Lab Pilot Project represent the diversity of the county’s vibrant biotechnology industry. In many cases, the leaders of these growth stage companies are building on decades of industry experience to create new enterprises.

“Most small life sciences entrepreneurs are looking for this type of infrastructure assistance as they outgrow their shared bench or incubator space,” said Dr. Gary Fanger, President and CEO of Rise Therapeutics. “Compared to other parts of the country, Montgomery County continues to provide a strong support system for new and growing life science companies. Local programs like the SBIR matching fund and the Bio Lab Pilot Project are unique components of our county’s biohealth cluster.”

Montgomery County’s Small Business Innovation Research/ Small Business Technology Transfer (SBIR/STTR) matching grant program allows county companies receiving a federal NIH SBIR or STTR grant award to apply for a local match of 25%, up to a maximum of $25,000 for a Phase I grant or a maximum of $75,000 for a Phase II grant. It is the only local jurisdiction SBIR/STTR matching program in the country.

“The Bio Lab Pilot Project allowed us to not only support emerging growth-stage life science companies but also helped us to create durable laboratory infrastructure. As these companies prosper and move into larger spaces elsewhere, they can free up these labs for the next generation of biotech startups,” said Benjamin H. Wu, MCEDC President & CEO.

Montgomery County is the anchor of the fourth largest biopharma cluster in the United States, according to Genetic Engineering and Biotechnology News, with abundant opportunities to launch new products and advance discoveries.


ABOUT MCEDC

The Montgomery County Economic Development Corporation (MCEDC) is the official public-private economic development organization representing Montgomery County, Maryland. Created in 2016, MCEDC is led by a Board of Directors of business executives. Its mission is to help businesses start, grow and relocate in Montgomery County by helping them gain access to top talent, business and market intelligence and prime locations. For more information, visit our website. Follow us on TwitterFacebook and LinkedIn.

Leading Children’s Hospitals and Phlow Corp. form an Unprecedented Coalition to Deliver Essential Medicines to Address Pediatric Drug Shortages

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RICHMOND, Va., March 18, 2021 – Phlow Corp., a U.S.-based, public benefit corporation committed to a bold mission of providing every American with access to affordable, high-quality essential medicines, today joins in announcing the launch of a groundbreaking Children’s Hospital Coalition: Powered by PhlowTM (CHC). This first-in-kind coalition brings together some of the top children’s hospitals across the nation, in collaboration with Phlow, to provide certainty in availability and access for key medicines necessary to sustain life and conquer disease and to address the nation’s broken essential medicines supply chain.

“The care of America’s children is unnecessarily impacted by essential medicine shortages, which sometimes lead to compromised patient care, clinician frustration, and increased hospital pharmacy costs and inefficiencies,” said Eric Edwards, M.D., Ph.D., co-founder, president, and CEO of Phlow. “By empowering an innovative and unique coalition of the top children’s hospitals in the country, we will be able to work with visionary leaders to solve this chronic and vexing problem.”

Shortages of essential medicines for children are a persistent problem plaguing hospitals across the United States. A 2019 survey of 330 U.S. hospitals, including 29 children’s hospitals, demonstrated that medicine shortages disproportionately and uniquely impact children’s hospitals. (Vizient, 2020) The COVID-19 pandemic has exposed further vulnerabilities in the overall U.S. hospital supply chain, particularly regarding essential injectable medications. To address this issue, the CHC is charged with a mission to deliver on the promise of ensuring a reliable supply of high-quality, affordable essential medicines to treat children.

Currently, the 11 founding hospital members of the CHC are: Arkansas Children’s, Boston Children’s Hospital, Children’s Hospital Los Angeles, Children’s Hospital of Richmond at VCU, Children’s National Hospital, Children’s Wisconsin, Cincinnati Children’s, Cook Children’s, Intermountain Primary Children’s Hospital, Ann & Robert H. Lurie Children’s Hospital of Chicago, and Nationwide Children’s Hospital.

“Far too often, the health care needs of children are not a priority. The coalition will draw attention to this important issue of shortages of essential medicines and more importantly, start to fix the problem,” said Kurt Newman, President and CEO of Children’s National Hospital in Washington, D.C. “I know we can do better for children who require these life-saving treatments and cures, and I’m proud to join this great group of organizations in developing an innovative solution.”

The coalition is working together to further escalate this issue on the national agenda, to encourage children’s hospitals to join in this cause, and educate other hospitals on how this coalition will aid in ending shortages of essential medicines. Ultimately, the goal of the CHC is to increase the resiliency and reliability of the pediatric pharmaceutical supply chain. “We believe that supporting this national pediatric-focused initiative will improve access, quality, and the costs of care for children,” said Dan Hackman, Chief Commercial Officer of Phlow. “We are thrilled to support the CHC and look forward to working together to improve the pediatric-focused essential medicine supply chain.”

Coalition hospitals are collaborating to identify and prioritize the most needed essential medicines, including sterile injectable medicines and medications used to treat pediatric cancers and rare diseases. Phlow will work quickly to ensure a high-quality, reliable supply of these essential medicines and will provide transparent, cost-plus pricing for all coalition members under uniform long-term purchasing agreements. Through this collaboration, the CHC will work toward improving the delivery of pediatric care.

The founding members of the CHC, including Phlow, recognize that essential medicine supply is a critical problem nationwide and welcome new children’s hospital members to join in this bold initiative. Please visit www.childrenshospitalcoalition.org for more information on how to join the CHC.

About Phlow

Phlow Corp. is a trailblazing, essential medicines impact company that is reimagining essential medicines from start to finish through the use of flow chemistry. Everything Phlow does is designed to promote access to affordable, high-quality essential medicines for all Americans. Phlow provides a solution to the broken essential medicines supply chain by offering a resilient end-to-end solution that is U.S.-based, comprehensive, and fully integrated. With the support of an industry leading team, experienced strategic partners, and established relationships at the policy, regulatory, and federal levels, Phlow will manufacture active pharmaceutical ingredients (APIs) and finished pharmaceutical products domestically for essential medicines critical to the nation’s healthcare. Through the use of continuous-flow technology and green chemistry, Phlow is able to reduce costs and waste, improve quality and yield, and offer a more environmentally friendly alternative to batch manufacturing.

NeoImmuneTech Announces Closing of Initial Public Offering

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ROCKVILLE, Md.–(BUSINESS WIRE)–NeoImmuneTech, Inc. (KOSDAQ: 950220), a clinical-stage T cell-focused biopharmaceutical company, today announced the closing of its initial public offering of 3,133,334 shares of common stock, equivalent with 15,666,670 Korea Depository Receipts (KDRs) priced at KRW 37,500 per share, equivalent with KRW 7,500 per KDRs. The aggregate gross proceeds to NeoImmuneTech, before deducting underwriting discounts and commissions and other offering expenses, were KRW 117.5 billion ($103.4 million). NeoImmuneTech’s common stock began trading on the Korea Exchange on March 16, 2021, under the KOSDAQ code number “950220.”

Hana Financial Investment and Mirae Asset Daewoo acted as joint book-running managers for the offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About NeoImmuneTech

NeoImmuneTech, Inc. (NIT) is a clinical-stage T cell-focused biopharmaceutical company, dedicated to expanding the horizon of immuno-oncology and enhancing immunity to infectious diseases. NIT is led by the scientific founder and inventor of NT-I7 (efineptakin alfa) and complemented by a strong executive team with rich industry experience at companies such as Novartis, BMS, GSK, Pfizer, Amgen, Eli Lilly, MedImmune/AstraZeneca and PwC. NIT is expanding rapidly in personnel and operations, as well as partnering with industry and academic leaders to investigate NT-I7 as monotherapy and in combination with various immunotherapeutics. For more information, please visit www.neoimmunetech.com.

Contacts

Investors:
Hayoung Lee
+82 31 709 5858
hylee@neoimmunetech.com

Media:
MacDougall
Carolyn Noyes
+1 781 235 3060
cnoyes@macbiocom.com

VLP Therapeutics raises $16M Series A for cancer treatment vaccine R&D

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GAITHERSBURG, Md., March 15, 2021 /PRNewswire/ — US-based biotech company VLP Therapeutics, Inc. (VLPT) announced on March 15 that it has raised US$16 million in a Series A funding round from MIYAKO Capital Co., Ltd., Sojitz Corporation, Konishiyasu Co., Ltd., in Japan and three existing investors in the US (Mr. Robert G. Hisaoka, SK Impact Fund, LLC, and RJ Fund, LLC) for research and development of a cancer treatment vaccine. With this funding, VLPT aims to accelerate the project well underway in the US and move into clinical trials at the earliest date possible.

“I have a high hope for VLP Therapeutics to become a leading company with its innovative platform technologies in the fields of infectious diseases and cancer, deep-rooted with CEO Wataru Akahata’s continuing commitment to virus and vaccine research and extensive experience of clinical trials,” says Dr. Hiroyuki Misawa, director and partner of MIYAKO Capital Co., Ltd. “It is my great pleasure to back up, as a shareholder, a biotech company with such advanced technologies.”

VLPT aims to further the project in the US and get the green light to clinical trials at the earliest date possible.Tweet this

“I am optimistic that the innovative vaccines now being developed at VLP Therapeutics will make a significant contribution to the treatment of cancer, the prevention of malaria and dengue fever, and the fight against new threats such as COVID-19. In turn, I believe this will improve health and well-being for all and advance the development of medicine,” says Masayoshi Fujimoto, president and CEO of Sojitz Corporation. “We, Sojitz Corporation, are very pleased to work with VLPT CEO Wataru Akahata, an ambitious scientist with considerable experience in vaccine R&D, as well as with the members of the research team and the company founders who are well-versed in pharmaceutical development. We will do whatever we can to help VLPT grow going forward.”

“Since its inception over 190 years ago, we, Koshishiyasu, have been devoted to making the world a better place through the sales of industrial chemicals. It is therefore our great honor to invest in the cancer treatment vaccine R&D underway at VLP Therapeutics, which is also combating malaria and Covid-19 with its novel technologies,” says Toshiyuki Konishi, president and CEO of Konishiyasu Co., Ltd. “We are confident that, by financially supporting VLPT, we can contribute to the well-being of society, and they will make further progress in their vaccine R&D efforts.”

# # #

About VLP Therapeutics: VLP Therapeutics, Inc. (VLPT), co-founded in 2013 by Drs. Wataru Akahata, Ryuji Ueno, and Sachiko Kuno, is a Gaithersburg, MD-based biotech company with a mission to address unmet medical needs worldwide and expand the frontiers of vaccine treatment. Led by CEO Akahata VLPT is currently engaged in research and development of a cancer treatment vaccine as well as prophylactic vaccines against malaria, dengue, and novel coronavirus disease (COVID-19) using VLPT’s proprietary platform technologies.
https://vlptherapeutics.com/

About VLP Therapeutics Japan: VLP Therapeutics Japan, LLC (VLPTJ), founded in 2020 by Dr. Wataru Akahata and headquartered in Tokyo, Japan, is a wholly-owned subsidiary of US-based VLP Therapeutics, Inc. VLPTJ is currently engaged in research and development of novel coronavirus disease (COVID-19) vaccine using self-amplifying (replicon) RNA technology proprietary to VLPT, with support from the Japan Agency for Medical Research and Development (AMED)1. Fujifilm Corporation has agreed to manufacture the vaccine formulations.2
https://vlptherapeutics.co.jp/

  1. AMED grant program: “FY2020 Development of Vaccines for the Novel Coronavirus Disease (COVID-19)(2nd)” | Proposal selected: “Development of COVID-19 vaccine in Japan using self-amplifying RNA technology”
  2. News release (October 1, 2020): “Fujifilm Concludes a Manufacturing Contract Agreement with VLP Therapeutics, for a COVID-19 Vaccine Formulation”
    https://www.fujifilm.com/jp/en/news/hq/5493

About Dr. Wataru Akahata: Upon graduation from the University of Tokyo in 1997, Akahata studied at Kyoto University’s Graduate School of Human and Environmental Studies. In 2002 he earned his PhD for HIV vaccine studies under supervision of professor Hayami Masanori at the Kyoto University Institute for Virus Research. He then started his career at the National Institutes of Health (NIH) Vaccine Research Center in the US through 2012. During that time he invented a virus-like particle (VLP) vaccine for chikungunya virus in 2009, on which he published an original article in Nature Medicine with the VLP image featured on the cover in 2010. He eventually won a NIH Director’s Award for his discovery of the vaccine and three other alphavirus vaccines in 2012. In addition to his role as the co-founder and CEO of VLP Therapeutics, Inc. in the US and CEO and chief R&D officer of VLP Therapeutics Japan, LLC, Akahata serves as a visiting professor at the Tokyo Institute of Technology and specially appointed associate professor at the Kyoto University Graduate School of Medicine in Japan.

Contact: Yutaka Iijima, Global Communications and IR Manager, info@vlptherapeutics.com

SOURCE VLP Therapeutics, Inc.

Lonza to Commission a Dedicated Suite for Clinical and Commercial Supply of Altimmune’s COVID-19 Vaccine Candidate at its Houston Facility

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GAITHERSBURG, Md. and BASEL, Switzerland, March 12, 2021 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that it has expanded its previously-announced AdCOVID manufacturing collaboration with Lonza. Under the expanded agreement, Lonza will commission a dedicated manufacturing suite for clinical and commercial production of AdCOVID, Altimmune’s single-dose intranasal vaccine candidate for COVID-19, at its facility near Houston, Texas.

“Manufacturing capacity for COVID-19 vaccines has been severely constrained, and this limitation has presented considerable challenges for vaccine developers,” said Dr. Vyjayanthi Krishnan, Ph.D., Vice President of Product Development for Altimmune. “By expanding our Lonza collaboration and commissioning our own dedicated manufacturing suite, we are building extra capacity and redundancy into our manufacturing to support potential late-stage clinical trials with AdCOVID and potential future commercial supply. Lonza continues to be an outstanding partner in this mission, and we are pleased to have the opportunity to further our relationship with this world class team.”

Alberto Santagostino, SVP, Head of Cell and Gene Technologies for Lonza, commented, “Altimmune’s COVID-19 vaccine candidate could be a complete game-changer in the fight against COVID-19. Our reinforced commitment is to enable the team at Altimmune to scale-up production as needed and deliver vaccines at a global scale when ready.”

AdCOVID is a COVID-19 vaccine candidate that is administered via nasal spray. In preclinical studies, AdCOVID was shown to activate systemic immunity (neutralizing antibodies and T cell responses) and mucosal immunity in the respiratory tract. Activation of mucosal immunity may prevent both SARS-CoV-2 virus infection and transmission. In preclinical studies, AdCOVID stimulated a 29-fold increase in mucosal IgA, well above the level associated with protection in clinical studies of influenza.

“We recently commenced our AdCOVID Phase 1 clinical trial and anticipate having a data readout in the second quarter of 2021,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer at Altimmune. “If the clinical data from our Phase 1 trial and subsequent clinical trials validate our preclinical observations, and AdCOVID is successfully commercialized, we believe that it could become an important new option for vaccination against COVID-19, offering the simplicity of nasal administration, potential ease of deployment and storage, and the potential to block viral transmission.”

Based on clinical experience with Altimmune’s vaccine platform technology, Altimmune anticipates that AdCOVID could provide immunity of up to a year or more following a single dose with the potential for a favorable tolerability profile. Vaccine stability is critical for efficient vaccine deployment and based on data from Altimmune’s other intranasal vaccine candidates, AdCOVID is expected to be shipped without cold chain logistics, permitting common refrigerated storage at community-based vaccination centers without the need for specialized freezer storage.

About AdCOVID

AdCOVID is a single-dose intranasal vaccine candidate for COVID-19. It is designed to stimulate a broad immune response including both systemic immunity (neutralizing antibody) and local immunity (mucosal IgA, resident memory T cells) in the nasal cavity and respiratory tract.

In published preclinical studies (www.biorxiv.org/content/10.1101/2020.10.10.331348v1) conducted in collaboration with the University of Alabama at Birmingham, potent serum neutralizing antibody responses, T cell responses, and a robust induction in mucosal immunity were observed in mice following a single intranasal dose of AdCOVID. Mucosal immunity was characterized by IgA antibody and resident memory T cell responses in the respiratory tract, both of which are believed to be important in fighting infection, and importantly, transmission.

Based on data from Altimmune’s other intranasal platform vaccine candidates, AdCOVID is expected to have extended stability at room temperature that would allow for cold chain-free shipment of the vaccine. If demonstrated, AdCOVID could be stored in the common refrigerators found in community-based doctors’ offices and pharmacies for two years or more. The Company believes that these simple and convenient handling requirements, together with the potential ability to block SARS-CoV-2 transmission, could position AdCOVID as a leading intranasal COVID-19 vaccine.

About Lonza

Lonza is the preferred global partner to the pharmaceutical, biotech and nutrition markets. We work to prevent illness and enable a healthier world by supporting our customers to deliver new and innovative medicines that help treat a wide range of diseases. We achieve this by combining technological insight with world-class manufacturing, scientific expertise and process excellence. These enable our customers to commercialize their discoveries and innovations in the healthcare sector.

Founded in 1897 in the Swiss Alps, today Lonza operates across three continents. With approximately 14,000 full-time employees, we are built from high-performing teams and of individual talent who make a meaningful difference to our own business, as well as to the communities in which we operate. The company generated sales of CHF 4.5 billion in 2020 with a CORE EBITDA of CHF 1.4 billion. Find out more at www.lonza.com.

Follow @Lonza on LinkedIn
Follow @LonzaGroup on Twitter

About Altimmune

Altimmune is a clinical stage biopharmaceutical company focused on developing intranasal vaccines, immune modulating therapies and treatments for liver disease. Our diverse pipeline includes proprietary intranasal vaccines for COVID-19 (AdCOVID™), anthrax (NasoShield™) and influenza (NasoVAX™); an intranasal immune modulating therapeutic for COVID-19 (T-COVID™); and next generation peptide therapeutics for NASH (ALT-801) and chronic hepatitis B (HepTcell™). For more information on Altimmune, please visit www.altimmune.com.

Follow @Altimmune, Inc. on LinkedIn
Follow @AltimmuneInc on Twitter

Forward-Looking Statement for Altimmune

Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the timing of key milestones for our clinical assets, the timing of the data readout from the AdCOVID Phase 1 clinical trial in Q2 2021, the potential immunization effects of AdCOVID, the potential of AdCOVID to block SARS-CoV-2 transmission, the shipping and storage requirements for AdCOVID, and the prospects for regulatory approval, our ability to manufacture AdCOVID for our clinical trials and commercial needs, commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Altimmune, Inc. (the “Company”) may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward looking statements or historical experience include risks and uncertainties, including risks relating to: potential impacts due to the COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company’s product candidates; the Company’s ability to manufacture clinical trial materials and commercial supply on the timelines anticipated; the Company’s ability to secure manufacturing approval from its SARS-CoV-2 cell licensor on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company’s business, financial conditions and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, including under the heading “Risk Factors” in the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2020 filed with the SEC, which is available at www.sec.gov.

Altimmune Investor & Media Contacts:

Will Brown
Chief Financial Officer
Phone: 240-654-1450
wbrown@altimmune.com
Stacey Jurchison
Sr. Dir, Investor Relations
Phone : 410-474-8200
sjurchison@altimmune.com

Additional Information and Disclaimer for Lonza

Lonza Group Ltd has its headquarters in Basel, Switzerland, and is listed on the SIX Swiss Exchange. It has a secondary listing on the Singapore Exchange Securities Trading Limited (“SGX-ST”). Lonza Group Ltd is not subject to the SGX-ST’s continuing listing requirements but remains subject to Rules 217 and 751 of the SGX-ST Listing Manual.

Certain matters discussed in this news release may constitute forward-looking statements. These statements are based on current expectations and estimates of Lonza Group Ltd, although Lonza Group Ltd can give no assurance that these expectations and estimates will be achieved. Investors are cautioned that all forward-looking statements involve risks and uncertainty and are qualified in their entirety. The actual results may differ materially in the future from the forward-looking statements included in this news release due to various factors. Furthermore, except as otherwise required by law, Lonza Group Ltd disclaims any intention or obligation to update the statements contained in this news release.

Lonza Contact Details:

Victoria Morgan
Head of External Communications
Lonza Group Ltd
Tel +41 61 316 2283
victoria.morgan@lonza.com

Dr. Martina Ribar Hestericová
Trade Media Lead
Lonza Group Ltd
Tel +41 61 316 8982
martina.ribarhestericova@lonza.com

Dirk Oehlers
Investor Relations
Lonza Group Ltd
Tel +41 61 316 8540
dirk.oehlers@lonza.com

Primary Logo

Source: Altimmune, Inc.

Investor Contacts

Stacey Jurchison
Altimmune

Email: sjurchison@altimmune.com

Ashley Robinson
LifeSci Advisors, LLC

Email: arr@lifesciadvisors.com

Novavax Confirms High Levels of Efficacy Against Original and Variant COVID-19 Strains in United Kingdom and South Africa Trials

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– 100% protection against severe disease

– Final analysis in U.K. trial confirms 96% efficacy against original strain of COVID-19

– Efficacy against variants confirmed in U.K. and South Africa

GAITHERSBURG, Md., March 11, 2021 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced final efficacy of 96.4% against mild, moderate and severe disease caused by the original COVID-19 strain in a pivotal Phase 3 trial in the United Kingdom (U.K.) of NVX–CoV2373, the company’s vaccine candidate. The company also announced the complete analysis of its Phase 2b trial taking place in South Africa, with efficacy of 55.4% among the HIV- negative trial participants in a region where the vast majority of strains are B1.351 escape variants. Across both trials, NVX-CoV2373 demonstrated 100% protection against severe disease, including all hospitalization and death. Both studies achieved their statistical success criteria. Today’s final analyses build on the successful interim results announced in January 2021, adding substantially more COVID-19 cases and statistical power.

“We are very encouraged by the data showing that NVX-CoV2373 not only provided complete protection against the most severe forms of disease, but also dramatically reduced mild and moderate disease across both trials. Importantly, both studies confirmed efficacy against the variant strains,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “Today marks one year since the WHO officially declared the COVID-19 pandemic, and with this data in hand, we are even more motivated to advance our vaccine as a potential weapon in the fight to end the suffering caused by COVID-19.”

United Kingdom Phase 3 Trial
The study enrolled more than 15,000 participants between 18-84 years of age, including 27% over the age of 65. The primary endpoint of the U.K. Phase 3 clinical trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline.

Efficacy was 96.4% (95% CI: 73.8, 99.5) against the original virus strain and 86.3% (95% CI: 71.3, 93.5) against the B.1.1.7/501Y.V1 variant circulating in the U.K (post hoc). The primary efficacy endpoint demonstrated an overall vaccine efficacy of 89.7% (95% CI: 80.2, 94.6). 106 cases were observed, with 10 in the vaccine group and 96 in the placebo group. NVX-CoV2373 was effective against severe disease: five severe1 cases were observed in the study, and all occurred in the placebo group. Four of the five severe cases were attributed to the B.1.1.7/501Y.V1 variant. Fourteen days after dose 1, vaccine efficacy was 83.4% (95% CI: 73.6, 89.5).

In volunteers 65 years of age and older, 10 cases of COVID-19 were observed, with 90% of those cases occurring in the placebo group. Older adults are among the groups most impacted by the disease and are at high risk of complications from COVID-19.

Novavax expects the data to serve as the basis for submission for authorization to various regulatory agencies worldwide.

South Africa Phase 2b Trial
The South Africa trial was a randomized, observer-blinded, placebo-controlled Phase 2b clinical trial of NVX-CoV2373. One cohort evaluated efficacy, safety and immunogenicity in approximately 2,665 healthy adults. The second cohort evaluated safety and immunogenicity in approximately 240 medically stable, HIV-positive adults.

A complete analysis of vaccine efficacy among 147 PCR-positive cases (51 cases in the vaccine group and 96 in the placebo group) demonstrated an overall efficacy of 48.6% against predominantly variant strains (95% CI: 28.4, 63.1). The vast majority of cases circulating during the efficacy analysis were due to the B.1.351/501Y.V2 variant circulating in South Africa. All five cases of severe disease observed in the trial occurred in the placebo group. Among HIV-negative participants, 55.4% efficacy was observed (95% CI: 35.9, 68.9). The complete analysis shows that vaccine-induced protection began 14 days after dose 1 (42.7% 95% CI: 25.0, 56.3), although increased efficacy was observed 7 days after dose 2, the primary endpoint for the study.

A previously reported initial analysis from the study through 60 days indicated that prior infection with the original COVID-19 strain might not completely protect against subsequent infection by the variant predominantly circulating in South Africa. However, the complete analysis of the South Africa trial indicates that there may be a late protective effect of prior exposure with the original COVID-19 strain. In placebo recipients, at 90 days the illness rate was 7.9% in baseline seronegative individuals, with a rate of 4.4% in baseline seropositive participants.

In both the U.K. and South Africa trials, these analyses showed that the vaccine is well-tolerated, with low levels of severe, serious (SAEs) and medically attended adverse events at day 35, balanced between vaccine and placebo groups.

For further information, including media-ready images, b-roll, downloadable resources and more, click here.

About NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax’ patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials, a trial in the U.K that demonstrated efficacy of 96.4% against the original virus strain and 89.7% overall, and the PREVENT-19 trial in the U.S. and Mexico that began in December 2020. It is also being tested in two ongoing Phase 2 studies that began in August: a Phase 2b trial in South Africa that demonstrated 48.65% efficacy against a newly emerging escape variant, and a Phase 1/2 continuation in the U.S. and Australia.

NVX-CoV2373 is stored and stable at 2°- 8°C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.

About Matrix-M™
Novavax’ patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

About Novavax
Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company’s proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

Novavax Forward Looking Statements
Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading “Risk Factors” in the Novavax Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

 

1 Please see trial protocols for endpoint definitions of COVID-19 severity at https://www.novavax.com/resources#protocols

Cision View original content:http://www.prnewswire.com/news-releases/novavax-confirms-high-levels-of-efficacy-against-original-and-variant-covid-19-strains-in-united-kingdom-and-south-africa-trials-301246019.html

SOURCE Novavax, Inc.

Adaptive Phage Therapeutics Announces FDA Clearance of IND Application for PhageBank™ in Treatment of Diabetic Foot Osteomyelitis

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GAITHERSBURG, Md.–(BUSINESS WIRE)–Adaptive Phage Therapeutics (APT), a clinical-stage biotechnology company dedicated to advancing therapies that address the global rise of multi-drug resistant infections, announced today that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for PhageBank™ phage therapy for the treatment of Diabetic Foot Osteomyelitis (DFO).

“Advancing PhageBank therapy targeting diabetic foot osteomyelitis is a critical step in providing viable treatment options to diabetic patients facing significant morbidities, including potential amputation,” said Greg Merril, CEO and co-founder of Adaptive Phage Therapeutics. “Today’s announcement marks the third successful IND application by APT in the last year, further validating the potential of our novel PhageBank™ platform to more effectively treat a range of drug-resistant bacterial infections and enabling APT to rapidly progress towards multiple clinical inflection points.”

DFO is the result of soft tissue infections in diabetic patients that spread into bone. Based on research by The Center for Biosimilars, someone is diagnosed with diabetes every 17 seconds, and 230 people with diabetes will suffer an amputation every day in the United States. Globally, it is estimated that a leg is amputated every 30 seconds, with 85% of these amputations resulting from a diabetic foot ulcer(1). With more than 1.5 million patients worldwide being diagnosed with diabetes each year, amputations as a result of diabetes comprise a significant portion of non-trauma related amputations. The American Diabetes Association estimates that 20% of patients with diabetic foot infections, and more than 60% of those with severe infections, have underlying osteomyelitis, placing patients at significantly higher risk of amputation(2).

APT’s PhageBank™ is a precision-matched phage therapy that specifically targets bacterial pathogen(s) identified as the cause of patient infection. PhageBank™ comprises a library of purified phages covering a broad spectrum of bacterial species. APT has also developed a proprietary PhageBank Susceptibility Test™ (PST) to rapidly identify the specific phage(s) required to provide precision therapy of bacterial infections.

The Defense Health Agency, a branch of the Department of Defense (DoD), is an integrated Combat Support Agency that enables the military’s medical services to provide a ready medical force in any situation. In 2019 the DoD awarded APT a $14 million contract for advanced development of its PhageBank™ platform. The award is funded by the Defense Health Agency and the Naval Medical Research Center.

APT is advancing clinical trials for all three initial PhageBank™ target indications: in Diabetic Foot Osteomyelitis (DFO), Prosthetic Joint Infections (PJI), and Urinary Tract Infections (UTI). APT’s Phase I/II PhageBank™ DFO trial is planned as a randomized, open-label, parallel-group, controlled study to evaluate the safety and efficacy of PhageBank™ therapy in conjunction with standard of care versus standard of care. APT plans to initiate the DFO clinical trial in 2021, with a first interim data analysis expected in 2022.

Adaptive Phage Therapeutics, Inc.

Adaptive Phage Therapeutics (APT) is a clinical-stage company advancing therapies addressing multi-drug resistant infections. Prior antimicrobial therapeutic approaches have been “fixed,” while pathogens continue to evolve resistance to each of those therapeutics, causing those drug products to become rapidly less effective in commercial use as antimicrobial resistance (AMR) increases over time. APT’s PhageBank™ approach leverages an ever-expanding library of bacteriophage (phage) that collectively provide evergreen broad spectrum and polymicrobial coverage. PhageBank™ phages are matched through a proprietary phage susceptibility assay that APT has teamed with Mayo Clinic Laboratories to commercialize on a global scale. APT’s technology was originally developed by the biodefense program of U.S. Department of Defense. APT acquired the world-wide exclusive commercial rights in 2017. Under FDA emergency Investigational New Drug allowance, APT has provided investigational PhageBank™ therapy to treat more than 40 critically ill patients in which standard-of-care antibiotics had failed.

For more information, visit http://www.aphage.com.

Contacts

Investors
Gilmartin Group, LLC.:
Laurence Watts, 619-916-7620
laurence@gilmartinir.com

The BioHealth Capital Region, 2021 and Beyond: After an Unprecedented Year, What’s Next?

By | BioBuzz, News | No Comments

The BioHealth Capital Region (BHCR) had a remarkable 2020, and there is palpable momentum and excitement in the air as we approach the end of Q1 2021. How will the pandemic impact the region’s push to be “Top 3 by 2023?” Where will this significant momentum lead? These questions are yet to be answered.

This year’s BioHealth Capital Region Forum, which will take place in September 2021, will be a must-attend virtual event for those seeking insights into where the region is headed.

The BHCR Forum’s theme will be the convergence of Big Bio and Big Data. The event should be fascinating given the pandemic’s unprecedented nature and its profound, ongoing impact on the region.

Click here to read more via BioBuzz.

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