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

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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?

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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.

BioBuzz – BioHealth Capital Region Women Making Waves in Venture Capital

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Improving access to venture capital for life science entrepreneurs and emerging biopharma companies in the BioHealth Capital Region (BHCR) is a top priority. However, elevating the region’s funding profile is not the only type of access undergoing a transformation in recent years.

Like many biopharma boardrooms, the world of venture capital has historically lacked diversity and, specifically, the presence of women in leadership roles.

The BHCR has made significant progress in generating VC interest in regional companies; events like BioHealth Innovation’s annual Investment Forum and conferences hosted by TEDCO and the Maryland Tech Council have contributed to increased access to venture capital private equity.

And now, we’re starting to see more and more women in venture capital positions of influence.

Both the venture capital access and gender gaps are beginning to close. Necessary changes won’t happen overnight, but both lines of progress are truly exciting and promising developments for the region and the entrepreneurs and young life science companies that call it home.

In 2019, BioBuzz produced a feature story called “Five Female Investors Who Are Making Their Mark in Life Science.” The story highlighted prominent women investors active in the BHCR, including Kyparissia (Kyp) Sirinakis, Co-Founder, Managing Partner at Epidarex CapitalClaire Broido Johnson, Managing Director, Maryland Momentum Fund; Sara Nayeem, Partner, New Enterprise Associates (NEA); and Arti Santhanam, Executive Director, Maryland Innovation Initiative (MII).

Today we’re profiling several other female leaders at investment funds that play a key role in shaping the investment landscape within the BHCR.

Click here to read more via BioBuzz

Genetic Engineering & Biotechnology News – BHCR is 60% toward its goal of becoming a top-three cluster by 2023

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4. BioHealth Capital Region [Maryland/Virginia/Washington, D.C.]

Well before COVID-19 wreaked havoc on the world, the Maryland/Virginia/Washington, DC “BioHealth Capital Region (BHCR)” had the building blocks of a region well-positioned against infectious disease. Baltimore-based Johns Hopkins University received nearly half the region’s total NIH basic research funding. In Gaithersburg, MD, COVID-19-focused vaccine developers with substantial operations include AstraZeneca, Emergent BioSolutions—and Novavax, whose expansion plans were announced during a visit by Maryland Gov. Larry Hogan (R).

Maryland Gov. Larry Hogan [2d from left] chats with Gale Smith, PhD, Novavax Discovery and Preclinical Research and Chief Scientist, during a tour of the company’s Gaithersburg, MD, facilities. [Office of Governor Larry Hogan]

Bethesda, MD, is home to the FDA and NIH—and its National Institute for Allergy and Infectious Disease, whose director led by Anthony S. Fauci, MD. Northern Virginia will soon be home to Drugviu, developer of a real-world evidence and patient-reported outcomes platform for immunological research, which is moving from New York City. In Richmond, VA, Phlow won up to $812 million over 10 years from the Biomedical Advanced Research and Development Authority (BARDA) in May toward manufacturing generic COVID-19 therapeutics. BHCR companies racked up more than $5.8 billion in awards from BARDA toward COVID-19 vaccines and drugs.Ceres Nanosciences of Manassas, VA, plans to add 50 jobs by increasing its manufacturing capacity for COVID-19 testing, Virginia Gov. Ralph Northam said March 3. Gene therapy developer Vigene Biosciences said it will more than triple its 125-person staff by adding 245 employees as it doubles its manufacturing footprint in Rockville, MD, where the company last year opened its HQ, R&D, and manufacturing sites.

BHCR is 60% toward its goal of becoming a top-three cluster by 2023. The region is already third in NIH funding (4,051 awards totaling just over $3 billion), patents (6,015) and lab space (29.7 million square feet, according to JLL)—with almost 3 million new square feet under development or planned. The region places sixth in jobs (74,542 as of March, according to JLL), and seventh in venture capital ($1.677 billion, according to Crunchbase, GlobalData, and JLL).

Click here to read more via Gen.

Dr. Dipanjan Pan and Phil Robilotto of the University of Maryland, Baltimore, join Rich Bendis on BioTalk

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Dr. Dipanjan Pan and Phil Robilotto of the University of Maryland, Baltimore, join BioTalk to discuss RNA Disease Diagnostics, UM Ventures, and the commercialization of new medical technologies

Listen via Apple http://apple.co/3bsUsda, Google http://bit.ly/38l26Vd , Spotify http://spoti.fi/38kp9zu, and TuneIN http://bit.ly/2MVFqDp.

 

Prof. Dipanjan Pan, MS, Ph.D., is an expert in nanomedicine, molecular imaging, drug delivery, and biosensing. He is presently a tenured Full Professor in Diagnostic Radiology & Nuclear Medicine, Pediatrics and Chemical, Biochemical and Environmental Engineering at the University of Maryland Baltimore School of Medicine and University of Maryland Baltimore County. Prior to moving to Maryland, he was a tenured Associate Professor and Associate Head of the department in Bioengineering and Materials Science and Engineering and Institute of Sustainability in Energy and Environment at the University of Illinois, Urbana-Champaign. He administratively directs the Nanofabrication and Characterization Core at CBOTH and a Director for the Investigational Probe Design Resources in Radiology.

He serves as study section review board member for NIH, CDMRP (DoD), NSF, and multiple review committee member for American Heart Association. In 2016 he received Nanomaterials Letter (NML) Researcher award, in 2017 a Young Innovator Award from Biomedical Engineering Society (BMES), and a Deans Award for Research Excellence in 2018. He is an elected fellow of the Royal Society of Chemistry, a Fellow of the American Heart Association, and an elected fellow of the American College of Cardiology. Professor Pan is an Associate Editor for WIRES Nanomedicine and Nanobiotechnology (Wiley) and an editorial advisory board member of Molecular Pharmaceutics (ACS).

Phil Robilotto, DO, MBA, is director of the technology development and commercialization program, University of Maryland (UM) Ventures, at the University of Maryland, Baltimore (UMB). Since joining UMB In 2012, Dr. Robilotto has grown UMB’s intellectual property, and licensing efforts, launched a new business venture initiative, and started an early-stage investment program that supports UMB start-ups.

Dr. Robilotto has over 20 years of clinical practice and pharmaceutical/biotechnology strategic planning and business development experience, most recently with Celera and DuPont Pharmaceuticals. He has led valuation and planning efforts for technology platforms and clinical-stage products and has successfully developed, negotiated, and executed collaborations across a broad range of life science-based technologies with a variety of commercial partners.

Dr. Robilotto is a licensed physician in the state of Maryland and received his DO from the Chicago College of Osteopathic Medicine. He also holds a BS in Biology from the College of William and Mary and an MBA from Duke University.

Click here to read the transcript.

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