Monthly Archives

March 2021

Maryland Biotech IES Life Sciences Developing Test to Detect How Severe a COVID Case Could Become

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IES Life Sciences is currently applying for an Emergency Use Authorization for the test from the FDA.

MARYLAND, USA — A Maryland biotech company is hoping to help doctors save lives by developing a new test that would indicate how severe a COVID case could become.

IES Life Science has partnered with the University of Maryland to develop the patented test, which will be administered via nasal swabs, like the majority of the standard COVID tests, once a patient has tested positive.

When the pandemic hit in February, IES Life Sciences pivoted the cancer detection technology it had been working on to measure the immune response to COVID-19 in patients. With that knowledge, they said physicians should be able to better focus their resources on the patients who need them most.

Director of Research and Development, Dr. Robert Figliozzi, said so far the team has tested a few hundred samples to measure the success of their technology. They’re working to procure thousands more.

“We’re looking at individuals’ … total immune health, and how they’re responding to this infection,” Dr. Figliozzi said. “And we’re grouping them into little groups. And different groups have different severity levels.”

Click here to read more via WUSA9

BioBuzz: BioHealth Capital Region Passes San Francisco in NIH funding

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The National Institutes of Health provides significant funding for drug development research to universities, companies, and organizations. Over the course of 2020, the NIH provided a significant amount of funding to the BioHealth Capital Region.

The top recipients of NIH funding in the BHCR were research universities, with Johns Hopkins University topping the list with $807,432,003 in financing for different research programs. The top 10 recipients of NIH funding in the BioHealth Capital Region secured more than $2.18 billion in financing. Life sciences organizations within the state of Maryland secured $2.3 billion in NIH funding, an increase from the $1.9 billion granted in 2019.

Since the year 2000 when life sciences companies within Maryland received $863 million, the state has seen significant growth in NIH funding, with Johns Hopkins alone surpassing that this year. In fact, the BHCR surpassed California’s Bay Area in NIH funding. Organizations across that important biotech region garnered $1.83 billion in NIH grant monies.

Click here to read more via BioBuzz.

BioBuzz: The BioHealth Capital Region, Epicenter of U.S. Regulatory Infrastructure

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As one of the world’s top bio hubs, the BioHealth Capital Region (BHCR) is rife with life science assets.

The region has been at the forefront of the SARS-CoV-2 vaccine race, and it is rapidly becoming a center for advanced manufacturing. The BHCR cell and gene therapy ecosystem is thriving, and the area boasts one of the richest and most diverse tapestries of life science talent and workforce development programming. What’s more, Maryland, Washington, DC, and Virginia are home to several dynamic university systems that keep the talent and tech transfer pipeline humming and full.

That said, one major BHCR asset tends to fly under the radar, yet just might be the source from which all else flows—the region’s expansive regulatory ecosystem.

The BHCR is home to a wide array of government and private sector regulatory organizations, including but not limited to the National Institutes of Health (NIH), the National Institute of Standards and Technology (NIST), the U.S. Food and Drug Administration (FDA), U.S. Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA), and private-sector regulatory stalwarts like United States Pharmacopeia (USP).

These critical regulatory bodies, and the non-dilutive funding some can provide to promising companies, have acted as a magnet, drawing (and keeping) scores of entrepreneurs, international companies, established biopharma organizations, and emerging life science entities to the region.

Indeed, COVID-19 has temporarily disrupted the value of proximity, as companies in all sectors were forced to transition to nearly 100% remote work environments. However, as more vaccinations get into arms and the pandemic recedes, the intrinsic value of proximity and access will recover. That’s not to say the 9 to 5 in the office, road warriors of the I-270 corridor will return full force; remote work is here to stay. But the importance of face-to-face interactions and connecting in person at lunch or via conferences will eventually return. That is to say that the BHCR’s robust regulatory ecosystem will continue to be a significant biopharma industry asset even in the COVID-19 new normal.

Click here to read more via BioBuzz.

GSK to support manufacture of Novavax’ COVID-19 vaccine

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LONDON and GAITHERSBURG, Md., March 29, 2021 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, GSK and the UK Government Vaccines Taskforce announced that they have reached an agreement in principle to support manufacturing of up to 60 million doses of Novavax’ COVID-19 vaccine candidate (NVX-CoV2373) for use in the UK. GSK will provide ‘fill and finish’ manufacturing capacity at its Barnard Castle facility in the North East of England beginning as early as May 2021, with a rapid technology transfer between the two companies beginning immediately. GSK and Novavax will negotiate a final agreement to include additional terms and conditions.

The UK Government has secured 60 million doses of the vaccine under an advance purchase agreement with Novavax. The protein antigen component of NVX-CoV2373 is also produced in the North East of England by Novavax’ manufacturing partner, FUJIFILM Diosynth Biotechnologies, at their site in Billingham, Stockton-on-Tees.

Fill and finish, to be provided by GSK, is the completion stage of vaccine manufacturing, preparing vials of the final vaccine and packaging them for distribution and use. The GSK site at Barnard Castle, which will deliver the vaccine doses under this collaboration, is a specialised facility in GSK’s global manufacturing network, which supports production of GSK pharmaceutical and vaccine products.

Roger Connor, President, GSK vaccines, said: “GSK is delighted to support Novavax and the UK Vaccines Taskforce with this manufacturing arrangement for the UK and our Barnard Castle facility is now undertaking the rapid preparation work required to manufacture up to 60m doses of this vaccine. We have ensured that we can deliver these volumes without impacting supply of our other vital medicines and vaccines, and without disruption to the other COVID-19 collaborations GSK is engaged in globally.”

“This partnership with GSK continues the expansion of our global supply network, which we expect to increase overall production capacity and, if approved by regulatory agencies, support access to a potentially important new vaccine against COVID-19,” said Rick Crowley, Executive Vice President and Chief Operations Officer, Novavax. “We thank the UK government’s Vaccine Taskforce for its instrumental role in ensuring the progress of our COVID-19 vaccine, from both a clinical and now manufacturing perspective, as well as GSK for making their facilities available to help fight the pandemic.”

Prime Minister Boris Johnson said: “I’m delighted by GSK’s investment, which shows the strength of UK manufacturing, and will further boost our vaccine rollout. The Vaccines Taskforce has worked hand in glove with business to successfully deliver vaccines to the whole of the UK, and this agreement will continue to support our approach. We remain on track to offer a first jab to all over 50s by 15 April, and all adults by the end of July, and I want to once again encourage everyone to come forward for a vaccine when you’re called.”

Health and Social Care Secretary Matt Hancock said: “We’ve all seen just how important onshore vaccine manufacturing capabilities are, and this fantastic deal will ensure more of these vital products can be produced here in the UK. The UK’s vaccination programme has been a national success, with over 30 million people now having received a first dose of a COVID-19 vaccine. Should the Novavax vaccine meet our medicines regulator’s high standards of safety and effectiveness, the agreement reached today will boost these efforts over the coming months.”

The Novavax vaccine candidate has demonstrated strong potential efficacy in Phase 3 clinical trials, including against the B.1.1.7 variant circulating in the UK. Submission of the vaccine for review by regulatory authorities in the UK is expected during the second quarter.

GSK commitment to tackling COVID-19
GSK’s response to COVID-19 has been one of the broadest in the industry, with two potential treatments in addition to our vaccine candidates in development.

GSK is collaborating with several organisations around the world on COVID-19 vaccines by providing access to our adjuvant technology. Our collaboration with Canada’s Medicago, combining our pandemic adjuvant with its plant-derived vaccine candidate is in Phase 3 clinical trials, and a collaboration with French company Sanofi on an adjuvanted, protein-based vaccine candidate is in Phase 2. An earlier stage collaboration with SK Bioscience of South Korea, with funding from CEPI and the Bill and Melinda Gates Foundation, aims to develop differentiated, affordable COVID-19 vaccines for supply globally through the COVAX facility. The use of an adjuvant can be of particular importance in a pandemic since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and contributing to protecting more people.

GSK is working with German mRNA specialist, CureVac, to jointly develop next generation, multi-valent mRNA vaccines for COVID-19 with the potential to address multiple emerging variants in one vaccine. GSK will also support manufacturing of up to 100m doses of CureVac’s first generation COVID-19 vaccine at our facilities in Belgium.

GSK is also exploring potential therapeutic or treatment options for COVID-19 patients. We are collaborating with Vir Biotechnology to develop existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options for COVID-19. We recently reported that an Independent Data Monitoring Committee recommended that the Phase 3 COMET-ICE trial evaluating VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation be stopped for enrolment due to evidence of profound efficacy, based on an interim analysis of data from the trial. We are now seeking Emergency Use Authorization in the US and authorisations in other countries. We are also assessing whether an investigational monoclonal antibody, otilimab, can help severely ill COVID-19 patients aged over 70 who experience an overreaction of their immune system.

About GSK
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit

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 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, 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.

GSK Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company’s Annual Report on Form 20-F for 2020 and any impacts of the COVID-19 pandemic.

Novavax enquires:

Investor enquiries:
Novavax, Inc.
Erika Schultz | 240-268-2022

Solebury Trout
Jennifer Porcelli | 617-974-8659

Media enquiries:
Amy Speak | 617-420-2461
Laura Keenan | 410-419-5755

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


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

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

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 

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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:


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.


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 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


Hayoung Lee
+82 31 709 5858

Carolyn Noyes
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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.”

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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.

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

  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”

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,

SOURCE VLP Therapeutics, Inc.

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