APEIRON Biologics Experts in cancer immunotherapy and respiratory treatments

VIENNA, AUSTRIA and GAITHERSBURG, MD, July 8, 2020 APEIRON Biologics AG (“APEIRON”), a private biotechnology company specializing in the discovery, development and commercialization of novel immunotherapies for cancer and respiratory diseases, and MaxCyte, Inc., a global cell-based therapies and life sciences company, today announces the signing of a clinical and commercial licensing agreement.

APEIRON Biologics will obtain non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform for the advancement of APN401, a siRNA-based cell therapy currently in clinical development for various solid tumors. In return, MaxCyte will receive undisclosed development and approval milestones and sales-based payments in addition to other licensing fees.

 

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NEW YORK and GAITHERSBURG, Md. and NEW ORLEANS and LAFAYETTE, La., July 08, 2020 (GLOBE NEWSWIRE) -- The Mount Sinai Health System, Emergent BioSolutions (NYSE: EBS), and ImmunoTek Bio Centers today announced that they will collaborate to develop, manufacture, and conduct clinical trials to evaluate Emergent’s COVID-19 hyperimmune globulin product, COVID-HIG, including a post-exposure prophylaxis (PEP) study on health care providers at high risk of COVID-19 infection and other high-risk populations, with $34.6 million in funding from the U.S. Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND).

 

GSK

GSK and Medicago today announced a collaboration to develop and evaluate a COVID-19 candidate vaccine combining Medicago’s recombinant Coronavirus Virus-Like Particles (CoVLP) with GSK’s pandemic adjuvant system. CoVLPs mimic the structure of the virus responsible for COVID-19 disease, allowing them to be recognised by the immune system. Use of an adjuvant can be of particular importance in a pandemic situation as it may boost the immune response and reduce the amount of antigen required per dose, allowing more vaccine doses to be produced and therefore contributing to protect more people.

 

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WASHINGTON, June 29, 2020 /PRNewswire/ -- Ten finalists have been named in the prestigious annual "Make Your Medical Device Pitch for Kids!" competition presented by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI). Representing innovations in cardiovascular, orthopaedic and spine, and neonatal intensive care unit (NICU) medical devices, finalists were selected from a field of 30 semi-finalists who competed in March 2020.  The ten innovators now have access to a new pediatric accelerator program and will compete for FDA-funded grants of up to $50,000 each in the final virtual pitch event on Oct. 7 as part of the 8th Annual Symposium on Pediatric Device Innovation, co-located with the MedTech Conference, powered by AdvaMed.

 

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Gentian Diagnostics AS is pleased to announce that the Research Council of Norway (Norges Forskningsråd) has awarded Gentian up to NOK 8.0 million of funding to support the development of a high-throughput COVID-19 antibody test. Gentian has in cooperation with Professor Ørjan Olsvik and Dr. Vegard Skogen at the University of Tromsø, The Arctic University of Norway performed explorative test work that supports an idea of developing a COVID-19 antibody test based on Gentian’s proprietary technology. The assay, if successfully developed, will be designed for use on clinical analysers already available in major laboratories around the world.

 

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Inner Harbor-based biotech company PathSensors will be acquired by global security screening and threat detection company Smiths Detection, the companies announced this week.

With the deal, PathSensors will become part of a London-based company with 2,200 employees and a U.S. headquarters in Edgewood.

Image: PathSensors is headquartered at Columbus Center. (Photo by Wikimedia Commons user Smash the Iron Cage, used under Creative Commons license)

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GAITHERSBURG, Md., July 06, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced a five-year manufacturing services agreement with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, for large-scale drug substance manufacturing for Johnson & Johnson’s investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant based on the AdVac® technology. Emergent will provide contract development and manufacturing (CDMO) services to produce drug substance at large scale over five years, valued at approximately $480 million for the first two years.

 

Fueling an innovation ecosystem

BHI's own Rich Bendis will Moderate.

Join us for a lively discussion between our region’s top innovators and connectors to hear about their efforts to help grow the innovation ecosystem and the pipeline of successful startups across the BioHealth Capital Region.

On this webinar, you will learn how you can take advantage of the many resources available throughout the region that will help your company go to market AND increase the opportunity to find success in the process.

Fueling an Innovation Ecosystem for Startups to Thrive

Click here for more information and to register.

 
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In a recent conversation someone shared the quote “You can’t throw a stone in the BioHealth Capital Region and not hit somebody who worked at MedImmune”. This statement emphasizes how important the company was in seeding the growth of the biotech industry in Maryland. Founded by Wayne T. Hockmeyer in 1988 as Molecular Vaccines, Inc., MedImmune became one of the cornerstone Biotech companies in what eventually was named the BioHealth Capital Region.

 

Novavax hires new manufacturing chief to take COVID 19 flu vaccine hopefuls across the finish line FiercePharma

With its COVID-19 vaccine hopeful cycling through clinical trials, shot maker Novavax is working to flesh out its executive team to help lead the company to the commercial stage. But you can't get regulatory approval without a sturdy manufacturing operation—and now Novavax has hired an exec to get that operation in order.

Novavax tapped Ben Machielse as its executive vice president of chemistry, manufacturing and controls (CMC) as the vaccine maker works to take its COVID-19 and four-strain flu hopefuls across the finish line, the company said Monday.

Image: Novavax's newest manufacturing head will join newly hired Chief Medical Officer Filip Dubovsky. (Novavax) 

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VENLO, The Netherlands--(BUSINESS WIRE)--QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced that its shareholders today approved all agenda items at the Company’s Annual General Meeting related to the proposed voluntary public takeover offer for the acquisition of all ordinary shares in QIAGEN by Quebec B.V., a wholly-owned subsidiary of Thermo Fisher Scientific Inc. (NYSE: TMO) for EUR 39 per share in cash (the “Offer”).

 

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BALTIMORE--(BUSINESS WIRE)--Protaryx™ Medical, a company committed to reimagining access to the left atrium for transcatheter cardiac procedures, today announced that it has raised $8.3 million in funding to develop the company’s first-in-class device for precision transseptal access to the left atrium during structural heart and catheter ablation procedures. The company’s funding includes non-dilutive grants and a seed round totaling $3.2 million and the recently closed $5.1M Series A financing led by Ajax Health, with participation from University of Maryland (UM) Ventures, a returning investor.

 

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ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms and Ichor Medical Systems (“Ichor”), a privately held biotech company based in San Diego, CA, announced today that the companies have entered into a license agreement to support the development of ITI’s investigational plasmid DNA vaccine therapy, ITI-1001.

ITI will leverage Ichor’s TriGrid® Electroporation technology to increase cellular uptake of ITI-1001 when administered to patients with newly diagnosed Glioblastoma, or GBM. DNA vaccines delivered by conventional injection have experienced challenges to delivery efficiency, resulting in suboptimal immune responses in clinical trials. Ichor’s TriGrid technology utilizes the application of electrical fields in a target tissue to increase intracellular nucleic acid uptake in the local area, resulting in enhanced gene expression.

 

Avantor® Avantor

RADNOR, Pa., June 30, 2020 /PRNewswire/ -- Avantor, Inc. (NYSE: AVTR), a leading global provider of mission-critical products and services to customers in the life sciences, advanced technologies and applied materials industries, today announced the expansion of the company's Bridgewater, N.J. (USA) innovation center. Located close to biotech companies, the site now has nearly double the laboratory and support space.

Bioprocessing efficiency that doesn't compromise quality continues to be a top priority for the biopharma industry. At the same time, it's critical to meet increasingly stringent global regulatory standards.

 

Alexandria LaunchLabs

PASADENA, Calif. and DURHAM, N.C., June 30, 2020 /PRNewswire/ -- Alexandria Real Estate Equities, Inc. (NYSE: ARE), an urban office REIT and the first, longest-tenured and pioneering owner, operator and developer uniquely focused on collaborative life science, technology and agtech campuses in AAA innovation cluster locations, today announced the winner of its inaugural $100,000 AgTech Innovation Prize that called on innovators with demonstrated novel approaches to agriculture-, food- and nutrition-related challenges, which are key to advancing human health. The prize was awarded to TerMir Inc., a North Carolina–based agtech company pioneering an innovative and environmentally safe treatment for citrus greening disease—one of the most devastating citrus diseases in the world. Citrus greening disease has resulted in a drop in citrus production and harvesting while driving up costs and job losses. In response to this presently incurable agricultural, environmental and economic challenge, TerMir has developed a cutting-edge and effective solution for breaking the greening cycle with the potential to eradicate the disease.

 

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Across Maryland and the BioHealth Capital Region (BHCR), state-level support for veteran-owned and operated life science businesses is strong. 

This is evidenced by the rich and diverse tapestry of veteran led life science organizations in the region that spans a number of disciplines, including genomics, regenerative medicine, lab equipment and support, testing and biorisk management services.

Here are BHCR veteran-owned life science companies to keep an eye on as we move deeper into 2020. 

Image: https://biobuzz.io

Five BioHealth Capital Region Companies Make List of Largest COVID 19 Government Contracts BioBuzz

At BioBuzz, we’ve been chronicling the BioHealth Capital Region’s contributions to the battle against the coronavirus pandemic. We’ve covered BHCR companies developing vaccine candidates and creating diagnostic and serological COVID-19; we’ve also written about companies across the region that have delivered essential materials for the fight against COVID-19 and pivoted their business models to help the region navigate this public health crises.  

Image: https://biobuzz.io

The Life Sciences Report Summer 2020 Wilson Sonsini Goodrich Rosati JDSupra

The latest issue of The Life Sciences Report features an interview with Matthew J. Meyer, the firm's chief client corporate development officer, who has broad management experience in the life sciences sector; a piece authored by Paul Grand and Kathryn Zavala of MedTech Innovator outlining 10 reasons why health care start-ups fail; an interview with Ryan Phelan, co-founder and executive director of Revive & Restore, a 501(c)(3) foundation using 21st century biotechnology to address urgent conservation challenges; and an article by Paul P. Campbell of W. L. Gore & Associates on life sciences innovation culture and deconstruction. In addition, the publication includes articles covering life sciences venture financings in which firm clients participated during 2019, the FDA's recent issuance of a MAPP on the conversion of ANDA approval to tentative approval, and a sampling of COVID-19-related client activity in which the firm has been involved, as well as a summary of other select recent life sciences client highlights.

Image: https://www.jdsupra.com

artificial Intelligence

Paul Rothman, MD, CEO of Baltimore-based Johns Hopkins Medicine and dean of the medical faculty at Johns Hopkins University, discussed the health system's COVID-19 data platform and the potential for artificial intelligence to make a difference in how health systems approach treatment in the future in an interview with The Media Line.

Since the pandemic began, Johns Hopkins has gathered COVID-19 data and reported it on a public dashboard for cases and deaths in the U.S. and across the world. Dr. Rothman said the health system is using artificial intelligence and machine learning in its platform and aims to collaborate with others to incorporate data in the future.

 

Crop man putting medical mask on face of ethnic child Free Stock Photo

Families often turn to dietary supplements inspired by nature with ingredients such as Elderberry, Vitamin C, and Zinc with the aim to help safely support their immune systems. A heightened awareness for the need to support your immune system throughout the year has resulted in an increased demand for products with immune-supporting and wholesome ingredients.*

To that end, we’re launching the Next in Naturals QuickFire Challenge on Immune-Support, calling on innovators to submit potential solutions inspired by nature that aim to support healthy immune systems in babies, children, or adults.

The innovator(s) with the best idea(s) will receive up to $50,000 in grant funding, one year of residency at an available JLABS, and the opportunity to engage with leadership from Johnson & Johnson Innovation.

 

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Welcome to GEN’s COVID-19 DRUG & VACCINE CANDIDATE TRACKER website.

Total Drug & Vaccine Candidates: 237 (as of June 8)

The goal of this resource is to provide a comprehensive collection of news, milestones, and updates on drug and vaccine candidates currently being developed for the COVID-19 pandemic.

This resource is based on the reporting of GEN senior news editor Alex Philippidis, who began compiling information on drug and vaccine candidates in the early weeks of the pandemic. The numbers of verified candidates ballooned rapidly from 35 in February 2020, to 60 in March, to 160 in April.

 

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Across the country today, not just in Boston and San Francisco, in leading and emerging life science clusters, life sciences institutions and innovative companies are working on cell and gene therapies, corona virus vaccines and drugs, and new bioengineering technologies that have the potential to change the way we feed, fuel and heal the world.

 

Jason Mast Endpoints News

Four more US biotechs filed to go pub lic Fri day as yet more com pa nies clam ber to get through a yawn ing IPO win dow and on to a mar ket that’s sig naled its will ing ness to re ward near ly any new drug mak er.

The new en trants are led by ALX On col o gy and the bi o log i cal an a lyt ics biotech Berke ley Lights, each of whom filed to raise $100 mil lion. The au toim mune com pa ny Pan dion Ther a peu tics al so filed for $75 mil lion, and Kiromic Bio phar ma, a tiny im muno-on col o gy start up based in San An to nio, filed for $25 mil lion.

 

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Emergent BioSolutions (NYSE:EBS) has closed a five-year agreement with Johnson & Johnson (NYSE:JNJ) unit Janssen Pharmaceuticals for large-scale drug substance manufacturing for J&J's SARS-CoV-2 vaccine, Ad26.COV2-S.

EBS will provide contract development and manufacturing services over the contract term valued at ~$480M for the first two years. Volume manufacturing will start in 2021 at its Baltimore Bayview facility subsequent to technology transfer.

The company will release updated 2020 guidance when it reports Q2 results.

JNJ is up 2% premarket and EBS up 1%, both on light volume.

 

AlexandRich

Alex Philippidis joins Rich Bendis on BioTalk to discuss the BioHealth Capital Region from a National viewpoint, other Hubs, and how the industry has adapted in the age of COVID-19.

Alex specializes in biopharma business news and industry issues for GEN. He joined GEN in 2011 after four years at GenomeWeb, where he covered research institutes and spent three years following biotech economic development as editor of the weekly newsletter BioRegion News. Alex reports a variety of news stories for GEN and Clinical OMICs and compiles the popular A-Lists series.

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Novavax Inc. plans to advance its Covid-19 vaccine candidate with new additions to the company and about $200 million in new funds from selling convertible preferred stock — the latest cash infusion for the Gaithersburg vaccine maker.

The preferred private placement with a Boston-based RA Capital Management investment fund, in a deal that closed June 16, came fewer than two weeks after Novavax (NASDAQ: NVAX) won a Department of Defense contract worth up to $60 million to help manufacture its coronavirus vaccine candidate. It also builds upon $388 million Novavax landed from the Norway-based Coalition for Epidemic Preparedness Innovations for the same program. And it follows the company’s preparations to sell up to $250 million in common stock, a move that sent its stock soaring toward the end of May.

 

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GAITHERSBURG, Md., June 29, 2020 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced it was awarded $4.7 million from the U.S. Army Medical Research & Development Command (USAMRDC) to fund its Phase 1/2 clinical trial of T-COVID, an investigational intranasal immune modulator for the treatment of outpatients with early COVID-19. The competitive award was granted by USAMRDC in collaboration with the Medical Technology Enterprise Consortium (MTEC), a 501(c)(3) biomedical technology consortium working in partnership with the Department of Defense (DoD). The award is expected to provide Altimmune sufficient funding to cover the entire cost of conducting this clinical trial.

 

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BALTIMORE, MD, June 24, 2020 – AsclepiX Therapeutics, Inc., a biopharmaceutical company that uses computational biology to identify potent peptide regulators of vascular homeostasis for the treatment of retinal and other important diseases, today announced that it has closed a $35 million Series A financing led by Perceptive Xontogeny Venture Fund (“PXV Fund”) with participation from the Perceptive Life Sciences Fund, both funds managed by Perceptive Advisors, and existing investors Rapha Capital Management and Barer & Son Capital.

 

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In response to medical data highlighting the serious impact of COVID-19 on children’s health, Children's National is partnering with the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) on a special pitch competition focused on COVID-19 related pediatric medical devices. “Make your Medical Device Pitch for Kids! - COVID-19 edition” is seeking devices that support home health monitoring and telehealth and improve sustainability, resiliency, and readiness in diagnosing and treating children during a pandemic.

Image: https://www.todaysmedicaldevelopments.com

HemoShear Therapeutics Receives FDA Clearance of IND for Phase 2 Study of its Investigational Drug HST5040 for the Treatment of Methylmalonic Acidemia and Propionic Acidemia BioHealth Capital Region

Charlottesville, Va., June 24, 2020 –  HemoShear Therapeutics, a clinical stage company developing treatments for rare metabolic disorders, has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to conduct a phase 2 clinical trial of HST5040, an oral small molecule drug for the treatment of patients with methylmalonic acidemia (MMA) and propionic acidemia (PA).  MMA and PA are rare genetic disorders caused by the deficiency of certain enzymes required to metabolize amino acids. The diseases result in the rapid buildup of life-threatening metabolites that can lead to severe organ damage, seizures, developmental deficits, and premature death. 

 

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GAITHERSBURG, Md., June 29, 2020 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced it was awarded $4.7 million from the U.S. Army Medical Research & Development Command (USAMRDC) to fund its Phase 1/2 clinical trial of T-COVID, an investigational intranasal immune modulator for the treatment of outpatients with early COVID-19. The competitive award was granted by USAMRDC in collaboration with the Medical Technology Enterprise Consortium (MTEC), a 501(c)(3) biomedical technology consortium working in partnership with the Department of Defense (DoD). The award is expected to provide Altimmune sufficient funding to cover the entire cost of conducting this clinical trial.