416th Edition – July 28, 2020

BioFactura, Inc. Co-Founder, President & CEO, Darryl Sampey, PH.D., joins BioTalk to discuss his background with the University of Maryland, the BioHealth Capital Region, and the creation of his company in Frederick.

Listen now via Google https://bit.ly/3hz2jpU, Apple https://apple.co/3eYLiUs, Spotify https://spoti.fi/3f3cqBU, TuneIn https://bit.ly/302voUG, and YouTube (Audio Only) https://bit.ly/3f3cQZ0

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GAITHERSBURG, Md., July 27, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has signed an agreement to provide contract development and manufacturing (CDMO) services for large-scale commercial drug substance manufacturing for AstraZeneca’s COVID-19 vaccine candidate, AZD1222. The agreement is valued at approximately $174 million through 2021 and follows an $87 million contract in June for development services, performance and process qualification, raw materials and an initial capacity reservation.

“Emergent is driven by our desire to advance solutions that will make an impact on this pandemic,” said Robert G. Kramer Sr., president and chief executive officer of Emergent BioSolutions. “Sharing a passion for science, we are encouraged by AstraZeneca’s investigational COVID-19 vaccine and look forward to supporting its continued progress.”

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GAITHERSBURG, Md. and MORRISVILLE, N.C., July 23, 2020 /PRNewswire/ — Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, and FUJIFILM Diosynth Biotechnologies (FDB), a world leading contract development and manufacturing organization (CDMO) for biologics, viral vaccines and gene therapies, announced today an agreement to manufacture bulk drug substance for NVX-CoV2373, Novavax’ COVID-19 vaccine candidate. FDB’s site in Morrisville, North Carolina has begun production of the first batch of NVX-CoV2373.

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GAITHERSBURG, Md., July 22, 2020 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the Company has entered into an agreement with Vigene Biosciences (“Vigene”) to manufacture AdCOVIDTM, Altimmune’s single-dose intranasal vaccine candidate for COVID-19. Vigene, a Rockville, Maryland-based award-winning Contract Development and Manufacturing Organization (CDMO), specializes in viral vectors and will deploy its capabilities to manufacture AdCOVID. Following recent positive pre-clinical data, Altimmune plans to start a Phase 1 clinical trial of AdCOVID in Q4 2020.

“Vigene is a fantastic partner to advance AdCOVID into Phase 1 clinical testing and beyond,” said Dr. Vipin K. Garg, President and CEO of Altimmune. Dr. Garg continued, “We believe Vigene’s deep experience in viral vector production and their collaborative, client focused approach will help facilitate Altimmune’s timeline for clinical development of AdCOVID.”

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TEDCO, Maryland’s state-backed agency that supports early-stage tech companies, has named Troy LeMaile-Stovall as its next CEO.

Lemaile-Stovall, who is currently COO of the University of the District of Columbia (UDC) and leads a management consulting firm, will start in the role on Sept. 7. He was introduced at a virtual press conference on Wednesday, where he spoke about leadership in a time that includes a pandemic, economic downturn and a nationwide push for racial justice. While we’re still in the midst of what could be long-term shifts taking place, he said he was “excited about how we move from economic development to economic empowerment for all of the citizens of Maryland.”

Image: Troy Lemaile-Stovall will begin as CEO of TEDCO in September. (Courtesy photo)

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ROCKVILLE, Md. and BEIJING, July 21, 2020 /PRNewswire/ — CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today announced that it has commenced an underwritten public offering, subject to market and other conditions, to issue and sell shares of its common stock. In connection with the offering, CASI expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. There can be no assurances as to whether or when the offering may be completed, or as to the actual size or terms of the offering. All of the shares of common stock in the offering will be sold by CASI.

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Manassas, VA – On June 17, 2020, Serpin Pharma was notified by the U.S. Food and Drug Administration (FDA) that it may proceed with its proposed clinical investigation for the use of SP16 to treat COVID-19 hospitalized patients. The Principal Investigator is Serpin Pharma’s collaborator,

Dr. Michael Yun Shim, John L. Guerrant Assoc. Professor of Medicine and Medical Imaging, Div. of Pulmonary & Critical Care of the University of Virginia. Dr. Larry Altstiel, acting Chief Medical Officer for Serpin Pharma, said, “SP16 is a potent new antiinflammatory drug rather than a non-specific, toxic immunosuppressive drug. SP16 reduces the production of inflammatory cytokines (e.g., IL-1β, TNF-α, IL-6) while sparing normal and protective immune function. It is effective in several animal models of acute inflammation, in particular, following a severe lung infection. Therefore, SP16, by its ability to inhibit excess cytokine production, may attenuate the development of inflammation-induced lung injury in individuals with COVID-19 infection.”

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This invitation-only event is free for executive level biotech leaders and is presented by BioHealth Innovation, Virginia Bio, Children’s National Health System, Johns Hopkins University, JPMorgan, Maryland Department of Commerce, George Mason University, University System of Maryland, Wilson Sonsini Goodrich & Rosati and AstraZeneca.

The BioHealth Capital Region—Maryland, Virginia, and Washington, DC—sets the bar high for biotech innovation. So please join us for our 6th Annual BioHealth Capital Region Forum that will highlight the accomplishments of today and chart our successes of tomorrow.

For more information about our speakers and event schedule, please visit www.biohealthcapital.com/forum-2020

#BHCRForum20

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Emergent BioSolutions (NYSE:EBS) has signed an agreement with AstraZeneca (NYSE:AZN) to provide contract development and manufacturing (CDMO) services for large-scale drug substance manufacturing for AZN’s COVID-19 vaccine candidate, AZD1222.

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Driven entrepreneurs and savvy startup leaders participated in the recent “Fueling an Innovation Ecosystem for Startups to Thrive” webinar that featured prominent connectors and innovators from the BioHealth Capital Region (BHCR). The virtual event was sponsored by WorkForce Genetics and covered a wide range of topics including the pandemic, critical regional resources for startups, advice for approaching investors and a list of the biggest mistakes made by entrepreneurs when seeking funding.

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Excited to announce that TruGenomix just won Start Up of the Year Pitch Event. Great pitch Charles Cathlin !!!!! #SDVOB #ptsd #TruGenomix #veteranshelpingveterans

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SIOUX FALLS, S.D., July 23, 2020 /PRNewswire/ — Sanford Health, the largest provider of rural healthcare in the country, today announced an $800,000 investment in TruGenomix, a veteran-owned precision behavioral health company.

As part of the strategic partnership, Sanford Health will support TruGenomix by providing its state-of-the-art lab and research capabilities to validate a first-to-market patented blood test for post-traumatic stress disorder (PTSD). The genomic test enables earlier identification and improves outcomes for high-risk populations, including veterans, active-duty service members, frontline health care workers, and first responders.

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ROCKVILLE, Md., July 21, 2020 (GLOBE NEWSWIRE) — Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for rare pediatric and orphan diseases, today announced the first patient has been enrolled in a proof-of-concept trial evaluating the safety and efficacy of the anti-LIGHT monoclonal antibody, CERC-002, in patients with COVID-19 cytokine storm-induced Acute Respiratory Distress Syndrome (ARDS).

The proof-of-concept, randomized, multicenter, double-blind, placebo-controlled trial will enroll approximately 82 subjects hospitalized with COVID-19 ARDS. The primary objective of the study is to demonstrate that treatment with CERC-002 results in fewer instances of respiratory failure and death versus the standard of care. Patients in the CERC-002 arm will receive a single dose of drug and be followed for 28 days. Key secondary endpoints include intensive care unit (ICU) length of stay, hospital length of stay, and oxygen saturation at the end of the study. Top-line data are expected in the fourth quarter of 2020.

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Virologist Andrew Pekosz has a team of 15 people working around the clock in his lab at the Johns Hopkins Bloomberg School of Public Health supporting work on a potential treatment for COVID-19. Pekosz’s lab is testing the blood of coronavirus survivors for plasma antibodies that researchers think might help treat critically ill coronavirus patients.

Image: Nekeshia Maloney, JHTV’s director of contracts

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BALTIMORE, July 23, 2020 /PRNewswire/ — Vita Therapeutics, Inc. announced today that it received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for VTA-110, a novel regenerative therapy for the treatment of Duchenne’s Muscular Dystrophy (DMD).

VTA-110, is a potential first-in-class allogenic iPSC-based therapy that has shown the ability to repair and regenerate healthy muscle in preclinical studies and has the potential to benefit patients with DMD. The company plans to continue to progress this treatment towards clinical trials and plans to bring it forward for other congenital muscular dystrophy diseases as well. This therapy was exclusively licensed from technology originally invented at Johns Hopkins University and the Kennedy Krieger Institute in the labs of Dr. Kathryn Wagner and Dr. Gabsang Lee.

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WASHINGTON – (July 22, 2020) – The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announces eight winners chosen in its special COVID-19 edition of the “Make Your Medical Device Pitch for Kids!” competition. Focused on innovations in COVID-19-related pediatric medical devices that will improve children’s health care, 16 finalists competed on Monday, July 20 in a virtual pitch event for a share of $250,000 in total grant awards.

Image: Judges award grants for pediatric medical devices that address COVID-19-related needs – https://www.openpr.com

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Pascal Soriot isn’t letting the all-consuming R&D and manufacturing work on a Covid-19 vaccine slow down his hunt for AstraZeneca’s next blockbuster cancer drugs.

The latest deal with Daiichi Sankyo consists of $1 billion in upfront cash payment spread over 2 years: $350 million upon completion, and $325 million each at the 12-month and 24-month mark. Regulatory milestones add up to another $1 billion while sales-related fees tot up to $4 billion.

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When it comes to Maryland companies, the pandemic isn’t slowing down venture capital funding.

Data from the latest MoneyTree report by PricewaterhouseCoopers/CB Insights shows that Maryland companies collectively received $358 million in venture capital funding for the second quarter of 2020, marking a big uptick in dollars over the prior quarter even amid a global pandemic and economic downturn.

Image: Looking up in Harbor East. (photo by Wikimedia Commons user Bohemian Baltimore, obtained under a Creative Commons license.)

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“Today, we feel forgotten. Everyone believes we still won. The class of 2024 didn’t win. After calls and emails, we’re met with another unyielding reality: we can’t come to campus.”

These are the words of an open letter circulating among international students of the class of 2024 asking for Hopkins to advocate for them.

Last week, the Trump administration abruptly dropped its plans to ban international students taking online-only courses from residing in the U.S. Given that instruction at Hopkins will go fully online following Thanksgiving break, international students at Hopkins would not have been able to return to campus for any portion of the semester had the rule stayed in place.

Image: CC BY-NC-SA 2.0 Most incoming international students will not be able to enter the United States this fall.

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Since May, the University System of Maryland has said that remote learning and in-person classes will return in the fall. It recently explained why it is sticking with that model.

“Opting for a hybrid model — combining in-person and remote learning — is, by no stretch, an easy out. It doesn’t save us money, it doesn’t save us time, it doesn’t save us planning. It’s a high-cost, high-effort undertaking,” Chancellor Jay A. Perman said in a statement.

However, it is choosing the model because he said there are students who need the campus environment.

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Alexandria LaunchLabs™ in Maryland, will provide fully equipped, affordable laboratory/office space with flexible lease terms, supporting infrastructure, access to amenities, and supporting services and programming through the project’s consortium of world-class partners, including Alexandria Venture Investments, BioHealth Innovation, Montgomery County, and the City of Gaithersburg. This unique, startup environment will accelerate the growth of local early-stage life science companies.

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Vaccitech is a spinout company from the University of Oxford’s Jenner Institute, one of the oldest and most renowned vaccine research centers in the world.

You probably haven’t heard of them, but they are now working alongside AstraZeneca on a COVID-19 vaccine the World Health Organization believes is leading the race in creating an inoculation against SARS-CoV-02.

Data posted this month from just over 1,000 patients in a phase 1/2 trial showed it to be broadly effective in creating an immune response, though many questions remain and a series of bigger, late-stage tests is necessary to find those answers out.

Image: Bill Enright, Vaccitech CEO (Vaccitech)

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Deloitte has launched the Life Sciences Catalyst in Cambridge, a collaborative platform enabling organisations in the biotech, medtech, pharmaceutical and technology sectors, as well as prospective investors, to come together to tackle the biggest challenges facing their industries.

The Life Sciences Catalyst will facilitate connections between people, businesses and investors to support companies with their growth, regardless of their evolutionary stage.

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To limit the spread of Covid-19, the U.S. Centers for Disease Control and Prevention recommends that individuals practice social distancing. When local conditions allow for retail stores to open, they confront a variety of guidelines that vary by state. For example North Carolina places specific limits on the number of customers allowed per square foot, while Oregon generally advises that the number of customers in the store should be limited so that customers can remain six feet apart. Whether or not customers are required by law to wear masks in stores depends on the state. How retailers implement these guidelines also varies among types of retailers and even within store categories. Grocery stores, for example, have adopted a wide variety of specific methods to ensure that customers remain apart.

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D.C. is requiring people making travel into Washington from 27 states to self-quarantine because of new surges in Covid-19 cases.

The order went into effect Monday.

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Today, July 22nd, a virtual summit was hosted by KidneyX to announce the six winners of the Redesign Dialysis Phase 2 prize. The goal of the Redesign Dialysis prize is to provide prize money for novel ideas and innovations that will lead to better outcomes for people with kidney diseases and eventually to a truly artificial kidney. The eventual artificial kidney and innovations made along the way will lead to better outcomes for individuals with kidney diseases and improve their quality of life by bypassing in-center hemodialysis.

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By accepting a scholarship, you are consenting to allow the SHRM Foundation (and the award’s sponsor, if any) to use without limitation, and in any media, your name, city, state, photos, and captions (if uploaded), and verbiage for marketing and promotional purposes.

Employees or board members of SHRM or the SHRM Foundation and members of their immediate family are not eligible to apply for SHRM Foundation grants, awards or scholarships.

The SHRM Foundation does not discriminate against individuals on the basis of race, color, gender, sexual orientation, marital status, religion, disability, age, veteran status, ancestry, national origin or citizenship in the administration of its scholarship programs. Scholarship recipients are selected primarily on merit.

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GAITHERSBURG, Md., July 23, 2020 /PRNewswire/ — Shreis Scalene Therapeutics LLC (SSTx), a MD-USA-based medical device company will fast-track the manufacture and distribution of the CE-marked (EU-Class 1) Scalene Hypercharge Corona Canon (SHYCOCAN) under US FDA ‘Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.”

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