Monthly Archives

November 2021

AB Agri has Partnered with Maryland’s Intralytix, Inc. to Explore the Use of Bacteriophages

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Peterborough, 30 November 2021

  • Gut health could be boosted without reliance on antibiotics and other medicines
  • Bacteriophages are natural and abundant
  • Exploration aligns with AB Agri’s sustainability agenda for food production

AB Agri has partnered with US biotechnology company Intralytix to explore the use of bacteriophages – the natural viruses of bacteria – in animal feed as an alternative to antibiotics and other drugs.

Both companies believe there is potential to use the abundant probiotic microorganisms to intensify natural processes, thereby tackling bacteria and boosting gut health without the need for broad spectrum antibiotic medication.

The new partnership follows AB Agri’s collaborative research project with the University of Leicester earlier this year, which centred around the delivery of bacteriophages in feed for broiler chickens. The study demonstrated a low dose of bacteriophages reduced targeted pathogenic bacteria levels in chickens to below detection limits; a result that could have far-reaching impact in poultry production and food hygiene. This new partnership between AB Agri and Intralytix is initially investigating one animal health pathogen, with the potential to move on to other targets and indications.

Intralytix Founder and CEO, Dr Alexander Sulakvelidze, said: “Bacteriophages have been around for three billion years and are the most ubiquitous organisms on earth. They are the natural enemies of bacteria and can very effectively kill targeted specific bacteria without affecting anything else, ensuring an unprecedented level of safety for an antimicrobial.”

He added: “At Intralytix we are working with several partners to develop bacteriophage-based products to control bacterial pathogens in environmental, food processing, and clinical settings. We are looking forward to working with AB Agri to see which applications we can work on together to benefit animal nutrition and agriculture more widely.”

AB Agri’s Innovation Director, Dr. Nell Masey O’Neill said: “We need to produce our food in a more sustainable way to meet growing demand and higher standards and are very excited about the opportunities ahead.”

“We are at the development stage with the team at Intralytix, researching the efficacy and safety of bacteriophages in animal nutrition. By using naturally occurring bacteriophages we would be building on the existing mode of action in the gut, putting back what should already be present.”

AB Agri is committed to supporting science and innovation as part of its ambition to help responsibly feed the world’s growing population.

About AB Agri

AB Agri manufactures animal feed, nutrition- and technology-based products and offers data services for the agri-food industry. It operates all along the food industry supply chain. It produces and supplies compound animal feed, feed enzymes, specialised feed ingredients and a range of value-added services to farmers, feed and food manufacturers, processors, and retailers. Associated British Foods is a diversified international food, ingredients, and retail group with sales of £13.9bn and 133,000 employees in 53 countries. It has significant businesses in Europe, Africa, the Americas, Asia, and Australia. Its aim is to achieve strong, sustainable leadership positions in markets that offer potential for long-term profitable growth. It looks to achieve this through a combination of growth of existing businesses, acquisition of complementary new businesses and achievement of high levels of operating efficiency.

About Intralytix, Inc.

Intralytix, Inc. is a privately held company headquartered in Columbia, Maryland, USA. The Company is focused on using its core bacteriophage technology platform for developing and commercializing innovative bacteriophage-based products for food safety, animal health, human therapeutics, oral care, cosmetic, and dietary supplements/probiotic applications. Intralytix was founded in 1998 to address growing problems in the control and treatment of disease-causing bacteria. These problems are presently compounded by the overuse of traditional chemical antibiotics and the lack of new potent antibiotics, and the reluctance of the public to employ new and potentially hazardous chemical agents or solutions born of recombinant technology. Presently, Intralytix has the largest in the World portfolio of FDA-approved commercial phage products for food safety applications and is the largest manufacturer of phage preparations under cGMP standards worldwide. For more information, contact Dr. Alexander Sulakvelidze (410-625-2533 or

Media enquiries contact:
Katie Bramwell, Head of Communications

BioHealth Capital Region Spotlight: Creative Bio-Peptides Awarded $5.78 Million from NIH to Develop Breakthrough Treatments for Neuroinflammatory/Neurodegenerative Indications

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Creative Bio-Peptides, Inc., an emerging drug development company focused on the development of leading-edge multi-chemokine antagonist therapeutic peptides for neuroinflammatory/neurodegenerative conditions, has been awarded $5.8M in non-dilutive funding from three NIH agencies.

“BHI congratulates Creative Bio-Peptides on this significant accomplishment and recognition by the National Institutes of health,” said Rich Bendis, President & CEO, BioHealth Innovation. “We are proud of our partnership with Creative Bio-Peptides and how both teams worked together in successfully submitting multiple proposals which were funded in this extremely competitive SBIR process.”

The two grants each represent multi-million-dollar funding over a 2-year period as part of the NIH’s HEAL Initiative, committed to providing safe non-opioid pain treatments for the 50 million Americans living with daily chronic pain as well as the 2 million Americans living with dependency or addiction to opioids.

The National Institute on Drug Abuse (NIDA) SBIR phase II award is for the further development of Creative Bio-Peptides’ oral formulation of chemokine antagonist RAP-103, a safe, non-opioid treatment for OUD that can block motivation to maintain opioid use and mitigate signs of opioid withdrawal, as demonstrated in a previous phase I grant from NIDA.

The National Institute of Neurological Disorders and Stroke award is to develop RAP-103 as a non-opioid treatment for the relief of chronic pain. Pre-clinical data supports evidence that these oral peptides block and reverse neuropathic pain by blocking microglial activation and monocyte infiltration, reversing neuro-inflammation, and repairing nerve damage.

The National Institute on Aging awarded a second research grant to Creative Bio-Peptides for the optimization of a chemokine receptor antagonist peptide as a synapse protecting treatment for neurodegeneration in Alzheimer’s Disease. Creative Bio-Peptides is developing a safe, oral treatment that has the potential to reverse the cognitive decline of this debilitating disease.

Michael Ruff

“We are excited to announce our partnerships with multiple Institutes of the NIH with a goal of pursuing an IND designation for our lead compound, RAP-103, in the first half of 2023”, said Michael Ruff, President/CEO. “Our talented team has worked tirelessly to move us closer to accomplishing our mission of offering life-changing treatments for three significant unmet medical needs: chronic pain, OUD and dementia.  RAP-103’s mechanism of action has the potential to repair and regenerate neurons in neurodegenerative diseases and enable OUD patients to reduce their dependance on deadly opioids. In addition to the hard work of our team, we appreciate the assistance from BioHealth Innovation in preparing the SBIR grant applications through its Federal Funding Assistance program.

About Creative Bio-Peptides. Inc.

Creative Bio-Peptides was founded in 2017 by Michael Ruff, PhD, with the mission of advancing a class of novel multi-chemokine receptor antagonists, therapeutic peptides, into clinical trials to treat debilitating neurological diseases. Creative Bio-Peptides’ portfolio consists of over 25 peptides representing over $75M in total research and development. Most recently, Creative Bio-Peptides’ focus has been on the research and validation of its lead compound, RAP-103. The company is currently conducting IND enabling studies and expects to pursue an IND designation for RAP-103 in the first half of 2023.

About BioHealth Innovation, Inc.

BioHealth Innovation, Inc. (BHI) is a public-private nonprofit organization focused on accelerating biohealth (therapeutic, diagnostic, medtech, and health IT) commercialization in the BioHealth Capital Region (Maryland, DC and Virginia). BHI’s team of expert Entrepreneurs-in-Residence, in-house venture analysts, and other professional staff work in the region to:

  • Facilitate technology commercialization,
  • Raise the profile of the industry cluster and individual organizations,
  • Increase access to capital for early stage and growing companies, and
  • Expand the pool of talent with commercially relevant experience.

BHI’s early stage company support includes market research and commercialization plan development; non-dilutive funding application assistance; a jobs board;  event calendar; and introductions to investors, strategic partners, business advisors, and potential clients. BHI also manages wet lab space and provides referrals to other space for early stage companies, offers soft-landing support for international companies, and works with partners to co-host the annual BioHealth Capital Region Forum and an annual BioHealth Capital Region investor partnering conference. For more information:

# # #

Media Contacts:
Michael Simon
Creative Bio-Peptides, Inc.
Phone: 301-351-2240, email:

Rich Bendis
BioHealth Innovation, Inc.
Phone: 301-637-6439, email:

Montgomery County Hires State House Vet to Coordinate White Flint BioHub Proposal

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Montgomery County failed in its bid lure Amazon, the e-commerce giant that opted to build its second headquarters in Arlington, Va.

But top county officials have an alternate vision for the area surrounding the White Flint Metro station — a “life sciences hub” that exploits the presence of the close-by National Institutes of Health and Food and Drug Administration.

“My goal is to produce a signature project that restates Montgomery County’s case as the leading life sciences center in the country,” said Montgomery County Executive Marc B. Elrich (D) in an interview. “(White Flint) is sitting on the Metro. It’s right down from the Beltway, and there’s a ton of under-developed property there.”

Elrich has hired Tom Lewis, who served as chief of staff to former Maryland House Speakers Michael E. Busch (D-Anne Arundel) and Casper R. Taylor Jr. (D-Allegany), to the newly created position of development ombudsman.

In June, Lewis retired from Johns Hopkins University and Medicine, where he spent 16 years as vice president for government and community affairs, a post in which he served as a conduit between the school, state and local government, the private sector, and communities surrounding the campus.

If confirmed by the county council, Lewis would have a similar job nurturing the White Flint project.

“Tom brings this unparalleled level of experience within the state working on these issues, working for one of the premiere global research organizations [and] NIH and FDA on joint projects,” said Chief Administrative Officer Richard S. Madaleno Jr. “Tom was part of the Hopkins team that worked on the Maryland bid for Amazon.”

The Washington Metropolitan Area Transit Authority (WMATA), the agency that provides rail and bus service in the D.C. region, owns a large, undeveloped parcel adjacent to the White Flint station — and in the coming weeks the agency is expected to solicit requests from potential developers.

WMATA has engaged Jones Lang LaSalle, an internationally-known real estate consultant based in Chicago, to guide its pursuit of partners and a development vision.

Click here to read more via Maryland Matters.

Immunomic Therapeutics Announces Collaboration With iOncologi

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– Potential to bring in-house cell-based therapies that potentiate checkpoint inhibitors

November 23, 2021 06:41 PM Eastern Standard Time

ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., (“ITI”) a privately held clinical-stage biotechnology company focused on advancing its proprietary nucleic acid immunotherapy platform, announced today an exclusive option to license or acquire a series of innovative technologies in the immuno-oncology space from iOncologi, Inc., (“iOi”).


Preclinical studies led by iOi Co-Founders, Drs. Duane Mitchell and Catherine Flores, have demonstrated that resistance to immune checkpoint inhibitors (ICIs) can be overcome by iOi’s novel, intravenously delivered stem cell-based therapeutic. Rapid translation of this possible breakthrough discovery into first-in-human clinical trials is underway. ITI’s option offers potential opportunities for both companies to further facilitate clinical and commercial development in the field of cell therapy and for collaboration in the development of nucleic acid vaccines that complements ITI’s own UNITE™ technology. The option agreement contemplates additional investment by ITI dependent upon iOi achieving certain clinical trial milestones.

“We are pleased to expand our collaboration with Dr. Duane Mitchell, both in his role as Founder & President of iOncologi, and as a leading academic researcher in the immuno-oncology field. Dr. Mitchell has been instrumental in the development and leadership of our ATTAC-II clinical trial for patients with Glioblastoma,” said Dr. William Hearl, CEO of Immunomic Therapeutics. “His determination to bring innovative treatments to patients is what compounds the complementary technologies in both companies.”

“We are very excited to have iOncologi and Immunomic Therapeutics bring together complementary expertise in the advancement of new treatments for patients with refractory cancers,” said Dr. Mitchell. “This agreement expands upon a longstanding and very fruitful collaboration with Dr. Hearl and the team at ITI in bringing forward novel immunotherapy treatments for patients with Glioblastoma. I look forward to the advances that will come from this agreement between the two companies.”

About Immunomic Therapeutics, Inc.

Immunomic Therapeutics, Inc. (ITI) is a privately-held, clinical stage biotechnology company pioneering the development of vaccines through its proprietary technology platform, UNiversal Intracellular Targeted Expression (UNITE), which is designed to utilize the body’s natural biochemistry to develop vaccines that generate broad immune responses. UNITE has a robust history of applications in various therapeutic areas, including infectious diseases, oncology, allergy and autoimmune diseases. ITI is primarily focused on applying the UNITE platform to oncology, where it could potentially have broad applications, including antigen-derived antibodies as biologics. The Company has built a pipeline leveraging UNITE with programs in oncology, animal health, infectious disease and allergy. ITI has entered into a significant allergy partnership with Astellas Pharma and has formed several academic collaborations with leading Immuno-oncology researchers at Fred Hutchinson Cancer Research Institute, Johns Hopkins University of Medicine, and Duke University School of Medicine. ITI maintains its headquarters in Rockville, Maryland. For more information, please visit

About iOncologi, Inc.

iOncologi, Inc. (iOi) is a privately held biotechnology company focused on the advancement of novel immunotherapies for the treatment of refractory cancers and infectious diseases. iOi’s core platform technology involves the proprietary use of intravenously delivered stem cells to overcome resistance to immune checkpoint inhibitors (ICIs) in a variety cancers. iOi holds particular expertise in the treatment of malignant brain tumors and is focused on advancing its immunomodulatory stem cell therapy for adult and pediatric patients with malignant gliomas, as well as for patients with brain metastasis. iOi’s stem cell therapy has also demonstrated a capacity to enhance the effectiveness of adoptive T cell therapy and holds significant potential in the treatment of severe infectious diseases and sepsis. iOi maintains its headquarters at The Hub at Innovation Square in Gainesville, Florida.


Barbara Frentzen

Melissa Kemp

Supernus Pharmaceuticals Completes Acquisition of Adamas Pharmaceuticals

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November 24, 2021 at 9:12 AM EST

Acquisition strengthens Parkinson’s disease portfolio and diversifies revenue and cash flow
ROCKVILLE, Md., Nov. 24, 2021 (GLOBE NEWSWIRE) — Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN) today announced that it has successfully completed its previously announced acquisition of Adamas Pharmaceuticals, Inc. (NASDAQ: ADMS).

“Adamas fits squarely within our corporate development strategy, adding a late-stage commercial product with significant revenue,” said Jack Khattar, President and CEO of Supernus Pharmaceuticals. “In addition, the acquisition adds a new growth catalyst, diversifies our revenue base and cash flow, and is expected to be significantly accretive in 2022.”

Compelling Strategic Rationale

  • Strengthens Parkinson’s disease portfolio with GOCOVRI® (amantadine) extended release capsules, the first and only FDA-approved medicine indicated for the treatment of both OFF and dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy and Osmolex ER® (amantadine) extended release tablets, approved for the treatment of Parkinson’s disease and drug-induced extrapyramidal reactions in adult patients.
  • Diversifies and increases revenue base and cash flow, and combined with the acquisition of US WorldMeds CNS products in 2020, significantly reduces the reliance on net sales of Trokendi XR®.
  • Potential synergies of $60 million to $80 million in year one due to strong overlap with existing infrastructure.
  • The acquisition is expected to be significantly accretive in 2022.

The Offer and the Merger

The tender offer (Offer) for all outstanding shares of common stock of Adamas for (1) $8.10 per Share, in cash, less any applicable withholding taxes and without interest (Cash Amount), plus (2) two non-transferable and non-tradable contingent value rights per Share, each of which represents the contractual right to receive a contingent payments of $0.50 in cash, less any applicable withholding taxes and without interest (each, a CVR), which amount will become payable, if at all, if specified milestones are achieved prior to December 31, 2024 and December 31, 2025, as applicable (collectively, the Cash Amount with the CVRs, the Offer Price), expired as scheduled at one minute following 11:59 p.m., New York time, on November 23, 2021. American Stock Transfer & Trust Company, LLC, the depositary for the Offer, has advised Supernus that a total of 35,478,225 Adamas shares were validly tendered and not properly withdrawn in the Offer, representing approximately 77.3 percent of the shares of Adamas common stock outstanding. All of the conditions of the Offer have been satisfied, and on November 24, 2021, Supernus and its wholly-owned subsidiary, Supernus Reef, Inc. (Reef), accepted for payment all Adamas shares that were validly tendered and not properly withdrawn in the Offer, and will as promptly as practical pay for all such validly tendered shares.

Following the completion of the Offer, Supernus completed the acquisition of Adamas through the merger of Reef with and into Adamas, without a vote of Adamas stockholders in accordance with Section 251(h) of the General Corporation Law of the State of Delaware (DGCL), with Adamas surviving the merger as a wholly-owned subsidiary of Supernus. In connection with the merger, each Adamas share not previously purchased in the Offer (other than (i) Adamas shares held by Adamas (or held in Adamas’ treasury) immediately prior to the effective time of the merger, (ii) any Adamas shares held by Supernus or any direct or indirect wholly owned subsidiary of Supernus immediately prior to the effective time of the merger, or (iii) Adamas shares held by any stockholder who was entitled to demand and properly demanded appraisal of such shares pursuant to, and who complied in all respects with, Section 262 of the DGCL and who, as of the effective time of the merger, has neither effectively withdrawn nor lost its rights to such appraisal and payment under the DGCL with respect to such shares) was converted into the right to receive the Offer Price, less any applicable withholding taxes and without interest. Adamas’s common stock will be delisted from the NASDAQ Stock Market.

Each CVR paid to Adamas stockholders represents a non-transferable and non-tradable contractual contingent right to receive a cash payment of $0.50, without interest and less any required withholding taxes, upon the achievement of the applicable milestone (each such amount, a Milestone Payment) in accordance with the terms of a Contingent Value Rights Agreement entered into among Supernus and American Stock Transfer & Trust Company, LLC, as rights agent, (CVR Agreement). One Milestone Payment is payable (subject to certain terms and conditions) upon the first occurrence of the achievement of aggregate worldwide net sales of GOCOVRI® in excess of $150,000,000 during any consecutive 12-month period ending on or before December 31, 2024 (Milestone 2024). Another Milestone Payment is payable (subject to certain terms and conditions) upon the first occurrence of the achievement of aggregate worldwide net sales of GOCOVRI in excess of $225,000,000 during any consecutive 12-month period ending on or before December 31, 2025 (Milestone 2025 and, together with Milestone 2024, the Milestones). Each Milestone may only be achieved once. The maximum amount payable with respect to the two CVRs issued in respect to each Share is $1.00 in the aggregate. There can be no assurance any payments will be made with respect to any CVR.


Jefferies LLC acted as the exclusive financial advisor to Supernus. Lazard acted as the exclusive financial advisor to Adamas. Saul Ewing Arnstein & Lehr LLP served as legal counsel and Grant Thornton provided due diligence services to Supernus, and Cooley LLP served as legal counsel to Adamas.

About Supernus

Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases.

Our diverse neuroscience portfolio includes approved treatments for epilepsy, migraine, ADHD, hypomobility in Parkinson’s disease, cervical dystonia and chronic sialorrhea. We are developing a broad range of novel CNS product candidates including new potential treatments for hypomobility in Parkinson’s disease, epilepsy, depression and rare CNS disorders.

For more information, visit

Cautionary Statement Regarding Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not convey historical information but relate to predicted or potential future events that are based upon management’s current expectations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In addition to the factors mentioned in this press release, such risks and uncertainties include, but are not limited to, the risk that the effects of disruption from the transactions of Adamas’s business and the fact that the transactions may make it more difficult to establish or maintain relationships with employees, manufactures, suppliers, vendors, business partners and distribution channels to patients; the risk that stockholder litigation in connection with the transactions may result in significant costs of defense, indemnification and liability; the Company’s ability to sustain and increase its profitability; the Company’s ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Company’s corporate strategy; the Company’s future financial performance and projected expenditures; the Company’s ability to increase the number of prescriptions written for each of its products and products acquired through the acquisition of Adamas; the Company’s ability to increase its net revenue from its products and products acquired through the acquisition of Adamas; the Company’s ability to commercialize its products including Qelbree; the Company’s ability to enter into future collaborations with pharmaceutical companies and academic institutions or to obtain funding from government agencies; the Company’s product research and development activities, including the timing and progress of the Company’s clinical trials, and projected expenditures; the Company’s ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company’s product candidates; the Company’s ability to protect its intellectual property and operate its business without infringing upon the intellectual property rights of others; the Company’s expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Company’s product candidates; the accuracy of the Company’s estimates of the size and characteristics of the markets that may be addressed by its product candidates; the Company’s ability to increase its manufacturing capabilities for its products and product candidates; the Company’s projected markets and growth in markets; the Company’s product formulations and patient needs and potential funding sources; the Company’s staffing needs; and other risk factors set forth from time to time in the Company’s filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. The Company undertakes no obligation to update the information in this press release to reflect events or circumstances after the date hereof or to reflect the occurrence of anticipated or unanticipated events.

Supernus Contacts
Jack A. Khattar, President and CEO
Timothy C. Dec, Senior Vice President and CFO
Supernus Pharmaceuticals, Inc.
Tel: (301) 838-2591


Peter Vozzo
ICR Westwicke
Office: (443) 213-0505
Mobile: (443) 377-4767

Red Cell Forms Zephyr AI to Revolutionize Drug Discovery and Precision Medicine

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November 22, 2021

TYSONS, Va.–(BUSINESS WIRE)–Red Cell Partners (“Red Cell”), an investment and incubation firm that backs, builds, and scales technology-led companies in healthcare and defense, today announced the formation of Zephyr AI, Inc. (“Zephyr AI”).

Zephyr AI’s mission is to transform drug discovery, redefine personalized medicine, and empower healthcare systems to achieve better patient outcomes at lower cost. Zephyr AI integrates artificial intelligence with extensive datasets to upend traditional “guess and test” drug development and personalized medicine processes to unearth novel therapeutics, new applications for existing therapeutics, and advanced biomarkers for individualized treatments.

The company is co-founded by Dr. Yisroel Brumer, Zephyr AI Chief Executive Officer (formerly of the Office of the Secretary of Defense), Grant Verstandig, Zephyr AI Executive Chairman (Senior Advisor to the Chief Executive Officer UnitedHealth Group; Chief Digital Officer UnitedHealth Group 2017-2021; Founder and former CEO of Rally Health), and Jeff Sherman, Zephyr AI Chief Technology Officer (former ML Architect at Rally Health).

“Integrating a massive array of datasets from our healthcare, pharmaceutical, and biotech partners coupled with our extraordinary team building truly revolutionary algorithms is what sets us apart,” said Zephyr AI CEO Yisroel Brumer. “We could not be more excited about the potential to transform targeted patient care and to drastically reduce healthcare and drug development costs.”

“We are in the early stages of understanding the extent of what can be uncovered by data science techniques,” said Executive Chairman Grant Verstandig. “Zephyr AI’s deep insights and enduring partnerships will enable us to uncover paradigm-shifting discoveries in healthcare.”

Zephyr AI’s founders are joined by an exceptional board of directors composed of internationally recognized leaders with expertise across biotechnology, healthcare delivery, health insurance, and government. Grant Verstandig (Executive Chairman) and Yisroel Brumer (CEO) are joined on the Board by Dr. Sol J. Barer (Co-founder & former CEO, Celgene Corporation); Dr. Jack Rowe (former CEO, Aetna); Ken Samet (President & CEO, MedStar Health); and Michael Cohen (Vice President of Investments at Lerner). The Board will work closely with Zephyr AI’s leadership and advise on all matters relating to the company’s growth, deployment of technology across industries, and the delivery of future technologies currently in development.

“While drug development has always used the best scientific processes available, those processes have been exceedingly slow, sapping hope from patients awaiting new treatments. Zephyr AI will take a targeted approach with their technologies to expedite discoveries,” said Zephyr AI Board member Jack Rowe. “The enthusiasm for what we are doing from the pharma, biotech, and payer sectors is significant. They understand that our model to advance precision medicine is the future of drug development.”

Reflecting on its strong value proposition, Zephyr AI is building industry partnerships to gather and maximally utilize an unprecedented array of data and develop machine-learning pipelines. This will drive discoveries that allow Zephyr AI to rescue orphan drugs, create new synergistic therapeutic combinations, and repurpose existing drugs for new uses.

Zephyr AI is additionally putting extensive effort into biomarker discovery to aid in optimal patient selection for existing and in-development therapeutics. This is intended to revitalize the current, outmoded clinical trial model through more efficient recruitment, using artificial intelligence insights to match patients to therapeutics based on their specific disease characteristics.

Moreover, the Company is pursuing the development of patient and healthcare provider tools to fully leverage the potential of precision medicine to enhance outcomes and reduce the cost of care.

Earlier this year, the Zephyr AI founders published two peer-reviewed articles about the company’s technology in the medical journal Oncogene. “These findings demonstrate that Zephyr AI can already identify novel-use cases for existing therapeutics in cancer,” said CTO Jeff Sherman. “The progress we’ve made in the months since publication is astounding. It’s a testament to our team at Zephyr AI and just a small sample of the groundbreaking progress on the horizon.”

About Zephyr AI, Inc.

Zephyr AI is a high-growth healthcare technology company committed to radically rebuilding drug discovery and precision medicine from the ground up. By harnessing the power of next-generation artificial intelligence and machine learning to sort through massive data sets, Zephyr AI empowers the healthcare system with the advanced analytical tools to redefine drug development, streamline clinical trials, and battle disease in ways that once were thought impossible—until today. At Zephyr AI, our mission-focused team of world-class software engineers and biologists integrates unprecedented datasets and leverages cutting-edge technology to derive transformational insights and build enduring partnerships that will revolutionize the treatment of cancer, diabetes and other diseases.

About Red Cell Partners

Red Cell is an incubation and investment platform creating rapidly scalable, technology-led companies that seeks to address the Nation’s most pressing challenges. Employing a flexible model, Red Cell directly incubates, invests in, and acquires companies with the potential to transform health care and defense through the application of technology. Currently investing shareholder capital, Red Cell supports leading growth companies throughout their lifecycles.

To stay up-to-date: visit us at and follow us on LinkedIn.


Media Contact:
Charles V. Zehren

REGENXBIO Announces Orphan Drug Designation Granted to RGX-202, a Novel Gene Therapy Candidate for the Treatment of Duchenne Muscular Dystrophy

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ROCKVILLE, Md., Nov. 22, 2021 /PRNewswire/ —

  • Potential one-time gene therapy for the treatment of Duchenne, includes a novel, optimized microdystrophin transgene and REGENXBIO’s proprietary NAV® AAV8 vector
  • Commercial-scale cGMP material to be used in clinical development
  • Company on track to submit IND by end of 2021

REGENXBIO Inc. (Nasdaq: RGNX) today announced the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for RGX-202, a potential one-time gene therapy for the treatment of Duchenne muscular dystrophy (Duchenne). RGX-202 is designed to deliver a novel, optimized microdystrophin transgene with a unique C-terminal domain and a muscle specific promoter to support targeted therapy for improved resistance to muscle damage associated with Duchenne. RGX-202 uses REGENXBIO’s proprietary NAV® AAV8 vector.

“This important designation is a milestone in the development of RGX-202 and highlights the need for potential new treatment options for patients with Duchenne,” said Olivier Danos, Ph.D., Chief Scientific Officer of REGENXBIO. “The novel microdystrophin transgene in RGX-202 includes coding regions that retain essential functional elements of naturally occurring dystrophin to potentially improve muscle strength and resistance in patients with Duchenne. We look forward to advancing this one-time gene therapy into the clinic.”

REGENXBIO expects to submit an Investigational New Drug (IND) application to the FDA for RGX-202 by the end of 2021. Commercial-scale cGMP material has already been produced at 1,000 liter capacity using REGENXBIO’s suspension cell culture manufacturing process, and the Company’s internal cGMP facility is expected to allow for production up to 2,000 liters for the clinical development of RGX-202.

FDA Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. Orphan drug status provides benefits to drug developers, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of post-approval marketing exclusivity.

About RGX-202

RGX-202 is designed to deliver a novel microdystrophin transgene which retains key elements of the dystrophin protein, including an extended coding region of the C-Terminal (CT) domain found in naturally-occurring dystrophin, as well as other fundamental improvements to the transgene. Presence of the CT domain has been shown to recruit several key proteins to the muscle cell membrane, leading to improved muscle resistance to contraction-induced muscle damage in dystrophic mice. Additional design features, including codon optimization and reduction of CpG content, may potentially improve gene expression, increase translational efficiency and reduce immunogenicity. RGX-202 is designed to support the delivery and targeted expression of genes throughout skeletal and heart muscle using the NAV AAV8 vector, a vector used in numerous clinical trials, and a well-characterized muscle targeting promoter (Spc5-12).


REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. REGENXBIO’s NAV® Technology Platform, a proprietary adeno-associated virus (AAV) gene delivery platform, consists of exclusive rights to more than 100 novel AAV vectors, including AAV7, AAV8, AAV9 and AAVrh10. REGENXBIO and its third-party NAV Technology Platform Licensees are applying the NAV Technology Platform in the development of a broad pipeline of candidates in multiple therapeutic areas.

Forward-Looking Statements
This press release includes “forward-looking statements,” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements express a belief, expectation or intention and are generally accompanied by words that convey projected future events or outcomes such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “assume,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would” or by variations of such words or by similar expressions. The forward-looking statements include statements relating to, among other things, REGENXBIO’s future operations and clinical trials. REGENXBIO has based these forward-looking statements on its current expectations and assumptions and analyses made by REGENXBIO in light of its experience and its perception of historical trends, current conditions and expected future developments, as well as other factors REGENXBIO believes are appropriate under the circumstances. However, whether actual results and developments will conform with REGENXBIO’s expectations and predictions is subject to a number of risks and uncertainties, including the timing of enrollment, commencement and completion and the success of clinical trials conducted by REGENXBIO, its licensees and its partners, the timing of commencement and completion and the success of preclinical studies conducted by REGENXBIO and its development partners, the timely development and launch of new products, the ability to obtain and maintain regulatory approval of product candidates, the ability to obtain and maintain intellectual property protection for product candidates and technology, trends and challenges in the business and markets in which REGENXBIO operates, the size and growth of potential markets for product candidates and the ability to serve those markets, the rate and degree of acceptance of product candidates, the impact of the COVID-19 pandemic or similar public health crises on REGENXBIO’s business, and other factors, many of which are beyond the control of REGENXBIO. Refer to the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of REGENXBIO’s Annual Report on Form 10-K for the year ended December 31, 2020 and comparable “risk factors” sections of REGENXBIO’s Quarterly Reports on Form 10-Q and other filings, which have been filed with the U.S. Securities and Exchange Commission (SEC) and are available on the SEC’s website at All of the forward-looking statements made in this press release are expressly qualified by the cautionary statements contained or referred to herein. The actual results or developments anticipated may not be realized or, even if substantially realized, they may not have the expected consequences to or effects on REGENXBIO or its businesses or operations. Such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Readers are cautioned not to rely too heavily on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this press release. Except as required by law, REGENXBIO does not undertake any obligation, and specifically declines any obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Tricia Truehart
Investor Relations and Corporate Communications

Brendan Burns, 212-600-1902

David Rosen, 212-600-1902



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Study aiming to define acute traumatic encephalopathy (ATE) published by leading neurology journal

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BrainBox HeadSmart II Study Investigators Aim to Provide Clinicians with First-Ever Biomarkers and other Functional measurements for Acute Traumatic Encephalopathy (ATE.) A clinical trial of multi-modal diagnostic/prognostic test, already underway, is published in Frontiers in Neurology/NeuroTrauma.

Investigators in a major clinical trial of patients with mild traumatic brain injury (mTBI or concussion) describe for the first time objective diagnostic criteria, based on blood biomarkers and neurologic testing, for acute traumatic encephalopathy (ATE), the immediate physiologic consequence the injury.

Acute Traumatic Encephalopathy (ATE) represents the condition of an objective measure of TBI associated symptoms or dysfunction that occur as long as 90 days following an acute head injury, according to the investigators. It may be manifest by neuropsychiatric dysfunction, imaging pathology, or biomarker abnormalities in a patient presenting with a history consistent with TBI. Objective criteria for ATE have the potential to advance the understanding of mild TBI and significantly improve its subsequent clinical management.

The ATE description was published in Frontiers in Neurology/NeuroTrauma along with the protocol for HeadSMART II clinical study (HEAD injury Serum markers and Multi-modalities for Assessing Response to Trauma), which is evaluating diagnostic and prognostic potential of BrainBox Solutions’ BrainBox TBI test.

“There is an urgent need for an objective testing approach to diagnose early TBI,” said W. Franklin Peacock MD FACEP, lead study investigator and Professor of Emergency Medicine and Vice Chair for Research in the Department of Emergency Medicine at Baylor College of Medicine. “Despite an estimated 2.8 million annual emergency department visits, TBI diagnosis is based largely on a report of loss of consciousness, post-traumatic amnesia, and/or confusion, without readily available objective diagnostic tests at the time of presentation, nor an ability to identify a patient’s prognosis at the time of injury.”

Objectives of the HeadSMART II study, which began enrolling patients earlier this year, are to:

  • Diagnose ATE using statistical modeling methods that combine blood biomarker values, focused patient health information including imaging based on institutional standard of care, and neurocognitive/neuropsychiatric (NC/NP) testing; and
  • Predict persistent symptoms up to 90 days after a diagnosis of ATE by using statistical modeling combining biomarkers, focused patient health information including imaging as required, and NC/NP testing.

The study is an international trial that will enroll up to 2,000 patients at up to 30 sites including Level I Trauma Centers, Emergency Departments (EDs) and urgent care settings in systems and community-based hospitals.

“Computerized tomography (CT), the leading technologic tool for diagnosing TBI, is considered insensitive for this injury. CT shows TBI-related abnormalities in only approximately 10 percent of patients evaluated in EDs, despite the fact that many patients have disabling TBI symptoms even after initial negative imaging,” said Damon Kuehl MD, Vice Chair of Emergency Medicine for Carilion Clinic and Vice Chair of the Virginia Tech Carilion School of Medicine’s Department of Emergency Medicine. Like Dr. Peacock, Dr. Kuehl is also a member of the BrainBox Scientific Advisory Board.

ATE diagnosis is defined by abnormal post-traumatic biomarkers, abnormal functional tests in patients who may also have normal CT scans, according to the investigators.

“Recent studies indicate biomarkers and neurocognitive assessments can identify injured patients and those likely to have post-concussive symptoms, regardless of imaging testing results, providing a physiologic basis for an ATE diagnosis,” said Ramon Diaz-Arrastia MD, PhD, John McCrea Dickson MD, Professor of Neurology, Director, Clinical TBI Research Center, University of Pennsylvania, Perelman School of Medicine, and Co-PI for the study. He noted that biomarkers provide objective evidence of injury-related leakage of brain proteins into the bloodstream.

“Neurocognitive and neuropsychiatric assessments can also be utilized to characterize functional deficits at the time of injury, and identify patients likely to have post-concussion symptoms,” he said. “mTBI patients, particularly those with repeat injuries, are at significant risk of long-term neuropsychiatric symptoms and late-life dementia. Objective diagnostic criteria for ATE will enable clinicians to monitor patients across the continuum of injury and assess the impact of interventions—and, long term, lead to improved outcomes.”

The BrainBox TBI test is a multi-modal test that includes blood biomarkers, a set of neurocognitive tests and proprietary AI algorithms to generate an objective score for diagnosis up to 96 hours from the time of injury and a prognosis report or likely injury related symptoms up to three months post-traumatic event. The test has received “Breakthrough Designation” from the FDA and can be used either at point-of-care or in clinical settings.

The publication is entitled, “Defining Acute Traumatic Encephalopathy (ATE): Methods of the “HEAD injury Serum markers and Multi-modalities for Assessing Response to Trauma” (HeadSMART II) Study.” In addition to Drs. Peacock, Kuehl, and Diaz-Arrastia, the authors include: Jeff Bazarian, MD FACEP, University of Rochester; Adam J. Singer, MD, FACEP; Renaissance School of Medicine at Stony Brook; Chad Cannon, MD, FACEP, University of Kansas Medical Center;  Zubaid Rafique, MD FACEP, Baylor College of Medicine (Houston, TX; James P. d’Etienne, MD, MBA, FACEP, ); Integrative Emergency Services/JPS Health System (Ft. Worth, TX); Robert Welch, MD FACEP, Detroit Medical Center; Carol Clark, MD FACEP, and William Beaumont Hospital (Royal Oak, MI).

To learn more visit the link.

TEDCO Generates $2.3 Billion in Economic Benefits to the State of Maryland and Supports 10,433 Maryland Jobs, According to New Independent Study

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COLUMBIA, Md.Nov. 17, 2021 /PRNewswire/ — TEDCOMaryland’s economic engine for technology companies, announced today the findings of an independent study detailing the impact of TEDCO’s six core programs to the state of Maryland.

Conducted by the University of Baltimore’s Jacob France Institute, the study found that TEDCO provides significant value to the state’s start-up community, supporting 10,433 Maryland jobs and more than $2.3 billion in statewide economic activity as of 2021.

“This study reinforces the role TEDCO has played in the state’s innovation ecosystem,” said TEDCO CEOTroy LeMaile-Stovall. “By creating a more connected suite of funding and resources, TEDCO is able to provide significant value to the state’s start-ups. It’s encouraging to see the continuous growth in our economy from the support provided by our programs.”

The study states that TEDCO has generated significant economic and fiscal returns to the state. Reviewing the change from 2018 to 2021, the job creation impact of the portfolio of companies supported by TEDCO’s six core research and investment vehicles increased from 7,746 in 2018 to 10,433 in 2021. Similarly, the economic impact of these companies has also seen a significant increase from $1.6 billion in 2018 to $2.3 billion in 2021. The jobs supported by these companies earn $885 million in labor income and generate an estimated state and local government revenues of $100.1 million, according to the study, including estimated State of Maryland revenues of $57 million, an amount greater than TEDCO’s appropriation.

See the study:

The previous study in 2018 projected that by 2023 TEDCO’s economic impact would increase to $2.4B and will support a total of 11,812 jobs. TEDCO is set to achieve these projections nearly two years early.

“It’s exciting to see the changes the organization has brought to our community,” said Omar Muhammad, TEDCO Board of Directors chairperson, director and EN-TRE-PRE-NEUR for the Entrepreneurial Development and Assistance Center at Morgan State University. “Where the greatest impact is seen through it’s growing portfolio of companies. At the time of this study, TEDCO’s programs have supported the formation and growth of 366 active Maryland companies with 4,845 employees. These technology-based start-ups will be leading the state through continuous innovative growth for years to come.”

Programs under the TEDCO umbrella include the Maryland Venture Fund, the Seed Investment Funds, the Pre-seed Builder Fund, the Pre-Seed Rural Business Innovation Initiative Fund, the Maryland Innovation Initiative Fund, and the Maryland Stem Cell Research Fund. The Seed Investment Funds consists of the following: Technology Commercialization Fund; Life Sciences Investment Fund; Cybersecurity Investment Fund; and Gap Fund.

Watch TEDCO’s 23rd Anniversary video highlighting the historical achievements and success stories from the organization since 1998. Visit TEDCO’s YouTube Channel to view the video:

TEDCO, the Maryland Technology Development Corporation, enhances economic empowerment growth through the fostering of an inclusive entrepreneurial innovation ecosystem. TEDCO identifies, invests in, and helps grow technology and life science-based companies in Maryland. Learn more at

Media Contact
Tammi Thomas
Chief Marketing & Communications Officer, TEDCO


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Deka Biosciences Raises USD 20 Million in Series A Financing

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GERMANTOWN, Md., Nov. 16, 2021 /PRNewswire/ — Maryland-based biotech company Deka Biosciences (“Deka”) today announced that it has successfully closed a USD 20 Million Series A financing with a syndicate of life science investors led by Leaps by Bayer, the impact investment arm of Bayer AG, and new investor Lumira Ventures. Additional investors include O-Bio (Echo Investment Capital), Viva BioInnovator, and Alexandria Venture Investments.

Deka Biosciences 2021 Novel cytokine-based therapies have the potential to provide patients with innovative curative treatment options for cancer, autoimmune diseases, and many types of infectious diseases. Understanding the known function of each cytokine, Deka has developed Diakines™ – intentionally engineered therapeutic proteins that are designed to deliver clinically validated cytokines, coupled in combination in the Diakine™ structure, to diseased tissue. Deka has also combined this therapeutic platform with companion diagnostic assays that ensure delivery of each Diakine™ to patients that will benefit the most.

In Deka’s Diakines™, the scaffold platform is derived from a human antibody fragment, called a single-chain variable fragment, that uniquely functions both as a stabilizing, half-life extension technology and a targeting vector to deliver the cytokine(s) function to specific cell types or the microenvironment of affected tissues. Through stabilization and improved manufacturing techniques, the Diakine™ scaffold increases production yields and reduces manufacturing costs, and the unique structure enhances the specific functions of each cytokine, unlike most other half-life extending technologies. The company has demonstrated positive responses in preclinical studies, in both cancer and inflammatory disease models. Through extensive investigation, Deka has found that not all people respond to the same cytokine in the same way. Deka has therefore developed assays that evaluate each patients’ response to each cytokine pair and found genetic signatures that are uniquely associated with response to each Diakine™. Deka will evaluate this genetic signature in future clinical trials to ensure that each patient is matched with their best Diakine™. The team at Deka is committed to developing Diakines™ that can treat every patient.

“This investment by our multi-national, top-tier syndicate enables our first step in developing the Diakine™ platform,” said John Mumm, CEO and founder of Deka Biosciences. “We are proud to join forces with our board of directors to bring these life-changing medicines to patients as quickly and effectively as possible. We share the vision to fundamentally change the nature of drug development and change the standard of healthcare through coupling our platform technology with predictive precision medicine. We are honored to have Leaps by Bayer as our lead investor as we share the goals to develop cures for patients through innovative science and precision medicine. We dare to leap as they do.”

“Leaps by Bayer aims to achieve life transforming breakthroughs for patients, this is why we invest in technologies of tomorrow already today,” said Juergen Eckhardt, MD, Head of Leaps by Bayer. “One of humankind’s biggest challenges and one of the big goals Leaps by Bayer is trying to solve is to prevent and cure cancer. We believe next-generation immunotherapies will play a pivotal role in addressing this challenge and Deka Biosciences’ cytokine therapy approach has the potential to change treatment-paradigms for cancer patients and for those suffering from auto-immune diseases.”

“Deka Biosciences has developed a unique and strongly differentiated platform to produce cytokines with therapeutically complementary functions that circumvent several challenges associated with naturally occurring and modified cytokines,” said Benjamin (Beni) Rovinski, PhD, Managing Director of Lumira Ventures. “At Lumira, our mission is to invest in companies at the forefront of biomedical innovation whose products have the potential to transform patient outcomes. It is gratifying to support Deka in pursuit of such a goal.”

“Deka has made impressive progress since its inception. We are excited to partner with Deka, and its Diakine™ platform, to provide best-in-class therapies to patients,” said Yi-Yen Chen, managing director at Echo Investment Capital’s O-Bio fund, a life science focused fund headquartered in Oklahoma City.

The investment will enable Deka to advance its research and talent acquisition and further expand development of its platform, in particular to file the Investigation New Drug (IND) application for the lead oncology program and advance the lead compound into Phase I clinical trials.

About Deka Biosciences Deka is an early-stage biotech company focused on the development of novel cytokine therapies to treat cancer and inflammatory diseases such as Crohn’s, psoriasis, rheumatoid arthritis and sepsis. The company is led by serial entrepreneur John Mumm, who is backed by a team of experienced biopharma and CDMO innovators with expertise in drug discovery, product development, characterization and testing. Deka has developed disease specific Diakines™ that maximize patient benefits through improved pharmacokinetics / pharmacodynamics (PK/PD) function via targeted delivery of dual and complimentary cytokines to affected tissues or cells. Through the use of precision medicine, Deka’s vision is to maximize the impact of its Diakine™ therapeutic proteins by ensuring treatment of patients who will best benefit from and respond to our cytokine therapies. To learn more, visit

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