The SARS-CoV-2 virus continues to shut down society as it spreads unchecked across the world. Scores of biopharma and med-tech companies have mobilized resources to test and scale-up potential treatments, vaccines and diagnostics to fight COVID-19, while others are adjusting their clinical trial plans in response to health care restrictions globally. Across Europe, biomedical research projects and clinical trials are grinding to a halt, as universities shut down and administrators stop any work not related to the coronavirus.

University College London, the largest biomedical research university in Europe, for example, put all its research on hold, as it released clinical staff from academic and research responsibilities to join those on the front line treating COVID-19 patients.

Research activity intensified last week including:

Novartis AG, Becton Dickinson and Co., Biomérieux Inc., Boehringer Ingelheim GmbH, Bristol Myers Squibb Co., Eisai Co. Ltd., Eli Lilly and Co., Gilead Inc., Glaxosmithkline plc, Johnson & Johnson, Merck & Co. Inc., Merck KGaA, Pfizer Inc. and Sanofi SA forming a collaboration with the Bill & Melinda Gates Foundation to coordinate resources to develop, manufacture and deliver vaccines, diagnostics and treatments for COVID-19. The companies will share their libraries of compounds that already have some degree of safety and activity data with the COVID-19 Therapeutics Accelerator, which was recently launched by the Gates Foundation, Wellcome and Mastercard Inc.

Aldeyra Therapeutics Inc. said it will begin screening its library of reactive aldehyde species inhibitors, including ADX-629 and reproxalap, for potential anti-inflammatory and antiviral activity in the treatment of COVID-19 infection. ADX-629 and reproxalap are structurally related to chloroquine and hydroxychloroquine, drugs currently in clinical testing for the treatment of COVID-19 infection.

Allovir Inc. has expanded its research and development collaboration with Baylor College of Medicine to include the discovery and development of allogeneic, off-the-shelf, virus specific T-cell therapies to combat SARS-CoV-2.

Ampio Pharmaceuticals Inc. is preparing an expanded access FDA protocol to study the potential benefit of nebulized treatment with Ampion in SARS-Cov-2-induced acute respiratory distress syndrome.

Bold Therapeutics Inc. said recent developments have suggested the potential utility of its lead drug, BOLD-100, as an antiviral agent. Its main mechanism of action is to inhibit stress-induced up-regulation of GRP78, a common receptor for viral recognition of host cells.

CNS Pharmaceuticals AG Inc. signed an agreement with WPD Pharmaceuticals sp. z o.o. for the development of several preclinical drug candidates, including WP-1122, which is being tested on a range of viruses, including the coronavirus SARS-CoV-2.

Dynavax Technologies Corp. and Clover Biopharmaceuticals Inc. said they've formed a research collaboration to develop a vaccine candidate to prevent COVID-19. Clover is evaluating its protein-based coronavirus vaccine candidate, COVID-19 S-Trimer, in preclinical studies, while Dynavax is providing technical expertise and the company’s Toll-like receptor 9 agonist adjuvant, CpG 1018, to support the initiative.

Etherna Immunotherapies NV said a consortium has been formed with North American and European partners to develop a novel mRNA vaccine against SARS-CoV-2 and preclinical development has started.

Grifols SA said it formed a collaboration with the U.S. Biomedical Advanced Research and Development Authority (BARDA), the FDA and other U.S. public health agencies to collect plasma from convalescent COVID-19 patients, process the plasma into a hyperimmune globulin and support preclinical and clinical studies to determine if anti-SARS-CoV-2 hyperimmune globulin therapy can treat COVID-19 successfully.

Hoth Therapeutics Inc. and Voltron Therapeutics Inc. have formed a joint venture, Halovax, to develop a vaccine for COVID-19 that can be advanced to clinical testing. The venture is based on a self-assembling vaccine (SAV) platform that can be focused against specific pathogen targets; the platform has been licensed by Voltron from Massachusetts General Hospital’s Vaccine and Immunotherapy Center. Proof-of-concept studies, funded by the U.S. Department of Defense, support the SAV’s ability to evoke immune responses to viruses. The SAV platform, also known as the Vaxcelerate platform, was developed for rapidly generating vaccines for emerging infectious diseases.

Humanigen Inc., a developer of an anti-human-GM-CSF monoclonal antibody for preventing and treating cytokine storms, is urgently working on a phase III trial of the candidate, lenzilumab, for COVID-19 patients whose immune systems have gone into overdrive. Meanwhile, its team is trying to get the drug added to open protocols of NIH-administered trials of other potential therapies and into the hands of individual patients by opening up compassionate use requests.

Novan Inc. plans to explore the use of its Nitricil technology to advance a potential topical oral or nasal candidate for COVID-19, targeting the reduction of viral shedding and transmission based on nitric oxide’s ability to inhibit viral replication of viruses within the Coronaviridae family.

Pharnext SA has identified 97 frequently prescribed drugs as potential candidates to be repositioned for treating COVID-19 through the use of its Pleotherapy platform. Most of the drugs identified are not known to have antiviral activities, the company said, and four of the drugs identified are already undergoing clinical trials for COVID-19, including chloroquine.

Soligenix Inc. is expanding its ongoing collaboration with the University of Hawaii at Mānoa to assess potential coronavirus vaccines (including against COVID-19). Ongoing collaborations have demonstrated the feasibility of developing heat stable subunit filovirus vaccines, including Ebola virus disease caused by either Zaire or Sudan ebolavirus variants, as well as Marburg virus disease, with both monovalent and bivalent vaccine combinations.

Sorrento Therapeutics Inc. signed an exclusive license agreement with antibody biopharmaceutical company Mabpharm Ltd. for the clinical development and commercialization of the ACE-MAB fusion protein (STI-4920/CMAB-020) for the potential treatment of COVID-19. Mabpharm has generated a fusion protein (CMAB-020) that binds to the spike protein of the SARS-CoV-2 virus.

Sorrento Therapeutics Inc. and Smartpharm Therapeutics Inc. are collaborating to develop a next-generation, gene-encoded antibody vaccine for COVID-19. They will utilize monoclonal antibodies against SARS-CoV-2 virus discovered and/or generated by Sorrento that will be encoded into a gene for delivery utilizing Smartpharm’s nonviral nanoparticle platform.

Twist Bioscience Corp. is collaborating with Vanderbilt University Medical Center to develop antibodies for the treatment of COVID-19. The company will provide synthetic genes and custom antibody drug discovery libraries and will screen the libraries for potential antibody therapeutics. Vanderbilt is providing antibody sequences from a patient who recovered from COVID-19, which Twist will use to develop its library.

Vyripharm Biopharmaceuticals LLC will repurpose development of a theranostic platform for diagnosing, monitoring and treating viral infections such as COVID-19, SARS and MERS. The company said it will use radiopharmaceuticals for detection and diagnosis with the ability to incorporate combination therapies to interrupt the replication of the virus.

Xencor Inc. and Vir Biotechnology Inc. entered a technology license agreement giving Vir nonexclusive access to Xencor’s Xtend Fc technology to extend the half-life of antibodies that Vir is developing as treatments for COVID-19. Financial terms of the agreement were not disclosed.

Regenerative medicines treating rare disease

There are now 420 companies around the world that are active in developing regenerative medicines and advanced therapies for the treatment of rare diseases, according to a new report released by the Alliance for Regenerative Medicine. The report identified 42 late-stage studies among the 647 ongoing rare disease clinical trials utilizing regenerative medicine technologies.

Deals of the week

Agios Pharmaceuticals Inc. said that Celgene Corp., a wholly owned subsidiary of Bristol Myers Squibb Co. declined to exercise its opt-in right for AG-270, a methionine adenosyltransferase 2a inhibitor candidate in phase I development in combination with taxane-based therapy to treat methylthioadenosine phosphorylase-deleted non-small-cell lung cancer and pancreatic cancer.

Bellus Health Inc. closed an agreement to acquire the remaining BLU-5937 and related P2X3 antagonist intellectual property assets from Admare Bioinnovations’ Neomed Institute, disclosed earlier, issuing to Admare and Astrazeneca AB, a wholly owned subsidiary of Astrazeneca plc, about 4.7 million common shares representing 7.3% of the company’s fully diluted equity.

Cytomx Therapeutics Inc. signed a deal with Astellas Pharma Inc. that will focus on T-cell engaging bispecific antibodies targeting CD3 and tumor cell surface antigens in cancer, with Astellas paying $80 million up front. Preclinical, clinical and commercial milestone-related rewards could push the deal’s value beyond the $1.6 billion mark.

Evox Therapeutics Ltd. has validated its exosome drug delivery technologies in a $882 million deal with Takeda Pharmaceutical Co. Ltd., in which the partners will develop protein replacement and messengerRNA therapies in five rare disease indications.

Silence Therapeutics plc entered a wide-ranging siRNA-based drug discovery and development deal with Astrazeneca plc. It is banking an up-front payment of $60 million, another $20 million as an equity investment and up to $400 million in option fees and milestone payments per candidate drug, in an alliance that could entail up to five active programs within three years

Financial transactions

Public offerings: Baudax Bio Inc. said it closed its public offering for gross proceeds of $25 million.

Venture funding: Castle Creek Biosciences Inc. raised $75 million to support phase III research with FCX-007 in recessive dystrophic epidermolysis bullosa. Kallyope Inc., which is developing therapies targeting the gut-brain axis, secured a $112 million series C financing. Nanjing Iaso Biotherapeutics Co. Ltd. raised $60 million in a series B round to advance its CT-103A, an anti-BCMA CAR T therapy candidate for multiple myeloma, among other plans. Recode Therapeutics Inc. brought in $80 million through an oversubscribed series A financing with plans to continue its preclinical work in primary ciliary dyskinesia and cystic fibrosis. Redpin Therapeutics Inc. raised $15.5 million from a series A financing to continue developing its ion channel-based chemogenetics platform for addressing neural circuit dysfunctions such as epilepsy, neuropathic pain and Parkinson’s disease. Regenacy Pharmaceuticals Inc. closed on a $30 million series A financing designed to initiate a phase II proof-of-concept trial for ricolinostat, an oral, selective HDAC6 inhibitor, in diabetic peripheral neuropathy. Sutrovax Inc. closed a $110 million series D preferred stock financing.

Regulatory news

Given the need to act quickly and efficiently to respond to the COVID-19 emergency, the FDA said it will implement coronavirus-related guidances without first seeking public comment. However, it will accept comments on the documents and make changes as needed. Rather than publishing a separate notice in the Federal Register for each guidance, the FDA said it plans to publish periodic notices announcing the guidances issued since the previous notice. Also, instead of opening a docket for comments for each guidance, the agency is opening a docket for each center’s COVID-19-related guidance.

The White House announced the launch of the COVID-19 High Performance Computing Consortium to provide researchers worldwide with access to computing resources that could “significantly advance the pace of scientific discovery in the fight to stop the virus.” Spearheaded by the White House, U.S. Department of Energy and IBM, the public-private consortium includes government, industry and academic leaders who have volunteered free compute time and computer resources. Researchers will submit COVID-19-related proposals to the consortium via an online portal. Requests will be reviewed and matched with computing resources from one of the partner institutions. A panel of top scientists and computing researchers will work with the proposers to assess the public health benefit of the research and coordinate the allocation of the consortium’s computing assets, which can process massive numbers of calculations related to bioinformatics, epidemiology and molecular modeling, helping scientists develop answers to complex scientific questions about COVID-19 in hours or days vs. weeks or months, according to the White House.

The FDA took several actions last week in its fight against COVID-19. For one, the agency is allowing compounding pharmacies to use hydroxychloroquine to compound human drugs. In moving hydroxychloroquine to category 1 under its interim policy on bulk drug substances that can be used in compounding, the agency said it prioritized the substance due to the coronavirus emergency.

Word on the Street: Industry responses to the issues of the week

“This is a great opportunity to show that as an industry we’re really the good guys. We can maybe save the world. I think the world is counting on us.”
George Yancopoulos, president and chief scientific officer, Regeneron Inc., commenting during the first day of Bio-Europe Spring 2020, in a virtual session focused on Combatting Coronavirus. Regeneron is working on both an interleukin-6 agent to address current critical care patients, as well as human monoclonal antibodies developed using its Velocisuite technologies

“For five years, we have been telling the Congress and the administration and the previous administration that it is not if there is a pandemic, but when. Importantly, we said the Medicare program should reimburse hospitals so that those hospitals can pay for and stockpile the things that they would need for a pandemic. That didn’t happen, tragically, so we are where we are.”
James Greenwood, president and CEO of BIO, during his participation at the virtual Bio-Europe Spring 2020 meeting

“The authorization of Somryst by the FDA provides patients suffering from chronic insomnia with a digitally delivered CBTi therapeutic, where CBTi is the guideline-recommended, long-term, first-line treatment for chronic insomnia.”
Charles Morin, professor of psychology and director of Sleppe Research Centre at the Université Laval in Quebec City, on the FDA’s approval of Somryst, from Pear Therapeutics Inc., the first prescription digital therapeutic for chronic insomnia