Six months to the day that the World Health Organization (WHO) declared it a public health emergency, the SARS-CoV-2 virus, with its hideous red spikes, continues to taunt the world, hopping from host to host and haunting humans, many of whom wonder the same thing: What’s next? To provide the answer, scientists are working around the clock and in record time. Efforts to track this research began in late February with roughly 30 therapeutics and vaccines monitored by BioWorld. That grew to 433 by late May, then 588 by late June. Now, there are 672 – a one-month rise of 14%.
Sangamo snags Novartis with a $795M neurodevelopmental deal
Sangamo Therapeutics Inc. continued its collaboration spree, signing up its sixth big pharma/biotech partner: Novartis AG. The three-target deal will use Sangamo's zinc finger protein transcription factors to up-regulate genes to treat autism spectrum disorder and other neurodevelopmental disorders. Sangamo will receive $75 million up front and is eligible for $720 million in milestones, as well as tiered royalties that start in the high single-digits.
Lexicon sells Xermelo, turns focus to neuropathic pain program
In a move that Lexicon Pharmaceuticals Inc. chief Lonnel Coats said will focus the company on its phase II neuropathic pain program, the Texas-based venture has agreed to sell one of its two approved products, the carcinoid syndrome diarrhea therapy Xermelo (telotristat ethyl), to Tersera Therapeutics LLC for $159 million in cash. The transaction could be worth up to $224 million with milestones, plus royalties and will allow the company to significantly reduce its debt, Coats said. Company shares (NASDAQ:LXRX) rose 13.5% by midday.
Edesa’s COVID-19 IND sparks the stock
Edesa Biotech Inc., of Toronto, filed an IND to initiate a phase II/III study of EB-015, a monoclonal antibody for treating hospitalized COVID-19 patients. EB-05, which inhibits Toll-like receptor 4 (TLR4) signaling, is designed to regulate the overactive immune response associated with acute respiratory distress syndrome. TLR4 signaling is thought to mediate inflammation that is activated by SARS-CoV-1 and influenza viruses, Edesa said. About 450 patients will be enrolled in the phase II study. Edesa received expedited approval from Health Canada in June to conduct a phase II/III study for treating moderate to severe COVID-19 patients with EB-05. The company stock (NASDAQ:EDSA) rocketed 113% upward at midday on Thursday.
Genocea sinks on phase I/IIa data with neoantigen vaccine in solid tumors
Shares of Genocea Biosciences Inc. (NASDAQ:GNCA) dipped midday by $1.75 to 3.22, or 35%, as Wall Street digested clinical data on the first five patients from part B of the ongoing phase I/IIa study exploring the neoantigen vaccine GEN-009 and checkpoint inhibitor (CPI)-based regimens in advanced solid tumors. The trial combines GEN-009 with the standard-of-care CPI regimen about four months into CPI treatment. Preliminary findings turned up three independent RECIST responses starting from the first GEN-009 dose, with accelerated tumor shrinkage beyond the CPI gains. One patient recorded a complete response (CR) and two showed partial responses (PRs). Overall, two of the first five patients achieved CRs and three reached PRs.
Vacancy sign continues to flash at the FDA
In a time when the FDA needs its best and brightest people onboard, nearly half the senior leadership at the agency will be eligible for retirement this year. The potential loss of institutional memory and talent comes as the FDA is trying to shift from a lengthy, reactive hiring process that focuses on filling existing vacancies to a more streamlined, proactive system that anticipates and plans for future personnel needs. The agency has made some gains in that shift, but “there’s a lot more to be done,” Melanie Keller, director of the FDA’s Office of Talent Solutions, acknowledged at a meeting today on PDUFA and BsUFA hiring and retention commitments.
Iacta, Zhaoke Ophthalmology agree to co-develop novel eye treatments
HONG KONG – California-based Iacta Pharmaceuticals Inc. and Hong Kong-based Zhaoke Ophthalmology Pharmaceutical have inked a definitive license agreement for two of Iacta’s products, progressing from a binding letter of intent in May regarding exclusive rights to IC-265 for dry eye and IC-270 for allergic conjunctivitis in China and other countries in Southeast Asia. The companies said the agreement enables unprecedented drug development cooperation, including the sharing of existing and future data and regulatory documents, access to existing or soon-to-be-produced drug materials, and expedited regulatory and development plans in territories including China, Hong Kong, Macau, Singapore, Thailand and Vietnam.
Terns out-licenses Bcr-Abl inhibitor for CML to Hansoh to accelerate entry to clinic
Terns Pharmaceuticals Inc., a nonalcoholic steatohepatitis specialist based in San Francisco and Shanghai, has out-licensed the greater China rights to its Bcr-Abl inhibitor, TRN-000632, for treating chronic myeloid leukemia to Chinese pharma giant Hansoh Pharmaceutical Group Co. to move the preclinical oncology asset to the clinic faster.
Free access to BioWorld coronavirus articles
The articles from BioWorld’s ongoing coverage of the COVID-19 coronavirus outbreak are available at www.bioworld.com/coronavirus. Note that we have added three critical tables which are constantly updated:
- Vaccines and therapeutics in development
- Diagnostics on the market and in development
- Clinical trials of biopharma and med-tech products affected by COVID-19
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Affinity, Apogenix, Appili, Arya, Astrazeneca, Betterlife, Bluebird, Boehringer Ingelheim, Bristol Myers Squibb, Cannabis Global, Celltrion, Cerevel, Cyclerion, Cynata, Cytodyn, Direct Biologics, Diurnal, Dynacure, Edesa, Eisai, Enterome, Eton, FSD, Genocea, Imago, Imara, Inovio, Johnson & Johnson, Lilly, Marinus, Merck, Neurotrope, Onconova, PDL, Pharvaris, Poxel, Redhill, SAB, Salarius, Seegene, Siga, Spectrum, Sumitomo Dainippon, Synthetic Biologics, Takeda, Terns, Teva, TFF, Theralase, Trillium, Viralclear, Xeris, Zentalis