Abveris Inc., of Canton, Mass., said it would collaborate with South San Francisco-based Nkarta Inc. to discover fully human monoclonal antibodies supporting the advancement of Nkarta's natural killer cell-based cancer therapeutic candidates.
Acer Therapeutics Inc., of Newton, Mass., said it formed a collaboration with the NIH’s National Center for Advancing Translational Sciences to develop emetine hydrochloride as a potential treatment for patients with COVID-19. Acer said it's working toward submitting an investigational new drug application at midyear and targeting clinical trial initiation in the third quarter, subject to additional capital. The company has proposed an adaptive design phase II/III randomized, blinded, placebo-controlled multicenter trial to evaluate the safety and antiviral activity of emetine in high-risk, symptomatic adult patients with confirmed COVID-19 infection not requiring hospitalization.
Adamis Pharmaceuticals Corp., of San Diego, is reacquiring from Princeton, N.J.-based Sandoz Inc. the rights to its Symjepi (epinephrine) injection products currently marketed and available in the U.S. As part of the termination agreement, Sandoz will continue to support the products in the U.S. under the existing commercialization agreement through the end of the transition period to help minimize any potential impact to patients and customers. Adamis simultaneously, in exchange for an up-front payment and potential regulatory and commercial milestones totaling up to $26 million, entered an exclusive distribution and commercialization agreement with Louisville, Ky.-based US Worldmeds LLC for the U.S. commercial rights for the Symjepi products, as well as its Zimhi (naloxone) candidate.
Adaptimmune Therapeutics plc, of Oxfordshire, U.K., presented data at the virtual American Society for Gene and Cell Therapy annual meeting demonstrating that its edited stem cell-derived T cells can kill MAGE-A4+ cancer targets in vitro. The company has also reached a milestone in editing its engineered T cell receptors into the human induced pluripotent stem cell genome to enable successful differentiation, the company said.
Advanced Biodesign SAS, of Lyon, France, said that new data published in Oncogene demonstrate that, in lung cancer xenografts with high to moderate cisplatin resistance, a combination treatment with dimate, the active compound in the company's lead candidate ABD-3001, promotes "strong synergistic responses with tumor regression."
Bicycle Therapeutics plc, of Cambridge, U.K., said that preclinical data on its second-generation bicycle toxin conjugate, BT-5528, published in Molecular Cancer Therapeutics the key features of the class, "such as their low molecular weight, short systemic half-life and renal route of elimination, can result in a therapeutic candidate with an in vivo pharmacokinetic profile that yields a wider preclinical therapeutic index" than that of a comparator antibody-drug conjugate.
Gryt Health, of Rochester N.Y., and Bristol Myers Squibb Co., of New York, plan to develop the COVID Advocacy Exchange, a virtual platform to promote the exchange of information between patient advocacy organizations, patients, policymakers and health care practitioners. The virtual platform will provide access to data and information, as well as the opportunity to participate in weekly live, interactive sessions to foster discussion and collaboration. The virtual platform will provide advocacy organizations and patients with access to materials and information offering support in oncology, cardiovascular, fibrosis, immunoscience, immunology, hematology and multiple sclerosis. Participants will have access to materials from BMS, other advocacy organizations and third-party experts, including curated best practices, white papers, peer-reviewed articles and multimedia content.
National Research Council of Canada (NRC) is collaborating with Cansino Biologics Inc., of Tianjin, China, to advance bioprocessing and clinical development of Ad5-nCoV, a vaccine against COVID-19, in Canada. NRC will scale-up production in Canada using its HEK293 cell line.
Kyoto’s CiRA Foundation and London’s Cell and Gene Therapy Catapult are launching a stem cell collaborative research project focused on induced pluripotent stem (iPS) cell characterization. The collaboration is designed to evaluate cell differentiation and establish tests to predict the potential of iPS cell to differentiation bias, which would help to advance the use of iPS cells for regenerative medicine products.
Fresh data from Dyne Therapeutics Inc, of Waltham, Mass., show enhanced dystrophin expression in multiple muscle tissues and significant improvement in muscle function in a preclinical model of Duchenne muscular dystrophy (DMD) following treatment with the company’s platform, which targets the TFR-1 receptor. The platform delivers exon-skipping antisense oligonucleotides to muscle cells to enable expression of a more complete, functional dystrophin protein and to halt the severe muscle degeneration that characterizes DMD.
The AIDS Healthcare Foundation, of Washington, issued demands that remdesivir, the Foster City, Calif.-based Gilead Sciences Inc. drug approved in Japan and, under an emergency use authorization, in the U.S. for the treatment of COVID-19, be priced at no more than $1 per dose. The foundation also demanded that Gilead disclose all public R&D costs and public investments in connection with the drug's development.
New data supporting NTLA-5001, an engineered cell therapy candidate for treating acute myeloid leukemia (AML) from Intellia Therapeutics Inc., of Cambridge, Mass., show the company developed a sequential genome editing process in primary human T cells that lead to the knockout of three genes with up to >98% efficiency and no detectable target-to-target translocations. The data also revealed an applied sequential editing approach to achieve knockout of the endogenous T-cell receptor (TCR) with up to >99% efficiency, along with insertion of the tgTCR targeting WT1 into 50% to 70% of the cells, the company added. Intellia said it will submit an IND or IND-equivalent for NTLA-5001 for treating AML in the first half of 2021.
Newly launched Lengo Therapeutics Inc., of Menlo Park, Calif., created to discover and develop treatments targeting driver mutations in oncology, completed a $15 million series A financing from Frazier Healthcare Partners and received an exclusive license from Jubilant Life Sciences Ltd., of Uttar Pradesh, India, to develop and commercialize a portfolio against undisclosed oncology targets.
Kiadis Pharma NV, of Amsterdam, released new data showing how its platform uses K562 feeder cells that express membrane bound IL-21 and 41BB ligand. The PM21 platform consists of the membrane particles of FC21 that retain the stimulatory properties of the feeder cells without the need to use intact tumor cells. Kiadis’ process allows K-NK cells to be expanded with PM21 in an industrial GMP-compliant process to enable high-dose, low-cost and scalable production without the risk of residual tumor cells in the final product. The bridging data supported the recent FDA approval of Kiadis’ investigational new drug application enabling the company to initiate a phase II study K-NK002 as an adjunctive therapy to the haploidentical hematopoietic stem cell transplant standard of care with the goal of reducing relapse rates.
The Montreal Heart Institute said it received a $3 million grant from the COVID-19 Therapeutics Accelerator via the Bill & Melinda Gates Foundation for the institute’s Colcorona COVID-19 clinical trial to study colchicine to reduce severe inflammatory conditions associated with the virus. The clinical study is contact-less and is done from home. Colchicine is a generic, orally administered anti-inflammatory medication that is currently indicated for the management of pericarditis, gout and familial Mediterranean fever.
Nanoviricides Inc., of Shelton, Conn., has developed nanoviricide drug candidates with antiviral activity against multiple coronaviruses in cell culture. Two of the candidates were several-fold more effective against tested viruses than favipiravir. The drugs were effective against the NL63 (hCoV-NL63) coronavirus, which uses the same ACE2 receptor as SARS-CoV-2 that causes COVID-19, as well as hCoV-229E that causes seasonal common colds in humans. Nanoviricides plans to test the drugs against SARS-CoV-2 and perform animal safety and toxicology studies before filing for human clinical studies.
Nascent Biotech Inc., of San Diego, and Manhattan Biosolutions Inc., of New York, are collaborating to develop a vaccine for the prevention of COVID-19 or other viral infections based on Manhattan's recombinant Mycobacterium Bovis Bacillus Calmette-Guerin vaccine platform, which will be genetically engineered to express SARS-CoV-2 proteins. Manhattan will receive up to $200,000 from Nascent, consisting of a $100,000 initial equity investment.
Neos Therapeutics Inc., of Dallas, is reducing its workforce by approximately 50 employees, or approximately 25%, to accelerate its path to profitability. The company recorded $14.5 million in sales in the first quarter and lost $8 million.
Neurocrine Biosciences Inc., of San Diego, exercised its option to license ACT-709478, a T-type calcium channel blocker, from Idorsia Ltd., of Allschwil, Switzerland. Neurocrine plans to start a phase II study of the drug in patients with a rare pediatric epilepsy in the second half of 2020.
Oncimmune Holdings plc, of Nottingham, U.K., signed an agreement with an undisclosed U.S. biopharmaceutical company to use Serotag, Oncimmune's biomarker discovery engine, to identify antigen targets from human antibodies. Oncimmune retains the rights to develop companion diagnostics for each candidate or receive milestone payments if the diagnostics are developed by a third party.
Otonomy Inc., of San Diego, reported preclinical results for its gap junction beta-2 deficiency gene therapy at the American Society of Gene & Cell Therapy meeting. In conjunction with Applied Genetic Technologies Corp., of Gainesville, Fla., the companies showed AAV capsids can target cochlear cells with higher expression than has been seen for other capsids. Expression was seen for at least 12 weeks after a single injection.
Promis Neurosciences Inc., of Toronto, has identified 18 conformational peptide antigens on the SARS-CoV-2 coronavirus that could be used to develop an antibody test for COVID-19. The company plans to validate the antigens in the serology lab of Hans Frykman at the University of British Columbia.
Rubius Therapeutics Inc., of Cambridge, Mass., presented preclinical data for its artificial antigen-presenting cell, RTX-321, at the American Society of Gene and Cell Therapy meeting. RTX-321 induced activation of T cells, resulting in up-regulation of 4-1BB, CD25 and PD-1 expression.
Skyhawk Therapeutics Inc., of Waltham, Mass., and Merck & Co. Inc., of Kenilworth, N.J., expanded their collaboration developing small molecules that modulate RNA splicing to four disease areas: neurodegeneration, oncology, autoimmunity and metabolic diseases. Merck will have the option to license candidates from the collaboration and will be responsible for further development and commercialization. Skyhawk will receive an up-front payment and be eligible for milestone payments and royalties on sales of approved products resulting from the collaboration.
Specifica Inc., of Santa Fe, N.M., transferred a suite of antibody libraries to Bayer AG, of Leverkusen, Germany, under an agreement for Bayer to develop antibody-based therapeutics.
Washington University, of St. Louis, is running a 152-patient phase II study of fluvoxamine, a selective serotonin reuptake inhibitor, in patients with mild cases of COVID-19. The primary endpoint of the study is time to clinical worsening, defined as presence of dyspnea and/or hospitalization for shortness of breath or pneumonia plus a decrease in O2 saturation to less than 92% on room air and/or supplemental oxygen requirement in order to keep O2 saturation above 92%. In 2019, researchers at the University of Virginia School of Medicine discovered fluvoxamine lowers cytokine levels in patients with sepsis.