Agios Pharmaceuticals Inc., of Cambridge, Mass., said that Celgene Corp., a wholly owned subsidiary of Bristol Myers Squibb Co., of New York, 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. The research term of the companies’ metabolic immuno-oncology collaboration, focused on altering the metabolic state of immune cells to enhance the body's immune response to cancer, also will conclude in May 2020 at the end of the initial four-year period. Under terms of the 2016 research agreement, Celgene agreed to pay $200 million up front plus milestone payments and held an opt-in right through the end of phase I dose escalation for a fee of at least a $30 million. An undisclosed, ongoing metabolic immuno-oncology research program remains. Celgene may agree to continued development within 60 days following the end of the research term, giving it an opt-in right for the program through the end of phase I dose escalation. On March 26, Agios shares (NASDAQ:AGIO) lost 39 cents to close at $37.75.
Bellus Health Inc., of Laval, Quebec, said it closed the agreement to acquire the remaining BLU-5937 and related P2X3 antagonist intellectual property assets from Admare Bioinnovations’ Neomed Institute, disclosed earlier in the week, issuing to Admare and Astrazeneca AB, a wholly owned subsidiary of London-based Astrazeneca plc, about 4.7 million common shares representing 7.3% of the company’s fully diluted equity.
Benitec Biopharma Ltd., of Melbourne, Australia, a company working on a platform combining RNAi with gene therapy, said the shareholder resolution to redomicile to the U.S. was passed.
Bioduro LLC, of San Diego, said it initiated a COVID-19 nanobody therapeutic program, leveraging the company’s biologics discovery platform and a specialized COVID-19 dedicated team. The cornerstone of the effort includes screening more than 10 billion human synthetic antibodies generated using artificial intelligence computing and high-speed DNA mutagenesis technology. Bioduro said its program relies on synthetic antibody technology, targeting both ACE2 receptor on the human cell and spike protein on the virus. The goal is to block the viral entry and fusion into the cell. Part of the funding for Bioduro’s COVID-19 initiative is from the city of Wuxi, Jiangsu local government, the same district where Bioduro said it is opening its fourth global site in the third quarter of 2020.
Biopharmx Corp., of Campbell, Calif., said it was notified that the NYSE American plans to begin delisting proceedings after the company failed to remedy its noncompliance with continued listing standards. The company plans to appeal, and the NYSE American is expected to allow continued listing and trading of common shares during that time. In January 2020, Biopharmx agreed to merge with Timber Pharmaceuticals LLC, of Woodcliff Lake, N.J., and a special meeting of Biopharmx stockholders is scheduled for April 30, 2020, to seek approval of the merger. Prior to that time, Biopharmx plans to file an initial listing application with the NYSE American for the combined company, which is expected to meet the exchange’s listing rules when the merger becomes effective.
Bluebird Bio Inc., of Cambridge, Mass., said it expects the COVID-19 pandemic to affect some commercial launch plans and to shift the timing of enrollment and completion of ongoing studies by at least three months. Although Zynteglo (betibeglogene autotemcel) is available in Germany and the process of consenting and preparing patients continues, Bluebird expects treatment of the first commercial patient in Germany to be shifted to the second half of 2020. The COVID-19 pandemic also is expected to affect the company’s ability to achieve market access and reimbursement elsewhere in Europe. Ongoing studies of the HBB gene stimulator lentiglobin for beta-thalassemia and sickle cell disease, the ABCD1 gene stimulator lenti-D (elivaldogene autotemcel) for cerebral adrenoleukodystrophy (CALD) and the APRIL receptor modulator bb-21217 for multiple myeloma remain active, but the effects of the pandemic are resulting in disruptions to study conduct. Bluebird said it updated guidance to investigators for all studies to ensure additional precautions and communications are in place. In addition, Bluebird does not expect to complete the rolling BLA submission to the FDA for lentiglobin in beta-thalassemia until mid-2021 and estimates that it will submit the BLA for lenti-D to treat CALD around the same time. Although development partner Bristol Myers Squibb Co. (BMS), of New York, temporarily suspended screening, enrollment and apheresis in cellular therapy studies of APRIL receptor modulator idecabtagene vicleucel, Bluebird said the BMS decision does not affect ongoing BLA activities with the FDA for the candidate.
Cerecor Inc., of Rockville, Md., said it plans to explore the role of the inflammatory cytokine, LIGHT, in patients with COVID-19-induced acute respiratory distress. The company will use its LIGHT assay as well as a multiplex assay to assess differences in LIGHT levels and other inflammatory markers, including IL-18 and IFN-g, in those with mild to moderate vs. severe disease who have acute lung injury or acute respiratory distress syndrome (ARDS). Because LIGHT has a co-stimulatory role in T-cell activation driving proinflammatory and tissue damaging effects and plays a role in driving pulmonary fibrosis, neutralizing the cytokine may prove beneficial in severe COVID-19 infection in individuals at high risk of ARDS and respiratory failure, according to the company.
Citius Pharmaceuticals Inc., of Cranford, N.J., said an in vitro study of Mino-Lok (minocycline + edetate + ethyl alcohol) against strains of Candida auris showed complete eradication of the tested strains within one hour of exposure to the antibiotic lock solution, designed to treat catheter-related bloodstream infections. The findings were published in the March 2020 issue of Antimicrobial Agents and Chemotherapy.
Delmar Pharmaceuticals Inc., of San Diego, said it received a listing extension from Nasdaq allowing the company until Sept. 21, 2020, to regain compliance with the $1 minimum bid price requirement.
Dynavax Technologies Corp., of Emeryville, Calif., said it formed a collaboration with the Coalition for Epidemic Preparedness Innovations to develop a vaccine to prevent COVID-19. Dynavax will make its Toll-like receptor 9 agonist adjuvant, CpG 1018, used in Heplisav-B (hepatitis B vaccine [recombinant], adjuvanted), available for vaccine development against COVID-19, and the partners will work together to identify and coordinate engagements with organizations working on COVID-19 vaccines.
Evofem Biosciences Inc., of San Diego, said its board adopted a shareholder rights agreement generally designed to restrict individuals or groups from acquiring beneficial ownership of 32% or more of the company's outstanding shares following the effective date of March 24, 2020.
Grifols SA, of Barcelona, 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. Grifols will volunteer its expertise and resources in the areas of plasma collection using its network of FDA-approved plasma donor centers; test and qualify donors in conjunction with other health agencies; process plasma into hyperimmune globulin at its specialized facility in Clayton, N.C.; and support preclinical and clinical studies assessing the safety and effectiveness of hyperimmune globulin from the plasma of convalescent donors to treat COVID-19 and to serve as a platform to treat infectious diseases that may emerge in the future. Grifols also is providing viral inactivation technology (methylene blue) to ensure the use of inactivated plasma units for treatment and plans to build a dedicated facility at the Clayton site for that purpose. In Spain, Grifols is working to conduct a trial with inactivated plasma from recovered patients through a collaboration with select donation centers and public hospitals, and the company is collaborating with certain hospitals to design studies assessing the effectiveness of certain plasma-derived products, such as intravenous immunoglobulin and alpha-1 antitrypsin, to treat COVID-19. Grifols also accelerated the development and validation of a transcription-mediated amplification-based diagnostic procedure to detect the coronavirus whose sensitivity is equivalent or potentially superior to that of polymerase chain reaction. The test, performed on automatic instrumentation, with each unit able to run more than 1,000 samples per day, is expected to be ready in weeks.
Lift Biosciences Ltd., of London, is collaborating with King’s College London to develop an induced pluripotent stem cells version of its N1a neutrophil cancer cell therapy product, N-LIfT. The current product, which is on track to begin clinical trials in 2022, uses N1a neutrophils from donors.
Lipocine Inc., of Salt Lake City, said the judge issued a claim construction order after the Markman hearing for its lawsuit with Clarus Therapeutics Inc., of Northbrook, Ill. Lipocine claims that Clarus's Jatenzo (testosterone undecanoate) infringes Lipocine's U.S. patents.
Mylan NV, of Hertfordshire, U.K., and Pfizer Inc., of New York, expect to close the merger of Mylan and Pfizer's Upjohn division in the second half of 2020. The delay from previous guidance of mid-2020 is due to the COVID-19 pandemic. Mylan's extraordinary general meeting of shareholders to vote on the merger has been rescheduled from April 27 to June 30.
Myokardia Inc., of Brisbane, Calif., said it has temporarily suspended enrollment in two ongoing studies, which includes the rollover of patients from its pivotal EXPLORER study of mavacamten into the MAVA-LTE study and enrolling of healthy volunteers in the phase I study testing MYK-224. The company also said new clinical trials planned to start in the second quarter of 2020 will be delayed. Those include the VALOR-HCM phase III trial testing mavacamten as an alternative to septal reduction therapy procedures, the phase II study testing mavacamten in subgroups of patients with heart failure with preserved ejection fraction, and a phase II study of danicamtiv in genetic dilated cardiomyopathy. At this time, Myokardia said it does not foresee changes to clinical and regulatory milestones associated with development of mavacamten for obstructive hypertrophic cardiomyopathy, including reporting top-line data from the phase III EXPLORER-HCM study in the second quarter of this year.
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 have formed 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.
Pfizer Inc., of New York, is pausing recruitment of clinical trial participants outside of China, Japan and South Korea for three weeks to reduce demands on the health care system. Studies for life-threatening diseases with few or no other therapeutic options will continue to enroll patients. Separately, Pfizer reported that six patients in a study of COVID-19 in France who received hydroxychloroquine plus Zithromax (azithromycin) achieved a virologic cure after six days.
Revive Therapeutics Ltd., of Toronto, is using Pharm-Olam LLC, of Houston, as its contract research organization to run its clinical trial of bucillamine as a treatment for COVID-19.
Saniona AB, of Ballerup, Denmark, entered a second collaboration with Boehringer Ingelheim GmbH, of Ingelheim, Germany, to develop drugs targeting an undisclosed central nervous system ion channel for the treatment of schizophrenia. Saniona will receive research funding from Boehringer and is eligible for up to €76.5 million (US$84.5 million) in milestones plus royalties on worldwide net sales.
Scholar Rock Inc., of Cambridge, Mass., published preclinical data in Science Translational Medicine showing SRK-181-mIgG1, which inhibits transforming growth factor-beta 1, plus an anti-PD-1 therapy produced tumor regression or control and improved survival in three mouse cancer models that recapitulate resistance to checkpoint inhibitor therapy.
Secarna Pharmaceuticals GmbH & Co. KG, of Munich/Martinsried, Germany, published data on its locked nucleic acid (LNA)-modified antisense oligonucleotides (ASOs) in Cancer Immunology, Immunotherapy. The LNA-modified ASOs were able to block expression of TDO2 and IDO1 in vitro. The IDO1-specific ASO plus epacadostat synergistically reduced production of kynurenine by cancer cells.
Twist Bioscience Corp., of South San Francisco, is collaborating with Vanderbilt University Medical Center to develop antibodies for the treatment of COVID-19. Twist 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.
Unum Therapeutics Inc., of Cambridge, Mass., disclosed in its fourth-quarter and full-year 2019 earnings plans to explore strategic options, including an acquisition, merger, business combination, in-licensing or other transaction. Unum, which is developing products based on its Bolt-on Chimerix, or BOXR, platform, had cash and equivalents totaling $37.4 million as of Dec. 31, though on March 20 it inked a stock purchase agreement for up to $25 million with Lincoln Park Capital Fund LLC.
Xencor Inc., of Monrovia, Calif., and Vir Biotechnology Inc., of San Francisco, 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.