Alivio Therapeutics Inc., of Boston, disclosed a $3.3 million U.S. Department of Defense Technology/Therapeutic Development Award to advance its product candidate, ALV-304, for the treatment of inflammatory bowel disease. The funds will support Alivio’s preclinical research and development activities to potentially enable the filing of an IND application for the product. In multiple preclinical models, ALV-304 showed significant improvements in several efficacy endpoints compared to untreated controls.
Amgen Inc., of Thousand Oaks, Calif., disclosed a new partnership with the North West Coast Innovation Agency and Imperial College Health Partners. The collaboration is meant to help tackle high cholesterol across the northwest coast of England, an area heavily impacted by heart attacks, strokes, and premature deaths due to cardiovascular disease. Amgen and partners will be working to develop scalable, evidence-based solutions that deliver cost efficiencies and capacity savings, the company said.
Avrobio Inc., of Cambridge, Mass., disclosed an exclusive, worldwide license agreement and a collaborative research funding agreement with The University of Manchester for an investigational lentiviral gene therapy for mucopolysaccharidosis type II, or Hunter syndrome. The investigator-sponsored phase I/II trial is expected to start in the second half of 2021. The program was developed by Brian Bigger, a professor of cell and gene therapy at the university.
Bone Therapeutics SA, of Gosselies, Belgium, Link Health Pharma Co. Ltd., of Guangzhou, China, and Shenzhen Pregene Biopharma Co. Ltd., of Guangdong, China, signed an exclusive license agreement for the manufacturing, clinical development and commercialization of Bone’s allogeneic, off-the-shelf, bone cell therapy platform, Allob, in China (including Hong Kong and Macau), Taiwan, Singapore, South Korea and Thailand. Under the agreement, Bone is eligible to receive up to €55 million (US$64.8 million) in development, regulatory and commercial milestone payments, including €10 million in up-front and milestone payments anticipated in the next 24 months. Bone also is in line for tiered double-digit royalties on annual net sales of Allob and retains development and commercialization rights in all other geographies.
Bridgebio Pharma Inc., of Palo Alto, Calif., and Eidos Therapeutics Inc., of San Francisco, signed a definitive agreement under which Bridgebio has agreed to acquire all of the outstanding common stock of Eidos it does not already own, representing approximately 36.3% of Eidos’ outstanding shares. Eidos stockholders will have the right to receive in the transaction, at their election, either 1.85 shares of Bridgebio common stock or $73.26 in cash per Eidos share in the transaction, up to an aggregate maximum of $175 million. The agreement was unanimously approved by Bridgebio’s board and was approved by Eidos’ board based upon the unanimous recommendation of a special committee of independent directors of Eidos. Bridgebio disclosed Eidos as its second portfolio company in 2017. Eidos subsequently went public and its shares (NASDAQ:EIDX) jumped $21.59, or 41.6%, to close Oct. 5 at $73.51.
Cancer Research UK in London disclosed a new drug that could be effective against the childhood cancer neuroblastoma. Findings with the compound, fadraciclib, were published in The Journal of Clinical Investigation. The drug could be available by way of a clinical trial by the end of this year. Fadraciclib targets N-Myc.
Elevar Therapeutics Inc., of Salt Lake City, said it entered an exclusive agreement with Taiba Middle East FZ LLC, of Dubai, UAE, under which Taiba will commercialize and distribute Apealea (paclitaxel micellar) in certain countries throughout the Middle East and North African region. Apealea has been approved by the European regulatory authorities for use in combination with carboplatin for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. The partnership agreement will include royalties and arrangements for manufacturing and supply. Specific financial terms were not disclosed.
Flexion Therapeutic Inc., of Burlington, Mass., presented preclinical efficacy and pharmacokinetic data on FX-301, a NaV1.7 antagonist being developed for the control of postoperative pain, at the virtual Anesthesiology 2020 meeting. The drug produced a greater analgesic effect from 12 hours through 72 hours and a longer duration of effect through 72 hours compared to liposomal bupivacaine or placebo. Plasma levels of funapide, the active ingredient in FX-301, were relatively flat, while there were high local concentrations where the gel was applied. Flexion plans to file an IND for FX-301 in 2021.
Hepion Pharmaceuticals Inc., of Edison, N.J., has developed AI-POWR, an artificial intelligence machine learning platform that uses genomics, proteomics, metabolomics, transcriptomics and lipidomics data to determine potential responders to drugs. The company plans to use the platform to identify which patients with nonalcoholic steatohepatitis are most likely to respond to CRV-431, which is currently in a phase IIa study. Hepion also plans to make AI-POWR available to other companies.
Kempharm Inc., of Celebration, Fla., expanded its relationship with Corium Inc., of Menlo Park, Calif. Kempharm will provide product development consultation services for certain current and potential future products in Corium’s portfolio. Kempharm will receive service fees of up to $15.6 million paid in quarterly installments through March 31, 2022.
Lantern Pharma Inc., of Dallas, reported that LP-184, which it’s developing with Georgetown University, had nanomolar potency across a wide variety of prostate cancer cell lines. The DNA damaging agent was most potent against cells that overexpress PTGR1 and cell lines that had targeted DNA damage repair gene mutations. Lantern and Georgetown plan to study the drug in patient-derived xenograft models to further validate the role of PTGR1 and the genetic mutations driving the DNA damage repair pathways.
Medicure Inc., of Winnipeg, Manitoba, has licensed an undisclosed cardiovascular biosimilar from Reliance Life Sciences Private Ltd., of Mumbai, India. Medicure will be responsible for gaining regulatory approval and selling the drug in the U.S., Canada and the EU. Financial terms of the deal weren’t disclosed.
Nimble Therapeutics Inc., of Madison, Wis., said it entered a collaboration with Incyte Corp., of Wilmington, Del., to discover first-in-class peptide therapies across various disease areas using Nimble’s peptide synthesis, screening and optimization platform. Under the terms, Nimble will receive an undisclosed up-front payment, reimbursement of certain research program costs and may become eligible for downstream milestone payments and royalties. Incyte has exclusive rights to develop and commercialize any peptides discovered under the collaboration, and an option to further expand the collaboration to include additional targets.
Springworks Therapeutics Inc., of Stamford, Conn., and Pfizer Inc., of New York, are collaborating to test Springworks’ gamma-secretase inhibitor, nirogacestat, with Pfizer’s anti-B-cell maturation antigen-CD3 bispecific antibody, PF‐06863135, in patients with relapsed or refractory multiple myeloma. The phase Ib/II study, which will be run by Pfizer, is expected to start in the first half of 2021. Springworks will cover the costs of nirogacestat and certain expenses related to intellectual property rights.
Unum Therapeutics Inc., of Cambridge, Mass., changed its name to Cogent Biosciences Inc. The name reflects the company’s mission to design rational precision therapies. Cogent will start trading on Nasdaq under the ticker COGT on Oct. 6.
Vaxxas Inc., of Cambridge, Mass., was awarded $22 million from the U.S. Biomedical Advanced Research and Development Authority to support development of its HD-MAP patch to deliver vaccines against infections, including influenza and COVID-19.
Zenith Epigenetics Ltd., of Calgary, Alberta, is collaborating with the U.S. National Cancer Institute (NCI) to test ZEN-3694, a BET inhibitor, in multiple oncology indications. NCI will initially run a clinical trial testing ZEN-3694 plus Opdivo (nivolumab) and Yervoy (ipilimumab) from New York-based Bristol Myers Squibb in patients with resistant ovarian cancer.