9 Meters Biopharma Inc., of Raleigh, N.C., will collaborate with the Celiac Disease Foundation to support clinical trial enrollment in 9 Meters' phase III study, CeDLara, for drug candidate larazotide in celiac disease. CeDLara is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of larazotide for adult patients with at least a six-month history of celiac disease who continue to experience gastrointestinal symptoms despite maintaining a gluten-free diet for at least six months. Interim results and top-line data readouts are anticipated in 2022.
Actimed Therapeutics Ltd., of London, disclosed a license agreement for S-oxprenolol to Faraday Pharmaceuticals Inc., of Seattle. S-oxprenolol is one of a new class of anabolic-catabolic transforming agents under development by Actimed. Using a similar mode of action as ACM-001 (S-pindolol), the lead asset of Actimed, S-oxprenolol exhibits a multimodal pharmacology that specifically targets the underlying pathophysiology of cachexia, and has demonstrated significant beneficial effects on survival, body mass and functional parameters in preclinical models of cancer cachexia, the company said. Actimed will receive an up-front payment of $550,000 in equity investment and cash and is also eligible to receive a near-term milestone payment of $2.7 million and up to $123.5 million in total potential milestone payments, plus royalties. Faraday gains global rights to develop and commercialize S-oxprenolol for cancer cachexia and any other indications outside of amyotrophic lateral sclerosis (ALS). Actimed retains global rights to S-oxprenolol in ALS.
Akers Biosciences Inc., of Thorofare, N.J., said its proposed merger partner, Mymd Pharmaceuticals Inc., of Baltimore, has reached an agreement with a major medical school to conduct a phase II trial to investigate the effectiveness of MYMD-1 to treat immune-mediated depression in patients affected with COVID-19. Mymd believes that this investigator-initiated study is the first of its kind and addresses a significant unmet medical need. In findings published in JAMA Network Open, it was discovered that 52% of individuals who had COVID-19 had an associated moderate to severe major depressive disorder.
Aytu Biopharma Inc., of Englewood, Colo., licensed the rights to AR-101 (enzastaurin), a protein kinase C beta isoform inhibitor, from Rumpus Therapeutics Inc., of Ambler, Pa. Aytu will have rights to develop the drug in the fields of rare genetic pediatric onset or congenital disorders outside of oncology. The company plans to start with vascular Ehlers-Danlos syndrome. Denovo Biopharma LLC, of San Diego, owns the rights to the drug, which it calls DB-102, for oncology indications. Aytu will pay Rumpus $1.5 million up front in cash and will take over royalty obligations under Rumpus’ licenses. Rumpus is eligible for up to $22.5 million in regulatory milestone payments, including $15 million if AR-101 receives approval by the FDA and another major market regulatory authority, and commercial milestones of up to an additional $45 million. All milestone payments can be paid in cash or stock not to exceed 19.9% of the now-outstanding shares of Aytu unless subsequently approved by Aytu's shareholders.
Positive preclinical results from Biomica Ltd., of Rehovot, Israel, demonstrated the efficacy of BMC-128 in a mouse model for treating melanoma. BMC-128 combined with immune checkpoint inhibitors (ICI) immunotherapy significantly enhanced antitumor activity, resulting in an increased response of melanoma tumors to anti-PD-1, as demonstrated in an improved objective response rate (ORR) and Percent Tumor Growth Inhibition. The group treated with only anti-PD-1 showed no response (ORR = 0%) as measured by the Response Evaluation Criteria in Solid Tumors, while the group treated with a combination of BMC-128 and anti-PD-1 demonstrated a 13% ORR. Biomica said its immuno-oncology program is based on the premise that the gut microbiome affects the efficacy of cancer immunotherapy, specifically that of the ICI involving the blockade of PD-1 or PD-L1 and CTLA4.
Bridgebio Pharma Inc., of Palo Alto, Calif., has cut seven new collaboration deals with various institutions to advance development of genetically driven disease treatments. Bridgebio will work with scientists at Brown University to evaluate new discoveries in neurology research, with select therapeutic programs potentially spun out and advanced in Bridgebio affiliate companies. Another partnership was formed with the Canadian Glycomics Network to develop carbohydrate-based drugs. Bridgebio also signed several agreements for work focused on development of therapies against genetically driven diseases and cancer with the Lundquist Institute for Biomedical Innovation at the Harbor-UCLA Medical Center; Oregon Health and Science University; the Roswell Park Comprehensive Cancer Center; the University of California, Davis; and the University of California, San Diego.
Cybin Inc., of Toronto, said it plans to advance preclinical work as part of FDA-required IND-enabling trials for CYB-003 (dissolving tablet) and CYB-004 (inhaled formulation), deuterated tryptamine development candidates in development for treatment-resistant psychiatric disorders and addiction.
Evotec SE, of Hamburg, Germany, and Bristol Myers Squibb Co., of New York, have launched beLAB2122, through Evotec's BRIDGE (Biomedical Research, Innovation & Development Generation Efficiency) collaborations. BeLAB2122 will bring together the European Molecular Biology Laboratory, the German Cancer Research Center, the Goethe University Frankfurt, Heidelberg University and the University of Tübingen to develop drugs invented by the institutions.
Eyam Vaccines and Immunotherapeutics Inc., of Vancouver, British Columbia, started preclinical work on its self-amplifying mRNA COVID-19 vaccine candidates targeting SARS-CoV-2 variants. The candidates were licensed from the University of British Columbia in November 2020.
Intravacc of Bilthoven, the Netherlands, reported preclinical data for its Lyme vaccine, which uses meningococci to produce immunogenic vesicles expressing Lyme lipoprotein OspA on the surface of the vesicles. The vaccine produced strong antibody responses in animals.
Nkgen Biotech Inc., of Seoul, South Korea, and Merck KGaA, Darmstadt, Germany, expanded their clinical trial and supply agreement to test Nkgen’s autologous natural killer cells, SNK-01, in combination with either gemcitabine/carboplatin or gemcitabine/carboplatin plus Merck’s Erbitux (cetuximab) in patients with locally advanced or metastatic non-small-cell lung cancer that has progressed after prior tyrosine kinase inhibitor therapy. Nkmax will sponsor the phase I/IIa trial, and Merck will supply Erbitux for the study.
Philogen SpA, of Siena, Italy, published preclinical data on its small-molecule ligand OncoFAP, which targets fibroblast activation protein (FAP), in PNAS. After intravenous administration in mice, both fluorescently labeled and radiolabeled OncoFAP derivatives accumulated in FAP-positive tumors. The ligand was used for targeted delivery of a beta-emitter (lutetium-177), fluorescein-specific CAR T cells and highly cytotoxic auristatin derivatives to FAP-positive tumors in vitro and in vivo.
Sanofi SA, of Paris, said 95.03% of the shares of Amsterdam-based Kiadis Pharma NV have been tendered or irrevocably committed to be delivered to Sanofi at the settlement of the offer. Sanofi declared the offer unconditional and expects to close the acquisition on April 16, 2021.
Teamedon International Inc., of Rockville, Md., licensed the rights to rAAV2tYF-CB-hRS1, a gene therapy for X-linked retinoschisis, from Applied Genetic Technologies Corp. (AGTC), of Gainesville, Fla. AGTC discontinued development of the treatment in 2018 because efficacy endpoints were not met using intravitreal injection. Teamedon plans to test the therapy as a subretinal injection. AGTC is eligible to receive undisclosed milestone payments based on clinical progress as well as royalties on sales.
Therapeutic Solutions International Inc., of Elk City, Idaho, filed a patent for the use of a cord blood based intranasal product to reduce adverse mental effects associated with opioid addiction. In animal studies with TLR4 activated, the cord blood-based therapeutic suppressed TLR4 and inhibited inflammation in the brain.