Applied Biomath Inc., of Concord, Mass., disclosed a collaboration with Immunitas Therapeutics Inc., of Waltham, Mass., for the development of a systems pharmacology model for an oncology pathway with complex receptor-ligand dynamics. The model will be used to understand the importance of targeting multiple receptors simultaneously and will inform the optimal therapeutic modality, the companies said. Applied Biomath employs a fit-for-purpose model development process which quantitatively integrates knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms.
Astrazeneca plc, of London, said the U.S. District Court for the Northern District of West Virginia has decided in favor of the firm in litigation against Mylan Pharmaceuticals Inc., of Canonsburg, Pa., and Kindeva Drug Delivery LP, of St. Paul, Minn., determining that asserted claims in three of Astrazeneca’s patents protecting Symbicort (budesonide/formoterol) in the U.S. are not invalid. The litigation was begun in October 2018 by Astrazeneca.
Betterlife Pharma Inc., of Vancouver, British Columbia, signed an agreement with Eurofins CDMO Alphora Inc., of Mississauga, Ontario, for TD-0148A’s GMP manufacturing. Betterlife’s TD-0148A is a second-generation lysergic acid diethylamide (LSD) derivative molecule, 2-bromo-LSD, that Betterlife believes will mimic the projected therapeutic potential of LSD without causing its undesirable psychoactive dissociative side effects, such as hallucinations. Eurofins CDMO will be conducting process development, scale-up and GMP manufacture of TD-0148A at its cGMP plant facility.
Black Diamond Therapeutics Inc., of Cambridge, Mass., offered preclinical data from two programs emerging from the company’s MAP platform targeting BRAF and fibroblast growth factor receptor at the European Society of Medical Oncology Targeted Anticancer Therapies virtual congress. BRAF program candidates were shown to potently inhibit the proliferation of Ba/F3 transformants expressing a broad spectrum of non-canonical, dimer-promoting class II/III mutations.
Cipla Ltd., of Mumbai, India, said its subsidiary, Gulf FZ LLC, expanded the partnership with Alvotech hf, of Reykjavik, Iceland, for the marketing and distribution of four biosimilar medicines in Australia and New Zealand. Gulf will be responsible for commercialization of patented biosimilars of leading products covering therapeutic categories across immunology, osteoporosis, oncology as well as ophthalmology. The products are developed and manufactured by Alvotech and will be distributed by Gulf through Australia and New Zealand distribution networks.
Emmaus Life Sciences Inc., of Torrance, Calif., signed an agreement with Kainos Medicine Inc., of Seoul, South Korea, to lead the preclinical development of Kainos' patented IRAK4 inhibitor, KM-10544, as a cancer drug and further advance the research and development activity currently underway at Kainos. The latter plans to complete the study of the therapeutic mechanism of action of KM-10544 in solid cancers, blood cancers and lymphoma. Emmaus will be responsible for the investigation and proof-of-target disease selection, efficacy and safety. Kainos will receive $500,000 in cash and $500,000 in shares of Emmaus common stock in consideration for entering the agreement. Emmaus has been granted rights of first negotiation and first refusal for an exclusive license regarding the development and commercialization of products based on the intellectual property resulting from the agreement.
ERS Genomics Ltd., of Dublin, signed a license agreement with Otsuka Pharmaceutical Co. Ltd., of Tokyo, granting Otsuka access to CRISPR/Cas9 genome editing technology for its internal research and development initiatives. ERS holds an exclusive worldwide license from co-founder and recent Nobel prize winner Emmanuelle Charpentier to the intellectual property covering CRISPR/Cas9 for use as a research platform.
Exmceuticals Inc., of Vancouver, British Columbia, disclosed a proposed stock merger with Global Cannabinoids Inc., of Las Vegas, distributor of bulk and wholesale hemp derived cannabinoids and finished products. The company also made public a best-efforts, private placement of up to CA$6 million (US$4.7 million).
Halberd Corp., of Jackson Center, Pa., said it produced a proprietary monoclonal antibody that has at least 20 times greater neutralizing affinity than its original antibody against the SARS-CoV-2 spike protein. Its researchers, the company added, are developing additional antibodies targeting the characteristic spike protein and the lesser known nucleocapsid protein.
Hoth Therapeutics Inc., of New York, said it is developing peptide candidates that have been optimized chemically to maximize their potential for viral inhibition. All three are being studied using live SARS-CoV-2 viral inhibition assays to determine their levels in vitro. One candidate, the company added, demonstrated low level viral inhibition assay with no toxicity to the host cell. The peptide sequence modeling analysis suggests the optimized peptides could be effective against the U.K. and South African SARS-CoV-2 strain variants, according to Hoth.
Isa Pharmaceuticals BV, of Leiden, the Netherlands, said it completed preclinical work for ISA-106, a COVID-19 immunotherapy, and a phase I dose-finding study in healthy volunteers. ISA-106 is an immunotherapy agent intended to treat patients with SARS-CoV2 infections, preventing progressive pneumonia, and avoiding hospital and intensive care unit admission. It is designed to elicit a T-cell immune response specifically against SARS-CoV-2. T cells generated by ISA-106 target multiple viral proteins that include known new variants, the company added.
DNA Script, of Paris, San Francisco and Boston, said it will receive up to $9.35 million to leverage its enzymatic DNA synthesis technology to develop vaccines and therapeutics in response to biothreats for the U.S. Defense Advanced Research Projects Agency’s Nucleic Acids On-Demand World-Wide program. The company will join GE Research to develop a rapid response, mobile medical manufacturing platform to enable on-demand production of nucleic acid-based vaccines and therapies. The collaboration seeks to create a platform that can produce thousands of ready-to-use vaccine doses at sites of need in under three days.
Kamada Ltd., of Rehovot, Israel, said it completed its acquisition of the FDA-licensed plasma collection center and certain related rights and assets from the privately held Blood and Plasma Research Inc., of Beaumont, Texas. Total consideration is approximately $1.66 million. Kamada’s commercial products include Glassia, the first liquid, ready-to-use, intravenous plasma-derived alpha-1 antitrypsin product.
Medicinova Inc., of La Jolla, Calif., said that, given the COVID-19 vaccines currently in use and others in advanced stages of development, the company will discontinue development of a SARS-CoV-2 vaccine for COVID-19. Medicinova's current strategy is to focus on MN-166 (ibudilast) for neurological disorders such as progressive multiple sclerosis, amyotrophic lateral sclerosis, degenerative cervical myelopathy, substance dependence and glioblastoma.
Morphosys AG, of Planegg, Germany, will receive a €16 million (US$19.3 million) milestone payment from Glaxosmithkline plc, of London, for the treatment of the first subject in the expanded cohort of patients 70 and older in the Oscar study, which is testing otilimab in patients with severe COVID-19.
New preclinical data from Nanobiotix SA, of Paris, show NBTXR-3, a radioenhancer being evaluated as a tumor-agnostic, combo-agnostic candidate across tumor types, can overcomes anti-PD-1 resistance, promote strong abscopal effect and long-term anticancer memory. A study examined NBTXR-3 activated by XRT in combination with anti-PD-1 along with TIGIT and LAG3 inhibitors in an in vivo anti-PD-1-resistant mouse model. Key findings include the combination therapy of NBTXR-3, radiotherapy, XRT, anti-PD-1, anti-LAG3 and anti-TIGIT promoted the proliferation activity of CD8+ T cells, improved local and distant tumor control and increased survival rate. NBTXR-3 is composed of sterile, functionalized, crystalline hafnium oxide nanoparticles that are delivered by intratumoral injection one time prior to radiotherapy.
Oasmia Pharmaceutical AB, of Uppsala, Sweden, said it will collaborate with the Karolinska Institutet, of Stockholm, to review data and experimental methods to better understand XR-17, a vitamin A-based excipient that can combine water-soluble and water-insoluble substances to form micelles of 20 nm to 60 nm size, and active pharmaceutical ingredient formulations in cancer with a focus on ovarian carcinoma. That will be followed by an experimental planning phase, which aims to test formulations in suitable systems to generate hypotheses for subsequent evaluation. The XR-17 platform technology enhances intravenous drug delivery, Oasmia said.
Partner Therapeutics Inc., of Lexington, Mass., said it entered a licensing and collaboration agreement with Munich-based Sirs Therapeutics GmbH and Vienna-based F4 Pharma GmbH to support development of FX-06, a synthetic peptide with a spectrum of potential indications. The partnership will focus on exploring potential collaborations with the U.S. government to develop FX-06 as a medical countermeasure against high priority threats for which there are significant unmet needs, according to Partner. Sirs and F4 are developing FX-06 in diseases associated with capillary leak with a focus on treating patients with COVID-19. FX-06 is a fibrin-derived peptide that binds to VE-Cadherin, restoring the barrier function of the endothelium.
Repertoire Immune Medicines Inc., of Cambridge, Mass., prepublished data on bioRxiv showing how SARS-CoV-2 variants may avoid immune surveillance. The company used its Decode platform to identify T cells that reacted to the variants. The company believes that information could be used to design T cell-based vaccines that might provide long-term immunity.
Resverlogix Corp., of Calgary, Alberta, published data on the use of apabetalone as a treatment for COVID-19 on the bioRxiv preprint server. Treatment of heart cells with apabetalone reduced the expression of ACE2, which deduced the infectivity of SARS-CoV-2. In mouse models, BET inhibitors, such as apabetalone, reduced cardiac injury resulting from a cytokine storm. All animals in the treatment group survived, compared to a 75% mortality rate in the control group.
United Therapeutics Corp., of Silver Spring, Md., decided to discontinue the development of Trevyent (treprostinil) after the company was informed by the FDA that it would need to redesign the product to improve pump accuracy and run an additional study of the redesigned product.
Vaxalto Biotherapeutics Inc., of New York, licensed rights to intellectual property and technology related to an avian paramyxovirus oncolytic virus platform and immunomodulator targeting the lymphatic system from Mount Sinai Innovation Partners, part of the Icahn School of Medicine at Mount Sinai. Financial terms of the deal weren't disclosed.