Applied Biomath LLC, of Concord, Mass., said it will develop a systems pharmacology model for CLN-0149, an FLT3XCD3 bispecific antibody for treating acute myeloid leukemia that is being developed by Cullinan Florentine, a company of Cambridge, Mass.-based Cullinan Oncology LLC. The model will be used to determine a first-in-human starting dose and to predict an efficacious dose range in the clinic, according to Applied Biomath, which focuses on accelerating and de-risking R&D.
Aqilion AB, of Helsingborg, Sweden, said it is initiating Polaris, a project to develop new drug candidates for preventing chronic inflammation and dysfunctional immune reactions such as autoimmune diseases. Collaborating in the project will be CRO companies Red Glead Discovery and Saromics Biostructures, of Lund, Sweden. The first step will be to identify and develop small molecules that bind to and inhibit a selected target protein, Aqilion said.
A new literature review from Axcella Health Inc., of Cambridge, Mass., details potential to develop endogenous metabolic modulator (EMM) compositions that target multiple biological pathways and address unmet needs in a range of complex diseases. Amino acids and related metabolites and precursors are a class of EMMs that have diverse biological functions, the company said. The review was published in Iscience. Axcella’s product candidates comprise EMMs and their derivatives that are engineered in combinations and ratios to impact multiple biological pathways. The company pipeline includes lead therapeutic candidates for nonalcoholic steatohepatitis and the reduction in risk of overt hepatic encephalopathy recurrence.
Axim Biotechnologies Inc., of San Diego, said it filed a provisional patent for a recombinant virus binding protein (VBP) for SARS-CoV-2 and is now manufacturing the VBP. The company noted studies showing the SARS-CoV-2’s spike protein enters human host cells by locking its receptor binding domain (RBD) to proteins on the human cell surface. Axim’s laboratory tests have proved the RBD spike protein binds with the VBP, the company said.
Cannassure Therapeutics Ltd., of Ashdod, Israel, and Lipidor AB, of Sweden, said they completed a feasibility study for topical cannabinoids delivered using the Akvano platform in conditions of skin inflammation, including psoriatic lesions. Cannassure tested the degree of product penetration into the skin by using known and acceptable models and found significant penetration of active ingredients into the skin tissue. Based on those results, Cannassure said it will proceed to accelerated development stages and more advanced testing.
Catalyst Pharmaceuticals Inc., of Coral Gables, Fla., said it is reviewing and will likely appeal a district judge's decision granting summary judgment favoring the FDA and Jacobus Pharmaceutical Co. Inc., of Princeton, N.J. Catalyst was suing the FDA to overturn approval of a competitor's drug for the rare autoimmune disorder Lambert-Eaton myasthenic syndrome, alleging the green light – arriving just months after its own approval – was "arbitrary, capricious" and violated the company's rights to market exclusivity for the medicine, Catalyst said.
Collegium Pharmaceutical Inc., of Stoughton, Mass, said it reached a settlement agreement with Teva Pharmaceutical USA Inc., a unit of Jerusalem-based Teva Pharmaceutical Industries Ltd., resolving patent litigation brought in response to Teva’s ANDA seeking approval to market a generic version of Xtampza ER (oxycodone) prior to the expiration of Collegium’s applicable patents. Collegium said it will grant Teva a license to market its generic version of Xtampza ER in the U.S. beginning on or after Sept. 2, 2033. As a result of the settlement, Collegium added, Teva has agreed to a consent judgment confirming that its proposed generic products infringe Collegium’s asserted patents and that those patents are valid and enforceable with respect to Teva’s proposed generic products. Additional details regarding the settlement are confidential.
Elevation Oncology Inc., of New York, and US Oncology Research will collaborate on a patient enrollment program in the registration-enabling phase II Crestone study for patients with solid tumors of any origin that have an NRG1 gene fusion. Elevation Oncology said its lead candidate, seribantumab, inhibits tumor growth driven by NRG1 fusions. US Oncology Research is a community-based oncology site management organization.
Emerald Bioscience Inc., of San Diego, said it updated its development plan to advance its lead product candidate, THCVHS, a prodrug of THC for the treatment of glaucoma and potentially other ocular diseases, toward human studies next year with data anticipated in early 2022. In preclinical studies, the company said THCVHS demonstrated greater ability to lower intra-ocular pressure, with comparable durability during the study period, vs. latanoprost and timolol, medications that comprise more than 90% of the current glaucoma market.
The International AIDS Society released a statement saying it “mourns the passing of Timothy Ray Brown, the first person to be cured of HIV.” Known as the Berlin patient, he was cured of HIV in 2008 after undergoing a complex stem cell transplant for lymphoma. The donor was naturally resistant to HIV infection because of a mutation in the CCR5 gene, a critical protein required by HIV to enter and infect cells. For the past six months, Brown had been living with a recurrence of the leukemia that had entered his spine and brain. He had remained HIV-free.
Ligand Pharmaceuticals Inc., of San Diego, said its tender offer to purchase any and all issued and outstanding shares of common stock of San Diego-based Pfenex Inc. at $12 each in cash, plus one nontransferable contractual contingent value right per share representing the right to receive a contingent payment of $2 in cash, if a certain specified milestone is achieved, has expired. Approximately 2.59 million shares were validly tendered and not withdrawn, representing approximately 80.3% of Pfenex’s outstanding shares. Ligand expects the merger to close on Oct. 1, with Pfenex becoming a wholly owned subsidiary of Ligand.
Locus Biosciences Inc., of Morrisville, N.C., said it signed a contract with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to co-fund development of LBP-EC01, a CRISPR/Cas3-enhanced bacteriophage product that will target Escherichia coli bacteria causing recurrent urinary tract infections. BARDA will provide up to $77 million in funding as part of a $144 million program to support phase II and phase III trials and other activities required to seek marketing approval from the FDA for LBP-EC01.
Neurotrope Inc., of New York, and Metuchen Pharmaceuticals LLC, of Manalapan Township, N.J., said they entered an amendment to their definitive merger agreement with Neurotrope stockholders to now hold 49% of the combined company, which is up from approximately 22.5% ownership. The all-stock transaction will result in the formation of a Nasdaq-traded holding company to be named Petros Pharmaceuticals Inc. Upon closing, Neurotrope Bioscience Inc.'s current lead asset, Bryostatin-1 to treat neurodegeneration, and substantially all of its existing assets, operations and liabilities, except for cash retained by Petros in accordance with the terms of the amended merger agreement, will be spun out into a new, separately traded company. Metuchen's lead pipeline program includes in-licensed drug candidate H-100, a non-invasive, compounded, topical treatment for Peyronie's disease. It also has exclusive marketing rights to Stendra (avanafil), which is FDA-approved for the treatment of erectile dysfunction.
Pulmatrix Inc., of Lexington, Mass., said data from partner Sensory Cloud detailing the utility of Fend, a hypertonic calcium chloride salt solution with nasal mister, in the reduction of bioaerosol generation in the airways has been published Molecular Frontiers. Pulmatrix licensed the rights to its Nasocalm formulations (PUR-003 and PUR-006) to Sensory Cloud. In studies across adults and children, Fend nasal salt aerosols lowered exhaled particles by approximately 75% and outperformed surgical masks in the clearing of submicron particles.
Relief Therapeutics Holding AG, of Geneva, and Neurorx Inc., of Radnor, Pa., said they established supply chain agreements and ordered sufficient drug substance (RLF-100) to prepare to treat 1 million patients with COVID-19, should the pandemic continue. RLF-100 is still in phase IIb/III trials for the treatment of critical COVID-19 in the U.S. A readout by the study’s data monitoring committee is expected within the next month. European trials with RLF-100 are in preparation and are scheduled to start in the first quarter of next year. The companies have contracted with Nephron Pharmaceuticals Inc. to manufacture commercial supplies of the product in order to ensure that adequate drug inventory will be immediately available, should the clinical trials demonstrate safety and efficacy. They have similarly contracted with Bachem Americas to manufacture sufficient RLF-100 drug substance to treat 1 million patients.
The Russian Direct Investment Fund (RDIF) in Moscow and Pharco Pharmaceuticals, of Alexandria, Egypt, agreed to secure the supply of 25 million doses of the Sputnik V vaccine to Egypt for use against COVID-19. The agreement will enable 25% of Egypt's population to have access to the Sputnik V vaccine. In the future, it is planned to distribute it to neighboring countries. Sputnik V, developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, was registered by the Ministry of Health of Russia in August.
Recce Pharmaceuticals Ltd., of Sydney, said it entered an agreement with the Murdoch Children’s Research Institute to conduct preclinical studies assessing the potential of Recce-435 for the treatment of Helicobacter pylori (H. pylori) infections. Researchers will evaluate the antimicrobial activity of Recce-435 against H. pylori across a range of internationally recognized in vitro and in vivo study models.
Secura Bio Inc., of Las Vegas, said it completed the acquisition of global rights to Copiktra (duvelisib), an oral PI3K inhibitor, for all oncology indications from Verastem Inc., of Boston. The transaction was partially financed with a $70 million debt and convertible debt financing. Copiktra is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies and relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. It also is being developed for peripheral T-cell lymphoma and is being investigated in combination with other agents. A European MAA is pending seeking approval for use in patients with relapsed or refractory CLL/SLL and relapsed or refractory FL.
The Serum Institute of India Ltd., of Pune, India, is receiving support from biopharmaceutical manufacturer ABEC, which is delivering six 4,000-liter CSR bioreactors for manufacturing of COVID-19 vaccine candidate NVX‑CoV2373 (Novavax Inc.). Serum Institute will utilize ABEC’s single-use technologies to advance a global supply of NVX‑CoV2373 throughout India and low- and middle-income countries.
Sorrento Therapeutics Inc., of San Diego, and Viralclear Pharmaceuticals Inc., of Westport, Conn., said they are exploring the synergistic potential of small molecules and antibodies in combination therapies against COVID-19. The agreement will allow for testing of merimepodib with neutralizing antibodies in the Golden Syrian hamster model of COVID-19. Viralclear will contribute the oral antiviral merimepodib (IMPDH inhibitor), which is currently in a phase II trial in combination with remdesivir to treat COVID-19, while Sorrento will initially make available its STI-1400 neutralizing antibody candidate for testing. The study will look for synergy at the effective doses and will try to specifically demonstrate that the combined benefits in strengthening and accelerating viral clearance exceed what each drug could deliver by itself.
Stabilitech Biopharma Ltd., of Burgess Hill, U.K., said it has been renamed Iosbio. The company is working on development of thermally stable vaccines designed to provide both mucosal and systemic immunity against infectious diseases.
Taigen Biotechnology Co. Ltd., of Taipei, Taiwan, said it signed an exclusive licensing agreement with Luminarie Canada Inc., of Montreal, to develop and commercialize Taigexyn (nemonoxacin) in Canada, Australia and New Zealand. Taigexyn is an antibiotic for the treatment of bacterial infections, including those caused by drug-resistant bacteria. Under the terms, Luminarie will be responsible for the development, registration and commercialization of Taigexyn in the territory and will assume all associated costs. Taigen will receive additional regulatory and commercial milestones in the future.
Researchers at the University of Oxford in the U.K. said they are starting a study to explore effectiveness of anti-TNF drug adalimumab as a treatment of patients with COVID-19 in the community, especially care homes. The AVID-CC trial will enroll up to 750 patients from community care settings. The trial is funded by the COVID-19 Therapeutics Accelerator, an initiative set up by Wellcome, the Bill and Melinda Gates Foundation and Mastercard, with support from an array of public and philanthropic donors.
Vedanta Biosciences Inc., of Cambridge, Mass., said it was awarded up to $76.9 million, including $7.4 million up front, from the U.S. Biomedical Advanced Research and Development Authority (BARDA) to advance clinical development of VE-303 for high-risk Clostridioides difficile infection. The funding will support completion of an ongoing phase II trial and further clinical development of VE-303, a rationally defined, orally administered live biotherapeutic product (LBP) consisting of eight commensal bacterial strains. A previous phase Ia/Ib study demonstrated rapid, durable, dose-dependent colonization and accelerated restoration of gut microbiota in healthy volunteers who were pretreated with antibiotics.