Antion Biosciences SA, of Geneva, said it launched its allogeneic T-cell technology platform, known as miCAR, to offer the ability both to silence and express therapeutic proteins in a single step and simplify their development and manufacturing. The miCAR construct is underpinned by the company’s Therapeutic Minigene, or TMG, a synthetic microRNA construct with the ability to silence multiple target genes simultaneously. MiCAR is derived using TMG to form a bimodal gene construct with a chimeric antigen receptor, or CAR. The company’s primary therapeutic focus is oncology, with multiple myeloma as the lead target. Antion also plans to use the miCAR technology to target infectious diseases such as HIV and COVID-19 and sensory disorders, including an inner ear gene therapy.
Privately held Boston Pharmaceuticals Inc., of Cambridge, Mass., said it formed a three-year out-license and option agreement with Glaxosmithkline plc (GSK), of London, becoming a preferred GSK partner for selected pre-phase II programs. Boston Pharma assumed responsibility to develop selected programs through proof of concept, when GSK may opt to reacquire each program under pre-arranged terms for subsequent development and global commercialization. If GSK exercises a repurchase option, Boston will receive a one-time payment and be eligible for approval and sales milestones and royalties. Should GSK choose not to reacquire a program, Boston may continue development and potential commercialization, with GSK eligible to receive milestones and royalty payments. Initially, GSK will out-license and option two programs to Boston: GSK-3903371, a monoclonal antibody targeting the IL-1 receptor accessory protein, which drives tumor growth and immunosuppression, and GSK-3502421, an orally available small-molecule inhibitor targeting receptor interacting serine/threonine kinase 1 for potential treatment of neurological disorders. The agreement builds on a relationship established in 2018, when Boston Pharma acquired five GSK programs.
Can-Fite Biopharma Ltd., of Petach Tikva, Israel, reported data from a preclinical study of CF-602, an adenosine A3 receptor modulator, in a diabetes experimental model of erectile dysfunction (ED). Diabetic Sprague-Dawley (SD) rats were dosed with topical CF-602 at 100 nM or 500 nM or with placebo, with naïve rats serving as a comparative negative control. When assessed by tracing intracavernous pressure under cavernous nerve stimulation, CF-602 dosed at 500 nM showed statistically significant improvement of ED compared to vehicle-treated controls (p<0.001), with better improvement than recorded for the naïve animals.
Dyadic International Inc., of Jupiter, Fla., plans to develop DYAI-100, a SARS-CoV-2-S-RBD vaccine produced using the company's C1-cell protein production platform. Dyadic has contracted with CR20 BV, of Maarssen, the Netherlands, to manage preclinical and clinical development of DYAI-100.
Exelixis Inc., of Alameda, Calif., is collaborating with Merck KGaA, of Darmstadt, Germany, and Pfizer Inc., of New York, to test Exelixis' tyrosine kinase inhibitor, XL-092, with Merck and Pfizer's PD-L1 antibody, Bavencio (avelumab), in patients with locally advanced or metastatic urothelial carcinoma. The combination will be tested in three new cohorts in Exelixis' ongoing Stellar-001 phase Ib study: in patients who have progressed following treatment with an immune checkpoint inhibitor, in patients previously treated with platinum-containing chemotherapy and as a maintenance therapy.
Gilead Sciences Inc., of Foster City, Calif, and Novo Nordisk A/S, of Bagsvaerd, Denmark, expanded their clinical collaboration in nonalcoholic steatohepatitis to include a phase IIb study testing Novo Nordisk’s GLP-1 receptor agonist, semaglutide, and Gilead’s FXR agonist, cilofexor, and its ACC inhibitor, firsocostat. The four-arm 440-patient study, which will test the drugs alone and in combination, is expected to begin recruitment in the second half of 2021.
Hoth Therapeutics Inc., of New York, entered a research agreement with the University of Cincinnati Research Institute for the antimicrobial in vitro characterization of its antibiotic HT-006. Hoth plans to use the data for an FDA program that allows the use of nonclinical animal studies to reduce clinical studies required for approval of antibiotics that treat serious bacterial diseases with an unmet need.
Indivumed GmbH, of Hamburg, Germany, and Xlife Sciences AG, of Zurich, co-founded Ix Therapeutics GmbH to develop oncology drugs. Ix will initially focus on colon and lung cancer, working with Xlife spinout Veraxa Biotech AG to use its platform to develop therapeutic antibodies. Indivumed will contribute its Indivutype multi-omics database to validate drug targets.
ITM AG, of Garching, Germany, signed two strategic agreements with Telix Pharmaceuticals Ltd., of Indianapolis, to supply of its therapeutic radioisotope no-carrier-added lutetium-177, Endolucinbeta, for Telix's prostate cancer treatment, TLX-591 (177Lu-rosapatamab). The agreements cover supply for both the upcoming phase III study and commercial production if the drug is approved.
Matrisys Bioscience Inc., of La Jolla, Calif., licensed MSB-3163 from Richard Gallo’s laboratory at the University of California San Diego School of Medicine. MSB-3163 is a strain of Staphylococcus capitis that was effective against Cutibacterium acnes in multiple preclinical models of acne.
Novamind Inc., of Toronto, will help run a clinical trial testing MK-1942 from Kenilworth N.J.-based Merck & Co. Inc. for treatment-resistant depression through its Cedar Clinical Research unit. The phase IIa study is expected to start enrolling patients in March 2021.
Onk Therapeutics Ltd., of Galway, Ireland, licensed the rights to make and use a clinically validated GMP-grade feeder cell line that enables expansion of natural killer (NK) cells from the U.S. NIH. Onk plans to use the feeder cell line to manufacture its NK cells that expresses both a chimeric antigen receptor targeting a tumor antigen and a TNF-related apoptosis-inducing ligand variant targeting the death receptor pathway.
Pyxis Oncology Inc., of Boston, licensed two antibody-drug conjugate (ADC) drugs, PYX-201 and PYX-203, from Pfizer Inc., of New York. Pyxis also gains access to Pfizer's ADC technology platform to develop additional drugs. PYX-201 targets an undisclosed tumor-restricted antigen that is overexpressed in several solid tumor types. PYX-203 targets an undisclosed antigen expressed in certain hematologic malignancies.
Spybiotech Ltd., of Oxford, U.K., licensed the Suretechnology Platform to generate stable, high-yield production cell lines from Geneva-based Selexis SA. Spybiotech plans to use the technology to produce SPYVLP-102, its vaccine for human cytomegalovirus.
The University of Oxford published data on the pre-print server Biorxiv that show antibodies generated from ChAdOx1 nCoV-19 (Oxford and Astrazeneca plc) and BNT-162b2 (Pfizer Inc. and Biontech SE) were capable of neutralizing coronavirus variants, albeit at a lower level. Serum from ChAdOx1 nCoV-19 had geometric mean neutralization titers that were reduced 2.9-fold (p<0.0001) for the P.1 (Brazil) strain relative to the original Victoria strain. Neutralization titers for BNT-162b2 were reduced 2.6-fold (p<0.0001) for P.1 relative to the Victoria virus. For the B.1.351 (South Africa strain) the neutralization titers were reduced ninefold and 7.6-fold for serum from people vaccinated with ChAdOx1 nCoV-19 and BNT-162b2, respectively.