Atreca Inc., of South San Francisco, said it entered a strategic research collaboration with Merck & Co. Inc., of Kenilworth, N.J., to identify the antigenic targets of select antibodies discovered by the company that could be focused on oncology. Under the terms of the agreement, Atreca will receive an up-front cash payment and retain exclusive ownership and rights to develop all Atreca antibodies included in the collaboration, while Merck will receive a right-of-first-negotiation should the company seek to partner or out-license one or more of those antibodies. Following target identification, both companies will have freedom to advance therapeutic candidates against the target(s) identified under the collaboration, with development and commercial milestones payable by either party.
Chiesi Farmaceutici SpA., of Parma, Italy, said it created Chiesi Global Rare Diseases, a new business unit based in Boston, that will take advantage of the resources of the Chiesi Group to advance research and new product development for rare and ultra-rare diseases. The initial focus of the unit will be research and product development in lysosomal storage disorders, rare hematology and ophthalmology disorders.
Curis Inc., of Lexington, Mass., said it has amended its collaboration, license and option agreement with Bangalore, India-based Aurigene Discovery Technologies Ltd. that specifies Aurigene will fund and conduct a phase IIb/III randomized study evaluating CA-170, an orally available, dual inhibitor of V-domain Ig suppressor of T-cell activation (VISTA) and PD-L1, in combination with chemoradiation, in approximately 240 patients with nonsquamous non-small-cell lung cancer. In return, Aurigene receives the rights to develop and commercialize CA-170 in Asia, in addition to its existing rights that cover India and Russia, based on the terms of their original agreement signed in January 2015. Curis retains the U.S., EU, and rest-of-world rights to CA-170, and is entitled to receive royalty payments on potential future sales of CA-170 in Asia.
Evgen Pharma plc, of Wilmslow, U.K., which is developing sulforaphane-based medicines for the treatment of multiple diseases, said its longstanding collaboration with the University of Manchester has led to the discovery of a gene signature that may predict patient response to SFX-01 in advanced estrogen receptor-positive breast cancer. Previously, they have shown that SFX-01 inhibits activity of STAT3, a transcription factor known to play a role in therapy resistance, and cancer metastases. In the latest study, in hormone therapy-resistant patient tumors, SFX-01 was shown to inhibit expression of key STAT3-regulated genes. That discovery yields further insight into the mechanism of action of SFX-01 and moves the company closer to determining those patients who are most likely to respond favorably to treatment.
Foamix Pharmaceuticals Ltd., of Rehovot, Israel, and Menlo Therapeutics Inc., of Redwood City, Calif., said shareholders of both firms voted to approve all proposals necessary to complete the companies’ previously announced merger. The two said in November they would merge to create a company focused on the commercialization and development of therapeutics to serve patients in the dermatology space.
Generex Biotechnology Corp., of Miramar, Fla., said it is working with third party groups and government agencies to reactivate previous research and development to generate Ii-Key peptide vaccines against pandemic viruses. The Nugenerex Immuno-Oncology (formerly Antigen Express) Ii-Key technology uses synthetic peptides that mimic essential protein regions from a virus that are chemically linked to the four-amino acid Ii-Key to ensure robust immune system activation. That modification can be applied to any protein fragment of any pathogen to increase the potency of immune stimulation (up to 100-fold) while maintaining absolute specificity of response, the company said.
Genprex Inc., of Austin, Texas, said it has regained compliance with the minimum bid price requirement for continued listing on Nasdaq.
Janone Inc., of Las Vegas, said it executed a manufacturing agreement for the formulation and manufacturing of TV-1001SR, a treatment for peripheral artery disease, with CDMO Corerx. Janone said it expects formulation process to begin in March and phase IIb trials to start in the fourth quarter of 2020.
Jounce Therapeutics Inc., of Cambridge, Mass., said new data on the identification of the predictive biomarker to be used for patient selection in the SELECT clinical trial of vopratelimab (vopra) was presented at the ASCO-SITC Clinical Immuno-Oncology symposium in Orlando, Fla. It introduces TISvopra, a baseline RNA signature with a threshold optimized for the emergence of ICOS hi CD4 T cells, a vopratelimab pharmacodynamic biomarker not associated with PD-1 inhibitor therapy. When applied to ICONIC clinical data, it predicted clinical outcomes from the trial better than PD-L1 immunohistochemistry. TISvopra-positive patients treated with vopratelimab alone or in combination with Opdivo (nivolumab, Bristol-Myers Squibb Co.) also showed improved clinical benefit as compared with TISvopra-negative patients in the ICONIC trial. In the upcoming SELECT trial, TISvopra will be used to select patients for treatment with vopratelimab and JTX-4014, Jounce’s PD-1 inhibitor. Separately, the company announced a research collaboration with Nanostring Technologies Inc., of Seattle, a provider of life science tools for translational research, to support the application of the predictive biomarker to be used in the SELECT trial to evaluate the efficacy of JTX-4014 alone and in combination with vopratelimab. The companies will apply an optimized selection threshold of the TIS based on the emergence of ICOS hi CD4 T cells.
Researchers from Marinomed Biotech AG, of Vienna, and the University of Utah published initial evidence suggesting that pergolide solubilized by the Marinosolv platform could provide a therapeutic approach to restore corneal sensation and visual acuity loss due to neurotrophic keratopathy. Marinosolv was identified as a feasible aqueous carrier for the poorly soluble drug’s formulation as eye drops. The study was published in Investigative Ophthalmology & Visual Science.
Oncternal Therapeutics Inc., of San Diego, said that a single dose of its anti-ROR1 chimeric antigen receptor T-cell (CAR T) constructs, evaluated in an animal model of human leukemia, expanded in treated animals and the chimeric T cells trafficked to disease sites. By week four, leukemia cells were cleared from major tissue reservoirs, including bone marrow, kidneys and spleen. CAR T cell-treated animals survived longer than 90 days compared to 21 days for animals in control groups, and the cells remained active and detected in mouse tissues more than two months after injection. The data were presented at the American Society of Clinical Oncology-Society for Immunotherapy of Cancer meeting in Orlando, Fla. The company is developing ROR1 CAR T therapy to treat aggressive hematological malignancies or solid tumors.
Scholar Rock Holding Corp., of Cambridge, Mass., presented a preclinical poster on SRK-015, an inhibitor of latent myostatin activation, at the SMA Europe 2nd International Scientific Congress in Paris, showing improved muscle strength following administration of muSRK-015P, a mouse analogue of SRK-015, in mouse models of early and late SMN restoration. Treatment with muSRK-015P resulted in increases of 20% to 51% in maximal torque (at ≥ 40 Hz) of the plantar flexor muscle group and a greater percentage of muscle fibers vs. placebo (vehicle). Multifold increase in serum latent myostatin levels following treatment with muSRK-015P in both early and late SMN restoration mouse models confirmed the presence of the latent myostatin target in a modeled diseased setting. Relative dose-proportional accumulation of serum latent myostatin also showed target engagement in rats and cynomolgus monkeys following administration of SRK-015 vs. no meaningful change with placebo.
Summit Therapeutics plc, of Oxford U.K., said it achieved the initial enrollment target at sites in Latin America for phase III trials of ridinilazole to treat Clostridium difficile infection, triggering its first milestone payment of $1 million under its license and collaboration agreement with Eurofarma Laboratórios SA, of Sao Paulo, Brazil.
The Bill & Melinda Gates Foundation said it will immediately commit up to $100 million for the global response to the 2019 novel coronavirus (2019-nCoV) outbreak. The support is designed to strengthen detection, isolation and treatment efforts; protect at-risk populations; and develop vaccines, treatments and diagnostics. That funding is inclusive of the $10 million it committed to the outbreak last month. Up to $20 million has been earmarked for the acceleration of the detection, isolation and treatment of people diagnosed with the virus with the goal of interrupting transmission and containing the disease and will go to multilateral organizations such as WHO and the U.S. CDC. Support will also be directed to national public health authorities in China and other countries that have reported confirmed cases. In order to help accelerate the discovery, development and testing of vaccines, treatments and diagnostics for 2019-nCoV, the foundation will commit up to $60 million.