Ability Pharmaceuticals SL, of Barcelona, Spain, said the mechanism of action of ABTL-0812 has been published in Autophagy and that the findings confirm a new strategy to tackle cancer based on the reticular stress (ER stress) that the compound induces in tumors, causing cell destruction by cytotoxic autophagy. ABTL-0812 is being tested in a phase II open-label trial in Spain and France in patients with endometrial cancer or squamous cell lung cancer, as a first-line treatment in combination with chemotherapy and as a maintenance treatment after the chemotherapy cycles.
Acepodia Inc., of San Francisco, and Taipei, Taiwan, presented data at the 2020 BIO Digital Conference from its cell therapy pipeline that leverages both antibody cell conjugation technology (ACC) and current CAR technologies, including preclinical data from lymphoma models showing that ACE-1755, a CD19-targeting CAR-oNK cell therapy candidate, demonstrated antitumor potency and better survival extension in comparison to CD19 CAR cord blood-derived NK cells being developed by other research groups. Preclinical studies from ACE-1975, a CD70-targeting ACC-oNK cell therapy in development for acute myeloid leukemia and renal cell carcinoma, demonstrated the ability to potentially kill cancer stem cells. Data from PD-L1-targeting ACC-oNK therapy ACE-1708 showed antitumor efficacy against PD-L1-expressed cancer cells of both solid and liquid tumors.
Alphamab Oncology Co. Ltd., of Suzhou, China, and Paris-based Sanofi SA said Jiangsu Alphamab Biopharmaceuticals Co. Ltd., a wholly owned subsidiary of Alphamab Oncology, signed an agreement with Sanofi (China) Investment Co. Ltd. for a collaboration to advance clinical studies of KN-026 in combination with Taxotere (docetaxel) in HER2-positive breast cancer, and Sanofi has been granted an exclusivity period to negotiate the in-licensing of KN-026 if it achieves certain clinical milestones. Current clinicals trials with the compound have shown promising preliminary efficacy and safety in late-stage breast cancer patients who have failed multiple treatments in China.
Applied Biomath Inc., of Concord, Mass., said it was awarded a grant, supported by the National Institute of General Medical Sciences of the NIH, for the development of its antibody-drug conjugate (ADC) workbench software platform to facilitate knowledge discovery and enable rapid knowledge qualification in support of the development of quantitative systems pharmacology models for ADC projects. The ADC workbench will integrate the company’s mechanistic understanding of ADC pharmacokinetics and pharmacodynamics with its emerging understanding of ADC toxicodynamics particularly for hematological toxicities (e.g., neutropenia and thrombocytopenia), to help partners quantify risk, develop better ADCs, and reduce late-stage attrition rates.
Azitra Inc., of Branford, Conn., said it opened a new 12,000-square-foot laboratory and office complex in Branford, moving from three small labs located at the Technology Incubator Program accelerator in Farmington.
Brainstorm Cell Therapeutics Inc., of New York, said the ALS Association and I AM ALS have awarded the company a combined grant of $500,000 to support an amyotrophic lateral sclerosis (ALS) biomarker research study. The grant will be used to draw insights from data and samples collected from patients enrolled in its ongoing phase III trial of Nurown treatment, and to further understand biomarkers associated with treatment response for people with ALS. The study will evaluate how Nurown interacts with its targets in the brain and spinal cord and explore the changes in the biomarkers that may correlate with response to the treatment. The company will share data and samples with the ALS community so that the results can be independently validated and to advance other ALS research.
Canbridge Pharmaceuticals Inc., of Beijing, said it initiated a research program with the Horae Gene Therapy Center at the UMass Medical School in Worcester, Mass., for gene therapy research in rare genetic diseases, with a focus on neuromuscular conditions.
Cardiff Oncology Inc., of San Diego, initiated its Expanded Access Program for onvansertib in combination with standard-of-care FOLFIRI and bevacizumab for second-line treatment of patients with KRAS-mutated metastatic colorectal cancer (mCRC). The compassionate use program is recognized by the FDA as a follow-on to granting fast track designation to onvansertib, an oral, selective adenosine triphosphate competitive inhibitor of the serine/threonine polo-like-kinase 1 enzyme, which is overexpressed in multiple cancers, including leukemias, lymphomas and solid tumors. The Cardiff program is intended for patients with KRAS-mutated mCRC who have progressed on prior FOLFOX (with or without bevacizumab) therapy.
Chelation Partners Inc., of Halifax, Nova Scotia, said its lead molecule, DIBI, may be useful in treating sepsis. A new study assessing the effects of the iron chelator on the immune response to systemic inflammation induced by gram-positive and gram-negative bacterial toxins concluded that DIBI treatment decreased leukocyte hyperactivation induced by gram-positive and gram-negative toxins. In some cases, it preserved capillary perfusion, reduced plasma inflammatory markers and attenuated tissue damage. Those findings support DIBI, a water soluble, 9kDa, polymer anti-infective agent equipotent against drug-resistant organisms, for treating COVID-19 patients and systemic inflammation, including sepsis, the company said.
CN Bio Innovations Ltd., of Cambridge, U.K., and Cambridge University said they have identified a novel regulatory pathway regulating the underlying mechanism of nonalcoholic steatohepatitis (NASH). The group said it demonstrated that bone morphogenetic protein 8B (BMP8B), a poorly characterized member of the BMP/TGF-beta superfamily, exhibits marked up-regulation during nonalcoholic fatty liver disease to NASH disease progression. The surge of BMP8B was shown to be an important mediator of liver disease progression and a leading pathogenic mediator of the wound healing response of NASH, presenting itself as a potential therapeutic target, the company added.
Cortexyme Inc., of South San Francisco, said the International Nonproprietary Naming Committee of the World Health Organization selected atuzaginstat as the proposed international nonproprietary name for the company’s lead product candidate, COR-388. Atuzaginstat is an oral, twice-daily investigational medicine in late-stage clinical development for treating Alzheimer’s disease. It is designed to inhibit lysine gingipain, a virulence factor protease released by P. gingivalis.
Debiopharm International SA, of Lausanne, Switzerland, granted Verity Pharmaceuticals Inc., of Wayne, Pa., the rights to commercialize Trelstar (triptorelin pamoate for injectable suspension), a hormone therapy for patients living with prostate cancer. Trelstar is an agonist analogue of the natural gonadotropin-releasing hormone (GnRH). It is the only GnRH agonist that differs from natural GnRH by a single amino acid, the company said. Trelstar is engineered to deliver superagonist activity to decrease the amount of certain hormones in the body.
Destiny Pharma plc, of Brighton, U.K., said it was jointly awarded a National Biofilms Innovation Centre grant to fund a research collaboration with Cardiff University. The project will establish the potential of three of the company's XF drug compounds, DPD‑207, XF-70 and XF-73, as treatments for clinically important fungal infections in mucosal mouth models of disease. Financial terms of the collaboration have not been disclosed. Oral fungal biofilms are responsible for serious oral infections but successful treatment is hindered by biofilm resistance and a limited number of effective antifungal drugs, the company said. The project will evaluate the XF drug candidates in combatting Candida biofilms and their infection risk using Cardiff's oral mucosal models.
Fujifilm Corp., of Tokyo, plans to make a capital investment of about ¥100 billion (US$928 million) in the Denmark site of Fujifilm Diosynth Biotechnologies, a contract development and manufacturing organization for biologics and advanced therapies.
IGY Immune Technologies & Life Sciences Inc., of Thunder Bay, Ontario, said it will collaborate with clinical data and regulatory expert MMS Holdings to further the development of IgY-110, an anti-CoV-2 therapeutic antibody with a focus on a nasal spray application. The approach of an IgY antibody in a nasal spray will be complementary to any vaccine developed, the company said. Currently in the preclinical stage, the antibody is being tested at the Canadian Government National Microbiology Lab in Winnipeg, Manitoba, and is intended to treat those currently infected with COVID-19 by controlling and blocking the spread of coronavirus.
Isoplexis Corp., of Branford, Conn., said it was awarded a Phase 2 Small Business Innovation Research grant from the National Institute on Aging for $2 million to continue analyzing the highly multiplexed proteomic responses of trafficking leukocytes in patients with Alzheimer's disease, neuroinflammation and related neurodegenerative diseases. Funds will be used to expand the development of a functional proteomic platform to determine effects of the inflammatory immune response on Alzheimer's progression.
Kalytera Therapeutics Inc., of San Francisco, said preclinical proof-of-concept data show its R-107 liquid nitric oxide donor candidate for pulmonary arterial hypertension (PAH) was effective in a classic rodent model designed to mimic life-threatening COVID-19 lung disease. The company said the rodent model correlates closely with the human clinical presentation of lung failure during COVID-19-associated acute respiratory distress syndrome and PAH.
Leading Biosciences Inc. (LBS), of Carlsbad, Calif., is working with Donnelley Financial Solutions to manage remote monitoring of its COVID-19 study. The FDA recently cleared LBS to conduct a phase II study of its lead investigational drug, LB-1148, for the treatment of pulmonary dysfunction associated with COVID-19 pneumonia.
Meabco Inc., of Chicago, said it was awarded a contract valued at up to $5.9 million, funded in whole or in part with federal funds from the NIH’s National Institute of Allergy and Infectious Diseases, to accelerate the development of BP-C2 as a treatment for cutaneous radiation injuries. The three-year contract consists of a one-year base period with two one-year optional periods that will allow Meabco to complete IND-enabling studies and advance BP-C2 as a therapy for treating the effects of unintentional radiation exposure.
Nanomab Technology Ltd., of London, is participating as an industrial partner in the Engineering and Physical Research Council (EPSRC) program for Next Generation Imaging and Therapy with Radionuclides (MITHRAS). The program was awarded £6 million (US$7.6 million) from EPSRC.
Nanoviricides Inc., of Shelton, Conn., signed a memorandum of understanding for antiviral treatments targeting coronavirus infections with Theracour Pharma Inc., of West Haven, Conn. Nanoviricides plans to retain an independent consultant to evaluate the assets before signing a full license agreement.
Oncology Venture A/S, of Hoersholm, Denmark, acquired the remaining 37% ownership in its pan-tyrosine kinase inhibitor, dovitinib, from Saas & Larsen ApS for SEK36 million (US$3.9 million) and a 10% royalty for the first 24 months. Oncology Venture will pay for the up-front payment with about 25.9 million shares of the company.
Ose Immunotherapeutics SA, of Nantes, France, said preclinical data it plans to present at the American Association of Cancer Research virtual meeting describe identification and characterization of a new myeloid checkpoint target, CLEC-1 (a C-type lectin receptor), and the first monoclonal antibody antagonists of CLEC-1 identified as a step in cancer immunotherapy. Tumor cells inhibit myeloid cells phagocytosis through CLEC-1. The antagonists developed by Ose block the new CLEC-1/CLEC-1L myeloid checkpoint and constitute a novel cancer immunotherapy, in particular synergistic with chemotherapy, the company said.
Pharmamar SA, of Madrid, licensed the rights to its cancer drug, Yondelis (trabectedin), in Taiwan, Hong Kong and Macao to TTY Biopharm Co. Ltd., of Taipei, Taiwan, for an undisclosed up-front payment. Pharmamar is also eligible for a regulatory milestone payment. Pharmamar will produce the drug.
Royalty Pharma, of New York, acquired a partial royalty interest on Prevymis (letermovir) from Aicuris Anti-infective Cures GmbH, of Wuppertal, Germany. Aicuris will receive $220 million for the undisclosed royalty.
Sensorion SA, of Montpellier, France, reported preclinical data on its gene therapy program expressing otoferlin. Through its partnership with Institut Pasteur, the company was able to express green fluorescent protein in the cochlear tissue of two out of three treated nonhuman primates. Sensorion plans to develop the program for deafness caused by a mutation in otoferlin.
Thermogenesis Holding Inc., of Rancho Cordova, Calif., noted that the Institute of Biomedical Sciences and School of Life Sciences, East China Normal University, the research partner of Thermogenesis' joint venture Immunecyte Inc., published data on neutralizing antibodies to SARS-CoV-2, the coronavirus that causes COVID-19, in bioRxiv. Three rounds of phase display screening were performed to find four fully human monoclonal antibodies able to block entry of SARS-CoV-2 into cells at 12.5 nM.
Twist Bioscience Corp., of South San Francisco, is collaborating with Serimmune Inc., of Goleta, Calif., to develop an antibody targeting SARS-CoV-2, the coronavirus that causes COVID-19. The collaboration will use Serimmune's Serum Epitope Repertoire Analysis (SERA) platform to map the antigenic targets of antibody candidates from Twist's libraries. Those epitopes will be used to rescreen Twist's libraries. Twist will be responsible for advancing all antibodies resulting from the collaboration.
Ubivac Inc., of Portland, Ore., said it entered a clinical trial collaboration with Bristol Myers Squibb Co., of New York, to evaluate the safety, tolerability and preliminary efficacy of Ubivac’s investigational product, DPV-001, a cancer vaccine that exploits autophagy, in combination with BMS’ anti-OX40 (BMS-986178) combined with sequenced administration of PD-1 immune checkpoint inhibitor Opdivo (nivolumab). The phase Ib multicenter trial will test the combination immunotherapy in patients with advanced triple-negative breast cancer.
Valneva SE, of Saint-Harblain, France, noted that its Lyme disease vaccine collaboration with Pfizer Inc., of New York, became effective, triggering a $130 million up-front payment from Pfizer.
Vault Pharma Inc., of Los Angeles, is working with the University of California, Los Angeles and other universities to incorporate its bioparticle-based delivery system in potential COVID-19 vaccination.