Arvinas Inc., of New Haven, Conn., made public five programs from its preclinical pipeline based on its Protac platform. They include programs targeting B-cell lymphoma 6 protein, a transcriptional repressor implicated in B-cell lymphomas and facilitates B-cell tolerance of rapid proliferation and somatic gene recombination via repressing cell cycle checkpoints, terminal differentiation, apoptosis, and the DNA damage response; KRAS, a classic “undruggable” target; Myc proteins, which are implicated in up to 70% of all human cancers; hematopoietic progenitor kinase 1, a suppressor of T-cell activation; and huntingtin gene, which is mutated in patients with Huntington’s disease.
Blue Oak Pharmaceuticals Inc., of Concord, Mass., and Exscientia Ltd., of Oxford, U.K., said they entered a drug discovery collaboration to treat brain disorders, combining Blue Oak’s therapeutic area expertise and ability to design CNS-focused privileged chemotypes with Exscientia’s ability to apply AI technologies to design bispecific small molecules. Financial terms were not disclosed.
Boehringer Ingelheim GmbH, of Ingelheim, Germany, and Oxford Biotherapeutics Ltd., of Abingdon, U.K., said they are building on their partnership and are establishing a new alliance. The push focuses on finding additional selective cancer targets. Boehringer will use Oxford’s OGAP platform to identify target opportunities for immunotherapies utilizing its T-cell engager, cancer vaccine and oncolytic virus platforms. That follows the start of the first patient dosing in a phase I trial with a bispecific antibody for the treatment of patients with small-cell lung carcinoma and other neoplasms, where the target for the bispecific antibody was discovered during the first phase of the partnership.
Dendreon Pharmaceuticals Inc., of Seal Beach, Calif., disclosed publication of an analysis examining real-world survival outcomes in men with metastatic castrate-resistant prostate cancer (mCRPC) who were treated with the company’s Provenge (sipuleucel-T) and commonly prescribed oral treatments. The analysis of Medicare claims data from more than 6,000 fee-for-service beneficiaries showed that the addition of Provenge to either Zytiga (abiraterone, Johnson & Johnson) or Xtandi (enzalutamide, Astellas Pharma Inc./Pfizer Inc.) at any point in a patient’s mCRPC treatment regimen, reduced the risk of death by 41% and prolonged median overall survival by 14.5 months. Findings were published in Advances in Therapy.
Emmaus Life Sciences Inc., of Torrance, Calif., said it sold all remaining common shares of South Korea-based Telcon RF Pharmaceutical Inc., in accordance with the Telcon agreement reported by Emmaus in an 8-K filed Dec. 23, 2019. The total net sale proceeds were ₩42 billion (about US$36.6 million). Based on the terms of the 2019 agreement, Emmaus will lend ₩30 billion to Telcon in the form of a convertible bond, a move the company said will eliminate the volatility and negative impact the Telcon shares periodically had on Emmaus' stockholders' equity and better position Emmaus for a potential future up-listing of its common stock to Nasdaq or the NYSE American.
Enzolytics Inc., of Plano, Texas, signed a binding letter of intent to merge with Bioclonetics Immunotherapeutics Inc., of Dallas, replacing the earlier nonbinding letter signed on Sept. 12. Bioclonetics is in the final stage of development of a parent monoclonal antibody that is non-toxic and has shown in initial in vitro testing to be effective against more than 95% of all strains and viral subtypes of HIV-1 against which it has been tested. Terms were not disclosed.
Gilead Sciences Inc., of Foster City, Calif., disclosed that the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 with respect to Gilead’s cash tender offer for Immunomedics Inc., of Morris Plains, N.J., has expired. On Sept. 25, Gilead and Immunomedics filed premerger notification and report forms with the Federal Trade Commission and the Antitrust Division of the U.S. Department of Justice.
Kadmon Holdings Inc., of New York, said it will voluntarily transfer its stock exchange listing from the New York Stock Exchange to Nasdaq. The company will retain the KDMN ticker with trading on Nasdaq expected to begin on Oct. 26.
Lactiga Inc., of Princeton, N.J., said it is collaborating with the Icahn School of Medicine at Mount Sinai to advance preclinical research into LCTG-001 as a potential treatment for COVID-19 patients. The collaborative team, led by Rebecca Powell, assistant professor of medicine (infectious diseases), secured an NIH R01 Emergency Award of $2 million to expand that study. To date, preliminary in vitro studies have shown full neutralization of SARS-CoV-2 viral components, emphasizing the potential applicability of LCTG-001 to COVID-19 infections. Lactiga has engaged the FDA through the Coronavirus Treatment Acceleration Program to optimize its transition from research toward first-in-human testing.
Mediwound Ltd., of Yavne, Israel, said it is exploring the pharmacological effect of Escharex on biofilm burden associated with chronic wounds based on the scientific evidence showing that enzymatic debridement might be an effective means to treat and reduce the biofilm burden. Escharex contains a mixture of proteolytic enzymes enriched in bromelain and has demonstrated in phase II trials that it can debride various chronic hard-to-heal wounds within a few daily applications. A paper published in Infection and Drug Resistance indicated that bromelain enzyme may be an effective means of eradicating biofilm and a promising strategy to improve treatment of multidrug-resistant bacterial infections.
Moberg Pharma AB, of Stockholm, said it will request pre-submission meetings with regulatory agencies, with the goal of submitting a registration application in the second half of 2021 in Europe for MOB-015. In June, Moberg offered top-line results from the second of two clinical trials in onychomycosis. After the European meetings, the company intends to discuss next steps for the U.S. market in an advice meeting with the FDA.
Novan Inc., of Morrisville, N.C., said positive in vitro results show the potential efficacy of its platform technology as an antiviral against SARS-CoV-2, the virus that causes COVID-19. The company initiated in vitro assessments targeting the reduction of viral burden in differentiated normal human bronchial epithelial cells, and the results demonstrate the first instance of an antiviral effect from a nitric oxide-based medicine in a 3D tissue model that has similar structure to the human airway epithelium, according to Novan. The results from the in vitro assessment of concentrations as low as 0.75 mg/mL demonstrated that berdazimer sodium reduced 90% of virus after repeat dosing, once daily.
Passage Bio Inc., of Philadelphia, said data in a murine model of GM1 gangliosidosis (GM1) demonstrate that a single intracerebroventricular injection of an optimized adeno-associated virus into cerebral spinal fluid resulted in significant expression of beta-galactosidase (β-gal) in the brain and peripheral tissues, and demonstrated dose-related reductions in neuronal lysosomal storage lesions, neurological impairment and improvement in survival. GM1 is a rare and often life-threatening monogenic lysosomal storage disease caused by mutations in the GLB1 gene, which encodes lysosomal acid β-gal. Reduced β-gal activity results in the accumulation of toxic levels of GM1 in neurons throughout the brain, causing rapidly progressing neurodegeneration, according to Passage.
Polyphor AG, of Allschwil, Switzerland, said it received a new and second nondilutive funding award from CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator), a global partnership led by Boston University supporting development of antibacterial products and for diagnosing, preventing and treating drug-resistant infections. The award will support development of the thanatin derivatives program belonging to Polyphor’s Outer Membrane Protein Targeting Antibiotic class of antibiotics to potentially treat life-threatening infections caused by difficult-to-treat gram-negative bacteria. CARB-X will provide Polyphor with initial funding of up to $2.62 million to complete the hit-to-lead stage and up to $15.82 million if certain project milestones are met. The funding is the second major support for Polyphor’s antibiotics program and follows a 2019 grant.
Qihan Biotech Inc., of Hangzhou, China, said it initiated a program to create immunologically privileged human stem cells enabling development of improved allogeneic cell therapies. In collaboration with an undisclosed company in the production and differentiation of clinical, GMP-grade human stem cells, Qihan said it will leverage its genome editing technology to reduce immunogenicity of human stem cells to limit their ability to provoke an immune response. Once differentiated into different cell types, the cells have the potential to be used as universal, allogeneic therapies while reducing or eliminating the need for immunosuppressive drugs, the company added.
Redhill Biopharma Ltd., of Tel Aviv, Israel, and Raleigh, N.C., said it will collaborate with two specialist pharmaceutical manufacturers in Europe and Canada to ramp up manufacturing of opaganib, currently in global phase II/III and phase II studies for severe COVID-19 pneumonia, to support potential emergency use applications and subsequent demand. Opaganib is an oral, sphingosine kinase-2 selective inhibitor with dual anti-inflammatory and antiviral activity that targets a host cell component, potentially minimizing the likelihood of viral resistance.
Secarna Pharmaceuticals GmbH & Co. KG, of Marburg, Germany, and Denali Therapeutics Inc., of South San Francisco, entered a research and option agreement to develop antisense therapies for treating neurodegenerative diseases. Secarna will receive an undisclosed target-based technology access fee. Following the discovery and lead selection phase, Denali has a target-based option to in-license the development programs. If Denali exercises an option, Secarna will receive an option exercise fee as well as development and commercial milestone payments plus tiered royalties.
Vaxart Inc., of South San Francisco, said top-line results from its hamster challenge study show that all hamsters receiving two oral doses of its COVID-19 vaccine candidate showed no systemic weight loss, a key indicator of protection against COVID-19 in an animal model. The study evaluated Vaxart’s recombinant adenoviral vaccine, with doses given at zero and four weeks. Animals were challenged with SARS-CoV-2 at week eight. Top-line data demonstrated that all unvaccinated animals lost at least 8% of their body weight and all showed evidence of lung disease as measured by relative weight gain in the lungs. By contrast, all animals vaccinated with two doses of the oral vaccine maintained or gained body weight by the end of the experiment, a statistically significant result (p<0.001).
Xoma Corp., of Emeryville, Calif., said it earned $1.9 million in payments from two partners. The company earned $1.4 million in accelerated payments from Rezolute Inc., of Redwood City, Calif., in connection with its recent private placement to continue advancing RZ-358 for congenital hyperinsulinism and RZ-402 for diabetic macular edema in clinical development. In a separate collaboration, Xoma said it was told by another partner that it advanced an undisclosed asset in Xoma’s milestone and royalty portfolio into phase II development, triggering a $500,000 milestone payment.