Allakos Inc., of Redwood City, Calif., reported results from a prospective study examining the rates of elevated eosinophil and mast cell levels in patients with chronic unexplained gastrointestinal (GI) symptoms or functional gastrointestinal GI disorders such as irritable bowel syndrome and functional dyspepsia. The results suggest that eosinophilic gastritis and/or eosinophilic duodenitis are significantly underdiagnosed, Allakos said. The study involved biopsies of 556 patients.
Anaptysbio Inc., of San Diego, said it amended its immuno-oncology collaboration with Glaxosmithkline plc (GSK), of London, which agreed to increase royalties to Anaptysbio on net sales of PD-1 inhibitor dostarlimab from a range of 4% to 8%, with the 8% tier applicable to global net sales above $1 billion, to an amended range of 8% to 25%. Anaptysbio is set to receive 8% of annual global net sales below $1 billion and 12% to 25% of net sales above $1 billion. Cash milestone payments of $1.1 billion due under the collaboration agreement remain unchanged. With dostarlimab under review by the FDA and EMA for the first two indications, Anaptysbio said it stands to receive $75 million in milestone payments over the next 18 months, along with $165 million in potential sales milestones. GSK also agreed, starting Jan. 1, 2021, to pay Anaptysbio a 1% royalty on GSK’s global net sales of Zejula (niraparib), gained during its December 2018 acquisition of Tesaro Inc., which also originally licensed dostarlimab from Anaptysbio. In addition, GSK agreed to pay Anaptysbio a one-time cash payment of $60 million within 30 days. In return, GSK gained the freedom to conduct development and commercialization of Zejula in combination with any third-party molecules. On Oct. 26, Anaptysbio shares (NASDAQ:ANAB) defied market trends, gaining $2, or 7.7%, to close at $27.73.
Biovaxys Technology Corp., of Vancouver, British Columbia, said it entered a research collaboration with Ohio State University covering the company’s preclinical SARS-CoV-2 vaccine candidate, BVX-0320. Researchers from the organizations will study neutralizing antibodies generated by the agent against live SARS-CoV-2 virus.
Cohbar Inc., of Menlo Park, Calif., offered preclinical data demonstrating that combination of a CB5138 analogue with Ofev (nintedanib, Boehringer Ingelheim GmbH), the leading standard of care for treatment of idiopathic pulmonary fibrosis (IPF), produced enhanced effects compared to Ofev alone in mice. The new data from the therapeutic mouse model of IPF showed that treatment with the combination of CB5138-2 and Ofev produced greater reductions in fibrosis, inflammation, pro-inflammatory cytokine levels and collagen deposition. CB5138 analogue peptides are modified analogues of a natural peptide sequence encoded in mitochondrial DNA.
Collegium Pharmaceutical Inc., of Stoughton, Mass., said a report in Pain Medicine presented real-world evidence related to abuse, misuse and diversion of Xtampza ER (oxycodone) extended-release capsules assessed using Researched Abuse, Diversion and Addiction-Related Surveillance, or RADARS, system data sources. When Xtampza ER was compared to immediate-release oxycodone, other abuse-deterrent formulation extended-release products and non-abuse-deterrent formulation extended-release products, the publication concluded that its abuse, misuse, diversion and tampering were low vs. comparators and that abuse and diversion did not increase over the study period. Collegium cautioned that data generated in real-world studies are inherently less controlled than those in clinical trials and should be interpreted with caution.
Contrafect Corp., of Yonkers, N.Y., said it initiated an expanded access program to provide exebacase, its recombinantly produced lysin, for use in treating persistent bacteremia caused by methicillin-resistant Staphylococcus aureus (MRSA). The company is providing access under a treatment protocol available to clinical sites participating in the ongoing phase III study, which enables physicians to use exebacase to treat severely ill COVID-19 patients with persistent MRSA bacteremia, despite treatment with standard-of-care antibiotics.
Cytodyn Inc., of Vancouver, British Columbia, reported that two patients have demonstrated noticeable signs of improvement following treatment with leronlimab (PRO-140), a CCR5 antagonist, in helping their recovery from stroke. The most recent patient was administered under Mississippi’s Right to Try statute. The second patient was receiving treatment with leronlimab as part of her therapy for breast cancer. The treating physician noted her partial paralysis was mitigated relatively quickly, which may have been causally related to the posited role of CCR5 in stroke.
Geovax Labs Inc., of Atlanta, said it concluded a patent and biological materials license agreement with the National Institute of Allergy and Infectious Diseases (NIAID), a unit of the U.S. NIH, supporting development of the company’s vaccine against SARS-CoV-2. The agreement gives Geovax access to NIAID’s patent rights in the stabilized Spike protein and allows the company to use materials and patent rights owned by HHS agencies in combination with its technology to create a modified vaccinia ankara virus-virus like particle, or MVA-VLP, candidate aiming to prime and/or boost the immune system against COVID-19. Geovax also gained nonexclusive rights to develop, manufacture and commercialize a resulting COVID-19 vaccine. Financial terms were not disclosed.
Lidds AB, of Uppsala, Sweden, said intratumoral injection of NZ-TLR9, its Nanozolid formulation of a Toll-like receptor 9 agonist, resulted in antitumoral efficacy and antitumoral immune responses in mouse tumor models. NZ-TLR9 forms an intratumoral depot that releases the TLR9 agonist for least six weeks, minimizing repeated injections. The study also identified plasma biomarkers suitable to measure the biological activity of NZ-TLR9 in a planned human trial.
Moderna Inc., of Cambridge, Mass., said it concluded a supply agreement with the Ministry of Public Health of Qatar for mRNA-1273, its vaccine candidate against COVID-19.
Olema Pharmaceuticals Inc. (Olema Oncology), of San Francisco, said it formed a clinical collaboration with Novartis AG, of Basel, Switzerland, to evaluate OP-1250, its complete estrogen receptor antagonist and selective estrogen receptor degrader, in combination with the pharma’s Kisqali (ribociclib) or Piqray (alpelisib) in recurrent, locally advanced or metastatic ER+/HER2-negative breast cancer. Olema is responsible for conducting the trial, and Novartis agreed to supply its drugs and contribute funding.
Quell Therapeutics Ltd., of London, said it agreed to conduct a joint research program with the Sheffield Institute for Translational Neuroscience (Sitran), an international center of excellence within the University of Sheffield, to accelerate validation of Quell’s engineered T regulatory cell therapy platform to treat neuroinflammatory diseases. Quell plans to access the disease expertise and translational capabilities of the Sitran team, including Sitran’s suite of in vitro and in vivo disease models, to validate multiple therapeutic candidates. The collaboration will include translational work to explore the immunobiology of neurodegenerative diseases by profiling patient biosamples.
Resverlogix Corp., of Calgary, Alberta, said its late-stage candidate, apabetalone, was featured in an article in Medicine in Drug Discovery that highlighted the link between BET proteins and COVID-19. The paper noted that the two most frequently mentioned causes of multi-organ damage produced by SARS-CoV-2 are direct viral toxicity and cytokine-release syndrome, with damage involving organs and systems where apabetalone previously showed clinical benefits. As a direct inhibitor of BET proteins with the potential to counter inflammation, the authors proposed apabetalone as a potential therapeutic with likely efficacy against COVID-19.
Revolution Medicines Inc., of Redwood City, Calif., said it signed an agreement with Astrazeneca plc, of Cambridge, U.K., to enter a clinical collaboration to study RMC-4630 in combination with an emerging asset from Astrazeneca’s preclinical efforts targeting KRAS G12C. Under the agreement, Astrazeneca will sponsor and conduct the combination study and Revolution Medicines will provide clinical supply of RMC-4630.
TFF Pharmaceuticals Inc., of Austin, Texas, said it expanded its engagement with contract manufacturing organization Experic LLC, of Cranbury, N.J., through an agreement to install a thin film freezing processing line and associated capabilities at the company’s cGMP facility in Cranbury. Installation of TFF’s equipment is expected to conclude early in the second quarter of 2021.
Titan Pharmaceuticals Inc., of South San Francisco, said it reached an agreement to settle approximately $5.2 million in debt obligations with Molteni & C. dei F.lli Alitti Società di Esercizio SpA and Horizon Credit LLC II, secured with a lien on Titan’s assets, in exchange for $1.6 million in cash to the companies; the transfer of certain Probuphine (buprenorphine) assets to Molteni, including equipment, inventory and non-U.S. Probuphine intellectual property; and termination of Titan's rights to future payments under its asset purchase, supply and support agreement with Molteni. Closing of the agreement is subject to Titan's completion of a financing to cover the cash payments. Upon closing, Titan will have no liens against its assets, including its Proneura (buprenorphine sustained release implant) intellectual property.