Aimmune Therapeutics Inc., of London, said findings from the European qualitative APPEAL-2 (Allergy to Peanuts ImPacting Emotions And Life-2) study evaluating the psychosocial burden of peanut allergy were published in Clinical & Experimental Allergy. In the study, children and teenagers reported a negative impact of peanut allergy on social activities, indicating they avoid restaurants and other places, including school, as a strategy to manage the disease. More than one-third of caregivers reported that their child’s peanut allergy had a negative impact on their own work, including the need for time off and reduced work hours.
Bio-Thera Solutions Ltd., of Guangzhou, China, and Beigene Ltd., of Beijing, said they executed a license, distribution and supply agreement for China, including Hong Kong, Macau and Taiwan, for BAT-1706, Bio-Thera’s biosimilar candidate to Avastin (bevacizumab, Roche Holding AG). Bio-Thera, which retained rights outside the partnered territory, is set to receive an up-front payment and is eligible for regulatory and commercial milestone payments of up to $165 million, along with tiered double-digit sales royalties. The agreement is subject to approval by Bio-Thera shareholders at a meeting planned for September 2020. The NMPA recently accepted the BLA for the VEGF ligand inhibitor, whose reference drug is approved in China to treat advanced, metastatic and relapsed non-small-cell lung cancer and metastatic colorectal cancer.
Bristol Myers Squibb Co. (BMS), of New York, said it inked a definitive agreement to acquire privately held Forbius, also known as Formation Biologics Inc., of Toronto, in exchange for an up-front and potential milestone payments, all undisclosed. The transaction includes the TGF-beta assets in Forbius’ portfolio, including lead candidate, AVID-200, a selective TGF-beta 1/3 antagonist that BMS plans to advance initially in oncology. Prior to the transaction’s closing, assets outside Forbius’ core TGF-beta portfolio will be transferred to a newly formed company that will be retained by existing Forbius shareholders. The companies expect to complete the transaction in the fourth quarter of 2020. Bofa Securities serves as financial adviser to Forbius.
Cancer Genetics Inc., of Rutherford, N.J., and privately held Stemonix Inc., of Maple Grove, Minn., said they agreed to merge through an all-stock transaction. Cancer Genetics will acquire the outstanding stock of Stemonix in exchange for shares representing approximately 78% of its outstanding common stock, with its current equity holders retaining 22% of the combined entity’s common shares. Stemonix is expected to operate as a wholly owned subsidiary of Cancer Genetics under the Stemonix name, and the combined company expects to remain listed on the Nasdaq, where Cancer Genetics trades as CGIX. The boards of directors of both companies approved the proposed merger, which is expected to close in the fourth quarter of 2020, subject to approval by shareholders of both companies and other customary conditions. H.C. Wainwright & Co. is financial advisor to Cancer Genetics, with Northland Securities Inc. serving as financial advisor to Stemonix. On Aug. 24, CGIX shares reached a one-year high of $10.39 before closing at $7.33 for a gain of $4.42, or more than 150%.
Cassava Sciences Inc., of Austin, Texas, said lead candidate PTI-125 was assigned the chemical drug name sumifilam by the U.S. Adopted Names Council. Sumifilam, which Cassava is advancing to treat Alzheimer’s disease, is the first of a class of drugs that bind filamin proteins.
Compass Therapeutics Inc., of Cambridge, Mass., said data describing the discovery and preclinical characterization of CTX-2026, its anti-CD277 antibody, were published in Science. CTX-2026 binds to the CD277 antigen expressed on members of the butyrophilin family, including BTN3A1. The paper reported that BTN3A1 is overexpressed in malignant ovarian cancers compared to benign ovarian tumors and normal tissue and that higher average BTN3A1 expression in samples from 200 ovarian cancer patients with clinical data was associated with reduced patient survival. In preclinical models, CTX-2026 elicited coordinated alpha beta and gamma delta T-cell responses, preventing alpha beta T-cell inhibition while inducing gamma delta T-cell activation to suppress the growth of established ovarian tumors. CTX-2026 antibodies transformed BTN3A1 from an immunosuppressive to an immunostimulatory mediator, restoring pre-existing antitumor immune responses in immunocompetent syngeneic mouse models. CTX-2026 targeting of CD277 also was associated with greater activity than a PD-1 blocker in orthotopic xenograft and syngeneic models of ovarian cancer.
Cytrx Corp., of Los Angeles, disclosed additional steps to strengthen its corporate governance and support its strategic priorities, including its focus on achieving operational efficiencies and preserving capital. The company said it reached an agreement with stockholder Jerald Hammann, who agreed to withdraw his notice of nomination and not stand for election to the board of directors at the company’s 2020 annual meeting, scheduled for Sept. 3, 2020. Cytrx also agreed to add an independent director to its board within one year of the 2020 annual meeting, using a process that will include retention of a professional search firm and input from stockholders. The company said it will cap compensation to the CEO and chief financial officer and fees paid to board members at current levels for a two-year period following the 2020 annual meeting and will refrain from submitting proposals to authorize additional shares during that time.
Eyepoint Pharmaceuticals Inc., of Watertown, Mass., said it secured a purchase and marketing agreement for Dexycu (dexamethasone intraocular suspension) 9% with Vantage Outsourcing, of Effingham, Ill., a cataract surgical service provider to hospitals, ambulatory surgery centers and physicians across a 25-state service area. Financial terms were not disclosed.
Privately held Harbour Biomed, of Shanghai, said it concluded a strategic collaboration with Vir Biotechnology Inc., of San Francisco, to discover, develop and commercialize therapeutic molecules in immuno-oncology and infectious diseases. Harbour Biomed will employ its technologies, including its transgenic Harbour Mice platforms, to generate antibodies for the partnership. Both companies then will apply their expertise in basic science to advance immunotherapeutic candidates into the clinic. Financial terms were not disclosed.
Hercules Pharmaceuticals Inc., of Leiden, the Netherlands, published preclinical data in Nature Neurosciences on its aryl hydrocarbon receptor (AhR) inhibitor HP-163. The drug reduced viral replication in animals infected with Zika virus and reduced microencephaly. HP-163 also had in vitro efficacy against dengue. In a prepublication article on Research Square, Hercules showed AhR is activated during coronavirus infection, suggesting that HP-163 could be used as a treatment for COVID-19.
Immunogenesis Inc., of Houston, said it was awarded a $15.5 million grant from the Cancer Prevention and Research Institute of Texas to advance development of IMGS-001, its dual specific checkpoint inhibitor and tumor microenvironment (TME) remodeling agent. IMGS-001 is thought to have the potential to provide superior blockade of the PD-1 pathway and to clear immunosuppressive elements in the TME, facilitating efficacy in immunologically cold cancers of the prostate, colon and pancreas.
Innovation Pharmaceuticals Inc., of Wakefield, Mass., reported the receipt of additional data from a U.S. regional biocontainment laboratory derived from ongoing in vitro testing of brilacidin, a polymer-based antibiotic, to treat SARS-CoV-2. In a human lung epithelial cell line, when incubated with the live virus, brilacidin was shown to inhibit the virus by 50% at a mid-nanomolar concentration while remaining non-cytotoxic to cells at high micromolar concentrations, establishing a selectivity index exceeding 300 in the lung cell line. Innovation said it is preparing to expedite trials of brilacidin in COVID-19. Interactions with the FDA, through the agency’s coronavirus treatment acceleration program, are expected to begin in early September, along with the company’s selection of a contract research organization.
Medexus Pharmaceuticals Inc., of Montreal, said triamcinolone hexacetonide (TH) injectable suspension 20 mg/mL was approved for inclusion as a general benefit on the list of medications in the Basic Plan and List of Medications for institutions administered by the Régie de l’assurance maladie du Québec, ensuring that the long acting corticosteroid is covered by the basic prescription drug insurance plan with no restrictions on reimbursement.
Moderna Inc., of Cambridge, Mass., said it concluded advanced exploratory talks with the European Commission regarding a potential purchase agreement to supply 80 million doses of mRNA-1273, its vaccine candidate against COVID-19, to member states, with an option to purchase 80 million additional doses. The company said the phase III study of mRNA-1273, which began on July 27, 2020, is on track to complete enrollment of approximately 30,000 participants in September 2020.
Nantkwest Inc., of El Segundo, Calif., and privately held Immunitybio Inc., of Culver City, Calif., said they signed a definitive agreement to develop, manufacture, market, and commercialize therapeutics and vaccines targeting COVID-19, agreeing to share equally costs incurred after Aug. 21, 2020, and to split profits from the arrangement on a 60% to 40% basis, with the larger share going to the company that developed the product. The companies also agreed to shared governance of the collaboration. Candidates in development under the agreement include an allogeneic bone marrow-derived mesenchymal stem cell therapy from Nantkwest aimed to reduce the time a critically ill patient spends on a ventilator and a recombinant bivalent adenovirus vector-delivered SARS-CoV-2 S + N protein vaccine from Immunitybio that is being readied for a phase I trial.
Organicell Regenerative Medicine Inc., of Miami, reported results from the first outpatient "long-hauler" COVID-19 patient treated with Zofin as part of an emergency, expanded access program. When discharged from the hospital after a seven-week stay, the patient was physically limited due to severe deconditioning and having shortness of breath. After three doses of Zofin, the patient was free of post-COVID-19 complications. Organicell has additional expanded access approvals from the FDA to treat two additional patients and plans to submit phase I/II INDs to treat COVID-19 long-haulers.
Xbiotech Inc., of Austin, Texas, said the FDA’s emergency use authorization for COVID-19 convalescent plasma (CCP) to treat COVID-19 enabled the company to deploy its antibody screening technology to identify CCP. Xbiotech collaborated with Biobridge Global, of San Antonio, to develop the test to detect antibodies in patient blood that attack the COVID-19 virus. Biobridge is using the test to identify CCP and using the plasma to produce naturally immune blood products to treat people hospitalized with the coronavirus. Xbiotech also is using CCP samples from Biobridge to identify precise genetic information in individuals who produce natural antibodies against COVID-19 and to discover true human therapeutic antibodies.
Yumanity Therapeutics Inc., of Cambridge, Mass., and Proteostasis Therapeutics Inc. (PTI), of Boston, said they plan to merge, with the combined company operating under the Yumanity name and pursuing development of Yumanity’s pipeline of disease-modifying programs targeting neurodegenerative diseases. The agreement calls for PTI to acquire outstanding shares of privately held Yumanity in exchange for newly issued PTI shares, with existing PTI shareholders expected to own approximately 32.5% of the combined company and Yumanity shareholders the remainder. Richard Peters, Yumanity’s president and CEO, is expected to assume those roles in the combined company, and Yumanity’s board of directors will be expanded to nine individuals to include the appointment of two current PTI directors. The transaction, endorsed by the boards of both companies, is expected to close in the fourth quarter of 2020. The combined company is expected to trade on the Nasdaq as YMTX. PTI also said that it is pursuing a strategic transaction related to its CFTR modulators and plans to share proceeds from any monetization of those assets. In conjunction with the merger, PTI said it reduced its work force by 79%, with five full-time employees remaining to support the proposed transaction and strategic efforts related to the cystic fibrosis assets. MTS Health Partners LP is exclusive financial advisor to PTI. On Aug. 24, 2020, PTI’s shares (NASDAQ:PTI) gained 6 cents to close at $1.36.