Autifony Therapeutics Ltd., of Stevenage, U.K., said it regained full rights to its clinical stage Kv3 program as Boehringer Ingelheim GmbH will not exercise its option under the asset purchase agreement they created in December 2017. Autifony received €25 million (US$29.57 million) up front, followed by €17.5 million (US$20.7 million) in milestone payments during the option period. The Kv3 program produced positive data in a ketamine challenge clinical trial in healthy volunteers, in which the lead molecule, AUT-00206, demonstrated CNS target engagement. During the option period, Autifony also completed a safety study with AUT-00206 in treating schizophrenia, generating biomarker data supporting further development.
Bavarian Nordic A/S, of Copenhagen, said it initiated a new share buy-back program in which the company intends to buy back up to 52,397 of its shares. The buybacks meet the company’s obligations arising from share-based incentive programs for the board of directors and executive management under the company’s remuneration policy. Bavarian Nordic said it may purchase up to 10% of its share capital.
Cancer Research UK and the U.S. National Cancer Institute have created the Cancer Grand Challenges initiative to target research roadblocks. The partnership brings the Cancer Grand Challenges investment to £426 million (US$550 million). The two said they expect to co-fund approximately four awards for each round of Cancer Grand Challenges, with each multidisciplinary team being awarded approximately £20 million (US$25 million) over five years.
Positive preclinical COVID-19 vaccine results from Heat Biologics Inc., of Durham, N.C., show the company’s gp96-based vaccine, gp96-Ig-S, significantly increased the frequency of systemic and tissue-specific CD8+ T-cells by conferring cellular immunity needed against any viral infection, including SARS-CoV-2. The data also said the vaccine primed potent effector memory CD8+ T-cell responses and tissue resident memory CD8+ T cells localized in the lung as protection against respiratory virus infection. The company's gp96 platform is designed to activate immune responses against cancer or pathogenic antigens.
Hitgen Inc., of Chengdu, China, achieved a milestone in its collaboration with Almirall SA, of Barcelona, Spain, as Hitgen said it generated “a number” of novel small-molecule leads for an undisclosed target nominated by Almirall. Hitgen will grant exclusive rights to Almirall for further development and commercialization, and be eligible for preclinical and clinical milestone payments from Almirall as the project progresses, in addition to an up-front license fee. Almirall is a global biopharmaceutical company focused on skin health.
Oncology Venture A/S, of Hørsholm, Denmark, said that it adopted stenoparib as the name for its PARP1/2 inhibitor, 2X-121. The company also reported that stenoparib, tested as a single agent in preclinical studies, inhibited coronavirus in LLC-MK2 cells. In addition, when combined with the antiviral remdesivir (Gilead Sciences Inc.), which blocks the RNA replication enzyme, stenoparib inhibited SARS-Cov-2 in VERO E6 cells. Based on the findings, Oncology Venture plans to advance the compound into trials to treat COVID-19.
OS Therapies LLC, of Cambridge, Md., said it agreed to co-exclusive licensing of Si-linker and cassette payload technologies developed by Blinkbio Inc., of Juno Beach, Fla., and exclusive licensing of the company’s technology targeting folate receptor alpha to treat tumors and other diseases. Financial terms were not disclosed.
PTC Therapeutics Inc., of South Plainfield, N.J., said it received a $20 million milestone payment from Roche Holding AG, of Basel, Switzerland, triggered by the first U.S. commercial sale of Evrysdi (risdiplam), approved by the FDA on Aug. 7, 2020, to treat spinal muscular atrophy in adults and children 2 months of age and older.
Q Biomed Inc., of New York, said that a GMP production contract was initiated, in conjunction with technology partner Mannin Research Inc., of Toronto, for MAN-19, a therapeutic whose undisclosed mechanism is designed to treat complications associated with COVID-19 infection. The companies said a phase I trial is slated to begin in February 2021.
Trevena Inc., of Chesterbrook, Pa., said a clinical utility function analysis conducted on data from the phase I study of Olinvyk (oliceridine) regarding the ventilatory response to hypercapnia showed that, over the clinically relevant concentration range, the opioid agonist had a higher probability of providing analgesia than producing respiratory depression, while morphine had a higher probability of producing respiratory depression than providing analgesia, as predicted in the drug’s clinical utility function model. The data were reported in Anesthesiology. The drug was approved by the FDA on Aug. 7, 2020, to manage moderate to severe acute pain in adults in controlled use settings.
Tyme Technologies Inc., of Bedminster, N.J., said it selected TYME-19, a synthetic bile acid, to advance into the clinic against COVID-19 infection. In preclinical testing, TYME-19 prevented COVID-19 viral replication without attributable cytotoxicity to the treated cells. The company is partnering with Massachusetts General Hospital and the Weill Cornell Medical Center to design a proof-of-concept trial for recently diagnosed, symptomatic patients with defined risk factors that will measure indicators of safety and efficacy, including time to resolution of symptoms, changes in viral load and rate of hospitalization. The study is expected to begin following customary site approvals.
VBI Vaccines Inc., of Cambridge, Mass., reported findings from preclinical studies that evaluated antibody binding and neutralizing antibody titers across multiple vaccine constructs. The studies were designed to assess the impact of VBI’s enveloped virus-like particle (eVLP) platform technology vs. recombinant vaccine candidates along with differences in the conformation of the spike protein and a variety of adjuvants. After a single dose, VBI’s eVLPs expressing a stabilized pre-fusion form of the COVID-19 spike protein elicited a neutralizing antibody geometric mean titer (GMT) four times higher than the GMT of high-titer convalescent sera, increasing to 64 times higher after a second dose. The same eVLPs induced, after one dose, an antibody binding GMT 10 times higher than both the GMT of high-titer convalescent sera and the GMT induced with a stabilized pre-fusion recombinant spike protein. As a result of the studies, VBI selected VBI-2901 – a trivalent pan-coronavirus vaccine candidate expressing the SARS-CoV-2 (COVID-19), SARS-CoV (SARS) and MERS-CoV (MERS) spike proteins, and VBI-2902, a monovalent vaccine candidate expressing the SARS-CoV-2 spike protein – to advance into an adaptive phase I/II study, expected to begin around year-end 2020. GMP clinical manufacturing is set to begin in September 2020 at Therapure Biomanufacturing, a unit of Therapure Biopharma Inc., of Mississauga, Ontario.