4D Pharma plc, of Leeds, U.K., said it filed a registration statement Form F-4 with the U.S. SEC, following its Oct. 22 announcement of the proposed merger with Longevity Acquisition Corp., a Nasdaq-listed special purpose acquisition company. On completion of the merger and listing of its American depositary shares on Nasdaq under the ticker LBPS, the company will become dual-listed, with ordinary shares continuing to be traded on the London AIM market under the ticker DDDD. The merger is expected to be complete and Nasdaq listing to become effective in the first quarter of 2021.
AB Science SA, of Paris, and the European Investment Bank (EIB) disclosed the signing of a loan agreement totaling €15 million (US$17.9 million) to fund the clinical development program evaluating masitinib as a treatment for COVID-19. The initial partnership with the EIB might be expanded in the future, as discussions are already underway about additional financing for other indications in which masitinib is or could be evaluated, for a maximum budget of €30 million. The COVID-19 loan consists of two tranches of €6 million each, and a third tranche worth €3 million. The first tranche is expected to be released in the coming weeks. The remaining two tranches will be made available at a later stage, subject to certain milestones, including clinical progress in AB Science’s study regarding the treatment of COVID-19 and the company’s future equity funding.
Abu Dhabi has spearheaded the launch of the Hope Consortium to facilitate COVID-19 vaccine distribution across the world. The Hope Consortium represents a complete supply chain solution to address vaccine transport, demand planning, sourcing, training and digital technology infrastructure, and facilitate vaccine availability across the world. The consortium has pooled its collective expertise to garner a multifaceted capability to move and store more than 600 million vials – whether in single or multidoses – in cold and ultra-cold conditions in 2021, rising to more than 1.8 billion vials by the end of next year – the largest capacity and capability regionally and one of the largest globally.
Ascentage Pharma Group International, of Suzhou, China, said it entered an agreement with the University of Michigan, through which the company may obtain the exclusive global rights to a MDM2 protein degrader developed using the Proteolysis-Targeting Chimeras (PROTACs) technology. The drug candidate is currently entering IND-enabling studies.
Bioinvent International AB, of Lund, Sweden, and Cantargia AB, of Stockholm, said the former was contracted as manufacturer for Cantargia’s antibody, CAN-10, in preclinical development for treating systemic sclerosis and myocarditis. CAN-10 is a fully humanized monoclonal antibody targeting IL1RAP and has been designed to block the signaling of the inflammatory cytokines IL-1, IL-33 and IL-36. Under the agreement, which may generate revenue for Bioinvent of up to SEK30 million (US$3.5 million), Bioinvent will provide process development, scale-up, supply of material for toxicological studies and clinical-grade material in 1,000-liter scale for use in phase I and II trials. The majority of the work will be completed in 2021 to start clinical trials as early as possible during 2022.
Biovaxys Technology Corp., of Vancouver, British Columbia, said it received further data from its completed murine model study, demonstrating that immunizing mice with two doses of BVX-0320, its COVID-19 vaccine candidate, induced high levels of antibodies against the S1 fragment of the SARS-CoV-2 spike protein associated with inhibition of the binding of the virus to cells of the respiratory tract. Biovaxys scientists also observed a clear dose response, with lower levels of antibodies induced by the two lowest doses tested of 0.3 ug and 1 ug (median titers 1:59 and 1:124, respectively), and with significantly higher antibody levels with the two highest doses tested of 3 ug and 10 ug (median titers 1:4800 and 1:9430, respectively). No toxicity was noted in mice at any dose level.
Dr. Reddy’s Laboratories Ltd., of Hyderabad, India, said it entered a definitive agreement with Glenmark Pharmaceuticals Ltd., of Maharashtra, India, to acquire, subject to completion of certain precedent actions and closing activities, brands Momat Rino (for Russia, Kazakhstan and Uzbekistan), Momat Rino Advance (for Russia), Momat A (for Kazakhstan and Uzbekistan), Glenspray and Glenspray Active (for Ukraine), along-with rights to the trademarks, dossiers and patents for the territories mentioned. The acquired brands represent two types of products, a mometasone mono product and a combo product comprising mometasone and azelastine, and are indicated for the treatment of seasonal and perennial allergic rhinitis. Terms were not disclosed.
Egle Therapeutics SAS, of Paris, said it achieved the first milestone in its research alliance with Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, in which Egle will validate tumor-infiltrating regulatory T-cell (Treg) targets and Takeda will develop potential therapies. Upon achievement of the target identification, Egle will receive an undisclosed R&D milestone payment and investment from Takeda.
Eisai Co. Ltd., of Tokyo, and Wren Therapeutics Ltd., of Cambridge, U.K., said they entered an exclusive research collaboration agreement aiming to advance the discovery of small molecules that target alpha-synuclein for the potential treatment of synucleinopathies, including Parkinson’s disease and dementia with Lewy bodies. The collaboration will use Wren’s network kinetics drug discovery platform, alongside Eisai’s experience in drug discovery for neurodegenerative disorders, to accelerate the development of clinical candidates.
Entheon Biomedical Corp., of Vancouver, British Columbia, which is developing psychedelic medicines to treat addiction, said its shares have commenced trading on the Frankfurt Stock Exchange under the symbol 1XU1.
Gain Therapeutics Inc., of Bethesda, Md., said it inked a research collaboration with the University of Maryland School of Medicine (UMSOM) to investigate Gain’s structurally targeted allosteric regulators (STARs) in cellular models of neuronopathic Gaucher disease (nGD) and Parkinson’s disease (PD). STARs are small molecules targeting allosteric binding sites on enzymes. They are designed to cross the blood-brain barrier and penetrate other hard-to-treat organs such as bone and cartilage, stabilize the effective enzyme to restore function and reduce toxic substrate. Under the terms, UMSOM will investigate Gain’s STAR candidates in macrophage and neuronal models of nGD and GBA-associated PD.
Geovax Labs Inc., of Atlanta, said it signed a patent and biological materials license agreement with the National Institute of Allergy and Infectious Diseases, part of the U.S. NIH, in support of Geovax’s nonclinical development of vaccines against numerous pathogens. The agreement provides Geovax with access to certain materials and patent rights owned by agencies of the Department of Health and Human Services for use in combination with the company’s technology for the creation of preventive and/or therapeutic vaccines against Ebola-Zaire, Ebola-Sudan, Lassa virus, Marburg virus, Zika virus and malaria. The agreement also extends to the company’s research and development efforts in certain oncology areas. Financial terms were not disclosed.
Hitgen Inc., of Chengdu, China, and Cedilla Therapeutics Inc., of Cambridge, Mass., entered a research collaboration to identify and develop drug candidates directed to a validated, high-value target in oncology that has remained beyond the reach of previous efforts. Hitgen has applied it DEL technology and discovered program compounds that met certain criteria, and Cedilla has received an exclusive license to those compounds as well as associated intellectual property for further development and commercialization. Under the terms, Hitgen will be eligible for milestone payments and sublicensing income from Cedilla as the project progresses, in addition to research payments and an up-front license fee.
Jaguar Health Inc., of San Francisco, said it and its wholly owned subsidiary, Napo Pharmaceuticals Inc., are planning to develop and commercialize crofelemer for an indication of prophylaxis and/or symptomatic relief of inflammatory diarrhea, initially to be studied in a “long-hauler” COVID-19 recovery patient population in Europe. As part of that plan, the company is engaged in preliminary discussions with Swiss Growth Forum, a sponsor of a European special purpose acquisition company (SPAC), "Post Pandemic Recovery Equity,” regarding the SPAC's potential merger with an operational subsidiary of the company to be established in Europe with an exclusive license to crofelemer and Mytesi for the indications of inflammatory diarrhea and HIV-related diarrhea. The preliminary terms under discussion include an up-front cash license fee to Napo ranging from about $2 million to $10 million; funding for the European operation of at least $20 million to pursue clinical development of crofelemer for inflammatory diarrhea in a long-hauler COVID-19 recovery patient population; and equity ownership in the European subsidiary by Napo ranging from 30% to 49.9% post-acquisition by the SPAC, with lower equity ownership in conjunction with a higher up-front cash license fee received by Napo. Other customary financial terms include royalties and transfer pricing on the supply of crofelemer and Mytesi to the European operation.
Macrogenics Inc., of Rockville, Md., said $25 million in milestones have been achieved under its exclusive global collaboration and license agreement with Incyte Corp., of Wilmington, Del., for retifanlimab, an anti-PD-1 monoclonal antibody designed by Macrogenics and licensed to Incyte (as INCMGA-0012). The milestones were triggered by clinical and regulatory activities related to the further advancement of the molecule, including the recent initiation of POD1UM-303, Incyte’s phase III global study in patients with metastatic squamous cell anal carcinoma.
Maplight Therapeutics Inc., of San Francisco, said it received a $8.1 million grant from the Michael J. Fox Foundation for Parkinson's Research (MJFF) to undertake a large-scale, systematic investigation of the brain circuits and mechanisms that are responsible for triggering psychiatric symptoms in Parkinson's disease. Results are expected to inform identification of drug targets and therapeutic strategies to address anxiety and depression related to Parkinson's disease neurodegeneration.
NMD Pharma A/S, of Aarhus, Denmark, said it received a grant of €629,000 (US$751,966) from The Innovation Fund Denmark to develop a ClC-1 inhibitor as a drug to reverse neuromuscular blockade after surgery. In separate news, the firm said it moved its corporate headquarters to Incuba A/S, one of Denmark’s leading research parks for companies in the health care, cleantech and IT sectors.
Oncolys Biopharma Inc., of Edison, N.J., said it was informed of the achievement of the first milestone in accordance with the license agreement for OBP-601 concluded between Oncolys and Transposon Therapeutics Inc., of Westport, Conn. Under terms of the deal, entered June 15, Transposon is conducting development of OBP-601 for the treatment of life-threatening and debilitating diseases. The achievement entitles Oncolys to receive undisclosed milestone revenue. In addition, Oncolys is expected to receive an up-front payment from Transposon in the spring of 2021 ahead of schedule. The exclusive worldwide license, with sublicensing rights, is valued at more than $300 million.
SAB Biotherapeutics Inc., of Sioux Falls, S.D., said, as part of Operation Warp Speed, the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, and the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense have awarded SAB $57.5 million in expanded scope for its Diversitab Rapid Response Antibody Program contract for the manufacturing of SAB-185, the company’s clinical-stage therapeutic candidate for COVID-19. SAB-185 is currently being tested in an ongoing phase I trial in healthy volunteers and an ongoing phase Ib trial in patients with mild or moderate COVID-19.
Sanofi SA, of Paris, and Kiadis Pharma NV, of Amsterdam, provided a status update on Sanofi’s pending acquisition of Kiadis. The companies anticipate the offer, in which Sanofi values shares of Kiadis at €5.54 (US$6.62) per share, will close in the first half of 2021.
Sonnet Biotherapeutics Holdings Inc., of Princeton, N.J., said it completed a nonhuman primate (NHP) study of SON-1010, a fully human interleukin-12 therapeutic candidate configured using Sonnet's Fully Human Albumin Binding (FHAB) platform, designed to target tumor and lymphatic tissue, providing a mechanism for dose-sparing and an opportunity to improve the safety and efficacy profile of IL-12, as well as other immunomodulators. Data from the study indicate that in healthy cynomolgus macaques of both sexes, a single dose of SON-1010 is well-tolerated at dosage levels greater than 50 times the anticipated exposure in human clinical trials. Additionally, SON-1010 elicited a prolonged and potent on-target pharmacodynamic effect as measured by interferon-gamma, a key biomarker of antitumor activity. On-target and transient changes in clinical chemistry and pathology parameters were observed, but resolved completely within 14 to 21 days post-dosing. Signs of cytokine imbalance, or uncontrolled increase of pro-inflammatory cytokines, including TNF-α, IL-1β and IL-6 were notably absent from all dose levels tested in the study. Pharmacokinetic analysis of serum samples from the study animals indicated a mean half-life of 40 (±6.9) hours for subcutaneous dose routes and 27.45 (±2.8) hours for intravenous dose routes. The company anticipates an IND submission in the second half of 2021.
Sunesis Pharmaceuticals Inc., of South San Francisco, and Viracta Therapeutics Inc., of San Diego, said they entered a definitive merger agreement, in which Viracta will combine with Sunesis in an all-stock transaction. The merged company will focus on the advancement and expansion of Viracta’s clinical-stage, precision oncology pipeline targeting virus-associated malignancies, including Viracta’s lead program for the treatment of Epstein-Barr virus-positive relapsed/refractory lymphomas. Under the terms, pending stockholder approval, stockholders of Viracta will receive shares of newly issued Sunesis common stock. Viracta stockholders are expected to own about 86% and Sunesis stockholders will own about 14% of the combined company on a fully diluted basis using the treasury stock method. The combined firm will be led by Viracta’s current management team and will be headquartered in Cardiff, Calif. Upon completion of the merger, the combined company will operate under the name Viracta Therapeutics Inc. and intends to be listed on Nasdaq under the symbol VIRX. Shares of Sunesis (NASDAQ:SNSS) closed Nov. 30 at 1.86.
Telix Pharmaceuticals Ltd., of Melbourne, Australia, said it entered an agreement with Scintec Diagnostics GmbH, of Baar, Switzerland, to acquire Therapharm GmbH, a Swiss-German biotech company developing diagnostic and therapeutic solutions in the field of hematology. The deal will provide Telix with access to a portfolio of patents, technologies, production systems, clinical data and know-how in relation to the use of Molecularly Targeted Radiation (MTR) in hematology and immunology. Therapharm is developing antibody MTR technology against CD66, a cell surface target highly expressed by neutrophils and tumor-infiltrating lymphocytes. Terms of the deal were not disclosed.
Titan Pharmaceuticals Inc., of South San Francisco, said its board approved a 1-for-30 reverse stock split of the company's common stock, which became effective at 5 p.m. ET Nov. 30, Shares will begin trading on a split-adjusted basis on Nasdaq upon market open on Dec. 1.
Viiv Healthcare Ltd., of London, and the Medicines Patent Pool said they signed a new voluntary licensing agreement to enable greater access in certain upper-middle-income countries to dolutegravir (DTG)-based regimens that have been recommended by the World Health Organization or the U.S. Department of Health and Human Services. The countries are Azerbaijan, Belarus, Kazakhstan and Malaysia. Under the agreement, selected generic manufacturers will have the opportunity to supply DTG-based medicines at a significantly reduced price compared to local prices, the company said.