AC Immune SA, of Lausanne, Switzerland, reported additional data on ACI-3847, its alpha-synuclein positron emission tomography-(PET) tracer, during an oral presentation at the Alzheimer’s Association International Conference. The company said the agent showed brain uptake and low non-specific retention in a first-in-human study in idiopathic Parkinson’s disease (PD) patients and healthy volunteers. AC Immune said a second imaging agent from the company’s Morphomer platform, ACI-12589, showed target occupancy and signal specificity ex vivo and an expected optimal signal-to-noise ratio in patients, making it a potential precision diagnostic tool for PD.
Acerus Pharmaceuticals Corp., of Toronto, said that production of Natesto (testosterone nasal gel) was underway, with shipments resuming to markets in North America and Asia. The U.S., where the intranasal formulation of testosterone is approved to treat male hypogonadism, is the first country being resupplied to support the Acerus specialty sales force. In August, EU Hwa Pte. Ltd., a subsidiary of Acerus licensee Orient Europharma Co. Ltd., of Taipei, plans to introduce Natesto in Taiwan. OEP also is preparing entry strategies for nearby markets in Asia.
Agenus Inc., of Lexington, Mass., said it closed a $20 million equity investment, at $4.03 per share, by Betta Pharmaceuticals Co. Ltd., of Hangzhou, China, bringing the total received to $35 million. The equity investment by Betta is part of the broader immuno-oncology partnership the firms announced last month. Under the terms, Agenus also is eligible to receive up to $100 million in potential milestones plus royalties on net sales. In exchange, Betta received exclusive rights for the development and commercialization of balstilimab and zalifrelimab, as both monotherapies and combination therapies, excluding intravesical delivery, in greater China, including Mainland China, Hong Kong, Macau and Taiwan.
Anixa Biosciences Inc., of San Jose, Calif., said it plans, in conjunction with the Cleveland Clinic, to file an IND application with the FDA by the end of the third quarter of 2020 for its prophylactic breast cancer vaccine. The technology, invented by Cleveland Clinic researchers, takes advantage of self-proteins that function only at certain times in life. They discovered that one such protein, alpha-lactalbumin, expressed normally in the mammary glands only during lactation, is abnormally expressed again when a woman contracts breast cancer, especially triple-negative breast cancer. The vaccine, validated in animal models, is designed to immunize women following child-bearing age, training the immune system to destroy those cancer cells. Anixa said it is completing the CMC section of the IND and has held two pre-IND meetings with the FDA.
Axial Biotherapeutics Inc., of Waltham, Mass., said The Michael J. Fox Foundation for Parkinson’s Research (MJFF) has awarded the firm a research grant of $440,000 through its Therapeutic Pipeline program. The award will enable development of an in vitro model system of the enteric nervous system derived from alpha-synuclein-overexpressing mice to support the discovery of a small molecule for the treatment of Parkinson’s disease.
Bergenbio ASA, of Bergen, Norway, noted the UK Research and Innovation’s decision to cease the grant funding to the University Hospital Southampton NHS Trust for the COVID-19 ACCORD clinical study in which Bergenbio’s bemcentinib was the lead drug candidate to be tested. Subsequently, the University Hospital Southampton NHS Trust, who is the study sponsor, has notified all sites in the Accord study to cease recruitment of new patients into the trial. Patients already recruited, including those dosed with bemcentinib, will continue on treatment as per the protocol. The move followed the recent reduction of new COVID-19 cases in the U.K. Bergenbio said it is in late-stage set-up to sponsor and conduct a similar study to ACCORD in a country of high COVID-19 incidence and expects to be in a position to update the market in the near future.
Cancer Research UK, the University of Southampton and London-based Touchlight Genetics, said they have established a clinical development partnership to progress a therapeutic DNA vaccine, TGL-100, into an early phase clinical trial targeting head and neck squamous cell carcinoma (HNSCC). The newly designed DNA vaccine combines cancer antigens with Touchlight Genetics’ DNA vector – Doggybone DNA (dbDNA). Unlike plasmid DNA vectors, dbDNA is a double-stranded, linear, covalently closed molecule, which has shown to be an optimal vector for advanced therapies. TGL-100 encodes two antigens overexpressed in HNSCC to induce an antigen-specific antitumor immune response. Under the terms of the agreement, Cancer Research UK’s Centre for Drug Development will sponsor and manage a phase I/II trial to test TGL-100 in HNSCC patients with recurrent metastatic disease.
Crescita Therapeutics Inc., of Laval, Quebec, said it entered an amendment to the development and commercialization agreement with Taro Pharmaceuticals Inc., of Hawthorne, N.Y., with regard to Pliaglis in the U.S. The amendment entitles Crescita to receive a one-time payment of $3.9 million, largely representing a royalty adjustment to past sales as well as an upward modification of future royalty payments. Crescita continues to pursue out-licensing partnerships, with a focus on about 20 countries where Pliaglis has already received regulatory approval. Pliaglis is a topical local anesthetic cream designed to provide local dermal analgesia on intact skin prior to superficial dermatological procedures.
Cure Pharmaceutical, of Oxnard, Calif., said it entered a memorandum of understanding to acquire 100% of Sera Labs for total up-front consideration of $20 million, comprising $19 million in the company’s stock valued at $2.75 each, and $1 million in cash, with an initial, additional commitment of $4 million for working capital in support of accelerating Sera Labs’ growth. The transaction also includes the potential for an earn-out of up to $20 million in Cure stock at $3.34 per share within two years of the closing of the acquisition, contingent upon Sera Labs achieving certain key financial targets.
Futurx Ltd., of Ness Ziona, Israel, a biotech incubator, said Leaps by Bayer, the impact investments unit of Bayer AG, of Leverkusen, Germany, will join Futurx as an investor for incepting and incubating early stage biotechs. Leaps by Bayer will work with the incubator's management team and investors to support its portfolio companies and will participate in seed investment rounds in the new companies to be incepted at Futurx going forward. Futurx has established 20 companies to date.
Grifols SA, of Barcelona, Spain, said it delivered the first manufactured batches of its anti-SARS-CoV-2 hyperimmune globulin for clinical trials. It specifically targets SARS-CoV-2 by providing passive immunity to infected patients and boosting their immune system's ability to fight the disease, the company said. Clinical trials are set to start this summer.
Humanigen Inc., of Burlingame, Calif., said the company and the U.S. NIH executed a clinical trial agreement for lenzilumab, the company’s Humaneered anti-human GM-CSF monoclonal antibody candidate, as an agent to be evaluated in the NIH-sponsored Big Effect Trial (BET) in hospitalized patients with COVID-19. BET will help advance the government’s plan for COVID-19 research, which includes conducting studies to advance high-priority therapeutic candidates. The trial builds on initial data from NIH’s adaptive COVID-19 treatment trial that demonstrated Foster City, Calif.-based Gilead Sciences Inc.’s investigational antiviral, remdesivir, may improve time to recovery in hospitalized patients with COVID-19.
Hutchison China Meditech Ltd. (Chi-Med), of Hong Kong, and Indianapolis-based Eli Lilly and Co. said they have amended their 2013 license and collaboration agreement on fruquintinib with Lilly Shanghai, an affiliate of Lilly. It covers the expansion of Chi-Med’s role in the commercialization of Elunate (fruquintinib capsules), an oral inhibitor of VEGR1/2/3, in China where Lilly will maintain the exclusive commercialization rights, and as a consequence, will continue to consolidate the sales of Elunate in China. Chi-Med will collaborate with Lilly in commercializing the drug across China and will be responsible for the development and execution of all on-the-ground medical detailing, promotion and local and regional marketing activities.
Iacta Pharmaceuticals Inc., of Irvine, Calif., and Zhaoke Ophthalmology Pharmaceutical Ltd., of Hong Kong, said they entered a definitive license agreement for two of Iacta’s products, IC-265 for dry eye and IC-270 for allergic conjunctivitis, for ophthalmic indications in China and other countries of Southeast Asia. The agreement will accelerate the development of IC-265 and IC-270 in both China and the U.S., the companies said. Under the terms, Iacta will receive nondilutive, up-front license fees and reimbursement for certain development costs. There is potential for additional payments upon achievement of certain development milestones as well as additional milestone payments for achievement of certain commercial milestones. The agreement also includes the payment of potential tiered royalties. Specific terms were not disclosed.
Imcyse SA, of Liège, Belgium, said it was awarded a €1.1 million (US$1.3 million) subsidy from the Walloon Region over a period of 29 months to support its neuromyelitis optica spectrum disorder (NMOSD) program. The company aims to develop a therapeutic vaccination treatment to specifically target immune cells in NMOSD patients. The subsidy will be used to demonstrate proof of concept both in an animal model and on human cells (phase 0 study) to select and establish the clinical relevance of the NMOSD Imotope, leading to a phase I trial in NMOSD patients.
Immunome Inc., of Exton, Pa., said the U.S. Department of Defense has awarded the company up to $13.3 million to use its technology to develop a biosynthetic convalescent plasma (BCP) as a new potential approach to combat the COVID-19 pandemic. The company’s technology harnesses B-cell responses from patients who have successfully recovered from the COVID-19 infection. Through this effort, it intends to identify a combination of antibodies that are broadly active against the virus, enable multiple viral clearance mechanisms and synthetically manufacture the antibodies for availability to broad patient populations.
Karuna Therapeutics Inc., of Boston, and PGI Drug Discovery LLC, of Paramus, N.J., signed a multiyear drug discovery and development agreement to identify potential candidates for the treatment of severe neuropsychiatric disorders. Karuna will provide an up-front payment to PGI for access to its screening platforms, which leverage computer vision and machine learning, to discover novel neuropsychiatric treatments. Each party is eligible to receive payments upon reaching prespecified development, regulatory and commercial milestones, as well as royalties on net sales for products developed under the agreement.
Lumos Pharma Inc., of Austin, Texas, signed a definitive agreement to sell its share of a priority review voucher to Merck & Co. Inc., of Kenilworth, N.J. The voucher was granted in conjunction with the approval by the FDA of Ervebo, a vaccine developed by Lumos’ licensee, Merck, for the prevention of the Zaire Ebola virus disease. Under the terms of the original license agreement, Lumos is entitled to retain 60% of the value of the voucher. Based upon an agreed valuation of $100 million, Merck will pay Lumos $60 million.
Nascent Biotech Inc., of San Diego, said it entered a research collaboration with Syracuse University to further the development of pritumumab, a monoclonal antibody that binds to cell-surface vimentin, for potential use in COVID-19 treatment. Pritumumab will be tested for its ability to block SARS-CoV-2, the virus responsible for COVID-19, from entering cells.
Promedica Inc., of Toledo, Ohio, disclosed promising results of its new study that evaluated the use of stem cells in the treatment of adult COVID-19 patients. Eight patients elected to participate in a study under an emergency IND approval by the FDA. Patients received either one or two doses of allogeneic bone marrow-derived mesenchymal stem cells manufactured by Stemedica Cell Technologies Inc., of San Diego. The first set of patients was treated with one dose of 100 million cells, and the second set received two doses of 50 million cells. Within 24 to 48 hours of receiving the stem cells, all patients had a significant reduction in oxygen requirements. Several went from an inability to talk or eat due to shortness of breath to speaking in full sentences and eating full meals comfortably shortly after treatment.
Recursion Pharmaceuticals Inc., of Salt Lake City, said it acquired Vium, a digital vivarium company boasting a platform that combines computer vision, machine learning and sensor technologies to non-invasively collect and derive insights from digital biomarkers in preclinical in vivo research. Terms were not disclosed.
Restorbio Inc., of Boston, disclosed an award from the U.S. National Institute on Aging to fund a randomized, double-blind, placebo-controlled pilot study of RTB-101, an orally administered small-molecule inhibitor of target of rapamycin complex 1, as compared to placebo for COVID-19 post-exposure prophylaxis in older adults. The study is supported by additional data observed in Restorbio’s phase IIb and phase III trials, which suggest the potential of RTB-101 to reduce the severity of laboratory-confirmed coronavirus infections. The new study is a randomized, double-blind, placebo-controlled experiment to obtain preliminary data on the feasibility of studying RTB-101 as compared to placebo for COVID-19 post-exposure prophylaxis in adults ages 65 and older.
Santen Pharmaceutical Co. Ltd., of Osaka, Japan, and RVL Pharmaceuticals Inc., a subsidiary of Dublin-based Osmotica Pharmaceuticals plc, disclosed an exclusive license agreement covering the development, registration and commercialization rights in Japan, China and other Asian countries as well as EU countries to RVL-1201, oxymetazoline hydrochloride ophthalmic solution 0.1%, which is the first and only ophthalmic formulation approved by the FDA for acquired blepharoptosis or ptosis in adults. Santen will be responsible for further development of RVL-1201 and regulatory approvals as well as commercialization in its licensed territories.
Schrödinger Inc., of New York, and Viva Biotech Holdings, of Shanghai, signed a collaboration to expand the reach of structure-based drug discovery by generating de novo crystal structures of high-value targets. Schrödinger will identify drug discovery targets for which there are currently no crystal structures in the public domain, including those that could lead to first-in-class therapeutic candidates for its internal pipeline. Viva will deploy X-ray crystallography designed to structurally enable those targets by generating high-resolution structures with bound ligands. Schrödinger will then use its computational platform at scale to explore large portions of chemical space with the goal of designing therapeutic candidates.
Sol-Gel Technologies Ltd., of Ness Ziona, Israel, noted that its unnamed partner plans to launch an unnamed generic drug in the second quarter of 2021, at which point, Sol-Gel will receive payments based on product sales.
Soligenix Inc., of Princeton, N.J., published preclinical data on Civax, a heat-stable COVID-19 vaccine in npj Vaccines. In mice, the vaccine induced high titers of antigen-binding IgG after a single dose and elicited cell-mediated immunity and virus neutralizing antibody titers.
Swedish Orphan Biovitrum AB, of Stockholm, and Selecta Biosciences Inc., of Watertown, Mass., completed their $730 million licensing deal for serum uric acid controller SEL-212 following the expiration of the Hart-Scott-Rodino Antitrust Improvements Act waiting period.
Terns Pharmaceuticals Inc., of Foster City, Calif., licensed the rights to TRN-000632, a Bcr-Abl inhibitor for the treatment of chronic myeloid leukemia, in greater China to Hansoh Pharmaceutical Group Co. Ltd., of Shanghai. Terns will receive an undisclosed up-front payment and is eligible to receive development, regulatory and commercial milestones of up to $68 million, as well as royalties from future product sales.
Theragen Bio, of Seoul, South Korea, is collaborating with the Korea Research Institute of Chemical Technology, Kyungpook National University Hospital and the Daegu Metropolitan Government to sequence genomes of approximately 1,000 COVID-19 patients as well as their SARS-CoV-2 virus samples. The project aims to identify correlations between patient genome and the SARS-CoV-2 virus genome, which will be used to develop better vaccines.
Tscan Therapeutics Inc., of Waltham, Mass., pre-published data on medRxiv.org highlighting the targets on SARS-CoV-2 of T cells isolated from COVID-19 convalescent patients. The immunodominant targets were primarily located outside the spike protein and were not found in other coronaviruses.