Adamas Pharmaceuticals Inc., of Emeryville, Calif., entered a settlement agreement with Zydus Cadila Healthcare Ltd., of Ahmedabad, India, concerning Zydus’s ANDA seeking approval by the FDA to market a generic version of Gocovri (amantadine) extended-release capsules. Adamas grants Zydus a nonexclusive license to make, use, sell, offer to sell and import generic versions of Gocovri as of March 4, 2030, or earlier in certain circumstances, including a potential for an accelerated license date if the unit sales of Gocovri in the 12-month period ending July 31, 2025, or any subsequent 12-month period decline by a specified percentage below the unit sales of Gocovri in the year ended Dec. 31, 2019. Gocovri was approved in the summer of 2017 for dyskinesia in Parkinson’s disease patients.
Adverum Biotechnologies Inc., of Redwood City, Calif., disclosed the publication of preclinical data on ADVM-022 intravitreal (IVT) gene therapy in Translational Vision Science & Technology, a journal of the Association for Research in Vision and Ophthalmology. ADVM-022 is in clinical trials for wet age-related macular degeneration and diabetic macular edema. Results showed long-term, sustained aflibercept expression out to 30 months following ADVM-022. The levels of aflibercept were sustained at therapeutic levels, with no measurable adverse effects on normal retinal structure and function. The preclinical study in nonhuman primates is the longest safety and expression study to date, with measurements out 30 months following a single IVT injection.
Aeterna Zentaris Inc., of Charleston, S.C., through its wholly owned subsidiary, Aeterna Zentaris GmbH, signed an exclusive option agreement to evaluate a preclinical COVID-19 vaccine developed at the Julius-Maximilians-University Wuerzburg. The vaccine technology developed at the university uses a typhoid fever vaccine as a carrier strain and has the potential to be an orally active COVID-19 live-attenuated bacterial vaccine. Aeterna has the right to negotiate an exclusive worldwide license to develop the technology for the prevention of coronavirus diseases, including COVID-19.
Aikido Pharma Inc., of New York, executed a $2 million convertible promissory note purchase agreement with Convergent Therapeutics Inc., of Wilmington, Del., securing an early investment in Convergent. Convergent has exclusive rights to technology related to next-generation radiopharmaceutical therapy for prostate cancer that is covered by multiple issued U.S. and foreign patents. Convergent is conducting advanced human trials relating to prostate cancer treatments involving peptide receptor radionuclide therapy that targets the prostate-specific membrane antigen on prostate cancer cells.
Annovis Bio Inc., of Berwyn, Pa., disclosed study data showing that a combination treatment using the company's lead candidate, ANVS-401, and pifithrin-α (PFT-α) after stroke improved mice locomotor activity and cognitive function more so than treatment with just one or the other agent. The study was conducted by Case Western Reserve University in Cleveland, and challenged mice with MCAo-induced stroke (middle carotid artery occlusion induced stoke). After four weeks, the number of surviving neurons was quantified and the locomotor function, behavior and cognition of the mice were evaluated.
Ascentage Pharma Group International, of Suzhou, China, released results from a preclinical study of APG-115, a MDM2-p53 inhibitor being developed by Ascentage for the treatment of non-small-cell lung cancer harboring STK11 mutations. The company provided the data by way of an oral presentation on Jan. 29, 2021, at the 2020 World Conference on Lung Cancer. APG-115, an orally administered, selective, small-molecule inhibitor of the MDM2 protein, showed strong binding affinity to MDM2 and is designed to activate tumor suppression activity of p53 by blocking the MDM2-p53 protein-protein interaction. The candidate is the first MDM2-p53 inhibitor entering clinical development in China.
Biovaxys Technology Corp., of Vancouver, B.C., said its COVID-19 vaccine candidate, BVX-0320, elicits a neutralizing antibody response against SARS-CoV-2, as evidenced by further analysis of sera samples from a preclinical animal study of its haptenized viral protein vaccine technology. Under a Biovaxys-sponsored research collaboration with the Ohio State University (OSU) Wexner School of Medicine, OSU researchers observed in a pooled sample that BVX-0320 elicited the production of neutralizing antibodies to SARS-CoV-2. OSU is one of the few institutions that has the laboratory capability to study live SARS-CoV-2 virus, Biovaxys noted.
Can-Fite Biopharma Ltd., of Petach Tikva, Israel, said it completed a set of preclinical studies demonstrating that CBD-rich T3/C15 cannabis fraction has an inhibitory effect on liver fibrosis. The cannabis-derived compounds bind to A3 adenosine receptors (A3AR), inhibiting proliferation of LX-2 hepatic-stellate cells, the liver cell type mediating fibrosis development. The inhibitory response was neutralized by an antagonist to the A3AR, the company added. Fibrosis results in a large amount of scar tissue and is associated with liver diseases, including nonalcoholic fatty liver disease, nonalcoholic steatohepatitis, cirrhosis and liver cancer.
Cevec Pharmaceuticals GmbH, of Köln, Germany, and Rznomics Inc., of Gyeonggi-do, South Korea, said they signed a clinical and commercial license agreement to use Cevec’s technology to manufacture adenoviruses for gene therapy applications. Rznomics will use Cevec’s cell-line technology combined with Rznomics’ trans-splicing ribozyme technology to manufacture gene therapies targeting various cancer indications. Financial details were not disclosed. Cevec’s cell line is based on an engineered human suspension cell line of non-tumor origin, derived from human amniocyte cells.
A day after announcing their immuno-oncology collaboration, Coherus Biosciences Inc., of Redwood City, Calif., said Shanghai Junshi Biosciences Co. Ltd., of Shanghai, will invest $50 million in Coherus. In the original deal, Junshi could receive an aggregate $1.1 billion from Coherus for the rights to develop and commercialize Junshi’s anti-PD-1 antibody, toripalimab, in the U.S. and Canada. The deal is powered by Coherus’ core biosimilar business and is designed to steer the company into the immuno-oncology business.
Engrail Therapeutics Inc., of San Diego, said it has acquired Neurocycle Therapeutics Inc., of Cambridge, Mass., giving Engrail a higher profile in the GABA-A modulation space by adding a second pipeline asset. Neurocycle specializes in targeting specific receptor subtypes in the CNS to fight central sensitization disorders that include chronic pain. In June 2020, Engrail raised a $32 million series A financing to support its first pipeline asset, ENX-101, a subtype selective GABA-A inhibitor.
Evozyne LLC, of Chicago, said it will collaborate with an unnamed company specializing in rare disorders for the development and commercialization of biopharmaceuticals in immune modulation. Evozyne is eligible for an up-front payment and additional R&D and regulatory milestone payments plus royalties on sales resulting from the collaboration. Evozyne is responsible for protein design and related activities, with the partner responsible for all development and commercialization activities.
Exelixis Inc., of Alameda, Calif., said it will use Adagene Inc.’s technology platform to generate masked versions of monoclonal antibodies from Exelixis’ preclinical pipeline for developing antibody-drug conjugates or other biologics. Exelixis will make an up-front payment of $11 million to Suzhou, China-based Adagene and can nominate two targets. Adagene will be eligible for development and commercialization milestones, as well as royalties on net sales of products developed around each target. Adagene’s platform incorporates a masking peptide that covers the binding domain of the biologic therapy.
Ilias Biologics Inc., of Daejeon, South Korea, said it has second proof-of-concept data in preventing preterm birth and improving fetus viability with ILB-202, the company’s anti-inflammatory exosomes. The study suggested, the company said, novel therapeutics may delay preterm birth and increase the survival rate of the fetus via regulation of inflammatory cytokine expression and activation of inflammatory cells in maternal and fetal tissues by ILB-202 exosome delivery. Exosomes are a type of extracellular vesicles, sized from 50 nm to 200 nm, released by cells in the body, the company added, that act as intercellular messengers delivering a variety of materials, including RNA and proteins. The results were published in Science Advances.
Immunome Inc., of Exton, Pa., said a preprint article was released on biorxiv.org describing findings from its ongoing preclinical COVID-19 research program. Data showed that more than 50% of antibodies isolated from super-responders are directed at non-spike antigens, suggesting non-spike-related antibodies may play a role in effective immunological clearance of the virus. Nucleocapsid proteins and the open reading frame-encoded (ORF) proteins, ORF8 and ORF10, represented the most prevalent non-spike targets. Antibody response against both neutralizing and non-neutralizing epitopes on spike protein were committed to B-cell memory, and the response appeared to extend beyond immunoglobulin G (IgG), comprising affinity-matured antibodies with specialized function, including IgA and IgM.
Maia Biotechnology Inc., of Chicago, said it formed a clinical supply agreement with Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., to evaluate THIO (6-thio-2-deoxyguanosine) followed by the PD-1 inhibitor Libtayo (cemiplimab, Regeneron/Sanofi SA) in a phase I/II trial in people with second-line or later advanced non-small-cell lung cancer (NSCLC) who progressed following treatment with a standard-of-care regimen that included a checkpoint inhibitor. Maia will sponsor and fund the planned trial, expected to begin enrolling participants in 2021, with Regeneron providing Libtayo. Maia retained global development and commercial rights to THIO and is free to develop the program in combination with other agents outside of NSCLC.
Mati Therapeutics Inc., of Austin, Texas, said it purchased all rights related to its Evolute punctal plug delivery system (PPDS) from Novelion Therapeutics Inc., of Vancouver, British Columbia, as part of Novelion’s voluntary liquidation process. Mati previously acquired intellectual property and other assets comprising the PPDS from Novelion in April 2013. As part of that purchase agreement, Mati was obligated potentially to pay Novelion development and commercial sales milestones, royalties on product sales to third parties and a share of consideration received from third parties for any transfer, license or sale of rights related to the PPDS. The rights purchase eliminated future payment and other obligations to Novelion from the PPDS, according to Mati.
In collaboration with scientists at the National Institute of Infectious Diseases (NIID) in Tokyo, Max Biopharma Inc., of Los Angeles, said its scientists identified substances with antiviral activity against the SARS-CoV-2 virus. The substances, called semisynthetic oxysterols, were derived from sterol molecules created by the company as part of its oxysterol therapeutics platform technology. Preclinical studies identified oxysterol-based lead compounds that inhibited the replication of the SARS-CoV-2 virus in host cells by more than 99%, with potencies comparable to established antiviral medications but through a different biological mechanism and using oral administration. Because they act on host cells and not on the virus, oxysterols are expected to remain effective even as the virus mutates. Max Biopharma and the NIID next plan to perform in vivo efficacy studies in animal models of COVID-19. The company also is seeking strategic partnerships with biotechnology and pharmaceutical companies and raising a series A round to advance its programs.
Moleculin Biotech Inc., of Houston, said a preclinical animal study showed potential therapeutic benefit from its anthracycline, annamycin, against metastatic osteosarcoma. The finding appeared to result from the cytotoxic potential of annamycin previously shown in vitro against sarcoma cells in combination with high uptake by the lungs, where the tumors in the study were localized. CT scans revealed that animals treated with annamycin exhibited suppression of tumor growth. No deaths were observed in treated animals, while tumor burden contributed to the deaths of 90% of untreated animals. Following report of the data on Feb. 2, Moleculin shares (NASDAQ:MBRX) spiked 36% to close at $6.39, a gain of $1.69.
Ocugen Inc., of Malvern, Pa., and Bharat Biotech International Ltd., of Hyderabad, India, said they formed a definitive agreement to co-develop, supply and commercialize Bharat Biotech’s Covaxin, a whole-virion inactivated COVID-19 vaccine candidate, in the U.S. Ocugen gained U.S. rights to the vaccine candidate and will oversee clinical development, regulatory approval, including emergency use authorization (EUA), and commercialization in the market. Bharat Biotech will supply initial doses to be used in the U.S. upon Ocugen’s receipt of an EUA. In addition, Bharat Biotech will support technology transfer for manufacturing in the U.S. The companies will share profits from U.S. sales of Covaxin, with Ocugen retaining 45% of those profits. Ocugen said its leadership and vaccine scientific advisory board initiated discussions with the FDA and with the U.S. Biomedical Advanced Research and Development Authority to develop a regulatory path to an EUA and to eventual BLA approval for the COVID-19 spike glycoprotein modulator. Ocugen also engaged manufacturers in the U.S. to discuss production to support its U.S. immunization program. In January, the Drugs Controller General of India granted emergency conditional approval to Covaxin.
Oragenics Inc., of Tampa, Fla., said the stabilized pre-fusion spike protein CoV-2 S-2P created by the U.S. NIH and licensed by the company showed protective immunity in immunized mice challenged with mouse-adapted SARS-CoV-2 virus. NIH data showed the COVID-19 spike protein, dosed at 0.1 mcg or 1 mcg and combined with an adjuvant, completely inhibited virus growth in the nasal cavities and lungs of mice when infected four weeks after their second immunization vs. unvaccinated control animals.
Paragon Biosciences LLC, of Chicago, said it acquired Circ Biosciences Inc., of Dallas, which has preclinical programs in chemically induced retinal cells for vision restoration in geographic atrophy age-related macular degeneration and advanced retinitis pigmentosa. The mechanism of action for the company’s cell therapy platform is designed to convert fibroblasts into other cell types using a cocktail of small molecules in an 11-day chemical conversion process. Financial terms were not disclosed.
Probiogen AG, of Berlin, and Harbour Biomed, of New York and Rotterdam, the Netherlands, have agreed on a cell line development project and application of the ADCC-enhancement technology Glymaxx, which enables flexible and reversible adjustment of the antibody fucosylation level from afucosylated to fully fucosylated. Harbour Biomed is developing antibody therapeutics to treat cancer and immunological diseases.
Q BioMed Inc., of New York, said it was awarded a contract with UroGPO, the largest group purchasing organization for urology private practice clinics in the U.S., to establish Strontium89 (strontium chloride Sr-89 Injection) as a radionuclide therapeutic option to treat people with painful bone metastases from prostate and other urological cancers.
Ribon Therapeutics Inc., of Cambridge, Mass., said it formed an exclusive license agreement with Ono Pharmaceutical Co. Ltd., of Osaka, Japan, covering development and commercialization of Ribon’s PARP7 inhibitor, RBN-2397, in Japan, South Korea, Taiwan and the ASEAN countries. Ribon is set to receive an up-front payment of approximately $16.3 million and is eligible for up to $132 million (at current exchange rates) in regulatory and commercial milestone payments and tiered royalties ranging from the high single digits to low teens on net sales in Ono’s territory. In addition to its development and commercialization rights, Ono gained the right to participate in global studies of RBN-2397 by bearing the costs of such studies in its territory. Ribon retained global rights to RBN-2397 outside the Ono territory. RBN-2397 is in phase I development to treat solid tumors.
Viewpoint Molecular Targeting Inc., of Coralville, Iowa, said preclinical data from its VMT-01 program, presented at the 2021 Society of Nuclear Medicine and Molecular Imaging mid-winter meeting, showed that a single dose of the 212Pb-labeled glucosamine conjugate arrested tumor growth of B16 melanoma and extended survival. Although immune checkpoint inhibitors did not reduce tumor growth compared with control, the combination of 212Pb-VMT-01 with immune checkpoint inhibitors induced synergistic antitumor effect, with 43% (3/7) complete tumor remission. Animals with complete tumor clearance also developed antitumor immunity to reject further tumor challenge.
Virios Therapeutics Inc., of Atlanta, said it formed a collaboration with Mayo Clinic researcher Michael Camilleri to explore the role of antiviral therapy in irritable bowel syndrome (IBS), with the initial focus on designing a phase II proof-of-concept study on treating pain associated with IBS and a longer-term goal of conducting the phase II study.
X-Chem Inc., of Waltham, Mass., said it formed a research collaboration and license agreement with Genentech, a unit of Roche Holding AG, of Basel, Switzerland, to discover and develop small-molecule oncology treatments. X-Chem will deploy its DNA-encoded library, or DEL, platform to identify drug-like leads against oncology targets of interest to Genentech and may also conduct hit-to-lead optimization for the programs. In addition, X-Chem granted Genentech an exclusive license to a preclinical small-molecule oncology program consisting of several series of compounds previously identified by X-Chem using the DEL platform. Genentech gained exclusive global rights to compounds derived from the collaboration and assumed responsibility for research, development and commercialization of any potential medicines emerging from the alliance in exchange for an up-front payment to X-Chem, which also is eligible for predefined research, development and regulatory milestone payments and sales royalties.
Zebiai Therapeutics Inc., of Waltham, Mass., said it formed a strategic collaboration with TB Alliance, which will provide funding for Zebiai to develop small-molecule probes against key tuberculosis targets. TB Alliance also has the right to exercise options for additional machine learning-driven discovery work on each target, in collaboration with Zebiai.