Aeterna Zentaris Inc., of Charleston, S.C., through its wholly owned subsidiary, said it entered an exclusive licensing agreement with Consilient Health Ltd. that is focused on commercializing medicines in Europe and Middle East. The agreement covers the commercialization, in Europe and the U.K., of macimorelin, Aeterna’s orally available ghrelin agonist, in any diagnostic application, including the diagnosis of patients with adult growth hormone deficiency and, subject to receipt of regulatory approval, childhood-onset growth hormone deficiency (CGHD). Consilient Health will be responsible for obtaining pricing and reimbursement approval in the European economic area and the U.K., as well as bearing the regulatory cost for the label extension for pediatric use pending successful outcome of the upcoming safety and efficacy study, AEZS-130-P02, evaluating macimorelin for the diagnosis of CGHD. The pivotal phase III study is expected to be initiated in the first quarter of next year. Consilient Health will make an up-front payment of €1 million (US$1.21 million) and will pay royalties on net sales of macimorelin ranging from 10% to 20%.
Aligos Therapeutics Inc., of South San Francisco, said it entered an exclusive license and research collaboration agreement with Kenilworth, N.J.-based Merck & Co. Inc. to apply Aligos’ oligonucleotide platform technology to develop oligonucleotides directed against a nonalcoholic steatohepatitis (NASH) target and up to one additional target of interest in the cardiometabolic/fibrosis space. Aligos will receive an up-front payment as well as an additional payment upon designation of a second target for the collaboration. The company will be eligible for up to $458 million in development and commercialization milestones for each collaboration target, as well as tiered royalties on net sales. Aligos will be primarily responsible for designing, preparing and evaluating the oligonucleotide molecules and delivering optimized lead molecules, and Merck will be responsible for subsequent research, clinical development and commercialization efforts.
Bioxcel Therapeutics Inc., of New Haven, Conn., said it will collaborate with the VA Connecticut Healthcare System and the Yale University Medical School on a U.S. Department of Defense’s Congressionally Directed Medical Research Programs grant to evaluate BXCL-501, an orally dissolving thin film formulation of dexmedetomidine in late-stage development for the treatment of agitation and opioid withdrawal symptoms, in patients suffering from post-traumatic stress disorder (PTSD) related to alcohol and substance abuse disorder. Following an initial safety assessment that is being funded by the U.S. Department of Defense, a follow-on assessment study is anticipated that will include an evaluation of patients self-administering BXCL-501 daily at home over a 28-day period.
Boehringer Ingelheim GmbH, of Ingelheim, Germany, and Proxygen GmbH, of Vienna, said they have struck a collaboration and license agreement to enable the identification of molecular glue degraders against various oncogenic targets. Proxygen is entitled to receive up-front payments, research and development support and milestone-gated development payments, as well as tiered royalties based on future commercial sales of developed products.
Bridgebio Pharma Inc., of Palo Alto, Calif., and Maze Therapeutics Inc., of South San Francisco, said they have established a joint venture, Contour Therapeutics, focused on transforming and advancing precision medicine approaches designed to treat cardiovascular disease. The joint venture will leverage Maze’s genetically driven approach to drug discovery with Bridgebio’s expertise in cardiac drug discovery and clinical development. Together, the companies will focus on advancing genetically validated therapeutic candidates through clinical development and will initially work on the development of a treatment for patients with an undisclosed, genetically defined form of heart failure.
Cybin Inc., of Toronto, which is focused on psychedelic pharmaceutical therapies, said it will acquire 100% of the shares in Adelia Therapeutics Inc., of Boston, for up to CA$20.16 million (US$15.75 million) in an all-stock transaction. Adelia is developing psychedelic therapeutics with improved dosing efficacy and therapeutic indices.
Exelixis Inc., of Alameda, Calif., said it exercised its exclusive option for Bangalore, India-based Aurigene Discovery Technologies Ltd.’s CDK7 inhibitor under their July 2019 agreement. Exelixis has assumed responsibility for the future clinical development, commercialization and global manufacturing of the compound now known as XL-102 (formerly AUR-102). The company has also submitted an IND to the FDA to evaluate XL-102 alone or in combination therapy for the treatment of inoperable locally advanced or metastatic solid tumors. Under the terms of the agreement, Exelixis made an up-front payment of $10 million for exclusive options to license three preexisting programs, including the compound now known as XL-102, from Aurigene. In addition, Exelixis and Aurigene initiated three Aurigene-led drug discovery programs on mutually agreed upon targets, in exchange for additional up-front option payments of $2.5 million per program. Exelixis is also contributing research funding to Aurigene to facilitate discovery and preclinical development work on all six programs. For XL-102, Exelixis will make an option exercise payment of $12 million.
Eyam Vaccines and Immunotherapeutics Inc., (EYAM), of Vancouver, British Columbia, said it entered a license agreement with the University of British Columbia for the commercialization of several unique COVID-19 vaccine candidates in a self-amplifying mRNA vaccine platform. Eyam anticipates it will soon start animal trials.
Initium Therapeutics Inc., of Natick, Mass., said it has launched a single B-cell-based antibody development platform through a collaboration using Nanjing, China-based Genscript Probio's ultra-rapid Berkeley Lights Beacon platform. The partnership will potentially be extended to include a bispecific antibody platform, human antibody transgenic mouse and/or downstream therapeutic antibody development and manufacturing processes.
Kalivir Immunotherapeutics LLC, of Pittsburgh, and Tokyo-based Astellas Pharma Inc. said they entered a worldwide licensing agreement for the research, development and commercialization of VET2-L2, an intravenously administered oncolytic virus for immuno-oncology, as well as a research collaboration to generate a second product, a follow-on virus. Astellas will pay up to $56 million in the form of an up-front payment and support for research and preclinical activities related to VET2-L2 and the second product. Additionally, Astellas may pay up to $307 million and up to $271 million for development, regulatory and commercialization of VET2-L2 and the second product, respectively.
Marinus Pharmaceuticals Inc., of Radnor, Pa., said an expanded access program (EAP) has been launched that will allow the company to offer ganaxolone to patients with CDKL5 deficiency disorder (CDD) who were unable to participate in the company’s Marigold phase III trial. Candidates for the EAP must be at least 2 years of age, with a confirmed diagnosis of CDD, and experiencing uncontrolled seizures. The investigational treatment will initially be available in sites in the U.S. In the Marigold study, patients given oral ganaxolone showed a significant 32.2% median reduction in 28-day major motor seizure frequency, compared to a 4% reduction for those receiving placebo. The company said it is preparing to meet with the FDA in the first quarter of 2021 regarding its planned mid-2021 NDA submission.
Matinas Biopharma Holdings Inc., of Bedminster, N.J., said it plans to collaborate with the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. NIH to test oral formulations of Foster City, Calif.-based Gilead Sciences Inc.’s Veklury (remdesivir) in preclinical models. One or more formulations of remdesivir will be developed using the company’s lipid nanocrystal platform delivery technology, which enables the development of a wide range of difficult-to-deliver molecules. Matinas plans to utilize NIAID’s suite of preclinical services to carry out antiviral testing with selected formulations. Gilead will provide remdesivir and work with Matinas to evaluate the data generated from the planned series of preclinical studies.
Maze Therapeutics Inc., of South San Francisco, and Alloy Therapeutics Inc., of Lexington, Mass., said they have formed Broadwing Bio to develop targeted antibody therapies for the treatment of ophthalmic diseases. It will advance programs directed to genetically validated ophthalmology targets identified using Maze’s human genetics and functional genomics platform. Alloy Discovery Services will generate therapeutic candidates using its broad suite of antibody discovery technologies, including the ATX-Gx mouse platform. Both companies will retain certain rights to participate in the development and commercialization of products originating from Broadwing Bio.
The Menarini Group, of Florence, Italy, said it plans to present results of preclinical studies on MEN-1611, its phosphatidylinositol 3-kinase (PI3K) inhibitor in development to treat breast cancer, at the 2020 San Antonio Breast Cancer Symposium. A preclinical study on the antitumor activity of MEN-1611 in p110 alpha- and beta-dependent tumors suggested the asset is active against HER2-positive, PIK3CA-mutated and PTEN-null breast tumor in those animal models. A second study showed that the compound’s inhibition of the PI3K-gamma isoform led to macrophage reprogramming, from an immune-suppressive to an immune-activating phenotype. Tumor regression induced by MEN-1611 was associated with changes to the inflammatory microenvironment characterized by an increased recruitment of T cells, which may contribute to the antitumor activity of MEN-1611 in that model.
Moderna Inc., of Cambridge, Mass., said the Canadian government increased its confirmed order for the company’s vaccine candidate against COVID-19, mRNA-1273, by 20 million doses, raising its confirmed commitment to 40 million doses. Moderna initiated the rolling review process with Health Canada and intends to seek prequalification and/or emergency use listing with the World Health Organization. The Canadian vaccine supply will be sourced from Moderna’s European production capacity with strategic manufacturing partner Lonza in Switzerland and ROVI in Spain for fill-finish services.
Nabriva Therapeutics plc, of Dublin, said it restructured its license agreement with Sinovant Sciences Ltd., of Beijing, covering Xenleta (lefamulin) in greater China. Nabriva will provide additional manufacturing collaboration and regulatory support to Sinovant to help expedite delivery of Xenleta to patients in the region. The restructured agreement accelerates components of the $5 million milestone payment to Nabriva that was previously payable upon Xenleta’s regulatory approval in China, including a payment of $1 million in the fourth quarter of 2020. Nabriva remains eligible for up to approximately $90 million in payments tied to completion of certain regulatory and commercial milestones related to Xenleta to treat community-acquired bacterial pneumonia in China as well as low double-digit royalties on sales in the region.
Orexo AB, of Uppsala, Sweden, said it agreed to an exclusive licensing deal with Accord Healthcare Ltd., of London, to commercialize Zubsolv (buprenorphine + naloxone), which is licensed in Europe to treat adults and adolescents 15 and older as substitution treatment for opioid drug dependence. Orexo will supply the product, with Accord assuming responsibility for commercialization activities. Orexo is set to receive double-digit royalties on net sales.
Passage Bio Inc., of Philadelphia, and Catalent Inc., of Somerset, N.J., said manufacturing operations were initiated to support adeno-associated virus production for Passage Bio’s lead gene therapy candidates to treat rare monogenic central nervous system disorders following construction and cGMP qualification of a dedicated manufacturing suite at Catalent Cell & Gene Therapy’s facility in Harmans, Md. Catalent also will play a role in delivering Passage Bio’s candidates to trial sites by providing packaging, labeling and distribution services through its Fastchain supply services.
Postera, of San Francisco, which specializes in machine learning solutions for preclinical drug discovery, said it formed a strategic partnership with Pfizer Inc., of New York, to accelerate small-molecule drug discovery by developing a platform technology based on generative chemistry. The companies intend to produce scalable models that could potentially be deployed across in-house preclinical drug discovery efforts. Postera is set to receive an up-front payment and is eligible for additional payments as the project progresses, and it will retain ownership rights to algorithms developed during the collaboration.
Roivant Sciences Ltd., of Basel, Switzerland, disclosed a targeted protein degradation platform that includes degraders for multiple diseases across oncology, immunology and neurology indications, with the first therapeutic candidate to emerge from the platform on track to enter the clinic in 2021. Roivant said it expects to build multiple Vant units over time around drug candidates emerging from the platform.
Sellas Life Sciences Group Inc., of New York, and 3D Medicines Inc., of Shanghai, said they agreed to an exclusive license granting 3D Med rights to develop and commercialize the lead late-stage candidate, galinpepimut-S (GPS), from Sellas as well as its preclinical heptavalent immunotherapeutic, GPS+, for therapeutic and diagnostic uses in greater China. Sellas will receive an up-front license fee of $7.5 million, payable in the fourth quarter of 2020, and is eligible to receive potential near-term milestones of up to another $8 million. During the collaboration, Sellas could potentially receive up to $202 million in license and milestone payments, and the company is entitled to royalties ranging from the high single to low double-digit percentage of Chinese sales. 3D Med assumed responsibility for costs of development and regulatory activity for greater China, while Sellas retained sole rights to GPS and GPS+ outside the region. GPS is a WT1-targeting artificially engineered synthetic heteroclitic immunotherapeutic in development to treat hematological malignancies and solid tumors characterized by overexpression of the Wilms tumor protein antigen.
Seqirus, a unit of CSL Ltd., of Melbourne, Australia, presented data at the European Scientific Working Group on Influenza virtual conference assessing immunogenicity data from four trials of its MF59-adjuvanted, cell-based pandemic influenza A (H5N1) vaccine, branded Audenz, that enrolled 7,484 participants, including children, adults and older adults. Across all age groups (6 months to ≥ 65 years), two doses of the vaccine induced antibody responses that met both the Center for Biologics Evaluation and Research and former Committee for Medicinal Products for Human Use criteria for licensure. The highest responses were seen in children 6 months to less than 3 years of age, with almost 100% of that population achieving HA inhibition titers ≥ 1:40 after two doses. An overview of safety data from the trials showed pain was the most frequently reported solicited local adverse event (AE), with fatigue the most frequent solicited systemic AE. Overall, two doses were well-tolerated in all age groups, with no safety concerns. The FDA approved the vaccine in February.
Sesen Bio Inc., of Cambridge, Mass., said it inked a commercial manufacturing and supply framework agreement with its Chinese partner, Qilu Pharmaceutical Co. Ltd., of Shandong. Qilu will become part of the contract manufacturing network for global commercial supply of Sesen Bio’s lead program, Vicineum (oportuzumab monatox), which is in the follow-up stage of a phase III registration trial in the U.S. to treat high-risk, Bacillus Calmette-Guerin-unresponsive non-muscle invasive bladder cancer. In July, Sesen Bio granted Qilu an exclusive license to develop, manufacture and commercialize Vicineum in China.
Sherlock Biosciences Inc., of Cambridge, Mass., said it discovered thermostable CRISPR-associated (Cas) enzymes in partnership with researchers at Rosetta Biosciences Inc., of Allston, Mass. Thermostable Cas proteins enable real-time detection of RNA and/or DNA targets that, when used in tandem with Sherlock’s licensed Cas12 and Cas13 enzymes, may advance the simultaneous detection of multiple RNA and/or DNA targets in a single test. Developed by Sherlock’s co-founders and licensed exclusively from the Broad Institute, the SHERLOCK, or Specific High-sensitivity Enzymatic Reporter unlocking, method is being applied initially to the CRISPR SARS-CoV-2 test kit.
Syros Pharmaceuticals Inc., of Cambridge, Mass., said it acquired from Orsenix LLC, of Wilmington, Del., the assets related to SY-2101 (previously ORH-2014), an oral form of arsenic trioxide that Syros plans to advance in newly diagnosed acute promyelocytic leukemia. The asset purchase agreement included intellectual property, clinical and preclinical data, the regulatory dossier and product inventory related to SY-2101 in return for an up-front cash payment of $12 million to Orsenix, which also is eligible for a $6 million regulatory milestone and commercial milestones of up to $10 million. Orsenix is eligible to receive single-digit million milestone payments related to the development of SY-2101 in additional indications. Syros plans to initiate a dose-confirmation study of SY-2101 in the second half of 2021 to confirm a dose with comparable pharmacokinetics to an approved intravenous formulation of the agent, followed by a registration-enabling phase III trial in 2022.
VBI Vaccines Inc., of Cambridge, Mass., and contract commercialization organization Syneos Health Inc., of Morrisville, N.C., said they formed a partnership to commercialize VBI’s 3-antigen prophylactic hepatitis B vaccine in the U.S., Europe and Canada, pending regulatory approvals. Financial terms were not disclosed.
Xencor Inc., of Monrovia, Calif., said it agreed to a research collaboration and license with Janssen Biotech Inc., a unit of Johnson & Johnson, of New Brunswick, N.J., covering discovery of Xmab bispecific antibodies against CD28 in an undisclosed prostate tumor target to treat prostate cancer. Xencor will apply its Xmab bispecific Fc technology to create and characterize Xmab CD28 bispecific antibody candidates against the tumor target specified by Janssen, with preclinical activities and development, regulatory and commercial activities conducted by Janssen, which gained exclusive global rights to develop and commercialize resulting drug candidates. Xencor is set to receive an up-front payment of $50 million and is eligible for development, regulatory and sales milestone payments and high-single to low-double-digit royalties on net sales. Upon clinical proof of concept for a bispecific antibody candidate, Xencor retained an opt-in right to fund 20% of development costs and to perform up to 30% of detailing efforts in the U.S. in return for milestone payments and low-double-digit to midteen percent royalties on net sales. Xencor also gained a right to access predefined agents from Janssen’s portfolio of clinical-stage drug candidates and commercialized medicines to evaluate potential combination therapies with agents in its pipeline for non-registrational studies in prostate cancer, with Janssen gaining the same right with Xencor’s portfolio of clinical-stage drug candidates for potential combination therapies in prostate cancer. The agreement is expected to close by year-end 2020.