Agenus Inc., of Lexington, Mass., signed Betta Pharmaceuticals Co. Ltd., of Hangzhou, China, to an exclusive collaboration and license agreement for developing and commercializing balstilimab and zalifrelimab in greater China, including mainland China, Hong Kong, Macau and Taiwan. Agenus receives $35 million, including $15 million in up-front cash and a $20 million equity investment. The agreement also includes $100 million in potential milestones plus royalties on net sales. Betta receives exclusive rights to develop and commercialize balstilimab and zalifrelimab either as monotherapies or combination therapies, excluding intravesical delivery in greater China. Balstilimab, a PD-1 inhibitor, is planned to be studied as a monotherapy and combined with zalifrelimab, a CTLA4 inhibitor, to treat refractory or metastatic cervical cancer. The FDA granted fast track designation for balstilimab alone and in combination with zalifrelimab for the indication.
Applied Genetic Technologies Corp., of Gainesville, Fla., and Cambridge, Mass., said improvements to its platform have improved adeno-associated virus quality and yields. The company said it is hitting new product specifications demonstrating nearly 90% full capsids with extremely low residuals, many of which fall below the level of detection, resulting in purity levels exceeding 97%. The company said it is at commercial-scale manufacturing for its ophthalmology programs since it can produce thousands of low cost doses from a 40L bioreactor and its scalable bioreactor format is designed to enable it to meet the production demands for large market indications and indications requiring substantially higher dosing.
Fresh preclinical data from Allogene Therapeutics Inc., of South San Francisco, about ALLO-819, an investigational CAR T therapy targeting FLT3 to treat acute myeloid leukemia, shows healthy donor T lymphocytes were engineered to express CARs that bound to different domains of the FLT3 protein. The CARs were then tested for their ability to mediate specific killing of FLT3-expressing cells without off-target activity. A CAR construct was selected based on exhibiting minimal potential for exhaustion and potent antitumor activity in vitro and in vivo models.
Boston’s CARB-X said it expanded awards to Amicrobe Inc., of Carlsbad, Calif., by $4.6 million to accelerate development of an extended formulation of Amicidin-beta topical antimicrobial products for treating surgical and traumatic wound infections in low- and middle-income countries. The new formulation targets ease of use and climate-zone stability in parts of the world where cold storage systems are not always available. The funds are in addition to the $6.2 million awarded by CARB-X in 2017 to support development of Amicrobe’s Amicidin-beta Solution through a phase I trial. The product is designed for direct application to contaminated and infected tissues in surgical and emergency settings, including in the management of hip and knee prosthetic joint infections.
Eli Lilly and Co., of Indianapolis, reported real-world data at the American Diabetes Association’s Scientific Sessions showing Trulicity (dulaglutide) had significantly higher adherence and longer persistence compared to weekly injections of semaglutide or exenatide (BCise pen) in people with type 2 diabetes new to GLP-1 receptor agonist treatment. At six months, people taking Trulicity showed higher adherence and persistence than people taking semaglutide or exenatide. Further, significantly fewer people discontinued treatment with Trulicity compared to semaglutide or exenatide.
G1 Therapeutics Inc., of Research Triangle Park, N.C., and Genor Biopharma Co. Inc., of Shanghai, signed an exclusive license agreement to develop and commercialize lerociclib, a differentiated oral CDK4/6 inhibitor designed to enable combination treatment strategies, in the Asia-Pacific region, excluding Japan. G1 will receive $6 million in cash up front and is eligible to receive up to an additional $40 million in development and commercial milestone payments. Genor will pay G1 tiered royalties ranging from high single to low double-digits based on annual net sales.
Halozyme Therapeutics Inc, of San Diego, said it will receive a $10 million payment from Janssen Biotech Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson, triggered by the first commercial sale in the European Union of Janssen’s subcutaneous formulation of Darzalex (daratumumab), a monoclonal antibody for treating multiple myeloma.
Immunoprecise Antibodies Ltd., of Victoria, Canada, and Litevax BV, of Oss, the Netherlands, will collaborate on a preclinical study to analyze the immunogenicity, safety and potency of Immunoprecise's SARS-CoV-2 vaccine candidates. Immunoprecise is developing a monoclonal antibody therapy for treating patients with COVID-19 that could also be used prophylactically in high-risk patients who may have been exposed to the virus.
Preclinical results in mice for treating whooping cough by Intravacc, of Bilthoven, the Netherlands, show an intranasal immunization induced systemic and local immune responses while preventing colonization of the lung, trachea and nose. Intravacc’s vaccine consisted of outer membrane vesicles to immunize mice via the subcutaneous or intranasal route. The vesicles are naturally secreted by gram-negative bacteria and contain proteins that play a role in the survival of bacteria in the body.
Lantheus Holdings Inc., of North Billerica, Mass., and New York, said it completed its merger with Progenics Pharmaceuticals Inc., of Tarrytown, N.Y. For each share of Progenics common stock, Progenics stockholders received about one-third of a share of Lantheus common stock and one nontradeable contingent value right, payable in two contingent payments, subject to a cap, upon the achievement of certain milestones related to the financial performance of Pyl (18F-DCFPyL), Progenics’ prostate-specific membrane antigen-targeted imaging agent designed to visualize prostate cancer. The combined company will trade on Nasdaq under the ticker symbol LNTH.
Minerva Biotechnologies Corp., of Waltham, Mass., licensed Memorial Sloan Kettering Cancer Center’s T-cell signaling technology for sustained CAR T-cell function and persistence to use with Minerva’s anti-MUC1 antibodies. Minerva is conducting a first-in-human trial for metastatic breast cancers with CAR T targeting a cleaved form of MUC1, the growth factor receptor form of MUC1 that is aberrantly expressed on more than 75% of all solid tumors and more than 90% of breast cancers.
Nervgen Pharma Corp., of Vancouver, British Columbia, said that Jerry Silver of Case Western Reserve University in Cleveland, received a $250,000 research grant from the state of Ohio to conduct preclinical studies in spinal cord injury in collaboration with Nervgen, including the effect of NVG-291, a protein tyrosine phosphatase sigma inhibitor, in a chronic setting. The study will investigate PTP-sigma inhibition and/or a perineuronal net synthesis inhibitor for treating acute (treatment begins one day post-injury) and chronic (treatment begins 12 weeks post-injury) cervical spinal cord injuries and will also investigate how physical rehabilitation aids recovery. Nervgen will contribute the equivalent of $110,000 by providing manufactured drug product, as well as technical and drug development expertise.
Orgenesis Inc., of Germantown, Md., said it entered a preliminary, nonbinding term sheet with Leidos Holdings Inc., of Reston, Va., to develop Orgenesis’ ranpirnase to treat severe acute respiratory syndrome associated with SARS-CoV-2, the virus that causes COVID-19. Ranpirnase catalyzes the degradation of RNA and mediates several biological activities, including regulation of cell proliferation, maturation, differentiation and cell death. Leidos conducted in vitro studies of ranpirnase at the University of Tennessee Health Sciences Center Regional Biocontainment Laboratory and George Mason University National Center for Biodefense and Infectious Diseases against SARS CoV-2.
Preclinical results of PDS-0101, the lead program from PDS Biotech Corp., of Florham Park, N.J., generated both human papillomavirus (HPV)-specific T cells and an associated antitumor response when used as a monotherapy. When PDS-0101 was combined with two other development-stage cancer agents, bintrafusp alfa (M7824) and NHS-IL12, the data suggest the agents worked synergistically to provide enhanced tumor regression and T-cell response as compared to the agents alone. PDS-0101 targets antigens in HPV-expressing cancers and is in a phase II study combining Keytruda (pembrolizumab, Merck & Co. Inc.) as first-line treatment of recurrent or metastatic head and neck cancer.
Preclinical data from Precigen Inc., of Germantown, Md., shows PRGN-3005 demonstrated superior expansion and persistence compared to traditional CAR T therapy in treating advanced, recurrent platinum-resistant ovarian, fallopian tube or primary peritoneal cancer. Traditional methods for CAR T-cell manufacturing involve viral vectors and ex vivo cell expansion at centralized manufacturing facilities, contributing to potentially high costs and extended waiting periods, the company said. Precigen's platform is based on a nonviral multigene delivery system combined with a decentralized manufacturing process without ex vivo expansion. Following isolation of the patient's own T cells after a blood draw, nonviral gene transfer occurs overnight at the medical center's cGMP facility. The next day, UltraCAR T cells are infused into the patient. PRGN-3005 is an autologous CAR T treatment simultaneously expressing three gene products.
Sarepta Therapeutics Inc. and Codiak Biosciences Inc., both of Cambridge, Mass., entered a global research and option agreement to design and develop engineered exosome therapeutics for delivering gene therapy, gene editing and RNA technologies to neuromuscular diseases. The two-year agreement includes up to five neuromuscular targets. Codiak could receive up to $72.5 million in up-front and near-term license payments plus research funding. Sarepta has the option to any of the candidates developed in the alliance.
Start Codon, a Cambridge, U.K.-based life science and health care business accelerator, debuted its first cohort of startup companies. They are Enhanc3D Genomics, a functional genomics spin-out of the Babraham Institute, whose platform technology links noncoding sequence variants to their target genes in order to identify novel therapeutic targets; Drishti Discoveries, leveraging gene silencing technology to develop therapies for rare inherited diseases; Spirea, a spin-out from the University of Cambridge, which is developing antibody-drug conjugate cancer therapeutics that carry drug payloads to tumor cells; and Semarion, a University of Cambridge spin-out, which uses cell-based assays for drug discovery and life science. Start Codon said it plans to invest in and support up to 50 startup companies during the next five years.
Tetraphase Pharmaceuticals Inc., of Watertown, Mass., said its board received an unsolicited proposal from La Jolla Pharmaceutical Co., of San Diego, to acquire Tetraphase for $43 million in cash, plus an additional aggregate amount of $16 million in cash potentially payable under contingent value rights (CVRs). On June 21, the board determined that the La Jolla proposal is superior to an offer by Melinta Therapeutics Inc., of New Haven, Conn. Tetraphase said it told Melinta it is considering terminating the Melinta merger agreement unless Melinta revises its terms or makes another proposal on or prior to June 26. Under that agreement, Melinta would acquire Tetraphase through a cash tender offer by its subsidiary for all of Tetraphase’s outstanding shares of common stock, for an aggregate of $39 million in cash plus CVRs representing the right to receive cash consideration based on achieving certain net sales milestones in an aggregate amount of up to $16 million.
Therapeutic Solutions International Inc., of Oceanside, Calif., said it will use its clinical-stage cancer immunotherapy platform for treating COVID-19 patients. The company said treating cancer patients with its dendritic cell platform enhances the activity of natural killer cells, which have been shown to inhibit SARS-CoV-2.