A2A Pharmaceuticals Inc., of New York, signed an agreement to design and co-develop oncology drug candidates with Daewoong Pharmaceutical Co. Ltd., of Seoul, South Korea, using its artificial intelligence-enabled drug discovery platform called Sculpt. The companies will collaborate on up to three oncology drug targets to accelerate Daewoong’s efforts to develop innovative oncology treatments through open collaboration. A2A will use its computational drug discovery platform to design new compound structures, which will be synthesized and evaluated by Daewoong. Both parties will actively cooperate in preclinical optimization and selection of lead candidates to enter the clinic.
Adimab LLC, of Lebanon, N.H., extended its platform license agreement with Novo Nordisk A/S, of Bagsvaerd, Denmark, for the discovery and optimization of antibody-based protein therapeutics. This agreement extends an ongoing partnership between the two companies that began in 2013. Novo will have continued access to a human antibody library and will receive a license to the platform for use on an unlimited number of targets. Novo also has the ability to access improvements to the platform, including new antibody libraries, software upgrades and protein engineering capabilities. Adimab will receive an undisclosed extension fee as well as development and sales milestones plus tiered royalties on the annual net sales.
Alpha Holdings Inc., of Seongnam, South Korea, the largest stockholder of Oncosec Medical Inc., of San Diego, with an approximate 15.1% ownership stake, delivered a binding term sheet to the board of Oncosec containing a detailed alternative proposal for consideration. Alpha’s offer provides more monetary value overall, the potential for immediate cash for stockholders at a premium and none of the “onerous” terms of the proposed takeover by China Grand Pharmaceutical and Healthcare Holdings Ltd., of Hong Kong, Alpha said. The proposal represents an additional $9.3 million of value compared with the $30 million takeover offer from China Grand, along with the opportunity for stockholders to receive a cash premium for 35% of Oncosec shares through a tender offer of $2.50 per share.
ASC Therapeutics Inc., of Milpitas, Calif., said it entered a long-term manufacturing partnership with Vigene Biosciences, a Maryland-based contract develop and manufacturing organization, in which Vigene will provide ASC with access to GMP manufacturing, including viral vectors and plasmid DNA for its hemophilia A gene therapy clinical program, as well as a manufacturing platform for future gene therapy programs.
Aska Pharmaceutical Co. Ltd., of Tokyo, and Kinopharma Inc., also of Tokyo, signed an option agreement for an exclusive license for the development and commercialization of a candidate drug for cervical dysplasia under preclinical development by Kinopharma. Under the agreement, Aska will obtain a right to exercise an option to jointly develop the drug with Kinopharma and to exclusively sell the drug in Japan, and Kinopharma will receive consideration for the option agreement followed by an up-front payment and milestone payments of the exclusive license from Aska. Detailed terms were not disclosed.
Clinigen Group plc, of London, signed a supply agreement with Iovance Biotherapeutics Inc., of San Carlos, Calif. Iovance is undertaking pivotal studies of its tumor-infiltrating lymphocytes (TIL) technology for the treatment of metastatic melanoma and advanced cervical cancer. Proleukin (aldesleukin), part of the TIL therapy treatment regimen being studied, will be made available by Clinigen in bulk supply over the course of a two-year period, with the first shipment under the agreement supplied in December 2019 and ensuring that Iovance has uninterrupted access to Proleukin to continue ongoing clinical trials. No financial details were disclosed.
CNS Pharmaceuticals Inc., of Houston. signed a contract with NCK A/S, of Farum, Denmark, for the large-scale production of berubicin, its lead drug candidate for the treatment of glioma brain tumors. NCK is a GMP manufacturer of complex drugs and the previous producer of berubicin for Reata Pharmaceuticals Inc., of Plano, Texas. Production of large-scale berubicin is set to commence in January and will ensure drug availability through the end of phase II trials for glioblastoma, CNS said.
Evotec SE, of Hamburg, Germany, said its wholly owned Seattle-based subsidiary company, Just-Evotec Biologics Inc., has expanded its collaboration with Merck & Co. Inc., of Kenilworth, N.J. Under the terms of the agreement, Just-Evotec grants Merck access to capacity in the J.POD facility in Redmond, Wash., which is currently under construction. The J.POD facility, the first in North America, gives Merck access to manufacturing capacity, which is compatible with the innovative manufacturing platform co-developed by Merck and Just-Evotec under a previous agreement disclosed in 2015.
Genome & Co., of Seoul, South Korea, Merck KGaA, of Darmstadt, Germany, and Pfizer Inc., of New York, are partnering on a clinical trial and supply agreement to evaluate GEN-001 with avelumab, a human anti-PD-L1 therapy for treating cancer. Genome will sponsor the study while Merck and Pfizer will supply avelumab for the phase I/Ib study the companies have in mind. The study, which includes dose-escalation and expansion cohorts, is expected to launch this year. GEN-001 is a single-strain human bacteria designed to activate dendritic cells, macrophages and T-cell response.
Hitgen Inc., of Chengdu, China, said it entered a drug discovery research collaboration with Kymera Therapeutics Inc., of Cambridge, Mass., to identify small-molecule leads against targets of interest to Kymera. Hitgen will apply its platform technology, based on the design, synthesis and screening of DNA-encoded libraries, to discover compounds that bind to certain targets. The identified compounds will be exclusively licensed to Kymera. Under the terms, Hitgen will receive an undisclosed up-front payment and will be eligible for milestone payments from Kymera.
Horizon Discovery Group plc, of Cambridge, U.K., exercised its option to exclusively license Rutgers University’s base-editing technology for therapeutic, diagnostic and service applications. The original Horizon-Rutgers agreement from January 2019 was a collaboration to develop the base-editing technology, which included evaluation and proof-of-concept studies. Horizon can now sublicense the tech to other entities’ therapeutic development to make edits to base pairs in DNA by recruiting specific deaminases. No financial terms were disclosed.
Innovent Biologics Inc., of Suzhou, China, signed an out-licensing agreement with Coherus Biosciences Inc., of Redwood City, Calif., to commercialize Innovent’s biosimilar version of Avastin (bevacizumab) in the U.S. and Canada. Coherus said it plans to file a BLA late this year or early next. Coherus also has a nonexclusive option to license Innovent's biosimilar to Rituxan (rituximab) for development and commercialization in the U.S. and Canada. Coherus will pay up to $45 million in up-front and milestone payments, plus a double-digit percentage of royalty payments based on future sales.
Jamp Pharma Group, of Boucherville, Quebec, said it signed an exclusive agreement with Alvotech ehf, of Reykjavik, Iceland, covering commercial rights in Canada to five biosimilars of branded drugs with a market value estimated to exceed $2 billion annually in the country. Jamp said the pact will allow it to expand its near-term new product pipeline of six biosimilars, along with its traditional generics portfolio. Alvotech's pipeline includes biosimilar candidates aimed at the treatment of autoimmune, oncologic and inflammatory conditions. Financial terms of the deal were not disclosed.
Kannalife Inc., of Doylestown, Pa., said it further elucidated the mechanism of action of lead candidate KLS-13019, a cannabinoid-like molecule targeting treatment of neuropathic pain. Under a recently completed NIH-NIDA phase I grant study, research showed that KLS-13019 played a role in the regulation of mNCX-1, a target in the prevention and partial reversal of chemotherapy-induced peripheral neuropathy, in a preclinical animal model.
Ligand Pharmaceuticals Inc., of San Diego, said it inked a global license agreement with Pandion Therapeutics Inc., of Cambridge, Mass., covering use of Ligand’s full Omniab antibody discovery platform in exchange for an up-front platform access fee, development and regulatory milestone payments, and potential royalties on product sales.
Nextcure Inc., of Beltsville, Md., disclosed in an SEC filing that it was notified by Eli Lilly and Co., of Indianapolis, of the termination of their 2018 R&D collaboration agreement, effective March 3, without providing details. The agreement, which came with $25 million up-front fee and a $15 million equity stake in Nextcure, covered use of the company’s FIND-IO platform in a multiyear program seeking to identify oncology targets for additional collaborative research and drug discovery by the companies. Lilly received an exclusive option to obtain global licenses to research, develop, manufacture and commercialize multiple compounds and products directed to oncology targets identified through the program in exchange for milestone payments of up to $1.4 billion. In the event of Lilly’s termination, the agreement called for licenses and rights granted by Nextcure to terminate and those granted by Lilly to survive.
Pfizer Inc., of New York, will use Hong Kong-based Insilico Medicine Inc.’s machine learning technology and platform to identify therapeutic targets for a variety of diseases. No financial terms were disclosed. Insilico's platform imagines potential protein structures based on existing research and certain pre-programmed design criteria.
Phasebio Pharmaceuticals Inc., of Malvern, Pa., said it inked an agreement with Viamet Pharmaceuticals Holdings LLC, of Durham, N.C., and wholly owned subsidiary Selenity Pharmaceuticals (Bermuda) Ltd. to acquire assets and intellectual property rights related to aldosterone synthase inhibitors that include the lead compound formerly known as SE-6440 or VT-6440. Designating that compound as PB-6440, Phasebio will seek to develop the asset for treatment-resistant hypertension. In preclinical studies, PB-6440 appeared to be a potent and selective inhibitor of aldosterone synthase (CYP11B2) when compared to the closely related steroid 11-beta-hydroxylase enzyme (CYP11B1), demonstrating dose-dependent aldosterone reduction without a significant increase in 11-deoxycorticosterone or deoxycortisol in rodent and primate models. Phasebio assumed responsibility for development, manufacturing and commercialization of the asset and agreed to an undisclosed up-front payment to Viamet along with development, approval and sales milestones and tiered royalties on global net sales. Nonclinical investigational new drug application-enabling studies are planned for 2020, with an IND filing and first-in-human study expected early next year.
Phio Pharmaceuticals Corp., of Marlborough, Mass., said its board approved a reverse stock split of its shares at a ratio of 1-for-55. The move is intended to increase the per share trading price for the purpose of ensuring compliance with the minimum $1 bid price requirement for continued listing on Nasdaq.
Preveceutical Medical Inc., of Vancouver, British Columbia, said it added another siRNA construct to its panel of Smart-siRNAs and that screening is underway. If successful, the screening will complete one aspect of the current phase of the company’s dual gene therapy program aimed at identifying Smart-siRNA sequences for a target gene of interest in type 2 diabetes and obesity. In the final phase of the program, the construct's biostability will be assessed in preclinical mouse models.
Probiogen AG, of Berlin, and Lava Therapeutics BV, of Utrecht, the Netherlands, said they closed a cell line development and manufacturing agreement covering Lava’s bispecific antibody lead candidate. Using its Cho.Right expression platform, including its directed luck transposase technology to generate stable high-titer cell lines, Probiogen will conduct cell line development of a gamma-delta T-cell-engaging bispecific antibody format. Financial terms were not disclosed.
Qiagen NV, of Hilden, Germany, said it formed a strategic collaboration with Amgen Inc., of Thousand Oaks, Calif., seeking to develop Therascreen-based companion diagnostics that will identify individuals with cancers that have the KRAS G12C mutation for treatment with the KRAS GTPase inhibitor AMG-510. Although the program initially will focus on non-small-cell lung cancer, the agreement allows for the development of tests for other oncology programs at Amgen. Financial terms were not disclosed.
The Quantum Leap Healthcare Collaborative (QLHC) in San Francisco, and G1 Therapeutics Inc., of Research Triangle Park, N.C., said they formed a collaboration to evaluate trilaciclib, a dual cyclin-dependent kinase-4/6 inhibitor, in a new randomized arm of the ongoing phase II I-SPY 2 trial for neoadjuvant treatment of locally advanced breast cancer. QLHC will be responsible for running the trial, and G1 Therapeutics will provide funding and the study drug, which will be evaluated across all high-risk, early stage breast cancer subtypes, including HR-positive, HER2-positive and triple-negative breast cancer. Participants will receive standard neoadjuvant treatment prior to surgical resection of breast tissue, and those in two arms of the study also will receive anti-PD-1 immunotherapy in combination with paclitaxel prior to surgery. Biomarker data to evaluate the impact of trilaciclib on the tumor immune microenvironment and prespecified endpoints to evaluate antitumor efficacy and myelopreservation will be collected. Additional details were not disclosed.
Ripple Therapeutics Corp. is a new, privately held spinout of Interface Biologics Inc., of Toronto. Ripple’s technology is founded on the premise that drugs can be engineered into controlled-release pharmaceuticals and medical device coatings without using polymers or excipients. Ripple’s lead product, IBE-814 IVT, is a degradable intravitreal dexamethasone prodrug implant targeting diabetic macular edema and retinal vein occlusion. The company plans to start a phase II trial in Australia in the second half of this year.
Sanofi SA, of Paris, and Biocorp SA, of Issoire, France, signed a new contract involving Biocorp’s smart sensor, Mallya. The smart sensor will record the dosage when a person uses a Solostar pen to administer insulin. That information can be combined with blood glucose levels recorded by Sanofi’s digital monitoring platform, which currently includes the Mystar Dosecoach blood glucose meter and the My Dose Coach smartphone app. Biocorp, which already received €6 million (US$6.7 million) in up-front payments from Sanofi in 2019, now receives a new €1 million up-front payment with an additional €12 million in potential milestone payments spread over the period of the collaboration. Additional revenues will be generated from the production of Mallya devices by Biocorp on behalf of Sanofi.
Scientist.com, a biopharma industry medical research marketplace, said it partnered with startup Denovicon Therapeutics Inc., of San Diego, in an effort to speed research using artificial intelligence (AI)-powered computational chemistry. Denovicon uses a computational platform and AI-powered molecular modeling algorithms to identify hits from a virtual library of billions of compounds and transform them into clinical candidates. The company said its hit rates are orders of a magnitude higher than traditional high-throughput screens, producing a faster process with lower costs. Terms of the alliance were not disclosed.
Sosei Group Corp., of Tokyo, said progress by its spin-off companies, Orexia Ltd. and Inexia Ltd., launched last year, triggered the next tranche of funding from venture firm Medicxi under its €40 million (US$44.5 million) commitment. The companies are pursuing therapies based on positive modulators of the G protein-coupled receptors orexin OX1 and OX2 for neurological diseases, including narcolepsy. Orexia is seeking to develop oral therapies while Inexia aims to develop candidates for intranasal delivery using an exhalation delivery system licensed from Optinose Inc., of Yardley, Pa.
Taxis Pharmaceuticals Inc., of Wilmington, Del., said it was awarded up to $3.2 million in nondilutive funding, with the potential for up to $11.4 million in additional milestone-based funding, from the global CARB-X partnership to develop efflux pump inhibitors (EPIs) designed to address a major mechanism of multidrug-resistant (MDR) Pseudomonas aeruginosa bacteria. EPIs have the potential to revive the therapeutic activity of antibiotics that no longer work against MDR P. aeruginosa bacterial infections. Taxis’ EPI development program is focused on extended-spectrum beta-lactamase pathogens, including hospital-acquired and ventilator-associated infections.