Amag Pharmaceuticals Inc., of Waltham, Mass., and Palatin Technologies Inc., of Cranbury, N.J., mutually terminated the January 2017 license agreement whereby Amag was granted exclusive rights to develop and commercialize Vyleesi (bremelanotide), a melanocortin receptor agonist indicated for the treatment of acquired, generalized hypoactive sexual desire disorder in premenopausal women, in North America. All of Amag’s rights and obligations will terminate and full ownership of Vyleesi will transfer back to Palatin. Amag will pay Palatin $12 million at closing and $4.3 million on March 31, 2021. Palatin will assume all Vyleesi manufacturing agreements and associated minimum commitments and Amag will transfer to Palatin all related data and assets. Palatin also has agreed to compensate Amag to provide certain transitional services to Palatin for a period of time to ensure continued patient access during the transition.
Amyris Inc.. of Emeryville, Calif., and the Infectious Disease Research Institute (IDRI) signed a binding term sheet for a planned COVID-19 RNA (ribonucleic acid) vaccine technology program. The program combines IDRI's expertise against infectious diseases with Amyris' fermentation platform technology, with the goal to create semisynthetic squalene-based adjuvants at scale. IDRI's RNA vaccine platform is expected to offer significant differentiated advantages over other RNA vaccines currently in development and will be further enhanced by a scalable Amyris adjuvant, the company said.
The Anacura Group, of Evergem, Belgium, sold its animal health stem cell branch, GST, to Boehringer Ingelheim GmbH, of Ingelheim, Germany. The acquisition follows two years of successful cooperation. Research and production will continue in Anacura’s labs near Ghent, Belgium. Terms were not disclosed. GST became part of Anacura in 2014.
Axoprotego Therapeutics Inc., of Glen Burnie, Md., licensed an investigational therapy for patients with chemotherapy-induced peripheral neuropathy (CIPN). The deal with Johns Hopkins University involves rights to ethoxyquin and its derivatives (including EQ-6, Axoprotego’s lead compound). EQ-6 is a patented approach to cytoprotection of the peripheral nerves against chemotherapy-induced toxicities and may limit CIPN, the company said.
Centogene NV, of Rostock, Germany, and Molecular Health GmbH, of Heidelberg, Germany, said they will collaborate exclusively to initiate the Real-Life Data and Innovative Bioinformatic Algorithms (RIBA) project with epilepsy as the first indication. RIBA aims to foster a novel precision medicine environment to accelerate, de-risk and improve the development of new orphan drugs, based on the combination of large real-life datasets in rare disease with big data, artificial intelligence and computational know-how. Terms were not disclosed.
Cerevel Therapeutics Inc., of Boston, and Cyclica Inc., of Toronto, started a research collaboration aimed at accelerating the discovery of medicines for neurological diseases. Cerevel will use Cyclica’s Ligand Express and Ligand Design artificial intelligence platforms to screen, identify, design and evaluate compounds directed at prespecified targets. Terms were not disclosed.
Clearside Biomedical Inc., of Alpharetta, Ga., said multiple posters and oral presentations on its pipeline and its SCS Microinjector targeting the suprachoroidal space were delivered at the American Society of Retina Specialists virtual annual meeting. Included were preclinical data with CLS-AX (axitinib injectable suspension) as a potential therapy for neovascular age-related macular degeneration. The treatment proved well-tolerated in all animal species evaluated, with sustained, high exposure observed in ocular tissues, the company said.
Elevar Therapeutics Inc., of Salt Lake City, and Tanner Pharma Group, of Charlotte, N.C., disclosed a partnership that will allow access to Apealea (micellular paclitaxel) from Elevar partner Oasmia Pharmaceutical AB, of Uppsala, Sweden, on a named-patient basis in areas outside of the U.S. where Apealea is not commercially available. The drug has been approved by the European regulatory authorities for use in combination with carboplatin for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. Tanner will be the exclusive supplier of Apealea to health care providers.
Emergent Biosolutions Inc., of Gaithersburg, Md., agreed to provide contract development and manufacturing services for large-scale commercial drug substance manufacturing for Cambridge, U.K.-based Astrazeneca plc’s COVID-19 vaccine candidate, AZD-1222. The deal is valued at about $174 million through 2021 and follows an $87 million contract in June for development services, performance and process qualification, raw materials and an initial capacity reservation. The adenovirus vector-based vaccine candidate was co-invented by the University of Oxford and its spinout company, Vaccitech, and licensed by Astrazeneca.
Heat Biologics Inc., of Durham, N.C., said that on July 24, the company received a letter from Nasdaq, confirming that the firm has regained compliance with the $1 per share minimum closing bid price requirement for continued listing. Shares (NASDAQ:HBTX) closed July 27 at $2.36.
Immodulon Therapeutics Ltd., of Uxbridge, U.K., said it expanded its ongoing collaboration with Erasmus University Medical Center Rotterdam, and a phase I/II study is being planned in patients with limited metastatic pancreatic cancer. The trial will test the safety and efficacy of immunomodulator candidate IMM-101 administered in combination with stereotactic radiotherapy of metastases in the liver and lung in patients with limited metastatic pancreatic cancer. That follows the recruitment of 20 patients in a separate phase I/II study combining IMM-101 with stereotactic radiotherapy in locally advanced pancreatic cancer. Recruitment is expected to begin by the end of 2020.
LGM Pharma Inc., of Boca Raton, Fla., acquired the formulation development and drug product contract manufacturing business of Nexgen Pharma Inc., of Irvine, Calif. The combined firm will continue to be known as LGM Pharma. Nexgen specializes in the development and manufacture of solid dose, powder, semi-solid and liquid drugs.
Lynk Pharmaceuticals, of Hangzhou, China, signed exclusive licensing agreements with Kobe University in Japan and with Riken Research Institute in Saitama, Japan, to develop RAS inhibitors with a novel mechanism of action. The agreement with Kobe also includes a joint collaboration which will continue to provide screening and structural support. Using the two parties’ early structural biology and screening outcome, Lynk will deploy its medicinal chemistry and drug design to target a broader range of undruggable RAS onco-drivers, the company said. and ultimately develop the compounds for clinical use.
Medicinova Inc., of La Jolla, Calif., and the Jasdaq Market of the Tokyo Stock Exchange disclosed an agreement with Biocomo Inc., of Mie, Japan, and Mie University for joint development of a COVID-19 vaccine using BC-PIV, a human parainfluenza virus type 2 vector developed by Biocomo and the university. Medicinova has been granted exclusive worldwide rights to use the vector for COVID-19 vaccine development. Terms were not disclosed.
Onconova Therapeutics Inc., of Newtown, Pa., submitted an application for NIH funding to conduct human studies with rigosertib in COVID-19 disease patients. Recent preclinical studies conducted with rigosertib have shown inhibition of the virus’ replication in Vero cells when compared to controls, including agents currently being administered and studied in COVID-19 infection. Cancer-focused Onconova said it does not intend to pursue clinical development in the virus without additional, nondilutive funding.
PDS Biotechnology Corp., of Florham Park, N.J., said its COVID-19 vaccine candidate, Versamune-CoV-2 (PDS-0203), appeared to induce "highly active and potent virus-specific CD8 killer and CD4 helper T-cells within 14 days of treatment" in a preclinical study. The candidate pairs the company's T-cell activating Versamune platform with a recombinant protein recognized by the human immune system that is derived from SARS-CoV-2. Preclinical work continues on PDS-0204, a COVID-19 vaccine candidate that combines Versamune with a recombinant fusion protein of SARS-CoV-2 developed by Ribeirão Preto, Brazil-based Farmacore Biotecnologia Limitada.
Redhill Biopharma Ltd., of Tel-Aviv, Israel, said Envisionrx, a pharmacy benefit manager that's part of Rite Aid Corp., of Camp Hill, Pa., added Talicia (omeprazole magnesium, amoxicillin and rifabutin) to its formularies, as the unrestricted branded agent for H. pylori treatment. The drug was approved in November 2019.
Sandoz International GmbH, the generics and biosimilars division of Basel, Switzerland-based Novartis AG, said it would make a joint investment, together with the Austrian federal government, to strengthen the long-term future of integrated antibiotics manufacturing in Europe. Sandoz intends to invest more than €150 million (US$174.1 million) over the next five years to strengthen the long-term competitiveness of its integrated antibiotic manufacturing operations at Kundl, Austria, developing and introducing new manufacturing technology for both active pharmaceutical ingredients and finished dosage forms. The Austrian federal government would contribute or coordinate public funding totaling about €50 million toward the total investment, as part of its efforts to increase European-based production of essential medicines.
Researchers from Singapore-MIT Alliance for Research and Technology, MIT's research enterprise in Singapore, said they've found "a practical way to induce a strong and broad immunity to the dengue virus based on proof-of-concept studies in mice." The study is reported in a paper published in NPJ Vaccines. Investigators will aim to test the sequential immunization in humans in the near future, they said.
Tvardi Therapeutics Inc., of Houston, said its collaborators will receive more than $5 million in U.S. National Cancer Institute grants to support ongoing validation and clinical development of its lead compound, TTI-101, a small-molecule inhibitor of STAT3, in hepatocellular carcinoma and gastrointestinal cancer. The company said the new funding brings the total nondilutive support of TTI-101 to approximately $20 million from multiple sources, including the NIH, V Foundation and the Cancer Prevention & Research Institute of Texas.
Venatorx Pharmaceuticals Inc., of Malvern, Pa., said the U.S. National Institute of Allergy and Infectious Diseases has awarded it a contract to advance a series of penicillin-binding protein inhibitors targeting multidrug-resistant Acinetobacter baumannii through phase I testing. The estimated cost of the base period for the contract is about $3.2 million, but the total funding could reach $44.2 million if all project milestones are met. A. baumannii is ranked as a “Priority 1: Critical” carbapenem resistant pathogen on the World Health Organization’s list of bacteria for which new antibiotics are urgently needed.
Zentalis Pharmaceuticals Inc., of New York, agreed to work with Indianapolis-based Eli Lilly and Co. to evaluate the combination of ZN-c5, its oral selective estrogen receptor degrader candidate, and Verzenio (abemaciclib), Lilly’s CDK4 and 6 inhibitor, in patients with ER-positive/HER2-negative advanced breast cancer. Under the terms of the nonexclusive collaboration, Zentalis is responsible for conducting the study with Lilly providing all required doses of abemaciclib. Zentalis maintains full ownership of ZN-c5. The new study is an addition to an ongoing phase I/II trial Zentalis is running to test ZN-c5 in a similar patient population, both as a monotherapy and in combination with Ibrance (palbociclib, Pfizer Inc.).