Aerami Therapeutics Inc., of Durham, N.C., licensed its tyrosine kinase inhibitor, AER-901, for the treatment of pulmonary arterial hypertension in mainland China, Hong Kong, Macau and Taiwan to Hangzhou Chance Pharmaceuticals Co. Ltd., of Hangzhou, China. Aerami will receive an up-front license fee and is eligible for development and sales milestone payments. Aerami will supply the drug to Chance at an agreed transfer price and will receive a high single-digit royalty on net sales.
Antibe Therapeutics Inc., of Toronto, licensed its pain drug, otenaproxesul, to Shanghai-based Nuance Pharma Co. Ltd. for commercialization in China, Hong Kong, Macau and Taiwan. Antibe will receive $20 million up front and is eligible for $80 million in development and milestone payments, as well as a double-digit royalty on sales.
Apollomics Inc., of Foster City, Calif., and Iterion Therapeutics Inc., of Houston, said they formed an exclusive collaboration and license agreement to develop and commercialize tegavivint in mainland China, Hong Kong, Macau and Taiwan. Apollomics assumed responsibility for development and commercialization in greater China, including the costs of those activities. Iterion received an initial cash payment, which was not disclosed, and is eligible for potential development and sales milestone payments plus tiered royalties. The companies plan to form a joint development committee to ensure harmonized development of the beta-catenin inhibitor across indications and geographies. Iterion is advancing tegavivint to treat cancers where nuclear beta-catenin signaling is known to play a role, including an ongoing phase I/IIa trial in people with progressive desmoid tumors.
Apollomics Inc., of Foster City, Calif., licensed the rights to EO-1001, a pan-erbB inhibitor of EGFR, HER2 and HER4, from Edison Oncology Holding Corp., of Menlo Park, Calif. Apollomics will have global rights to the drug, except in China, Hong Kong and Taiwan. Edison will receive an undisclosed up-front payment and is eligible for development and sales milestone payments, as well as tiered royalties on net sales. In other news, Apollomics said it signed an exclusive license agreement to develop and commercialize TYG-100, a checkpoint control immunotherapy recombinant vaccine, in China, Hong Kong, Macau, Taiwan and South Africa. TYG-100 comprises the amino-terminal sequence of G17, a gastrointestinal peptide hormone. The technology induces a novel mechanism of action that is able to unmask tumors, according to Apollomics. TYG-100 was developed by Tyg Oncology Ltd., of Mansfield, U.K.
Aqualung Therapeutics Corp., of Tucson, Az., said that of more than 5,000 proteins identified as perturbed in COVID-19 patients who did not survive their illness compared to controls, nicotinamide phosphoribosyltransferase (NAMPT) expression was linked to life-threatening multi-organ injuries via participation in multiple inflammatory signaling pathways. The data were published in Cell. NAMPT has also, the company said, been noted as a damage-associated molecular pattern and a master regulator of systemic inflammation, including in patients with COVID-19 infection. Aqualung is developing the monoclonal antibody ALT-100 to treat inflammation.
Atea Pharmaceuticals Inc., of Boston, published preclinical data on its antiviral, AT-527, in Antimicrobial Agents and Chemotherapy. The freebase of AT-527 inhibited replication of SARS-CoV-2 in several in vitro assays. The drug was activated by human primary cells, nasal and bronchial epithelial cells. AT-527 is currently being tested in a phase II trial for hospitalized patients with moderate COVID-19 and in a phase II virology study in the outpatient setting.
Azurrx Biopharma Inc., of Delray Beach, Fla., entered an agreement with contract research organization PPD Inc., of Wilmington, N.C., to run its phase II trial testing FW-1022, a formulation of micronized niclosamide, as a treatment for COVID-19-associated gastrointestinal infections. The study is scheduled to begin in the first half of 2021. Terms of the agreement weren't disclosed.
Biontech SE, of Mainz, Germany, said it began manufacturing mRNA for the COVID-19 vaccine it is co-developing with Pfizer Inc. The batch will produce enough mRNA for about 8 million doses at Biontech’s GMP-certified and Marburg, Germany-based production plant. The two companies increased manufacturing capacity to as many as 2 billion doses for 2021, assuming ongoing process improvements, expansion at current facilities, adding new suppliers and contract manufacturers, and an updated six-dose labeling, according to Biontech.
Celltrion Group, of Incheon, Korea, said that CT-P59, its anti-COVID-19 monoclonal antibody treatment candidate, confirmed neutralizing potency against emerging virus mutations and that the company has begun developing a neutralizing antibody cocktail treatment with CT-P59. The Korea Disease Control and Prevention Agency assessed and independently confirmed CT-P59 successfully neutralizes the SARS-CoV-2 variants first identified in the U.K. (B.1.1.7), the company said, in addition to the previously identified six variant genome mutations of SARS-CoV-2 (variants S·L·V·G·GH·GR). The agency also said the cocktail therapy of CT-P59 with another monoclonal antibody candidate demonstrated neutralizing capability against the U.K. (B.1.1.7) and South African (B1.351) variants.
China SXT Pharmaceuticals Inc., of Taizhou, China, said it inked a nonbinding letter of intent to acquire 70% of the equity of Jiangsu Renji Pharmaceutical Chain Co. Ltd. in exchange for an undisclosed amount of cash and common shares. The companies said final terms will be negotiated following an audit of Renji. The transaction’s close also is subject to approval by China SXT’s board and Renji’s shareholders.
Eikonizo Therapeutics Inc., of Cambridge, Mass., formed a collaboration with the McQuade Center for Strategic Research and Development LLC, part of Otsuka Pharmaceutical Co. Ltd., of Tokyo, to develop inhibitors of histone deacetylase-6 focused on treating amyotrophic lateral sclerosis and other diseases. The pair will advance candidates though preclinical and phase Ib studies, with the opportunity to expand the collaboration after those studies.
Jubilant Biosys, of Bengaluru and Noida, India, and Yale University will collaborate on multiple small-molecule research programs, including medicinal chemistry, structural biology, and in vitro and in vivo pharmacology. Jubilant specializes in contract R&D services. Yale’s Office of Cooperative Research facilitates research from Yale’s labs into products and services.
Lassen Therapeutics Inc., of San Diego, said it will collaborate with the Olivia Newton-John Cancer Research Institute in Melbourne, Australia, to study IL-11 signaling and assess the potential of monoclonal antibodies that block IL-11 signaling in preclinical models of triple-negative breast cancer. Combating tumor progression through inhibition of cytokines that play a key role in the tumor microenvironment, such as IL-11, is the goal, the company said. Lassen’s lead candidate is LASN-01, a monoclonal antibody targeting IL-11 receptor alpha. IL-11, a member of the IL-6 family of cytokines, is a mediator of fibrosis.
Moderna Inc., of Cambridge, Mass., disclosed two supply agreements for the COVID-19 Vaccine Moderna: one with the government of Taiwan for 5 million doses and another with the government of Colombia for 10 million doses. Under the terms of the agreements, deliveries would begin in mid-2021. The COVID-19 Vaccine Moderna is not currently approved for use in Taiwan or Colombia, and the company will work with regulators to pursue necessary approvals prior to distribution. In U.S. news, Moderna said it will sell an additional 100 million doses of its COVID-19 vaccine to the U.S. government, bringing its confirmed order to 300 million doses. The company has supplied 41 million doses of its vaccine so far to the U.S. government and is on track to deliver the first 100 million doses in the first quarter of 2021 and the second order of 100 million doses in May 2021. The company is shooting for delivering the third batch of 100 million doses before the end of July 2021. Moderna also said the Canadian government increased its confirmed order commitment by 4 million doses of the COVID-19 Vaccine Moderna (mRNA-1273 SARS-CoV-2 vaccine), bringing its confirmed order commitment to 44 million doses. On Dec. 23, Health Canada authorized the COVID-19 vaccine for the immunization of people 18 and older under an interim order.
Olix Pharmaceuticals Inc., of Suwon, South Korea, said OLX-104C, a self-delivering RNAi agent in development to treat androgenic alopecia, or hair loss, showed signs of efficacy in a preclinical model. OLX-104C was administered topically to a mouse model with suppressed hair growth (dihydrotestosterone administered mouse). The study evaluated the percentage of hair regrowth and duration of knockdown of the target protein, AR, following a single injection. Mice that received OLX-104C showed substantial hair regrowth vs. controls, and results suggested that a single dose could inhibit expression of the target gene for more than three weeks. The findings were presented at SMI Group’s 12th annual RNA Therapeutics Conference.
Pfizer Inc., of New York and Biontech SE, of Mainz, Germany, said the U.S. government exercised its option for an additional 100 million doses of their COVID-19 vaccine, bringing the total order to 300 million doses. The government will pay $1.95 billion for the additional 100 million doses.
Sandoz International GmbH, a division of Novartis AG, of Basel, Switzerland, said it agreed to acquire the cephalosporin antibiotics business from Glaxosmithkline plc (GSK), of London. The agreement includes rights to the branded drugs Zinnat (cefuroxime), Zinacef (cefuroxime) and Fortum (ceftazidime) in more than 100 markets, excluding the U.S., Australia and Germany, where GSK previously divested certain rights, and India, Pakistan, Egypt, Japan and China, where GSK retained rights. Sandoz agreed to pay $350 million at closing and to make milestone payments of up to $150 million. The transaction is expected to close in the second half of 2021. Sandoz plans eventually to manufacture Zinnat at sites in its network. In the meantime, GSK agreed to supply Zinnat to Sandoz under a manufacturing and supply agreement while supporting a transfer of manufacturing operations over a period of approximately four years.
Scientists from Jemincare Shanghai Research Institute, part of the Jemincare Group, of Nanchang, China, published a preprint paper on BioRxiv, titled "A human antibody with blocking activity to RBD proteins of multiple SARS-CoV-2 variants including B.1.351 showed potent prophylactic and therapeutic efficacy against SARS-CoV-2 in rhesus macaques.” The paper said Jemincare's neutralizing antibody, JMB-2002, now in a phase I trial, showed broad-spectrum in vitro blocking activity against the hACE2 binding to the RBD/S protein of multiple SARS-CoV-2 variants, including the South African mutant (B.1.351).
Sunshine Biopharma Inc., of Montreal, said a transgenic mice study was started with its COVID-19 treatment that has been under development since May of last year. Sunshine’s treatment consists of a series of small molecules which suppress replication of the virus by inhibiting a key virus encoded protease that is responsible for compromising the immune system of infected patients.
Yingli Pharma Co. Ltd., of Shanghai, said it entered a collaboration with Hengrui Medicine Co. Ltd., of Jiangsu, China, in which Hengrui will invest $20 million in Yingli as an equity investment in exchange for joint development rights and exclusive commercialization rights to PI3K-delta inhibitor YY-20394 in greater China.