Xencor Inc. and Janssen Biotech Inc., already partners on the development of bispecific antibodies against CD28 for prostate cancer, have reached a second agreement licensing to Janssen exclusive rights to Xencor's phase I bispecific antibody plamotamab for the treatment of B-cell malignancies. Xencor will also create and characterize CD28 bispecific antibody candidates using its bispecific Fc technology XmAb against B-cell targets over a two-year term, with Janssen having an exclusive license to develop select molecules in combination with plamotamab and other agents. In return, Xencor will receive $100 million from Janssen up front plus a $25 million equity investment from Johnson & Johnson Innovation. It's also eligible for a mid-teen to low-twenties percent royalty for plamotamab and potential milestone payments up to $1.19 billion.
For up to $1.1B, Selecta joins with Takeda in AAV gene therapies
Selecta Biosciences Inc. joined a licensing agreement with Takeda Pharmaceutical Co. Ltd. to develop AAV-driven gene therapies for two lysosomal storage disorders that could bring Watertown, Mass.-based Selecta up to $1.1 billion. Payments depend upon hitting development or commercial milestones. Selecta is also receiving an undisclosed up-front payment and is eligible for tiered royalties on commercial sales. Selecta’s platform, ImmTOR, is designed to develop tolerogenic therapies for selectively mitigating unwanted immune responses. Through the platform, Selecta is working on therapeutic programs using enzyme therapies, gene therapies and autoimmune diseases.
EMA reverses course on COVID-19 boosters
LONDON – The EMA has changed its stance on booster doses of the Pfizer Inc./Biontech SE COVID-19 vaccine and said they “may now be considered” at least six months after the second dose for people ages 18 and over. However, the EMA is still weighing evidence on whether Moderna Inc.’s COVID-19 vaccine should also be administered as a booster. This is an about turn for the EMA, which on Sept. 2 put out a joint statement with the European Center for Disease Control, saying evidence on vaccine effectiveness and duration of protection showed that all vaccines authorized in the EU remained highly protective against COVID-19-related hospitalization, severe disease and death.
Subgroup analysis prompts Redhill to claim opaganib cuts COVID-19 mortality
DUBLIN – Redhill Biopharma Inc. is claiming a 62% relative reduction in day 42 mortality from COVID-19 among hospitalized severe patients who received its oral drug, opaganib, as compared with those on placebo. It is also reporting a shorter median time to discharge (10 days vs. 14 days) and a higher proportion of patients on treatment being able to breathe unassisted by day 14 (77% vs. 63.5%). The findings represent a concerted effort to rescue a drug candidate that failed to meet the primary endpoint in a global phase II/III trial in hospitalized patients with severe disease who were in need of oxygen supplementation but not ventilation. They emerged from a subgroup analysis of 251 patients of the total study population of 475 patients.
Nobel Prize for Red Hot Chili Pepper and Cool Mint receptors
The 2021 Nobel Prize in Physiology or Medicine was awarded today to David Julius and Ardem Patapoutian “for their discoveries of receptors for temperature and touch.” Julius, who is a professor of physiology at the University of California at San Francisco, identified TRPV1 as the receptor for capsaicin, the ingredient in chili peppers that responded to capsaicin, and showed that TRPV1 was also directly responsive to temperatures above 110 degrees Fahrenheit. In further work, Julius and his colleagues identified a series of channels whose actions combine to sense temperature range.
Cynata regains rights to Cymerus from Fujifilm after COVID-19 slows development in Japan
PERTH, Australia – Cynata Therapeutics Ltd. has regained rights to its Cymerus mesenchymal stem cell (MSC) product, CYP-001, for graft-vs.-host disease (GVHD) from former licensee Fujifilm Corp., with the two companies negotiating a new partnership under which Fujifilm will manufacture the product. Fujifilm exercised a licensing option in 2019 following the completion of a phase I trial of CYP-001. Under the terms of the deal, Fujifilm was granted an exclusive, worldwide license to develop and commercialize Cymerus for GVHD. Cynata received an up-front cash payment of $3 million, and Fujifilm was to be responsible for all development, regulatory and commercialization costs. Fujifilm had planned to get a phase II trial underway in Japan in 2020, but the COVID-19 pandemic threw their plans sideways, Cynata CEO Ross Macdonald told BioWorld.
Newco news: Micreos sidesteps antibiotic resistance, targeting superbugs with $37M for endolysin research
Developing the next generation of antibiotics is proving to be a major problem, with research reaching an almost standstill due to a lack of funding because of the poor return on R&D investment from the products. While antibiotics are as costly as other drugs to develop, they must be used sparingly and as a result sales are likely to be low if approved by regulators. At the same time bacteria through the process of evolution are developing resistance to the antibiotics that are already used, posing a major risk to public health globally. But a Netherlands-based biotech, Micreos BV, aims to change this with a new approach to resistant strains of bacteria that eschews use of antibiotics altogether using €32 million (US$37 million) in funding.
340B litigation continues with PhRMA suit challenging state law
In the latest skirmish over who can get the 340B discounts on prescription drugs that are supposed to help qualifying U.S. providers give charity care, the Pharmaceutical Research and Manufacturers of America (PhRMA) filed suit against an Arkansas law requiring drug manufacturers to give the discounts to all contract pharmacies located in the state. Claiming the state mandate violates both the Supremacy and Commerce clauses of the Constitution, PhRMA Executive Vice President and General Counsel James Stansel said the state law “places requirements on manufacturers that directly conflict with the federal 340B statute and attempts to regulate commercial transactions that occur outside of Arkansas.”
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