Cal­i­for­nia-based Cy­to­ki­net­ics an­nounced that pos­i­tive re­sults from a Phase II tri­al of afi­camten showed pos­i­tive re­sults in pa­tients bat­tling hy­per­trophic car­diomy­opa­thy.

The third co­hort of the RED­WOOD-HCM tri­al showed sub­stan­tial re­duc­tions in the av­er­age left ven­tric­u­lar out­flow tract gra­di­ent in pa­tients whose back­ground in­clud­ed be­ing treat­ed with disopy­ra­mide and a be­ta-adren­er­gic block­er. Each pa­tient re­ceived up to three dos­es dai­ly.

Re­sults showed that there were no in­stances of left ven­tric­u­lar ejec­tion frac­tion be­low 50%. Afi­camten is an in­ves­ti­ga­tion­al car­diac myosin in­hibitor. Treat­ment in the tri­al last­ed 10 weeks, with a 4-week fol­low-up pe­ri­od com­ing in af­ter the last dose. Thir­teen pa­tients were en­rolled, and all of them com­plet­ed the study on treat­ment, Cy­to­ki­net­ics said.

In a state­ment, EVP of R&D Fady Ma­lik said:

These re­sults rep­re­sent the first re­port of pa­tients with ob­struc­tive HCM treat­ed with a com­bi­na­tion of a car­diac myosin in­hibitor and disopy­ra­mide and sup­port our plan to in­clude this pa­tient pop­u­la­tion in SE­QUOIA-HCM, our Phase 3 tri­al, which is im­por­tant giv­en these pa­tients have ex­haust­ed oth­er avail­able med­ical ther­a­pies. We look for­ward to ini­ti­at­ing screen­ing of pa­tients in SE­QUOIA-HCM soon and look for­ward to shar­ing these re­sults from Co­hort 3 with the med­ical com­mu­ni­ty in April.

Ear­li­er this month, Roy­al­ty Phar­ma agreed to lend up to $300 mil­lion to sup­port the com­mer­cial­iza­tion of ome­cam­tiv mecar­bil, Cy­to­ki­net­ics’ lead can­di­date, and the de­vel­op­ment of afi­camten. In re­turn, Roy­al­ty is due a 4.5% roy­al­ty on sales for up to $1 bil­lion, and 3.5% on sales above $1 bil­lion. — Kyle Blanken­ship

Pol­ish CRO plots re­struc­ture, re­ori­ent­ing lead­er­ship team

Pol­ish CRO Selvi­ta is tear­ing down and re­build­ing its busi­ness with plans to com­plete­ly re­jig­ger its lead­er­ship team as it hunts for growth, the small firm said Tues­day.

First, the firm is plan­ning to in­te­grate its “drug dis­cov­ery area, in­te­gra­tion of busi­ness de­vel­op­ment ac­tiv­i­ties, and cre­ation of a de­part­ment sup­port­ing the man­age­ment of op­er­a­tions and in­vest­ments,” ac­cord­ing to a re­lease. That unit will be led by Adri­jana Vin­ter, who was most re­cent­ly a man­ag­ing di­rec­tor at Fi­delta.

Next, the firm will al­so in­te­grate its sales and busi­ness unit. That area will be helmed by Milosz Gru­ca, who will take the CCO role.

Selvi­ta al­so plans to add a new R&D fa­cil­i­ty in Krakow that will even­tu­al­ly hold up to 1,000 re­searchers, the com­pa­ny said. — Josh Sul­li­van

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Drug discovery and development player Evotec entered another licensing deal with Big Pharma — this time with J&J’s Janssen.

The companies put out word that they entered into a strategic collaboration and license agreement with each other that focuses on targeted immune-based cancer therapies, to be commercialized by Janssen.

According to a statement, the collaboration will hinge on Evotec’s integrated drug discovery and manufacturing capabilities. During the pre-clinical R&D phase, the companies will collaborate closely — and then Janssen will take on full responsibility for both clinical development and commercialization.

Magenta Therapeutics is pausing an early-stage clinical trial after a patient died. The death was deemed to be possibly related to its drug, MGTA-117.

The biotech said the pause of the Phase I/II trial is voluntary and gives it time to review all available data before deciding what to do next. It’s also reported the known information to the FDA.

The dose-escalation trial was designed to test whether MGTA-117, an antibody-drug conjugate, could serve as a more targeted alternative to high-intensity chemotherapy as a conditioning agent for cancer patients who are set to receive a stem cell transplant. It recruited patients with relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome.

Regeneron has won a patent case against Swiss pharma giant Novartis over the delivery system for its eye drug Eylea.

The US Patent Trial and Appeal Board ruled that Novartis’ pre-filled syringe for injecting its eye medication Lucentis was “unpatentable” and handed the victory to Regeneron and its AMD drug Eylea.

In the initial complaint in 2020, Novartis alleged to the US International Trade Commission that certain pre-filled syringes for the intravitreal injection, and ultimately Regeneron’s delivery system for Eylea, were infringing on Novartis’ patent. Regeneron filed a petition to review Novartis’ claims in 2021.