The ven­ture in­vestors at Medicxi are fund­ing a pair of biotech spin­outs from UK-based So­sei Hep­tares, which has been fine tun­ing its ex­per­tise in G pro­tein-cou­pled re­cep­tors for a num­ber of years now.

Francesco De Ru­ber­tis

Medicxi is of­fer­ing €40 mil­lion to kick­start two new com­pa­nies — the twins Orex­ia and In­ex­ia, which will tar­get Orex­in OX1 and OX2 for neu­ro­log­i­cal dis­eases. The Hep­tares sub­sidiary will put its re­searchers to work on the two projects, iden­ti­fy­ing nar­colep­sy as one key dis­ease on the menu.

Orex­ins are well known tar­gets in the biotech world. These neu­ropep­tides are in­volved in the reg­u­la­tion of sleep, wake­ful­ness and ap­petite.

Mal­colm Weir

Medicxi part­ner Francesco De Ru­ber­tis will sit on the board to watch over the firm’s in­vest­ment. Both of these groups have deep roots in the UK, with So­sei look­ing to build up the Hep­tares op­er­a­tion un­der Mal­colm Weir.

The VC’s cash should be enough to get through proof-of-con­cept stud­ies, fit­ting neat­ly in Medicxi’s as­set-cen­tric fo­cus, which of­ten fo­cus­es the mon­ey on ear­ly-stage re­search pro­grams stripped of as much over­head as they can.

The first batch of pivotal data on Autolus Therapeutics’ CAR-T is in, and execs are ready to plot a path to market.

With an overall remission rate of 70% at the interim analysis featuring 50 patients, the results set the stage for a BLA filing by the end of 2023, said CEO Christian Itin.

Perhaps more importantly — given that Autolus’ drug, obe-cel, is going after an indication that Gilead’s Tecartus is already approved for — the biotech highlighted “encouraging safety data” in the trial, with a low percentage of patients experiencing severe immune responses.

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

The notorious drug testing company Valisure, which has made a name for itself by forcing FDA’s hand with some of its safety-related uncoverings, received a letter this week after the FDA uncovered violations at its Connecticut-based testing lab in 2021.

The letter, which was sent on Dec. 5, stated that the FDA is “concerned” that Valisure was not aware of  drug supply chain security requirements.

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.