Xenikos BV

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here . I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities. News of several biotechs shuttering came out this week. A small player looking to carve a lane in the tRNA field by the name of Theonys has folded , Kyle LaHucik reports, due to disagreements between investors, although the scientific co-founder hinted the work may be continued elsewhere. Xenikos , a 13-year-old Dutch biotech, is going through a liquidation process after disappointing results in its Phase III trial in graft-versus-host disease. Then kidney-focused Goldfinch Bio confirmed it’s the latest to shut down . Thirty-five years after the first cell therapy company she worked for went under, stem cell pioneer Jeanne Loring is still pushing for more recognition for the setback-ridden field — and she’s making another shot using a unique approach that’s set to enter the clinic soon. Endpoints features editor Jared Whitlock takes a long look back at her career just as she marked another special moment: sending her cells into space. George Scangos , one of the all-time great biotech CEOs, says the time has come to turn over the reins one last time. After spending close to three decades in a CEO post, the 74-year-old biotech legend is handing the Vir Biotechnology keys to Marianne De Backer , one of the most prominent BD chiefs in the business currently at Bayer . He talks to Endpoints founding editor John Carroll about the “complicated” decision. Newly released FDA emails shed new light on a series of vigorous exchanges among top officials, including how the top vaccine leader raised concerns that a sharply accelerated process to review and formally approve Pfizer’s Covid-19 vaccine would undermine public confidence in the shots. Endpoints senior editor Zach Brennan distilled the biggest takeaways from well over 100 pages of internal documents. Eli Lilly succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck. The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma. Amid frequent chatter about R&D layoffs as biotechs of all stripes seek longer runways, buzz about a burst of Bristol Myers Squibb resumes hitting the market out of New Jersey drew some special attention. Endpoints’ John Carroll got an answer — but the company isn’t saying much. PREMIUM For those who missed our events at #JPM23, we have some more video recaps and transcripts for you: PEOPLE DEALS CELL/GENE TX CORONAVIRUS PHARMA R&D FINANCING STARTUPS LAW MARKETINGRX FDA+ MANUFACTURING DON’T MISS

A 13-year-old Dutch biotech is going through a liquidation process after an unexpected end to its Phase III trial testing whether its combination of two monoclonal antibodies was superior to Incyte’s Jakafi. Xenikos had hoped to prove its investigational therapy, named T-Guard, was better than Jakafi at garnering a complete response in patients experiencing life-threatening complications in which new cells from a hematopoietic stem cell transplant begin to fight the body. Jakafi was approved for the indication, steroid-refractory acute graft-versus-host disease, in May 2019. But Xenikos flashed a stop sign this week in an update to the Phase III study on the US clinical trials database, saying it had terminated the testing because the study “met the protocol defined stopping boundary for Day 60 mortality when comparing mortality between the T-Guard and ruxolitinib [Jakafi] arms.” In an interview, Xenikos founder and CEO Ypke van Oosterhout said the biotech hadn’t expected the outcome. The drug developer, which he said has let most employees go, is still going through the results with its trial partners, including the Blood and Marrow Transplant Clinical Trials Network. He said it was too early to provide details about the future of the asset. T-Guard combines two monoclonal antibodies going after CD3 and CD7 on T cells and NK cells. The antibodies hook up to an immunotoxin with the goal of stopping the activated T cells from producing new proteins. FDA and EU assigned it orphan drug status and the US regulator also gave it fast track designation. Xenikos had aimed to enroll 246 patients in the trial, but only a dozen were actually brought into the study. Patients in the T-Guard group received an IV infusion over the course of four hours for four times in one week. In the Jakafi group, patients took the oral drug twice a day until day 56. Data from the first 150 patients were expected to form the basis for a biologics license application to the FDA, and data from all patients in the study were anticipated to support an approval request in the EU, Xenikos had previously guided. The biotech had tried running a single-arm Phase III in the US in 2019, but the FDA placed a hold on it after the first three patients died within 30 days of the trial start. Xenikos said the FDA conducted an “in-depth investigation” that “found no reason to stop further development of T-Guard.” After meeting with the FDA, the parties hashed out the new Phase III trial, which also included sites in the EU. Financing for the private biotech had come from the likes of RA Capital and Medicxi, via a $30 million Series B in 2018. Another €40 million came via convertible debt in fall 2021 , and just last month Xenikos had announced funding from the European Innovation Council. Social: Shutterstock

The leaves are brown, the temperature is warm and Red Tree Venture Capital is dreaming of California — and some other West Coast states as well. The VC firm is out with its first fund, two years in the making and officially wrapped up in June, to bankroll at least a dozen biotechs and medical device startups for which the capital deployer wants to be the first institutional backer. Named after its co-founder’s Stanford roots and the team’s love for the outdoors, Red Tree wants to replicate the university spinout approach that has cemented the biotech creation blueprint for Boston funds like Third Rock, Polaris, Atlas and Flagship, managing partner Heath Lukatch told Endpoints News in a preview of the Thursday unveiling. Except Red Tree’s sights are set on its academic neighbors in San Francisco, Los Angeles, San Diego and elsewhere across the West Coast, including Seattle. Lukatch founded the firm with chief scientific advisor Jennifer Cochran, and the duo brought on board former Medicxi partner Jon Edwards as managing director. “I pinged my trusted network,” Lukatch said, and a CEO friend connected the two. “I’ve spent a lot of time investing early, putting companies together and just saw the opportunity and thought it was a once-in-a-lifetime chance to be able to help create a new fund and build the team out together,” Edwards said in an interview with Lukatch. Red Tree has already backed 10 companies, including clinical-stage Pipeline Therapeutics, and the goal is to fund at least another two with the initial pool of $272 million. The VC’s leaders will hit the road for fund two next year, Lukatch said. Cochran, who chairs the bioengineering department at Stanford, said Red Tree is “particularly proud” that more than half of its investments to date have been in companies with female founders and/or CEOs. Check sizes range from a couple hundred thousand dollars to $15 million, with Red Tree aiming to invest about $20 million to $30 million over the span of their financial relationship with each portfolio company, Lukatch said. The goal is to focus on oncology, neurology and immunology, the managing partner said, noting those areas have garnered a majority of M&A and IPO exits in recent years, as well as FDA nods. “We like to take the teams out and replicate it as quickly as possible and really do the initial de-risking in a fairly virtual way and scaling these companies as the data has earned that capital,” Edwards said, “and then we look to go syndicate these companies with our friends, other great early-stage investors and really turn the human clinical data card.” The portfolio’s spread includes about 70% seed-stage and early-clinical companies, and the other 30% in late-clinical or early-commercialization phases, with the latter mainly coming from the medical device investments, Lukatch explained. Biotech represents about three in four investments, with the remainder in medical devices. Red Tree’s investments to date include: gene editing shop Acrigen Biosciences; brain monitor maker Ceribell; food allergy-focused Alladapt Immunotherapeutics; small molecule drugmaker Sardona Therapeutics and others. While at Medicxi, Edwards was on the board of multiple companies, including Xenikos , Phathom, Palladio, Celgene-acquired Impact Biomedicines and others, including serving a short stint as board observer at Checkmate Pharmaceuticals, which Regeneron bought earlier this year. Lukatch was previously a partner at PE firm TPG and has served on the boards of more than a dozen companies.