LianBio

Earlier this month, Kezar Life Sciences announced that the mid-stage test of zetomipzomib in lupus nephritis had been placed on an FDA clinical hold. Now, that program is being terminated. Kezar Life Sciences is discontinuing a lupus program after four patient deaths occurred during a Phase IIb trial and will focus on developing the same drug in autoimmune hepatitis. Earlier this month, Kezar announced that the mid-stage study of zetomipzomib in lupus nephritis had been placed on an FDA clinical hold. The regulatory action came after the company reported four patient deaths in the Phase IIb PALIZADE trial. Other serious adverse events were reported as well that “showed a similar proximity to dosing.” Kezar voluntarily suspended enrollment and began looking at mitigation strategies for the drug. Now, an independent data monitoring committee that had been examining the PALIZADE trial and the Phase IIa PORTOLA trial of zetomipzomib in hepatitis has recommended that the lupus program be suspended. Kezar will proceed with the hepatitis study and expects a readout in the first half of 2025, according to a Thursday press release. Kezar noted that one of the deaths that occurred in the PALIZADE study was in a patient who had received a placebo. The trial was conducted in Argentina and the Philippines. The trial will be unblinded and a full investigation will be conducted into the safety events, the company said. At the time the study was terminated, 84 patients were enrolled. Kezar promised to release available data at a later time. CEO Chris Kirk said Kezar’s decision was a difficult one, as the company had seen a favorable safety pro clinical activity in an earlier trial called MISSION. The PALIZADE trial also enrolled very quickly. “However, a focused development effort in AIH [autoimmune hepatitis] extends our cash runway and provides flexibility as we work to bring zetomipzomib forward as a treatment for patients living with this life-threatening disease,” Kirk said. The data committee recommended that the PORTOLA trial proceed without modification after examining all safety data from the patients enrolled in the trial. No serious adverse events rated grade 4 or higher, which would indicate a death, have occurred in the PORTOLA trial which is being conducted in the U.S. In other news, Kezar has rejected an unsolicited bid from Concentra Biosciences to acquire the biotech. The offer had been to buy all outstanding shares for $1.10 apiece, plus a contingent value right. Kezar has decided that the value significantly undervalues the company and zetomipzomib. Concentra, meanwhile, has moved to acquire 9.9% of Kezar’s common stock. Kezar has adopted a stockholder rights plan, also known as a “poison pill” defense, to protect against any party buying a controlling stake through the open market without paying stockholders their due. The rights plan does not block a more traditional buyout, even from Concentra, if the board deems it in the best interests of shareholders, Kezar noted. Kezar’s shares were trading at 80 cents on the Nasdaq Capital Market Thursday morning, down more than 9% from the prior close. Concentra is owned by Tang Capital, a life sciences-focused investment firm. The company has made many attempts over the years to buy out struggling biotechs, most recently succeeding in acquiring Theseus Pharmaceuticals. Similar buyouts offered to LianBio, Rain Oncology and Atea Pharmaceuticals were unsuccessful.

Concentra Biosciences, a shell company from Tang Capital, wants to buy another biotech that has found itself in a bind. Kevin Tang’s shop told Kezar Life Sciences’ board on Tuesday that it is willing to pay $1.10 per share to buy out the Bay Area biotech. The move comes just days after Kezar stopped its Phase 2b clinical trial in lupus nephritis after four patients died. The trial was then put on official hold by the FDA this week. Kezar’s share price $KZR spiked 22% to 91 cents apiece in post-market trading after Concentra’s proposal became public. Kezar had closed Tuesday at 74 cents per share. The biotech debuted as a public company at $15 per share in June 2018. Tang Capital owns 9.9% of Kezar’s outstanding shares. The investor has bought more than six million shares in Kezar since Sept. 30, according to an SEC filing . Concentra’s non-binding proposal also comes with the potential for further payments. If the deal goes through and Concentra is able to out-license or sell Kezar’s experimental drugs and intellectual property, then shareholders could get 80% of those net proceeds. In his letter to the board, Tang said Concentra “has funds immediately available to execute this transaction.” “Concentra has the expertise and resources to maximize the value of the CVR for the benefit of Kezar shareholders,” Tang wrote. “This may include, if appropriate, completing PORTOLA, an ongoing Phase 2a study of zetomipzomib in patients with autoimmune hepatitis.” Concentra has had a mixed bag of success. Atea Pharmaceuticals and LianBio rejected the shell company’s unsolicited bids last year. Theseus Pharmaceuticals and Jounce Therapeutics , meanwhile, both went with the takeover bids. DNA sequencing company Singular Genomics was also targeted by Concentra last month. Tang wants to hear back from Kezar by the close of business on Oct. 18. Otherwise, the offer will expire, he wrote in the letter. A Kezar spokesperson didn’t immediately respond to an Endpoints News inquiry. The 2015 Amgen spinout has had a string of setbacks in the past 12 months. In August, Kezar stopped enrolling patients in a Phase 1 solid tumor trial. Last October, it laid off 41% of its staff, swapped CEOs and ended preclinical R&D to keep the lights on. At the end of June, the company had $164 million in cash, equivalents and marketable securities.

GENEVA, Aug. 27, 2024 /PRNewswire/ -- As part of their Healthcare investment platform, LIAN Group, an innovative investor and operator known for its healthcare investment in the #1 Swiss dentistry network, Cheeze, announces the acquisition of Scientis, a pioneering Swiss Cosmeceutical company. This acquisition strengthens LIAN's healthcare footprint, as part of their cross-industry investments, focusing on leading solutions that address evolving needs. Scientis is a Swiss dermatology company dedicated to skin pigmentation with its flagship product Cyspera®. The Cyspera® product line, contains proprietary Cysteamine Isobionic-Amide Complex™ , clinically proven as a pigment corrector. Its unique formula featuring powerful antioxidant properties, positions Cyspera as the first topical product to harness these benefits for uneven skin tone and discoloration. This unique proposition positions the company for global market penetration, with a strong presence already established in Asia and the US. "We are thrilled to welcome Scientis to LIAN Group's healthcare platform. We are committed to accelerating Scientis' growth and sales in new markets by leveraging our network, expertise and resources to expand into new markets, streamline operations, develop innovative products and services, and empower patients and healthcare professionals with high-quality solutions." says Fiorenzo Manganiello, Managing Partner of LIAN Group. This acquisition signifies LIAN Group's commitment to expanding its healthcare platform beyond dentistry as they plan for further acquisitions in the beauty and wellbeing sectors. The LIAN core team will work with Scientis to unlock new markets, optimize operations, and develop new offerings that benefit both patients and healthcare professionals. About: LIAN Group is a diversified holding group with an "owner and operator" model, fostering innovation and growth across three core platforms: Healthcare, Crypto/Blockchain and AI/Digital Infrastructure. They operate through two models: Venture Studio and Direct Investment, focusing on strategic deals that align with their vision. Logo - Media Contact: Erenik Yzeiraj; +41787995758; [email protected] SOURCE LIAN Group