Cullgen, Inc.

+Plus, news about Autolus, MacroGenics and BlissBio: Akeso bispecific looks promising in cervical cancer: The China-based biotech said Friday that all patients in a Phase 3 cervical cancer trial responded to treatment with a bispecific antibody called cadonilimab. The addition of the PD-1xCTLA-4 bispecific on top of chemoradiotherapy in the COMPASSION-18 study generated complete and partial response rates of 84.8% and 15.2%, respectively. Median PFS was not reached, but the 12-month PFS rate was 74.9%. Cadonilimab is already approved in China for patients with recurrent or metastatic cervical cancer who have not responded to platinum-based chemotherapy. — Elizabeth Cairns Pulmatrix to divest assets ahead of merger: The biotech will seek buyers for three of its pipeline programs as well as its iSPERSE platform technology. Pulmatrix in November agreed to a reverse merger with Cullgen, which was expected to close this month but is now set to close in the first half of 2025. — Max Gelman BioNTech’s option for Autolus CAR-T fizzles out: The German biotech allowed its option to lapse for AUTO1/22, a CAR-T cell therapy in Phase 1 trials for childhood acute lymphoblastic leukemia. Back in February 2024 , BioNTech paid $50 million in cash and bought $200 million of Autolus’ shares in a deal that granted it access to AUTO1/22. The deal also covered AUTO6NG, a programmed T-cell therapy in early trials in neuroblastoma, and Aucatzyl, which has since been approved for an aggressive form of leukemia. BioNTech declined to exercise its time-limited option to AUTO1/22 because of a pipeline prioritization , and it lapsed Feb. 8. — Elizabeth Cairns MacroGenics shelves prostate cancer ADC: The company had to stop dosing prostate cancer patients in a Phase 2 trial of its antibody-drug conjugate, called vobramitamab duocarmazine, in July . On Thursday , it said it would shut down all development and seek a partner for the product, which targets the tumor antigen B7-H3 and delivers a cytotoxic duocarmycin payload. MacroGenics said the results of the trial do not justify any more investment; in the patients treated before dosing was halted, mature median radiographic progression-free survival was 9.5 months with the lower dose and 10 months with the higher. — Elizabeth Cairns BlissBio to proceed with ADC on its own: Eisai had signed an option deal in 2023 to advance a BlissBio program called BB-1701, but last month said in its third-quarter earnings that it would no longer do so. Instead, BlissBio will develop BB-1701 on its own. Eisai had been partnered with liquid biopsy company Angle on development plans, and now Angle is planning to work with BlissBio. — Max Gelman

Pain marks the second therapeutic area for Cullgen’s lead protein degrader CG001419 SAN DIEGO, CA, USA I January 22, 2025 I Cullgen Inc. (“Cullgen”), a privately-held, clinical-stage biopharmaceutical company applying its proprietary targeted protein degradation uSMITE™ platform to discover and advance therapeutics for the treatment of cancer and other diseases, today announced that it has begun dosing in human subjects to evaluate its potential first-in-class, oral, pan-TRK protein degrader for the treatment of pain. CG001419 is a highly active small molecule designed to selectively degrade both mutant and wild-type TRK proteins and is being developed to be a new, non-opioid, non-NSAID analgesic therapy as part of a new class of pain signal inhibitors that have the potential to reduce the risk of addiction associated with other pharmaceutical therapies for the treatment of pain. “We are pleased to be ushering our lead candidate, CG001419, into a second clinical trial as planned. This protein degrader program is now in clinical testing in two different indications,” said Dr. Ying Luo, Chairman and CEO of Cullgen. “Cullgen has successfully generated a portfolio of multiple, highly active, selective, and bioavailable targeted protein degrader compounds. Exploration of these molecules across therapeutic disciplines aligns with our goal of becoming a leader in the pursuit of the next generation of targeted protein degraders.” Cullgen received ethics committee approval in Australia to begin enrollment into the Phase 1 healthy volunteer study (NCT06636500). The trial is a single-center, randomized, placebo-controlled, double-blind, single-ascending-dose/food-effect and multiple-ascending-dose study of orally administered CG001419. The study is designed to evaluate the safety, tolerability and pharmacokinetic characteristics of CG001419. As previously announced, Cullgen entered into a merger agreement with Pulmatrix, Inc. (Nasdaq: PULM) on November 13, 2024. Subject to the terms and conditions of the merger agreement, and upon the closing of the merger, the combined company which will operate under the name Cullgen Inc., be headquartered in San Diego, CA and trade on The Nasdaq Capital Market (Nasdaq). About Cullgen Inc. Cullgen is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class new chemical entities (NCEs) for the treatment of diseases lacking effective therapeutic approaches. The Company applies its proprietary uSMITE™ (ubiquitin-mediated, small molecule -induced target elimination) platform technology to build the next generation of targeted protein degraders and degrader-antibody conjugates (“DACs”). Cullgen’s mission is to utilize its proprietary platform to expand the drug design paradigm beyond functional site inhibition, enabling the targeting of historically “undruggable” proteins for selective destruction. Leveraging years of work by its founders on the proteasome system and key discoveries regarding its functionality, Cullgen has successfully generated multiple highly active, selective, and bioavailable targeted protein degrader compounds. Cullgen is also actively advancing several of its highly active degraders as payloads for use in degrader-antibody conjugates (DACs). For more information, visit www.cullgen.com . SOURCE: Cullgen

Plus, news about Allogene, Telix, Cullgen, Pulmatrix, Gilead, Innocoll, Durect and Sensei: Zai Lab’s $200M offering: The Shanghai-based drugmaker is selling shares the same week as announcing revenue growth of 47% year-over-year. It also said it plans to submit the schizophrenia drug KarXT for approval in China “early” next year. The FDA in September approved the medicine, owned by Bristol Myers Squibb. — Kyle LaHucik Kronos Bio to seek “strategic alternatives”: The company made the decision after looking at the data for a CDK9 inhibitor called istisociclib and deeming “the benefit-risk profile” as not warranting additional development. Istisociclib was designed to treat platinum-resistant high-grade serous ovarian cancer. Kronos had $124.9 million in cash, cash equivalents and investments as of the end of September. — Max Gelman Allogene halts enrollment in Phase 1 leukemia trial: The company was investigating cemacabtagene in patients with relapsed or refractory chronic lymphocytic leukemia. In its latest securities filing, Allogene blamed slow enrollment and “the emergence of new alternative treatment options” for its decision to halt enrollment altogether. The company added that it would be reallocating resources from the trial to other programs. Its shares $ALLO were down about 6% on Thursday morning. — Katherine Lewin Telix’s Nasdaq debut : The Australian radiopharma started trading on the Nasdaq as $TLX on Thursday. The company didn’t sell any new shares as part of the listing, though. It had pulled its Nasdaq IPO plans in the 11th hour in June. — Kyle LaHucik Cullgen to take Pulmatrix’s spot: Cullgen and the Nasdaq-listed Pulmatrix will reverse merge in a deal expected to close by the end of March. Cullgen makes protein degraders and degrader-antibody conjugates, or DACs, that are in Phase 1. Another DAC maker, Orum Therapeutics, is looking to go public , but in South Korea. Pre-merger Cullgen stockholders will get about 96.4% of the combined company. — Kyle LaHucik Gilead lays off 72 workers in Seattle: The cuts were attributed to a site closure and are set to begin in January, according to a WARN notice in Washington state. A spokesperson for Gilead did not immediately respond to a request for comment. The pharma gained a foothold in the Seattle area after acquiring Corus Pharma for $365 million in 2006. — Max Bayer Innocoll Pharmaceuticals ends licensing pact with Durect: Durect said the termination is effective in May. Innocoll had snagged US commercial rights to Durect’s non-opioid analgesic in December 2021. — Max Bayer Sensei to lay off 46% of staff, close research site in Rockville, MD: The cuts will extend Sensei’s runway into 2026, the company said. They will also help Sensei “focus resources on advancing the clinical development of SNS-101,” which the company is developing both as a monotherapy and a combination in advanced solid tumors. It had 27 employees as of Feb. 23. Its stock $SNSE fell about 11% on Thursday morning. — Max Gelman