Yuhan Corp.

Plus, news about Gilead Sciences and Yuhan: Vanda gets second unsolicited offer: Cycle Group Holdings again submitted a proposal to buy Vanda for $8 per share in cash. Vanda, which is currently trading at about $4.87 $VNDA per share, rejected Cycle’s offer of the same size in May. It later received an FDA rejection for a gastrointestinal treatment in September. — Kyle LaHucik Ocean Biomedical, Molecure ink deal: The Rhode Island-based company will pay up to $32 million for access to Molecure’s preclinical YKL-40 inhibitor, called OAT-3912, and other inhibitors in that class. Molecure gets $600,000 in cash and stock to start. — Kyle LaHucik Gilead Sciences, Yuhan terminate deal : The companies “mutually agreed” to end an agreement first inked in 2019 to develop a pair of MASH therapies, according to a Gilead spokesperson. At the time, Gilead had paid $15 million upfront and promised up to $770 million in milestones. — Jaimy Lee

SEOUL, South Korea I October 08, 2024 I Ubix Therapeutics, Inc., a clinical-stage biotechnology company dedicated to the discovery and development of innovative oncology therapeutics using Targeted Protein Degradation (TPD) technology, announced today its acceptance as a member of the Johnson & Johnson Innovation – JLABS (JLABS) Korea community. JLABS is one of the largest global networks of health incubators pioneering the next wave of healthcare solutions with early-stage innovators. Powered by Johnson & Johnson, JLABS empowers its member companies working across the spectrum of healthcare with the experience, mentorship, partnerships and venture connections to accelerate their science. Ubix Therapeutics is currently conducting a phase 1 clinical trial for UBX-303-1, an oral small molecule degrader targeting B cell malignancies. In July, the company inked a license agreement granting Yuhan Corporation the rights to develop and commercialize AR degrader UBX-103, a prostate cancer drug candidate. “Our acceptance into JLABS is a tremendous opportunity for us to accelerate our R&D efforts.” said BK Seo, CEO of Ubix Therapeutics. “We plan to leverage the membership to further advance our pipeline, including UBX-106, a SHP2 degrader program set to enter IND-enabling studies, and to strengthen our efforts in building global partnerships.” About Ubix Therapeutics, INC. Ubix Therapeutics is a biotechnology company dedicated to discovery and development of TPD therapeutics. Ubix’ proprietary TPD platform technology, Degraducer®, leverages the body’s own natural protein degradation machinery to eliminate diseased proteins, thereby leading to near-complete inactivation of disease-causing pathways. Ubix’ wholly owned TPD pipeline includes its clinical program UBX-303-1, a BTK degrader for treatment of relapsed or refractory B cell malignancies, UBX-106, a SHP2 degrader set to enter IND-enabling studies for MAPK signaling dependent cancers, and multiple other preclinical and research stage degrader assets in targeted and immuno-oncology. For additional information, please visit http://en.ubixtrx.com SOURCE: Ubix Therapeutics

AstraZeneca's TKI Tagrisso generated sales of $5.8 billion last year but Johnson & Johnson's Rybrevant is poised to make its mark in the non-small cell lung cancer (NSCLC) market. The J&J med has picked up three FDA approvals in different NSCLC indications in the last seven months. Approvals are coming fast and furious for Johnson & Johnson’s Rybrevant as it is lining up to challenge the dominance of AstraZeneca’s Tagrisso in non-small cell lung cancer (NSCLC).Rybrevant has earned its third FDA nod in the last seven months, each covering a new indication. The U.S. regulator has signed off on Rybrevant plus standard-of-care chemotherapy (carboplatin and pemetrexed) to treat patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletions or L858R substitution mutations who have had disease progression with an EGFR tyrosine kinase inhibitor (TKI).Rybrevant plus chemo is the first targeted regimen to cut the risk of disease progression by more than half in second-line EGFR-mutated advanced lung cancer, J&J said.The endorsement comes a month after J&J’s combo of Rybrevant and new, Yuhan-partnered TKI, Lazcluze, got a thumbs up for patients with newly diagnosed EGFR-mutated advanced NSCLC with one of the two common EGFR mutations at exon 19 or exon 21. That nod was backed by a phase 3 trial which showed that the combo reduced the risk of disease progression or death by 30% compared to Tagrisso as a first-line treatment.In March, the FDA blessed Rybrevant plus chemotherapy as a first-line treatment for NSCLC with EGFR exon 20 insertion mutations. That approval came after a study showed the combo cut the risk of progression or death by 60% over standard of care chemo.  The most recent FDA endorsement is based on results from the phase 3 MARIPOSA-2 study which showed that Rybrevant plus chemotherapy reduced the risk of disease progression or death by 52% over chemotherapy alone in patients who had shown disease progression on or after use of Tagrisso.Patients in the study survived without disease progression for a median duration of 6.3 months on the combo versus 4.2 months for chemo alone. Additionally, the overall response rate for those on the combo was 53% compared to 29% for the chemo group.“Rybrevant plus chemotherapy may address the most common mechanisms of treatment resistance to third generation EGFR TKIs, such as osimertinib (Tagrisso), in the first line,” Martin Dietrich, M.D., Ph.D., an oncologist at the Cancer Care Centers of Brevard, said in a release. The advancement of Rybrevant is positive news as the five-year survival rate is less than 20 percent for all people with advanced EGFR-mutated NSCLC. In the U.S. about 30,000 are diagnosed annually with EGFR-mutated NSCLC, J&J said.With the battery of approvals, Rybrevant is poised to begin to challenge Tagrisso, which generated sales of $5.8 billion in 2023.