Epithelioid Hemangioendothelioma

SAN JOSE, Calif., June 28, 2024 /PRNewswire/ -- BridGene Biosciences, Inc., a leader in developing covalent small molecule drugs for traditional "hard-to-drug" targets, announced today that the first patient has been dosed in its Phase 1 clinical trial of BGC515, a novel TEAD inhibitor discovered through BridGene's cutting-edge chemoproteomic platform, IMTAC™. This milestone highlights the potential of BridGene's innovative chemoproteomics approach. The Phase 1 study will enroll subjects in both the US and China (NCT06452160) to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGC515 as a single agent in patients with advanced solid tumors, including malignant mesothelioma, epithelioid hemangioendothelioma, and other solid tumors with hippo pathway dysregulation. Dr. Timothy Yap, Ph.D., FRCP, Professor in the Department of Investigational Cancer Therapeutics (Phase I Program) and Head of Clinical Development, Therapeutics Discovery Division at the University of Texas MD Anderson Cancer Center, is the principal investigator at the initial US site, where the first patient has been enrolled. "We are delighted to begin the clinical evaluation of BGC515 with the dosing of our first patient, and we look forward to the evaluation of the initial safety and efficacy of this exciting compound," said Jeremy Barton, M.D., Chief Medical Officer of BridGene Biosciences. "The initiation and dosing of our first drug in clinical development from our chemoproteomic platform marks a major inflection point for BridGene," stated Ping Cao, Ph.D., Co-Founder and CEO of BridGene Biosciences. "This achievement underscores our commitment to addressing unmet medical needs through innovative therapeutic solutions. BGC515 represents a breakthrough in targeting the TEAD proteins, a critical component in the Hippo signaling pathway. We are proud of the progress we have made in a short time, developing a pipeline that includes previously undruggable targets for prominent oncology and immunology diseases." BridGene Biosciences is advancing multiple novel drug discovery programs toward the clinic and has over a dozen similar opportunities emerging in early discovery. About the Hippo Pathway and BGC515 The Hippo pathway is a key pathway used by cells to control expression of a group of genes by regulating activity of transcription factors YAP and TAZ. YAP and TAZ function in a complex with partner proteins, the TEADs, which are the targets of BGC515. A variety of human cancers depend on activation of YAP and TAZ, which can occur by various mechanisms. BGC515 is an internally-developed, orally-administered, covalent TEAD inhibitor. About BridGene Biosciences BridGene is a biotechnology company focused on discovering and developing innovative small molecules that drug traditionally undruggable targets, providing new paths to treat diseases. By using its proprietary chemoproteomic platform, IMTAC™, BridGene is able to screen small molecules against all proteins in live cells to discover drug candidates for high value and previously undruggable targets. For this purpose, BridGene takes advantage of its proprietary, diverse covalent library of tagged, drug-like small molecules. The ultimate goal is to enable breakthrough small-molecule drug discovery and to expand the mechanisms to treat diseases, with targets previously inaccessible to small molecules. BridGene is advancing a diversified pipeline of first-in-class drugs for targets in multiple disease areas. For more information, visit . Contact Tiberend Strategic Advisors, Inc. Daniel Kontoh-Boateng (investors) 862-213-1398 [email protected] Dave Schemelia (media) [email protected] 609-468-9325 SOURCE BridGene Biosciences

Ikena will terminate approximately 18 employees, 53% of its workforce, by the end of Q3 this year. Image Credit: Zern Liew / Shutterstock. For the second time this year, US-based Ikena Oncology has announced plans for workforce reduction and pipeline prioritisation. Recommended Buyer's Guides Buyer's Guide Top Guide for Drug Delivery Systems Buyer's Guide Top Guide for Cleanrooms and Cleanroom Flooring The company plans to reduce its workforce by 53% by Q3 this year. The staff layoffs are expected to cost approximately $1.2m. Ikena reported cash reserves of $157m as of 31 March 2024, down $18m from the end of Q4 last year. Ikena has also discontinued developing its selective Hippo pathway inhibitor, IK-930, and will start “winddown activities”. The company added it will seek “strategic options” for the programme, including partnership agreements that could explore the “development of IK-930 in combination with other targeted agents”. In January, Ikena announced cash-saving measures , including a 35% reduction in its workforce and the stoppage of its exploratory research and discovery efforts. At that time, the company had focused on IK-930 as one of the two therapies for further development. See Also: Dupixent gets closer to EU approval as the FDA delays its decision on COPD Bristol Myers Squibb’s Breyanzi gains FDA approval for lymphoma IK-930 is a selective Hippo pathway inhibitor that targets TEA domain transcription factor 1 (TEAD1). The drug was being investigated in a Phase I trial (NCT05228015) in patients with solid tumours. The company planned to focus its development on treating epithelioid haemangioendothelioma (EHE) and mesothelioma. Following the latest round of pipeline reprioritisation, Ikena has one therapy in its pipeline – IK-595, a MEK-RAF molecular glue. It targets the RAS signalling pathway, responsible for cancer cell proliferation. The drug is currently in Phase I trial in patients with RAS and RAF mutant cancers. Early Phase I data with the drug showed an 80% pERK inhibition at four hours post-dosing, with an above 60% inhibition sustained through 24 hours. pERK is one of the major transducers of endoplasmic reticulum stress, participating in regulating fundamental cell functions. Multiple pharmaceutical companies have announced layoffs in recent months amid a difficult economic environment . Last month, Novartis announced plans to lay off approximately 680 staff members . The plans were separate from the company’s overall restructuring programme, which could involve up to 8,000 workers. Xilio Therapeutics also dismissed 21% of its staff in April. Additionally, the company terminated the development of XTX202, a tumour-activated beta-gamma biased interleukin (IL)-2. Similar to Ikena, Xilio did not outright dismiss the development of the therapy but instead stated that it would explore partnerships to develop the therapy as a combination treatment.

Ikena Oncology is evaluating strategic options for the company and its development pipeline. Ikena Oncology is again shrinking its herd and signaling a tough fight ahead as one of two assets, a TEAD1-selective Hippo pathway inhibitor, is cut. The cancer biotech is laying off more than half of its workforce, which means 18 people, according to a Tuesday regulatory filing. The move comes after January cuts saw 35% of the workforce let go. Ikena expects to incur $1.2 million in expenditures related to the most recent round of layoffs, which will be completed in the third quarter. About 16 employees are expected to remain on staff when all is said and done, according to the filing. At the same time, the company is axing development of IK-930, which is one of two meds Ikena had zeroed in on during the January reprioritization. The therapy had been under development for mesothelioma and epithelioid hemangioendothelioma. Now, Ikena will solely focus on the molecular glue IK-595 for RAS and RAF mutant cancers. A phase 1 trial is currently enrolling, with additional cohorts expected to be added in the second half of this year. Despite all of these dramatic cuts, the company is still not in the clear. Ikena said it is also evaluating strategic options for the company and its development pipeline, which could include an acquisition, merger, asset sale partnership or other transactions, the filing stated. “Ikena is in a strong position to create value through multiple avenues. We have been diligent with our capital expenditure, fortifying a cash position that may unlock new strategic opportunities for the company, in addition to the parallel partnership potential of our pipeline,” said Chief Financial Officer Jotin Marango, M.D., Ph.D., in a Tuesday evening press release. The biotech had $157 million in cash and equivalents as of March 31. William Blair analysts called the reprioritizations a tough decision and the discontinuation of IK-930, particularly, a "disappointment." The therapy had been rejigged after an earlier clinical failure, and William Blair had been expecting a meaningful catalyst to come later this year thanks to the treatment.  Executives pointed to a limited market opportunity for IK-930 alone and a long timeline to prove it can provide benefit in a combination regimen. IK-595, meanwhile, is advancing through the clinic a little faster, William Blair noted.  "Clear single-agent activity with IK-595 will be needed to generate significant interest and share appreciation beyond the cash balance," the analysts wrote. "Management emphasized that it is enthusiastic about the profile of IK-595 to date and the potential for a more straightforward development path in much large market opportunities."