BridgeBio, Astellas, Kelun-Biotech Tout Progress in Mid-Stage Trials, R&D

BridgeBio

BridgeBio Pharma, Astellas and Kelun-Biotech recently reported positive updates in their research and discovery studies for potential cancer treatments. 

BridgeBio Shares Positive Interim Phase II Results

Initial results from BridgeBio Pharma's Phase II PROPEL 2 trial on infigratinib showed potential in treating children ages five years and up diagnosed with achondroplasia (ACH). Using infigratinib at the highest dose level of 0.128 mg/kg once a day, researchers found an average percent change from baseline of 60% among the 64% of responders. 

ACH is the most common cause of disproportionate short stature and affects around 55,000 people in the United States. The complications from this disease can lead to middle ear dysfunction, obstructive sleep apnea, spinal stenosis and kyphosis. The trial involved children as young as three years old.

"We are encouraged by what we have seen to date, including the overall safety profile and promising initial efficacy data of infigratinib. We look forward to completing enrollment in Cohort 5 with the goal of presenting the full study results next year," Professor Ravi Savarirayan, M.D., Ph.D., the clinical geneticist and group leader of skeletal therapies research at Murdoch Children's Research Institute in Australia, commented. Savarirayan is the lead investigator for the study. 

Infigratinib is not yet approved in any country to treat children for the said indication. 

Astellas, Seagen Announce Favorable Topline Outcomes From Padcev Plus Keytruda Trial

Astellas and Seagen shared positive topline results from their Phase IB/2 EV-103 KEYNOTE-869 clinical trial evaluating Padcev (enfortumab vedotin-ejfv) in combination with Merck's Keytruda (pembrolizumab) to treat unresectable locally advanced or metastatic urothelial cancer in patients who are not eligible for cisplatin-based chemotherapy. 

EV-103 Cohort K is a randomized cohort looking into the use of Padcev alone versus using it alongside Keytruda. Initial findings from Cohort K showed the combination's ability to deliver a 64.5% confirmed objective response rate (ORR), the primary endpoint. However, the mean duration of response per BICR metric was not achieved. Secondary endpoints include ORR per investigator assessment, disease control rate and progression-free survival per BICR and investigator evaluation, safety and overall survival.

"We are encouraged by the positive topline results of Cohort K for the combination of enfortumab vedotin and pembrolizumab in first-line locally advanced or metastatic urothelial cancer, and we look forward to sharing results at an upcoming medical meeting," Roger Dansey, M.D., the interim CEO and chief medical officer at Seagen noted.

Padcev is approved in the U.S. for adult patients with locally advanced or mUC. Keytruda is approved for a wide range of cancers, including advanced urothelial bladder cancer and high-risk non-muscle invasive bladder cancer. 

Kelun-Biotech Signs Exclusive Deal With MSD For Solid Tumor Product

Sichuan Kelun Pharmaceutical subsidiary Kelun-Biotech entered into an exclusive license agreement with MSD, Merck's name outside of Canada and the U.S., to create an investigational antibody drug conjugate (ADC) to treat solid tumors. 

Under the terms of the deal, MSD will have global and exclusive development, manufacturing and commercialization rights for the ADC, while both companies will collaborate on early clinical development activities. MSD will pay $35 million upfront and Kelun-Biotech stands to gain as much as $901 million more from future development, approval and sales milestones, plus royalties. 

"Incorporating MSD's deep and broad global expertise with Kelun-Biotech's innovation power has the potential to generate great development synergy, significantly accelerating the development and commercialization of the collaboration programs. These collaborations will also strengthen our strategic position in building a global, innovative, fully-integrated biopharmaceutical company," Dr. Junyou Ge, the CEO of Kelun-Biotech, said.

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