Wednesday, March 29, 2023


Biotechnology News Magazine


Verona Pharma Announces Ensifentrine Meets Primary and Key Secondary Endpoints in Phase 3 ENHANCE-1 Trial for COPD

Ensifentrine is a first-in-class, selective dual inhibitor of the enzymes phosphodiesterase 3 and 4 combining bronchodilator and non-steroidal anti-inflammatory activities in one compound.

Arcutis Enrolls First Patient in Phase 1b Alopecia Areata Study Evaluating ARQ-255

The phase 1b, vehicle-controlled, double-blind, multicenter study will evaluate the safety, tolerability, and pharmacokinetics of treatment with ARQ-255 topical suspension 3% or vehicle in healthy adult volunteers and individuals with patchy alopecia areata.

TransCode Therapeutics Announces eIND Submission to US FDA for Planned First-in-Human Clinical Trial in Patients with Advanced Solid Tumors

The planned clinical trial is to evaluate TransCode’s lead therapeutic candidate, TTX-MC138, in cancer patients with advanced solid tumors. ​TTX-MC138 is designed to inhibit the pro-metastatic RNA, microRNA-10b, described as the master regulator of metastasis in a number of advanced solid tumors. TransCode Therapeutics believes that TTX-MC138 could be used as a treatment for many of these cancers.

CG Oncology Presents New Phase 2 Data With CG0070 in Combination With KEYTRUDA® (pembrolizumab) in Non-Muscle Invasive Bladder Cancer Unresponsive to Bacillus Calmette-Guérin

“We’re excited to present these results, which continue to support CG0070’s promise in patients with bladder cancer unresponsive to BCG, a difficult-to-treat patient population,” said Arthur Kuan, Chief Executive Officer, CG Oncology. “We are seeing continued positive results for CG0070 in combination with pembrolizumab in NMIBC patients unresponsive to BCG. Enrollment in this study is now completed, and data readout on all patients through a minimum of 12 months is expected in 2023.”

Iovance Biotherapeutics Announces Updated Clinical Data for Lifileucel in Advanced Melanoma at Society for Immunotherapy of Cancer (SITC) Annual Meeting

Amod Sarnaik, M.D., Professor of Cutaneous Oncology and Immunology at H. Lee Moffitt Cancer Center, presenting author and lead C-144-01 trial investigator, stated, “We are excited to present the comprehensive clinical data on behalf of the C-144-01 investigators. The trial demonstrated a robust and clinically meaningful response rate and long-term durability following one-time treatment. Patients in this study were difficult to treat and lacked approved therapies after current standard of care. We hope to offer lifileucel to many more patients after initial progression on immune checkpoint inhibitors.”

Guided Therapeutics Provides Update of Significant Progress in Chinese Clinical Study for Marketing Approval of the LuViva Advanced Cervical Scan

According to Guided Therapeutics Chinese partner, Shandong Yaohua Medical Instrument Corporation (SMI), the results so far indicate that LuViva meets or exceeds the success criteria as described in the current study protocol and has been demonstrated to be safe for use on nearly 200 women tested thus far in China.