Metastatic Microsatellite Stable Colorectal Carcinoma

Just over a year after going public, Turnstone Biologics is axing staff, adjusting its leadership team and changing its pipeline focus to extend its cash runway for another two years. The San Diego biotech is reducing its headcount by around 60%, according to a Friday release . The terminations should be complete by the end of the year and will cost $2.3 million in severance-related fees. The drugmaker had 82 full-time employees at the end of June, according to an SEC filing . Separately, several members of Turnstone’s executive team are also stepping down, including interim Chief Medical Officer Michael Burgess, who is retiring, and Chief Financial Officer Venkat Ramanan. The company’s interim chief technology officer, Vijay Chiruvolu, is shifting to an advisory role, while Chief Business Officer Saryah Azmat has been promoted to chief operating officer. Turnstone is shifting resources away from its preclinical work to focus on advancing its Phase 1 tumor-infiltrating lymphocyte therapy asset, TIDAL-01. The candidate is in several studies in patients with colorectal cancer, head and neck cancer and uveal melanoma. The next milestone is a data update in the first half of next year. These moves should help Turnstone finance its activities through the second quarter of 2026, the company said. The biotech had just $62.4 million in cash, equivalents and short-term investments at the end of June. In August, the drugmaker released data in four metastatic microsatellite stable colorectal cancer patients showing TIDAL-01 achieved a 25% overall response rate and 50% disease control rate. At the time, Leerink analysts said they were “encouraged” by the responses but questioned “the extent of TIDAL-01 contribution to the benefit” because the patients were also receiving chemotherapy-based bridging treatment and short courses of immunotherapy. “Maintaining a 25% response rate in substantially more patients…would meaningfully increase our enthusiasm into a necessary financing round,” the analysts added. Turnstone debuted on the public markets in July last year with a $75 million IPO. The biotech had had a tough few years prior to that, losing key partnerships with AbbVie and Takeda . Turnstone’s stock $TSBX plummeted around 82% year to date.

iStock, simplehappyart Turnstone is shifting resources to focus on clinical advancement of its selected tumor-infiltrating lymphocyte therapy as three C-suite members exit their roles. As part of a strategic restructuring, Turnstone Biologics will lay off about 60% of its employees and change up its leadership team, the La Jolla, California–based clinical-stage biotech announced Oct. 11. The company expects to complete the workforce reduction by the end of the fourth quarter, according to an SEC filing on the same day. Turnstone had 80 employees as of Dec. 31, according to a March SEC filing , meaning the layoffs could affect about 48 people. While the company lists a second location in Ontario on its website, neither the Oct. 11 announcement nor SEC filing specified if the layoffs will affect both sites. As a result of the changes it’s making, the biotech expects to extend its cash runway into the second quarter of 2026. Moving forward, Turnstone will focus resources on clinical advancement of its selected tumor-infiltrating lymphocyte (TIL) therapy via its Phase I program, TIDAL-01, over other preclinical pipeline assets. Turnstone is evaluating TIDAL-01 in multiple Phase I trials including in colorectal cancer, head and neck cancer and uveal melanoma. The company expects to provide a clinical update in the first half of 2025, according to the Oct. 11 announcement. The biotech in August reported positive initial data from its Phase I STARLING trial of TIDAL-01 in metastatic microsatellite stable colorectal cancer (MSS mCRC). The data showed a 25% overall response rate and 50% disease control rate in the first four evaluable patients in the study and a complete response in a heavily pretreated late-line patient, with progression-free survival extending beyond one year. Turnstone’s C-suite shakeup includes the exits of Michael Burgess, interim chief medical officer; Vijay Chiruvolu, interim chief technology officer; and Venkat Ramanan, chief financial officer, according to the announcement. Burgess is retiring and will continue to serve as a board member, while Chiruvolu has completed his agreed-to term of service and will move into a strategic advisory role for Turnstone. Ramanan is stepping down from his role. Other C-suite changes include: Ines Verdon, senior vice president of clinical development, is assuming leadership of all clinical activities. Saryah Azmat has been promoted to chief operating officer. She was previously chief business officer. Wendy Worcester, vice president of finance, will lead the finance function as principal financial and accounting officer. Michael Fitch has been promoted to senior vice president of manufacturing. He will oversee all manufacturing and technical operations activities. The restructuring, leadership changes and layoffs come a little over a year after the biotech filed for an $86 million initial public offering amidst the company’s doubts about its “ability to continue as a going concern” without an IPO, according to an SEC filing at that time.

SAN DIEGO and SUZHOU, China, Oct. 09, 2024 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced poster presentations at the upcoming SITC 39th Annual Meeting, taking place in Houston, Nov. 6 – 10, 2024. Details include: Deciphering Improved Clinical Therapeutic Index (TI) of Muzastotug (ADG126), a Masked Anti-CTLA-4 SAFEbody® over its Unmasked Form (ADG116) as Monotherapy or in Combination with anti-PD-1 Therapy Date: Saturday, November 9Lunch & Poster Viewing: 12:15–1:45 PM CST Poster Reception: 7:10-8:30 PM CSTOnsite Location: George R. Brown Convention Center (Level 1, Exhibit Halls AB)Abstract Number: 506 Phase 1b/2, Multicenter Dose Escalation and Expansion Study of Muzastotug (ADG126, a Masked Anti-CTLA-4 SAFEbody®) in Combination with Pembrolizumab in Advanced/Metastatic MSS CRCs Date: Saturday, November 9Lunch & Poster Viewing: 12:15–1:45 PM CST Poster Reception: 7:10-8:30 PM CST Onsite Location: George R. Brown Convention Center (Level 1, Exhibit Halls AB)Abstract Number: 744 Both posters will be made available on the Publications page of the company’s website here. About AdageneAdagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biotechnology company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address globally unmet patient needs. The company has forged strategic collaborations with reputable global partners that leverage its SAFEbody® precision masking technology in multiple approaches at the vanguard of science. Powered by its proprietary Dynamic Precision Library (DPL) platform, composed of NEObody™, SAFEbody, and POWERbody™ technologies, Adagene’s highly differentiated pipeline features novel immunotherapy programs. The company’s SAFEbody technology is designed to address safety and tolerability challenges associated with many antibody therapeutics by using precision masking technology to shield the binding domain of the biologic therapy. Through activation in the tumor microenvironment, this allows for tumor-specific targeting of antibodies in tumor microenvironment, while minimizing on-target off-tumor toxicity in healthy tissues. Adagene’s lead clinical program, ADG126 (muzastotug), is a masked, anti-CTLA-4 SAFEbody that targets a unique epitope of CTLA-4 in regulatory T cells (Tregs) in the tumor microenvironment. ADG126 is currently in phase 1b/2 clinical studies in combination with anti-PD-1 therapy, particularly focused on Metastatic Microsatellite-stable (MSS) Colorectal Cancer (CRC). Validated by ongoing clinical research, the SAFEbody platform can be applied to a wide variety of antibody-based therapeutic modalities, including Fc empowered antibodies, antibody-drug conjugates, and bi/multispecific T-cell engagers. For more information, please visit: https://investor.adagene.com.Follow Adagene on WeChat, LinkedIn and Twitter. SAFEbody® is a registered trademark in the United States, China, Australia, Japan, Singapore, and the European Union. Safe Harbor StatementThis press release contains forward-looking statements, including statements regarding certain clinical results of ADG126, the potential implications of clinical data for patients, and Adagene’s advancement of, and anticipated preclinical activities, clinical development, regulatory milestones, and commercialization of its product candidates. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to Adagene’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or regulatory approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of Adagene’s drug candidates; Adagene’s ability to achieve commercial success for its drug candidates, if approved; Adagene’s ability to obtain and maintain protection of intellectual property for its technology and drugs; Adagene’s reliance on third parties to conduct drug development, manufacturing and other services; Adagene’s limited operating history and Adagene’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; Adagene’s ability to enter into additional collaboration agreements beyond its existing strategic partnerships or collaborations, and the impact of the COVID-19 pandemic on Adagene’s clinical development, commercial and other operations, as well as those risks more fully discussed in the “Risk Factors” section in Adagene’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Adagene, and Adagene undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. Investor & Media Contact:Ami KnoeflerAdagene650-739-9952ir@adagene.com