Press Release: Francis Medical Announces Completion of Enrollment in the VAPOR 2 Pivotal Study for Vanquish Prostate Cancer Treatment

On February 25, 2025 Francis Medical, Inc., a privately held medical device company developing an innovative and proprietary water vapor ablation therapy for the treatment of prostate, kidney, and bladder cancer, reported completion of enrollment and initial treatments in the company’s VAPOR 2 pivotal clinical study (Press release, Francis Medical, FEB 25, 2025, View Source;utm_medium=rss&utm_campaign=completion-of-vapor-2-enrollment-for-vanquish-prostate-cancer-treatment [SID1234650529]).

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VAPOR 2 is a prospective, multicenter, single-arm study treating 235 patients with intermediate-risk, localized prostate cancer at 26 U.S. clinical sites. Data gathered from the VAPOR 2 study will support 510(k) clearance of the Vanquish device, which the company expects to file for in July 2025. Patients will continue to be followed for a period of five years to gather longer-term cancer outcomes. Dr. Samir Taneja from NYU Langone and Dr. Arvin George from Johns Hopkins are co-principal investigators on the study.

"We are thrilled to announce the completion of enrollment in the VAPOR 2 study ahead of our expected timeline," said Dr. Taneja. "For a study of this scale to finish enrollment early is a remarkable achievement and speaks to the dedication of our participating investigators and the level of excitement surrounding this promising technology."

As the second most common cancer in U.S. men, the American Cancer Society estimates 1 in 8 American men will be diagnosed with prostate cancer during their lifetime. Prostate cancer is a serious disease often treated with therapies that cause complications, such as urinary incontinence and erectile dysfunction. Francis Medical’s Vanquish device’s thermal water vapor energy technology is a breakthrough therapy designed to use phase shift energy stored in sterile water vapor to convectively transfer thermal energy to cancerous tissue, causing cell death. Through this process, damage to surrounding structures can be minimized or eliminated by respecting the prostate’s natural boundaries. Vanquish aims to be a revolutionary cancer therapy that is tough on cancer yet gentle on patients.

"We are incredibly proud of the entire team for achieving this key milestone," said Michael Kujak, president and CEO of Francis Medical. "This success is the result of seamless collaboration between our employees, investors, investigators, research coordinators, and, most importantly, the patients. The entire Francis Medical team extends its heartfelt thanks to all the VAPOR 2 participants for partnering with us to help move closer to a kinder, gentler treatment for prostate cancer."

"Francis Medical’s primary focus has always been on creating a better experience for patients," said Michael Hoey, founder and chief technology officer of Francis Medical. "It’s extremely rewarding to see the years of hard work and dedication from so many people beginning to make a tangible difference in the quality of life for men suffering from prostate cancer."

Exelixis to Webcast Fireside Chats at Upcoming Investor Conferences in March

On February 25, 2025 Exelixis, Inc. (Nasdaq: EXEL) reported that company management will participate in fireside chats at the following investor conferences in March (Press release, Exelixis, FEB 25, 2025, View Source [SID1234650528]):

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TD Cowen 45th Annual Health Care Conference: Exelixis is scheduled to present at 9:50 a.m. ET / 6:50 a.m. PT on Tuesday, March 4 in Boston.
Barclays 27th Annual Global Healthcare Conference: Exelixis is scheduled to present at 1:30 p.m. ET / 10:30 a.m. PT on Tuesday, March 11 in Miami.
2025 Leerink Partners Global Healthcare Conference: Exelixis is scheduled to present at 10:40 a.m. ET / 7:40 a.m. PT on Wednesday, March 12 in Miami.
To access the webcast links, log onto www.exelixis.com and proceed to the Event Calendar page under the Investors & News heading. Replays will also be available at the same location for at least 30 days.

Evaxion extends phase 2 trial with personalized cancer vaccine EVX-01 to further enhance clinical data package

On February 25, 2025 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported that it will further enhance the data package from its ongoing phase 2 trial with the company’s lead asset EVX-01 by extending the trial from two to three years (Press release, Evaxion Biotech, FEB 25, 2025, View Source [SID1234650527]). Designed with Evaxion’s AI-Immunology platform, EVX-01 is a personalized cancer vaccine being developed as a treatment for advanced melanoma (skin cancer).

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Active participants in the trial will be given the opportunity to enter the one-year extension after completing the two-year protocol. They will receive additional EVX-01 doses as monotherapy, with close monitoring to assess clinical response duration and immune activation. In the first two years of the trial, patients received EVX-01 in combination with standard anti-PD-1 therapy.

The trial is progressing according to plan, with two-year data readout expected in the second half of 2025. All trial active patients have achieved reduction in tumor target lesions and are faring well, which should allow for a seamless transition into the extension of the trial.

"We are very pleased with how this trial has been progressing and the encouraging data obtained so far. Patients are responding positively to the therapy, which is generally well tolerated. We are happy to support patients further by offering additional EVX-01 treatment. Extending the trial also allows us to collect even more data and further enhance the data package for this promising new potential treatment option for advanced melanoma. Adding another year might allow us to document even better effects of the treatment than what will be observed after one and two years", says Birgitte Rønø, Chief Scientific Officer of Evaxion.

EVX-01 is designed with Evaxion’s AI-Immunology platform and tailored to target the unique tumor profile and immune characteristics of each individual patient. It engages the patient’s immune system to fight off cancer by mounting a targeted response against tumors.

The phase 2 trial investigates EVX-01 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with advanced melanoma (skin cancer). Each patient enrolled in the trial has received a unique vaccine designed and manufactured based on their individual biology.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Convincing one-year phase 2 data
Convincing interim one-year data from the trial was presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in September 2024. Data demonstrated a 69% Overall Response Rate, reduction in tumor target lesions in 15 out of 16 patients, and a positive correlation between the AI-Immunology platform predictions and immune responses induced by the individual neoantigens in the EVX-01 vaccine (p=0.00013). Further, 79% of EVX-01’s vaccine targets triggered a targeted immune response, which compares very favorably to what is seen with other approaches.

About EVX-01
EVX-01 is a personalized peptide-based cancer vaccine intended for first-line treatment of multiple advanced solid cancers. It is Evaxion’s lead clinical asset.

EVX-01 is a personalized therapy designed with our AI-Immunology platform and is tailored to target the unique tumor profile and immune characteristics of each patient. It engages the patient’s immune system to fight off cancer by mounting a targeted response against tumors.

In the completed Phase 1/2a clinical trial (NCT03715985), assessing EVX-01 in combination with a PD-1 inhibitor, eight of twelve metastatic melanoma patients (67%) had objective clinical responses with two complete and six partial responses.

In addition, vaccine-induced T cells were detected in all patients and a significant correlation between clinical response and the AI-Immunology predictions was observed, underlining the predictive power of the platform.

Vector Laboratories partner with Etcembly to develop new novel immunotherapeutics.

On February 25, 2025 Etcembly reported a new partnership with leading antibody manufacturer Vector Laboratories, Inc., using our AI platform EMLy to develop novel immunotherapeutics (Press release, Etcembly, FEB 25, 2025, View Source [SID1234650525]).

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Manufacturing problems such as poor yield and aggregation are significant issues in the development and production of antibody-based therapeutics.

In this partnership, we’ll be using EMLy’s cutting edge structural modelling and generative AI capabilities to redesign existing non-proprietary antibodies, creating optimised variants with enhanced manufacturability and improved therapeutic outcomes.

Our CEO, Michelle Teng, says:

"We’re excited to apply our AI-driven technology to Vector’s expertise in antibody engineering. This partnership will test different antibody variants and generate functional data, creating a powerful synergy that will advance cancer and autoimmune research."

Lisa V Sellers (Lisa V. S.) CEO of Vector Laboratories, adds:

"We’re excited to work with the Etcembly team to test optimized protein sequences and determine if their proprietary EMLy platform can enable us to improve them further for more effective therapies."

Elevation Oncology to Participate in Upcoming Investor Conferences

On February 25, 2025 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, reported that members of management will participate in upcoming investor conferences in March (Press release, Elevation Oncology, FEB 25, 2025, View Source;utm_medium=rss&utm_campaign=elevation-oncology-to-participate-in-upcoming-investor-conferences [SID1234650524]):

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TD Cowen 45th Annual Health Care Conference. Fireside chat on Tuesday, March 4, 2025 at 9:10 AM ET in Boston, MA.
Leerink Global Biopharma Conference. Fireside chat on Tuesday, March 11, 2025 at 8:40 AM ET in Miami, FL.
A live webcast and replay of the fireside chats will be available on the Events page of the Company’s Investor Relations website at View Source