On July 25, 2025 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported it will be presenting two-year clinical efficacy data from its phase 2 trial with lead compound EVX-01 at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 to be held in Berlin, Germany, from October 17-21, 2025 (Press release, Evaxion Biotech, JUL 25, 2025, View Source [SID1234654522]).

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Designed with Evaxion’s AI-Immunology platform, EVX-01 is a personalized cancer vaccine currently being evaluated as a treatment for advanced melanoma (skin cancer). The trial has yielded numerous convincing data already, including interim one-year data presented at the 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).

"We are delighted to have the two-year data from the EVX-01 phase 2 trial accepted for presentation at the ESMO (Free ESMO Whitepaper) Congress 2025. As one of the most important and prestigious medical oncology conferences in the world, the congress will be a great place for us to present the data to a large audience, including potential partners," says Birgitte Rønø, CSO and interim CEO of Evaxion.

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.

Presentation details

Abstract Title: EVX-01, a personalized cancer vaccine, induces potent T-cell responses and durable disease control in advanced melanoma: 2-year follow-up
Abstract#: #6308
Presentation#: 1516MO
Track: Mini oral session: Investigational immunotherapy
Location: Nuremberg Auditorium – Hall 5.2
Date/Time: October 17 at 14:10 – 14:15 CEST
Presenter: Dr. Muhammad Adnan Khattak, Director, Oncology, One Clinical Research, Hollywood Private Hospital & Edith Cowan University, Perth, WA, Australia
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.

On July 25, 2025 Inmagene Biopharmaceuticals ("Inmagene"), a clinical stage biotechnology company dedicated to developing disease-modifying treatments for immunological/autoimmune and inflammatory ("I&I") diseases, reported the completion of its previously announced merger with Ikena Oncology, Inc. (Nasdaq: IKNA) ("Ikena") (Press release, Ikena Oncology, JUL 25, 2025, View Source [SID1234654523]). The combined company will operate under the name ImageneBio, Inc. ("ImageneBio") and will trade on The Nasdaq Capital Market ("Nasdaq") under the ticker symbol "IMA" beginning at market open on July 28, 2025.

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Concurrent with the closing of the merger, Inmagene and Ikena completed a $75.0 million private placement with a syndicate of existing and new investors including Deep Track Capital, Foresite Capital, RTW Investments, and existing Ikena investors such as BVF Partners L.P., Blue Owl Healthcare Opportunities, Omega Funds, and OrbiMed. The combined company will be led by Kristin Yarema, Ph.D. as its Chief Executive Officer, as announced earlier this week.

"We are pleased with the outcome of this transaction and are well-positioned to advance IMG-007 into late-stage development. OX40 inhibition is a promising approach that may have the potential to treat a broad range of immunological and inflammatory diseases where patients continue to wait for more and novel treatment options. We are excited about the emerging profile of IMG-007, which we believe will prove to be differentiated, and we look forward to executing our development plan in atopic dermatitis and potentially initiating studies in additional indications," commented Dr. Kristin Yarema.

Additionally, in connection with the completion of the transaction and as recently approved by Ikena’s shareholders, Ikena implemented a reverse split of its common stock at a ratio of 1-for-12 shares. Following the reverse stock split and based on the final exchange ratio of approximately 0.003051 shares of Ikena common stock for each Inmagene share, immediately following the closing of the merger, the legacy equity holders of Inmagene owned approximately 55.0% of the combined company’s outstanding common stock and the legacy equity holders of Ikena owned approximately 45.0% of the combined company’s outstanding common stock, in each case, on a fully diluted basis. Following the consummation of the concurrent private placement, the legacy equity holders of Inmagene owned approximately 43.1% of the combined company’s outstanding common stock, the legacy equity holders of Ikena owned approximately 35.3% of the combined company’s outstanding common stock, and the investors in the concurrent financing owned approximately 21.6% of the combined company’s outstanding common stock, in each case, on a fully diluted basis. Following the reverse stock split, the closing of both the merger and concurrent financing, ImageneBio will have approximately 11.6 million shares of common stock outstanding. ImageneBio’s shares are expected to begin trading on Nasdaq at market open on July 28, 2025 under the ticker symbol "IMA" and new CUSIP number, 45175G 207.

Advisors

Goodwin Procter LLP served as legal counsel to Ikena, and Cooley LLP served as legal counsel to Inmagene. Leerink Partners LLC served as exclusive financial advisor to Ikena. Evercore served as exclusive financial advisor to Inmagene.

On July 24, 2025 Pierre Fabre Pharmaceuticals Inc. (PFP) reported the acceptance by U.S. Food and Drug Administration (FDA) of the Biologics License Application (BLA) and Priority Review of tabelecleucel, indicated as monotherapy for treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy (Press release, Pierre Fabre, JUL 24, 2025, View Source [SID1234654509]).

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Atara Biotherapeutics Inc. (Nasdaq: ATRA) resubmitted the tabelecleucel BLA on July 11, having in collaboration with PFP, swiftly addressed the third-party manufacturing facility observations outlined in the January 2025 Complete Response Letter.

"Patients diagnosed with relapsed or refractory EBV+ PTLD have no approved FDA treatment options, and following failure of initial therapy their survival is unfortunately measured in only weeks to months. Today’s BLA acceptance gives hope to these patients and is a significant step towards making this innovative cell therapy available in the United States," said Adriana Herrera, Chief Executive Officer of PFP, the Pierre Fabre Laboratories Pharmaceutical subsidiary in the U.S. "We are now completely focused on preparing for potential FDA approval of this innovative new treatment option."

Tabelecleucel is an allogeneic, off the shelf, EBV-specific T-cell immunotherapy which targets and eliminates EBV-infected cells. The BLA includes data covering more than 430 patients treated with tabelecleucel including the ongoing pivotal ALLELE study investigating the therapy in adults and children two years of age and older with relapsed or refractory EBV+ PTLD following SOT or HCT.

Tabelecleucel was granted marketing authorization under the brand name EBVALLO in December 2022 by the European Commission (EC). Marketing authorization was also granted by the Medicines and Healthcare Products Regulatory Agency in the United Kingdom in May 2023 and by Swissmedic in Switzerland in May 2024.

Since March 31, 2025, PFP has assumed global responsibility for tabelecleucel manufacturing of commercial product for European markets and for global clinical trial supply. On July 15, 2025, Atara Biotherapeutics transferred the tabelecleucel Investigational New Drug Application to Pierre Fabre Medicament, a subsidiary of Pierre Fabre Laboratories. As per the terms of the restated exclusive worldwide licensing agreement between Atara and Pierre Fabre Laboratories announced in November 2023, Atara is responsible for regulatory procedures up until BLA transfer to Pierre Fabre Pharmaceuticals.

On July 24, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that the United States Patent and Trademark Office (USPTO) will issue U.S. Patent Number 12,370,244 on July 29, 2025, covering key aspects of the Company’s breast cancer vaccine technology (Press release, Anixa Biosciences, JUL 24, 2025, View Source [SID1234654510]). The patent protects novel methods of immunizing patients against breast cancer by administering an immunogenic composition containing human α-lactalbumin protein—a protein typically found in breast tissue during lactation but also expressed in certain breast cancers, making it an attractive target for immunoprevention strategies.

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Anixa’s breast cancer vaccine, developed in collaboration with Cleveland Clinic, represents a novel approach to the prevention and treatment of breast cancer. The vaccine was invented at Cleveland Clinic, and this patent—along with others related to this technology—has been exclusively licensed to Anixa Biosciences. This issuance builds upon the Company’s broad and expanding intellectual property portfolio, extending foundational patent protection for the breast cancer vaccine program into the mid-2040s. The expanded claims provide additional coverage for immunogenic formulations, further enhancing Anixa’s ability to develop and commercialize differentiated immunopreventive solutions.

Despite significant progress in breast cancer treatment, the disease remains the most commonly diagnosed cancer among women worldwide. In the United States alone, over 297,000 new cases of invasive breast cancer are projected in 2025, with approximately 43,000 women expected to die from the disease. No FDA-approved vaccine currently exists to prevent breast cancer, representing a major and unmet need in the field of preventive oncology.

Anixa’s investigational vaccine aims to stimulate the immune system to recognize and eliminate pre-malignant and malignant cells expressing α-lactalbumin—while sparing normal tissue. By targeting this "retired" protein, which is generally absent from adult tissues except during lactation, the vaccine has the potential to minimize off-target effects and provide long-lasting immune protection.

The breast cancer vaccine platform represents a potential multi-billion dollar market opportunity, particularly among women at elevated risk of developing triple-negative breast cancer (TNBC)—an aggressive subtype with limited treatment options and poor long-term prognosis. As clinical data and regulatory frameworks evolve, the technology may also have broader applications for average-risk populations.

"Our breast cancer vaccine program is a cornerstone of our long-term strategy to develop next-generation preventive immunotherapies, and this patent issuance further secures our leadership in this field," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "With a robust portfolio of issued and pending patents in the U.S. and internationally, we are well-positioned to bring forward a vaccine that could transform how we address breast cancer risk in healthy women."

On July 24, 2025 Kling Bio ("Kling" or "the Company"), a biotech company developing antibody-based drugs for cancer and infectious diseases, reported it has entered into a collaboration and license option agreement with Sanofi for the discovery of antibodies and epitopes using its groundbreaking B cell immortalization and screening platform, Kling-Select (Press release, Kling Biotherapeutics, JUL 24, 2025, View Source [SID1234654511]).

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Kling-Select is a proprietary, clinically and commercially validated B cell immortalization platform that has played a pivotal role in the discovery of potent neutralizing antibodies. By leveraging patient-derived B cells, Kling-Select enables rapid identification of novel antibodies and conserved viral epitopes, significantly enhancing vaccine and therapeutic design. Utilizing function-first screening workflow, Kling-Select uncovers rare and highly effective immune targets, accelerating the development of next-generation prophylactics and treatments. The platform’s proven success includes validated antibody candidates against RSV, COVID-19, and influenza, underscoring its broad utility and scientific impact.

The objective of the collaboration is to identify and characterize monoclonal antibodies with potent neutralizing activity against a clinically relevant human viral pathogen. Insights gained from this joint discovery effort may enable the development of next-generaton antiviral therapeutics and inform the design of more efficacious vaccine candidates.

"This collaboration with Sanofi highlights the broad potential of our Kling-Select platform to address global health challenges by enabling the discovery of first-in-class, human-derived antibodies," commented Michael Koslowski, MD, Chief Executive Officer of Kling Bio. "Kling-Select provides a powerful window into the human immune response and accelerates the identification of functional antibodies and novel epitopes. We are excited to combine our expertise with Sanofi’s leadership in vaccine development to advance next-generation therapeutics and vaccines."