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New and Exciting Clinical Data on Evaxion’s AI-Immunology™-Based Personalized Cancer Vaccines to be Presented

On October 26, 2023 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage TechBio company specializing in developing AI-Immunology-powered vaccines, reported that it will be presenting clinical readouts on its two personalized cancer vaccine trials at SITC (Free SITC Whitepaper)’s 38th annual meeting, taking place in San Diego, California from November 1-5, 2023 (Press release, Evaxion Biotech, OCT 26, 2023, View Source [SID1234636370]).

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The results will be presented in two posters:

1. Title: "AI-designed personalized neoantigen vaccine, EVX-02, induces robust T-cell responses in melanoma patients"

Poster #: 623
Location: Exhibit Hall B – San Diego Convention Center
Time: Friday, November 3, 9 a.m. – 7 p.m. PDT

This poster will be presented by Evaxion’s senior project manager, Daniela Kleine-Kohlbrecher. The abstract was also selected by the SITC (Free SITC Whitepaper) Communications Committee to be presented at the SITC (Free SITC Whitepaper) 2023 Annual Meeting Press Conference, scheduled for Wednesday, November 1, from 12:00–1:30 p.m. PDT.

2. Title: "Effects of an AI-generated personalized neopeptide-based immunotherapy, EVX-01, in combination with pembrolizumab in patients with metastatic melanoma. A clinical trial update"

Poster #: 782-H
Location: Exhibit Hall B – San Diego Convention Center
Time: Saturday, November 4, 9 a.m. – 8:30 p.m. PDT

This poster will be presented by principal investigator Professor Adnan Khattak from the Hollywood Private Hospital in Nedlands, Australia.

Christian Kanstrup, Chief Executive Officer at Evaxion, commented, "We are thrilled about the continuous buildup of positive clinical evidence for the unique predictive capabilities of our AI-immunology platform, which we believe holds promise for truly groundbreaking cancer treatments."

Birgitte Rønø, Chief Scientific Officer at Evaxion, expressed her enthusiasm about the upcoming conference, stating, "We are looking forward to sharing these promising clinical trial results with the SITC (Free SITC Whitepaper) community, showcasing the advantages of our AI-Immunology platform to design personalized cancer vaccines. We believe this takes us one step closer to bringing novel treatments to the market and meeting the pressing global medical need for cancer patients."

About EVX-01 Phase 2 Clinical Trial
EVX-01 is Evaxion’s lead clinical asset and constitutes a peptide-based personalized cancer vaccine. The Phase 2 clinical study is a self-sponsored open-label, single-arm, multi-center trial carried out in collaboration with Merck Sharp & Dohme LLC, together with leading principal investigators and research centers from Italy and Australia, and aims at evaluating the efficacy and safety of EVX-01 vaccination in combination with anti-PD1 treatment (pembrolizumab) in treatment-naive patients with metastatic or unresectable malignant stage III or IV melanoma. More information can be accessed under clinical trial ID NCT05309421.

About EVX-02 Phase 1/2a Clinical Trial

The EVX-02 Phase 1/2a represents Evaxion’s first-in-human DNA-based personalized cancer vaccine study. This open-label, multi-center study aims at assessing the safety, tolerability, pharmacodynamic responses, and efficacy of EVX-02 neoantigen vaccine and anti-PD-1 treatment (nivolumab) in patients who have had a complete resection of a Stage IIIB/IIIC/IIID or Stage IV melanoma with risk of recurrence. More information can be accessed under clinical trial ID NCT04455503.

Lilly to Participate in UBS Biopharma Conference 2023

On October 26, 2023 Eli Lilly and Company (NYSE: LLY) reported that it will attend the UBS Biopharma Conference on Nov. 8, 2023. Patrik Jonsson, executive vice president; president, Lilly Immunology; president, Lilly USA; and chief customer officer, will participate in a fireside chat at 3 p.m., Eastern time (Press release, Eli Lilly, OCT 26, 2023, View Source [SID1234636369]).

A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

Clarity and PSI kick off SAR-bisPSMA Phase III

On October 26, 2023 Clarity Pharmaceuticals (ASX: CU6) ("Clarity", "the Company"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, and PSI CRO AG ("PSI"), a global contract research organisation committed to on-time enrollment in radiopharmaceutical clinical trials, have entered into an agreement and have commenced work towards Clarity’s Phase III diagnostic trial of SAR-bisPSMA in prostate cancer participants, CLARIFY (NCT06056830) (Press release, Clarity Pharmaceuticals, OCT 26, 2023, View Source [SID1234636368]).

CLARIFY derives from "Positron Emission Tomography using 64Cu-SAR-bisPSMA in participants with high-risk prostate cancer prior to radical prostatectomy: A prospective, single-arm, multi-centre, blinded-review, Phase III diagnostic performance study". It is a non-randomised, open-label clinical trial in 383 participants.

The aim of the Phase III trial is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect prostate cancer within lymph nodes located in the pelvic region. Evaluation will take place over 2 imaging timepoints, Day 1 (day of administration) and Day 2 (approximately 24 hours post administration). CLARIFY is expected to begin recruitment in late 2023.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are very excited to move one step closer to initiating our first registrational Phase III trial. With recent positive and valuable guidance from the US FDA in relation to our 64Cu-SAR-bisPSMA program, we look forward to commencing recruitment into the CLARIFY trial shortly and to gathering more data on this next-generation product to confirm the compelling preclinical and clinical trial results to date.

"The positive results from our completed PROPELLER2 trial showed that 64Cu-SAR-bisPSMA is safe and its uptake in PSMA-expressing cancer lesions was significantly higher compared to an approved standard-of-care PSMA imaging agent for prostate cancer in Australia and the US. This may enable diagnosis of additional and smaller lesions, which we observed in our PROPELLER2 trial, and we are eager to investigate the further benefits of delayed imaging, particularly in this patient population, a characteristic not available to the first generation of PSMA diagnostic agents. Furthermore, we believe that the additional shelf-life of up to 48 hours will not only allow clinics greater flexibility in scheduling of the scans, but also improve patients’ access to care in clinics and geographic areas where the short half-life of current PSMA PET tracers restricts the use of radiopharmaceuticals."

PSI’s Senior Director of Operations, Rhonda Critchlow, commented, "Using our global database of over 400 radiopharmaceutical sites, we will be able to identify sites with the best resources and capabilities for the CLARIFY trial. We are excited to begin our collaboration with Clarity and will focus on the startup of high-performing sites to achieve the first patient, in the shortest time possible. We believe that a myriad of clinical, logistical and manufacturing benefits of Clarity’s Targeted Copper Theranostics platform holds promise of improving treatment outcomes for patients with cancer and look forward to working together on achieving this important goal."

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a TCT that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA are unregistered products. Individual results may not represent the overall safety and efficacy of the products. The data outlined in this announcement has not been assessed by health authorities such as the US Food and Drug Administration (FDA). A clinical development program is currently underway to assess the efficacy and safety of these products. There is no guarantee that these products will become commercially available.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide3. The American Cancer Institute estimates in 2023 there will be 288,300 new cases of prostate cancer in the US and around 34,700 deaths from the disease.

CatalYm commences Dosing in a Phase 2 Study with Visugromab in Combination with Neoadjuvant Immunotherapy in Treatment-naive Muscle Invasive Bladder Cancer Patients

On October 26, 2023 CatalYm reported that the first patient has been dosed in the Phase 2 clinical trial, GDFather-NEO (NCT06059547), evaluating its lead anti-GDF-15 antibody candidate, visugromab, in combination with neoadjuvant immunotherapy (nivolumab, aPD-1 inhibitor) in muscle invasive bladder cancer (MIBC) (Press release, Catalym, OCT 26, 2023, View Source [SID1234636367]). The exploratory study expands visugromab’s clinical Phase 2 evaluation to a therapeutic front-line setting, building on the positive results from the ongoing GDFather-2 (NCT04725474) trial in last-line metastatic patients with a range of advanced, treatment-resistant solid tumors.

"Visugromab offers a very distinct mechanism of action that has the potential to break key immunotherapy resistance mechanisms preventing aPD-1 therapy to fully deliver," commented Prof. Dr. Andrea Necchi, Director of Genitourinary Medical Oncology at IRCCS San Raffaele Hospital and Principal Investigator of the study. "Based on the encouraging efficacy signs achieved with the visugromab-nivolumab combination in the last-line setting, we are looking forward to exploring this new approach in the front-line setting to open new avenues for the treatment of early-stage bladder cancer."

"This study provides us with the first opportunity to evaluate visugromab in an earlier clinical setting and allows us to gain a deeper understanding of its immunosupportive activity. It will also offer us expanded reference data on response-predictive biomarkers and provide further insights into visugromab’s extensive therapeutic potential for patients with hard-to-treat cancers that have built immune-resistance mechanisms," added Dr. Phil L’Huillier, Chief Executive Officer at CatalYm.

The exploratory, controlled GDFATHER-NEO Phase 2 study is assessing the safety and initial signs of clinical efficacy of a combination treatment of nivolumab plus visugromab compared to nivolumab plus placebo in patients with MIBC who are set to undergo radical cystectomy and cannot or refuse to receive cisplatin-based chemotherapy. In addition, the study will provide data on potential response-predictive biomarkers for patient stratification. The trial will be led from Milan, Italy, and will enroll 30 patients in a 1:1 setting at four sites in Italy.

Can-Fite to Harness Artificial Intelligence to Develop Novel Anti-Cancer Drugs

On October 26, 2023 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncology and inflammatory diseases, reported that it entered into an agreement with Collaborations Pharmaceuticals, Inc. (CPI) to develop anti-cancer drugs utilizing artificial intelligence (AI) and machine learning (ML) techniques (Press release, Can-Fite BioPharma, OCT 26, 2023, View Source [SID1234636366]). This project will aim to develop a next-generation A3 adenosine receptor drug agonists that significantly reduce the development time and cost of bringing such drugs to market.

CPI will utilize, apply and use AI and ML tools, including their MegaSyn generative AI method, to design new molecules with high affinity and selectivity to the A3AR Can-Fite target. CPI will also perform the chemical synthesis of the newly designed molecules with the ultimate goal of developing novel and robust anti-cancer drug candidates. Can-Fite will perform the testing of the biological anti-cancer effects and validate the molecular mechanism of the novel, chemically synthesized drug candidates.

"Our vision is to deliver in silico small molecule drug candidates in a better and faster way to patients via a collaboration with Collaborations Pharmaceuticals. Our accumulated experience of bringing anti-cancer drugs which target the A3AR from lab to patients will be implemented into this AI drug development project," stated Prof. Pnina Fishman, Executive Chairman and CSO at Can-Fite.

"We are delighted that Can-Fite chose our team of experts for this AI-led drug discovery collaboration and look forward to demonstrating what our technology can do," said Sean Ekins, PhD, DSc., CEO and Founder of Collaborations Pharmaceuticals, Inc. We also look forward to complementing their outstanding scientific approach with our integrated technology platform and ability to generate novel and selective molecules."