On November 28, 2023 Peptomyc, a Spanish clinical stage biotech company spin-off of the Vall d’Hebron Institute of Oncology (VHIO) and the Catalan Institute of Research and Advanced Studies (ICREA) in Barcelona, reported that in November the first patient of its Phase Ib clinical trial was successfully treated with OMO-103 – the first direct pan-Myc inhibitor to have completed Phase I clinical trial last year – in combination with the standard of care (SoC) drugs gemcitabine and nab-paclitaxel (Press release, Peptomyc, NOV 28, 2023, View Source [SID1234638010]).

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This Phase Ib trial includes patients with treatment-naïve metastatic pancreatic ductal adenocarcinoma (PDAC). 4 sites in Spain are currently recruiting: the Hospital Universitari Vall d’Hebrón in Barcelona, the Instituto Catalán de Oncología in Barcelona, the Hospital General Universitario Gregorio Marañón in Madrid and the Hospital Universitario Miguel Servet in Zaragoza. The objective of this study is to evaluate the safety and efficacy of OMO-103 in combination with SoC in first-line metastatic PDAC.

Peptomyc CMO Manuela Niewel said: "We are thrilled to see the first patient successfully treated in this trial and this represents a major milestone for the company and patients we hope to serve" and Peptomyc CEO Laura Soucek added: "I am proud of the work of our team and thankful for the support from clinicians and hospitals who have enabled this important milestone."

On November 28, 2023 Oxford Vacmedix (OVM), the UK-based biopharma company developing vaccines to treat cancer reported ongoing licensing discussions with its largest shareholder DxVx for lead cancer vaccine OVM-200 (Press release, Oxford Vacmedix, NOV 28, 2023, View Source;utm_medium=rss&utm_campaign=licensing-deal-for-ovm-200 [SID1234638009]). If concluded the licensing deal will grant DxVx rights to develop and to commercialise OVM-200 in South Korea and China, in return for an upfront payment, development milestone payments and royalties on sales. Under the proposed agreement DxVx would run trials in South Korea and China and manage regulatory and commercial aspects of development. All clinical trial data will be shared with OVM.

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OVM-200 targets survivin, a protein overexpressed by cancer cells that allow unregulated growth and stimulates an immune response. The vaccine is in a Phase 1 trial in the UK which is both the first time OVM-200 has been used in people and also the first time any ROP based vaccine has been tested in the clinic. The Phase I trial of OVM-200 is focused on safety and on establishing an immune response in advanced cancer patients in three cancer indications – non small cell lung cancer (NSCLC), prostate cancer and ovarian cancer. Patients are being treated at five leading hospitals in the UK. Twelve patients were treated in Phase 1a, the dose escalation part of the trial, with initial results showing very good safety and a strong immune response. A further 24 patients are now being treated in Phase 1b.

The announcement by DxVx stresses the benefits of the ROP technology and in particular the wide applicability of ROPs to treat cancer by being suitable for all HLAs (human leucocyte antigen).

William Finch, CEO of OVM said:

"We are very pleased that are largest shareholder will be licensing OVM-200 for South Korea and China. DxVx undoubtedly have the expertise and capabilities to run clinical trials and to commercialise in these countries and we look forward to working closely together on his programme. The OVM-200 vaccine will be used both alone and in combination to help patients with advanced cancer."

A DxVx official added:

"We plan to complete the license-in process soon and proceed with Phase 1b and Phase 2 clinical trials in major Asian countries (Korea, China and considering India in the future). We will try to launch it through an accelerated approval that will allow patients to benefit early from effective drugs before all clinical trials are completed around 2027."

On November 28, 2023 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to participate in a virtual fireside chat at the JMP Securities Hematology and Oncology Summit at 2:00 p.m. ET / 11:00 a.m. PT on Tuesday, December 5, 2023 (Press release, Kura Oncology, NOV 28, 2023, View Source [SID1234638008]).

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A live audio webcast of the presentation will be available in the Investors section of Kura’s website at www.kuraoncology.com, with a replay available shortly after the live event.

On November 28, 2023 Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, reported that it will host a virtual KOL event to discuss new data from the VISTA-101 clinical trial of KVA12123 in patients with advanced solid tumors (Press release, Kineta, NOV 28, 2023, View Source;utm_medium=rss&utm_campaign=kineta-to-host-kol-event-to-review-new-data-from-vista-101-clinical-trial-of-kva12123-in-patients-with-advanced-solid-tumors-on-december-5-2023 [SID1234638007]). Details are as follows:

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KOL Event to Review New Data from VISTA-101 Clinical Trial of KVA12123 in Patients with Advanced Solid Tumors
Tuesday, December 5, 2023 at 2:00 P.M. Eastern Time
To register, click here.

The event will feature presentations from two key opinion leaders in immuno-oncology:

Michael A. Curran, Ph.D., Associate Professor at MD Anderson Cancer Center Department of Immunology, who will discuss key challenges with current cancer therapies and the potential for VISTA blocking immunotherapy to reverse immunosuppression in the tumor microenvironment (TME) and drive anti-tumor activity.
Evan Y. Yu, M.D., Professor and Medical Oncology Section Head at Fred Hutchinson Cancer Center, who will join Kineta leadership to discuss immuno-oncology clinical trials and review the new positive monotherapy data from the ongoing VISTA-101 Phase 1/2 clinical trial evaluating KVA12123, the company’s VISTA blocking immunotherapy, in patients with advanced solid tumors.
A live question and answer session will follow the formal presentations.

On November 28, 2023 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported the presentation of its novel precision vaccine concept at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, taking place in San Diego, California, from December 9-12, 2023 (Press release, Evaxion Biotech, NOV 28, 2023, View Source [SID1234638006]).

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Selected for an Oral Presentation – Evaxion has been chosen for an oral presentation from a competitive pool of >5000 submitted abstracts. The presentation will unveil a breakthrough achievement using the Company’s proprietary AI target discovery and development platform, AI-Immunology. Based upon a novel source of targets, endogenous retroviruses (ERVs), combined with unique data insights, Evaxion has discovered a novel concept for precision vaccines in hematological malignancies and selected solid cancers.

Tailored Precision Vaccines – The precision vaccines are tailored to the specific tumor profiles and immune systems of patient groups. This marks a significant stride forward in addressing the complexities of cancers, including hematological malignancies. The discovery will potentially allow for a broader than previously expected application of vaccines in cancer therapy.

Event Details:

Title: "Endogenous Retroviral Elements Constitute a Promising Vaccine Antigen Source for Hematological Malignancies"
Talk: 243
Session: Emerging Tools, Techniques and Artificial Intelligence in Hematology: Emerging Technologies for Understanding Benign and Malignant Hematology
Session: 803
Location: Room 30 – San Diego Convention Center
Time: Saturday, December 9, 2:30 p.m. PDT
Presenter: Anders Bundgård Sørensen, Project Director of Research and Discovery

About ERVs
Endogenous retroviruses (ERVs) are remnants of ancient viruses incorporated into the human genome. While dormant in normal cells due to strict epigenetic control, cancer cells may express these traces, making ERVs ideal targets for cancer vaccines.