On September 9, 2024 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that its research collaborators were selected to present at the upcoming 2024 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics being held October 23-25, 2024 in Barcelona, Spain (Press release, Genprex, SEP 9, 2024, View Source [SID1234646431]). The collaborators will present posters on positive preclinical data from studies of its lead drug candidate, Reqorsa Gene Therapy (quaratusugene ozeplasmid), for the treatment of Ras inhibitor resistant lung cancer, mesothelioma and glioblastoma.

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"We are very pleased that these studies with our academic partners have been selected for presentation, which expands the growing body of preclinical evidence supporting REQORSA’s potential to treat a variety of cancers," said Ryan Confer, President and Chief Executive Officer at Genprex. "We look forward to these presentations next month which will share the compelling data that support the potential for new clinical studies evaluating Reqorsa as a potential treatment for additional types of lung cancer, mesothelioma and glioblastoma."

Featured Genprex-supported posters to be presented at the 2024 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics include:

Title: "TUSC2 gene therapy in KRASG12C mutant NSCLC overcomes acquired resistance to sotorasib"

Collaborator: The University of Texas MD Anderson Cancer Center

Catalog Number: 384

Presentation Number: PB372

Title: "TUSC2 Suppresses Tumorigenic Properties in Malignant Pleural Mesothelioma Cells"

Collaborator: New York University Langone Health

Catalog Number: 364

Presentation Number: PB352

Title: "Efficacy of Quaratusugene Ozeplasmid TUSC2 Gene Therapy in Glioblastoma"

Collaborator: The University of Texas Health Science Center at Houston

Catalog Number: 130

Presentation Number: PB118

Genprex has filed two provisional patent applications based on data from two of the presentations. One application involves using REQORSA to treat mesothelioma and the other to treating glioblastoma. Genprex is a co-owner of the applications along with the respective institutions. TUSC2 is the tumor suppressor gene used in REQORSA. REQORSA consists of a TUSC2 gene expressing plasmid encapsulated in non-viral lipid-based nanoparticles in a lipoplex form (the Company’s Oncoprex Delivery System), which has a positive charge. REQORSA is injected intravenously and specifically targets cancer cells. REQORSA is designed to deliver the functioning TUSC2 gene to negatively charged cancer cells while minimizing uptake by normal tissue. Laboratory studies conducted at MD Anderson show that the uptake of TUSC2 in tumor cells in vitro after REQORSA treatment was 10 to 33 times the uptake in normal cells.

On September 9, 2024 Galectin therapeutics presented its corporate presentation (Presentation, Galectin Therapeutics, SEP 9, 2024, View Source [SID1234646430]).

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On September 9, 2024 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported new exciting clinical phase 2 data for its lead compound EVX-01 (Press release, Evaxion Biotech, SEP 9, 2024, View Source [SID1234646429]). The data show that 11 out of 16 patients had objective clinical responses, equaling a 69% Overall Response Rate (ORR). 15 out of the 16 patients had reduction of their tumors (target lesions).

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This topline data is part of a one-year interim analysis of the ongoing phase 2 trial assessing 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). The complete one-year clinical data will be presented at a poster session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024, taking place in Barcelona, Spain, from September 13-17, 2024.

"We are very excited about these data, which strongly support both the clinical profile of EVX-01 as a promising personalized cancer treatment and the unique predictive capabilities of our AI-Immunology platform. To present phase 2 efficacy data for an AI-designed vaccine is a major milestone for Evaxion. Huge unmet medical needs remain in the field of melanoma, and we believe that EVX-01 could potentially be an improved treatment option for patients.
We look forward to presenting the complete one-year dataset at ESMO (Free ESMO Whitepaper), discussing the data with potential partners and advancing the phase 2 trial towards its completion next year," says Christian Kanstrup, CEO of Evaxion.

Evaxion’s innovative approach to develop personalized cancer vaccines builds on its AI-Immunology platform. The vaccines are designed to target the unique genetic makeup of an individual’s tumor and are tailored to the patients’ immune system, potentially enhancing the efficacy of treatment and improving patient outcomes.

Webinar on September 18
Evaxion will be hosting an online webinar featuring key opinion leader and the trial’s principal investigator, Professor Georgina V. Long, on September 18, 2024, at 19:00 CEST/13.00 EST. The webinar can be attended through registration via this link.

In the webinar, Professor Long will present the data from the one-year interim analysis and discuss challenges in the medical treatment of advanced melanoma. In the end, a Q&A session will be held, and participants are encouraged to present questions.

ESMO presentation details:

Abstract Title: Phase 2 study of AI-designed personalized neoantigen cancer vaccine, EVX-01, in combination with pembrolizumab in advanced melanoma
Abstract#: 1084P
Poster#: 2904
Track: Melanoma and other skin tumours
Location: Hall 6
Date/Time: September 14 at 12:00 – 13:00 CEST
Presenter: Dr. Paola Queirolo, Director, Medical Oncology of Melanoma, Sarcoma and Rare Tumors, European Institue of Oncology, Milan, Italy

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.

About EVX-01 phase 2 clinical trial
The Phase 2 clinical study (NCT05309421) is a self-sponsored open-label, single-arm, multi-center trial carried out in collaboration with leading principal investigators and research centers from Italy and Australia. The trial aims to evaluate the efficacy and safety of EVX-01 vaccination in combination with MSD’s anti-PD1 therapy KEYTRUDA (pembrolizumab) in treatment-naive patients with metastatic or unresectable malignant stage III or IV melanoma. KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Merck Sharp & Dohme LLC supplies KEYTRUDA (pembrolizumab) for the trial.

About melanoma
Melanoma accounts for approximately 1 in 5 of the 1.5 million new skin cancer cases estimated globally in 2020 with approximately 325,000 cases and 57,000 deaths. The global burden from melanoma is estimated to increase to 510,000 new cases and 96,000 deaths by 2040 (Arnold et al., JAMA Dermatology 2022). The global market for melanoma treatments is estimated to grow to $7.4 billion by 2029.

On September 9, 2024 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologic therapeutics, reported that the first patient has been dosed with CX-801 monotherapy in a Phase 1 study (NCT06462794) in patients with solid tumors (Press release, CytomX Therapeutics, SEP 9, 2024, View Source [SID1234646428]). CX-801 is a dually-masked interferon alpha-2b PROBODY cytokine with potential broad applicability in both traditionally immune-oncology sensitive as well as insensitive (cold) tumors.

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The CX-801 Phase 1 dose escalation study is designed to evaluate safety and signs of clinical activity for CX-801 as monotherapy and in combination with Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy KEYTRUDA (pembrolizumab). In dose escalation, the Phase 1 study will enroll patients with select solid tumors including advanced melanoma, renal cell carcinoma, and head and neck squamous cell carcinoma to inform a potential decision to move into Phase 1b indication-specific dose expansion cohorts.

"Interferon-alpha-2b is a powerful immune-modulating cytokine that has demonstrated clinical activity in multiple cancer types such as metastatic melanoma, renal cancer and bladder cancer but its clinical benefit has been limited by significant toxicities when administered systemically. CX-801 utilizes CytomX’s industry leading conditional activation platform to maintain potency and expand interferon’s therapeutic index to potentially become a foundational component of immuno-oncology combination regimens," said Wayne Chu, M.D., chief medical officer of CytomX Therapeutics.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA

On September 9, 2024 CureVac N.V. (Nasdaq: CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), reported that the first clinical data from CureVac’s ongoing Phase 1 CVGBM cancer vaccine study in patients with resected glioblastoma will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (Barcelona, Spain, September 13-17, 2024). Clinical data will be presented as an oral presentation on Friday, September 13, along with a poster presentation of preclinical data supporting the program’s development.

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"Cancer vaccines have tremendous potential to improve the outcome of cancer patients and particularly, mRNA technologies offer innovative and promising platforms that could enable us to finally make cancer vaccines a reality in clinical practice," said Dr. Myriam Mendila, Chief Scientific Officer of CureVac. "We are assessing a breakthrough approach to cancer vaccines that uses our distinctive mRNA technology in one of the most aggressive forms of brain cancer and are very excited to share the first-in-human results of our mRNA technology platform in the GBLM trial in glioblastoma at ESMO (Free ESMO Whitepaper)."

The Phase 1 study includes a dose-escalation part (Part A) and dose-expansion part (Part B). Results for Part A will be covered in the oral presentation, with safety and tolerability as well as initial immunogenicity data provided for all evaluable patients at dose levels of 12-100 µg. A summary of treatment-emergent adverse events (TEAEs), which were mostly Grade 1-2 and yielded no dose-limiting toxicities as confirmed by a Data Safety Monitoring Board, will also be provided.

The Phase 1 study is evaluating the safety and tolerability of CVGBM in patients with newly diagnosed and surgically resected MGMT-promoter unmethylated glioblastoma or astrocytoma with a molecular signature of glioblastoma. CVGBM features a single unmodified mRNA encoding eight epitopes derived from known tumor-associated antigens, with demonstrated immunogenicity in glioblastoma. Enrollment began earlier this year for Part B of the study, which is expected to include up to an additional 20 patients at the recommended 100 µg dose.

Details on the presentations are below.

Abstract: 440O

Title: First in human study of the mRNA-based cancer vaccine CVGBM in patients with newly diagnosed and surgically resected MGMT-unmethylated glioblastoma (GBM): First results from the dose escalation phase

Session type: Proffered Paper

Date and Time: September 13, 14:00-14:10 CEST

Location: Pamplona Auditorium (Hall 3)

Speaker: Prof. Dr. Dr. Ghazaleh Tabatabai

Abstract: 22P

Title: Pre-clinical development of CVGBM: A therapeutic mRNA-based multiepitope vaccine for glioblastoma

Session type: Basic Science Poster

Date and Time: September 15, 09:00-17:00 CEST

Location: Hall 6

Speaker: Dr. Ronja I. Mülfarth