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 [SID1234646894]). 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 Candid Therapeutics, Inc. ("Candid"), a biotechnology company dedicated to developing potentially transformative drugs to address autoimmune diseases, reported its official launch today (Press release, Candid Therapeutics, SEP 9, 2024, View Source [SID1234646464]).

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Recent groundbreaking clinical data has showcased the pivotal role of a specific subset of immune cells, B lymphocytes, in autoimmune diseases. B lymphocytes lead to autoimmune pathology by producing autoantibodies that attack the body’s own tissues and also through antigen presentation and cytokine release. Selective depletion of B lymphocytes has shown unprecedented clinical efficacy in highly refractory patients across multiple autoimmune diseases such as rheumatoid arthritis and myasthenia gravis. Candid is developing T-cell engager ("TCE") antibodies that can deplete specific B lymphocyte cell populations and aims to be the first company to bring these novel therapies to market.

To accelerate development of and position Candid to become the leader in TCE antibodies for autoimmune diseases, Candid acquired Vignette Bio and TRC 2004 through a simultaneous three-way merger and multi-step financing. This acquisition integrates two cutting-edge bispecific TCEs:

CND106, a BCMAxCD3 bispecific antibody from Vignette Bio, which was initially founded by Foresite Labs who exclusively licensed ex-China rights for the drug candidate from EpimAb Biotherapeutics.
CND261, a CD20xCD3 bispecific antibody from TRC 2004, which was established through a collaboration between Two River and Third Rock Ventures who exclusively licensed ex-China rights for the drug candidate from Genor Biopharma.
CND106 and CND261 have both completed Phase 1 dose escalation studies with combined data in over 130 oncology patients. Both drug candidates have shown potential to become best-in-class therapies for various autoimmune diseases.
The founding Candid team includes an accomplished set of seasoned entrepreneurs who have repeatedly advanced nascent ideas into late-stage development products and commercialization.

Ken Song, MD as Chairman, President and CEO has successfully led several life science companies with over $5.5 billion in realized shareholder value. Most recently he led RayzeBio, a radiopharmaceutical company, from concept to Phase 3 in just over 3 years and negotiated a $4.1 billion sale of the company earlier this year to Bristol Myers Squibb.
Timothy Lu, MD, PhD as Chief Medical and Scientific Officer was instrumental in the clinical development of novel oral IL-17 drugs for autoimmune diseases at DICE Therapeutics which was acquired last year by Eli Lilly, where he stayed on until joining the Candid team.
Bernie Huyghe, PhD as Chief Technology Officer has over 30 years of experience in manufacturing of biologics and other complex therapeutic products and prior to Candid, was overseeing two Phase 3 antibody programs at Viridian Therapeutics.
Arvind Kush as Chief Financial and Business Officer has had an illustrious career first as a managing director in healthcare banking at Bank of America before transitioning to RayzeBio as CFO where he navigated a highly successful oversubscribed IPO in September 2023.
In conjunction with the merger, Candid has successfully raised over $370 million in capital from an extensive roster of investors, which includes a recently completed financing co-led by Venrock Healthcare Capital Partners, Fairmount, TCGX, and venBio Partners. Other notable healthcare investors supporting the company include Foresite Capital, Third Rock Ventures, Fidelity Management & Research Company, Samsara BioCapital, Qiming Venture Partners USA, OrbiMed, Boxer Capital, Redmile Group, Vida Ventures, Two River, Franklin Templeton, LifeSci Venture Partners, Mirae Asset Capital Life Science, Polaris Innovation Fund, Soleus Capital and other reputable institutional and mutual fund investors. This substantial financial backing highlights strong investor confidence in Candid’s purposeful approach and strategic vision, positioning the company for significant impact in bringing forth first-in-class therapies to patients with autoimmune diseases.

"TCE antibodies have the most promise as scalable and patient friendly drugs to deplete B cells for treatment of a myriad of autoimmune conditions and represents a once in a generation development opportunity," said Dr. Ken Song, Chairman, President, and CEO of Candid Therapeutics. "The drugs we are developing at Candid have the potential to go above and beyond the clinical and commercial success of Humira and Rituxan and I am thrilled to be leading the Candid team knowing we can possibly make history by changing the paradigm in how autoimmune diseases are treated."

On September 9, 2024 NiKang Therapeutics Inc. ("NiKang"), a clinical-stage biotech company focused on developing innovative small molecule oncology medicines to bring transformative therapies to patients in need, reported that preliminary data from its ongoing Phase 1/2 clinical trial evaluating NKT2152 for the treatment of previously treated advanced clear cell renal cell carcinoma (ccRCC) will be presented in an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2024 Congress on September 13, 2024, in Barcelona, Spain (Press release, NiKang Therapeutics, SEP 9, 2024, View Source [SID1234646463]).

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"This oral presentation marks an important milestone in the clinical development of NKT2152, a highly selective, potent and orally available HIF2α inhibitor with a potential best-in-class profile. The findings strengthen our belief that deep inhibition of HIF2α can lead to meaningful clinical benefits in patients at dose levels that are generally well tolerated," said Zhenhai Gao, Ph.D., co-founder, president and CEO of NiKang. "These data demonstrate NKT2152’s robust anti-tumor activity in heavily pretreated, high risk advanced ccRCC patients. They also support the hypothesis that NKT2152’s potency and improved systemic exposure have the potential to enhance the current standard of care."

Details for the presentation are as follows:

Presentation Title: NKT2152, a novel oral HIF2α inhibitor, in participants (pts) with previously treated advanced clear cell renal cell carcinoma (accRCC): Preliminary results of a Phase 1/2 study
Session Title: Proffered paper session 1: GU tumors, non-prostate
Session Date and Time: Friday, September 13, from 14:00 – 15:30 CET (8:00 – 9:30am ET)
Presentation Number: 1690O
Presenter: Eric Jonasch, MD (MD Anderson Cancer Center, Houston, TX)
Location: Santander Auditorium – Hall 5

After the oral presentation, the full presentation will be available at Science & Pipeline – NiKang Therapeutics (www.nikangtx.com).

About NKT2152

NKT2152 is a potent, selective and orally available small molecule HIF2α inhibitor which binds to HIF2α allosterically and disrupts the HIF2α/HIF1β transcription factor complex, thereby reducing the production of proteins which lead to tumorigenesis. NKT2152 is currently under evaluation in a Phase 1/2 clinical study in ccRCC as a single agent (NCT05119335) and a Phase 2 clinical study in ccRCC in combination with palbociclib and sasanlimab (NCT05935748). A third clinical study, sponsored by F. Hoffman-La Roche Ltd., evaluating the combination with standard-of-care atezolizumab (Tecentriq) and bevacizumab (Avastin) in first-line unresectable/advance hepatocellular carcinoma (HCC) (NCT04524871) is planned.

On September 9, 2024 Novocure (NASDAQ: NVCR) reported that it will present a real-world analysis of usage of its Tumor Treating Fields (TTFields) therapy and survival outcomes in newly diagnosed glioblastoma (ndGBM) patients at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024, September 13 – 17, Barcelona, Spain (Press release, NovoCure, SEP 9, 2024, View Source [SID1234646462]).

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The results of the real-world analysis suggest higher TTFields therapy device usage is significantly associated with improved survival outcomes in a broad population of ndGBM patients.

Novocure’s ESMO (Free ESMO Whitepaper) 2024 Data Presentation Details:

Poster #459: Association of Tumor Treating Fields Device Usage with Survival in Newly Diagnosed GBM: A Real-World Analysis of Patients in the US
Authors: Jennifer M. Connelly, Department of Neurology, Medical College of Wisconsin, Milwaukee, WI, United States; Santiago Cabezas-Camarero, Department of Medical Oncology, Hospital Universitario Clínico San Carlos (IdISSC), Madrid, Spain; Nick Avgeropoulos, Novocure, Inc., Portsmouth, NH, United States; Patrick Conlon, Novocure, Inc., Portsmouth, NH, United States; Gordon Chavez, Novocure, Inc., Portsmouth, NH, United States; Ori Farber, Novocure, Ltd., Haifa, Israel
Date: Monday, September 16

Abstracts are available on the ESMO (Free ESMO Whitepaper) website, esmo.org/meeting-calendar/esmo-congress-2024/programme.

Novocure has also sponsored an ESMO (Free ESMO Whitepaper) Colloquium, The Role of Alternating Electric Fields in the Therapeutic Management of Patients with Advanced Non-Small Cell Lung Cancer, which will be held Monday, September 16, 13:00 – 14:30 CEST, in the Oviedo Auditorium, Hall 3.

About Tumor Treating Fields

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors. To learn more about TTFields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.

On September 9, 2024 Agenus Inc. ("Agenus") (Nasdaq: AGEN), a leader in developing novel immunological agents to treat various cancers, reported that updated data from the clinical trial of botensilimab and balstilimab in refractory sarcomas will be featured in a mini oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, taking place September 13-17, 2024, in Barcelona, Spain (Press release, Agenus, SEP 9, 2024, View Source [SID1234646461]).

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The presentation will feature updated efficacy and safety data from the large, ongoing Phase 1 trial, highlighting the potential of this combination therapy in treating patients with refractory sarcomas, including visceral angiosarcoma and leiomyosarcoma, populations with limited therapeutic options. Botensilimab, a novel investigational Fc-enhanced CTLA-4 inhibitor, and balstilimab, an investigational PD-1 antibody, have shown promising clinical responses in multiple tumor types, including "cold" tumors that are typically unresponsive to standard therapies.

Presentation Details:

Abstract Title: Updated efficacy and safety of botensilimab plus balstilimab in patients with refractory metastatic sarcoma from an expanded phase 1 study

Abstract Number: 1726MO

Presenting Author: Breelyn A. Wilky, MD, University of Colorado Cancer Center

Session: Mini Oral Session, Sarcoma

Session Date and Time: Friday, September 13th, 2024, at 4:00 p.m. – 5:30 p.m. CEST (10:00 a.m. – 11:30 a.m. ET)

Complete abstracts are available through the ESMO (Free ESMO Whitepaper) Congress program. The presentation will also be available in the publications section of the Agenus website following the ESMO (Free ESMO Whitepaper) Congress on Friday, September 13th.

About Botensilimab

Botensilimab is an investigational human Fc enhanced CTLA-4 blocking antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to "cold" tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses.

Approximately 1,100 patients have been treated with botensilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov with the identifiers NCT03860272, NCT05608044, NCT05630183, and NCT05529316.