On April 12, 2023 Biomunex Pharmaceuticals, a French biopharmaceutical company focused on the development of immunotherapies based on the discovery and development of bi- and multi-specific antibodies for the treatment of cancer, reported that it will participate in and present new scientific data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, which will take place from April 14th to April 19th, 2023 at the Orange County Convention Center, Orlando, Florida, USA (Press release, BIOMUNEX Pharmaceuticals, APR 12, 2023, View Source [SID1234630024]).

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Information about the presentation:
Title: MAIT engagers: An efficacious novel modality in the field of T-cell engagers for the treatment of solid tumors
Session Category: Immunology
Session Title: Therapeutic Antibodies 3
Session Date and Time: Monday Apr 17, 2023 1:30 PM – 5:00 PM
Location: Poster Section 24
Poster Board Number: 1
Published Abstract Number: 2954

On April 12, 2023 MAIA Biotechnology, Inc. (NYSE American: MAIA) reported that it will present a poster that will feature the design of its ongoing Phase 2 clinical trial, THIO-101 evaluating THIO in patients with advanced Non-Small Cell Lung Cancer (NSCLC) (Press release, MAIA Biotechnology, APR 12, 2023, View Source [SID1234630023]). The poster will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, which is taking place in-person at the Orange County Convention Center in Orlando, Florida from April 14-19, 2023.

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Details on the poster and the corresponding abstract are shown below.

Poster Title: A phase 2, multi-center, open-label, dose-finding study evaluating telomere targeting agent THIO sequenced with cemiplimab in patients with advanced NSCLC
Session Title: Phase II and Phase III Clinical Trials in Progress
Abstract Number: CT050 / 8
Session Date: Monday, April 17, 2023, 9:00 am to 12:30 pm ET
Speaker/Lead Author: Mihail Obrocea, MD, MAIA’s Chief Medical Officer

Clinical trial abstract texts will be published online on AACR (Free AACR Whitepaper)’s Online Itinerary Planner at 12:00 pm ET on April 14, 2023.

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dosing finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s potential immune system activation effects in NSCLC patients by administering THIO in advance of administration of an immune checkpoint inhibitor allowing for immune activation and PD-1 sensitivity to take effect. The trial will test the hypothesis that low doses of THIO administered prior to a checkpoint inhibitor will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer agent and a priming immune system agent (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is an investigational telomere-targeting agent currently in clinical development to evaluate its activity in NSCLC. Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being developed for patients with NSCLC that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

On April 12, 2023 Synthekine Inc., an engineered cytokine therapeutics company, reported that two poster presentations showcasing its next series of oncology programs will be delivered at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023 taking place in Orlando, FL from April 14-19, 2023 (Press release, Synthekine, APR 12, 2023, View Source [SID1234630022]).

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"We are excited to present on two programs from our maturing oncology pipeline at AACR (Free AACR Whitepaper) 2023," said Debanjan Ray, chief executive officer of Synthekine. "We are introducing the clinical trial design for our orthogonal IL-2 and CD19 CAR-T combination therapy, STK-009 + SYNCAR-001. This unique combination pioneers new ground in the field of cytokine supported cell therapy, and is our second oncology program to enter clinical studies, behind STK-012, our alpha/beta-biased IL-2 partial agonist."

Ray continued, "We are also introducing STK-026, our IL-12 partial agonist program, which is currently in IND-enabling studies and shows promise as a potent immunotherapy for the treatment of cancer. Systemically administered wild-type IL-12 has been shown to cause significant toxicity. Our approach with STK-026 leverages Synthekine’s expertise in structural biology, immunology, and protein engineering to bias IL-12 activity and expand the therapeutic index."

Details are as follows and available on the AACR (Free AACR Whitepaper) online itinerary planner:

Title: Trial in Progress: A Phase 1 Study to Evaluate the Safety and Tolerability of a Combination Autologous CD19 CAR T Cell Therapy (SYNCAR-001) and Orthogonal IL-2 (STK-009) in Subjects With Relapsed or Refractory CD19+ Hematologic Malignancies (NCT05665062)
Session Title: Phase I Clinical Trials in Progress
Session Date & Time: Monday Apr 17, 2023 1:30 PM – 5:00 PM ET
Location: Poster Section 46
Poster Board Number: 13
Abstract Number: CT125
Summary: A first-in-human, open-label, dose escalation study of combination SYNCAR-001 + STK-009 in adults with relapsed or refractory (r/r) CD19+ hematologic malignancies (NCT05665062). The objectives of this study are to evaluate the safety, preliminary efficacy, pharmacokinetics, immunogenicity, and pharmacodynamics of SYNCAR-001 + STK-009. Recruitment in the Phase 1 study is underway.

Title: Novel IL-12 Partial Agonist For Cancer Immunotherapy Avoids NK-cell Mediated Toxicity
Session Title: Immunomodulatory Agents and Interventions 2
Session Date & Time: Monday Apr 17, 2023 9:00 AM – 12:30 PM ET
Location: Poster Section 24
Poster Board Number: 5
Abstract Number: 1833
Summary: A novel human IL-12 partial agonist (STK-026) has been designed to more selectively engage antigen activated T-cells and to reduce stimulation of NK cells. In preclinical models, a mouse surrogate of STK-026 retained anti-tumor efficacy without induction of severe toxicities and spike in NK cell activation associated with wild-type mouse IL-12 treatment. Similarly, STK-026 avoided NK hyperactivation on human cells. These data suggest IL-12 partial agonists may represent a novel immunotherapy approach to maintain efficacy while avoiding classical toxicity associated with IL-12 therapy.

Copies of the posters will be available on Synthekine’s website following presentation at the meeting.

On April 12, 2023 Naveris, Inc., a leader in molecular diagnostics for viral cancers, reported the launch of the DART 2.0 prospective clinical trial (NCT05541016) by Mayo Clinic (Press release, Mayo Clinic, APR 12, 2023, View Source [SID1234630021]).

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The DART 2.0 trial will evaluate the ability of NavDx, Naveris’ flagship blood test for tumor tissue modified viral (TTMV)-HPV DNA, to improve treatment selection in patients with HPV-driven head and neck cancer. NavDx provides a non-invasive and precise method for monitoring molecular residual disease (MRD) and recurrence by analyzing tumor-derived viral DNA in patients’ blood samples.

Barry M. Berger MD, Chief Medical Officer of Naveris, added, "This trial will build upon the validation of NavDx as a valuable tool for assessing the risk of post-treatment cancer recurrence in these patients, enabling earlier detection of recurrence and application of therapeutic interventions."

Head and neck cancer is a significant health concern worldwide, with HPV-driven head and neck cancer being the fastest growing type of this cancer. NavDx has the potential to improve outcomes for patients by enabling physicians to select the best treatment options for each individual patient, with the goal of improving patient outcomes while reducing the side-effects and morbidity of medical treatment.

"This clinical trial represents a significant step forward in personalized medicine for head and neck cancer patients," said Piyush B. Gupta PhD, Founder and CEO of Naveris. "NavDx has the potential to be a game-changer in treatment selection, allowing physicians to tailor treatment plans to individual patients based on their unique biomarker profiles."

DART 2.0 builds upon the results of the previously reported phase III MC1675 DART clinical trial, where NavDx-detected molecular residual disease (MRD) was a significant risk factor for cancer recurrence in patients with head and neck cancer. The presence of MRD, both post-operatively and at 3 months post-treatment, was strongly associated with shorter progression-free survival. The MC1675 trial results were presented at the ASTRO 2022 annual meeting.

For more information on NavDx and the DART 2.0 clinical trial please visit ClinicalTrials.gov, NCI and Naveris.

On April 12, 2023 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported that the Company has entered into a clinical trial support agreement (the "Agreement") with Janssen Research & Development, LLC ("Janssen") to enable evaluation of ESSA’s first-in-class N-terminal domain androgen receptor inhibitor, EPI-7386, in combination with apalutamide as well as the combination of EPI-7386 with abiraterone acetate plus prednisone in patients with prostate cancer (Press release, ESSA, APR 12, 2023, View Source [SID1234630020]).

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Under the terms of the Agreement, ESSA will sponsor and conduct a Phase 1 clinical trial evaluating the safety, pharmacokinetics, drug-drug interactions, and preliminary anti-tumor activity of EPI-7386 when administered in combination with either apalutamide or abiraterone acetate plus prednisone. Janssen will supply apalutamide and abiraterone acetate. ESSA will retain all rights to EPI-7386.

Cohort A of the Phase 1 clinical trial will assess EPI-7386 in combination with abiraterone acetate plus prednisone in patients with metastatic castration-resistant prostate cancer ("mCRPC") and high-risk metastatic castration-sensitive prostate cancer ("mCSPC"). Cohort B is a Window of Opportunity study in which patients with non-metastatic CRPC will receive up to 12 weeks of single agent EPI-7386 before adding standard-of-care apalutamide.

"We are pleased to have this agreement in place in order to further investigate EPI-7386 in combination with apalutamide and abiraterone acetate plus prednisone in a variety of prostate cancer patient populations," said David R. Parkinson, President and Chief Executive Officer of ESSA. "Preliminary clinical data from EPI-7386 combination studies with standard-of-care antiandrogens in mCRPC patients have shown a favorable safety profile and encouraging early signs of anti-tumor activity. We look forward to examining EPI-7386 with apalutamide and abiraterone acetate with prednisone in additional prostate cancer populations to assess the safety, tolerability, optimal dose(s) and preliminary anti-tumor activities of these approaches."

About EPI-7386
EPI-7386 is an investigational, highly-selective, oral, small molecule inhibitor of the N-terminal domain of the androgen receptor. EPI-7386 is currently being studied in a Phase 1 clinical trial (NCT04421222) in men with castration-resistant prostate cancer ("CRPC") whose tumors have progressed on standard-of-care therapies. The U.S. FDA has granted Fast Track designation to EPI-7386 for the treatment of adult male patients with mCRPC resistant to standard-of-care treatment. ESSA is also conducting a Phase 1/2 clinical trial (NCT05075577) of EPI-7386 in combination with enzalutamide in metastatic CRPC patients who have not yet been treated with second-generation antiandrogen therapies. ESSA retains all rights to EPI-7386 worldwide.