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Triumvira Immunologics to Present New Clinical and Preclinical Data on its TAC-T Cell Technology at SITC 2023 Annual Meeting

On October 30, 2023 Triumvira Immunologics, a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors, reported that it will participate with one oral presentation and four posters at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2023 Annual Meeting in San Diego, California, from November 1-5 (Press release, Triumvira Immunologics, OCT 30, 2023, View Source [SID1234636467]). The company will showcase clinical and preclinical data across various programs, including its ongoing Phase I/II study investigating the safety and efficacy of autologous TAC-T cells targeting human epidermal growth factor receptor 2 (HER2) in relapsed or refractory solid tumors (TACTIC-2 /NCT04727151) and its CLDN18.2, GUCY2C and allogeneic TAC T cell technologies.

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TAC01-HER2 is an innovative cell-based therapy that involves the utilization of genetically modified T cells derived from the patient themselves. These cells express a T-cell Antigen Coupler (TAC) which is designed to specifically recognize HER2 in tumors. In addition to the TAC01-HER2 candidate, the company is investigating TAC-GUCY2C for the treatment of colorectal cancer and TAC01-CLDN18.2 for the treatment of pancreatic ductal adenocarcinoma and gastric cancer.

"The new data we are presenting at SITC (Free SITC Whitepaper) demonstrates the robustness of our TAC-T cells platform and its potential for precise targeting of malignant cells expressing tumor-associated antigens such as HER2, Claudin 18.2 and GUCY2C," stated Dr. Paul Lammers, CEO of Triumvira Immunologics. "Our commitment to developing innovative T cell therapeutics that harness the natural biology of T cells is supported by the promising preliminary results from our ongoing Phase I/II study targeting HER2 in solid tumors. In addition, we are advancing our pipeline by evaluating the clinical efficacy of TAC01-CLDN18.2, a novel autologous cell therapy that recognizes Claudin 18.2, a promising therapeutic target that is selectively over-expressed in gastric cancers and other solid tumors."

Details of the abstract oral presentation are as follows:

Abstract Number: 654
Title: A phase I/II trial investigating safety and efficacy of autologous TAC01-HER2 in relapsed or refractory solid tumors
Presenter: Daniel Olson M.D., University of Chicago
Session: Concurrent Session 105b: Rapid Oral Abstracts – Clinical
Date: Friday, November 3 at 12:15 – 1:15 p.m. Pacific Time
Location: Ground Level, Exhibit Hall C, San Diego Convention Center

Details of the abstract poster presentations are as follows:

Abstract Number: 347
Title: Functional characterization of GUCY2C-TAC T cells for the treatment of colorectal cancer using preclinical models
Authors: Tania Benatar, Thanyashanthi Nitya-Nootan, Gargi Thakor, Suzanna Prosser, Philbert Ip, Prabha Lal, Alima Khan, Stacey Xu, Sailaja Pirati, Deepika Bhemarasetty, Christopher Helsen, Andreas Bader
Category: Cellular Therapies
Date: Friday, November 3 at 9 a.m. Pacific Time
Location: Exhibit and Poster Hall (Exhibit Hall B), San Diego Convention Center

Abstract Number: 372
Title: TAC-T cells persist and remain functional during and after repeated tumor exposure in vitro and in vivo
Authors: Heather MacGregor, Suzanna Prosser, Stacey Xu, Kyle MacDonald, Aksha Kadri, Ritu Randhawa, Swati Shetty, Sailaja Pirati, Deepika Bhemarasetty, Christopher Helsen, Sadhak Sengupta, Andreas Bader
Category: Cellular Therapies
Date: Saturday, November 4 at 9 a.m. Pacific Time
Location: Exhibit and Poster Hall (Exhibit Hall B), San Diego Convention Center

Abstract Number: 400
Title: Preclinical characterization and modeling of allogeneic Vγ9Vδ2 TAC T cells for the treatment of solid tumors
Authors: Stacey Xu, Suzanna Prosser, Ling Wang, Ritu Randhawa, Sailaja Pirati, Deepika Bhemarasetty, Kyle MacDonald, Seung Mi Yoo, Miyoung Jung, Laurentia Gheorghiu, Chris Ayers, Sadhak Sengupta, Christopher Helsen, Andreas Bader
Category: Cellular Therapies
Date: Saturday, November 4 at 9 a.m. Pacific Time
Location: Exhibit and Poster Hall (Exhibit Hall B), San Diego Convention Center

Abstract: Number 738
Title: A phase 1/2 study investigating the safety and efficacy of autologous TAC T cells in subjects with unresectable, locally advanced or metastatic claudin 18.2+ solid tumors
Authors: Daniel Olson, Ecaterina Dumbrava, Sam Saibil, Martin Gutierrez, Syma Iqbal, Davendra Sohal, Maria Apostolopoulou, Kara Moss, Deyaa Adib, Benjamin Schlechter
Category: Clinical Trial In Progress
Date: Friday, November 3 at 9 a.m. Pacific Time
Location: Exhibit and Poster Hall (Exhibit Hall B), San Diego Convention Center

Regen BioPharma, Inc. to Discuss Confirmation Study Results on Its DuraCar Program at the Emerging Growth Conference on November 1, 2023

On October 30, 2023 Regen BioPharma, Inc. (OTC PINK: RGBP) (OTC PINK: RGBPP), a biotechnology company advancing a diverse pre-clinical pipeline spanning cell therapies, RNA vaccines, RNA and DNA therapeutics and small molecule drugs reported that it will be presenting at the Emerging Growth Conference on November 1, 2023 (View Source) (Press release, Regen BioPharma, OCT 30, 2023, View Source [SID1234636466]).

This live, interactive online event will give existing shareholders and the investment community the opportunity to interact with the Company’s CEO, Dr. David Koos, in real time. Please ask your questions during the event and Dr. Koos and his team will do their best to address as many of them as possible.

"We plan to use this time to discuss our most recent scientific results around our DuraCAR program as well as update our shareholders on our financial plan," says Dr. David Koos, CEO and Chairman of the Company.

Regen BioPharma, Inc. will be presenting at 2:20 – 2:50 Eastern time on Wednesday, November 1, 2023. Please register here to ensure you are able to attend the conference and receive any updates that are released View Source;tp_key=f701725cb0&sti=rgbp.

If attendees are unable to join the event live on the day of the conference an archived webcast will also be made available on EmergingGrowth.com.

SparX Biopharmaceutical Announces FDA Greenlight for IND Application of SPX-303, A First-In-Human anti-LILRB2/PD-L1 Antibody Drug

On October 30, 2023 SparX Biopharmaceutical Corp. reported that its Investigational New Drug (IND) application for SPX-303, a First-in-Class anti-LILRB2/PD-L1 bispecific antibody drug candidate, has been greenlighted by the U.S. Food and Drug Administration (FDA) (Press release, Sparx Therapeutics, OCT 30, 2023, View Source [SID1234636465]). This approval propels SparX’s enduring commitment to deliver groundbreaking solutions to patients grappling with advanced or refractory solid tumors.

Dr. Gui-Dong Zhu, Chief Executive Officer of SparX Biopharmaceutical, shared his exhilaration: "Receiving the FDA’s green light on our IND application is a seminal moment in our ongoing journey to redefine the paradigms of cancer treatment. The preclinical data for SPX-303 not only showcases promise but facilitate out confidence to harness its therapeutic prowess in a clinical setting, particularly for patients who previously had limited treatment options."

With this FDA endorsement, SparX Biopharmaceutical is primed to launch a Phase 1 clinical study, aiming to assess the safety, tolerability, and preliminary efficacy of SPX-303 in patients beleaguered by advanced or refractory solid tumors. This human trial is geared to evaluate the therapeutic potential of SPX-303, potentially heralding a new dawn of innovative and superior healthcare outcomes.

Developed by SparX, SPX-303 is a First-in-Its Class bispecific antibody therapy, ingeniously engineered to engage two cardinal immune checkpoint proteins, LILRB2 and PD-L1, simultaneously. Acting as pivotal fulcrums in sustaining the immune system’s equilibrium and vigor, these checkpoints help deter autoimmune anomalies. While LILRB2 majorly tempers overactive innate immune reactions, preserving the body’s natural defense harmony, PD-L1—often overexpressed in tumor cells—judiciously modulates T cell activation, curating a precise immune response. Yet, cancers often manipulate these immune-checkpoints, equipping themselves with a defense mechanism against immune retaliation. SPX-303 is meticulously designed to dismantle this barrier, empowering the immune system to discern and fervently annihilate malignant cells, thereby charting a transformative trajectory in cancer therapy.

Applied BioMath, LLC Presents Quantitative Systems Pharmacology Model of T-cell Engagers for Solid Tumors at the Society for Immunotherapy of Cancer Annual Meeting

On October 30, 2023 Applied BioMath (www.appliedbiomath.com), the industry-leader in providing model-informed drug discovery and development (MID3) support to help accelerate and de-risk therapeutic research and development (R&D), reported their participation at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) occurring November 1-5, 2023 in San Diego, CA (Press release, Applied BioMath, OCT 30, 2023, View Source [SID1234636464]).

During the conference, Fei Hua, PhD, Vice President of Modeling and Simulation Services at Applied BioMath, will present the poster entitled, "Overcoming the dose-response prediction limitation from bench to clinic for T-cell engagers: Using Quantitative Systems Pharmacology (QSP) modeling in the development of CDR404 for solid tumors."

While T-cell Engagers (TCEs) offer a potentially very potent approach to treat cancer, they also have complex relationships between binding potency, exposure, and efficacy. These complex relationships bring challenges to drug discovery and development such as identifying optimal Kd for the drug candidate, predicting efficacious doses, and selecting dosing regimens for clinical study.

Applied BioMath’s poster describes a QSP model developed to support the first-in-human trial design for CDR404, a highly potent and highly specific antibody-based T-cell engager that binds bivalently to a MAGE-A4 peptide displayed on HLA-A*02:01 on cancer cells and monovalently to CD3 on T-cells. The QSP model will become an integrated part of the clinical development program and can be updated with emerging clinical data to facilitate discovery of a safe and therapeutic dose range for CDR404.

"For therapeutics with complex mechanisms of action (MoA), QSP modeling can be integral for progressing through the R&D pipeline," said John Burke, PhD, Co-founder, President and CEO. "Particularly for TCEs, we’ve had experience where QSP modeling has tested target feasibility, optimized molecule design, predicted therapeutic index, and guided clinical trial design."

To learn more about Applied BioMath, visit www.appliedbiomath.com.

Bridge Biotherapeutics Announces Initiation of Phase 1/2 Clinical Trial of BBT-207 in EGFR-Mutant NSCLC

On October 30, 2023 Bridge Biotherapeutics (KQ288330), a South Korean clinical-stage biotech company developing novel drugs for cancer, fibrosis, and inflammation, reported that the company has initiated the Phase 1/2 clinical trial evaluating the safety, tolerability, and antitumor activity of BBT-207 in non-small cell lung cancer (NSCLC) patients with EGFR mutations (Press release, Bridge Biotherapeutics, OCT 30, 2023, View Source [SID1234636463]).

BBT-207, a novel epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) is designed to inhibit the signaling pathway of EGFR with C797S mutations, which arises due to osimertinib (Tagrisso)-resistant mutations in NSCLC. The mutation results in a cysteine to serine change on amino acid 797 within the kinase domain sequence of the EGFR. Preclinically BBT-207 has shown activity against treatment-emergent complex EGFR mutations containing T790M and/or C797S as well as drug- naïve mutants providing a possibility to overcome resistance to prior TKIs.

The Phase 1/2 study (NCT05920135), an open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of BBT-207 in patients with NSCLC who have progressed following the use of at least one third-generation EGFR TKI, consists of three parts: dose escalation (Part 1), recommended phase 2 dose selection (Part 2), and dose expansion (Part 3). The study is expected to enroll approximately 92 patient participants who have advanced stage and refractory NSCLC with an activating EGFR mutation, documented partial response, complete response, or durable stable disease after the treatment of an EGFR TKI, and previous treatment with all standard therapeutic options and at least one third-generation EGFR TKI, including Osimertinib and Lazertinib.

The Phase 1a dose escalation cohort will determine the Recommended Dose Range (RDR), based on the totality of the data including toxicity/tolerability, efficacy, pharmacokinetic (PK), and pharmacodynamic (PD). During the Phase 1b RP2D selection stage, the safety monitoring committee will determine the Recommended Phase 2 Dose (RP2D) based on the totality of the data including overall safety, PK, PD, and preliminary antitumor activity including the percentage of patients with partial response (PR) or complete response (CR) based on RECIST Version 1.1. and duration of response (DOR). Finally, the Phase 2 dose expansion cohort will include assessments of preliminary anti-tumor activity utilizing the objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. In addition, detailed mutation profiles collected through liquid and tumor biopsy procedures will be analyzed after the study.

"We are highly encouraged to be able to initiate the first-in-patient study of BBT-207, which is expected to address unmet medical needs of advanced NSCLC patients with C797S mutations across the globe," said James Lee, CEO of Bridge Biotherapeutics.

Additional information about the clinical trial may be found at clinicaltrials.gov/study/NCT05920135.

Lung cancer is the leading cause of cancer death, accounting for about one-fifth of all cancer deaths. Lung cancer is classified into two main groups: non-small cell lung cancers (NSCLC) and small cell lung cancers (SCLC), where NSCLC accounts for approximately 85% of all lung cancer diagnoses. In 2019, there were a combined 0.79 million diagnosed cases of NSCLC in men and women, aged 18 years and older, across the US, France, Germany, Italy, Spain, the UK, Japan, and urban China. The incidence of NSCLC is expected to increase at an annual growth rate (AGR) of 3.01% from 2019 to 2029, reaching 1.03 million cases in 2029[1].

In September 2023, Bridge Biotherapeutics announced the discontinuation of the development of BBT-176, another fourth generation EGFR TKI at the Phase 1a stage, dose escalation part. The company will remain committed to the development of a fourth generation EGFR TKI, while seeking to concentrate its capacity and financial resources on BBT-207.

STUDY TITLE: First-in-Human Study of BBT-207 in Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation After Treatment with EGFR TKI
STUDY DESIGN: An open-label, Phase 1/2 study evaluating safety, tolerability, PK, PD, and preliminary antitumor activity of BBT-207 in patients with advanced NSCLC harboring EGFR mutation after treatment with EGFR TKI. The study will consist of 3 parts; dose escalation, recommended phase 2 dose selection, and dose expansion phases
TEST PRODUCT: Oral administration of BBT-207 throughout a 21-day cycle for each phase
STUDY OBJECTIVES: To evaluate the safety, tolerability, PK, PD, and preliminary efficacy (antitumor activity) of BBT-207 in patients with advanced NSCLC harboring EGFR mutation after treatment with EGFR TKI