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J INTS BIO, AACR 2024 – ‘JIN-A02’, a Novel Oral 4th Generation EGFR TKI, showing Clinical Benefits in the Ongoing Phase 1 Study

On April 11, 2024 J INTS BIO reported the results of its ongoing Phase 1 clinical study of JIN-A02, a 4th generation EGFR-TKI for NSCLC treatment, at the 8th April poster session of the 2024 American Cancer Research Society (AACR) (Free AACR Whitepaper) Annual Meeting held in San Diego, California, from 5th to 10th April (U.S. local time) (Press release, J INTS BIO, APR 11, 2024, View Source;jin-a02-a-novel-oral-4th-generation-egfr-tki-showing-clinical-benefits-in-the-ongoing-phase-1-study-302114115.html [SID1234642019]).

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‘JIN-A02’ is a 4th generation EGFR-TKI targeting C797S mutation that causes resistance to 3rd generation EGFR-TKI (such as Osimertinib, Lazertinib), commonly used in the treatment of NSCLC. ‘JIN-A02’ also targets T790M mutation independently of C797S mutation.

This ongoing Phase 1 clinical study is currently in its 4th Dose Level of 100mg daily and patients have showed increasing clinical benefits with each increasing dose levels. To-date, Partial Response (PR) was confirmed in one subject on the prior dose level of 50mg daily and stable diseases in two other subjects separately in Dose Level 50mg and 25mg daily.

Despite the initial low doses, JIN-A02 has showed clinical benefits immediately, cumulating in a Partial Response at the 3rd Dose Level of 50mg, which is an encouraging result in such an early stage of clinical development, the company explained. Furthermore, JIN-A02 has showed a favorable safety profile with no cardiotoxicity, rash or diarrhea reported, even at the current Dose Level of 100mg daily and the longest duration of treatment is over 8 months and still continuing, the company added. The 5th Dose Level of 150mg daily is expected to begin in 3Q 2024.

J INTS BIO confirmed the favorable safety and efficacy signals of ‘JIN-A02’ with clinical benefits in this poster presentation in San Diego and greater clinical impact is expected as the study progresses.

Citius Pharmaceuticals Announces Addition of City of Hope to UMN’s Phase 1 Trial of LYMPHIR in Combination with CAR-T for the Treatment of B-Cell Lymphoma

On April 11, 2024 Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, reported that the University of Minnesota Masonic Cancer Center intends to expand their ongoing investigator-initiated Phase 1 trial of LYMPHIR (denileukin diftitox) in combination with FDA-approved CAR-T products for the treatment of B-cell lymphomas (Press release, Citius Pharmaceuticals, APR 11, 2024, View Source [SID1234642018]). The ongoing study, led by Dr. Veronika Bachanova at the University of Minnesota (UMN), will include an additional study site at City of Hope (COH), a world-renowned cancer treatment and research institution, with Dr. Matthew Mei as the principal site investigator at COH. City of Hope is one of only 53 National Cancer Institute (NCI)-designated comprehensive cancer centers in the U.S.

"We are encouraged by the scientific community’s interest in exploring the potential benefits of LYMPHIR beyond cutaneous T-cell lymphoma, for which a Biologics License Application is currently under review by the FDA. We are very excited to support UMN’s expansion of its study to City of Hope as distinguished oncologists Dr. Bachanova and Dr. Mei conduct innovative research to evaluate LYMPHIR in combination with CAR-T treatment," stated Dr. Myron Czuczman, Chief Medical Officer of Citius. "This first-of-its-kind study will evaluate the potential value that transient depletion of T-regs within the tumor microenvironment by LYMPHIR has upon CAR-T-based anti-tumor activity," added Dr. Czuczman.

"This trial is designed to augment lymphodepletion prior to CAR-T cells by administration of targeted immunotoxin against IL-2 receptor-positive regulatory T-cells. The lymphodepleting chemotherapy augmented with LYMPHIR was combined with all three standard of care CAR-T products for diffuse large B-cell lymphomas in second or third line of therapy. We look forward to welcoming patients from City of Hope as we expand the trial and evaluate the maximum tolerated dose," stated principal investigator Veronika Bachanova, MD, PhD, Division of Hematology, Oncology, and Transplantation, Department of Medicine, University of Minnesota.

Citius is collaborating with the University of Minnesota (UMN) in this investigator-initiated study. This Phase 1 dose-finding study to evaluate LYMPHIR prior to CAR-T therapies tisagenlecleucel (KYMRIAH), axicabtagene ciloleucel (YESCARTA), or lisocabtagene maraleucel/BREYANZI), in patients with B-cell lymphomas (BCL) (NCT0485525) was initiated in May 2021 and has been expanded to include City of Hope. Enrollment is underway for patients diagnosed with relapsed or refractory BCL, for which treatment with CAR-Ts is planned, and who are considered at high risk for progression after CAR-T therapy.

Phio Pharmaceuticals Announces Upcoming Presentation at the 27th Annual Meeting of the American Society of Cell and Gene Therapy (ASCGT)

On April 11, 2024 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL siRNA gene silencing technology is designed to make immune cells more effective in killing tumor cells, reported it is presenting new data about its lead clinical product candidate, PH-762, an INTASYL compound (Press release, Phio Pharmaceuticals, APR 11, 2024, View Source [SID1234642017]).

Preclinical studies demonstrate that PH-762 is effective in silencing PD-1, boosting immune response, and inhibiting tumor growth. PH-762 is currently being studied in a U.S. clinical trial to assess safety and efficacy in specific skin cancers (NCT 06014086).

The data will be presented at the American Society of Cell and Gene Therapy (ASCGT) on May 8th in Baltimore, Maryland. The mission of ASGCT (Free ASGCT Whitepaper) is to advance knowledge, awareness, and education leading to the discovery and clinical application of genetic and cellular therapies to alleviate human disease.

Presentation Details are as follows:

Title: INTASYL PH-762: PD-1 Intratumoral Immunotherapy
Abstract Number: 774
Session Title: Cancer-Immunotherapy and Cancer Vaccines
Authors: Melissa Maxwell, Linda Mahoney, Mary Spellman
Date and Time: May 8, 2024 at 12:00 PM EST
Location: Exhibit Hall

Theratechnologies to Present at the 2024 Bloom Burton & Co. Healthcare Investor Conference

On April 11, 2024 Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that the Company’s President and CEO, Paul Lévesque will be presenting at the 2024 Bloom Burton & Co. Healthcare Investor Conference, which is taking place April 16-17 in Toronto, Canada (Press release, Theratechnologies, APR 11, 2024, View Source [SID1234642016]).

Presentation Details:
Date/Time: Wednesday, April 17, 2024, at 10:00 AM ET
Room: 104A
Location: Metro Toronto Convention Centre

Members of the Theratechnologies management team will also be taking meetings throughout the conference. Further information on the conference, including registration details can be found here.

PureTech Receives FDA Fast Track Designation for LYT-200 in Head and Neck Cancers

On April 11, 2024 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, reported that the U.S. Food and Drug Administration ("FDA") has granted Fast Track designation for LYT-200 in combination with anti-PD1 therapy for the treatment of recurrent/metastatic head and neck squamous cell carcinomas ("head and neck cancers") (Press release, PureTech Health, APR 11, 2024, View Source [SID1234642015]).

"In the U.S., there are approximately 66,000 people diagnosed with head and neck cancers each year, and the prognosis for metastatic disease is unfavorable, with a median survival rate of about ten months," said Eric Sherman, M.D., Memorial Sloan Kettering Cancer Center and an investigator in PureTech’s Phase 1/2 clinical trial. "There is an important need to explore promising new mechanisms and targets such as galectin-9 to bring therapeutic innovation to this patient population."

LYT-200 is an antibody against galectin-9, a potent cancer driver, and is the most advanced clinical program against this target. It is being evaluated in two ongoing clinical trials:

1. a Phase 1/2 adaptive design trial in advanced/metastatic solid tumors, including head and neck cancers. In this trial, LYT-200 is being evaluated as a monotherapy and in combination with tislelizumab, an anti-PD-1 antibody developed by BeiGene. LYT-200 has demonstrated a favorable safety profile in all cohorts, including the monotherapy and combination arms with BeiGene’s tislelizumab, and shown disease control and suggestions of initial anti-tumor activity.

2. a Phase 1b clinical trial evaluating LYT-200 as a monotherapy and in combination with venetoclax and hypomethylating agents in hematological malignancies, including acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome. LYT-200 has demonstrated a favorable safety and tolerability profile as well as early signals of potential clinical activity.

"By granting Fast Track designation to LYT-200 for head and neck cancers, the FDA continues to highlight areas of critical need within oncology as well as the potential for LYT-200," said Aleksandra Filipovic, M.D., Ph.D., Head of Oncology at PureTech. "As galectin-9’s role in suppressing immune-mediated activity has been well-validated, it represents an important area of clinical research, especially in aggressive cancers with increased mortality."

Fast Track designation is a process designed to streamline the development and accelerate the assessment of drugs that target serious conditions with unmet medical need. The FDA has also granted orphan drug designation to LYT-200 for the treatment of AML.

About LYT-200

LYT-200 is a fully human IgG4 monoclonal antibody targeting galectin-9 for the potential treatment of locally advanced/metastatic solid tumors that have poor survival rates, including head and neck cancers. It is also in development for the treatment of hematological malignancies, such as acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). Galectin-9 is a potent oncogenic driver and immunosuppressor, and in AML it has been described to work via engagement with cytotoxic CD8 T cells and natural killer cells.

A wide variety of preclinical data underscores the importance of galectin-9 as a target and suggests a potential opportunity for biomarker development. These data demonstrate high expression of galectin-9 across various blood cancers and solid tumor types and show that galectin-9 levels correlate with poor survival in several cancers.

LYT-200 has demonstrated direct cytotoxic, anti-leukemic effects through multiple mechanisms, as well as synergy with standard of care chemotherapy and venetoclax in preclinical models. Consistent with its hub-and-spoke model, PureTech intends to advance LYT-200 via its Founded Entity Gallop Oncology.