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Instil Bio Announces Poster Presentations of ITIL-306 Preclinical Data at SITC 2023 Annual Meeting

On November 6, 2023 Instil Bio, Inc. ("Instil") (NASDAQ: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported two poster presentations at the SITC (Free SITC Whitepaper) 2023 Annual Meeting demonstrating that its proprietary CoStimulatory Antigen Receptor (CoStAR) platform enhances the activity of CD4+ T cells across multiple axes (Press release, Instil Bio, NOV 6, 2023, View Source [SID1234637032]).

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TIL therapy utilizes a mixed population of tumor-reactive CD4+ and CD8+ T cells, with both populations of T cells able to drive tumor regression. CoStAR has previously been demonstrated to improve proliferation, secretion of soluble factors, and in vivo tumor control in preclinical studies with mixed populations of CD4+ and CD8+ T cells. New single-cell RNA sequencing data presented at the SITC (Free SITC Whitepaper) 2023 Annual Meeting revealed enhanced gene signatures of activation and cytotoxicity in CoStAR-transduced CD4+ T cells, with significant increases in cytotoxic function of these CD4+ T cells in an in vitro cytotoxicity assay. These data suggest that CoStAR is able to endow CD4+ T cells with novel cell-killing capacity, potentially broadening the repertoire of tumor-killing TIL to include CD4+ T cells in addition to naturally cytotoxic CD8+ T cells.

Additionally, CoStAR was demonstrated to enhance the secretion of soluble factors from CD4+ T cells to boost the proliferation and survival of companion CD8+ T cells. As CoStAR provides proliferative benefit to mixed populations of CD4+ and CD8+ T cells, these data demonstrate the importance of CD4+ CoStAR-T cells in supporting the proliferation of CD8+ CoStAR-T cells through the provision of soluble factors.

"The data presented at the SITC (Free SITC Whitepaper) 2023 Annual Meeting reinforce the potential of CoStAR to broadly enhance the function of TIL therapies through multiple functional enhancements," said Bronson Crouch, CEO of Instil.

Posters may be found on the Instil Bio Publications webpage:

POSTER | SITC (Free SITC Whitepaper) ANNUAL MEETING, NOVEMBER 3-5 2023
Single cell RNA sequencing reveals functionally validated signatures of cytotoxicity in anti-FRα CoStimulatory Antigen Receptor (CoStAR) activated CD4+ T cells.

POSTER | SITC (Free SITC Whitepaper) ANNUAL MEETING, NOVEMBER 3-5 2023
Anti-folate receptor alpha (FRα) CoStimulatory Antigen Receptor (CoStAR) drives distinct cytokine-mediated proliferation responses in CD4+ and CD8+ T cells.

IN8bio Presents Biologic Correlative Data from the INB-200 Phase 1 Trial in Newly Diagnosed Glioblastoma at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting

On November 6, 2023 IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, reported new biological correlative data from the ongoing Phase 1 clinical trial of INB-200 targeting newly diagnosed glioblastoma multiforme (GBM) in a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 38th Annual Meeting (Press release, In8bio, NOV 6, 2023, View Source [SID1234637031]).

Chemotherapy has remained a mainstay of solid tumor treatment. Alkylating agents such as temozolomide (TMZ) can directly kill chemotherapy-sensitive GBM cells but can also sensitize chemotherapy resistant tumor cells to immune recognition by upregulating stress-associated NKG2D ligands (NKG2DL) to drive immunogenicity. Unfortunately, the lymphodepleting effects of chemotherapy, such as TMZ, also kills T cells, and prevents an effective immune response to these stress targets. IN8bio’s DeltEx DRI gamma-delta T cells are designed to be resistant to chemotherapy, allowing them to remain functional and be used in combinations to create a strong synergistic tumor cell killing impact.

"Gamma-delta T cells are important in immune responses and their high levels are known to correlate with improved survival outcomes. Efficient immune reconstitution is pivotal for favorable outcomes in cancer patients. This new analysis sheds light on how our DeltEx DRI gamma-delta T cell approach may induce durable persistence and immune responses," said William Ho, Co-founder and CEO. "These important insights will help inform the ongoing development of our DeltEx DRI therapies across a variety of solid and hematological tumors.

These data demonstrate that the lymphodepleting effects of chemotherapy results in a globally suppressed immune system where the DeltEx DRI gamma-delta T cells can strengthen the immune response and potentially broadly eliminate cancer cells. Furthermore, conventional standard-of-care can act as a long-term lymphodepleting agent, an important component for the development of allogeneic and potentially ‘off-the-shelf’ cellular therapies. In June 2023, IN8bio presented positive data from the Phase 1 study of INB-200 in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting. The Company will present updated patient, survival and enrollment data from the study at the Society for Neuro-Oncology (SNO) Annual Meeting taking place November 15-19, 2023.

About INB-200
INB-200 is a genetically modified autologous drug resistant immunotherapy (DRI) product candidate for the treatment of solid tumors. This novel platform utilizes genetic engineering to generate chemotherapy resistant gamma delta T cells which can be administered concurrently with standard-of-care treatment in solid tumors. This is a powerful, synergistic treatment approach enabling gamma-delta T cells to persist in the presence of chemotherapy, and maintain their natural ability to recognize, engage and kill cancer cells.

INB-200 is the first genetically engineered gamma-delta T cell therapy to be administered to patients with solid tumors and our initial indication is in GBM.

Immutep Announces Completion of the Safety Lead-In and Opening of the
Randomized Phase II of the AIPAC-003 Phase II/III Trial in Metastatic Breast Cancer

On November 6, 2023 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported the open-label safety lead-in of its integrated AIPAC-003 Phase II/III trial evaluating for the very first time 90mg of eftilagimod alpha (efti) in combination with paclitaxel has been completed with no safety or tolerability issues (Press release, Immutep, NOV 6, 2023, View Source [SID1234637030]).

Six patients with metastatic breast cancer receiving this immuno-oncology chemotherapy (IO-chemo) combination, after exhaustion of all endocrine/CDK4/6 based therapies, tolerated the therapy very well and there were no dose limiting toxicities, as confirmed by the independent Data Monitoring Committee (IDMC) appointed for the trial. The IDMC recommended proceeding to the randomised Phase II portion of the trial.

The randomised (1:1) Phase II portion of the study will now open to include up to 58 evaluable patients with metastatic breast cancer receiving either 30mg efti or 90mg efti to determine the optimal biological dose. The evaluation of 90mg efti dosing in combination with paclitaxel is driven by efti’s excellent safety profile, along with the FDA’s Project Optimus initiative in oncology. Importantly the determination of the optimal biological dose is relevant for the whole efti program across all disease indications.

The integrated Phase II/III AIPAC-003 trial is evaluating efti, Immutep’s soluble LAG-3 protein and first-in-class MHC Class II agonist, in combination with standard-of-care paclitaxel for the treatment of metastatic hormone receptor positive (HR+), HER2-negative or HER2-low breast cancer and triple-negative breast cancer. It will take place at approximately 17 clinical sites across Europe and the United States of America. For more information on the trial, please visit clinicaltrials.gov (NCT05747794).

About Eftilagimod Alpha (Efti)

Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-g and CXCL10 that further boost the immune system’s ability to fight cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy.

Efti has received Fast Track Designation in 1st line HNSCC and in 1st line NSCLC from the United States Food and Drug Administration (FDA).

Immix Biopharma Presents NXC-201 Data at 65th American Society of Hematology (ASH) Annual Meeting in 9 Relapsed/Refractory AL Amyloidosis Patients

On November 6, 2023 Immix Biopharma, Inc. (Nasdaq:IMMX) ("ImmixBio", "Company", "We" or "Us"), a clinical-stage biopharmaceutical company pioneering personalized therapies for oncology and immunology, reported that additional NXC-201 clinical data in relapsed/refractory AL Amyloidosis has been selected for oral presentation at the upcoming 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting to be held in San Diego, California, December 9-12, 2023 (Press release, Immix Biopharma, NOV 6, 2023, View Source [SID1234637029]).

"NXC-201 is the only CAR-T being studied as a treatment for AL amyloidosis patients who relapsed, or are refractory to, 4-drug combination daratumumab-CyBorD," said Ilya Rachman, MD PhD, Chief Executive Officer of Immix Biopharma. "NXC-201 attacks the root cause of AL Amyloidosis: disease-causing plasma cells, representing a potential one-time treatment option."

"30,000 – 45,000 patients in the United States and Europe are living with AL Amyloidosis, for many of whom there are no additional approved treatment options beyond Dara-CyBorD," said Gabriel Morris, Chief Financial Officer of Immix Biopharma. "We are pleased to present our progress on advancing NXC-201 at the upcoming 65th annual ASH (Free ASH Whitepaper) meeting in San Diego."

ASH Presentation Details (NXC-201 AL Amyloidosis):

Event 65th ASH (Free ASH Whitepaper) Annual Meeting and Exposition, San Diego, CA
Title "Feasibility of a Novel Academic Anti-BCMA Chimeric Antigen Receptor T-Cell (CART) (HBI0101) for the Treatment of Relapsed and Refractory AL Amyloidosis"
Presentation
Date/Time (Pacific Time)
Publication #538
Session Date: Sunday, December 10, 2023
Session Name: 654. MGUS, Amyloidosis and Other Non-Myeloma Plasma Cell Dyscrasias: Clinical and Epidemiological: From Light Chain to Fibril-Novel Diagnostics to Treatments for Amyloidosis
Session Time: 12:00 PM – 1:30 PM PT
Presentation Time: 12:45 PM PT
About NXC-201

NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed/refractory AL amyloidosis and relapsed/refractory multiple myeloma.

About NEXICART-1

NEXICART-1 (NCT04720313) is an ongoing Phase 1b/2a, open-label study evaluating the safety and efficacy of NXC-201 (formerly HBI0101), in adults with relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis.

The primary objective of the Phase 1b portion of the study was to characterize the safety and confirm the recommended Phase 2 dose (RP2D) and Phase 2 dose of NXC-201. The Phase 2 portion of the study will evaluate the efficacy and safety of NXC-201 in relapsed/refractory Multiple Myeloma according to the International Myeloma Working Group (IMWG) Uniform Response Criteria and in relapsed/refractory AL Amyloidosis according to consensus recommendations.

The Phase 1b portion of the ongoing Phase 1b/2a clinical trial has been successful in determining the recommended Phase 2 dose (RP2D) of 800 million CAR+T cells. ImmixBio plans to submit an IND application to the FDA for a Phase 1b/2 of NXC-201 in relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis in order to expand the ongoing clinical trial to the U.S. The expected primary endpoint for the Phase 2 portion of the ongoing Phase 1b/2a clinical trial of NXC-201 in relapsed/refractory multiple myeloma is overall response rate and duration of response. ImmixBio plans to submit data to the FDA in relapsed/refractory multiple myeloma once 100 patients are treated with NXC-201. The expected primary endpoint for NXC-201 in relapsed/refractory AL Amyloidosis is overall response rate. ImmixBio plans to submit data to the FDA in relapsed/refractory AL amyloidosis once 30-40 patients are treated with NXC-201.

About AL Amyloidosis
AL amyloidosis is a rare systemic disorder caused by an abnormality of plasma cells in the bone marrow. Misfolded amyloid proteins produced by these cells cause a buildup of misfolded immunoglobulin proteins in and around tissues, nerves and organs, gradually affecting their function. This can cause progressive and widespread organ damage and high mortality rates.
AL amyloidosis affects roughly 30,000 – 45,000 patients in the U.S. and Europe, and it is estimated that there are approximately 3,000 – 4,000 new cases annually in the U.S. The estimated annual global incidence of AL Amyloidosis is ~15,000 patients. The Amyloidosis market was $3.6 billion in 2017, expected to reach $6 billion in 2025, according to Grand View Research.

Immix Biopharma Presents NXC-201 Data at 65th American Society of Hematology (ASH) Annual Meeting in 63 Relapsed/Refractory Multiple Myeloma Patients

On November 6, 2023 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us"), a clinical-stage biopharmaceutical company pioneering personalized therapies for oncology and immunology, reported that updated NXC-201 relapsed/refractory multiple myeloma clinical data has been selected for presentation at the upcoming 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting to be held in San Diego, California, December 9-12, 2023 (Press release, Immix Biopharma, NOV 6, 2023, View Source [SID1234637028]).

"75% of patients on multiple myeloma CAR-T waiting lists at U.S. hospitals do not receive the CAR-T therapy. As CAR-Ts are expected to be approved for earlier lines of treatment, we believe demand is likely to increase," said Ilya Rachman, MD PhD, Chief Executive Officer of Immix Biopharma. "We are working tirelessly to make NXC-201 an option for these patients waiting for multiple myeloma CAR-Ts."

"Today, only 5% of U.S. hospitals offer multiple myeloma CAR-Ts due to toxicities," said Gabriel Morris, Chief Financial Officer of Immix Biopharma. "Our N-GENIUS technology platform, which we believe overcomes neurotoxicity, aims to allow the remaining 95% of U.S. hospitals, including community hospitals, to offer our CAR-T NXC-201."

ASH Presentation Details (NXC-201 Multiple Myeloma):

Event 65th ASH (Free ASH Whitepaper) Annual Meeting and Exposition, San Diego, CA
Title "Safety and Efficacy of a Locally Produced Novel Anti-BCMA Chimeric Antigen Receptor T-Cell (CART) (HBI0101) for the Treatment of Relapsed and Refractory Multiple Myeloma"
Presentation
Date/Time (Pacific Time)
Publication #4852
Session Date: Monday, December 11, 2023
Session Name: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster III
Session Time: 6:00 PM – 8:00 PM
Presentation Time: San Diego Convention Center, Halls G-H
About NXC-201

About NEXICART-1

About Multiple Myeloma

Multiple myeloma ("MM") is an incurable blood cancer of plasma cells that starts in the bone marrow and is characterized by an excessive proliferation of these cells. Despite initial remission, unfortunately, most patients are likely to relapse. There are 35,730 patients in the United States diagnosed with MM each year. Prognosis for patients who do not respond to or relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents remains poor. The $13.9 billion Multiple Myeloma market in 2017 is expected to reach $28.7 billion in 2027 according to Wilcock, et al. Nature Reviews.