On November 8, 2024 Intensity Therapeutics, Inc. (Nasdaq: INTS), ("Intensity" or "the Company") a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumorally injected cancer therapies intended to kill tumors directly and increase immune system recognition of cancers, reported that its Phase 3 trial has been selected for an oral podium presentation at the 2024 Connective Tissue Oncology Society (CTOS) on November 16, 2024 (Press release, Intensity Therapeutics, NOV 8, 2024, View Source [SID1234648044]). Dr. Christian F. Meyer MD, Ph.D will be making the oral presentation highlighting completed Phase 2 results and the INVINCIBLE-3 (Phase 3) randomized soft tissue sarcoma trial design and important study criteria. The annual CTOS conference runs from November 13 to 16, 2024 in San Diego at the Grand Hyatt.

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Presentation Details
Session 11: Trials in Progress/Late Breaking Trials
Moderator: Palma Dileo, MD (she/her/hers) – University College London Hospitals NHS Foundation Trust
Moderator: Steven I. Robinson, M.B.B.S. (he/him/his) – Mayo Clinic
Paper 78 – A MULTICENTER, RANDOMIZED, PHASE 3 STUDY OF INTRATUMORAL INT230-6 (SHAO, VINBLASTINE, CISPLATIN) COMPARED TO STANDARD OF CARE THERAPY IN SELECTED METASTATIC SOFT TISSUE SARCOMAS: INVINCIBLE-3 TRIAL.
Date: Saturday, November 16, 2024
Time: 9:00 AM PST
Location: Harbor Ballroom
Author: Albiruni Abdul Razak, MB BCh, BAO, LRCP & SI – Toronto Sarcoma Program, Princess Margaret Cancer Center
Presenter: Christian F. Meyer, MD PhD (he/him/his) – Johns Hopkins University

On November 8, 2024 HUYABIO International reported it will present the final analysis of data from a phase 2 study evaluating HBI-8000 in combination with nivolumab (anti-PD1 therapy), a novel combination for the treatment of advanced and metastatic melanoma (Press release, HUYA Bioscience, NOV 8, 2024, View Source [SID1234648449]).

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The results will be presented by Study Chair, Dr. Nikhil Khushalani, Senior Member and Vice Chair, Department of Cutaneous Oncology from Moffitt Cancer Center, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2024 Annual Meeting on Saturday, November 9.

HBI-8000, an oral drug, when combined with nivolumab has shown encouraging efficacy signals in treating patients with advanced and metastatic melanoma. This innovative therapy has clinically meaningful advantages over traditional double immune checkpoint inhibitor combinations, offering patients an oral treatment in combination with nivolumab that has enhanced efficacy and reduced toxicities.

"The promising results from the HBI-8000 and nivolumab combination represent a significant advancement in treating advanced melanoma," said Dr. Mireille Gillings, President, CEO & Executive Chair at HUYABIO. "Coupling oral convenience with a reduction in immune-related toxicities will give clinicians new tools to improve patient outcomes. We are proud to contribute to this new era of immunotherapy that prioritizes both efficacy and patient well-being."

"We are pleased to share the final Phase 2 results of the HBI-8000 and nivolumab combination in patients with advanced melanoma at this year’s SITC (Free SITC Whitepaper) conference," said Dr Nikhil Khushalani. "The combination appears safe and effective in this Phase 2 study, which may show great promise in this patient population. HBI-8000 plus nivolumab could be an important addition to the armamentarium of oncologists treating this disease and is currently being investigated in a Phase 3 study."

Title: HBI-8000, a class I histone deacetylase (HDAC) inhibitor, in combination with nivolumab for treatment of anti-PD(L)1-naive advanced melanoma: final analysis of Study HBI-8000-302

Abstract Number: 620

Authors: Nikhil I. Khushalani1 (Presenter), Andrew Brohl1, Joseph Markowitz1, Heather Yeckes-Rodin2, Lori McCormick1, Charlie Liu3, Mireille Gillings3, Gloria Lee3, and Zeynep Eroglu1 1H. Lee Moffitt Cancer Center, Tampa FL, 2Hematology-Oncology Associates of the Treasure Coast, Port. St. Lucie, FL, 3HUYABIO International, San Diego, CA, USA

Oral Presentation Date and Time: Saturday, November 9th at 3:44 PM CST

Addressing the Unmet Need for Innovative Melanoma Therapies

The combination of HBI-8000 and nivolumab represents a significant advancement in melanoma treatment. As the first combination therapy that does not rely on dual immune checkpoint inhibitors, it presents a desirable option for community practices and specialty cancer centers, particularly in regions with limited technical support. This therapy can potentially expand combination therapy for melanoma containing nivolumab-backbone beyond established markets in the U.S. and EU, providing access to more patients worldwide.

About the HBI-8000 Phase 2 Trial

The trial was a Phase 1b/2 trial evaluating the combination of HBI 8000 with nivolumab (an anti-PD1 immune checkpoint inhibitor) in advanced melanoma, kidney cancer and non-small cell lung cancer. The recommended Phase 2 dose of HBI-8000 was determined to be 30mg orally twice weekly (BIW) combined with intravenous nivolumab administered at the manufacturer’s approved dosing schedule. Patients with metastatic melanoma not previously treated with anti-PD(L)-1 inhibitor, with measurable disease, ECOG performance status 0-1, and adequate hematologic and biochemical parameters were enrolled. Previously treated stable brain metastases not requiring steroids were permitted. Disease status was assessed by standard imaging using RECIST v1.1 every 8 weeks. Treatment was continued until disease progression, unacceptable toxicity or completion of 24 months of therapy. View Source

On November 8, 2024 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, reported its financial results for the fiscal quarter ended September 30, 2024 and provided an update on recent developments (Press release, IGM Biosciences, NOV 8, 2024, View Source [SID1234648025]).

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"The third quarter was transformative for IGM, punctuated by the announcement of our strategic pivot to focus exclusively on autoimmunity," said Mary Beth Harler, M.D., Chief Executive Officer of IGM Biosciences. "Our near-term focus for imvotamab remains generating robust initial data sets in rheumatoid arthritis, systemic lupus erythematosus and myositis. Based on enrollment timing, we expect to have sufficient information by the middle of 2025 to present initial imvotamab data at an appropriate venue as well as determine next steps to advance imvotamab in autoimmune indications."

Pipeline Updates

Imvotamab (CD20 x CD3 T cell engager)

•Clinical development of imvotamab in autoimmune diseases advances, with initial clinical data disclosure expected by mid-2025.
•
hird dose cohort in rheumatoid arthritis successfully completed. The Company has cleared the third dose cohort of its placebo-controlled clinical study testing imvotamab in severe rheumatoid arthritis.
•Enrollment in second dose cohort in systemic lupus erythematosus ongoing. The Company has cleared the first dose cohort of its open-label clinical study testing imvotamab in severe systemic lupus erythematosus (SLE) and is currently enrolling patients in a second dose cohort.
•First patient dosed in myositis. The Company has dosed the first patient in its single arm, open-label clinical study testing imvotamab in moderate-severe idiopathic inflammatory myopathies (myositis). Enrollment is ongoing in this study, which is being conducted in collaboration with Stanford University.
•Imvotamab preclinical data selected for poster presentation at ACR Convergence 2024. The Company will present a poster titled "Imvotamab, a CD20-Targeted Bispecific IgM T Cell Engager, Effectively Depletes Low-Expressing CD20+ B Cells in Preclinical Models of Autoimmune Disease" at the American College of Rheumatology’s annual meeting, ACR Convergence 2024, taking place in Washington, D.C., on November 17, 2024.
IGM-2644 (CD38 x CD3 T cell engager)

•Clinical development of IGM-2644 in autoimmune diseases to be initiated. The Company continues to make significant progress towards initiating clinical development of IGM-2644, a CD38 x CD3 T cell engager antibody, in the
treatment of autoimmune diseases. The Company expects to enter IGM-2644 into a single arm, open-label clinical study for generalized myasthenia gravis (gMG) by the end of 2024.
Corporate Updates

•Peer-reviewed article titled "Cutting-edge Approaches to B-cell Depletion in Autoimmune Diseases" published in Frontiers in Immunology. IGM co-authored this article with Bill Robinson, M.D., Ph.D., et al. and the article can be found online here. Dr. Robinson is Chief of the Division of Immunology and Rheumatology at Stanford University.
•Eric Humke, M.D., Ph.D., Senior Vice President, appointed as Head of Clinical Research and Development. Dr. Humke joined IGM in 2019 as Vice President, Clinical Development. Prior to IGM, he spent eight years at Genentech, most recently serving as Senior Medical Director, where he led the early clinical development of multiple first-in-human therapeutics. Prior to joining Genentech, he was an Instructor of Medicine at the Stanford University School of Medicine, where he conducted basic science research and cared for patients.
Third Quarter 2024 Financial Results

•Cash and Investments: Cash and investments as of September 30, 2024 were $218.8 million, compared to $337.7 million as of December 31, 2023.
•Collaboration Revenue: For the third quarter of 2024, collaboration revenues were $0.5 million, compared to $0.5 million for the third quarter of 2023.
•Research and Development (R&D) Expenses: For the third quarter of 2024, R&D expenses were $46.1 million, compared to $54.8 million for the third quarter of 2023. R&D expenses for the third quarter of 2024 included $5.5 million in one-time expenses related to the strategic pivot to focus exclusively on autoimmunity.
•General and Administrative (G&A) Expenses: For the third quarter of 2024, G&A expenses were $18.8 million, compared to $12.5 million for the third quarter of 2023. G&A expenses for the third quarter of 2024 included $8.5 million in one-time expenses related to the strategic pivot to focus exclusively on autoimmunity.
•Net Loss: For the third quarter of 2024, net loss was $61.4 million, or a loss of $1.01 per share, compared to a net loss of $62.0 million, or a loss of $1.04 per share, for the third quarter of 2023.

2024 Financial Guidance

The Company expects full year 2024 GAAP operating expenses of $215 million to $225 million including estimated non-cash stock-based compensation expense of approximately $40 million, and full year collaboration revenue of approximately $2 million related to the Sanofi agreement. The Company expects to end 2024 with a balance of approximately $180 million in cash and investments and for the balance to enable it to fund its operating expenses and capital expenditure requirements into 2027.

On November 8, 2024 Nammi Therapeutics, Inc. (Nammi), a clinical stage immuno-oncology company with a diverse pipeline created with the Masked-Immunocytokine (MIC) and Nammisome platforms, reported dosing of the first patient in the first in human Phase 1 trial (NCT06582017) (Press release, Nammi Therapeutics, NOV 8, 2024, View Source [SID1234648045]).

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The Phase 1 study is a two-part, open-label multi-center study that is expected to enroll approximately 100 patients with advanced CD138-expressing cancers. Part A of the study will evaluate the safety and tolerability of escalating doses of QXL138AM, with secondary endpoints assessing pharmacokinetics and immunogenicity. Part B of the study will involve dose expansion in three cohorts (two solid tumor indications with high CD138 prevalence and multiple myeloma) with primary endpoints focused on safety and tolerability and secondary endpoints assessing anti-tumor activity. The Company will conduct the Phase 1 study at investigator sites across the United States.

While the two solid tumor indications for expansion have not yet been determined, QXL138AM has been granted Orphan Drug Designation in Pancreatic Cancer. Other factors, including prevalence of CD138 expression, preclinical efficacy, previous reports on clinical efficacy with approved Interferon alfa therapeutics, the extent of unmet need, and Nammi’s clinical experience in Part A will also be used to determine the solid tumor indications for expansion.

"Interferon alpha 2 is a potent anti-cancer therapeutic, but its clinical benefit is limited by significant toxicity when administered systematically. QXL138AM utilizes Nammi’s masked immunocytokine technology, whereby the interferon alpha 2 is masked and fused to a tumor-targeting antibody. The antibody anchors QXL138AM on the surface of tumor cells where proteases can remove the mask thereby activating the Interferon alpha 2, facilitating a wider therapeutic window," said Dr. Dennis Kim, M.D., chief medical officer for the study.

"We’re very excited to have dosed the first patient with QXL138AM here at START," stated Dr. Drew W. Rasco, Associate Director at The START Center for Cancer Research in San Antonio, TX. "We believe that there is significant potential with Nammi’s immunocytokine technology in the treatment of multiple cancer types, and we look forward to working with the Nammi team to develop this new therapy over the coming years."

On November 7, 2024 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and NEC Corporation (NEC; TSE: 6701), a leader in IT, network and AI technologies, reported 24.1 month median follow-up data from the ongoing randomized Phase I trial of TG4050 in the adjuvant treatment of head and neck cancers (Press release, NEC, NOV 8, 2024, View Source [SID1234647967]). The data will be presented in a poster at the Society for ImmunoTherapy of Cancer (SITC) (Free SITC Whitepaper) 2024 Annual Meeting, November 9.

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TG4050 is an individualized immunotherapy being developed for solid tumors that is based on Transgene’s myvac platform and powered by NEC’s cutting-edge AI capabilities designed to optimize antigen selection.

After a median follow up of 24.1 months, all 16 patients who received TG4050 as adjuvant immunotherapy after completion of an adjuvant standard of care remain disease-free and have not relapsed. Out of the 16 patients in the control observation arm, 3 patients have relapsed. There remains a high medical need for these head and neck cancer patients, as approximately 30% of them are expected to experience a relapse within 24 months after standard surgery and adjuvant chemoradiotherapy.

Immune responses targeting selected neoantigens were identified in 100% of patients who received TG4050, demonstrating the strong immunogenicity of the cancer vaccine, with both de novo and amplified responses. An analysis over 7 months also shows that immune responses are sustained, during the induction and boost periods.

All treatment-related adverse events continue to be mild to moderate.

Pr. Le Tourneau, Head of the Department of Drug Development and Innovation (D3i) at Institut Curie, and Principal Investigator, said: "It is highly encouraging to see confirmation of TG4050’s clinical and immune response data after a median follow-up of 24.1-months. There remains a significant unmet need in head and neck cancer patients in the adjuvant setting. TG4050 has demonstrated its potential to prime an adaptive immune response against tumor antigens and prevent relapse in patients with locally advanced resected head and neck squamous cell carcinoma."

Dr. Emmanuelle Dochy, Chief Medical Officer of Transgene, added: "We are very encouraged to observe that all the patients treated with our neoantigen cancer vaccine TG4050 remain disease-free after a median follow-up of 24.1 months. Looking at these results and at the long-lasting immune response, we are confident that TG4050 has the potential to benefit these patients, who still face a significant risk of relapse with current therapies. A Phase II part of our trial is currently enrolling patients internationally, with the aim of further confirming these promising findings."

Motoo Nishihara, Corporate EVP, and CTO, at NEC, added: "These results illustrate the power of our collaboration with Transgene and our ability to develop a personalized approach to cancer patient treatment using our proprietary artificial intelligence and machine learning models. We have built a strong and compelling clinical data set to support the benefits of TG4050 as an individualized immunotherapy, and we remain committed to bringing novel AI-based treatments to patients across the globe."

The SITC (Free SITC Whitepaper) poster can be viewed in-person during the poster presentation at the new windowSITC 2024 meeting and can be accessed on PDFTransgene’s website on November 9.

Building on these promising data, the randomized Phase I trial has been expanded to a randomized Phase I/II trial in the adjuvant setting of head and neck cancer (new windowNCT04183166), which is currently enrolling patients in a Phase II part.

Poster details

Abstract Number: 650
Title: Randomized phase I trial of adjuvant individualized TG4050 vaccine in patients with locally advanced resected HPV-negative head and neck squamous cell carcinoma (HNSCC)
Presenting Author: C. Le Tourneau – Institut Curie
Poster Presentation Day: November 9