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 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 Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, reported the "Preclinical Development of 7MW4811, an Mtoxin (MF6)-based Antibody-drug Conjugate for the Treatment of Solid Tumors" as a poster presentation at the 15th World ADC San Diego, held from Nov. 4 to 7, 2024 (Press release, Mabwell Biotech, NOV 8, 2024, View Source [SID1234648043]). The post revealed compelling data from the studies on the efficacy of 7MW4811 in treating solid tumors.

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7MW4811 is developed with Mabwell’s next-generation ADC technology (IDDC) platform, and has demonstrated encouraging anti-tumor effects across a range of solid tumors, including lung, colorectal, pancreatic and gastric cancers. Notably, it has shown promising therapeutic potentials in gastrointestinal tumors.

IDDC is a clinically validated site-specific conjugation technology that has been instrumental in the development of ADCs with good homogeneity, efficacy, and safety profiles. Coupled with the novel payload Mtoxin (MF6), these ADCs have been furthered optimized, exhibiting enhanced pharmacodynamics, bystander killing efficacy, and anti-multidrug resistance capabilities.

On November 8, 2024 Lunit (KRX:328130.KQ), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, reported groundbreaking research findings demonstrating the potential of its AI to predict immunotherapy treatment outcomes in rare tumors (Press release, Lunit, NOV 8, 2024, View Source [SID1234648042]). Conducted in collaboration with The University of Texas MD Anderson Cancer Center, this study will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2024 Annual Meeting, held November 6-10 in Houston, Texas. Accepted as a Rapid Oral presentation, the study will be presented by Mohamed Derbala, M.D., a research scientist at MD Anderson. It has also been selected as one of the SITC (Free SITC Whitepaper) TOP 100 abstracts, underscoring its potential significance and impact in the field of immunotherapy.

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Immunotherapy, particularly immune checkpoint inhibitors like pembrolizumab, has emerged as a revolutionary treatment option for cancer patients. However, not all patients respond equally to this treatment, and predicting who will benefit most has been a significant challenge, especially in rare tumor types where treatment options and research data are limited.

Led by principal investigator Dr. Aung Naing, professor of Investigational Cancer Therapeutics at MD Anderson, the research utilized Lunit’s AI-powered whole-slide image analyzer, Lunit SCOPE IO, to assess tumor microenvironment characteristics in both pre-treatment and on-treatment biopsies from patients with rare tumors receiving pembrolizumab. The study analyzed over 500 slides across more than 10 different rare tumor types.

The findings indicate that Lunit SCOPE IO could effectively identify specific patterns in tumor samples that correlate with better treatment outcomes. The research showed that patients whose tumor samples displayed AI-detected changes in both intratumoral immune cell (intratumoral tumor-infiltrating lymphocyte; iTIL) presence and tumor content, were significantly more likely to have better treatment outcomes positively to immunotherapy treatment.

Key findings from the study include:

In certain tumor types, patients with higher pre-treatment iTIL density showed a 51% lower risk of disease progression or death (improved progression-free survival, PFS; HR: 0.49)
Patients who had greater iTIL density increase at on-treatment biopsy showed a 35% lower risk of disease progression or death (HR: 0.65) and a 41% lower risk of death (improved overall survival, OS; HR: 0.59)
Patients with greater tumor content decrease at on-treatment biopsy had a 49% lower risk of disease progression or death (HR: 0.51) and a 46% lower risk of death (HR: 0.54)
Most notably, patients who experienced both a greater iTIL density increase and tumor content decrease showed dramatically improved outcomes:
68% lower risk of disease progression or death
72% lower risk of death
"These findings highlight how our AI technology can provide deep insights into the unique and challenging tumor microenvironment seen in rare cancers, and represent a critical advancement in our understanding of rare tumor biology," said Brandon Suh, CEO of Lunit. "This study has demonstrated the value of Lunit SCOPE IO in an important clinical setting, showcasing its potential to personalize treatment for patients who have limited therapeutic options. We believe these advancements are a testament to the transformative impact AI can have on oncology and patient outcomes."

By expanding the capabilities of Lunit SCOPE IO, Lunit aims to continue partnering with leading cancer research institutions to deliver innovative and meaningful solutions for patients with limited treatment options, ultimately transforming cancer care.

For more details about the study and its findings, please visit Lunit’s booth #317 at the SITC (Free SITC Whitepaper) 2024 Annual Meeting.

Abstract #1207, "Artificial Intelligence-powered assessment of tumor microenvironment in pre-treatment and on-treatment biopsies informs treatment outcomes to pembrolizumab in patients with rare tumors." (Nov.9, 1:08 p.m., George R. Brown Convention Center – Level 3 – Grand Ballroom C)

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 [SID1234648041]).

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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.
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