On November 8, 2024 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported preclinical data showing strong anti-cancer activity of its next generation, personalized, off-the-shelf, cell-based breast and prostate cancer immunotherapies, Bria-BRES+ and Bria-PROS+, respectively, during a poster session at the 2024 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting, held November 6-10, 2024, in Houston, TX (Press release, BriaCell Therapeutics, NOV 8, 2024, View Source [SID1234648541]).

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Bria-OTS+ is an Off-The-Shelf (i.e. pre-manufactured and ready for use) cell-based personalized immunotherapy platform for cancer. First generation Bria-OTS immunotherapy is HLA matched to individual patients and expresses a variety of cancer-related antigens, including Tumor-Associated Antigens (TAAs) and Post-Translational Modifications (PTMs). Bria-OTS+ further expresses multiple immune activating cytokines and co-stimulatory molecules in addition to immune boosting granulocyte-macrophage colony-stimulating factor (GM-CSF). The Bria-OTS+ platform technology includes both Bria-BRES+ and Bria-PROS+, expansions of the Bria-OTS program.

"Bria-OTS+ represents a significant advancement in the fight against cancer, leveraging gene-modified allogeneic tumor cells as a comprehensive immunotherapeutic platform. This innovative approach is set to address major challenges in cancer therapy, including effective antigen selection, T-cell immune escape, and manufacturing complexities. The development of Bria-OTS+ builds on the success of BriaCell’s initial platform, Bria-IMT, which has shown promising clinical results in metastatic breast cancer," commented Miguel A. Lopez-Lago, PhD, BriaCell’s Chief Scientific Officer.

"We are thrilled with our pre-clinical data confirming the expected high potency and potential for long-lasting anti-tumor activity of our novel next-generation immunotherapy in multiple cancer models," commented Dr. William V. Williams, BriaCell’s President and CEO. "We believe that activating both adaptive and innate immune systems is a novel and highly effective approach for cancer treatment and look forward to generating proof of concept data in our ongoing Phase 1/2 study of Bria-OTS in metastatic breast cancer, and other cancers."

The poster is summarized below and linked here: View Source

Title: Bria-OTS+: A Cellular Cancer Vaccine Platform Targeting Innate and Adaptive Immunity
Location: Exhibit Halls A B George R. Brown Convention Center, Houston, TX
Date and Time: Friday, Nov. 8, 2024, 9:00 am -7:00 pm CST

Results:

Both Bria-BRES+ (clinical candidate for breast cancer) and Bria-PROS+ (clinical candidate for prostate cancer) activated key components of the innate immune system, the body’s first line of defense against cancer, including Natural Killer (NK) cells and NKT cells in preclinical cancer models.
Activation of the innate immune system by Bria-BRES+ and Bria-PROS+ was mediated by CD86, IL-12, NKG2D and inhibited by HLA class I molecules
Bria-BRES+ and Bria-PROS+ both effectively activated immune cells to destroy breast cancer and prostate cancer cells in a pre-clinical cancer model
Both Bria-BRES+ and Bria-PROS+ activated key adaptive immune responses demonstrating immunological memory and suggesting potent and durable anti-cancer effects in cancer patients
Conclusion:
The characteristics of the next generation Bria-OTS+ immunotherapy platform include the following:

Engages multiple facets of the adaptive immune response
Activates components of the innate immune system
Specifically activates Natural Killer (NK) cells to offset cancer immune escape caused by the loss of human leukocyte antigens (HLA)
Designed for both personalized and ready-to-use therapy with long-term stability
Simplified intradermal administration (injection into the skin)
Targeted mechanism of action expected drive high efficacy with a favorable side effect profile
"The preclinical data demonstrating targeted activation of both the innate and adaptive immune systems suggest potential efficacy and safety across multiple cancer indications," stated Adam M. Brufsky, MD, PhD, FACP, Professor of Medicine at the University of Pittsburgh School of Medicine and Medical Director of the Magee-Women’s Cancer Program. "Personalized off-the-shelf cancer immunotherapy is an especially exciting treatment modality that would benefit many cancer patients."

BriaCell is currently conducting its Phase 1/2 Study of Bria-OTS (first generation product), also known as Bria-BRES, in metastatic breast cancer (listed on ClinicalTrials.gov as NCT06471673).This is a bucket trial with other cancer indications expected to be added soon. The next generation (Bria-OTS+) is expected to enter the clinic in 1H2025 starting with Bria-PROS+ for prostate cancer.

Bria-OTS+ leverages advanced biomanufacturing techniques, ensuring scalability and cost-effectiveness, crucial for rapid global deployment. It is designed to target a range of cancer types and strong intellectual property strategy protects Bria-OTS+ innovations and strengthens BriaCell’s competitive position. Bria-OTS+ is designed as an open-ended, modular platform, allowing for continuous refinement and the addition of new components. This flexibility enables BriaCell to rapidly adapt to emerging scientific insights and therapeutic needs, ensuring long-term relevance and effectiveness.

On November 8, 2024 Amgen reported the company will present at the 2024 UBS Global Healthcare Conference at 10:15 a.m. PT on Wednesday, Nov. 13, 2024 (Press release, Amgen, NOV 8, 2024, View Source [SID1234648018]). Peter Griffith, executive vice president and chief financial officer at Amgen, will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On November 8, 2024 Medigene AG (Medigene or the "Company", FSE: MDG1, Prime Standard), an oncology platform company focused on the research and development of T cell receptor (TCR)-guided therapies for the treatment of cancer, reported recent advances in its proprietary End-to-End Platform to create optimal safe, sensitive, and specific (3S) T cell receptors that can be applied in various modalities, including therapies utilizing T cell receptor engineered T (TCR-T) cells, TCR-guided T cell engagers (TCR-TCEs) and TCR-natural killer cell therapies (TCR-NK) at the Cell 2024 Conference by Oxford Global taking place in London, UK from November 6-8, 2024 (Press release, MediGene, NOV 8, 2024, View Source [SID1234648038]).

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Data presented and discussed included

Kirsty Crame, MD, participated in the panel "Exploring Autologous vs. Allogeneic Therapies." which covered clinical insights, patient considerations, key immunological factors, and manufacturing challenges associated with each therapeutic approach.
Kirsty Crame, MD, held the keynote address "Making the Ordinary Extraordinary: MDG1015 A Clinic Ready 3rd Generation TCR-T Therapy" providing a comprehensive overview of MDG1015. MDG1015 is a first-in-class, 3rd generation T cell receptor engineered T cell (TCR-T) therapy targeting NY-ESO-1 / LAGE-1a, a well-recognized and validated cancer-testis antigen, which is expressed in multiple tumor types. MDG1015 received IND approval in Q3 2024 and is on track for CTA filing in Q4 2024.
Prof. Dolores Schendel presented the "TCR-T Platform for Solid Tumors" covering Medigene’s End-to-End Platform offering advanced technologies for developing 3S TCRs that can be utilized across multiple modalities. Precision tools enabling selection of 3S TCRs with high specificity, sensitivity, and safety for accurate tumor targeting were presented. Additionally, armoring and enhancement technologies were showcased which empower TCR-T cells to perform optimally within the challenging microenvironments of solid tumors. Furthermore, innovative tagging and tracing tools were highlighted, enabling seamless tracking of 3S TCRs throughout all phases of research and clinical development.
The presentations will be available on Medigene’s website: View Source

"Among other factors, the success of TCR-guided therapies for solid tumors hinges on several key innovations: developing optimal TCRs that are safe, sensitive, and specific; enhancing engineered cells to overcome the tumor microenvironment; and refining manufacturing strategies for optimized drug composition and timely patient delivery," said Dolores Schendel, Medigene’s Chief Scientific Officer. "Our E2E Platform addresses each of these critical areas, positioning us to deliver optimal 3S TCRs that can be utilized in multiple therapeutic modalities, such as TCR-T therapies, TCR-TCEs and TCR-NK cell therapies. This approach of developing different TCR-guided therapies enables us to provide innovative treatment options tailored to patients across various indications, disease stages, and specific individual needs."

On November 8, 2024 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that new preclinical data supporting the clinical development of its proprietary next generation antibody-drug conjugate (ADC) and innovative tetra-specific ANKET will be presented at the SITC (Free SITC Whitepaper) Annual Meeting 2024 (Press release, Innate Pharma, NOV 8, 2024, View Source [SID1234648054]).

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"We are thrilled to share our latest preclinical data at the SITC (Free SITC Whitepaper) Annual Meeting, highlighting the potential of IPH6501, our tetra-specific NK cell engager and IPH4502, our innovative ADC targeting Nectin-4. These findings underscore our commitment to advancing next-generation immunotherapies and reflect significant progress in the development of our drug candidates. We look forward to engaging with the scientific community as we continue to push the boundaries of next generation immunotherapies," commented Pr. Eric Vivier, Chief Scientific Officer of Innate Pharma.

Details of the presentations

Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting | 6-10 November, Houston, Texas and Virtual

Harnessing NK Cells in Cancer Therapies
Session 107d: NK Cells and Innate Immunity
Presentation Type: Oral Presentation
Session Date and Time: Friday, Nov. 8, 2024, 3:50-5:25pm CST
Presentation Time: 4:35pm CST
Speaker: Eric Vivier, Chief Scientific Officer, Innate Pharma (co-chair of the session)
Preclinical Characterization of IPH6501: A Novel IL2v-Armed Tetraspecific NK Cell Engager Targeting CD20 in Relapsed or Refractory B cell Non-Hodgkin Lymphoma Subtypes and Post-CAR-T Therapy.
Abstract Number: 1083
Presentation Type: Poster Presentation
Primary Category: Immuno-Conjugates and Chimeric Molecules
Poster Presentation Day: Friday, Nov. 8, 2024
IPH45, a next-generation antibody-drug conjugate (ADC) targeting Nectin-4
Abstract Number: 1056
Presentation Type: Poster Presentation
Primary Category: Immuno-Conjugates and Chimeric Molecules
Poster Presentation Day: Saturday, Nov. 9, 2024
More information can be found on the JITC website.

Protein & Antibody Engineering Summit (PEGS) Europe | November 5-7, Barcelona, Spain and virtual

In addition, the presentation entitled « A Next-Generation ADC for Nectin-4 Expressing Tumours: Preclinical Characterisation of IPH45, a Novel and Differentiated Exatecan-Based ADC Targeting Nectin-4 » was presented at the PEGS Europe Summit. The presentation is available on the Company website, in the publications section.

About IPH4502

IPH4502 is a novel topoisomerase I inhibitor Antibody Drug Conjugate (ADC) conjugated to exatecan targeting Nectin-4.

Nectin-4 is a cell membrane adhesion protein overexpressed in several solid tumors, including urothelial, breast, lung, ovarian, and pancreatic cancers, with limited expression in normal tissues.

In non-clinical models, IPH4502 is well tolerated and shows anti-tumor efficacy in vitro and in vivo.

In September 2024, the U.S Food and Drug Administration cleared Innate’s investigational new drug (IND) application to initiate a Phase 1 clinical study of IPH4502 in Nectin-4 expressing solid tumor indications.

About IPH6501

IPH6501 is the first Antibody-based NK cell Engager Therapeutic to co-engage activating receptors on NK cells (NKp46 and CD16), IL-2R (but not a subunit) through a variant of human IL-2, and a tumor antigen (CD20) via a single molecule, hence providing proliferation and activation signals targeted to NK cells and promoting their cytotoxic activity against CD20 expressing malignant cells.

IPH6501 has shown better anti-tumor efficacy than approved benchmark antibodies in preclinical tumor models (Demaria, EHA (Free EHA Whitepaper) 2023).

IPH6501 is currently being evaluated in a Phase 1/2 multicenter trial (NCT06088654), investigating the safety and tolerability of IPH6501 in patients with Relapsed and/or Refractory CD20-expressing B-cell Non-Hodgkin’s Lymphoma.

On November 8, 2024 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported a presentation of new, updated positive data from the Phase 1 clinical trial of its breast cancer vaccine (NCT04674306) at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting, being held in Houston, Texas (Press release, Anixa Biosciences, NOV 8, 2024, View Source [SID1234648019]). The trial is being conducted in collaboration with Cleveland Clinic with funding by a grant from the U.S. Department of Defense. The presentation, titled "Phase I Trial of alpha-lactalbumin vaccine in high-risk operable triple negative breast cancer (TNBC) and patients at high genetic risk for TNBC," was presented by Dr. Emily Rhoades, FDA/IND Trial Program Manager at Cleveland Clinic.

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"Triple negative breast cancer is the form of the disease for which we have the least effective treatments," said G. Thomas Budd, M.D. of Cleveland Clinic’s Cancer Institute and principal investigator of the Phase 1 study. "Long term, we are hoping that this can be a true preventive vaccine that would be administered to individuals who are cancer-free to prevent them from developing this highly aggressive disease."

"We are pleased with the data we have observed in this clinical trial. The data continues to exceed our expectations. As we near completion of the Phase 1 trial, with the very positive data to date, we are planning a Phase 2 study which is expected to commence in 2025," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "We want to thank all of the participants in this trial and also the extensive group of scientists and physicians (19 are listed as co-authors of the SITC (Free SITC Whitepaper) presentation) who have worked on this study, along with the numerous additional personnel including nurses, pharmacists, phlebotomists and others who have provided support."

The investigational vaccine is based on decades of groundbreaking pre-clinical research led by the late Vincent Tuohy, Ph.D., who was the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research at Cleveland Clinic’s Lerner Research Institute. Dr. Tuohy’s research led to the development of this investigational vaccine. The study is based on Dr. Tuohy’s research that showed that activating the immune system against α-lactalbumin was safe and effective in preventing breast tumors in mice. The research, originally published in Nature Medicine, was funded in part by philanthropic gifts to Cleveland Clinic from more than 20,000 people over the last 12 years.

The vaccine was developed at Cleveland Clinic and licensed to Anixa Biosciences. Cleveland Clinic is entitled to royalties and other commercialization revenues from the Company.

"It was Dr. Tuohy’s hope that this vaccine would demonstrate the potential of immunization as a new way to control breast cancer, and that a similar approach could someday be applied to other types of malignancy," said Dr. Budd.

Description of the Breast Cancer Vaccine

The vaccine targets a lactation protein, α-lactalbumin, which is only expressed in the breast when a woman is lactating but not at other times in her life or in other tissues. However, when a woman develops breast cancer, including TNBC or other types of breast cancer, many of the malignant cells will express α-lactalbumin. Activating the immune system, through vaccination, to direct cytotoxic T cells to the tumor cell expressing this protein may provide preemptive immune protection against emerging breast tumors that express α-lactalbumin.

Initial Phase 1 data was presented at the San Antonio Breast Cancer Symposium in December 2023. The synopsis below summarizes the additional findings which were presented today at the SITC (Free SITC Whitepaper) 39th Annual Meeting.

Presentation Summary

The trial is recruiting patients into three cohorts. Below is a description of each cohort as well as a summary of the key results and conclusions to date.

Cohort 1a participants: The patients enrolled are women who, within the previous three years, have completed standard of care (SOC) treatment, including surgery, for TNBC, the most lethal type of breast cancer. The study is evaluating the safety and tolerability of the vaccine, characterizing immune responses, and identifying a maximum tolerated dose (MTD).

Key Results: All three goals noted above have been achieved, in a group of 21 patients in this cohort. While the MTD has been successfully identified, additional dosages are being evaluated to confirm the MTD. In all patients at the current MTD, the vaccine was safe, producing no flu-like symptoms such as fever and myalgias, no abnormal clinical laboratory tests, or other observed adverse side effects. The only notable side effect was injection site irritation. The majority of patients exhibited protocol defined immune responses of α-lactalbumin specific T cell induced interferon gamma and interleukin-17.

Cohort 1b participants: The patients enrolled are women who carry mutations in their BRCA1, BRCA2, or PALB2 genes that place them at high risk of developing breast cancer, which is frequently TNBC. These women have chosen to have prophylactic mastectomies to reduce their risk of breast cancer. These participants were vaccinated prior to their surgeries, after which they were monitored for safety and immune responses. Immunohistochemistry (IHC) analysis will be performed on their resected breast tissue to evaluate their healthy breast tissue to determine if there are micro-foci of lactational cells, inflammation in the area of those foci and the presence of micro-tumors.

Key Results: Three women have been enrolled in this cohort to date. The safety and tolerability of the vaccine were similar to that in Cohort 1a. Enrollment of additional patients in this cohort is ongoing. The IHC analysis is ongoing and will be presented in a future scientific presentation.

Cohort 1c participants: The patients enrolled in this group are women diagnosed with TNBC who have completed SOC, including surgery, and are receiving pembrolizumab (Keytruda) in the adjuvant, post-surgery setting. Since Keytruda, a checkpoint inhibitor, is already a powerful immunotherapy with its own side effect profile, one of the primary goals of this cohort is to evaluate whether the administration of the vaccine in combination with Keytruda causes intolerable side effects. Immune responses are also being monitored in these participants.

Key Results: Three women have been enrolled in this cohort to date. Most notably, there were no major adverse side effects when the combination of vaccine and Keytruda were administered. As with the patients in cohorts 1a and 1b, the primary adverse side effect was injection site irritation. One patient exhibited a Grade 3 adverse event, which was a greater amount of irritation at one injection site. This patient had been diagnosed with breast cancer while she was pregnant, and she had recently lactated when the vaccine was administered. The trial protocol is being amended to provide for a six-month delay after lactation before a patient can be vaccinated. Similar to the patients enrolled in cohort 1a, the participants in this trial also exhibited antigen-specific T cell immune responses as hoped. Now that antigen-specific T cell responses have been confirmed in women receiving Keytruda and the vaccine, with no major side effects, the data provide the confidence to plan a Phase 2 study in the neoadjuvant setting with newly diagnosed breast cancer patients.

"Since the trial results to date have been very positive, the planned Phase 2 trial will enroll newly diagnosed breast cancer patients undergoing neoadjuvant treatment. Patients will be randomized in a one-to-one ratio, to receive either the standard of care, as defined by NCCN guidelines, alone or the vaccine plus standard of care. The important endpoints in this study will include characterization of T and B cell immune responses and repertoires, pathologic complete response and safety. Utilizing the vaccine in this type of setting will enable us to determine the effect within months for individual patients. The presence of a control group will allow us to determine efficacy in this setting. Assuming the trial data continues to be positive, such a trial may enable a quicker route to a strategic relationship with a large pharmaceutical partner for commercialization," stated Dr. Kumar.

The poster presented at SITC (Free SITC Whitepaper) can be viewed at View Source

For more information and eligibility requirements visit clinicaltrials.gov.