On September 27, 2023 Harpoon Therapeutics, Inc. (NASDAQ: HARP), a clinical-stage immunotherapy company developing novel T cell engagers, reported the presentation of interim data for the 2.15 to 12 mg target dose cohorts from its Phase 1 clinical trial evaluating single-agent HPN217 in relapsed/refractory multiple myeloma (RRMM) (Press release, Harpoon Therapeutics, SEP 27, 2023, View Source [SID1234635468]). HPN217 targets B-cell maturation antigen (BCMA) and is based on Harpoon’s proprietary Tri-specific T cell Activating Construct (TriTAC) platform designed to recruit a patient’s immune cells to kill tumor cells. The data will be presented at the 20th International Myeloma Society (IMS) Annual Meeting in a poster presentation on September 28, 2023 in Athens, Greece.

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As of the data cut-off on August 12, 2023, 97 patients were treated with HPN217 across 14 dose escalation cohorts. The trial enrolled heavily pre-treated patients, of whom 65% were penta-drug exposed and 20% had been treated with BCMA-targeted agents.

In patients at the 12 mg target dose (N=19), a manageable tolerability profile was observed with low rates of CRS (16%, all G1-2) and no ICANS. Additionally, robust, early clinical activity (63% ORR) was seen. Treatment remains ongoing in 7 responders, while the median responder time on treatment continues to mature, currently 8.3 months (6.0-17.3+).

For the earlier 2.15 mg to 6 mg target dose cohorts, the median responder time on treatment was 21.8 months (10.4-27.5+), with several remaining on treatment with a sustained response.

"The early and durable responses at the 12 mg cohort of HPN217 in an RRMM patient population that has undergone extensive prior treatments are encouraging. The 63% overall response rate at the target dose level is strong, with many responses occurring early and deepening over time," said Luke Walker, M.D., Chief Medical Officer for Harpoon Therapeutics. "The low frequency of CRS and compelling efficacy continue to support late-stage development of HPN217 and its potential to become a differentiated option for patients."

Enrollment in dose escalation cohorts up to 24 mg is complete, and the maximum tolerated dose (MTD) has not been reached. Follow up is ongoing, and the evaluation of regimens will inform the choice of a recommended Phase 2 dose(s) at year end 2023.

The poster will be available on Harpoon’s website following the presentation.

For more details about the IMS Annual Meeting, please visit:
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On September 27, 2023 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body, reported that two poster presentations highlighting the company’s Immuno-STAT platform and lead clinical assets CUE-101 and CUE-102, representative of the CUE-100 series, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 38th Anniversary Annual Meeting (SITC 2023) (Press release, Cue Biopharma, SEP 27, 2023, View Source [SID1234635466]). The conference will be held in San Diego, California and virtually on November 1-5, 2023.

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Presentation Details
Title: A phase 1 dose-escalation and expansion study of CUE-101, given as monotherapy in 3L and in combination with pembrolizumab in 1L recurrent/metastatic HPV16+ head and neck cancer patients
Abstract Number: 674
Presenter: Christine Chung, M.D., H. Lee Moffitt Cancer Center, Tampa, Fla. USA
Date: Saturday, November 4, 2023, Exhibit Halls A and B1, 9 a.m.–8:30 p.m. PDT

Title: A phase 1 trial of CUE-102, a novel WT1-pHLA-IL2-Fc fusion protein in HLA-A*0201 positive patients with WT1-positive recurrent/metastatic cancers
Abstract Number: 750
Presenter: Jennifer Eva Selfridge, M.D., Ph.D., University Hospitals Cleveland Medical Center, Cleveland, OH, USA
Date: Saturday, November 4, 2023, Exhibit Halls A and B1, 9 a.m.–8:30 p.m. PDT

All posters will be available to conference attendees as virtual e-posters on the virtual meeting platform available November 3, 2023 at 9 am PDT through January 12, 2024. The posters will also be available on November 4, 2023 in the Investor & Media section of the Company’s website at www.cuebiopharma.com, under Scientific Publications and Presentations.

About the CUE-100 Series
The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-MHC (pMHC) molecules along with rationally engineered IL-2 molecules. This singular biologic is anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient’s body. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing the potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies.

About SITC (Free SITC Whitepaper)
Established in 1984, the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) is a nonprofit organization of medical professionals dedicated to improving cancer patient outcomes by advancing the development, science and application of cancer immunotherapy and tumor immunology. SITC (Free SITC Whitepaper) is comprised of influential basic and translational scientists, practitioners, health care professionals, government leaders and industry professionals around the globe. Through educational initiatives that foster scientific exchange and collaboration among leaders in the field, SITC (Free SITC Whitepaper) aims to one day make the word "cure" a reality for cancer patients everywhere. Learn more about SITC (Free SITC Whitepaper) at sitcancer.org

On September 27, 2023 Candel Therapeutics, Inc. (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing and commercializing viral immunotherapies to help patients fight cancer, reported the Company will present three posters at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 38th Annual Meeting taking place November 3-5, 2023 in San Diego, CA and virtually (Press release, Candel Therapeutics, SEP 27, 2023, View Source [SID1234635465]).

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Presentation details are as follows:

CAN-2409 – Pancreatic Cancer
Poster Presentation Title: Neoadjuvant CAN-2409+Prodrug Plus Chemoradiation for Borderline Resectable or Locally Advanced Non-Metastatic Pancreatic Adenocarcinoma (PDAC)
Presenter: Garrett Nichols, MD, MS, Chief Medical Officer, Candel Therapeutics
Abstract Number: 653
Session Date/Time: Friday, November 3, 2023, 9 am – 7 pm PT
Location: Exhibit Halls A and B1 – San Diego Convention Center
enLIGHTEN Discovery Platform
Poster Presentation Title: A novel viral immunotherapeutic targeting the CD47/SIRPα axis demonstrates potent anti-tumor effects
Presenter: Anne R. Diers, PhD, Senior Director, Research, Candel Therapeutics
Abstract Number: 1096
Session Date/Time: Saturday, November 4, 2023, 9 am – 8:30 pm PT
Location: Exhibit Halls A and B1 – San Diego Convention Center
Poster Presentation Title: Development of enLIGHTEN Alpha-201 herpes simplex viral vectors encoding payloads targeting the tumor microenvironment
Presenter: Francesca Barone, MD, PhD, Chief Scientific Officer, Candel Therapeutics
Abstract Number: 1348
Session Date/Time: Saturday, November 4, 2023, 9 am – 8:30 pm PT
Location: Exhibit Halls A and B1 – San Diego Convention Center
Further details from the presentations will be available following the events on the Candel website at: www.candeltx.com/media

About CAN-2409

CAN-2409, Candel’s most advanced viral immunotherapy candidate, is an investigational off-the-shelf replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s specific tumor and induce an individualized, systemic immune response against the disease. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills nearby cancer cells. The intra-tumoral administration results in the release of tumor-specific neoantigens in the microenvironment. At the same time, the adenoviral serotype 5 capsid protein elicits a strong pro-inflammatory signal in the tumor microenvironment. This is designed to create the optimal conditions to induce an individualized and specific CD8+ T cell mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity. Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and ICI have previously been shown in several preclinical and clinical settings. Furthermore, more than 950 patients have been dosed with CAN-2409 with a favorable tolerability profile to date, supporting the potential for combination with other therapeutic strategies without inordinate concern of overlapping adverse events. Currently, Candel is evaluating the effects of treatment with CAN-2409 in NSCLC, borderline resectable pancreatic cancer, and localized, non-metastatic prostate cancer in ongoing clinical trials. The U.S. Food and Drug Administration granted Fast Track designation for CAN-2409 plus valacyclovir in combination with pembrolizumab in order to improve survival or delay progression in patients with stage III/IV NSCLC who are resistant to first line anti-PD(L)1 therapy and who do not have activating molecular driver mutations or have progressed on directed molecular therapy.

About the enLIGHTEN Discovery Platform

Candel’s enLIGHTEN Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors. In October 2022, the Company announced a discovery collaboration with the University of Pennsylvania Center for Cellular Immunotherapies to identify how viral immunotherapy could enhance the efficacy of CAR-T cell therapy in solid tumors. The enLIGHTEN Discovery Platform is designed to deconvolute the complexity of the tumor microenvironment to identify druggable properties that correlate with clinical outcomes. These discoveries are translated into optimized multi-gene payloads of tumor modulators that are tailored for specific indications, disease stage, and rationally designed therapeutic combinations.

On September 27, 2023 Affimed N.V. (Nasdaq: AFMD) ("Affimed", or the "Company"), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that an abstract with a comparison of NK cell redirected by the Company’s innate cell engagers (ICE) versus CAR-NK cells has been accepted for poster presentation at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), which will be held on November 1-5, 2023 in San Diego, California (Press release, Affimed, SEP 27, 2023, https://www.affimed.com/affimed-announces-acceptance-of-an-abstract-comparing-nk-cells-redirected-by-innate-cell-engagers-and-car-nk-cells-for-poster-presentation-at-the-38th-annual-meeting-of-the-society-for-immunotherapy-o/ [SID1234635464]).

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Details of the poster presentation are as follows:
Title: Redirecting NK cell cytotoxicity by Innate Cell Engagers: A differentiated and innovative approach compared to CAR-NK cells
Presenting Author: Sonya Ioana Ciulean
Abstract Number: 329
Poster Presentation Time: Friday, Nov. 3, 2023, 12:00 – 1:30 p.m. and 5:10 – 6:40 p.m.
Location: Exhibit Halls A and B1 – San Diego Convention Center

More details about the SITC (Free SITC Whitepaper) conference are available online at Home – SITC (Free SITC Whitepaper) 2023 (sitcancer.org).

On September 27, 2023 Beyond Cancer, Ltd. (the "Company"), an affiliate of Beyond Air, Inc. (NASDAQ: XAIR) that is developing ultra-high concentration nitric oxide (UNO) as an immunotherapeutic for solid tumors, reported that the Company will present data at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2023, which is scheduled to be held November 3rd – 5th at the San Diego Convention Center in San Diego, California (Press release, Beyond Air, SEP 27, 2023, View Source [SID1234635463]).

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Details of the Company’s poster presentation are as follows:

Title: Phase 1 study of ultra-high concentration nitric oxide ablation in relapsed refractory, unresectable, primary, or metastatic cutaneous and subcutaneous malignancies
Location: San Diego Convention Center, Exhibit Hall A and B1,
Abstract Number: 733
Date: Friday, November 3, 2023, 9 a.m. – 7 p.m. PDT
Authors:
Amichay Meirovitz, MD, Soroka University Medical Center, Beersheba, Israel,
David Greenberg, MD, Soroka University Medical Center, Beersheba, Israel,
Amir Avniel, Beyond Air, Rehovot, Israel,
Jedidiah Monson, MD, Beyond Cancer, Atlanta, GA, USA

About Nitric Oxide
Nitric Oxide (NO) is a potent molecule, naturally synthesized in the human body, proven to play a critical role in a broad array of biological functions. In the airways, NO targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs. Currently, exogenous inhaled NO is used in adult respiratory distress syndrome, post certain cardiac surgeries and persistent pulmonary hypertension of the newborn to treat hypoxemia. Additionally, NO is believed to play a key role in the innate immune system and in vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria, including both gram-positive and gram-negative, but also against other diverse pathogens.