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Beyond Cancer™ to Present Two Posters for Ultra-High Concentration Nitric Oxide (UNO) Therapy at the 2023 AACR Annual Meeting

On March 14, 2023 Beyond Cancer, Ltd., 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 Beyond Cancer, Ltd. will present two posters at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, which is scheduled to be held April 14-19 in Orlando, Florida (Press release, Beyond Air, MAR 14, 2023, View Source [SID1234628699]).

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Details of the poster presentations are as follows:

Title: Intratumoral administration of ultra-high concentration nitric oxide (UNO) is more efficacious than anti-PD1 therapy in 4T1 tumor-bearing mice
Session Category: Immunology
Session Title: Anticancer Immunotherapeutics
Session Date and Time: Wednesday, Apr 19, 2023, 9:00 AM – 12:30 PM EDT
Location: Orange County Convention Center, Poster Section 22
Poster Board Number: 3
Abstract Number: 6327
Participant: Hila Confino, PhD; Chief Scientific Officer, Beyond Cancer, Ltd.

Title: Short-term exposure of cancer cells to ultra-high concentrations of nitric oxide (UNO) induces PD-L1 upregulation
Session Category: Immunology
Session Title: Immune Checkpoints
Session Date and Time: Wednesday, Apr 19, 2023, 9:00 AM – 12:30 PM EDT
Location: Orange County Convention Center, Poster Section 23
Poster Board Number: 7
Abstract Number: 6363
Participant: Hila Confino, PhD; Chief Scientific Officer, Beyond Cancer, Ltd.

Please note that the proffered abstracts accepted for presentation at the AACR (Free AACR Whitepaper) Annual Meeting 2023 were released publicly at 4:30 PM EDT today, March 14, 2023.

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.

Bellicum Discontinues Phase 1/2 Trials and Initiates Evaluation of Strategic Alternatives

On March 14, 2023 Bellicum Pharmaceuticals, Inc. (Nasdaq: BLCM), reported its decision to discontinue its ongoing Phase 1/2 clinical trials evaluating the safety and preliminary efficacy of its GoCAR-T cell product candidates in combination with rimiducid in heavily pre-treated cancer patients (Press release, Bellicum Pharmaceuticals, MAR 14, 2023, View Source [SID1234628698]). The trials for BPX-601 and BPX-603 are being discontinued following the Company’s assessment of the risk/benefit profile of BPX-601 in combination with rimiducid.

The most recent patient treated in the Phase 1/2 trial of BPX-601 in metastatic castration-resistant prostate cancer (mCRPC) experienced serious immune-mediated adverse events including Grade 4 cytokine release syndrome (CRS), the second dose-limiting toxicity observed in this cohort of dose escalation. The company paused enrollment in its clinical studies and conducted a thorough review of the risk/benefit observed to date. While clinically meaningful efficacy has been observed—including 5 of 9 mCRPC patients treated achieving PSA50 response, 4 of whom achieved PSA90 response—the Company believes it does not have the necessary resources to optimize either the clinical dose and schedule of BPX-601 cells and the activating agent rimiducid, or the design of the BPX-601 cell construct to achieve a favorable risk/benefit profile.

The Company is communicating with clinical trial sites and regulatory agencies regarding its decision to discontinue its trials, and an evaluation of the Company’s strategic alternatives is underway.

More information about Bellicum can be found at www.bellicum.com.

Merus Announces Publication of an Abstract on Preclinical Mechanism of Action of MCLA-129 Selected for Poster Presentation at the AACR Annual Meeting 2023

On March 14, 2023 Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported the publication of an abstract highlighting the preclinical evaluation of the bispecific antibody MCLA-129 for poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023 taking place in Orlando, Florida April 14-19, 2023 (Press release, Merus, MAR 14, 2023, View Source [SID1234628696]).

The abstract and presentation describe the mechanism of action of MCLA-129, an antibody-dependent cellular cytotoxicity (ADCC) enhanced Biclonics that targets epidermal growth factor receptor (EGFR) and c-MET in non-small cell lung cancer (NSCLC) and other solid tumors in comparison to the EGFR x c-MET bispecific antibody amivantamab. MCLA-129 is a Biclonics common light chain bispecific antibody with multiple mechanisms of action, including inhibition of EGFR and c-MET ligand binding, which is observed in preclinical assays to have antibody-dependent cellular phagocytosis and ADCC comparable or more potent than amivantamab.

Presentation Details:

MCLA-129

Title: Preclinical evaluation of MCLA-129, a bispecific antibody targeting EGFR and c-MET on solid tumor cells, in comparison with amivantamab
Session Category: Experimental and Molecular Therapeutics
Session: Targeting Protein Kinases and Phosphatases for Therapy 1
Date: Tuesday, April 18, 2023
Time: 1:30-5:30 p.m. ET
Poster #: 12
Abstract #: 4999

The full abstract is available on the AACR (Free AACR Whitepaper) website. The poster will be available on the Merus website at the start of the session.

MCLA-129 is in clinical development in a phase 1/2, open-label clinical trial evaluating MCLA-129 monotherapy in EGFRex20 NSCLC, MetEx14 NSCLC, and in head and neck squamous cell carcinoma, as well as in combination with Tagrisso (osimertinib) in treatment naïve EGFR mutant (m) NSCLC and in EGFRm NSCLC that has progressed on Tagrisso.

MCLA-129 is subject to a collaboration and license agreement with Betta Pharmaceuticals Co. Ltd. (Betta), which permits Betta to exclusively develop MCLA-129 and potentially commercialize exclusively in China, while Merus retains global rights outside of China.

About MCLA-129
MCLA-129 is an antibody-dependent cellular cytotoxicity-enhanced Biclonics that is designed to inhibit the EGFR and c-MET signaling pathways in solid tumors. Preclinical data have shown that MCLA-129 can effectively treat TKI-resistant non-small cell lung cancer (NSCLC) in xenograft models of cancer. MCLA-129 is designed to have two complementary mechanisms of action: blocking growth and survival pathways to stop tumor expansion and recruitment and enhancement of immune effector cells to eliminate the tumor.

Merus Announces Petosemtamab in Previously Treated Head and Neck Squamous Cell Carcinoma Abstract Selected for Plenary Session Oral Presentation at the AACR Annual Meeting 2023

On March 14, 2023 Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported the selection of an abstract for a plenary session oral presentation that will highlight interim clinical data on the bispecific antibody petosemtamab in previously treated head and neck squamous cell carcinoma (HNSCC) along with the selection of a second abstract on petosemtamab in advanced gastric/esophageal adenocarcinoma for poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023 taking place in Orlando, Florida April 14-19, 2023 (Press release, Merus, MAR 14, 2023, View Source [SID1234628695]).

Petosemtamab is in clinical development in the expansion part of a phase 1 open-label, multicenter trial in advanced solid tumors, including previously treated HNSCC.

Presentation Details:

Petosemtamab (MCLA-158)

Title: Clinical activity of MCLA-158 (petosemtamab), an IgG1 bispecific antibody targeting EGFR and LGR5, in advanced head and neck squamous cell cancer (HNSCC)
Session Category: Clinical Trials Plenary Session
Session: Promising Novel Antitumor Strategies in Early Phase Clinical Trials
Date: Monday, April 17, 2023
Time: 10:15 a.m.-12:15 p.m. ET
Presentation #: CT012

Title: MCLA-158 (petosemtamab), an IgG1 bispecific antibody targeting EGFR and LGR5, in advanced gastric/esophageal adenocarcinoma (GEA)
Session: Phase II Clinical Trials 1
Date: Monday, April 17, 2023
Time: 1:30-5:30 p.m. ET
Poster #: 18
Abstract #: CT156

The abstracts will be available on the AACR (Free AACR Whitepaper) website at the start of the conference on Friday, April 14, 2023 at 1:00 p.m. ET. The presentations will be available on the Merus website at the start of each session.

Company Conference Call and Webcast Information
Merus will hold a conference call and webcast for investors on April 17, 2023 at 6:30 p.m. ET. A replay will be available after the completion of the call in the Investors and Media section of our website for a limited time.

Date & Time: April 17, 2023 at 6:30 p.m. ET
Webcast link: Available on our website
Dial-in: Toll Free: 1 (800) 715-9871 / International: 1 (646) 307-19631
Conference ID: 4032258

About MCLA-158
MCLA-158, or petosemtamab, is an ADCC-enhanced human IgG1 Biclonics designed to bind to cancer stem cells (CSCs) expressing leucine-rich repeat-containing G protein-coupled receptor 5 (Lgr5) and epidermal growth factor receptor (EGFR). In preclinical models, MCLA-158 binding triggers EGFR degradation in LGR5+ CSCs and is designed to have two different mechanisms of action. The first entails blocking of growth and survival pathways in cancer initiating cells. The second exploits the recruitment and enhancement of immune effector cells to directly kill cancer initiating cells that persist in solid tumors and can cause relapse and metastasis.

AFFIMED ANNOUNCES PRESENTATIONS OF CLINICAL DATA FROM AFM13 PHASE 2 REDIRECT AND PRE-CLINICAL DATA DEMONSTRATING CD16A SHEDDING FACILITATES REPETITIVE TARGETING OF TUMOR CELLS BY AFM13-ARMED NK CELLS AT THE ANNUAL MEETING OF THE AMERICAN ASSOCIATION FOR CANCER RESEARCH

On March 14, 2023 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that two abstracts with clinical and preclinical data on AFM13, its anti-CD30 targeting innate cell engager (ICE), have been accepted for presentation at the Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), taking place April 14-19, 2022 in Orlando, Florida (Press release, Affimed, MAR 14, 2023, View Source [SID1234628694]).

An oral presentation will show detailed results from the AFM13 REDIRECT study evaluating the treatment of patients with CD30-positive relapsed or refractory (R/R) peripheral T cell lymphoma (PTCL). In addition, a poster presentation will highlight results from the collaboration study with Prof. Björn Önfelt, further elucidating AFM13’s mechanism of action.

Oral presentation details:
Title: A phase 2 study of AFM13 in patients with CD30-positive relapsed or refractory (R/R) peripheral T cell lymphoma (PTCL).
Presentation: CT003
Authors: Won Seog Kim, Jake Shortt, Pier Luigi Zinzani, Natalya Mikhaylova, Ana Marin-Niebla, Dejan Radeski, Vincent Ribrag, Eva Domingo Domenech, Ahmed Sawas, Karenza Alexis, Michael Emig, Linta Garcia, Andre Overesch, Kerstin Pietzko, Steven Horwitz.
Session Category and Title: Novel Clinical Trials for Hematological Malignancies
Session Date and Time: Sunday April 16, 2023, 3:00 PM – 5:00 PM ET
Abstract Presentation Number: CT024

The full abstract will be released at 1:00 PM ET on Friday, April 14, 2023.

Poster details:
Title: CD16A shedding facilitates repetitive targeting of tumor cells by AFM13-armed NK cells
Authors: Chiara Zambarda, Karolin Guldevall, Damien Toullec, Susanne Wingert, Christian Breunig, Sheena Pinto, Jacopo Fontana, Joachim Koch, Björn Önfelt.
Session Category and Title: Immunology; Therapeutic Antibodies 2
Session Date and Time: Monday April 17, 2023 1:30 PM – 5:00 PM
Location: Poster Section 23
Poster Board Number: 28
Published Abstract Number: 2950

Antibody-Dependent Cellular Cytotoxicity (ADCC) is a powerful mechanism of Natural Killer (NK) cells to kill antibody-opsonized target cells. However, ADCC mediated by conventional antibodies has its limitations in killing of tumor cells commonly being characterized by low tumor antigen expression.

The collaboration study with Prof. Önfelt investigated whether ICE molecules can induce effective ADCC while maintaining the natural function of CD16A with a particular focus on preserved CD16A shedding.

The study showed that a single cell armed with AFM13, a CD16A/CD30 targeting ICE, induces stronger ADCC of NK cells towards CD30-positive target cells when compared to anti-CD30 antibodies. This stronger response was reached through increasing both the overall number of cytotoxic NK cells and the fraction of NK serial killers i.e., NK cells performing three or more kills in sequence, including cells expressing low levels of CD30.

More details about the programs for the AACR (Free AACR Whitepaper) Virtual Annual Meetings are available online at View Source

About AFM13
AFM13 is a first-in-class tetravalent bispecific innate cell engager (ICE) that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. AFM13 induces specific and selective killing of CD30-positive tumor cells, leveraging the power of the innate immune system by engaging and activating natural killer (NK) cells and macrophages. AFM13 is Affimed’s most advanced ICE clinical program and was evaluated as monotherapy in a phase 2 trial in patients with relapsed/refractory peripheral T-cell lymphoma (REDIRECT). Additional details can be found at www.clinicaltrials.gov (NCT04101331). The study achieved an ORR of 32.4% demonstrating anti-tumor activity with a DOR of 2.3 months and a well-managed safety profile. AFM13 acts as a bridge between the innate immune cells and the tumor creating the necessary proximity for the innate immune cells to specifically destroy the tumor cells.

About Affimed N.V.
Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to give patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The company’s proprietary ROCK platform enables a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors, enabling a broad pipeline of wholly-owned and partnered single agent and combination therapy programs. The ROCK platform predictably generates customized innate cell engager (ICE) molecules, which use patients’ immune cells to destroy tumor cells. This innovative approach enabled Affimed to become the first company with a clinical-stage ICE. Headquartered in Heidelberg, Germany, with offices in New York, NY, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by a bold vision to stop cancer from ever derailing patients’ lives. For more about the company’s people, pipeline and partners, please visit: www.affimed.com.