On May 19, 2021 Harpoon Therapeutics, Inc. (NASDAQ: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported that updated interim Phase 1 data for HPN424 for prostate cancer will be presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting beginning on June 4,2021 (Press release, Harpoon Therapeutics, MAY 19, 2021, View Source [SID1234580373]). The poster presentation will show interim data for HPN424 from its ongoing dose escalation Phase 1/2a clinical trial in patients with metastatic castration-resistant prostate cancer (mCRPC) and will be highlighted in a poster discussion session. HPN424 targets prostate-specific membrane antigen (PSMA) and is based on Harpoon’s proprietary Tri-specific T cell Activating Construct (TriTAC) platform designed to recruit a patient’s own immune cells to target and kill tumor cells.

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Full details of the presentation are as follows:

Abstract/Poster Title: Results of an ongoing phase 1/2a dose escalation study of HPN424, a tri-specific half-life extended PSMA-targeting T cell engager, in patients with metastatic castration-resistant prostate cancer (mCRPC)
First Author: Johann S. De Bono, M.D., Ph.D.
Session: Genitourinary Cancer – Prostate, Testicular, and Penile
Date and Time: June 4, available on demand beginning at 9 a.m. ET
Abstract Number: 5013
Location: ASCO (Free ASCO Whitepaper) Meeting Library at View Source

A copy of the presentation will be available on the company’s website at View Source." target="_blank" title="View Source." rel="nofollow">View Source

Conference Call and Webcast

Harpoon’s management will host a webcast and conference call at 4 p.m. ET / 1 p.m. PT on Friday, June 4, 2021 to review the data and provide an update on other pipeline programs. The live call may be accessed by dialing 866-951-6894 for domestic callers or 409-216-0624 for international callers and using conference ID # 2657278.

A live webcast of the call will be available from the Events and Presentations section of the company’s website at View Source and will be archived there shortly after the live event.

About the Phase 1/2a Clinical Trial for HPN424

This Phase 1/2a trial is a multicenter, open-label study designed to evaluate the safety, tolerability, pharmacokinetics and activity of HPN424 in patients with mCRPC who are progressing. The trial is titled, "Study of HPN424 in Patients with Advanced Prostate Cancer." For additional information about the trial, please visit www.clinicaltrials.gov using the identifier NCT03577028.

The initial phase of the trial is a dose escalation phase, with the goal of determining a recommended dose for the expansion phase of the trial. HPN424 is being administered to patients once weekly by intravenous infusion. The primary outcome measures are an assessment of safety and tolerability, pharmacokinetics, and determination of a dose for the expansion phase of the trial. Secondary endpoints include overall response rate, progression free and overall survival, and duration of response. The expansion portion of the trial will further evaluate the safety and activity of HPN424 in patients with mCRPC.

On May 19, 2021 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 the abstract highlighting interim data, as of a January 12, 2021 cutoff, from the phase 1/2 eNRGY trial and Early Access Program (EAP) of bispecific antibody zenocutuzumab (Zeno) in patients with NRG1+ cancers, on the ASCO (Free ASCO Whitepaper) website (Press release, Merus, MAY 19, 2021, View Source [SID1234580372]). An oral presentation containing an updated interim analysis with a data cutoff date of April 13, 2021 will be presented virtually by Lead Author, Dr. Alison Schram of Memorial Sloan Kettering Cancer Center (MSKCC) at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting on Friday, June 4, 2021 from 11:00 AM -2:00 PM ET.

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Dr. Andrew Joe, Chief Medical Officer at Merus stated, "We continue to be encouraged by the observed clinical activity and safety profile of Zeno in the ongoing eNRGy trial, especially in previously treated patients with pancreatic cancer. The clinical activity and durability data continue to mature, and we look forward to Dr. Schram’s presentation of an updated interim analysis of 45 evaluable patients with multiple tumor types at the ASCO (Free ASCO Whitepaper) Annual Meeting on June 4."

The reported data are from the ongoing phase 1/2 eNRGy trial and EAP, which are investigating the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancers. The eNRGy trial consists of three cohorts: NRG1+ pancreatic cancer; NRG1+ non-small cell lung cancer; and NRG1+ other solid tumors.

Key findings in the abstract include:

As of January 12, 2021, 51 patients were treated with Zeno, of whom 33 were evaluable for response. Tumor regression was observed in 25 out of 33 patients, with confirmed partial responses in 9 of 33 (27% ORR), including 4 of 10 patients (40% ORR) with pancreatic cancer.
Zeno continues to be well tolerated with the majority of adverse events of mild or moderate (Grade 1 or 2) severity, regardless of causality.
Presentation Details:

Title: Efficacy and safety of zenocutuzumab in advanced pancreas cancer and other solid tumors harboring NRG1 fusions
Lead Author: Alison Schram, MD, Memorial Sloan Kettering Cancer Center, NY
Abstract #: 3003
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Session Date and Time: June 4, 2021, 11:00 AM-2:00 PM EDT
Presentation Time: 12:00-12:12 PM EDT

Company Conference Call and Webcast Information

Merus will hold a conference call and webcast for investors on Sunday, June 6, 2021 at 6:00 pm ET to discuss the Zeno clinical data and provide a program update. A replay will be available after the completion of the call on the Investors and Media section of our website.

Date: Sunday, June 6, 6:00 pm ET
Webcast link: available on our website
Dial-in: Toll-Free: 1-877-260-1463 / International: 1-706-643-5907
Conference ID: 9678617

About the eNRGy Clinical Trial
Merus is currently enrolling patients in the phase 1/2 eNRGy trial to assess the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancers. The eNRGy trial consists of three cohorts: NRG1+ pancreatic cancer; NRG1+ non-small cell lung cancer; and NRG1+ other solid tumors. Further details, including current trial sites, can be found at www.ClinicalTrials.gov and Merus’ trial website at www.nrg1.com or by calling 1-833-NRG-1234.

About Zeno
Zeno is an antibody-dependent cell-mediated cytotoxicity (ADCC)-enhanced Biclonics that utilizes the Merus Dock & Block mechanism to inhibit the neuregulin/HER3 tumor-signaling pathway in solid tumors with NRG1 gene fusions (NRG1+). Through its unique mechanism of binding to HER2 and potently blocking the interaction of HER3 with its ligand NRG1 or NRG1-fusion proteins, Zeno has the potential to be particularly effective against NRG1+ cancers. In preclinical studies, Zeno also potently inhibits HER2/HER3 heterodimer formation and tumor growth in models harboring NRG1 fusions.

On May 19, 2021 Kadmon Holdings, Inc. (NASDAQ:KDMN) reported initial safety data from the ongoing Phase 1 clinical trial of KD033, its anti-PD-L1/IL-15 fusion protein, in patients with metastatic or locally advanced solid tumors (Press release, Kadmon, MAY 19, 2021, View Source [SID1234580371]). The data will be presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 4 – 8, 2021.

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"We are pleased to share initial safety data demonstrating that KD033 has been well tolerated in lower-dose cohorts of patients with metastatic or locally advanced solid tumors," said Harlan W. Waksal, M.D., President and CEO of Kadmon. "We are excited to advance into higher dose cohorts and assess the potential of KD033 to stimulate cancer-fighting cells via IL-15, a promising new immuno-oncology approach."

The KD033 data to be presented at ASCO (Free ASCO Whitepaper) includes initial safety results from the Phase 1 dose escalation portion of the KD033-101 clinical trial. Key highlights from the presentation include:

Nine patients from the first three cohorts of the trial have been treated with KD033 doses up to 50 µg/kg as of April 21, 2021, with the longest exposure being 30 weeks
KD033 has been well tolerated, with no dose-limiting toxicities reported
Dose escalation continues
Additional clinical data from the KD033-101 trial will be available in Q4 2021.

KD033 is an antibody-cytokine fusion protein harnessing the immunostimulatory activity of IL-15. The IL-15 cytokine expands key tumor-fighting immune cells, including natural killer (NK), NKT and memory CD8 cells, to induce long-lasting responses. Importantly, IL-15 does not expand immunosuppressive Treg CD4 cells, allowing for a robust and durable anti-tumor response. With KD033, Kadmon has fused IL-15 to a PD-L1 antibody to direct IL-15 activity to the tumor microenvironment, promoting efficacy and inducing durable responses while potentially increasing tolerability.

The abstract is now available on the ASCO (Free ASCO Whitepaper) website at meetinglibrary.asco.org. A copy of the poster presentation will be available on June 4th on the Publications and Posters page of Kadmon’s website. Details of the ASCO (Free ASCO Whitepaper) presentation are below:

Poster: Phase I dose escalation of KD033, a PDL1-IL15 bispecific molecule, in advanced solid tumors

Track: Developmental Therapeutics – Immunotherapy

Date & Time: Poster will be available beginning June 4th, 2021 at 9:00 a.m. E.T.

Abstract Number: 2568

About the KD033-101 Clinical Trial

KD033-101 is a Phase 1, open-label, dose-escalation and dose-expansion study investigating the safety and efficacy of KD033 in patients with metastatic or locally advanced solid tumors. The dose-escalation phase of the study will evaluate the pharmacokinetics and pharmacodynamics and identify the maximum tolerated dose (MTD) of KD033. The dose-expansion phase of the study will enroll patients who have progressed or are refractory to programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor therapy to assess safety, efficacy and determine the recommended Phase 2 dose (RP2D) of KD033.

About KD033

KD033 is a novel immunotherapy developed in-house and is fully owned by Kadmon. KD033 combines an anti-PD-L1 antibody with IL-15, a cytokine that expands key tumor-fighting cell types, including natural killer (NK), natural killer T (NKT) and memory T cells, to potentially induce durable responses and inhibit tumor growth. The anti-PD-L1 antibody directs IL-15 activity to the tumor microenvironment, limiting systemic exposure of IL-15 to potentially increase safety and tolerability.

KD033 is the most advanced candidate from Kadmon’s IL-15 fusion protein platform. The Company is developing a portfolio of therapies combining IL-15 with select antibodies for the treatment of cancer.

On May 19, 2021 NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, reported that clinical data from its Phase 1/2 dose escalation study of NEXI-001 will be presented in a poster session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting being held virtually from June 4 – June 8, 2021 (Press release, NexImmune, MAY 19, 2021, View Source [SID1234580370]).

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Poster Presentation:

Title: Preliminary Analysis of a Phase 1/2 Study of NEXI-001 Donor-Derived Multi-Antigen-Specific CD8+ T Cell Treatment of Relapsed Acute Myeloid Leukemia (AML) After Allogeneic Hematopoietic Cell Transplantation (HCT)

Abstract #: 2538

Session Title: Poster Session: Developmental Therapeutics – Immunotherapy

Authors: Monzr M. Al Malki, MD1, Sumithira Vasu, MBBS2, Dipenkumar Modi, MD3, Miguel-Angel Perales, MD4, Megan Nelson, RN, BSN5, Donna Bui1, Vineetha Edavana, PhD6, Sojung Kim, PhD6, Lauren Suarez, PhD6, Mathias Oelke, PhD6, Robert D. Knight, MD6, and Juan C. Varela, MD, PhD5

(1) Hematology/Hematopoietic Cell Transplant, City of Hope National Medical Center, Duarte, CA, (2)Division of Hematology, Department of Internal Medicine, The Ohio State University, Columbus, OH, (3)Division of Oncology, Karmanos Cancer Center/ Wayne State University, Detroit, MI, (4)Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, (5)Advent Health Blood and Marrow Transplant Program, Orlando, FL, (6)NexImmune Inc, Gaithersburg, MD.

On May 19, 2021 EXACT THERAPEUTICS AS ("EXACT-Tx" or the "Company"), a clinical stage precision medicine company utilizing Acoustic Cluster Therapy (ACT) across multiple therapeutic areas, reported that it has been granted a patent for its innovative Acoustic Cluster Therapy technology in Japan (Press release, Exact Therapeutics, MAY 19, 2021, View Source [SID1234580357]).

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The patent covers EXACT-Tx`s unique microbubble/microdroplet formulation and its use, co-administered with a range of pharmaceutical agents for ultrasound mediated therapeutic targeting.

"We are delighted with the decision of the Japanese Patent Office in granting this important patent for ACT, which complements the existing patent granted in China in November 2019. This core patent represents the foundation of our dynamic IP strategy, which encompasses the use of ACT with a variety of therapeutics across a multitude of indications",

said Dr Rafiq Hasan, CEO of EXACT Therapeutics AS.