On May 26, 2022 Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immunotherapy company developing novel T cell engagers, reported interim safety and efficacy data from the ongoing dose escalation and expansion study evaluating HPN328, Harpoon’s half-life extended TriTAC targeting delta-like canonical Notch ligand 3 (DLL3), for the treatment of SCLC and other neuroendocrine cancers (Press release, Harpoon Therapeutics, MAY 26, 2022, View Source [SID1234615193]). The first scientific presentation of these interim data will be featured in a poster session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2022, taking place in Chicago from June 3-7.

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The encouraging interim results, as of the data cut-off date of April 21, 2022, showed that HPN328 demonstrated anti-tumor activity and a favorable safety profile in patients with SCLC, neuroendocrine prostate cancer and other neuroendocrine cancers. Seven of 18 patients (39%) had a decrease in sum of target lesion diameters, with 3 of 11 patients (27%) with SCLC across all dose cohorts experiencing a greater than 30% decrease in sum of target lesion diameters. Additionally, 4 of 6 patients (67%) with SCLC treated at greater than or equal to 1.215mg/week experienced a decrease in sum of target lesion diameters. To date, there have been no dose-limiting toxicities observed and no discontinuations due to adverse events. Grade 1-2 CRS occurred in 22% of patients. No grade 3 or higher CRS or any immune effector cell associated neurotoxicity syndrome (ICANS) events have been observed.

"DLL3 is expressed on the surface of tumor cells in more than 70% of small cell carcinomas, including small cell lung cancer, neuroendocrine prostate cancer, and other small cell neuroendocrine cancers, and HPN328 is specifically engineered to hit this target," said Himisha Beltran, M.D., of Dana-Farber Cancer Institute, Boston, a Principal Investigator in this study. "The encouraging single-agent clinical activity observed to date in patients that have received multiple prior lines of therapy, combined with the favorable safety profile, suggest the investigational T cell engager HPN328 may offer meaningful clinical benefits as a monotherapy for patients expressing DLL3. I look forward to the clinical results from further investigations with this promising drug candidate."

To date, study investigators have observed 1 confirmed partial response with a 53% decrease in sum of target lesion diameters at week 10 in a patient with SCLC who previously achieved a best overall response of stable disease on platinum-based chemo-immunotherapy. Another SCLC patient treated with 3 prior lines of therapy achieved a 65% decrease in sum of target lesion diameters with deepening of target lesion response, with treatment ongoing beyond six months. There were 6 instances of patients with best overall response of stable disease (4 SCLC, 1 neuroendocrine prostate cancer, and 1 thymic atypical carcinoid).

"We are pleased to share our continued progress with the HPN328 anti-DLL3 T cell engager clinical program and these interim data in a peer-reviewed setting, providing further clinical validation for our TriTAC technology in solid tumors," said Julie Eastland, President and CEO of Harpoon Therapeutics. "Given the clinical activity and acceptable tolerability profile observed to date, we look forward to continuing dose escalation, with the goal of identifying a dose for expansion studies by the end of the year, as we further explore the full potential of HPN328 as both a single agent and in future combination studies with atezolizumab to help patients with cancer."

Details of the ASCO (Free ASCO Whitepaper) poster presentation are as follows:

Title: Interim results of an ongoing phase 1/2a study of HPN328, a tri-specific, half-life extended, DLL3-targeting, T cell engager, in patients with small cell lung cancer and other neuroendocrine cancers
Abstract/Poster: 8566/193
Session Title: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Session Date and Time: Monday, June 6, 8:00 a.m. to 11:00 a.m. CT

About HPN328

HPN328, a Tri-specific T cell Activating Construct (TriTAC), is being evaluated as monotherapy in an ongoing open-label, multicenter two-part study to assess the safety, tolerability and pharmacokinetics in patients with advanced cancers associated with expression of DLL3. Part 1 of the study is designed to determine dosage(s) for further evaluation in expansion cohorts during Part 2.

In March 2022, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to HPN328 for the treatment of SCLC.

For additional information on the HPN328 clinical study, please go to ClinicalTrials.gov and use Identifier NCT04471727.

On May 26, 2022 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate targeted T cells directly within the patient’s body, reported it will give a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held in-person June 3–7 at the McCormick Place Convention Center in Chicago, Illinois and virtually (Press release, Cue Biopharma, MAY 26, 2022, View Source [SID1234615192]).

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The poster presents interim clinical data supporting the tolerability and antitumor activity of Cue Biopharma’s lead interleukin 2 (IL-2)-based CUE-100 series therapeutic, CUE-101, both as a monotherapy and in combination with pembrolizumab (KEYTRUDA) for the treatment of patients with recurrent/metastatic HPV16+ head and neck cancer.

Presentation Details:
Title: A Phase 1 dose-escalation and expansion study of CUE-101, a novel HPV16 E7-pHLA-IL2-Fc fusion protein, given alone and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck cancer
Abstract #: 6045
Presenter: Dr. Christine Chung, M.D., Chair, Department of Head and Neck-Endocrine Oncology, Moffitt Cancer Center, Tampa FL
Date: Monday, June 6, 2022, 1:15–4:15 p.m. CDT

The poster will be available in the Investor & Media section of the Company’s website at www.cuebiopharma.com under Scientific Publications and Presentations, following the presentation.

About ASCO (Free ASCO Whitepaper)
Founded in 1964, the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), Inc. (ASCO) (Free ASCO Whitepaper) is committed to making a world of difference in cancer care. As the world’s leading organization of its kind, ASCO (Free ASCO Whitepaper) represents nearly 45,000 oncology professionals who care for people living with cancer. Through research, education, and promotion of the highest-quality patient care, ASCO (Free ASCO Whitepaper) works to conquer cancer and create a world where cancer is prevented or cured, and every survivor is healthy. More than 40,000 oncology professionals from around the world convene at the ASCO (Free ASCO Whitepaper) Annual Meeting to share new clinical cancer advances in every area of cancer research, gain real-time insights from world-renown faculty, and connect with one of the largest, most diverse audiences in global oncology.

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. 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 Immuno-STAT
The company’s Immuno-STAT (Selective Targeting and Alteration of T cells) biologics are designed for targeted modulation of disease-associated T cells in the areas of immuno-oncology and autoimmune disease. Each of our biologic drugs is designed using our proprietary scaffold comprising: 1) a pMHC to provide selectivity through interaction with the T cell receptor (TCR), and 2) a unique co-stimulatory signaling molecule to modulate the activity of the target T cells. The simultaneous engagement of co-regulatory molecules and pMHC binding mimics the signals delivered by antigen presenting cells (APCs) to T cells during a natural immune response. This design enables Immuno-STAT biologics to engage with the T cell population of interest, resulting in selective T cell modulation. Because our drug candidates are delivered directly in the patient’s body (in vivo), they are fundamentally different from other T cell therapeutic approaches that require the patients’ T cells to be extracted, modified outside the body (ex vivo), and reinfused.

On May 26, 2022 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 updated interim data from the ongoing phase 1/2 eNRGY trial and Early Access Program (EAP) of the bispecific antibody zenocutuzumab (Zeno) in patients with NRG1 fusion (NRG1+) cancer, on the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) website (Press release, Merus, MAY 26, 2022, View Source [SID1234615191]). The abstract includes data as of a January 12, 2022 data cutoff date. As of that time, 99 patients with NRG1+ cancer had been treated and efficacy was assessed in 73 patients with the opportunity to have ≥ 6 month follow-up, and that met the criteria for the primary efficacy population. The oral presentation will include updated interim data and will be presented by the Principal Investigator of the eNRGy trial, Dr. Alison Schram of Memorial Sloan Kettering Cancer Center (MSKCC), at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting on Sunday, June 5, 2022, 9:45-11:15 a.m. CT.

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"We are excited to provide a more mature, interim clinical dataset from the Zeno program and are thrilled that Zeno continues to demonstrate activity across different tumor types," said Dr. Andrew Joe, Chief Medical Officer at Merus. "We continue to be encouraged by the potential of Zeno to help patients with NRG1+ cancer."

The reported data are from the phase 1/2 eNRGy trial and EAP which are assessing the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancer.

Key findings of the abstract include:

As of January 12, 2022, 99 patients were treated with Zeno. 73 pts who were treated as of July 12, 2021 were evaluable for response and had the opportunity for ≥ 6 months follow-up and met the criteria for the primary efficacy population
The investigator-assessed overall responses rate (ORR) by RECIST 1.1. criteria was 34% (90%CI, 25;44)
The median duration of response (DOR) was 9.1 months (95% CI, 5.2-12.0) and Kaplan-Meier estimate of DOR rate at 6 month was 70%.
Responses were observed in patients with multiple types of NRG1+ cancer
Zeno continues to be well-tolerated
Oral Presentation Details:
Title: Efficacy and safety of zenocutuzumab, a HER2 x HER3 bispecific antibody, in advanced NRG1 fusion-positive (NRG1+) cancers
Lead Author: Alison Schram, MD, Memorial Sloan Kettering Cancer Center, NY
Abstract #: 105
Session Title: Clinical Science Symposium/ Bispecifics: Are Two Better Than One?
Session Date and Time: June 5, 2022, 9:45-11:15 a.m. CT

Company Conference Call and Webcast Information
Merus will hold a conference call and webcast for investors on Sunday, June 5, 2022 at 6:00 p.m. CT to discuss the Zeno clinical data and provide a program update. 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: Sunday, June 5, 6:00 p.m. CT
Webcast link: available on our website
Dial-in: Toll-free: 18772601463/ International: 17066435907
Conference ID: 7194538

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+ cancer. 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+ cancer). 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+ cancer. In preclinical studies, Zeno also potently inhibits HER2/HER3 heterodimer formation and tumor growth in models harboring NRG1 fusions.

On May 26, 2022 Adaptimmune Therapeutics plc (NASDAQ: ADAP), a leader in cell therapy to treat cancer, reported that pooled analyses from its Phase 1 and pivotal trials with afami-cel for synovial sarcoma and myxoid/round cell liposarcoma (MRCLS) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting (Press release, Adaptimmune, MAY 26, 2022, View Source [SID1234615189]).

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"People with sarcoma struggle with limited treatment options that are often ineffective and toxic," said Brandi Felser, Chief Executive Officer of the Sarcoma Foundation of America. "New and innovative treatments are long overdue for people with sarcoma."

"Our cell therapy, afami-cel, has produced impressive clinical responses in heavily pre-treated patients with late-stage, rare sarcomas – a patient population with a high unmet medical need," said Elliot Norry, Adaptimmune’s Chief Medical Officer. "Obtaining commercial approval for afami-cel for the treatment of synovial sarcoma is a top priority, and the pivotal trial, SPEARHEAD-1, met its primary endpoint for efficacy last year. These data provide evidence of the benefits of afami-cel across patient sub-groups, and further inform SPEAR T-cell development strategies for the treatment of solid tumors."

Data support the potential of afami-cel as a treatment option for people with rare sarcomas

Afami-cel is a cell therapy that uses a patient’s own T-cells to express an engineered T-cell receptor (TCR) designed to kill cancer cells in solid tumors expressing a protein called MAGE-A4
Pooled data were analyzed[1] from 69 patients with synovial sarcoma or MRCLS who received afami-cel in the Phase 1 trial or Cohort 1 of the SPEARHEAD-1 trial
The overall response rate was 36% in heavily pre-treated patients across both types of sarcomas (41% in synovial sarcoma and 10% for MRCLS), with a median duration of response of 52 weeks
Responses occurred across subgroups (i.e., age, gender, number of prior lines of therapy, tumor burden, and MAGE-A4 expression level)
Lower baseline tumor burden, fewer prior lines of prior therapy, and higher MAGE-A4 expression were associated with greater response rates
Among patients with clinical responses, median progression-free survival (PFS) was 58 weeks compared to 12 weeks in non-responders
Patients who received 2 or fewer prior lines of therapy had a response rate of 49% compared to 24% for patients who received 3 or more
As reported last year, the pivotal trial SPEARHEAD-1 met its primary endpoint for efficacy and the benefit:risk profile of afami-cel has been favorable with mainly low-grade cytokine release syndrome and tolerable/reversible hematologic toxicities
Adaptimmune is on-track for BLA submission to FDA in Q4 2022 and planned commercial launch in 2023

On May 26, 2022 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a clinical-stage precision oncology company designing and developing novel targeted therapies for cancer treatment, reported that President and CEO Athena Countouriotis, M.D., will participate in the Jefferies Healthcare Conference on June 8 and the 43rd Annual Goldman Sachs Healthcare Conference on June 14 (Press release, Turning Point Therapeutics, MAY 26, 2022, View Source [SID1234615188]).

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Dr. Countouriotis is scheduled to present a company overview in New York on June 8 at 11 a.m. ET and scheduled to participate in a fireside chat on June 14 in Rancho Palo Verdes, California at 1 p.m. ET.

Both sessions will be accessible via webcast through links that will be posted to the Investors page of www.tptherapeutics.com.