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U.S. Food and Drug Administration Accepts for Priority Review Supplemental New Drug Application for the Use of Trifluridine/Tipiracil (LONSURF®) in Combination With Bevacizumab for Refractory Metastatic Colorectal CancerTaiho

On April 13, 2023 Taiho Pharmaceutical and Taiho Oncology reported that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental new drug application (sNDA) for trifluridine/tipiracil (LONSURF) as monotherapy or in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an antiEGFR therapy (Press release, Taiho, APR 18, 2023, View Source [SID1234630262]). A Priority Review designation by the FDA reduces the review period of the sNDA by four months. In this case, the FDA provided an anticipated Prescription Drug User Fee Act (PDUFA) action date of August 13, 2023.

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The sNDA in the US is based on data from the pivotal Phase 3 SUNLIGHT trial, which demonstrated that the investigational combination use of trifluridine/tipiracil plus bevacizumab provided statistically significant improvements in overall survival (OS), which was the primary endpoint, and progression-free survival (PFS), one of the secondary endpoints, for patients with refractory mCRC following disease progression or intolerance on two prior chemotherapy regimens compared to trifluridine/tipiracil alone.

Results from the SUNLIGHT trial were presented by Professor Josep Tabernero, MD, PhD, Head of Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain, and Principal Investigator for the SUNLIGHT trial, at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI), held January in San Francisco.

"The poor prognosis for patients with previously treated late-stage metastatic colorectal cancer has been an ongoing challenge in the oncology community, which has driven our pursuit of a potential new treatment option," said Volker Wacheck, MD, PhD, Vice President, Clinical Development, Taiho Oncology, Inc. "We believe the combination of trifluridine/tipiracil plus bevacizumab may represent a significant advance in the treatment of refractory disease, and we look forward to working with the FDA as it considers this application."

Through research and development of innovative treatments, the Taiho group aims to contribute to patients and healthcare professionals around the world.

【About Colorectal Cancer】
Colorectal cancer is the fourth most commonly diagnosed cancer in the U.S.1 In 2022, there were an estimated 151,030 new cases and 52,580 deaths in the U.S. 2 Approximately 22% of U.S. patients with colorectal cancer are diagnosed at the distant or metastasized stage.2 Metastatic colorectal cancer is associated with a poor prognosis, with a five-year survival rate of approximately 15.1%.2

【About LONSURF】
LONSURF is an oral nucleoside antitumor agent discovered and developed by Taiho Pharmaceutical Co., Ltd. LONSURF consists of a thymidine-based nucleoside analog, trifluridine, and the thymidine phosphorylase (TP) inhibitor, tipiracil, which increases trifluridine exposure by inhibiting its metabolism by TP. Trifluridine is incorporated into DNA, resulting in DNA dysfunction and inhibition of cell proliferation.

＊LONSURF
Generic name：Trifluridine/ tipiracil
Product Name in Japan：LONSURF combination tablet T15, T20
Indications in Japan:
・Unresectable advanced or recurrent colorectal cancer
・Unresectable advanced or recurrent gastric cancer that has progressed after chemotherapy

【About the SUNLIGHT Trial】
SUNLIGHT is a multinational, randomized, active-controlled, open-label twoarm Phase 3 trial to investigate the efficacy and safety of trifluridine/tipiracil plus bevacizumab versus trifluridine/tipiracil alone, in patients with refractory mCRC following two chemotherapy regimens. A total of 492 patients were randomly allocated (in a 1:1 ratio) to receive trifluridine/tipiracil plus bevacizumab or trifluridine/tipiracil monotherapy. The primary objective was to assess trifluridine/tipiracil plus bevacizumab versus trifluridine/tipiracil alone, in terms of OS (primary endpoint). Key secondary endpoints were progression free survival (PFS), overall response rate (ORR), disease control rate (DCR) and quality of life (QoL), as well as the safety and tolerability of trifluridine/tipiracil used in combination with bevacizumab in comparison with trifluridine/tipiracil monotherapy. The SUNLIGHT trial was conducted by Servier and Taiho Oncology, Inc. For more information on SUNLIGHT, please visit: View Source

SUNLIGHT：An open-label, randomised, phase III study comparing trifluridine/tipiracil in combination with bevacizumab to trifluridine/tipiracil monotherapy in patients with refractory metastatic colorectal cancer. (SUNLIGHT Study)

Surface Oncology Presents New Preclinical Data on SRF114, a fully human anti-CCR8 antibody, at the AACR Annual Meeting 2023

On April 18, 2023 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported the presentation of new preclinical data for SRF114, a fully human anti-CCR8 antibody, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023 in Orlando, Florida (Press release, Surface Oncology, APR 18, 2023, View Source [SID1234630261]). The data will be presented in a poster session (abstract #5125) being held today.

"We are highly encouraged by these new preclinical data which indicate that therapeutic depletion of CCR8 positive tumor infiltrating Tregs results in robust anti-tumorigenic activity in both checkpoint inhibition-resistant and checkpoint inhibition-susceptible tumor models," said Vito Palombella, PhD, chief scientific officer, Surface Oncology. "These data bolster our belief that SRF114 holds the potential to become a best-in-class anti-CCR8 treatment and further support our ongoing Phase 1 clinical investigation of SRF114 in patients with advanced solid tumors."

Summary of key data

In human CCR8 knock-in mice, SRF114, a fully human antibody targeting human CCR8, conferred robust anti-tumor activity and reshaped the tumor microenvironment towards a proinflammatory milieu.
In different in vivo models, SRF114 monotherapy or treatment with a murine surrogate antibody promoted expansion of CD8+ effector T cells and increased the production of pro-inflammatory molecules including IFNγ, TNFα, and granzyme A in a checkpoint-resistant tumor model.
Anti-CCR8 therapy resulted in depletion of tumor Tregs without impacting peripheral lymphoid Treg cell populations and led to increases in the levels of co-stimulatory molecules CD80 and CD86 in a subset of tumor myeloid cells.
Anti-CCR8 and anti-PD-1 combination therapy increased tumor immune cell infiltration, cytokine production and improved overall survival in a checkpoint inhibitor resistant melanoma model.
Poster Session Information
Title: Depletion of CCR8+ tumor Treg cells with SRF114 or anti-CCR8 therapy promotes robust antitumor activity and reshapes the tumor microenvironment toward a more pro-inflammatory milieu
Abstract number: 5125
Session category: Immunology
Session title: Combination Immunotherapies 2
Session date and time: Tuesday, April 18, 2023, from 1:30 p.m. to 5:00 p.m. ET

A copy of the poster will be available on the Posters & Publications page of the company’s website following the presentation.

About SRF114
SRF114 is a fully human, afucosylated anti-CCR8 antibody designed to preferentially deplete CCR8+ Treg cells within the tumor microenvironment. In preclinical studies, Surface Oncology has shown that SRF114 induces antibody-dependent cellular cytotoxicity (ADCC) and/or antibody-dependent cellular phagocytosis (ADCP) pathways to deplete intratumoral Treg cells. In addition, SRF114 reduced tumor growth in murine models. These findings support the advancement of SRF114 as a therapeutic candidate that holds the potential to drive anti-tumor immunity in patients.

Sensei Biotherapeutics Presents New Preclinical Data on SNS-103 Targeting ENTPDase1 (CD39) at the American Association for Cancer Research (AACR) Annual Meeting 2023

On April 18, 2023 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), an immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported new preclinical data on its SNS-103 program aimed at developing a conditionally active, monoclonal antibody program targeting ENTPDase1 (also known as CD39) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023 (Press release, Sensei Biotherapeutics, APR 18, 2023, View Source [SID1234630260]).

"CD39 is an important target because it is the rate-limiting enzyme that creates an immunosuppressive tumor microenvironment through the production of adenosine. However, it has been difficult to target effectively due to its broad expression on various cells in both tumors and normal tissues," said Edward van der Horst, Ph.D., Chief Scientific Officer at Sensei Biotherapeutics. "The hypothesis driving our program is that a pH-sensitive antibody may inhibit the pro-tumoral activities of CD39 selectively within the tumor microenvironment while avoiding on-target/off-tumor binding and pharmacokinetic issues observed with prior CD39 antibodies."

Presentation highlights:

Poster presentation titled, "Identification of conditionally active antibodies that selectively block CD39 activity in the acidic tumor microenvironment"

CD39 is commonly upregulated in the tumor microenvironment, which is characterized by high levels of extracellular ATP (eATP) and low pH. Upregulation and activation of CD39 results in significant reductions of eATP and a rise in immunosuppressive adenosine.
SNS-103 is aimed at developing an antibody that binds to CD39 only under low pH conditions such as those found in the tumor microenvironment and achieves a high target occupancy selectively in the tumor, while maintaining extracellular ATP and inhibiting adenosine generation to enhance anti-tumor immunity.
From a panel of 83 antibodies identified and characterized for CD39 inhibition at neutral and acidic pH, Sensei has selected 8 antibodies for further optimization.
Sensei intends to select a lead product candidate for SNS-103 in 2023.
The full poster is available for viewing on Sensei’s corporate website.

SELLAS Life Sciences Independent Data Monitoring Committee Recommends Galinpepimut-S REGAL Trial to Continue as Planned

On April 18, 2023 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported a positive review of the ongoing Phase 3 REGAL clinical trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML) (Press release, Sellas Life Sciences, APR 18, 2023, View Source [SID1234630259]). The Independent Data Monitoring Committee (IDMC) performed a routine, prespecified risk-benefit assessment of unblinded data from the study and has recommended that the trial continue without modifications. The IDMC has further recommended to meet again within Q3 2023 and endorsed all clinical trial initiatives SELLAS has undertaken to advance GPS in the REGAL study, including the addition of clinical sites in China.

"This positive IDMC review marks another significant milestone in GPS development and builds on the favorable profile of our study drug, galinpepimut-S," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "Enrollment continues in our global Phase 3 REGAL registrational study, which currently remains on track for interim analysis by the end of 2023 or early 2024."

REGAL is a Phase 3 open-label registrational clinical trial for GPS in AML patients who have achieved complete remission following second-line salvage therapy (CR2 patients). The primary endpoint is overall survival. The IDMC is an independent group of medical, scientific and biostatistics experts who are responsible for reviewing and evaluating patient safety and efficacy data for REGAL, and for monitoring quality and overall conduct to ensure the validity, scientific and clinical merits of the study. The IDMC charter provides for periodic reviews for safety, efficacy, and futility in addition to the interim and final analyses.

QIAGEN N.V. to release results for Q1 2023 and hold webcast

On April 18, 2023 QIAGEN N.V. (NYSE: QGEN) (Frankfurt Stock Exchange: QIA) reported its plans to release results for the first quarter 2023 (Press release, Qiagen, APR 18, 2023, View Source [SID1234630258]).

Press release date / time: Wednesday, May 3, shortly after 22:05 Frankfurt time / 21:05London time / 16:05 New York time.

Conference call date / time: Thursday, May 4, at 15:00 Frankfurt time / 14:00 London time / 09:00 New York time.

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