On June 14, 2023 Alentis Therapeutics ("Alentis"), the clinical-stage biotechnology company developing treatments for Claudin-1 positive (CLDN1+) tumors and organ fibrosis, reported that the FDA cleared an IND application for ALE.C04 as a monotherapy and in combination with pembrolizumab, in a first-in-human clinical trial in recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) that is expected to start during the second half of 2023 (Press release, Alentis Therapeutics, JUN 14, 2023, View Source [SID1234632696]).

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"With ALE.C04 we aim to treat solid tumors in a unique way. By targeting exposed CLDN1 on cancer cells our antibody remodels the extracellular matrix favoring T- and NK-cell trafficking, which in turn directly kills CLDN1+ tumor cells and breaks the check-point inhibitor resistance in immune-excluded tumors," said Dr. Luigi Manenti, Chief Medical Officer of Alentis. "The high unmet medical need, strong scientific rationale and our compelling preclinical and translational data makes HNSCC an ideal first indication for ALE.C04 as a monotherapy and in combination with anti-PD-1 treatment."

Dr. Roberto Iacone, Chief Executive Officer of Alentis added, "The IND clearance for ALE.C04 is an important step for Alentis as it marks our entry into the oncology space. The planned Phase 1/2 study will tell us a lot about the anti-tumor efficacy of our antibody to treat CLDN1+ tumors. We are the leading company targeting CLDN1 across organ fibrosis and cancer."

About ALE.C04
ALE.C04 is a first-in-class monoclonal antibody developed to specifically target exposed CLDN1 on cancer cells. This investigational antibody is designed to treat cancer in two ways: remodeling of the extracellular matrix, leading to improved NK and T-cell trafficking and direct tumor cell killing through the effector function. This unique mechanism of action provides ALE.C04 with therapeutic potential as a monotherapy and, in combination with check-point inhibitors.

About Head and Neck Squamous Cell Carcinoma
HNSCC is the sixth most common type of cancer worldwide and its incidence continues to rise. Besides surgery, chemotherapy and/or radiation therapy additional approved therapies include cetuximab, and pembrolizumab. Pembrolizumab monotherapy has shown an overall survival improvement in first line setting. However, the need for new treatment options remains high.

On June 14, 2023 2seventy bio, Inc. (Nasdaq: TSVT), a leading immuno-oncology cell therapy company, reported that the Phase 1 trial of the PLAT-08 study of SC-DARIC33 in Acute Myeloid Leukemia (AML) has been paused by Seattle Children’s, the Company’s partner and the regulatory sponsor of the study (Press release, 2seventy bio, JUN 14, 2023, View Source [SID1234632695]). The pause was instituted as part of the clinical study protocol stopping rules in response to a recent Grade 5 (fatal) serious adverse event (SAE) and was followed by the required notification to the U.S. Food & Drug Administration (FDA). The root cause of this SAE and its potential relationship to the study drug is currently under investigation.

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PLAT-08 is the Phase 1 study of SC-DARIC33 in relapsed/refractory pediatric AML, conducted by Seattle Children’s, and couples 2seventy bio’s DARIC T cell platform with Seattle Children’s expertise in oncology cell therapies. This study is a first-in-human investigation of the DARIC T cell platform. The SAE occurred in the first patient treated at the second dose level in the Phase 1 trial.

"Importantly, I’d like to offer that our thoughts are with the family during this time. The safety of every patient who participates in our studies or is treated with our therapies is the utmost priority for us, and we are in communication with FDA while we assess the data surrounding this SAE, and the potential next steps for the study," said Steve Bernstein, M.D., chief medical officer, 2seventy bio.

On June 14, 2023 MorphoSys AG (FSE: MOR; NASDAQ: MOR) reported that it will host a virtual investor event on Wednesday, June 21, at 9:00 a.m. EDT / 3:00 p.m. CEST (Press release, MorphoSys, JUN 14, 2023, View Source [SID1234632672]).

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During the event, Jean-Paul Kress, M.D., MorphoSys’ Chief Executive Officer, and Tim Demuth, M.D., Ph.D., MorphoSys’ Chief Research and Development Officer, will discuss the potential of the company’s lead investigational asset, pelabresib. There will also be live presentations from – and a Q&A opportunity with – key opinion leaders John Mascarenhas, M.D., Professor of Medicine and Director of the Adult Leukemia Program at The Tisch Cancer Institute at Mount Sinai, New York, and Gabriela Hobbs, M.D., Assistant Professor of Medicine at Harvard Medical School, and Clinical Director of Leukemia Service at Massachusetts General Hospital.

Topics will include an overview of the disease burden for patients with myelofibrosis, including treatment gaps; a recap of encouraging findings in myelofibrosis from the pelabresib Phase 2 MANIFEST study in combination with ruxolitinib and background on the Phase 3 MANIFEST-2 study, which will report topline results by the end of 2023; and new proof of concept results and expansion plans for pelabresib in other myeloid diseases. The full agenda is below.

To access the live webcast, including audio, video and presentation slides, visit the Investors section of the MorphoSys website at View Source

A replay of the webcast and presentation will be available on the company’s website after the event.

Agenda:

Presenter Presentation
Jean-Paul Kress, M.D.
Chief Executive Officer, MorphoSys
Welcome and opening remarks
Gabriela Hobbs, M.D.
Assistant Professor of Medicine at Harvard Medical School and Clinical Director of Leukemia Service at Massachusetts General Hospital
Myelofibrosis burden of disease and medical need
John Mascarenhas, M.D.
Professor of Medicine and Director of the Adult Leukemia Program
at The Tisch Cancer Institute at Mount Sinai, New York
Pelabresib in myelofibrosis update
Tim Demuth, M.D., Ph.D.
Chief Research and Development Officer, MorphoSys
Pelabresib clinical development road map
All presenters Moderated Q&A

On June 13, 2023 Cidara Therapeutics, Inc. (NASDAQ: CDTX), a biotechnology company developing long-acting therapeutics designed to help improve the standard of care for patients facing serious diseases, reported that the company will deliver an oral presentation including highlights from its ongoing preclinical studies of CD421, a CD73-targeting DFC candidate, as well as the development of its novel drug-Fc conjugates (DFCs) from Cidara’s Cloudbreak platform, at the 2nd Annual Adenosine-Pathway Targeted Cancer Immunotherapy Summit in Boston, MA, which is being held June 20-22, 2023 (Press release, Cidara Therapeutics, JUN 13, 2023, View Source [SID1234636987]).

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The Adenosine-Pathway Targeted Cancer Immunotherapy Summit is a three-day conference that brings together over 80 industry and academic thought leaders to discuss the most recent advances of the last year in this field. The meeting will aim to improve the understanding of adenosine signaling in the tumor microenvironment and discuss drug combinations to improve patient responses and overcome obstacles related to resistance and immunosuppression.

Oral presentation details are as follows:

Title: Cidara Drug-Fc-Conjugates (DFCs): A New Approach To Treatment Of Cancer
Presenter: James Levin, Ph.D., Senior Director, Preclinical Development at Cidara Therapeutics
Session Date/Time: Thursday, June 22, 2023 at 9:30 a.m. ET
Session Location: Boston, MA

To view the full schedule, visit the Adenosine Pathway Targeted Cancer Immunotherapy Summit website here.

About Cloudbreak DFCs
Cidara is developing a new generation of immunotherapeutic agents from its Cloudbreak platform that couple targeted small molecule and peptide drugs to a human antibody fragment (Fc). These highly potent, long-acting drug-Fc conjugates (DFCs) are designed to inhibit specific disease targets while simultaneously engaging the immune system. In addition to multiple oncology programs, Cidara is advancing its antiviral DFC CD388 through Phase 1 and Phase 2a clinical trials in partnership with Janssen for the universal prevention and treatment of influenza.

On June 13, 2023 Mission Bio, the pioneer in high-throughput single-cell DNA and multi-omics analysis, reported successful results of validation studies of the Tapestri Platform (Press release, Mission Bio, JUN 13, 2023, View Source [SID1234632711]). Data from a recently published white paper show how single-cell DNA sequencing technology could complement traditional bulk sequencing with the added advantage of detecting potential therapeutic resistance mutations.

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Drug developers must understand why some patients respond to therapies, while others do not, in order to accelerate clinical trials and develop better treatments. Single-cell DNA and multi-omics analysis has already been shown in multiple publications to be well-suited to help untangle therapy resistance mechanisms that are impossible to discern through traditional methodologies. Now, Tapestri’s unique ability to sensitively detect rare cancer subclones and co-occurring cancer mutations using single-cell genomics offers a precise way to measure therapy response and disease progression.

Mission Bio’s Tapestri Platform Demonstrates Highly Robust And Reproducible Data

As described in a new white paper, scientists at Labcorp used the Tapestri Platform to interrogate 127 amplicons that target DNA mutations known to be present in patients with acute myeloid leukemia (AML). The goals of the experiments were to evaluate the effects of different sample preparation methods for human peripheral blood mononuclear cells (PBMCs) on the Tapestri cell encapsulation method, and to evaluate the robustness of detecting DNA mutations in controlled sample mixtures of human PBMCs and RAJI cell line cells using the AML gene mutation detection panel.

The assessment of assay performance including clonality, precision, accuracy, and analytical sensitivity demonstrated Tapestri’s unique ability to detect rare subclones at less than 1%, determine the zygosity of mutations, and measure the co-occurrence of multiple mutations in the same single cells. The robust and reproducible data generated on the Tapestri Platform gives drug developers a powerful tool to measure therapy response, potentially improve clinical trial outcomes, and ultimately deliver new targeted therapies.

"We are delighted to see the validation results, confirming the value add many of our partners have already seen," said George Kopitas, Senior Vice President, Sales & Customer Support at Mission Bio. "Biopharma companies need to know they can access cutting-edge and reliable technology through partners they trust. Labcorp is a global leader in drug development and a trusted partner for generating safety and efficacy data. We look forward to further validating Tapestri for use in CAP and CLIA settings."