On September 13, 2021 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, reported the start of a Phase 1 clinical trial in the United States for LB1901, an investigational autologous CD4-targeted chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of adults with relapsed or refractory peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma (CTCL) (Press release, Legend Biotech, SEP 13, 2021, View Source [SID1234587634]). LB1901 targets CD4, a surface membrane glycoprotein uniformly expressed in most TCL subtypes. The trial follows the U.S. Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application submitted by Legend Biotech.

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The Phase 1 trial is being led by Dr. Swaminathan P. Iyer, Professor of Lymphoma & Myeloma at The University of Texas MD Anderson Cancer Center, and is an open label, multi-center and multicohort clinical study in patients with relapsed or refractory PTCL or CTCL (NCT04712864). Recruitment in the trial has begun in the U.S.

"We are excited by the promise of LB1901, and we look forward to further evaluating the safety and tolerability of LB1901. Determining the optimal dose for subsequent evaluation is one of the key objectives of this trial," said Dr. Lida Pacaud, Vice President of Clinical Development at Legend Biotech. "The number of patients who relapse or are refractory to current TCL treatments is significant, and this trial will provide important information about the potential of CAR-T therapy to treat this disease."

T-cell lymphoma is a heterogeneous group of lymphoid malignancies that account for less than 15 percent of non-Hodgkin’s lymphoma cases in the US.i,ii PTCL comprises subtypes that are uncommon and often aggressive, with a 5-year overall survival of only 39%.iii,iv CTCL are a group of T-cell malignancies that occur primarily in the skin.v Despite current treatment options, a substantial proportion of patients with PTCL or CTCL experiences relapse. A high unmet medical need remains for patients with relapsed or refractory PTCL and CTCL.

About the Clinical Development Program

LB1901-TCL-001 (NCT04712864) is a Phase 1 open-label, multicenter study of LB1901 in patients with histologically confirmed CD4+ RR PTCL (PTCL not otherwise specified, or PTCL-NOS, and angioimmunoblastic T cell lymphoma, or AITL) or RR CTCL (mycosis fungoides and Sézary syndrome). The primary objectives are to characterize the safety and tolerability of LB1901 and determine the optimal dose.

On September 13, 2021 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, and Adicet Bio, Inc. (Nasdaq: ACET), a biotechnology company discovering and developing first-in-class allogeneic gamma delta T cell therapies for cancer and other diseases, reported a collaboration to accelerate the discovery of gamma delta T cell therapies against five undisclosed targets (Press release, Twist Bioscience, SEP 13, 2021, View Source [SID1234587633]). The companies will work together to engineer immune cells with fully human chimeric antigen receptors (CARs) and T-cell receptors (TCRs) directed to disease-specific cell surface antigens. This precise and targeted engagement is designed to provide a superior potential to facilitate recognition and killing of tumor cells.

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Under the terms of the collaboration, Twist will leverage its proprietary single chain fragment variable (scFv) and VHH (nanobody) technologies from its Library of Libraries to discover unique target-specific binders. These targeting technologies will enable Adicet Bio’s engineering and discovery of unique CARs used in the generation of novel gamma delta CAR T cell products. Twist will receive an upfront technology license fee for each program as well as clinical and regulatory milestones and royalties for any product resulting from the selected targets.

"We are excited to leverage Twist’s proprietary antibody discovery capabilities to potentially rapidly identify and optimize unique antibodies against key targets to further enhance our pipeline, both in cancer and other diseases," said Chen Schor, President and Chief Executive Officer of Adicet. "We’ve selected five key targets where we believe our expertise in gamma delta T cell therapies could be augmented with Twist’s ability to identify highly potent, specific antibodies and look forward to a robust partnership."

"There is huge potential in using gamma delta T cells for the treatment of a wide range of cancers, and Adicet is leading the development in this field," commented Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "We look forward to partnering with Adicet to translate these target-engagement technologies into next-generation off-the-shelf, CAR-T therapies and to potentially accelerate the treatment of patients with cancer."

On September 13, 2021 Cellworks Group, Inc., a world leader in Personalized Medicine in the key therapeutic areas of Oncology and Immunology, reported that results from patient stratification studies using the Cellworks Computational Omics Biology Model (CBM) and Biosimulation Platform to predict drug and immunotherapy responses within non-small cell lung cancer (NSCLC) patient tumors will be featured in four poster presentations at the IASLC 2021 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer and held virtually September 8-14, 2021 (Press release, Cellworks, SEP 13, 2021, View Source [SID1234587632]).

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The studies address the need for a personalized treatment approach that matches NSCLC patients with appropriate chemotherapy or immunotherapy using Cellworks Personalized Therapy Biosimulation. Personalized therapy biosimulation begins by optimizing the uniqueness of each patient’s cancer by utilizing their multiomic data to create a patient-specific protein network map or ‘personalized disease model’ using Cellworks proprietary Computational Omics Biology Model (CBM). The Cellworks Personalized Therapy Biosimulation Platform uses the personalized disease model to identify disease-biomarkers unique to each patient and biosimulate the therapy regimens to get drug response on patients.

Poster Presentations

Featured Poster Presentation FP16.05 – Computational Omics Biology Model (CBM) Identifies Novel Biomarkers to Inform Combination Platinum Compound Therapy in NSCLC.

Poster Presentation P70.20 – Impact of KRAS and Co-Occuring Mutations of NSCLC Master Regulator Network as Determined by Computational Omics Biology Model.

Poster Presentation P70.03 – Computational Omics Biology Model (CBM) Identifies Amplifications of Chromosome 6p to Predict Chemotherapy Response.

Poster Presentation P12.06 – Computational Omics Biology Model (CBM) Identifies PD-L1 Immunotherapy Response Criteria Based on Genomic Signature of NSCLC.

"Often single biomarker based approaches do not capture the true biological complexity of a NSCLC patient’s cancer and have limitations in their ability to predict clinical benefit and duration of response with treatments," said Dr. Vamsidhar Velcheti, Associate Professor, Department of Medicine at NYU Grossman School of Medicine; Director, Thoracic Medical Oncology Program; and Co-Principal Investigator for the Cellworks FP16.05, P70.20, P70.03 and P12.06 studies. "Study results show that biosimulation using the Cellworks CBM can identify novel biomarkers in NSCLC patients and inform the optimal drug combination for platinum-based therapies, which are used to treat a variety of malignancies including lung cancer. In another study, Cellworks biosimulation identified a unique chromosomal signature which permits a stratification of NSCLC patients that are most likely to not respond to gemcitabine and platinum treatments even though they have key response criteria. These important studies show how the Cellworks Biosimulation Platform can advance Personalized Oncology for NSCLC patients."

"In NSCLC patients, expression of the PD-L1 immune protein is used to predict the outcome of targeted treatment," said Dr. Apar Kishor Ganti, Professor in the Department of Internal Medicine, Division of Oncology/Hematology, at the University of Nebraska Medical Center; and Co-Principal Investigator for the Cellworks FP16.05, P70.20, P70.03 and P12.06 studies. "However clinical benefits of using PD-L1 to predict patient outcomes do not occur uniformly. In our study, biosimulation using the Cellworks CBM captured a holistic picture of the tumor microenvironment using tumor omics – revealing that alterations of the adenosine and STING pathways play key roles in determining benefit from PD-1/L1 targeting. Study results show that the Cellworks Biosimluation Platform can improve therapy response predictions for NSCLC patients beyond PD-L1 testing and improve outcome in specific patients."

"KRAS is a frequent oncogenic driver in NSCLC, but co-occurrence of other mutations alters the signaling pathways and the key transcription factors involved in the disease network," said Dr. Vamsidhar Velcheti, Associate Professor, Department of Medicine at NYU Grossman School of Medicine; Director, Thoracic Medical Oncology Program; and Co-Principal Investigator for the Cellworks FP16.05, P70.20, P70.03 and P12.06 studies. "Biosimulation using the Cellworks CBM identified the key transcriptional mediators and kinase of KRAS mutations and how they are shuffled by the presence of co-mutations in other common oncogenes. Study results show that Cellworks Biosimulation Platform can be used to identify the regulatory network in the cancer, which lays the foundation for new therapeutic strategies targeting key master regulators."

On September 13, 2021 Walking Fish Therapeutics, a leader in B cell engineering, reported the close of $50M Series A financing— led by investors including Emerson Collective, Illumina Ventures and Quan Capital— to develop B cell therapeutics for oncology, rare disease, regenerative medicine, autoimmune disease, and recombinant antibody production (Press release, Walking Fish Therapeutics, SEP 13, 2021, View Source [SID1234587631]).

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Walking Fish Therapeutics has made critical advances in developing a platform to harness B cells’ capability to activate the immune system in the treatment of cancer, and to serve as in vivo protein factories that produce replacement proteins for deficiency diseases, regenerative proteins, and engineered antibodies.

Walking Fish Therapeutics encompasses a powerful executive leadership team, including Co- founder and CEO, Dr. Lewis "Rusty" Williams, who has devoted his career to helping patients by discovering, developing, and commercializing first-in-class therapies for unmet medical needs. He is a former practicing cardiologist, current member of the National Academy of Sciences, co-founder of COR Therapeutics (now part of Takeda) and founder of Five Prime Therapeutics (now part of Amgen). Dr. Williams is joined by distinguished prior investors, board directors, and executives to set the foundation for B cell platform and drug development at Walking Fish Therapeutics.

"In my 35 years of academic and biotech research on protein drugs, the field of B cell therapeutics may be the biggest paradigm shift for human protein therapies," said Dr. Williams. "Walking Fish is harnessing the unique features of B cells to address unmet needs in the treatment for solid tumors, and in non-oncology indications in which B cells can uniquely and durably deliver important proteins with known therapeutic activity."

"B cells play an important role in the rejection of tumors by the immune system," said Dr. Mark Selby, co-founder and VP Immunology of Walking Fish Therapeutics and co-inventor of the immuno-oncology drug OPDIVO and multiple others. "We have learned to engineer B cells that can target certain cancers and provide a treatment modality that is different from that of other T cell or antibody therapies."

"Walking Fish is at the forefront of the burgeoning B cell therapeutics field, rooted in well understood biology, the evolutions of protein therapeutics, and recent progress in cell therapies," said Momo Wu, Ph.D., Investment Manager at Emerson Collective. "We believe these novel therapies will drive a paradigm shift in the treatment of a number of diseases.

"Walking Fish’s financial backing, combined with its high-caliber leadership team, positions it well for success in pioneering B cell engineering," said Alexis Ji, Ph.D., Partner at Illumina Ventures. "We believe the company has the potential to take the protein and cell therapeutics field to a new plane."

"We are encouraged by the tremendous progress Walking Fish has made during the seed funding phase, and we now look forward to the company developing its product candidate in B cell therapeutics, which can be used to treat diseases that are challenging to address with current methods," said Stella Xu, Ph.D., Managing Director at Quan Capital.

On September 13, 2021 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ("Silverback"), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases, reported that interim data from the dose-escalation portion of its Phase 1/1b clinical trial evaluating SBT6050 as a monotherapy and in combination with pembrolizumab in patients with advanced or metastatic HER2-expressing or amplified solid tumors will be presented at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2021 Congress from September 16-21, 2021 (Press release, Silverback Therapeutics, SEP 13, 2021, View Source [SID1234587630]).

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The accepted abstract, with a data cut-off date of April 4, 2021, is now available on the ESMO (Free ESMO Whitepaper) website. The upcoming poster will include additional data with a cut-off date of August 1, 2021. Details of the poster are as follows:

Title: "Interim results of a Phase 1/1b study of SBT6050 monotherapy and pembrolizumab combination in patients with advanced HER2-expressing or amplified solid tumors"
Poster Number: 209P
Presenter: Samuel J. Klempner, MD
Session Date and Time: The poster will be released virtually on Thursday, September 16th at 8:30 AM Central European Summer Time / 2:30 AM Eastern Time

Conference Call and Webcast on Thursday, September 16, 2021, at 6:30 AM ET

Silverback’s management team will host a conference call on Thursday, September 16, 2021, at 6:30 AM ET following the release of the poster at the ESMO (Free ESMO Whitepaper) 2021 Virtual Congress. A live webcast, including slides, can be accessed through the Events section of the Company’s website at View Source An archived replay will be available shortly after the conclusion of the event.

About SBT6050

SBT6050 is the first of a new class of targeted immuno-oncology agents designed to direct a TLR8 agonist linker-payload to activate myeloid cells in tumors expressing moderate to high levels of HER2. TLR8 is expressed in myeloid cell types prevalent in human tumors and TLR8 agonism can activate a broad spectrum of anti-tumor immune mechanisms, including pathways involved in the innate and adaptive immune response. SBT6050 was specifically designed to bind to the HER2 sub-domain II, the pertuzumab epitope, to enable combinations with trastuzumab-based therapies. SBT6050 is currently being evaluated in a Phase 1/1b trial in patients with advanced or metastatic HER2-expressing or amplified solid tumors.