SQZ Biotechnologies to Present New Data on Rapid Cell Therapy Manufacturing Capabilities and Advantages in Cell Performance at ASGCT 2021

On April 27, 2021 SQZ Biotechnologies (NYSE: SQZ), a cell therapy company developing novel treatments for multiple therapeutic areas,reported that it will present new data on the company’s scaled cGMP cell therapy manufacturing program at the 2021 American Society for Gene and Cell Therapy Virtual Annual Meeting (ASGCT) (Free ASGCT Whitepaper) from May 11-14 (Press release, SQZ Biotech, APR 27, 2021, View Source [SID1234578585]). The company will also present findings on the performance advantages of cells engineered through its proprietary Cell Squeeze Technology.

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"There is tremendous therapeutic need for faster and more efficient delivery of impactful cell therapies to patients around the world," said Armon Sharei, PhD, Chief Executive Officer at SQZ Biotechnologies. "Through our manufacturing and therapeutic development programs, we strive to transform the current cell therapy paradigm and are excited to share our progress at ASGCT (Free ASGCT Whitepaper)."

Rapid, Scaled cGMP and Aseptic Manufacturing Program Data

Company scientists will present new data on its proprietary Cell Squeeze manufacturing technology demonstrating its ability to rapidly and reproducibly deliver cell therapy doses at scale. The presentation will show that the company’s cGMP and aseptic manufacturing program can process 10 billion cells per minute with greater than 90 percent cell viability. The company is delivering its first investigational drug (SQZ-PBMC-HPV) utilizing this core technology for its Phase 1 clinical trial in patients with Human Papillomavirus positive (HPV+) tumors.

"The company’s cell therapy manufacturing program has proven in our Phase 1 trial its ability to deliver reproducible investigational drug batches rapidly and at scale," said Howard Bernstein, MD, PhD, Chief Scientific Officer at SQZ Biotechnologies. "Our advances in cell therapy manufacturing will potentially enable multiple therapeutics across oncology, infectious disease, and immune disorders to be developed and delivered to a broad patient population."

Cell Performance Advantages

Additionally, in a poster presentation, company scientists assessed the use of Cell Squeeze technology to deliver pre-complexed CRISPR/Cas9 RNPs to achieve multiplex-edited primary human T cells. When comparing the functional effects of the Cell Squeeze technology to the commonly used electroporation approach, the authors found significant differences in transcriptional changes between the two treatments. Cells treated with electroporation corresponded with aberrant cytokine production, potentially resulting in premature T cell exhaustion. SQZ treated T cells, however, did not have disrupted transcriptional profiles or cytokine production and readily expanded post treatment with robustness similar to untreated cells.

"This work highlights the advantages of using the Cell Squeeze technology for cell engineering," said Jonathan Gilbert, PhD, Vice President of Exploratory Research at SQZ Biotechnologies. "We demonstrate preclinically a clear distinction in cell performance with the ability to achieve multiple, distinct gene edits with more viable and functional cells."

Exelixis to Webcast Fireside Chats as Part of Virtual Investor Conferences in May

On April 27, 2021 Exelixis, Inc. (Nasdaq: EXEL) reported that Michael M. Morrissey, Ph.D., the company’s President and Chief Executive Officer, will participate in fireside chats at the following virtual investor conferences in May (Press release, Exelixis, APR 27, 2021, View Source [SID1234578584]):

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7th Annual Truist Securities Life Sciences Summit: Exelixis is scheduled to present at 3:30pm EDT / 12:30pm PDT on Tuesday, May 4, 2021.
BofA Securities 2021 Health Care Conference: Exelixis is scheduled to present at 2:00pm EDT / 11:00am PDT on Tuesday, May 11, 2021.
RBC Capital Markets 2021 Global Healthcare Conference: Exelixis is scheduled to present at 3:05pm EDT / 12:05pm PDT on Wednesday, May 19, 2021.
To access the webcast links, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentations to ensure adequate time for any software download that may be required to listen to the webcasts. Replays will also be available at the same location for 14 days.

ZYNLONTA™ (loncastuximab tesirine-lpyl) Now Approved for the Treatment of Adult Patients with Relapsed/Refractory Large B Cell Lymphoma After Two or More Lines of Systemic Therapy

On April 27, 2021 Onco360, the nation’s largest independent Oncology Pharmacy, reported that it has been selected by ADC Therapeutics to be the exclusive specialty pharmacy partner for ZYNLONTA (loncastuximab tesirine-lpyl), a new intravenous therapy option for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high grade B-cell lymphoma (Press release, Onco360, APR 27, 2021, View Source [SID1234578583]).

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"Onco360 is excited to be selected as a specialty pharmacy provider for ZYNLONTA patients," said Benito Fernandez, Chief Commercial Officer, Onco360. "The recent approval of ZYNLONTA provides a new therapy option for heavily pre-treated DLBCL patients who have failed prior lines of therapy. As a provider of this key treatment, Onco360 will support the highly specialized needs of relapsed/refractory DLBCL patients and their physicians across the US."

According to the National Cancer Institute‘s (NCI) Surveillance, Epidemiology, and End Results (SEER) Program, approximately 81,560 patients will be diagnosed with Non-Hodgkin Lymphoma (NHL) in 2021 with a corresponding 20,720 deaths. According to the National Comprehensive Cancer Network (NCCN) Guidelines, DLBCL is the common type of NHL, representing approximately 32% of all NHL cases annually. According to NCI SEER data, DLBCL has a five-year overall survival (OS) of 63.9% when considering all stages of disease. Based on data from various clinical trials, up to 30% of DLBCL patients will experience disease relapse, necessitating subsequent lines of therapy.

ZYNLONTA is manufactured by ADC Therapeutics, a commercial-stage biotechnology company which strives to improve the lives of cancer patients with its next-generation, targeted antibody drug conjugates (ADCs). The FDA’s approval of ZYNLONTA comes as a result of the Phase II LOTIS-2 (NCT03589469) clinical trial which demonstrated a 48.3% overall response rate (ORR) for relapsed/refractory DLBCL patients who failed at least two prior systemic therapies who were treated with ZYNLONTA. For full prescribing information, visit ZYNLONTA.com

Ultivue Announces $50M Financing Round

On April 27, 2021 Ultivue, a leader in advancing precision medicine solutions through a unique approach that combines multiplex biomarker analysis with same slide traditional H&E for tissue phenotyping, reported the completion of a $50 million Series D round of financing (Press release, Ultivue, APR 27, 2021, View Source [SID1234578582]). New investors include Ally Bridge Group, Pura Vida Investments and Tao Capital Partners. Previous venture investors in Ultivue who also participated in the financing include ARCH Ventures, Northpond Ventures and Applied Ventures, LLC.

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This additional funding will help Ultivue strengthen its position in the market, deliver innovative solutions to address the dynamic nature of tumor biology from precious tissue samples and to provide researchers and pathologists with the ability to fully realize the potential of tissue biomarkers within digital pathology workflows.

Anna Yaeger, President and Portfolio Manager commented, "Ally Bridge Group is excited to be long term partners with Ultivue. We believe the company’s differentiated kit-based approach to multiplex immunofluorescence is well positioned to capitalize on the spatial biology revolution and creates maximum flexibility to support academic, biopharma, and CRO customers."

"What Ultivue has is remarkably capable. They provide fast, accurate, previously unattainable multiplexed protein marker information at high resolution and on existing hardware. It is going to be exciting to see a well-resourced, well led Ultivue offer great capabilities to the biotech and pharma oncology community," said Keith Crandell, Co-founder & Managing Director from ARCH Ventures.

"Ultivue is driving to make immunotherapy a reality for every patient that needs it with leading technology that enables advanced exploration and interrogation of tissue samples for precision medicine research. We’re proud to continue supporting the Ultivue team," said Adam Wieschhaus, Ph.D., CFA, Director at Northpond Ventures.

"We’re excited to welcome our newest investors, and greatly appreciate the support from our existing investment partners," says Jacques Corriveau, President and CEO of Ultivue. "This funding will allow us to expand our commercial efforts while also increasing the scope of our research and development in order to remain at the forefront of innovation and provide biological insights for our customers as they work to address the challenge of therapeutic response rates in patients using immunotherapy."

BostonGene and the Medical College of Wisconsin Announce Research Collaboration

On April 27, 2021 BostonGene Corporation, a biomedical software company focused on defining optimal precision medicine-based therapies for cancer patients, reported a research collaboration with the Medical College of Wisconsin (MCW) to analyze the role of the tumor microenvironment of pancreatic ductal adenocarcinoma (PDAC) in modulating the response to various therapies (Press release, BostonGene, APR 27, 2021, View Source [SID1234578581]).

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MCW, based in Milwaukee, is a distinguished leader and innovator in the education and development of the next generation of physicians, scientists, pharmacists and health professionals. With a mission to improve the health of the communities they serve, MCW discovers and translates new knowledge in the biomedical and health sciences while providing cutting-edge, collaborative patient care of the highest quality.

The research study aims to understand the molecular underpinnings of patients with PDAC treated with various therapies. As part of the collaboration, BostonGene will perform large-scale analytics on next generation sequencing (NGS data), including significant somatic alterations, gene expression patterns and enrichment of signaling pathways from an integrated cohort of PDAC patients. Additionally, BostonGene will apply comprehensive integrated genomic (whole exome sequencing) and transcriptomic (RNA-seq) analysis to characterize and classify the tumor and tumor microenvironment of PDAC patients with localized and metastatic disease and will match defined patterns with clinical outcomes. The results of this study could provide insight into the role of pancreatic cancer microenvironment in response to specific therapies and further improve therapy selection.

"We are pleased to collaborate with BostonGene for their sophisticated analysis of RNA-seq and exome sequencing," said Ben George, MD, William F. Stapp Endowed Chair and Associate Professor of Hematology and Oncology at MCW and Medical Director of the Clinical Trials Office at the Froedtert & MCW Clinical Cancer Center. "By partnering with BostonGene we are one step closer to developing prospective, biomarker-driven clinical trials that could personalize treatment options and improve PDAC patient outcomes."

"We are proud to partner with the Medical College of Wisconsin by bringing our next generation multi-platform analytics to the study of PDAC patients," said Andrew Feinberg, President and CEO at BostonGene. "Our sophisticated NGS analysis will identify the genomic and transcriptional alterations that could serve as predictive biomarkers of response to therapy and improve patient outcomes."