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

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."

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."

On April 27, 2021 Guardant Health, Inc. (Nasdaq: GH) reported a strategic collaboration with Daiichi Sankyo, Inc. (Daiichi Sankyo) to pursue regulatory approval and commercialization of the Guardant360 CDx blood test as a companion diagnostic for Enhertu (fam-trastuzumab deruxtecan-nxki), a HER2-directed antibody-drug conjugate (ADC), being studied in the treatment of patients with advanced metastatic non-small cell lung cancer (NSCLC) (Press release, Guardant Health, APR 27, 2021, https://www.businesswire.com/news/home/20210427005136/en/Guardant-Health-Announces-Collaboration-With-Daiichi-Sankyo-to-Develop-Guardant360%C2%AE-CDx-as-a-Companion-Diagnostic-for-Enhertu%C2%AE-in-Advanced-Metastatic-Non-Small-Cell-Lung-Cancer [SID1234578580]).

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"For patients with metastatic non-small cell lung cancer, personalized medicines targeting actionable mutations, as revealed by our Guardant360 liquid biopsy test, have been life-changing," said Helmy Eltoukhy, Guardant Health CEO. "Such medicines may extend overall survival for many patients, and we are excited to work with Daiichi Sankyo, as there remains an unmet medical need to help non-small cell lung cancer patients with HER2 mutations."

The Guardant360 CDx test is FDA-approved to provide comprehensive genomic profiling results to guide treatment in all solid tumors, including NSCLC. Sequencing a broad number of genes to understand the molecular drivers of a patient’s cancer is critical, as the number of treatment-relevant genomic alterations continues to grow.

On April 27, 2021 Shasqi, a clinical-stage biotechnology company developing precision activated oncology therapeutics with its proprietary Click Activated Protodrugs Against Cancer (CAPAC) Platform, reported that it has been awarded a $2 million Direct-to-Phase-2 Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) (Press release, Shasqi, APR 27, 2021, View Source [SID1234578579]). These non-dilutive funds will support immune biomarker analysis of patient samples from Shasqi’s Phase 1 clinical trial of lead candidate SQ3370 as well as manufacturing process development.

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"We are thrilled the NCI sees the potential of SQ3370 as a novel therapy that could meaningfully impact outcomes for patients with solid tumors," said José M. Mejía Oneto, M.D., Ph.D., Founder and CEO of Shasqi. "Our goal at Shasqi is to improve the safety and efficacy of novel and existing standard of care cancer drugs by directly activating them at the tumor. Our approach is designed to improve the therapeutic window of a drug by maximizing the exposure of the drug to the tumor."

Wayne Saville, M.D., Chief Medical Officer of Shasqi commented, "We appreciate the NCI’s support to evaluate the immune signatures in patient samples from our ongoing Phase 1 trial of SQ3370. This information will provide mechanistic insight about the interplay between SQ3370 and changes to local and systemic immune responses observed in our preclinical tumor studies. In addition, funds from this grant will also allow us to fine-tune our current manufacturing process as we continue to advance SQ3370 through clinical studies."

CAPAC and SQ3370:

SQ3370 utilizes Shasqi’s proprietary CAPAC platform, a click chemistry-based approach that activates cancer drugs at a tumor with decreased systemic toxicity. The platform is based on the chemical reaction between an attenuated trans-cyclooctene-modified protodrug and a tetrazine-modified biopolymer. The biopolymer is injected into the target tumor lesion, where it precisely activates an intravenously infused protodrug. Unlike traditional targeted therapies, the CAPAC platform is agnostic to tumor characteristics that can vary from patient to patient, such as biomarker expression and enzymatic activity.