seqWell Announces Appointment of Dan Calvo as President and Chief Executive Officer

On April 28, 2021 seqWell reported the appointment of Dan Calvo as its President and Chief Executive Officer, effective as of April 19th, 2021 (Press release, Research Corporation Tech, APR 28, 2021, View Source [SID1234578643]). Dan brings over 30 years of leadership experience, most recently serving as President and CEO of Gyros Protein Technologies AB from 2013 through its acquisition by Mesa Labs in 2019. Prior to this role, Dan served as President and CEO of Oncimmune (USA) LLC, a leading early cancer detection company from 2009 thru 2013. He also brings strategic insights from earlier CEO roles at Cellomics and Assay Designs, having led both companies through acquisition by Fisher Scientific and Enzo Biochem, respectively.

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With accelerated growth of its core product offerings, seqWell welcomes Dan at a critical inflection point in the company’s commercial strategy. The recent release of seqWell’s first single-cell solution, plexWell Rapid scRNA, for single-cell RNA-seq applications, alongside strategic OEM partnerships, continues to broaden the company’s collaborative opportunities. According to seqWell Founder and Chief Scientific Officer, Joe Mellor, "Dan’s commercial leadership skills are essential and valuable at this stage of seqWell’s growth and development. I look forward to working closely with Dan as we build on our core capabilities to further meet the needs of the genomics market and build upon our strategic partnerships."

"The outlook for our business is exceptional," said Dan Calvo. "I am excited to work with the tremendous team at seqWell to accelerate development and commercialization of critical tools to meet the increasing global demand for workflow improvements in a wide variety of NGS applications."

Chad Souvignier, Vice-President and Investment Lead at RCT, added "seqWell’s progress this past year has been exceptional. The board worked cooperatively with management over this past year to recruit a CEO who could lead the company through its next stage of growth. We are fortunate to have found Dan and confident in his ability to aggressively move the company forward."

Biodesix Announces Intent to Launch Liquid Biopsy Next Generation Sequencing Test with Unprecedented Turnaround Time

On April 28, 2021 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported their plan to add a blood-based 52-gene next generation sequencing (NGS) test to their portfolio of molecular testing based on a recent publication (Press release, Biodesix, APR 28, 2021, View Source [SID1234578664]). Of critical importance, the publication, "Targeted Next-Generation Sequencing of Liquid Biopsy Samples from Patients with NSCLC," in Diagnostics showed that the rapid liquid biopsy testing was able to detect actionable genomic alterations in patients with non-small cell lung cancer (NSCLC) with an unmatched turnaround time of only 72 hours.

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The test has been in use for biopharma research testing and is performed in Biodesix’s ISO 13485-certified, New York Clinical Laboratory Evaluation Program (CLEP)-approved, College of American Pathologists (CAP)-accredited, Clinical Laboratory Improvement Amendments (CLIA)-high complexity certified clinical testing laboratory. With the turnaround time for existing, on-market liquid biopsy NGS tests ranging from 7-14 days, improving turnaround time to three days can be critical for patients with advanced NSCLC who are unable to undergo biopsy or whose biopsies have yielded insufficient test results.

"We observed significant agreement (95.7%–100%) with an orthogonal, high-sensitivity Droplet Digital Polymerase Chain Reaction (ddPCR) test," said Gary Pestano, Ph.D., Chief Development Officer at Biodesix. "This method offers a valuable supplement to assessing targeted mutations from blood while conserving specimens and maintaining sensitivity, with rapid turnaround time to actionable results."

The NGS test will complement the now 36-hour turnaround time that GeneStrat ddPCR and VeriStrat tests currently offer with the expanded coverage of 52-genes and broader molecular markers. The 52-gene NGS test will be used for advanced, late-stage, or recurrent cancer mutation detection, and the targeted 6-gene GeneStrat test can be used for identification of the select mutations for treatment guidance, recurrence monitoring, and detection of the development of resistance mutations over time. The company expects to begin offering this testing strategy in the first half of 2022.

"This test allows Biodesix to offer comprehensive molecular test results, with small and large genomic testing panels in combination with our immune profiling test for early and advanced NSCLC," said Scott Hutton, CEO of Biodesix. "We believe that by adding this NGS test to our current portfolio and multi-omics approach, we can enable physicians to make critical treatment decisions for their patients across the continuum of care in the shortest amount of time available today."

JCRI-ABTS and USMI Successfully Use Canady Helios™ Cold Plasma in Combination with FOLFIRINOX for the Treatment of Cholangiocarcinoma

On April 28, 2021 The Jerome Canady Research Institute for Advanced Biological and Technological Sciences (JCRI-ABTS), LLC and US Medical Innovations, LLC (USMI) reported that their recent article, "THE SYNERGISTIC EFFECT OF CANADY HELIOS COLD ATMOSPHERIC PLASMA (CHCAP) AND A FOLFIRINOX REGIMEN FOR THE TREATMENT OF CHOLANGIOCARCINOMA IN VITRO", has been published in Scientific Reports, a Nature Portfolio journal (Press release, JCRI-ABTS, APR 28, 2021, View Source [SID1234578686]).

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Authors on the paper were Olivia Jones, BS (JCRI-ABTS), Xiaoqian Cheng, PhD (JCRI-ABTS), Saravana R.K. Murthy, PhD (JCRI-ABTS), Lawan Ly, BS (JCRI-ABTS), Taisen Zhuang, PhD (USMI), Giacomo Basadonna, MD/PhD (Department of Surgery, University of Massachusetts School of Medicine), Michael Keidar, PhD (School of Engineering and Applied Science, The George Washington University) and Jerome Canady, MD (JCRI-ABTS/GWU).

The focus of the study was to characterize the efficacy of FOLFIRINOX in combination with CHCAP to understand potential synergetic effects on Cholangiocarcinoma (CCA) cells.

CCA is a rare biliary tract cancer with a high recurrence rate after surgical resection and a low five-year survival rate. Current treatments include systemic chemotherapeutic regimens such as FOLFIRINOX. A limitation of this chemotherapy regimen is its toxicity and adverse events. There exists a need for therapies to alleviate the toxicity of a FOLFIRINOX regimen while enhancing, or not altering, its anticancer properties.

According to Jerome Canady, MD, and Chief Science Officer, "Our analysis of cell viability, proliferation, and the cell cycle demonstrated that CHCAP in combination with FOLFIRINOX is more effective than either treatment alone. This study provides insights for the clinical application of CHCAP for cholangiocarcinoma cancer treatment, and we believe CHCAP could be a possible adjuvant therapy for the treatment of cholangiocarcinoma and pancreatic cancer."

JCRI-ABTS and sister company USMI have recently successfully completed their Phase 1 Clinical Trail using Canady Helios Cold Atmospheric Plasma (CHCAP) for the treatment of recurrent and stage 4 solid tumors (IDE #G190195).

The organizations have also developed dosage protocols for over 30 cancer types to be delivered with their newly developed robotic assisted surgical system and are planning several clinical trials for later this year including breast, prostate, sarcomas, head and neck and gastrointestinal solid tumor cancer trials.

Adcentrx Therapeutics Announces Completion of $50m Series A Financing Led By CBC Group To Accelerate Next-Generation Conjugate Drugs Research & Development

On April 28, 2021 Adcentrx Therapeutics ("Adcentrx"), a biotechnology company focused on accelerating breakthroughs in antibody drug conjugate ("ADC") therapeutic development, reported the closing of $50m Series A financing to power the development of next generation ADC for improving patient treatment options (Press release, Adcentrx Therapeutics, APR 28, 2021, View Source;development-301278632.html [SID1234578768]). This round of financing was led by CBC Group ("CBC"). Zoo Capital, Boyu Capital’s venture arm, also joined this round.

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Adcentrx was founded by a veteran ADC team with extensive experience in ADC conjugation, target biology and CMC. The founder, Dr. Hui Li, was the CEO of Levena Biopharma, the ADC subsidiary of Sorrento Therapeutics. Dr. Pia Challita-Eid, head of research at Adcentrx, has led teams at Agensys, responsible for novel target and drug discovery. She has contributed to the progression of a dozen ADCs into the clinic, including recently FDA approved PADCEV (Anti-Nectin-4). Dr. Alexander Chu-Kung, head of development at Adcentrx, was a principal engineer at AbbVie, overseeing process development to commercialization ready manufacturing of ADC drugs and other biological therapies. He has led development teams preparing multiple ADC projects for commercialization.

"We are pleased with the progress we have made to date on our proprietary conjugation platform and we are looking forward to moving a set of innovative new drugs into development," said Dr. Hui Li, CEO and founder of Adcentrx. "With this round of financing, we have the ability to progress multiple discovery and development programs. CBC has shown unwavering support in our endeavor and mission of bringing innovative and effective treatments to underserved patient populations."

"We’re thrilled to work alongside industry veterans with an impressive track record of efficiently developing drugs in the ADC space," said Ms. Meng Jiang, Managing Director of CBC. "Beyond the innovative pipeline already assembled, we see additional promise in creation of their proprietary conjugation platform and how it can accelerate development of more ADC programs that offers clear efficacy and safety differentiation."

CRISPR Therapeutics Announces Trials in Progress Poster Presentation at the 2021 American Society of Clinical Oncology Annual Meeting

On April 28, 2021 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that it will present a Trials in Progress poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper), to be held in a virtual format from June 4 to 8, 2021 (Press release, CRISPR Therapeutics, APR 28, 2021, View Source [SID1234578628]).

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The Trials in Progress poster presentation will summarize the study design for the Company’s ongoing Phase 1 CARBON trial assessing the safety and efficacy of several dose levels of CTX110, its wholly-owned allogeneic CAR-T investigational therapy targeting CD19, for the treatment of relapsed or refractory B-cell malignancies.

Title: A phase 1 dose escalation and cohort expansion study of the safety and efficacy of allogeneic CRISPR-Cas9–engineered T cells (CTX110) in patients (Pts) with relapsed or refractory (R/R) B-cell malignancies (CARBON).
Session Title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Abstract Number: TPS7570, e-poster
Date and Time: Friday, June 4, 2021 at 9:00 AM ET via the ASCO (Free ASCO Whitepaper) website, View Source

About CTX110
CTX110, a wholly owned program of CRISPR Therapeutics, is a healthy donor-derived gene-edited allogeneic CAR-T investigational therapy targeting cluster of differentiation 19, or CD19. CTX110 is being investigated in the ongoing CARBON trial.