Poseida Therapeutics to Present at American Society of Gene and Cell Therapy 25th Annual Meeting

On May 2, 2022 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, reported that preclinical data highlighting the use of anti-c-kit CAR-T cells, P-ckit-ALLO1 as a preconditioning agent to enable hematopoietic stem cell (HSC) transplants, will be presented at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting, being held in Washington, D.C. and virtually on May 16-19, 2022 (Press release, Poseida Therapeutics, MAY 2, 2022, View Source [SID1234613412]).

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The Company’s anti-c-kit CAR-T program leverages its proprietary piggyBac Gene Delivery System and Cas-CLOVER Site-specific Gene Editing System to develop fully allogeneic CAR-T cells targeting human c-kit which is highly expressed on HSCs, as well as on myeloid malignancies such as acute myeloid leukemia (AML), meaning the treatment can be used for either HSC transplant conditioning or as a treatment for AML. In addition to the CAR gene, the piggyBac transposon includes a selection marker for generation of a pure CAR+ product and a proprietary fast-acting safety switch enabling rapid clearance of the reactive CAR-T cells prior to donor HSC transplant.

Presentation details:

Poster Presentation: Anti-c-kit CAR-T Cells Enable HSC Engraftment in a Humanized Model of Stem Cell Transplant Conditioning
Session Title: Cell Therapies II
Session Date/Time: Tuesday, May 17, 2022, 5:30 – 6:30 PM ET
Poster Board Number: Tu-239
Location: Walter E. Washington Convention Center, Hall D
Abstract Number: 734

Kiniksa Pharmaceuticals to Report First Quarter 2022 Financial Results on May 3, 2022

On May 2, 2022 Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) reported that it will host a conference call and live webcast on Tuesday, May 3, 2022, at 8:30 a.m. Eastern Time to report its first quarter 2022 financial results and corporate activities (Press release, Kiniksa Pharmaceuticals, MAY 2, 2022, View Source [SID1234613410]).

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A live webcast will be accessible through the Investors & Media section of the company’s website at www.kiniksa.com. A replay of the webcast will also be available on Kiniksa’s website within approximately 48 hours of the event. The conference call can be accessed by dialing (866) 614-0636 (U.S. and Canada) or (409) 231-2053 (international) using conference ID number 7787467.

Phio Pharmaceuticals Announces Upcoming Presentation of PH-894 Data at ASGCT 25th Annual Meeting 2022

On May 2, 2022 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company developing the next generation of therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported that it will present new preclinical data on PH-894 for use in adoptive cell therapy (ACT) at the American Society for Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting, which is being held May 16-19, 2022 in-person in Washington, D.C. and virtually (Press release, Phio Pharmaceuticals, MAY 2, 2022, View Source [SID1234613354]).

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Sema4 Announces the Completion of the GeneDx Acquisition and a Streamlined Leadership Structure to Accelerate Growth of its Diagnostic and Clinical Data Platforms

On May 2, 2022 Sema4 (Nasdaq: SMFR), an AI-driven genomic and clinical data intelligence platform company, reported it has completed the acquisition of GeneDx, LLC ("GeneDx"), a leader in genomic testing and analysis for rare disorders, from OPKO Health, Inc. (Nasdaq: OPK) ("OPKO") (Press release, Opko Health, MAY 2, 2022, View Source [SID1234613353]). The transaction establishes Sema4 as one of the largest and most advanced providers of genomic testing in the U.S. and further strengthens its health information database to transform patient care and improve therapeutic development. The acquisition accelerates Sema4’s ability to deliver precision medicine while driving efficiency in its platform.

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Sema4 has streamlined its management team to enable focused execution across its top business priorities, including expanded molecular testing and data-driven health system and biopharma partnerships. Katherine Stueland, former President and CEO of GeneDx and former Chief Commercial Officer of Invitae, will serve as Sema4’s CEO and will serve on Sema4’s Board of Directors. Ms. Stueland brings more than 25 years of experience in the healthcare industry, having overseen multiple commercial organizations and corporate brand transformations.

"I am delighted to have the opportunity to lead Sema4 as we embark on this next chapter for the combined company, with a focus on growth, operating efficiency, scaling toward profitability, and transformational partnerships," said Ms. Stueland. "Our vision is to accelerate the use of genomics and leverage large-scale clinical data to enhance the standard of care through extensive precision medicine solutions. I look forward to realizing that vision with Sema4’s unmatched health intelligence platform, enabling comprehensive family health, from planning a pregnancy through every stage of life."

"The combined company has excellent momentum heading into the remainder of this year," continued Ms. Stueland. "We look forward to providing a comprehensive financial update and forward looking guidance during our first quarter earnings conference call on May 12th."

Eric Schadt, PhD, Sema4’s Founder, will serve as President and Chief Research & Development Officer, reporting to Ms. Stueland, and will continue to serve on the Board of Directors.

"We are very excited to add GeneDx’s complementary capabilities and are equally thrilled to welcome Katherine as our new CEO, given her extensive leadership, commercial, and operational experience," said Dr. Schadt. "This transformative evolution in the scale of our business positions Sema4 to further revolutionize patient care and to provide more holistic support to health system and biopharma partners. I am excited by the opportunity to redouble my efforts to drive our data platform forward and transform not only clinical practice but the way biopharma companies use data to drive innovation."

Summary of Transaction Details
Under the terms of the agreement, Sema4 has acquired GeneDx for an upfront payment of $150 million in cash, subject to adjustment, plus 80.0 million shares of Sema4’s Class A common stock, with up to an additional $150 million revenue-based milestones over the next two years (which will be payable in cash or shares of Sema4 Class A common stock at Sema4’s discretion). Based on the closing stock price of Sema4’s Class A common stock as of April 29, 2022, the trading date on the closing of the transaction, the total upfront consideration represents approximately $322 million, and the total aggregate consideration including potential milestones is approximately $472 million.

The transaction was announced on January 18, 2022 and received approval from Sema4 stockholders on April 27, 2022.

In connection with the transaction, Sema4 has also closed a private placement financing in which it sold $200 million of Sema4’s Class A common stock at a price of $4.00 per share with a syndicate of institutional investors, including Pfizer.

Athenex, Texas Children’s Cancer Center, and the Center for Cell and Gene Therapy at Baylor College of Medicine to Present Phase 1 Clinical Data for KUR-501, an autologous GD2 CAR-NKT Cell Therapy for Relapsed/Refractory High Risk Neuroblastoma at the ASG

On May 2, 2022 Athenex (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that the Company will present at the upcoming ASGCT (Free ASGCT Whitepaper) 25th Annual Meeting, taking place May 16-19, 2022, in Washington, D.C (Press release, Athenex, MAY 2, 2022, View Source [SID1234613349]). The abstract associated with the presentation is now available on the conference website.

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Details of the presentations are as follows:

Oral Presentation Details

Abstract 54: Anti-GD2 CAR NKT cells are safe and produce antitumor responses in patients with relapsed/refractory neuroblastoma
Date/Time: Monday, May 16, 2022, 2:30 PM – 2:45 PM ET
Session: Gene and Cell Therapy Trials in Progress
Presenter: Dr. Andras Heczey, Baylor College of Medicine
Location: Room 201, Walter E. Washington Convention Center, 801 Mt Vernon Pl NW Washington, D.C.

"Observing evidence of a dose response is extremely encouraging, and we are excited to see two out of three responses at 100 million cells/m2," said Dan Lang, M.D., President of Athenex Cell Therapy. "We are hopeful that we will see additional responses as we move to higher doses. We and our partners at Baylor College of Medicine (BCM) and Texas Children’s Hospital (TCH) continue to be motivated by the data and look forward to our next update."

About KUR-501

KUR-501, is an autologous NKT cell CAR product that targets GD2, a tumor-associated antigen that is expressed on almost all neuroblastomas as well as melanomas, some sarcomas, and a variety of other tumors. GINAKIT2, a phase 1 single arm clinical study (NCT03294954) of KUR-501, in patients with refractory or recurrent high-risk neuroblastoma will evaluate up to six dose levels of KUR-501 following lymphodepletion with cyclophosphamide and fludarabine.

Neuroblastoma, a pediatric cancer of the sympathetic nervous system, typically the adrenal gland, is associated with a poor prognosis in children with high-risk disease and is a significant unmet medical need. The KUR-501 development program will provide autologous proof-of-concept for CAR-NKT cells in solid tumors using a validated target.

The GINAKIT2 study is supported by Athenex, Inc., which acquired Kuur Therapeutics in May 2021, as well as by Alex’s Lemonade Stand Foundation. This study is currently recruiting patients at BCM/TCH.