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.

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.

On May 2, 2022 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to darovasertib, a potential first-in-class protein kinase C (PKC) inhibitor, for the treatment of uveal melanoma (Press release, Ideaya Biosciences, MAY 2, 2022, View Source [SID1234613343]).

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IDEAYA is currently evaluating the synthetic lethal combination of darovasertib, a PKC inhibitor, and crizotinib, a cMET inhibitor, in patients with metastatic uveal melanoma (MUM) and in patients with GNAQ or GNA11 mutant solid tumors, in an ongoing Phase 1/2 clinical trial (NCT03947385) pursuant to a clinical trial collaboration and supply agreement with Pfizer.

"We are excited to advance darovasertib towards a potential registration-enabling trial in metastatic uveal melanoma, and the orphan-drug designation is an important step towards our goal to bring this novel therapy to patients," said Matthew Maurer, M.D., Vice President, Head of Clinical Oncology and Medical Affairs, at IDEAYA Biosciences.

Orphan-drug designation (ODD) is granted by the FDA to a drug or biologic intended to treat a rare disease or condition, which generally includes a disease or condition that affects fewer than 200,000 individuals in the U.S. Under the ODD, IDEAYA may be entitled to certain tax credits, exemption from user fees, and seven years of statutory marketing exclusivity, subject to FDA approval of a marketing application for darovasertib as a designated orphan-drug product.

As of May 1, 2022, Darovasertib has been evaluated in over 200 patients, including 74 patients in combination with crizotinib. The company is targeting a clinical data update for darovasertib and crizotinib combination in mid-2022, including tolerability and clinical efficacy. IDEAYA is also planning to seek FDA regulatory guidance for a potential registration-enabling trial design to evaluate the darovasertib and crizotinib combination in MUM in mid-2022. IDEAYA is preclinically evaluating potential expansion opportunities for darovasertib in other oncology indications, including in additional cMET-driven tumors, such as hepatocellular carcinoma and non-small cell lung cancer, and in KRAS G12C non-small cell lung cancer.

On May 2, 2022 Compugen Ltd. (NASDAQ: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported that the Company will release its first quarter 2022 financial results on Monday, May 16, 2022, before the U.S. financial markets open (Press release, Compugen, MAY 2, 2022, View Source [SID1234613342]). Management will not host a conference call to accompany this release.

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Management plans to provide a corporate update at two global investor healthcare conferences in June 2022. Details of the planned presentations will be provided closer to the events.

On May 2, 2022 XNK Therapeutics AB ("XNK") reported that an abstract on the long-term follow-up of the Phase I/II clinical trial study ACP-001 with its leading candidate drug has been selected for a presentation at European Hematology Association (EHA) (Free EHA Whitepaper)’s hybrid conference EHA (Free EHA Whitepaper)2022, which is held in Vienna, Austria, on June 9th-12th (Press release, XNK Therapeutics, MAY 2, 2022, View Source [SID1234613341]).

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The abstract, titled Autologous NK Cells as Consolidation After Front-Line Stem Cell Transplantation in Multiple Myeloma: A Long-Term Follow-Up, will be presented by the first author Johan Lund at a poster session on Friday, June 10, 16:30 – 17:45 CEST. The other authors include Hareth Nahi, Stephan Meinke, Per-Henrik Holmqvist, Hans-Gustaf Ljunggren, Johan Aschan and Evren Alici.

"We are very happy to be able to present this clinical long-term follow-up at this prestigious conference. It further strengthens our belief in this exciting clinical program, which also includes an ongoing clinical Phase II combination study with Sanofi’s anti-CD38 antibody Sarclisa (Isatuximab)", said XNK’s CMO Johan Aschan.