On December 21, 2021 EXUMA Biotech, Corp., a clinical-stage biotechnology company discovering and developing cell and gene therapies and delivery solutions for liquid and solid tumors, reported the completion of a $41 million Series B2 financing (Press release, EXUMA Biotechnology, DEC 21, 2021, View Source [SID1234597526]). The Series B2 brings the total capital raised since its inception to approximately $130 million.

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Proceeds will be used to support further development of EXUMA’s autologous subcutaneous rPOC CAR-TaNK (T- and NK-like) platform for hematologic and solid tumors and continued clinical investigation of its Tumor Metabolism Regulated (TMR) CAR technology targeting solid tumors. New investors in the Series B2 financing included Americo Life, Inc., in addition to existing investors.

"We are pleased to expand our investor base with support from this strategic group of investors who recognize the potential of our technologies to translate into life-changing therapies for cancer patients," said Gregory Frost, Ph.D., EXUMA Biotech Chairman and Chief Executive Offer.

Additionally, the company announced that Houston Holmes, M.D., MBA, FACP has been appointed to its Board of Directors.

"Dr. Holmes is a renowned cancer specialist who will make an outstanding addition to our board of directors. He has dedicated his life to researching advanced cellular and immunotherapy treatments for hematologic malignancies and to the education of the oncology community about these new modalities," said Frost.

Houston Holmes, M.D., received a BS in medical microbiology from Stanford University School of Medicine, an MD from the University of Texas Southwestern Medical School, and an MBA from the University of Texas at Dallas. He completed an internship and residency in internal medicine at Baylor University Medical Center, and fellowship in medical oncology/hematology at the National Cancer Institute/National Heart, Lung, and Blood Institute. Dr. Holmes has been in practice for over 20 years.

"It’s an exciting time for cell and gene therapies. I’m thrilled to be a part of EXUMA and to join the company in its mission to advance innovative therapies towards the clinic and for cancer patients in urgent need of new treatments," said Houston Holmes, M.D.

On December 21, 2021 EVERSANA, the pioneer of next generation commercial services to the global life sciences industry, reported it has completed its acquisition of Intouch Group, a full-service global agency network serving the pharmaceutical industry (Press release, EVERSANA, DEC 21, 2021, View Source [SID1234597525]). The acquisition immediately propels EVERSANA’s position as a $1 billion commercial services leader with more than 40 locations and 5,500 employees worldwide, poised to solve any global pricing, access, reimbursement, promotion, adherence, or product delivery challenge.

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"Today marks a milestone day for not only our employees and clients, but for an industry desperately in need of a better way to bring innovations to market, create long-term value, and improve patient lives," said Jim Lang, CEO of EVERSANA. "With the added power of Intouch and millions more invested in data, analytics and digital transformation, we are reinventing commercial approaches for the benefit of our clients and their patients."

Under terms of the agreement announced in October 2021, Intouch’s industry-leading creative and media services, enterprise solutions and data analytics will join EVERSANA’s fully integrated commercialization services platform. Agencies from both firms will integrate, as EVERSANA ENGAGE joins forces with the Intouch agency network. Faruk Capan, CEO of Intouch Group, now reports to Jim Lang.

"This is so much more than an integration. This is our opportunity to improve every sector of product commercialization," said Capan. "Over the last 20 years we transformed pharmaceutical promotion and digital engagement. Imagine what the next 20 years will bring as we set our sights even higher, unafraid to transform healthcare as we know it."

Financial details will not be disclosed. Houlihan Lokey served as the exclusive financial advisor to Intouch Group.

On December 21, 2021 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a commercial-stage biopharmaceutical company developing innovative medicines to improve the lives of people with cancer, reported that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for QINLOCK (ripretinib) in the UK for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib1 (Press release, Deciphera Pharmaceuticals, DEC 21, 2021, View Source [SID1234597524]).

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"The approval of QINLOCK in the UK is an important milestone for patients with advanced GIST who have been waiting for a new treatment option," said Steve Hoerter, President and Chief Executive Officer of Deciphera. "The results from the INVICTUS study underscore the potential for QINLOCK to transform the treatment of advanced GIST and establish a new standard of care in the UK for fourth-line GIST."

The QINLOCK approval was supported by efficacy results from the primary analysis of the pivotal Phase 3 INVICTUS study in patients with advanced GIST as well as combined safety results from INVICTUS and the Phase 1 study of QINLOCK. In INVICTUS, QINLOCK demonstrated a median progression-free survival of 6.3 months compared to 1.0 month in the placebo arm and significantly reduced the risk of disease progression or death by 85% (hazard ratio of 0.15, p<0.0001)2. Secondary endpoints include Objective Response Rate (ORR) as determined by independent radiologic review using modified RECIST and Overall Survival (OS). QINLOCK demonstrated an ORR of 9.4% compared with 0% for placebo (p =0.0504)2 In addition, QINLOCK demonstrated a median overall survival of 15.1 months compared to 6.6 months in the placebo arm and reduced the risk of death by 64% (hazard ratio of 0.36)2.

The most frequently observed adverse drug reactions (≥25%) in a pooled safety population (n=392) treated with QINLOCK were fatigue, alopecia, nausea, myalgia, constipation, diarrhea, palmar-plantar erythrodysesthesia syndrome (PPES), weight decreased, and vomiting1,2.

In the INVICTUS study, adverse reactions resulting in permanent discontinuation occurred in 8% of patients, dosage interruptions due to an adverse reaction occurred in 24% of patients and dose reductions due to an adverse reaction occurred in 7% of patients who received QINLOCK2.

About QINLOCK (ripretinib)

QINLOCK is a switch-control tyrosine kinase inhibitor that was engineered to broadly inhibit KIT and PDGFRA mutated kinases by using a dual mechanism of action that regulates the kinase switch pocket and activation loop. QINLOCK inhibits primary and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18 involved in GIST, as well as the primary exon 17 D816V mutation3,4. QINLOCK also inhibits primary PDGFRA mutations in exons 12, 14, and 18, including the exon 18 D842V mutation, involved in a subset of GIST3,4.

On December 21, 2021 Biomea Fusion, Inc. ("Biomea") (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel irreversible small molecules to treat and improve the lives of patients with genetically defined cancers, reported that it will present at the upcoming virtual 40th Annual J.P. Morgan Healthcare Conference (Press release, Biomea Fusion, DEC 21, 2021, View Source [SID1234597523]). Thomas Butler, Chief Executive Officer and Chairman of the Board, is scheduled to present on Wednesday, January 12, 2022, at 12:00pm Pacific Time.

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A live audio webcast of the presentation can be accessed at www.biomeafusion.com and will be available for 30 days following the presentation.

On December 21, 2021 Bio-Techne Corporation (NASDAQ: TECH) reported William A. Geist has been appointed President, Protein Sciences Segment, effective January 3, 2022 (Press release, Bio-Techne, DEC 21, 2021, View Source [SID1234597522]). Mr. Geist succeeds N. David Eansor, who will be retiring from the Company. Mr. Eansor will remain with Bio-Techne through the end of February 2022 to ensure a smooth transition.

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Mr. Geist has over two decades of experience as a senior life science tools leader, most recently serving as Chief Operating Officer for Quanterix, where he was responsible for enterprise-wide operations and strategy deployment. Previously Mr. Geist was Vice President & General Manager for two of Thermo Fisher Scientific’s largest Business Units, Protein & Cell Analysis and qPCR. Prior to Thermo Fisher Scientific, Mr. Geist was Vice President of QuantaBiosciences, a QIAGEN company, where he held various roles of increasing responsibility from the company’s inception through its acquisition.

"I want to personally thank Dave for his leadership and significant contributions over the last seven years at Bio-Techne. He has played an integral role in the Company’s success, and I wish him the best in his retirement," said Chuck Kummeth, President and Chief Executive of Bio-Techne. "Will is joining Bio-Techne at a very exciting point in the Company’s growth trajectory. His experience running life science tools businesses generating over $1 billion in annual revenue make him the ideal candidate to take the Protein Sciences Segment through its next phase of growth."