On June 1, 2021 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported that Mark Gelder, M.D. will be joining Onconova as Chief Medical Officer (CMO), effective as of June 14, 2021 (Press release, Onconova, JUN 1, 2021, View Source [SID1234583327]).

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"Mark’s extensive experience leading clinical oncology programs at all stages of development makes him an ideal fit for Onconova. He will add great depth to our management team," said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. "His wide ranging medical and scientific expertise, which notably covers the development of kinase inhibitors as cancer therapeutics, will be invaluable as we work to advance ON 123300’s clinical development, facilitate the progression of rigosertib’s investigator-initiated trials, and evaluate potential candidates for in-licensing. I am thrilled that Mark will be joining Onconova and eager to begin working together."

Dr. Gelder is an accomplished industry leader with more than 35 years of experience in clinical development, medical affairs, and medical marketing. He was most recently the CMO of Elevar Therapeutics, where he led the company’s clinical development, medical affairs, regulatory affairs, and preclinical teams. Prior to his time at Elevar, Dr. Gelder served as the CMO of Pierian Biosciences (formerly DiaTech Oncology), Accelovance, Inc., and Heron Therapeutics, Inc. Dr. Gelder also has extensive experience at large pharmaceutical companies, as he previously worked in global medical affairs and led therapeutic oncology programs for Pfizer, Wyeth, and Bayer. Dr. Gelder has led successful early- and late-stage global clinical trials and has been involved in the approval and launch of several cancer therapeutics. Prior to his career in the biopharmaceutical industry, Dr. Gelder was an investigator in multiple clinical trials and authored numerous scientific papers in the areas of women’s health and oncology. He earned his M.D. from the University of Virginia School of Medicine and completed a fellowship in gynecologic oncology. He is a Fellow of the American College of Physicians and the American College of Obstetrics and Gynecology.

Dr. Gelder commented, "The opportunity to serve as Onconova’s CMO is truly exciting, and I look forward to leading the continued development of the Company’s pipeline at this important time. ON 123300 is rapidly progressing through its two Phase 1 trials and the potential to bring a best-in-class novel agent to women with HR+ HER2- metastatic breast cancer and additional oncologic indications is a unique opportunity based on its mechanism of action to overcome CKD 4/6 resistance mechanisms. I am also highly impressed with rigosertib’s investigator-initiated program and am eager to apply my expertise towards the Company’s in-licensing strategy to expand its pipeline. I believe that my skill set and those of my new colleagues are highly complementary, which will serve us well as we seek to deliver new therapeutics to cancer patients in need."

On June 1, 2021 argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, reported that members of management will participate in the following upcoming investor conferences (Press release, argenx, JUN 1, 2021, View Source [SID1234583326]):

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Goldman Sachs 42nd Annual Global Healthcare Conference. Fireside chat on Tuesday, June 8, 2021 at 2:10 p.m. ET.
JMP Securities Life Sciences Conference. Fireside chat on Wednesday, June 16, 2021 at 11:00 a.m. ET.
J.P. Morgan European Healthcare Conference. Management will participate in investor meetings on Thursday, June 17, 2021.
Raymond James Human Health Innovation Conference. Management will participate in a panel discussion on Tuesday, June 22, 2021 at 12:00 p.m. ET.
Additional information regarding these events will be available on the Company’s website at www.argenx.com.

On June 1, 2021 TRACON Pharmaceuticals (NASDAQ: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported that the Independent Data Monitoring Committee for the ENVASARC pivotal trial has recommended that the trial will proceed as planned following the review of safety data from more than 20 patients enrolled into the trial to date (Press release, Tracon Pharmaceuticals, JUN 1, 2021, View Source [SID1234583325]). The safety data reviewed included data from more than 10 patients enrolled into cohort A of treatment with single agent envafolimab and more than 10 patients enrolled into cohort B of treatment with envafolimab and Yervoy (ipilimumab).

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"We are pleased with the recommendation of the Data Monitoring Committee to continue the ENVASARC pivotal trial as planned," said James Freddo, M.D., TRACON’s Chief Medical Officer, "Envafolimab has been well tolerated as a single agent and when combined with Yervoy in these patients with refractory sarcoma who are enrolled in the ENVASARC trial. Based on the current accrual rate, we expect the Data Monitoring Committee to review additional safety data in the third quarter and to review interim efficacy data in the fourth quarter of this year."

About Envafolimab

Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in pivotal trials. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the U.S. sponsored by TRACON, has been studied in a completed Phase 2 pivotal trial as a single agent in MSI-H/dMMR advanced solid tumor patients in China and is being studied in an ongoing Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China, with both Chinese trials sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. Alphamab Oncology and 3D Medicines submitted an NDA to the NMPA in China for envafolimab in MSI-H/dMMR cancer that was accepted for review in December 2020 and granted priority review in January 2021.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multi-center, open label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in the United States that began dosing in December 2020. TRACON expects the trial to enroll 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into cohort A of treatment with single agent envafolimab and 80 patients enrolled in cohort B of treatment with envafolimab and Yervoy. The primary endpoint is ORR by blinded independent central review with duration of response a key secondary endpoint.

On June 1, 2021 Voisin Consulting Life Sciences (VCLS), a leading global HealthTech product development consultancy company, reported the acquisition of Quanta Medical, a privately-held company focusing on designing, implementing and reporting clinical studies with proprietary digital tools for the healthcare industry (Press release, VCLS, JUN 1, 2021, View Source [SID1234583324]).

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The transaction brings together two high-quality, innovative, and growing organizations with similar cultures and a shared commitment on high quality and efficient clinical trial protocol design and execution, from Phase 1 to post-approval studies.

The combination will address the growing market need for de-centralised and hybrid trial solutions with increasing volume of patient data from multiple data sources.

Biopharma, medical device and cosmetic manufacturers of all sizes will benefit from broader service offerings, deeper therapeutic expertise, digital healthcare technology innovation, and functional talent and capabilities.

"This acquisition will reinforce VCLS with a broaden foothold in the clinical operations space. Quanta Medical’s experience in protocol design and in running interventional and non-interventional clinical studies with a patient-centric approach, complements our clinical operations capacity. Quanta Medical’s expertise in Health Risk Assessment will also be a tremendous addition to VCLS. QData, its Malagasy subsidiary specializing in data management and biostatistics, also offers a suite of robust e-clinical applications. Both participate greatly to VCLS end-to-end solutions for HealthTech developers. We look forward to adding the talented employees of Quanta Medical and QData to our organization," said Emmanuelle Voisin, Founder and CEO of VCLS.

"I am thrilled to be joining with VCLS, a company with similar culture and values. I’m deeply indebted to Quanta Medical and QData outstanding employees who have helped me over the years bring healthcare to patients in a smart and efficient way", said Othar Zourabichvili, Founder & CEO of Quanta Medical and QData. "I am confident that VCLS, as a global leader in regulatory science and clinical operations, is the best organization to carry this expertise forward."

Redoaks (Benoît David) acted as the Sole Financial Advisor to both parties. Redoaks assisted Quanta Medical and Voisin Consulting Life Sciences in preparing and coordinating the process, organising the due diligence, providing sector and process intelligence, and helping in the negotiation of the transaction key terms.

On June 1, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported it has reached the terms of an agreement to acquire HalioDx in a transaction to further accelerate growth and strengthen Veracyte’s global leadership in cancer diagnostics (Press release, Veracyte, JUN 1, 2021, View Source [SID1234583323]).

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"The acquisition of HalioDx will further enable our long-term growth by providing key strategic capabilities to help us to execute on our powerful vision of improving outcomes for patients all over the world at every step of their journey," said Bonnie Anderson, Veracyte’s executive chairwoman. "Our prior strategic acquisitions brought exclusive global access to a best-in-class diagnostic platform and a significantly expanded cancer testing menu. We believe HalioDx will help fuel our global growth by accelerating IVD test development and manufacturing operations in Europe and by expanding our scientific expertise into the emerging immuno-oncology field. Additionally, their commercial-stage colon cancer immune response test will broaden our testing menu to 8 of the top 10 cancers."

HalioDx is an immuno-oncology diagnostics company providing oncologists and drug development organizations with first-in-class diagnostic products and services to guide cancer care and contribute to precision medicine. The company provides a unique range of immune assessment solutions, including its flagship Immunoscore assay for assessing the immune contexture of a tumor as a key determinant of patients’ outcomes and response to cancer treatments. HalioDx has developed a unique biopharma partnering ecosystem for the identification of clinically relevant biomarker signatures, the demonstration of their utility in clinical trials and the development and commercialization of resulting IVD and companion diagnostic tests. The company operates CLIA-certified laboratories in the United States and France, as well as a manufacturing facility in France that develops, manufactures, and distributes in vitro diagnostic clinical products.

Strategic Benefits for Global Growth

Enables Veracyte to develop and manufacture test kits for the nCounter diagnostic platform. The company plans to transition manufacturing of the kits, currently produced by NanoString, to HalioDx’s manufacturing facility in Marseille, France. This would further accelerate the expansion of test menu on the nCounter platform in Europe and other strategic global markets.
Deepens Veracyte’s scientific capabilities. HalioDx’s unique Immunogram multimodal analysis platform offers potential pipeline development opportunities in a range of clinical indications and can serve as a platform to grow Veracyte’s biopharma partnering business. HalioDx’s deep expertise in immuno-oncology is complementary with Veracyte’s expertise in cancer genomics and large biorepository of genomic content built from whole transcriptome data.
Expands Veracyte’s cancer diagnostics scope to 8 of the 10 top cancers by U.S. incidence. The addition of HalioDx’s Immunoscore test to guide treatment decisions in colorectal cancer will further expand Veracyte’s menu of high-value advanced diagnostic tests that address unmet needs at multiple points in the patient care continuum.
Marc Stapley, Veracyte’s chief executive officer, said, "Adding HalioDx to Veracyte is a strategic investment that we believe will position the company to unlock its growth potential. With this acquisition, we will have the parts needed to expand our business globally. Veracyte plays an increasingly vital role in advancing patient outcomes and care, and I’m excited to bring my experience building and leading complex global organizations to the company. I look forward to partnering with Bonnie, who will oversee completion of this acquisition and lead the strategic integration, and to welcoming the HalioDx team to Veracyte so we can work together to improve care for patients all over the world."

"Veracyte is a leading global diagnostics company with strong expertise in genomic testing through both centralized and distributed tests," said Vincent Fert, HalioDx’s chairman and chief executive officer. "We are aligned with their mission to improve care for patients and believe our capabilities and expertise in immuno-oncology and diagnostic development and manufacturing are highly complementary to their business and strategic vision. The transaction gives us the opportunity to significantly accelerate the scale and scope of our offerings and continue investing in our innovative Immunogram multimodal analysis platform, which is proven in its ability to help biopharma partners understand and predict patient response to immunotherapy."

Transaction Terms and Other Information

Upon completion of the required works council consultations, Veracyte expects that the shareholders of HalioDx will enter into a definitive purchase agreement with Veracyte for the purchase and sale of HalioDx. Upon the closing of the transaction, HalioDx will become a subsidiary of Veracyte. At closing, Veracyte will pay approximately €260 million in total consideration to HalioDx security holders, consisting of approximately €147 million in cash and up to approximately €113 million in stock, subject to customary purchase price adjustments. The number of Veracyte shares issued in the transaction will be based on a 10-day volume-weighted trading average of Veracyte shares prior to the closing date. However, without changing the total consideration paid at closing, Veracyte has the option, at its sole discretion, to substitute cash in lieu of shares in any amount up to the entire acquisition consideration. The transaction, which has been unanimously approved by Veracyte’s board of directors and is fully supported by the HalioDx board of directors, is expected to close in the third fiscal quarter of 2021, subject to the satisfaction of customary closing conditions, including foreign investment approval in France.

Veracyte expects the acquisition of HalioDx to be accretive to its revenue growth in 2021 and to expand the near-term addressable markets for Veracyte’s current and pipeline tests. Veracyte also expects the transaction to be strategically accretive to its gross margins once it transitions manufacturing of test kits to HalioDx for use on the nCounter Analysis System.

HalioDx’s operations and laboratories will remain in Marseille, France and Richmond, Virginia.

Advisors

Goldman Sachs & Co. LLC is serving as financial advisor to Veracyte, and Fenwick & West LLP and Latham & Watkins LLP are serving as Veracyte’s legal advisors in the United States and France, respectively. Shearman & Sterling LLP is serving as legal advisor to HalioDx.

Conference Call and Webcast Details

Veracyte will host a conference call and webcast on Tuesday, June 1, at 8:00 a.m. Eastern Time to discuss the transaction. The conference call will be streamed live via webcast from the company’s website at the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source