Fusion Pharmaceuticals Announces Pricing of Initial Public Offering

On June 25, 2020 Fusion Pharmaceuticals Inc. (NASDAQ: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported the pricing of its initial public offering of 12,500,000 common shares at a public offering price of $17.00 per share (Press release, Fusion Pharmaceuticals, JUN 25, 2020, View Source [SID1234561490]). All of the shares are being offered by Fusion. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Fusion, are expected to be $212.5 million. In addition, Fusion has granted the underwriters a 30-day option to purchase up to an additional 1,875,000 common shares at the initial public offering price.

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The shares are expected to begin trading on the Nasdaq Global Market on June 26, 2020 under the ticker symbol "FUSN." The offering is expected to close on June 30, 2020, subject to the satisfaction of customary closing conditions.

Morgan Stanley, Jefferies, and Cowen, are acting as joint book-running managers for the offering. Wedbush PacGrow is acting as lead manager for the offering.

A registration statement relating to these securities became effective on June 25, 2020. The offering will be made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, Second Floor, New York, New York 10014; or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone: (877) 547–6340 or by email at [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, by telephone at (833) 297-2926, or by email at [email protected].

Fusion obtained a receipt for a final base PREP prospectus filed with the securities commissions or similar securities regulatory authorities in each of the provinces of Canada, other than Québec, on June 25, 2020. A copy of the Canadian supplemented PREP prospectus containing pricing information and other important information relating to Fusion’s common shares may, when available, be obtained from Morgan Stanley Canada Limited and Jefferies Securities, Inc., care of the Morgan Stanley and Jefferies contact details referred to above. Prospective Canadian investors should clearly indicate in their request that they are a Canadian prospective investor and are requesting a copy of the Canadian supplemented PREP prospectus. When available, a copy of the Canadian supplemented PREP prospectus will be available on the SEDAR website at www.sedar.com under Fusion’s profile.

Eureka Therapeutics to Present at Oppenheimer’s Private Life Sciences Company Call Series

On June 25, 2020 Eureka Therapeutics, Inc., a clinical stage biotechnology company developing novel T cell therapies to treat solid tumors, reported that Dr. Cheng Liu, President and Chief Executive Officer, is scheduled to participate at Oppenheimer’s Private Life Sciences Company Call Series on Monday, June 29, 2020 (Press release, Eureka Therapeutics, JUN 25, 2020, View Source [SID1234561488]).

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Dr. Liu will be presenting the use of Eureka’s novel antibody-TCR receptor (ARTEMIS T cell) that has been engineered with a proprietary human TCR-mimic antibody to target the alpha fetoprotein (AFP)-peptide/HLA-A2 complex on HCC cancer cells.

Presentation Details

Title:


ARTEMIS Antibody TCR T Cell Therapy for Solid Tumors

Speaker:


Dr. Cheng Liu, President and CEO

Date:


Monday, June 29, 2020

Time:


3:00 p.m. EST

Location:


View Source

University of Arkansas for Medical Sciences Joins KIYATEC Clinical Study of Test to Predict Pre-Treatment, Patient-Specific Response to Ovarian Cancer Drugs

On June 25, 2020 KIYATEC, Inc. reported that the Winthrop P. Rockefeller Cancer Institute at the University of Arkansas for Medical Sciences (UAMS) has joined the growing roster of institutions participating in its 3D-PREDICT clinical study to validate the company’s test as a patient-specific predictor of response to recommended drug therapies for patients with ovarian cancer (Press release, KIYATEC, JUN 25, 2020, View Source [SID1234561487]).

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"Ovarian cancer patients and clinicians do not have the luxury of time to experiment with drug therapies they don’t know will work, so we developed our investigational ovarian cancer drug response profile to help optimize therapeutic decision-making over the course of the disease," said Matthew Gevaert, CEO of KIYATEC. "We are delighted to welcome UAMS to the 3D-PREDICT study as we endeavor to deliver on the promise of pre-treatment, patient-specific drug response profiling for ovarian cancer."

3D-PREDICT is a prospective, open-label, non-interventional study to validate KIYATEC’s ovarian cancer drug response profile, which leverages the company’s ex vivo 3D cell culture technology platform to assess pre-treatment, patient-specific response to a panel of 11 drugs most commonly used to treat patients with newly diagnosed or recurrent ovarian cancer. Details on the study can be found at View Source

"The Winthrop P. Rockefeller Cancer Institute is proud to offer 3D-PREDICT to our ovarian cancer patients. It is our hope that this trial will help develop a method to assist us in determining which drugs will most benefit individual patients and get them on the most effective treatment as quickly as possible," said Michael Birrer, M.D., Ph.D., vice chancellor and director of the Cancer Institute.

NeoImmuneTech Announces First Patient Dosed in Phase 1b/2a Study of NT-I7 (efineptakin alfa) and KEYTRUDA® (pembrolizumab) in Patients with Relapsed/Refractory Advanced Solid Tumors

On June 25, 2020 NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, reported the first patient has been dosed at The University of Texas MD Anderson Cancer Center in the Phase 1b/2a clinical trial of NT-I7 (efineptakin alfa) in combination with KEYTRUDA, a leading checkpoint inhibitor (CPI), for the treatment of patients with relapsed/refractory advanced solid tumors (Press release, NeoImmuneTech, JUN 25, 2020, View Source [SID1234561486]).

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"We’re very pleased to further progress this critically important clinical program quickly, despite the challenges due to the COVID-19 pandemic. Dosing the first patient in this study marks a major milestone in the development of NT-I7 for the treatment of patients with advanced solid tumors," said NgocDiep Le, M.D., Ph.D., Executive VP and Chief Medical Officer of NeoImmuneTech. "We will investigate clinically NT-I7’s potential to augment the already proven anti-tumor activity of pembrolizumab in CPI-responsive tumors. Additionally, we will also explore whether the combination can overcome CPI resistance. We hope that NT-I7 in combination with KEYTRUDA can improve the lives of cancer patients with various solid tumors."

The goal of the Phase 1b portion of the study, which will enroll up to 18 patients, is to establish a recommended dosing regimen. The Phase 2a portion will enroll up to 150 patients and will explore the preliminary anti-tumor activity of the combination therapy both in patients who have been treated with a CPI and patients who are CPI-naïve. The results of this study will be used to guide further clinical development of this combination in select tumor types.

More information can be found at www.neoimmunetech.com or www.clinicaltrials.gov, identifier: NCT04332653

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.

About NT-I7

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed in oncologic and immunologic indications, where T cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PD and safety profiles, making it an ideal combination partner. NT-I7 is being studied in multiple clinical trials in solid tumors and as vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

Aldevron Announces Agreement with Ziopharm Oncology for neoGMP® Production of Sleeping Beauty Plasmid DNA to Express TCRs for Treatment of Solid Tumors

On June 25, 2020 Aldevron, a leading provider of products and services for the biotechnology industry, reported an agreement with Ziopharm Oncology to produce plasmid DNA for T cell therapy of solid tumors(Press release, Aldevron, JUN 25, 2020, View Source [SID1234561484]). Aldevron has developed the neoGMP service level designed to address this new and rapidly growing market.

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"We are pleased to collaborate with Ziopharm Oncology on their innovative approach to expressing T cell receptors (TCRs) using the Sleeping Beauty non-viral gene transfer system," said Michael Chambers, Aldevron CEO. "Plasmid DNA is a key component in this process and Aldevron’s 22 years of experience enabled us to develop the neoGMP service to support this exciting area of personalized cancer treatment."

"Our strategic collaboration with Aldevron is an important part of our TCR-T therapy, as we advance our clinical programs for solid tumors targeting neoantigens," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of Ziopharm Oncology. "The rapid production of clinical-grade DNA plasmids expressing TCRs within the Sleeping Beauty system will help us achieve our goals of infusing genetically modified T cells to patients with solid tumors."

Under the agreement Ziopharm, based on their analyses of patient tumors, will identify TCRs on a patient-by-patient basis as well as assemble TCRs in a library for use in clinical trials. The company will use Aldevron’s neoGMP service to manufacture multiple DNA plasmids in an expedient, cost-effective manner.

For more information on Aldevron’s neoGMP service please visit aldevron.com/neoGMP.