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CASI Pharmaceuticals Announces CNCT19 (CD19 CAR-T) Receives China Breakthrough Therapy Designation

On December 23, 2020 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported that the Chinese Center for Drug Evaluation, a division of the China National Medical Products Association, has granted Breakthrough Therapy Designation ("Breakthrough Designation") to its partner Juventas Cell Therapy Ltd. for CNCT19, a potential CD19 CAR-T therapy for the treatment of adults with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) (Press release, CASI Pharmaceuticals, DEC 23, 2020, View Source [SID1234573227]). CASI has co-commercial rights to CNCT19 and is a shareholder of Juventas.

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The Breakthrough Designation for CNCT19 was granted based on initial data from the ongoing single arm, open-label, non-randomized, dose-escalation, Phase I study designed to determine the safety and efficacy of CNCT19 in B-ALL.

The Breakthrough Designation procedure is part of the recently revised Drug Registration Regulation which went into effect on July 1, 2020. The Breakthrough Designation process is designed to expedite the development and review of therapies that are intended for treatment of serious diseases for which there is no existing treatment and where preliminary evidence indicates advantages of the therapy over available treatment options.

Dr. Wei-Wu He, CASI’s Chairman, and CEO commented, "Our partner Juventas continues to make encouraging progress in developing their CD19 CAR-T therapy. Breakthrough Designation represents a significant regulatory milestone and has only been granted thirteen times in China. Receiving Breakthrough Designation is a very encouraging and important step forward for patients suffering from B-ALL."

About CNCT19

CNCT19 targets CD19, a B-cell surface protein widely expressed during all phases of B-cell development and a validated target for B-cell driven hematological malignancies. CD19- targeted CAR constructs from several different institutions have demonstrated consistently high antitumor efficacy in children and adults with relapsed B-cell acute lymphoblastic leukemia (B-ALL), chronic lymphocytic leukemia (CLL), and B-cell non-Hodgkin lymphoma (B-NHL). CD19 antigen is the most frequently used target in the CAR-T cell therapy clinical trials for hematological malignancies such as leukemia and lymphoma. Juventas is responsible for the development of CNCT19. CASI and Juventas will co-commercialize CNCT19 under the direction of the program’s joint steering committee.

About Juventas

Juventas Cell Therapy Ltd. is a China-based domestic company located in Tianjin City, China focused on cell therapy. The company’s lead product, CNCT19, devolved from the CD19 CAR-T, was originally created at the Institute of Hematology, Chinese Academy of Medical Sciences, one of the top hematology centers in China. CD19 CAR-T is used to treat patients with acute lymphoblastic leukemia and relapsed non-Hodgkin lymphoma.

Ziopharm to Participate in Upcoming January Conferences

On December 23, 2020 Ziopharm Oncology, Inc. ("Ziopharm" or "the Company") (Nasdaq: ZIOP), reported that Laurence Cooper, M.D., Ph.D., Chief Executive Officer of Ziopharm, is scheduled to participate in a fireside chat at the H.C. Wainwright Bioconnect 2021 Conference and will deliver a corporate overview at the 39th Annual J.P. Morgan Healthcare Conference (Press release, Ziopharm, DEC 23, 2020, View Source [SID1234573226]).

H.C. Wainwright Bioconnect 2021 Conference
Date: Monday, January 11, 2021
Time: 6:00 am ET (access to on demand webcast begins)

39th Annual J.P. Morgan Healthcare Conference
Date: Thursday, January 14, 2021
Time: 8:20 am ET
To access the webcast presentations, or the subsequent archived recordings, please visit the "Investors" section of the Ziopharm website at www.ziopharm.com.

Compugen Announces First Development Milestone in License Agreement with AstraZeneca for the Development of Bispecific and Multi-Specific Antibody Products

On December 23, 2020 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported progress from its ongoing license agreement with AstraZeneca (LSE/STO/Nasdaq: AZN), under which the program has achieved a preclinical milestone (Press release, Compugen, DEC 23, 2020, View Source [SID1234573223]). Under the terms of the agreement, Compugen provided an exclusive license to AstraZeneca for the development of bispecific and multi-specific antibody products based on one of Compugen’s pipeline programs, with AstraZeneca responsible for all research, development and commercial activities. In connection with this first milestone, Compugen is entitled to receive a $2 million payment from AstraZeneca.

"AstraZeneca choosing Compugen as a partner for its bispecific and multi-specific development plans is testament to the power of our platform, and we are proud that this program has now advanced to demonstrate therapeutic potential," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "This license agreement has enabled Compugen to monetize one of our programs outside our development focus and is part of our larger strategy to selectively collaborate with biopharmaceutical companies to leverage our diverse, computationally-discovered pipeline for the development of novel cancer immunotherapies. We are delighted that AstraZeneca has chosen to continue the development of this bispecific program, providing further validation of Compugen’s discovery and development capabilities."

About the Compugen-AstraZeneca License Agreement
In April 2018, Compugen and AstraZeneca entered into an agreement by which Compugen provided an exclusive license to AstraZeneca for the development of bispecific and multi-specific antibody products derived from one of Compugen’s pipeline programs. AstraZeneca has the right to create multiple products under this license and is solely responsible for all research, development and commercial activities. Compugen received a $10 million upfront payment and is eligible to receive up to $200 million in development, regulatory and commercial milestones for the first product as well as tiered royalties on future product sales. If additional products are developed, additional milestones and royalties would be due to Compugen. Under the terms of the license agreement, Compugen retained all other rights to its entire pipeline of programs as monotherapies and in combination with other products.

Halozyme Announces Roche Receives European Commission Approval For Phesgo® (Fixed-Dose Combination Of Perjeta® And Herceptin® For Subcutaneous Injection) Utilizing Halozyme’s ENHANZE® Technology For The Treatment Of Patients With HER2-Positive Breast Cancer

On December 23, 2020 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that the European Commission has approved Roche’s Phesgo, a fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with Halozyme’s ENHANZE technology, administered by subcutaneous injection for the treatment of patients with early and metastatic HER2-positive breast cancer (Press release, Halozyme, DEC 23, 2020, View Source [SID1234573222]). This is the first time the European Commission has approved a product combining two monoclonal antibodies that can be administered by a single subcutaneous injection utilizing Halozyme’s ENHANZE technology.

"We are pleased that HER2-positive breast cancer patients in Europe will now have the option to receive this important therapy in a substantially shorter period of time than standard IV therapy," said Dr. Helen Torley, president and chief executive officer. "The approval of Phesgo in Europe closes out a terrific year for Halozyme in which we received multiple regulatory clearances for products utilizing our ENHANZE technology, including 2 U.S. FDA approvals and now two European Commission approvals."

Phesgo is available in single-dose vials and can be administered via subcutaneous injection in approximately eight minutes for the initial loading dose and approximately five minutes for each subsequent maintenance dose.(1) This is compared to approximately 150 minutes for a sequential infusion of a loading dose of Perjeta and Herceptin using the standard IV formulations, and between 60-150 minutes for subsequent maintenance infusions of the two medicines.(2,3)

The approval of Phesgo in Europe is based on results from the pivotal phase III FeDeriCa study, which met its primary endpoint, with Phesgo showing non-inferior levels of Perjeta and Herceptin in the blood and demonstrated comparable efficacy versus IV administration of the two medicines. The safety profile of Phesgo with chemotherapy was comparable to IV administration of Perjeta plus Herceptin and chemotherapy. No new safety signals were identified, including no meaningful difference in cardiac toxicity.(1,4)

Phesgo has the potential to help minimize pressure on healthcare systems by reducing administration time, as well as other costs associated with treatment, such as time spent in the infusion chair and drug preparation(5). In addition, Roche’s phase II PHranceSCa study showed that 85% (136/160) of people receiving treatment for HER2-positive breast cancer preferred treatment under the skin to IV administration due to less time in the clinic and more comfortable treatment administration.(1)

About ENHANZE Technology
Halozyme’s proprietary ENHANZE drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

Biodesix Initiates Biomarker Study to Affirm Nodify XL2® Test’s Importance in Clinical Decision Making

On December 23, 2020 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company, reported the launch and active recruitment of a firstin-class biomarker study aligned with the recommendations from the official 2018 American Thoracic Society (ATS) policy statement on the early detection of lung cancer (Press release, Biodesix, DEC 23, 2020, View Source [SID1234573221]). The Nodify XL2 Classifier Clinical Utility Study in Low to Moderate Risk Lung Nodules (ALTITUDE), titled "A Multicenter, Randomized Controlled Trial, Prospectively Evaluating the Clinical Utility of the Nodify XL2 Proteomic Test in Incidentally Discovered Low to Moderate Risk Lung Nodules," is a randomized blinded controlled study with the objective of assessing how clinical decision making is impacted by the introduction of Nodify Lung test results into risk assessment. The study will focus on new, incidentally identified patients with lung nodules that are estimated to have low to moderate risk of lung cancer using the current standard of care.

The study is designed to generate key data to provide further support for a testing strategy that improves on the current standard of care and that significantly enhances guidelines. Biodesix has selected Dr. Gerard Silvestri, Hillenbrand Professor of Thoracic Oncology at the Medical University of South Carolina, to lead this trial. Dr. Silvestri is an internationally recognized researcher in all aspects of lung cancer care but with focused expertise in the early detection, evaluation and management of pulmonary nodules.

"I am excited to serve as principal investigator for the ALTITUDE trial, a study that I consider to be the first of its kind," said Dr. Silvestri. "We expect the trial to demonstrate that having the results of the Nodify XL2 Lung tests will lead to patients with benign disease avoiding unnecessary and invasive procedures. I believe that it will establish a new standard for future biomarker studies for the early detection of lung cancer."

With a total enrollment goal of 2,000 patients, Biodesix anticipates publishing interim results in 2022 and expects to complete the study in late 2023. "As a data-driven company, Biodesix is committed to continuing to study our tests and their impact on patients and the healthcare system. Through the ALTITUDE study, we want to better understand the impact on real-world decisions made in the clinic every day with the Nodify Lung test," said Scott Hutton, CEO of Biodesix. "We are proud that this important study will include leading experts in early detection of lung cancer from some of the most prestigious academic centers in the U.S."