On April 30, 2021 Shaperon, a new drug development bio company, reported that it would sign a business agreement (MOU) with Dong-A ST for the joint development of new bio drugs (Press release, Shaperon, APR 30, 2021, View Source;idx=45&pNo=3&code=press_en [SID1234629321]).

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This joint development agreement was made with the goal of jointly developing treatments for cancer and inflammatory diseases using nanobody-based biopharmaceuticals. Nanobodies are antibodies that are 1/10 the size of existing antibodies, and are attracting attention as a key technology for next-generation immuno-oncology drugs because of their excellent stability and water solubility, high production yield, and high homology with human antibodies, making it easy to develop therapeutics and diagnostic platforms.

The two companies will develop new bio drugs by combining Chaperone’s nanobody technology and Dong-A ST’s new drug development platform. Chaperone builds a nanobody library based on its own technology, develops an antibody suitable for the selected target, verifies the effect at the cellular level, and then proceeds with the effect verification in an animal model in collaboration with Dong-A ST. When efficacy verification is completed in an animal model, Dong-A ST will be in charge of building a cell line for the nanobody antibody. In addition, the two companies plan to jointly discover anti-cancer targets throughout the preclinical process and evaluate the efficacy of candidate antibodies.

Lee Myung-se, CEO of Chaperone, said, "Through this MOU, we expect to see results such as the development of new biologics to treat cancer and chronic inflammation and the creation of corporate value through technology transfer." We will do our best to succeed in commercialization," he said.

Chaperon is the only domestic company that has nanobody development platform technology. In the trend of new drug development, where the structure of protein-based drugs such as bispecific antibodies or antibody drug conjugates is becoming more complex, the side effects and low production efficiency of existing antibodies can be overcome, and various routes of administration such as oral or inhalation are available. It is high tech. Based on the nanobody platform, Chaperon is developing various pipelines such as immune checkpoint inhibitory bispecific antibodies and coronavirus neutralizing antibodies.

On April 30, 2021 Legend Biotech Corporation (NASDAQ: LEGN) ("Legend Biotech"), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, reported the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of ciltacabtagene autoleucel (cilta-cel) for the treatment of patients with relapsed and/or refractory multiple myeloma (Press release, Legend Biotech, APR 30, 2021, View Source [SID1234578873]).

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Cilta-cel is an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy being investigated as a treatment for multiple myeloma. The MAA is based on positive results from a Phase 1b/2 CARTITUDE-1 study, which were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2020 Annual Meeting.1 The submission was filed to the EMA by Janssen-Cilag International N.V., an affiliate of Janssen Biotech, Inc., Legend’s collaboration partner for cilta-cel.

"Today’s submission is a testimony to the promising results we have seen from the CARTITUDE-1 study showing the efficacy and safety of cilta-cel for treating patients with multiple myeloma who are heavily pretreated and in need of treatment options," said Ying Huang, PhD, CEO and CFO of Legend Biotech. "We are proud of our collaboration with Janssen and look forward to bringing this personalized treatment to patients in the EU following the accelerated assessment."

The EMA’s Committee for Medicinal Products for Human Use (CHMP) granted accelerated assessment for this MAA. An accelerated assessment is granted when the CHMP determines that a medicinal product is of major public health interest and therapeutic innovation and can significantly reduce the review timelines to evaluate an MAA.2 Cilta-cel previously received a PRIority MEdicines (PRIME) designation from the EMA. A Biologics License Application (BLA) seeking approval of cilta-cel based on the CARTITUDE-1 study is currently under review with the United States Food and Drug Administration.

About CARTITUDE-1

CARTITUDE-1 (NCT03548207) is an ongoing Phase 1b/2, open-label, multicenter study evaluating the safety and efficacy of cilta-cel in adults with relapsed and/or refractory multiple myeloma, 99 percent of whom were refractory to the last line of treatment; 88 percent of whom were triple-class refractory (to at least 1 immunomodulatory drug [IMiD], proteasome inhibitor [PI] and 1 anti-CD38 antibody).3 The primary objective of the Phase 1b portion of the study was to characterize the safety and confirm the dose of cilta-cel, informed by the first-in-human study with LCAR-B38M CAR-T cells (LEGEND-2). The Phase 2 portion further evaluated the efficacy of cilta-cel with overall response rate as the primary endpoint.

About Ciltacabtagene autoleucel (cilta-cel)

Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy, formerly identified as JNJ-4528 outside of China and LCAR-B38M CAR-T cells in China, that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed and/or refractory multiple myeloma and in earlier lines of treatment. Cilta-cel is a differentiated CAR-T therapy with two BCMA-targeting single domain antibodies. In December 2017, Legend Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. to develop and commercialize cilta-cel. In addition to a Breakthrough Therapy Designation (BTD) granted in the U.S. in December 2019, cilta-cel received a BTD in China in August 2020. In addition, Orphan Drug Designation was granted for cilta-cel by the U.S. FDA in February 2019, and by the European Commission in February 2020.

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.4 Although treatment may result in remission, unfortunately, patients will most likely relapse.5 Relapsed myeloma is when the disease has returned after a period of initial, partial or complete remission and does not meet the definition of being refractory.6 Refractory multiple myeloma is when a patient’s disease is non-responsive or progresses within 60 days of their last therapy.7,8 While some patients with multiple myeloma have no symptoms until later stages of the disease, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.9 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses and few treatment options.10

On April 30, 2021 Tessa Therapeutics Ltd. (Tessa), a clinical-stage cell therapy company developing next-generation cancer treatments for hematological malignancies and solid tumors, reported enrollment of 12 patient Pilot cohort of its Phase 2 trial (NCT04268706) in relapsed / refractory Classical Hodgkin Lymphoma (R/R cHL) (Press release, Tessa Therapeutics, APR 30, 2021, https://www.prnewswire.com/news-releases/tessa-therapeutics-announces-enrollment-of-12-patient-pilot-cohort-in-its-relapsed-or-refractory-hodgkin-lymphoma-phase-2-study-301281049.html [SID1234578907]). The next step in the two-part study is enrollment of the 82 patient Pivotal cohort to assess the safety and antitumor efficacy of Tessa’s autologous CD30 CAR-T in R/R cHL, which is planned to commence in 2H 2021.

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"Tessa’s CD30 CAR-Ts previously demonstrated excellent safety and efficacy in heavily pre-treated R/R cHL patients across two independent Phase 1/2 studies. It is exciting to see the rapid enrollment of the Pilot cohort, and we look forward to working with Tessa in the pivotal cohort of this trial. There is a high unmet need for effective treatments in R/R cHL and we are pleased to be able to advance this novel CD30 directed CAR-T cell therapy for our patients," said Sairah Ahmed, M.D., Associate Professor, The University of Texas MD Anderson, Cancer Center.

CD30 is a well validated lymphoma target with homogeneous expression in 98% of classical Hodgkin Lymphoma (cHL) and a significant proportion of subsets of non-Hodgkin Lymphomas. Tessa’s technology modifies the patient’s T-cells by introducing a CD30 directed Chimeric Antigen Receptor, or CAR, to target and kill cHL. Tessa’s CD30 CAR-T therapy, previously induced a Complete Response in 59% of heavily pretreated R/R cHL patients, with no instance of neurotoxicity or grade 3 Cytokine release syndrome (CRS) (and published in Journal of Clinical Oncology[1]). Tessa’s therapy was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration and PRIority MEdicines (PRIME) designation by European Medicines Agency.

"The speed of enrollment of our 12 patient Pilot cohort, in less than 3 months, is testament to the strong physician and patient interest in our CD30 CAR-T therapy, and further endorses the clinical data generated under the dual Phase 1/2 studies. This marks a critical milestone as Tessa gears up to commence our Pivotal cohort in second half of the year," said Jeffrey H. Buchalter, President and CEO of Tessa Therapeutics. "We believe that Tessa’s CD30 CAR-T therapy, with its promising efficacy and excellent safety profile, addresses current gaps in the treatment of cHL, and has the potential to rapidly move to earlier lines of therapy."

Eli Lilly has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On April 30, 2021 Leidos Holdings, Inc. (NYSE: LDOS) reported that its Board of Directors has declared a quarterly cash dividend of $0.34 per outstanding share of common stock of Leidos Holdings, Inc (Press release, Leidos, APR 30, 2021, View Source [SID1234578875]). The cash dividend is payable on June 30, 2021 to stockholders of record as of the close of business on June 15, 2021.

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