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Lion TCR Announces FDA IND Clearance for its LioCyx-M004 for Hepatocellular Carcinoma

On September 23, 2021 Lion TCR Pte Ltd, a clinical-stage biotech company specialized in T Cell Receptor (TCR) T cell therapy reported that it has received clearance from U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) Application for LioCyx-M004, autologous T-cells transfected with mRNA encoding Hepatitis B surface antigen (HBsAg) specific TCR (Press release, Lion TCR, SEP 23, 2021, View Source [SID1234590234]).

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Lion TCR intends to initiate a Phase 1b/2 multi-center study for its lead investigational product, LioCyx-M004, for patients with advanced Hepatitis B Virus (HBV)-related hepatocellular carcinoma (HCC). This will be the first Phase 1b/2 study that uses specific T cell receptor (TCR)-T cell therapy to target HBV-related HCC.

In 2020, there are more than 900,000 new cases with liver cancer worldwide, of which 90% been hepatocellular carcinoma (HCC). In Asia, HBV is an important inducer of HCC, for example, 80% – 90% of HCC is related to HBV infection in China. The use of LioCyx-M004 has been tested in Phase 1 study in primary HBV-related HCC. LioCyx-M004 infusions were well-tolerated with no occurrence of cytokine release syndrome (CRS) nor neurotoxicity. Disease control rate was 60% and partial response (PR) as per RECIST 1.1 was observed with a duration of response of 27.7 months. Median overall survival (OS) was 33.1 months.

The upcoming study aims to evaluate LioCyx-M004 as a monotherapy treatment and the safety and efficacy of LioCyx-M004 in combination with lenvatinib. Considering lenvatinib as a well-established first-line treatment for advanced HCC and its potential to revert the immunosuppressive tumor microenvironment towards an immune-supportive profile, the combination of lenvatinib and LioCyx-M004 treatment is expected to further improve clinical outcome.

"LioCyx-M004, with its unique mechanism of action and its excellent safety profile and radiological tumor response, has the potential to become a first-in-class TCR T cell therapy for HCC. We also have a strong scientific rationale for the use of our TCR-T therapy in combination with other therapies to extend its effectiveness. We are proud of our significant progress in recent years and look forward to initiating the Phase 1b/2 study in the upcoming weeks for the benefits of HCC patient refractory or relapsed to current systemic treatment. Patient recruitment for this study will begin at City of Hope Comprehensive Cancer Center in United States, a leading research and treatment center for cancer," said Dr Tina Tingting Wang, COO and CMO of Lion TCR.

"This Phase 1b/2 IND clearance is a very important milestone for Lion TCR! We will continue our dedication to be the world leading biotech company using cutting-edge TCR-T immunotherapy to provide innovative therapeutic options for patients in need. Lion TCR has developed various TCR-T technology platform including TCR discovery platform, autologous and allogeneic TCR platform incorporating with gene editing technologies. With the potential of our revolutionary TCR-T cell immunotherapy, we aim to be the pioneer company for benchmarking in the field of liver cancer treatment," said Dr Peng Xiaoming, Managing Director & CEO of Lion TCR.

Novavax to Participate in Fireside Chat at the 2021 Cantor Virtual Global Healthcare Conference

On September 23, 2021 Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing and commercializing next-generation vaccines for serious infectious diseases, reported that it will participate in a fireside chat at the 2021 Cantor Virtual Global Healthcare Conference (Press release, Novavax, SEP 23, 2021, View Source [SID1234590233]). Novavax’ recombinant nanoparticle protein-based COVID-19 vaccine candidate, NVX-CoV2373, will be a topic of discussion.

Fireside chat details:

Date:

Wednesday, September 29, 2021

Time:

8:40 – 9:10 a.m. Eastern Daylight Time (EDT)

Moderator:

Charles C. Duncan, Ph.D.

Novavax participants:

Gregory M. Glenn, M.D., President, Research and Development and John J. Trizzino, Executive Vice President, Chief Commercial Officer and Chief Business Officer

A replay of the recorded fireside session will be available through the events page of the Company’s website at ir.novavax.com for 90 days.

Thermo Fisher Scientific Authorizes $3 Billion of Share Repurchases

On September 23, 2021 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported that its board of directors has authorized the repurchase of $3 billion of shares of its common stock in the open market or in negotiated transactions (Press release, Thermo Fisher Scientific, SEP 23, 2021, View Source [SID1234590232]). The authorization has no expiration date. This replaces the company’s existing repurchase authorization, of which $500 million was remaining.

Fusion Pharmaceuticals To Present At The 2021 Cantor Fitzgerald Virtual Global Healthcare Conference

On September 23, 2021 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported that the Company will present at the 2021 Cantor Fitzgerald Virtual Global Healthcare Conference on Wednesday, September 29, 2021 at 2:40pm ET. Presenting on behalf of Fusion will be Chief Executive Officer John Valliant, Ph.D (Press release, Fusion Pharmaceuticals, SEP 23, 2021, View Source [SID1234590231]).

A live webcast of the event will be available on the "Events and Presentations" page in the "Investors & Media" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

New Drug Application for Cadonilimab (PD-1/CTLA-4 Bi-Specific Antibody) for the Treatment of Relapsed or Metastatic Cervical Cancer Accepted by NMPA

On September 23, 2021 Akeso, Inc. (the Company, 9926.HK) reported that the National Medical Products Administration (the NMPA) of China has officially accepted the new drug application for the world’s first-in-class Cadonilimab (PD-1/CTLA-4 bi-specific antibody, research and development code: AK104) for the treatment of relapsed or metastatic cervical cancer, which has received priority review. Cadonilimab, independently developed and manufactured by the Company, is the first PD-1 based bi- specific antibody drug in the world to submit new drug application (Press release, Akeso Biopharma, SEP 23, 2021, View Source [SID1234590230]).

Cadonilimab is the second innovative antibody drug of the Company to submit the new drug application and the fifth new drug application submitted by the Company in China and in the United States.

The clinical trial data has shown that Cadonilimab has favorable efficacy and safety profile for the treatment of relapsed or metastatic cervical cancer patients after the failure of platinum-based chemotherapy. Among the target indication population, Cadonilimab has shown better efficacy compared to the published data of PD-1 monoclonal antibody on the market. Relevant clinical data will be published in relevant international conferences and medical journals.

Director of Oncology and Gynecology, Fudan University Cancer Hospital, Prof. Wu Xiaohua said, "Although PD-1 monoclonal antibody for the treatment of cervical cancer indication has been approved for global market launch, but the clinical study results show that it only achieves an objective response rate of not more than 15% in second-line or more PD-L1 positive patients. The efficacy and safety data of Cadonilimab as monotherapy shown in the phase II pivotal clinical trial are encouraging. Not only does it achieve a high response rate among PD-L1 positive population, it also shows good effect in PD-L1 negative population, with a significant improvement in the median progression-free survival, offering better treatment for patients with advanced cervical cancer in China. 2030 is the critical year for both initiatives ”Global Strategy to Accelerate the Elimination of Cervical Cancer” and ”Healthy China 2030”. The Company believes that as the first self-developed bi-specific antibody drug in China, Cadonilimab will facilitate the smooth implementation of the global cervical cancer initiative and the health strategy of China as mentioned above."

Chairman-designate of Chinese Medical Association Gynecological Oncology Branch, Prof. Kong Beihua from the Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University, said, "Cervical cancer has the highest incidence among gynecological malignancies in China, and patients with advanced recurrent metastatic cervical cancer are refractory to routine treatment. This represents one of the biggest challenges faced by gynecologic oncologists with significant clinical needs. The clinical efficacy of immune checkpoint inhibitors as monotherapy is not satisfactory. Despite the potential improvement in efficacy in combination with other treatments, its clinical application is greatly restricted due to severe toxic side effects. The clinical trials of Cadonilimab have demonstrated high efficacy, low susceptibility to toxic side effects as well as safe and controllable results to patients with advanced recurrent metastatic cervical cancer who have failed routine treatment. Cadonilimab has already entered the fast track designation process, this is good news for both doctors and patients, which will lead China’s oncotherapy to enter immunotherapy new era ahead of the world, as well as improve the prevention and treatment of cervical cancer in China, benefiting the patients and making good cause for celebration."

Founder, president & CEO of Akeso, Inc., Dr. Xia Yu said, "Cadonilimab is developed by scientists at Akeso with years of dedication. It is a bi-specific antibody new drug with global patent that targets simultaneously PD-1/CTLA-4 and also the first PD-1 based bi- specific antibody drug in the world to submit new drug application. We much appreciate the excellent efforts from the Akeso team, clinical research center, medical experts and departments of drug administration at all levels for this. The Company will dedicate its leading advantages in the field of bi-specific antibodies, accelerate the clinical research of Cadonilimab in other indications. We are looking forward to the advantages of Cadonilimab in the immuno-oncology therapy to benefit more oncology patients.

Milestones of Cadonilimab for treatment of cervical cancer:

July 2021, the phase III clinical trial of Cadonilimab in combination with chemotherapy for treatment of advanced cervical cancer officially initiated.

Feb 2021, the Food and Drug Administration of the United States (the FDA) granted orphan drug designation to Cadonilimab for treatment of cervical cancer.

Oct 2020, Cadonilimab for treatment of relapsed or metastatic cervical cancer patients after the failure of platinum-based chemotherapy was included in the list of "Breakthrough Therapy Designation" by the Center for Drug Evaluation (the CDE) under the NMPA.

July 2020, the FDA granted fast track designation to Cadonilimab for treatment of relapsed or metastatic cervical cancer patients after the failure of platinum-based chemotherapy.

Currently major indications of Cadonilimab include gastric cancer, lung cancer, liver cancer, esophageal squamous cancer, nasopharyngeal cancer, etc. Among which the phase III clinical trial for first-line treatment of gastric cancer has officially initiated.

About Cadonilimab (PD-1/CTLA-4 Bi-specific Antibody)

Cadonilimab (AK104) is a novel, potential next-generation, first-in-class bi-specific PD-1/CTLA-4 immuno-oncology backbone drug independently developed by the Company, and its major indications include liver cancer, cervical cancer, lung cancer, gastric cancer, esophageal squamous cell cancer and nasopharyngeal carcinoma. The preliminary research data of cervical cancer, gastric cancer and other tumors shows that, as compared with the combination therapy of PD-1 and CTLA-4, Cadonilimab has much lower toxicity and demonstrated promising safety profile and efficacy.