On August 26, 2022 Akeso, Inc. (9926.HK) ("Akeso"), a biopharmaceutical company committed to the research, development, manufacturing and commercialization of either first-in-class or best-in-class therapies, reported a review article featuring on Cadonilimab, a first-in-class PD-1/CTLA-4 bi-specific antibody developed by the company, was published in Drugs, a peer-reviewed medical journal specializing in pharmaceutics (Press release, Akeso Biopharma, AUG 26, 2022, View Source [SID1234618711]).

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Article link: View Source

The article provides an in-depth and comprehensive summary of the prospective drug design rationale of Cadonilimab, clinical trials progress in different tumors, and milestones in the development of Cadonilimab leading to its first approval.

Cadonilimab received its first approval on June 2022 in China for use in patients withrelapsed or metastatic cervical cancer (r/m CC) who have progressed on or after platinum-based chemotherapy. Cadonilimab is the globally first dual immune checkpoint inhibitor bi-specific antibody approved for marketing. It is worth mentioning that the approval of Cadonilimab not only marks China’s innovative biotech companies starting to reap the fruits after years of R&D investments but also demonstrates that Chinese biotech companies represented by Akeso are closing the gap with global pharmaceutical companies rapidly in innovative drug development.

There are many ongoing trials of Cadonilimab as monotherapy or combination therapy for the treatment of a range of solid tumors, including cervical cancer, lung cancer, gastric/gastroesophageal junction cancer, oesophageal squamous cell cancer, liver cancer, and nasopharyngeal cancer.

In addition to Cadonilimab, Akeso also promotes many drug candidates efficiently. Ivonescimab (PD-1/VEGF bi-specific antibody, AK112), the second globally first-in-class bi-specific antibody, is in phase III trials, and the third bi-specific antibody(PD-1/LAG-3) is about to enter the clinical stage. Akeso hopes to bring more innovative high-quality biologics to the market for the benefit of patients worldwide.

For 50 years, Drugs has been the definitive journal of drugs and therapeutics, promoting optimum pharmacotherapy by publishing reviews and original research authored by leading international clinicians and researchers to support clinical decision-making. In 2022, Drugs has an impact factor of 11.431.

On August 26, 2022 Fosun International Limited ("Fosun International", stock code: 00656.HK) and HSBC Bank (China) Company Limited ("HSBC China") renewed a strategic cooperation agreement (the "Agreement") reported to provide strong support for Fosun International and its subsidiaries ("Fosun") in the aspects of global operation and investment capabilities, growth strategies, financial resources, etc (Press release, Fosun, AUG 26, 2022, View Source [SID1234618712]).

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In the presence of Wang Qunbin, Co-Chairman of Fosun International, and Wang Yunfeng, President and Chief Executive Officer of HSBC China, Zhang Houlin, Senior Vice President and Co-CFO of Fosun International, and Ma Jian, Executive Vice President, Country Head of Commercial Banking of HSBC China signed a strategic cooperation agreement today at Fosun’s Bund Finance Center in Shanghai, marking further cooperation between Fosun and HSBC. The two parties will work together to support the strategic goal of stabilizing economic growth, promote the high-quality development of private enterprises, and make new and greater contributions to advance both the pandemic prevention and economic and social development.

Wang Qunbin, Co-Chairman of Fosun International, said, "As a global innovation-driven consumer group, after 30 years of development, Fosun has grown into one of the few domestic enterprises that is equipped with global operation and investment capabilities, and accumulated profound technology and innovation capabilities. Fosun has a diversified business portfolio, globalized asset allocation, and has always maintained good relationship with financial institutions, resulted in its stable business operations and abundant capital. While continuing to develop the four business segments of Health, Happiness, Wealth, and Intelligent Manufacturing, Fosun remains true to its original aspiration and actively fulfills its corporate responsibility. Since the COVID-19 outbreak, Fosun has contributed to the prevention of the pandemic and promoted the resumption of work and production in an orderly manner. HSBC has always been an important long-term strategic partner of Fosun. In the future, Fosun will continue to work with HSBC to continuously deepen our globalization strategy, strengthen our investment and development in continuous innovation, actively fulfill corporate social responsibility to make greater contributions to national economic and social development."

Wang Yunfeng, President and Chief Executive Officer of HSBC China, said, "As a leading private enterprise in China, Fosun has been actively innovating in many fields and promoting globalization over the years, and has played an important role in the prevention of the COVID-19 pandemic and the resumption of work and production. Leveraging our global network advantage and local service capability, HSBC is committed to providing financial support to private enterprises with global vision like Fosun, and contributing to the growth and transformation of China’s economy. Through this renewal of the strategic cooperation agreement, HSBC will further strengthen its cooperation with Fosun to promote the win-win situation of both parties in more fields, providing support for the sustainable and high-quality development of private enterprises. "

HSBC is an internationally renowned financial institution. Through this Agreement, Fosun International and HSBC China are committed to strengthening the cooperation between the two parties. On the basis of strategic fit, complementary advantages, and mutual support, the two parties will carry out comprehensive cooperation in the future.

On August 26, 2022 Patrys reported that the Olivia Newton-John Cancer Research Institute (ONJCRI) has been awarded a $100,000 Victorian State Government Victorian Medical Research Acceleration Fund (VMRAF) grant to support its research investigating the potential for PAT-DX1 and PAT-DX3 to be incorporated into new treatments for metastatic breast cancer (Press release, Patrys, AUG 26, 2022, View Source [SID1234618662]).

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The research program, led by Professor Robin Anderson, Head of ONJCRI’s Translational Breast Cancer Program and Metastasis Research Laboratory, will evaluate the ability of PAT-DX1 and PAT-DX3 to control tumour growth and metastasis in preclinical models of breast cancer. It will also evaluate in animal models the use of PAT-DX1 and PAT-DX3, in combination with DNA damaging agents such as radiation and chemotherapy, for treating triple negative breast cancer.

Patrys CEO and Managing Director, Dr James Campbell, was delighted to share this news today:

"We are delighted that this VMRAF grant will allow us to expand our ongoing research program with Professor Anderson at the internationally-recognised ONJCRI. We have recently discovered that PAT-DX1 inhibits the formation of NETs, molecules that are implicated in the progression and metastasis in some cancers, and this new grant focused on metastatic breast cancer is an exciting addition to our programs."

On August 26, 2022 Shanghai Bao Pharmaceuticals reported that it closed a Series B round with over $100 million to support development of its recombinant protein and antibody drug candidates, including commercialization (Press release, Shanghai Bao Pharmaceutical, AUG 26, 2022, View Source [SID1234618714]). Bao Pharma will also advance its pre-clinical projects into clinical trials. The company is building a 75,000 square meter facility in Laodian Industrial Park, located in Shanghai’s Baoshin District, which will house its R&D operations and manufacturing facilities for recombinant protein drugs and injected drugs. The round was led by Oriental Fortune Capital and included Haitong Innovation and Sun Rock Capital.

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On August 25, 2022 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that it has initiated a rolling Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for lifileucel, a tumor infiltrating lymphocyte (TIL) therapy, in patients with advanced (unresectable or metastatic) melanoma who progressed on or after prior anti-PD-1/L1 therapy, and if BRAF mutation positive, also prior BRAF or BRAF/MEK inhibitor therapy (Press release, Iovance Biotherapeutics, AUG 25, 2022, View Source [SID1234618645]). There are no FDA approved therapies in this treatment setting.

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Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, "Initiating our rolling BLA submission for lifileucel is a significant step towards our goal to deliver the first individualized, one-time cell therapy for melanoma patients with significant unmet need. In parallel, we are executing our on-boarding and personnel training at authorized treatment centers, education and awareness initiatives, internal capacity planning, and launch readiness activities to prepare for commercialization. The FDA is supportive of our regulatory approach, and we look forward to continuing this collaboration throughout the submission and review process."

A rolling BLA allows Iovance to submit portions of the BLA to the FDA on an ongoing basis, which enables the FDA to begin review as early as possible while documents are received. Iovance expects to complete the BLA submission in the fourth quarter of 2022. The rolling BLA submission and eligibility for priority review are benefits available under the FDA’s guidance on expedited programs for serious conditions. The FDA previously granted a regenerative medicine advanced therapy (RMAT) designation for lifileucel in advanced melanoma.

"Lifileucel represents hope and a new treatment for thousands of people with advanced melanoma who have very limited options after they progress on available standard of care," said Kyleigh LiPira, CEO, Melanoma Research Foundation. "Cell immunotherapies are revolutionizing cancer treatment, and we are excited about the potential for the first FDA-approved TIL cell therapy for the treatment of melanoma, which helps us take another step towards finding a cure."

The BLA submission for lifileucel is supported by positive clinical data from the C-144-01 clinical trial in patients with advanced melanoma. Iovance plans to present additional results from the C-144-01 trial at a medical meeting later this year.