On July 15, 2022 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported that it has initiated a Phase I trial in China of HMPL-A83, an investigational novel IgG4-type humanized anti-CD47 monoclonal antibody (Press release, Hutchison China MediTech, JUL 15, 2022, View Source [SID1234616701]). The first patient received their first dose on July 15, 2022.

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The Phase I trial is a multicenter, open-label study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HMPL-A83 in patients with advanced malignant neoplasms. The primary endpoints are dose-limiting toxicity (DLT), safety, tolerability, recommended phase II dose (RP2D) and maximum tolerated dose (MTD). The secondary endpoints include pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy profile. The lead principal investigators are Dr Ye Guo of Shanghai East Hospital and Dr Yuping Sun of Shandong Cancer Hospital. Additional details may be found at clinicaltrials.gov, using identifier NCT05429008.

Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said: "HMPL-A83 marks a new chapter in our large molecule and immunotherapy exploration. It is our thirteenth oncology drug candidate to emerge from our innovative in-house discovery platform and it has significant potential to offer new combination therapy opportunities with our existing small molecule portfolio. This approach forms a key part of our multi-pronged strategy to treat cancer and immunological diseases and we are very excited to advance HMPL-A83’s development."

About HMPL-A83 and CD47
CD47 is a cell surface transmembrane protein that is ubiquitously expressed on virtually all human cells. The overexpression of CD47 is reported in a variety of tumors and is believed to be associated with immune escape from macrophage-mediated phagocytosis.

HMPL-A83 is an investigational IgG4-type humanized anti-CD47 monoclonal antibody that exhibits high affinity for CD47. HMPL-A83 blocks CD47 binding to Signal regulatory protein (SIRP) α and disrupts the "do not eat me" signal that cancer cells use to shield themselves from the immune system.

In preclinical studies, HMPL-A83 demonstrated weak affinity for red blood cells and no induction of hemagglutination, implying low risk of anemia. HMPL-A83 also demonstrated a high affinity for CD47 antigen on tumor cells and strong phagocytosis induction of multiple tumor cells. HMPL-A83 has also demonstrated strong anti-tumor activity in multiple animal models.

On July 15, 2022 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the company will present at the H.C. Wainwright 1st Annual Hereditary Angioedema Virtual Conference on Wednesday, July 20, 2022, at 10:00 a.m. ET (Press release, BioCryst Pharmaceuticals, JUL 15, 2022, View Source [SID1234616700]).

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The link to a live audio webcast and replay of the presentation may be accessed in the Investors & Media section of BioCryst’s website at http://www.biocryst.com.

On July 15, 2022 Glytherix reported that Congratulations to Prof Kris Thurecht for the funding of the ARC Research Hub for Advanced Manufacture of Targeted Radiopharmaceuticals (AMTAR) (Press release, Glytherix, JUL 15, 2022, View Source [SID1234616697]). GlyTherix Ltd is a proud partner organisation and is excited to see Australian radioimmunotherapy technology getting this great boost.

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The Hub with about $5 million in Federal support will drive growth and facilitate cutting-edge public research to bring the significant onshore capability to manufacture next-generation medical devices and technologies. GlyTherix will bring its experience in radioimmunotherapies to the project.

Radiopharmaceuticals are emerging as next generation medical technologies for addressing complex health challenges, and their manufacture offers significant economic benefit to Australia. AMTAR aims to establish a manufacturing platform for new medical technologies combining innovations in biotechnology and pharmaceutical science.

The program addresses industry-led challenges for translation of biologics as molecular radiopharmaceuticals, building capacity in biomanufacturing, radiobiology and radiochemistry. The program establishes a dedicated manufacturing pipeline, future-proofing production and securing supply chain of next generation medical technologies.

On July 14 , 2022 , Shenzhen Aixindawei Pharmaceutical Technology Co., Ltd. (hereinafter referred to as "Aixindawei" or "the Company") reported that the first subject of the Phase II clinical trial of its independently developed and world-first product AST – 3424 for the treatment of hepatocellular carcinoma has been successfully enrolled at Guangdong Qifu Hospital and successfully completed the first dose (Press release, Ascentawits Pharmaceuticals, JUL 14, 2022, View Source [SID1234650306]). This trial ( CTR20191399 ) is a development label, single-arm, non-randomized Phase II clinical study designed to evaluate the efficacy and safety of AST-3424 in the treatment of patients with hepatocellular carcinoma. The trial will be conducted in 7 research centers across the country. Dr. Duan Jianxin, founder and chairman of Aixindawei, said: "Liver cancer is a common cancer in China. According to the 2020 Global Cancer Report, in 2020 , the proportion of new liver cancer patients in China accounted for nearly 50% of the new liver cancer patients in the world . In recent years, with the addition of treatment options such as immunotherapy, the overall survival of patients with advanced liver cancer has been significantly improved. However, how to further improve the efficacy and reduce toxic and side effects, accurately select suitable patients, and reduce the payment pressure of patients are still the direction of future efforts. The company’s independently developed small molecule targeted conjugate drug AST-3424 is expected to bring different treatment options for liver cancer patients. "

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About AST-3424

AST-3424 is an innovative small molecule conjugate drug. After entering tumor cells overexpressing AKR1C3 enzyme, it can be highly selectively activated by AKR1C3 enzyme to release effective drugs and achieve precise killing of tumor cells. In the Phase I clinical study of solid tumors, AST-3424 showed good safety and tolerability. With the further development of subsequent clinical research, the company will combine the companion diagnostic kit developed independently to achieve accurate screening and treatment of the target population.

On July 14, 2022 EVERSANA and Compai Pharma, a full-service commercialization company with offices in Singapore and Malaysia, reported a strategic partnership to expand services across the Asia Pacific region (Press release, EVERSANA, JUL 14, 2022, View Source [SID1234617514]).

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The partnership will provide medical and commercial resources to healthcare partners to support full market implementation and development for life science and pharmaceutical companies ready to expand into these markets.

EVERSANA CEO Jim Lang commented: "The Asia Pacific region is one of the fastest-growing pharmaceutical markets in the world and requires regional expertise to increase patient access. Together with Compai Pharma, we’re now able to drive greater value and services for our clients to support their evolving commercialization needs."

Capabilities available through the partnership include consulting, market access, medical awareness, education and communication, pharmacovigilance, marketing & sales excellence, as well as distribution and additional services.

The partnership with Compai builds on EVERSANA’s continued global growth, including recent expansion across the European Union and the UK. Additionally in June 2021, EVERSANA announced the growth of its medical communications and integrated compliance services across 18 European countries and in 10 local languages.