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GlyTherix is a partner in ARC Hub for Advanced Manufacture of Targeted Radiopharmaceuticals

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.

Aixindawei announced that the first subject was enrolled and dosed in the Phase II clinical trial of the small molecule targeted anticancer new drug AST-3424

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. "

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.

EVERSANA Announces Partnership to Expand Commercialization Services across Asia Pacific

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]).

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.

Major Shareholders of Prestige Biopharma Group Have Bought KRW 10 billion Worth of Stock in Accumulation

On July 14, 2022 Major shareholders of Prestige Biopharma Group were actively defending their stock prices, while the local stock market reported that it has recently fluctuated and fallen sharply due to concerns over an economic slowdown (Press release, Prestige BioPharma, JUL 14, 2022, View Source [SID1234616867]).

According to the Data Analysis Retrieval and Transfer System by Korean Financial Supervisory Service on July 14, Octava Fund Limited, a major institutional shareholder, recently purchased KRW 1.3 billion of Prestige Biopharma stock and KRW 400 million of Prestige Biologics stock, amounting to a total of KRW 1.7 billion.

Chairman Lisa S. Park and Vice Chairman Michael J. Kim of Prestige Biopharma Group, the largest shareholders of the two companies, have also bought a total of KRW 7.5 billion worth of stock through Mason Partners, a joint investment company established by Chairman Park and Vice Chairman Kim. As a result, the investment that major shareholders have put in defending the stock price of Prestige Biopharma and Prestige Biologics amounts to nearly KRW 10 billion since EMA.

According to the company, Octava Fund has provided support in defending the stock price to show trust and confidence as a long-term investment partner. Previously, the major institutional shareholder had purchased KRW 6.9 billion stock in December 2021.

Meanwhile, Prestige BioPharma is focusing on preparing for the re-examination of Marketing Authorisation Application (MAA) for the company’s Herceptin biosimilar HD201 that it requested European Medicines Agency (EMA) in May. The company decided to seek approval through re-examination by setting up with a global expert team, instead of choosing withdrawal and reapplication which will take more than a year. Prestige Biologics is strengthening its business with signing new contracts as a global CDMO utilizing its global-scale facilities and state-of-the-art patented technologies.

Entry into a Material Definitive Agreement

On July 14, 2022 HTG Molecular Diagnostics, Inc. (the "Company") reported that entered into an amendment (the "Amendment") to its Loan and Security Agreement, dated June 24, 2020, by and between the Company and Silicon Valley Bank (the "Loan Agreement") (Filing, 8-K, HTG Molecular Diagnostics, JUL 14, 2022, View Source [SID1234616729]). Under the Loan Agreement, Silicon Valley Bank provided the Company with a $10.0 million principal amount secured term loan (the "Term Loan"), of which $7.5 million remained outstanding as of June 30, 2022.

Pursuant to the Amendment, the Company and Silicon Valley Bank agreed to remove the financial covenant under the Loan Agreement that had required the Company to maintain unrestricted cash, including short term investments available-for-sale, of not less than the greater of (i) $12.5 million and (ii) an amount equal to six times the amount of the Company’s average monthly Cash Burn (as defined in the Loan Agreement) over the trailing three months. In exchange for this accommodation, the Company prepaid $2.5 million of outstanding principal under the Term Loan (the "Prepayment"). Silicon Valley Bank waived the prepayment fee that otherwise would have applied to the Prepayment. The remaining outstanding principal amount under the Term Loan will continue to be paid in equal monthly payments of principal and interest through the maturity date of December 1, 2023.