mRNA Firms Enter the Oncology Era with First-in-China Patient Dosing Announcements

mRNA Biotechnology, After Successful Application in COVID-19 Vaccines, Is Advancing Towards Conquering Cancer.

On November 17, Abogen announced that it had jointly initiated the first human clinical trial of the tumor antigen mRNA therapeutic vaccine ABOR2014 injection (IPM511) with Beijing Zhenzhi Medical Technology Co., Ltd.

According to reports, the vaccine encodes nearly 20 types of hepatocellular carcinoma antigens, which are highly expressed in patients with liver cancer. The study aims to evaluate the safety, tolerability, and preliminary efficacy of IPM511 as a single agent and in combination with a PD-1 inhibitor for the treatment of advanced hepatocellular carcinoma that has progressed after first-line standard therapy.

The First Financial reporter learned that the first dosing of IPM511 was an "investigator-initiated exploratory clinical study" (IIT) and has not yet entered formal drug clinical trials (IND). However, this is still a significant advancement for mRNA therapeutic vaccines moving into clinical application.

Professor Haitao Zhao, the principal investigator of the project and chief physician of the Hepatic Surgery Department at Peking Union Medical College Hospital, stated: "The combination of mRNA therapeutic cancer vaccines with PD-1 represents an exciting emerging therapy in oncology. The mRNA therapeutic cancer vaccine can induce a strong tumor antigen T-cell response, while the combination with a PD-1 inhibitor further activates T cells. This novel therapy is expected to help address issues of drug resistance in immunotherapy or targeted-immunotherapy combination treatments for liver cancer."

In the future, the research team hopes to better explore whether emerging drug combinations can be more helpful in activating the immune system in multiple aspects, further understand the potential of mRNA tumor vaccines in treating liver cancer and discover possible advantageous populations, and provide new and accessible treatment options.

Yicai Global reporters also noticed that BioNTech ("Biontech"), the German mRNA technology company that supplied mRNA vaccines globally during the COVID-19 pandemic, announced last week that the first Chinese patient has been dosed in the phase III trial PRESERVE-003 for the next-generation anti-CTLA-4 antibody candidate BNT316/ONC-392 (gotistobart), co-developed with U.S.-based pharmaceutical company OncoC4 ("OncoImmune"), for the treatment of metastatic non-small cell lung cancer (NSCLC).

This marks BioNTech's official entry into China's oncology treatment market. It is reported that the PRESERVE-003 clinical trial in China is led by Professor Wu Yilong's team, the chief expert of the Oncology Department at Guangdong Provincial People's Hospital. The trial aims to evaluate the efficacy and safety of BNT316/ONC-392 as a monotherapy compared to the standard chemotherapy regimen (docetaxel) in patients with metastatic NSCLC whose condition has worsened after previous treatment with PD-(L)1 inhibitors. The trial plans to recruit approximately 600 patients across clinical research centers globally, including around 170 patients from over 40 clinical research centers in China.

Yicai Global learned that BioNTech's co-founder and CEO, Ugur Sahin, places great importance on the Chinese market and visited Shanghai quietly at the end of last month. In the field of cancer treatment, BioNTech has reached licensing cooperation agreements with multiple Chinese biopharmaceutical companies, focusing on areas such as ADC to expand cancer immunotherapy. Since the beginning of this year, BioNTech has struck deals with at least five Chinese biotech firms, including DualityBio and Aligned Bio.

Wu Shaxin once stated that the team of scientists at BioNTech can be regarded as "engineers of the human immune system," similar to how Apple engineers develop iPhone software programs based on a powerful computing platform. He believes that, with the mRNA platform, it will be possible in the future to provide different solutions for most diseases, including cancer, and repair damaged or diseased cells.

"Through mRNA technology, targeted drugs will achieve more dynamic and precise therapeutic effects, which is the biggest difference from other past cancer therapies," Brad Loncar, founder of biotech investment firm Loncar Investments, told the First Financial Daily.

Lunca stated that over the past few decades, many companies have been exploring therapies for late-stage cancer patients, but this has proven extremely difficult with almost no success. Now, Moderna and BioNTech are focusing on the early stages of tumors, using vaccines as a treatment method for patients who have undergone tumor removal to prevent recurrence. This approach is a very smart choice.

BioNTech and Moderna, the U.S. mRNA technology company, have gained a better understanding of how the human immune system responds to mRNA and mastered the large-scale manufacturing of mRNA vaccines through the development and industrialization of COVID-19 vaccines. They are now in repeated discussions with regulatory authorities regarding the approval of therapeutic cancer vaccine products to accelerate the future market entry of cancer vaccines.

Earlier this year, Moderna's mRNA therapeutic cancer vaccine mRNA-4157/V940 was granted Breakthrough Therapy Designation by the U.S. FDA for adjuvant treatment in high-risk melanoma patients following complete resection. This vaccine is chosen to be used in combination with the PD-1 inhibitor pembrolizumab to further enhance the patient's immune system capability and suppress tumor growth.

Editor: Zhang Hengxing SF142