TaiRx has made significant progress in developing a new cancer drug. On the 24th, the company announced that its investigational drug CVM-1118 has achieved its targeted goals in Phase II clinical trials for neuroendocrine tumors (NET) and hepatocellular carcinoma (HCC) this year, marking a major milestone. TaiRx Chairman, Andrew Lin, stated that NET will be the company’s priority focus, with expectations to complete international licensing or joint collaborations within the next six to nine months.
On the same day, TaiRx held a press conference to announce the clinical trial results. Several prominent figures from the biotech industry, including Pan-Chyr Yang, former president of National Taiwan University and chairman of Diamond Biofund, Hong-Jen Chang, chairman of YFY Biotech, and legislator Ching-Huei Chen from the Legislative Yuan’s Health and Welfare Committee, were in attendance to offer their congratulations.
Du-Shien Chien, General Manager of TaiRx, highlighted that the NET clinical trial conducted by TaiRx was selected for an oral presentation at this year’s European Society for Medical Oncology (ESMO) conference. The selection rate for oral presentations is just 4%, reflecting the high regard of the review committee for this trial. The study’s principal investigator, Chia-Jui Yen, Director of the Oncology Department at National Cheng Kung University Hospital, presented the findings. The conference chair emphasized that there has long been a lack of new drugs with novel mechanisms for NET treatment. CVM-1118’s innovative mechanism, which targets the mitochondrial protein TRAP1 to induce apoptosis and inhibit angiogenesis, was met with great anticipation.
Chien noted that the trial results for CVM-1118 showed a median progression-free survival (PFS) of 10.5 months among 35 evaluable patients, exceeding the historical control group's PFS of 4–6 months. Additionally, the safety profile of CVM-1118 was favorable, with no severe adverse events related to the treatment observed. The ESMO review committee acknowledged CVM-1118’s potential in extending PFS and expressed a desire to see larger trials for more precise evaluation of its clinical benefits. CVM-1118 was also featured in ESMO’s daily reports, highlighting its promising development.
In light of the ESMO presentation, TaiRx invited key opinion leaders in the field of NET development to participate, including the former chair of the European Neuroendocrine Tumor Society (ENETS) and experts from MD Anderson Cancer Center, Harvard Medical School, and Mayo Clinic, who had participated in clinical trials for approved NET drugs. These experts, along with physicians involved in TaiRx’s CVM-1118 clinical trials, discussed the next phase of the drug’s clinical development. They were particularly excited by the trial results, as the enrolled patients had all experienced tumor progression within six months prior to treatment, but were able to achieve over 10 months of progression-free survival with CVM-1118 monotherapy. Given the severe side effects of current NET drugs, the experts recognized CVM-1118’s safety profile as a significant advantage and suggested that it has the potential to enter the second-line treatment market for NET. TaiRx will incorporate these expert recommendations into the next phase of clinical planning and actively seek support from international pharmaceutical companies for technology transfer or co-development, with the aim of accelerating the drug's market entry.
Andrew Lin commented that although NET is classified as a rare disease, it represents a substantial market, exceeding $5 billion. The Phase II clinical results demonstrated both efficacy and high safety, confirming that TaiRx will continue advancing the drug. Strategically, the company plans to pursue both Phase IIb clinical trials in the U.S. and licensing negotiations concurrently. Given that CVM-1118 operates via a novel mechanism, time will be needed for negotiations with major international companies. Lin anticipates that licensing agreements will be finalized within the next six to nine months, with both joint development and direct licensing being considered.
In addition, the results of the clinical trial combining CVM-1118 with the immunotherapy drug nivolumab for patients with HCC who had failed first-line treatment were presented last month at the ASCO Breakthrough Summit. Among the 31 treated patients, two experienced complete tumor remission, and five showed more than a 30% reduction in target tumor size. These results suggest that the combination therapy outperforms immunotherapy alone. The combination was also confirmed to not increase drug toxicity, offering a promising alternative to current first-line therapies for liver cancer, providing more treatment options for both patients and physicians.
Du-Shien Chien emphasized that it is quite challenging for Taiwanese pharmaceutical companies to reach the Phase II clinical trial milestone, competing with numerous international clinical trials. This is particularly true for NET and liver cancer trials, which present significant challenges. It is crucial to align with clinical needs and drug characteristics to identify a niche that offers both efficacy and safety for patients, increasing the chances of success in drug development.
CVM-1118 has demonstrated its unique advantages through clinical trials, whether used as monotherapy or in combination with existing drugs, and holds promise for continued development. TaiRx will press forward with licensing and collaborative business models, leveraging international partnerships to bring the drug to market quickly, aiming to position the company as a key player in Taiwan's burgeoning biopharmaceutical industry.
Resource (mandarin): 台睿抗神經內分泌瘤新藥CVM-1118 力拚半年後國際授權
