National Cancer Centre of Singapore Pte Ltd.

Biofourmis founder launches health LMM startup Over a year after leaving biotechnology unicorn Biofourmis, ex-CEO and founder Kuldeep Singh Rajput recently announced that he set up a new health tech company focused on generative AI. In a LinkedIn post, he shared that his newly founded startup, OutcomesAI, has partnered with SingHealth to deploy its large multi-modal model (LMM) called Glia, which allows organisations to build clinician companion AI. National Heart Centre Singapore and National Cancer Centre Singapore were identified as the first sites of the LMM integration. JLK bags 510(k) for CT perfusion AI South Korean medical AI company JLK has obtained another regulatory approval in the United States for one of its stroke AI offerings. The company received its third 510(k) clearance from the US Food and Drug Administration for JLK-CTP, which uses AI to automatically identify the centre of cerebral infarction and the area of cerebral hypoperfusion in brain CT perfusion images. JLK received its first 510(k) in June for its MRI-based prostate analysis AI software, then a second one for another stroke AI solution that specifically detects large vessel occlusion in brain CT scans. Korea OKs Heuron's Parkinson's disease AI Fellow Korean medical imaging AI company, Heuron, also recently received regulatory approval from the South Korean Ministry of Food and Drug Safety. According to a press statement, its AI-powered software HeuronNM identifies and quantifies neuromelanin – a key biomarker of Parkinson's disease – in brain 3D MRI images. Meanwhile, Heuron is currently working to secure FDA approvals in Thailand for its range of AI solutions following its expansion there in August. Wadhwani AI backs AIIMS Indian non-profit Wadhwani Institute for Artificial Intelligence (Wadhwani AI) has been tapped to support the All India Institute of Medical Sciences in New Delhi in its healthcare AI integration projects. AIIMS was recently designated as one of India's "AI centres of excellence" under the government's Make AI in India, Make AI Work for India initiative, in which healthcare is one of the priority areas. As a partner, Wadhwani AI will be deploying its AI solutions that support the diagnosis of chest conditions and diabetic retinopathy. The Indian government has pledged to invest over $110 million in supporting the AI COEs over the next four years. NUS Medicine establishes digital health accelerator The Yong Loo Lin School of Medicine of the National University of Singapore (NUS Medicine) has recently launched an accelerator programme for digital health startups, including those developing AI solutions in mental health and hospital administration. A collaboration with 22Health Ventures, the Digital Accelerator Programme of the NUS Medicine Digital Advanced Technology Accelerator aims to support startups from conception through global expansion. The cohort includes 2Strands, which develops blood-based cancer recurrence monitoring tests; Health BETA, which offers genetic tests and digital therapeutics for personalised health monitoring; HealthBridge AI, which is currently testing its clinical product for streamlining administrative tasks; Marymount Lab, which provides patient engagement software for preventive health; and TenangAI, which offers an AI-driven solution to support youth mental health.

MONDAY, April 24, 2023 -- A two-drug combination therapy can enhance survival odds for people with early-stage liver cancer through targeted attacks on tumor cells, a new clinical trial shows. The combo -- atezolizumab (Tecentriq) and bevacizumab (Avastin) -- reduced risk of cancer recurrence or death by 28% in patients who’d had surgery to remove their liver tumor, researchers report. This is the first time that any drugs have been shown to lower the risk of liver cancer returning in patients whose tumors were caught early enough to be removable, said researcher Dr. Pierce Chow , a senior consultant surgeon at the National Cancer Centre Singapore. “In that context, the results of this trial are historical, because for the first time patients with primary liver cancer, if they were to undergo surgical resection or ablation, there's an opportunity for them to receive therapy that can reduce recurrence,” Chow said. For this clinical trial , Chow and his colleagues tested the two-drug combination on patients with early-stage hepatocellular carcinoma, the most common form of liver cancer. The atezolizumab/bevacizumb combo already is being used to treat liver cancer that has either spread or can’t be treated with surgery. The U.S. Food and Drug Administration approved the combo for this use in 2020. Atezolizumab blocks the ability of cancer cells to hide from the immune system using a protein called programmed death-ligand 1 (PD-L1). PD-L1 can make a cancer cell appear healthy and thus avoid attack from immune cells. Meanwhile, bevacizumab blocks a protein called VEGF that makes blood vessels grow. Some cancer cells produce large amounts of VEGF, to encourage the development of new blood vessels that will bring oxygen and nutrition to a tumor. Given its effectiveness in treating advanced liver cancer, researchers thought the combination therapy might also be useful in preventing the recurrence of early liver cancers. The main treatments for early-stage liver cancer are surgery or thermal ablation, a treatment that destroys cancer cells with heat or cold, the researchers explained in background notes. Unfortunately, the risk of liver cancer recurring in these patients runs between 70% and 80%, Chow said. In the study, 334 patients were recruited; half were randomly assigned to receive the two-drug combo for one year following surgery. The rest were put on active surveillance to see if their cancer returned, which up to now has been the only other option available. After an average 17 months of follow-up, the combination therapy had reduced risk of recurrence or death by 28% in patients receiving the drugs. The findings were presented this week at the American Association of Cancer Research annual meeting, in Orlando, Fla. Such research is considered preliminary until published in a peer-reviewed journal. “This represents a major therapeutic development in the field of liver cancer,” said Dr. Edith Mitchell , a clinical professor of medical oncology with the Sidney Kimmel Cancer Center at Thomas Jefferson University Hospitals in Philadelphia. Mitchell was not involved in the trial. “The 12-month recurrence rate in the patients who did not receive this therapy was 34%, so this is a very significant and powerful study,” Mitchell said. Importantly, the combination therapy also did not produce more serious side effects in early-stage liver cancer patients than it does in those with advanced disease, even though these latest patients were on the drugs for longer, both Chow and Mitchell noted. Patients in the early-stage trial took the combo for about 11 months, on average, compared with about seven months for patients involved in the earlier trials aimed at advanced liver cancer, results showed. “They were on the therapy significantly longer in terms of the number of months compared to patients on the earlier trial for advanced cancer, but we don't see an increase in side effects in spite of the longer duration of treatment,” Chow said. “And the side effects that we see, most of them are very easily managed.” Chow expects that the sponsor of the clinical trial, drugmaker Genentech/Roche, will soon ask the FDA to approve this new use of the two-drug combo. In the meantime, researchers plan to continue tracking the health of the patients for around five years, “so further down the line, expect to see more data,” Chow added. The five-year relative survival rate of patients with early-stage, localized liver cancer is 36%, according to the American Cancer Society. Sources Pierce Chow, MBBS, MMed, FRCS(E), PhD, senior consultant surgeon, National Cancer Centre Singapore Edith Mitchell, MD, clinical professor, medical oncology, Sidney Kimmel Cancer Center, Thomas Jefferson University Hospitals, Philadelphia American Association for Cancer Research Annual Meeting and news release, April 16, 2023 Posted April 2023

The 2023 American Association for Cancer Research (AACR) Annual Meeting kicked off over the weekend, featuring advances in the treatment of several cancer types. Here are some notable presentations. Roche’s Tecentriq-Avastin Combo in Adjuvant Liver Cancer Interim results from Roche subsidiary Genentech’s Phase III IMbrave050 study showed the combination of Tecentriq (atezolizumab) and Avastin (bevacizumab) significantly improved recurrence-free survival (RFS) in adjuvant hepatocellular carcinoma (HCC), as compared with active surveillance. IMbrave050 enrolled 668 patients who were deemed to be at a high risk of recurrence following surgery. After a median of 17.4 months, treatment with Genentech’s antibody combo reduced the risk of recurrence or death by 28%. Overall survival data and those for other secondary endpoints were not yet mature at the time of the interim analysis, Pierce Chow, lead study author and senior consultant surgeon at the National Cancer Centre Singapore, said in a press interview. There is a lack of proven and effective adjuvant treatments for HCC, Chow said, adding that patients who undergo resection or ablation typically have poor survival and often see their disease recur. Results from IMbrave050 help address this urgent need, he said. According to a story from Fierce Pharma, there were 27 deaths in the Tecentriq-Avastin arm, two of which were directly attributed to the study treatment. Twenty patients in the active surveillance group died. Serious adverse events occurred in 24.1% of patients treated with Tecentriq-Avastin, as opposed to 10.3% in active surveillance comparators. The Tecentriq-Avastin combo is approved for use in HCC patients with unresectable or metastatic disease who have not previously received systemic therapy. Moderna and Merck’s High-Risk Melanoma Combo In the Phase IIb KEYNOTE-942/mRNA-4157-P201 trial, Moderna’s individualized mRNA vaccine combined with Merck’s Keytruda (pembrolizumab), a PD-1 blocker, boosted recurrence-free survival in patients with resected stage III/IV melanoma. The mRNA vaccine, an individualized neoantigen therapy, works by priming the patient’s immune system to launch a potent anti-tumor response specific to their cancer’s mutation signature. Compared with Keytruda alone, the combination led to a 44% drop in the risk of recurrence or death. Over 12 months of observation, the RFS rate was 83.4%, which dropped slightly to 78.6% by 18 months. In an exploratory subgroup analysis of patients with high and low tumor mutational burden, the use of the mRNA vaccine reduced the risk of recurrence or death by 35% and 41%, respectively. As for safety, the observed adverse events were largely consistent with what had been previously recorded. Common toxicities included fatigue, injection-site pain and chills. These data point to the potential of combining an individualized vaccine with PD-1 blockage in high-risk melanoma, Kyle Holen, senior vice president and head of development, therapeutics and oncology at Moderna, said in a statement. Moderna looks forward to beginning a Phase III trial soon, he said. Beyond melanoma, Moderna also plans to study this candidate in lung cancer, Holen said. AstraZeneca’s Imfinzi in Late-Stage NSCLC In a planned interim analysis of the Phase III AEGEAN study, AstraZeneca’s Imfinzi (durvalumab) plus neoadjuvant chemotherapy, followed by Imfinzi on its own, significantly improved event-free survival (EFS) in patients with early-stage non-small cell lung cancer (NSCLC), as compared with neoadjuvant chemotherapy alone. The Imfinzi-based regimen cut the risk of recurrence, progression or death by 32%. Pathologic complete response (pCR), defined as having no viable tumor after neoadjuvant treatment, was a key secondary endpoint of AEGEAN. The Imfinzi regimen led to a 17.2% pCR rate, as opposed to 4.3% after neoadjuvant chemotherapy alone. AEGEAN’s results underline the importance of diagnosing NSCLC and initiating treatment earlier, when patients are most likely to be cured, Susan Galbraith, executive vice president of oncology R&D at AstraZeneca, said in a statement. AstraZeneca will discuss these data with the regulatory bodies, Galbraith said. The AEGEAN study consisted of 802 NSCLC patients who were given Imfinzi at a fixed dose of 1,500 mg. Those with tumor mutations in the EGFR and ALK genes were excluded from the study. AEGEAN found no new safety signals in either the neoadjuvant or adjuvant settings. Affimed’s Mid-Stage Lymphoma Study Final data from the Phase II REDIRECT study showed that Affimed’s AFM13 was effective for the treatment of heavily pretreated, advanced relapsed or refractory peripheral T Cell Lymphoma (PTCL). Affimed’s candidate induced a 32.4% objective response rate (ORR) and a 10.2% complete response rate (CRR) in the study’s intention-to-treat population. In the subgroup of patients with angioimmunoblastic T cell lymphoma, a common PTCL subtype, AFM13 elicited ORR and CRR values of 53.3% and 26.7%, respectively. AFM13’s effects endured for a median of 2.3 months, and treated patients showed a median progression-free survival of 3.5 months. Overall survival was 13.8 months. AFM13 is an investigational, first-in-class innate cell engager that works by activating innate immune players including natural killer cells and macrophages to attack CD30-positive hematologic cancer cells. It is Affimed’s most advanced innate cell engager. REDIRECT is a multicenter, registration-directed trial enrolling 108 patients who received 200-mg intravenous infusions of AFM13. Affimed reported an adverse event pro was consistent with what had previously been reported. Common treatment-emergent toxicities included infusion-related reactions, neutropenia and pyrexia. There were no side effects that led to death. Tristan Manalac is an independent science writer based in metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com