Latest news with #immunotherapy
Entrepreneur
10 hours ago
- Business
- Entrepreneur
Paradigm Shift in MDS Treatment: Faron Pharmaceuticals Unveils Landmark Phase II Trial Data at ASCO 2025
The ability to not only extend life but also improve quality of life by reducing transfusion needs and infection rates is what sets this treatment apart You're reading Entrepreneur United Kingdom, an international franchise of Entrepreneur Media. In a field long hindered by stagnation, Faron Pharmaceuticals may have just turned a critical corner in the fight against high-risk myelodysplastic syndromes (HR-MDS). The Finnish clinical-stage biopharmaceutical company unveiled highly promising results from its Phase II BEXMAB trial at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The updated data, presented during a Rapid Oral Abstract Session by Dr. Naval Daver of MD Anderson Cancer Center, revealed that Faron's investigational immunotherapy, bexmarilimab (bex), when combined with the standard-of-care drug azacitidine, achieved a median overall survival (mOS) of 13.4 months in patients with relapsed/refractory (r/r) MDS, which is more than double the typical 5-6 months expected under current treatments. "These are patients who historically have had virtually no effective options after standard HMA therapies fail," said Dr. Juho Jalkanen, CEO of Faron Pharmaceuticals. "To see such meaningful survival and response rates gives us real hope that we're on the path to a true therapeutic breakthrough." The study reported an objective response rate (ORR) of 63% in r/r MDS patients (n=32) and an even higher ORR of 72% in treatment-naïve, frontline HR-MDS patients (n=18). Moreover, 56% experienced a complete (100%) reduction. Under the recently updated 2023 International Working Group (IWG) criteria, the composite complete response (cCR) rate was 56%, more than double the typical 25% response seen with azacitidine alone. Bex is a first-in-class monoclonal antibody targeting the Clever-1 receptor, a key mediator in immune suppression within the tumor microenvironment. By blocking Clever-1, the drug reprograms macrophages in the bone marrow, enabling them to mount a more effective anti-tumor immune response. "The ability to not only extend life but also improve quality of life by reducing transfusion needs and infection rates is what sets this treatment apart," confirmed Dr. Juho. "This is especially critical for a patient population that is often elderly and frail." Indeed, the therapy has demonstrated a favorable safety profile. No new safety concerns were reported, and the treatment was well-tolerated even among patients with severe anemia and recurrent infections. The impressive data from the BEXMAB study supports Faron's plan to move forward with a registrational Phase III trial comparing bex + azacitidine versus placebo + azacitidine in frontline HR-MDS. Discussions with the FDA are scheduled for an upcoming end-of-Phase II meeting. "Given the strong correlation between cCR and survival under the new IWG 2023 guidelines, we believe this could form the basis for accelerated approval," Dr. Juho stated. As the oncology community digests the implications of this data, one thing is clear: Faron Pharmaceuticals has taken a bold step forward in its mission to reshape cancer treatment through immune reprogramming.
Globe and Mail
10 hours ago
- Business
- Globe and Mail
Why BioNTech Stock Soared Today
BioNTech (NASDAQ: BNTX), one of the companies made famous for its role developing vaccines with Pfizer (NYSE: PFE) during the COVID-19 pandemic, soared 20.2% through 12:50 p.m. Monday on news entirely unrelated to COVID. The German biotech announced this morning it is partnering with pharmaceuticals giant Bristol Myers Squibb (NYSE: BMY) to "co-develop and co-commercialize" BioNTech's drug candidate BNT327 as an immunotherapy against multiple kinds of cancer. BioNTech's big news BioNTech and Bristol will evenly split the costs of developing and commercializing BNT327, and will "work jointly to broaden and accelerate the development of this clinical candidate." The drug is already involved in "multiple" ongoing clinical trials, including an advanced phase 3 trial testing its usefulness in treating breast cancer and both small cell and non-small cell lung cancer. BioNTech CEO Dr. Uğur Şahin expressed the belief that "BNT327 has the potential to become a foundational immuno-oncology backbone, moving beyond single-mechanism checkpoint inhibitors and expanding into multiple solid-tumor indications." Bristol CEO Christopher Boerner agreed that BNT327 has "significant potential for transforming the standard of care for patients with solid tumors." What this means for BioNTech There are more immediate benefits for BioNTech stock, beginning with Bristol Myers Squibb paying BioNTech $1.5 billion up front for the rights to team up and a further $2 billion in noncontingent payments through 2028 as drug development continues. Additional developmental, regulatory, and commercial milestones, which are contingent on successful development, could add a further $7.6 billion to BioNTech's balance sheet over time. With its lucrative COVID days behind it, BioNTech reported nearly $690 million in losses last year and turned free-cash-flow negative. A tidal wave of cash from Bristol Myers Squibb could really come in handy right about now. Should you invest $1,000 in BioNTech Se right now? Before you buy stock in BioNTech Se, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and BioNTech Se wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $651,049!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $828,224!* Now, it's worth noting Stock Advisor 's total average return is979% — a market-crushing outperformance compared to171%for the S&P 500. Don't miss out on the latest top 10 list, available when you join Stock Advisor. See the 10 stocks » *Stock Advisor returns as of June 2, 2025
The Independent
12 hours ago
- Business
- The Independent
Innovative treatment uses patient's own immune system to fight cancer
An innovative treatment called lifileucel, which uses a patient's own immune system to combat advanced melanoma, has shown promising results in extending the lives of patients, according to researchers. In a trial led by The Royal Marsden NHS Foundation Trust involving 153 patients, almost 20 per cent of those with advanced melanoma survived for five years after receiving lifileucel, with the majority experiencing tumour shrinkage. Experts suggest lifileucel could be a transformative option for patients with advanced melanoma, where the cancer has spread to other parts of the body. The treatment involves isolating and growing T cells from tumours in a lab before infusing them back into the patient to fight cancer, and it has already been approved by the US Food and Drug Administration (FDA) for advanced melanoma treatment. Zoe Phillips, a participant in the TIL therapy trial, experienced complete remission of her tumours six weeks after treatment, highlighting the potential of this therapy for patients with limited options.
Bloomberg
14 hours ago
- Business
- Bloomberg
Bristol-Myers to Pay $11 Billion to License Cancer Drug
Bristol-Myers Squibb Co. will pay BioNTech SE as much as $11.1 billion to license a next-generation cancer drug, as competition intensifies in an area of oncology that seeks to harness the immune system to attack tumors. Bloomberg's Damian Garde reports. (Source: Bloomberg)
Daily Mail
15 hours ago
- Health
- Daily Mail
'Holy grail' cancer therapy gives terminal patients with same disease as Joe Biden new hope in breakthrough
A groundbreaking cancer treatment hailed as a 'holy grail' is offering fresh hope to patients once given just months to live. A new study in California looked at 15 men who were 'knocking on death's door' due to late-stage prostate cancer like the one suffered by former president Joe Biden. The therapy involved injecting liquid nitrogen to freeze their tumors, followed by a powerful cocktail of drugs that trigger the immune system to destroy their cancer. Overall, 53 percent - or eight of the patients - saw all signs of their cancer disappear. Another five saw their tumors shrink dramatically, while two saw their disease stop growing. None saw their cancer progress further. Doctors involved in the study underlined how sick the patients were, saying 13 had cancers that had spread to their bones and, in every case, their disease had not responded to standard treatments. In stage four prostate cancer, the median survival rate is just two to three years. Only a third make it to five years. But, in this study, nine in 10 patients are still alive after 14 months. Dr Jason Williams, the scientist who pioneered the therapy and who was involved in the study, told in an exclusive interview that he felt the results were 'really impressive' and underlined the effectiveness of the therapy. He said: 'These results were really good, even in those patients who were metastatic, patients who were heavily treated and failed all other immunotherapies, and basically had nothing left. 'If we got more healthy patients, patients before they were treated, it is likely that our results would be even better. But, of course, the fact our results are already so good says a lot.' Doctors said their experimental therapy works because it is able to 'harness the immune system', prompting it to hunt out and destroy cancer cells in the body. For the treatment - known as SYNC-T - doctors initially freeze part of a tumor to kill some of the cells and trigger an immune response. Then, they inject a cocktail of four immunotherapy drugs into the same tumor to further ramp up the immune system and help it identify and destroy cancer cells. Scientists said that the treatment helps the immune system to recognize the cancer in other parts of the body, such as the bones, leading it to also destroy tumors in those areas. The study was revealed at ASCO 2025, the largest cancer conference in the world being held in Chicago, Illinois, and prompted gasps from members of the audience. One member was quick to call it potentially the 'holy grail' of cancer treatments, while a second simply uttered 'damn' while the results were being revealed. Joe Biden, 82, revealed last month that he had been diagnosed with an aggressive form of prostate cancer, saying it had already spread to his bones. In comments last week, he told reporters he 'feels good' and expects to 'be able to beat this'. Dr Williams said his therapy could be offered to patients like Biden. 'We know that they have the information on our trial,' he said, 'so they [Biden's medical team] have seen it, and, hopefully, they can make a decision, because he clearly has advanced prostate cancer, and this is an advanced treatment option.' In the study, patients were 60 years old on average with an age range from 49 to 74 years. Nine of the patients were White, while five were Hispanic and one was Black. Ten had previously received hormone therapy to treat their cancer, while five had been refused the therapy. Three, or 20 percent, had done chemotherapy, while five, or 33 percent, had had radiation, and two, or 13 percent, had received immunotherapy. Each received up to 12 cycles of the therapy which was administered once every four weeks. Patients also underwent full-body MRI and PET scans every eight weeks, allowing doctors to track the progression of their tumors. On average, patients had elevated levels of immune cells that fight tumors in their blood within 24 hours of their first cycle of the treatment. Side effects such as fevers were recorded, which the scientists said was likely been triggered by a surge in immune system activity. There were no major adverse events, however. In one case, a patient saw all 50 cancerous growths in their bones disappear after receiving the treatment. The patients in this study had metastatic castration-resistant prostate cancer, meaning their cancer had spread to other areas of the body and hormone therapy was no longer effective in controlling its growth. Dr Williams has urged other doctors to adopt his method of injecting immunotherapy drugs directly into the tumor instead of systemically, or into the blood stream, as is standard practice. He added to this website: 'Hopefully, this is going to open people's eyes. 'Doctor's say, you think putting medication in tumors is going to work, and I say, that's like saying if you've got a house on fire, do you think you should put the water on that house or on another one nearby'. The therapy has also been used to treat other cancers previously, in cases covered by These include a doctor suffering from pancreatic cancer who had been told he had just six months to live, but then cleared his cancer with the therapy. And a mother-of-five given 24 months to live after her stage four breast cancer spread 'everywhere'. Prostate cancer is the most common cancer among men in the US, with about 236,000 men diagnosed with the disease in the US every year. Age is the biggest risk factor for the disease, with one in eight men being diagnosed with the disease during their lifetimes. Those aged 70 and over have about a 50:50 risk of developing the disease, studies suggest.
