Latest news with #KIMMTRAK
Yahoo
26-04-2025
- Health
- Yahoo
New cancer treatment available on NHS described as 'early Christmas present'
A cancer treatment described as 'the best early Christmas present I could've asked for', has been given approval. KIMMTRAK, a treatment for metastatic uveal melanoma, an aggressive form of eye cancer, has been approved by the FDA and NICE. The NHS has fast-tracked the treatment to hundreds of patients across England. Professor Peter Johnson, NHS national clinical director for cancer, said: "This type of melanoma is difficult to treat when it has spread in the body, so it is great news that the NHS can now offer this pioneering treatment, giving people an option that can extend their lives and offer them valuable extra time with their families and friends." Bahija Jallal, chief executive officer of Immunocore, said: "Every year, hundreds of people are diagnosed with metastatic uveal melanoma who, until now, had no approved treatment options. "KIMMTRAK is the first therapy to demonstrate a survival benefit to patients with this disease and we are focused on making KIMMTRAK available as quickly as possible." Elsewhere, Adaptimmune has received a Breakthrough Therapy Designation for lete-cel, a T-cell therapy used to treat synovial sarcoma, a rare form of cancer. Replimune has also secured FDA priority review and a Biologics License Application acceptance for RP1, a treatment for advanced melanoma. Sushil Patel, chief executive officer at Replimune, said: "There are limited treatment options and a significant unmet need for patients with advanced melanoma."
Yahoo
27-02-2025
- Business
- Yahoo
Immunocore Holdings PLC (IMCR) Q4 2024 Earnings Call Highlights: Strong Revenue Growth and ...
Total Revenue: $310 million for the full year 2024, representing a 30% year-on-year growth. Q4 Revenue: $84.1 million, a 5% increase from the prior quarter. KIMMTRAK Revenue: $310 million in net revenues for 2024, with $226 million from the United States, growing at 34% year-on-year. Cash Position: $820 million in cash and marketable securities at the end of 2024. R&D Expenses: Increased due to investments in three Phase 3 trials and Phase 1/2 expansions in ovarian and lung cancer. SG&A Expenses: Increased slightly due to general business functions needed to support operations. Warning! GuruFocus has detected 3 Warning Signs with IMCR. Release Date: February 26, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Immunocore Holdings PLC (NASDAQ:IMCR) reported a 30% year-on-year revenue growth, reaching $310 million in 2024. KIMMTRAK sales showed strong performance with a 5% increase in Q4 compared to Q3, and a 34% year-on-year growth in the US. The company has advanced its clinical pipeline with three ongoing Phase 3 trials and initiated two Phase 1 trials in 2024. KIMMTRAK has been launched in 24 countries, with recent approvals in Brazil, and has achieved over 80% market share in HLA-A*02:01 positive patients. Immunocore's R&D efforts have expanded into new therapeutic areas, including autoimmune diseases, with promising candidates targeting Type 1 diabetes and atopic dermatitis. The reimbursement environment in Europe remains challenging, affecting revenue recognition and price negotiations. SG&A and R&D expenses have increased compared to 2023, primarily due to investments in clinical trials and business operations. The company faces uncertainties in achieving viral control in its HIV program, as no therapy has reliably demonstrated this yet. There is a need for further data to confirm the efficacy and safety of new treatments in infectious diseases and autoimmune settings. Market penetration for KIMMTRAK in the US is at 65%, indicating limited headroom for growth in this market. Q: Can you provide details on the upcoming HIV results and what would be considered a good rate of patients not experiencing viral rebound? A: David Berman, Head of Research and Development, explained that all patients will have been off therapy to assess antiviral activity and viral reservoir reduction. He noted that this is a Phase 1 dose escalation with small cohorts, so specific rates are not the focus at this stage. The target product profile aims for suppression of viral copies to less than 200 copies per ml for two years in about 20% to 30% of people. Q: What factors will determine the go-forward dose for the HIV program, and what are the next steps after dose escalation? A: David Berman stated that safety and evidence of antiviral activity are key factors. The current focus is on dose optimization, and there might be two doses taken forward. After confirming the signal, a randomized Phase 2 trial with a placebo is typically the next step, although recent meta-analysis suggests single-arm trials might be sufficient. Q: Regarding the HIV program, is 12 weeks of ART interruption enough to have confidence in long-term control? A: David Berman mentioned that 12 weeks is used to gauge initial activity, as historical control rates at this point are about 1%. Longer-term control would be assessed in expansion phases, and the target product profile for commercial success is still being defined. Q: Can you provide an update on the current efforts to generate data in ovarian and lung cancers with Brene? A: David Berman highlighted that in ovarian cancer, they are expanding studies in platinum-resistant and sensitive settings. In lung cancer, they are in the signal detection phase with combinations. Data will be shared once a comprehensive understanding is achieved, likely in the next 12 to 18 months. Q: How are you thinking about business development opportunities for 2025? A: Travis Coy, Non-Executive Independent Director, stated that while they are excited about their current pipeline, they continuously look for opportunities that strategically fit and leverage their expertise. They are in a strong position but remain open to partnerships. Q: What is the potential for KIMMTRAK's market share in the US, and how is treatment duration trending? A: Ralph Torbay, Senior Vice President, noted that KIMMTRAK has 65% market penetration in the US, with significant growth in community settings. The duration of therapy is performing better than in clinical trials, but it's difficult to predict where it will land long-term. Q: Are there reimbursement challenges in Europe for KIMMTRAK, and do you anticipate similar challenges for Brene? A: Bahija Jallal, CEO, acknowledged challenges in Europe but highlighted successful negotiations and approvals. Ralph Torbay added that the reimbursement landscape is challenging for all companies, but they expect good data to facilitate access. Q: What preclinical data supports the HIV program's potential for viral control? A: David Berman shared that preclinical studies have shown the molecule can redirect T cells to kill HIV-infected cells, even without activating the T cell. The technology can target cells with low expression, supporting its potential effectiveness. Q: How are you thinking about the applicability of the autoimmune program to oncology? A: David Berman explained that both programs share tissue targeting technology, but differ in their effector mechanismsoncology activates T cells, while autoimmune turns them off. The programs leverage similar preclinical toxicology strategies. Q: What are the expectations for the upcoming HIV data, and what doses will be shown? A: David Berman stated that they will present data from three doses with five to six people per dose. Success would be indicated by signals of activity, such as reservoir reduction and altered viral kinetics, which would guide further trials. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
