Imatinib mesylate

Enliven “plans to explore strategic alternatives for the ELVN-002 program and does not intend to pursue its development beyond 2025,\" the company said in a press release.\n Enliven Therapeutics has decided against taking its phase 1-stage solid tumor drug into further development next year in order to keep resources flowing toward its leukemia candidate.The Colorado-based biotech is currently evaluating ELVN-002, which is designed to inhibit the HER2 pathway in solid tumors, in a pair of phase 1 trials. One of these studies is looking at ELVN-002 in combination with AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu as a treatment for HER2-positive breast cancer. The other study is looking at ELVN-002 in combination with Roche’s Herceptin for patients with HER2-positive colorectal cancer.However, Enliven said in its first-quarter earnings release that it now “plans to explore strategic alternatives for the ELVN-002 program and does not intend to pursue its development beyond 2025.”Mothballing work on ELVN-002 means Enliven can prioritize the upcoming pivotal trial of ELVN-001. The small-molecule kinase inhibitor is designed to inhibit BCR-ABL gene fusion, which is the oncogenic driver of chronic myeloid leukemia (CML).In an ongoing phase 1 trial, 44% of 36 evaluable patients with previously treated CML have experienced a major molecular response—meaning the level of the BCR-ABL1 gene is reduced to 0.1% or less—by 24 weeks, the biotech reported in the same May 14 release.Multiple BCR-ABL tyrosine kinase inhibitors are marketed to treat CML in Novartis’ Gleevec and Tasigna, Bristol Myers Squibb’s Sprycel and Pfizer’s Bosulif. But Enliven said its latest data “compare favorably to precedent phase 1 trials of the approved BCR::ABL1 tyrosine kinase inhibitors, particularly given the more heavily pre-treated patient population in the ELVN-001 clinical trial.”“We continue to gain confidence and momentum in the program as the efficacy, safety and tolerability data consistently compare favorably to the approved BCR::ABL inhibitors,” Enliven’s CEO Sam Kintz added in yesterday’s release. “Looking towards the rest of the year, we remain focused on clinical execution as we prepare for the potential start of a pivotal trial for ELVN-001 in 2026,” Kintz added.Having called time on further development of ELVN-002, Enliven now expects the $289.6 million it ended March with to last into late 2027.

Mumbai: India’s Commerce Minister Piyush Goyal tells it like it is. Weeks after he exhorted Indian startups to work on genuine scientific innovations while drawing comparisons with China, Goyal criticised companies that reached out to him to allow incremental changes to their patents and extend the right of patent protection over a longer period. He said this is “evergreening,” adding it is sad that for super-normal profits of a select few companies and their shareholders, the world must suffer. From a Union Minister, that comes as one of the boldest statements in recent years. It assumes significance in the backdrop of the strident position taken by the US Trade Representative (USTR) on India’s laws related to intellectual property protection rights. The latest report of the USTR named India on its priority watch list, a signal of its concerns on behalf of the US companies that rely on patent protection for business growth. For years, the USTR’s position has not changed. Goyal’s statement against attempts of patent evergreening comes from a deeper perspective. In 2013, India’s Supreme Court pronounced a landmark verdict dismissing the claims of Swiss drugmaker Novartis for a product patent on its chronic myeloid leukaemia drug Gleevec. The court cited Section 3(d) of the Indian Patents Act that clearly dismissed grants of patent extensions for products (medicine) that were merely new forms of known substances and had no benefit of enhanced efficacy. The high-profile case sparked a global controversy. While it drew flak from several countries that steadfastly backed patent protection, on the other extreme, legal experts and public health agencies hailed the decision as one of the defining moments in the history of international patent laws. There are distinct reasons for that big divide. The US espouses strong IP laws as a reward or recognition for its innovation-based pharmaceutical and biotech industry. But that comes with a plethora of shortcomings. A few leading multinational companies have been granted patent extensions for several years, which not only deprived patients of their lifesaving medicines but also drained the US healthcare system of billions of dollars. Take AbbVie’s Humira (adalimumab), a hugely popular drug for autoimmune conditions like rheumatoid arthritis, psoriasis, ulcerative colitis, and Crohn’s disease. Humira was the first-ever drug to have crossed $20 billion in sales, making it the biggest blockbuster medicine before US-based Merck’s Keytruda took the crown. Although one of AbbVie’s first US patents had expired in 2016, its earliest biosimilar competition was launched in the US only in 2023. A deal was struck as part of a settlement of the patent dispute. Between 2001 and 2022, Humira had earned over $200 billion before a bunch of biosimilars trickled in. According to reports, AbbVie filed over 311 patents for the drug, also called a patent thicket. Of those, the US had granted 165 patents. There was little scope for competition. Similarly, Amgen’s earliest patents for blockbuster drug Enbrel (etanercept) were to expire in the US in 2012. Yet, in one of the most talked-about examples of patent evergreening, its drug has secured protection in the US until 2029. The irony is that while Amgen extended its own patents on Enbrel, it disputed certain patents of AbbVie’s Humira. Later, Amgen and AbbVie agreed to a settlement and delayed the biosimilar launch till 2023. These are just two of several glaring examples where the US patent laws have delayed cheaper versions of medicines and drawn flak from public health activists. The Indian patent laws, in contrast, are seen by many as carefully drafted to strike out claims of frivolous patents. As a sole exception, India used its compulsory licensing rights for Bayer’s kidney cancer drug Nexavar (sorafenib) on grounds of non-availability and affordability. That was another protracted legal fight that was based on strong merits. For Piyush Goyal, where global powers assert pressure, the fight against evergreening will get tougher. By Vikas Dandekar ,