Osimertinib mesylate

MIAMI--(BUSINESS WIRE)-- Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that Jeff Huber has been appointed to its Board of Directors, effective immediately. “It is an honor to add Jeff Huber to our excellent, diverse group of board members,” stated Robert W. Duggan, Chairman and Chief Executive Officer of Summit. “Jeff’s executive leadership experience in healthcare and technology and his countless accomplishments evidence his ability to translate what’s possible into transformational success. As we seek to change the standard of care for solid tumors based on the potential of ivonescimab, we are thrilled to supplement our outstanding leadership team with a board member the caliber of Jeff.” Mr. Huber is the Co-Founder & General Partner of Triatomic Capital Private LP since 2022, a venture capital firm helping entrepreneurs build 'century-defining' businesses & technologies. Prior to founding Triatomic, Mr. Huber was the Founding CEO and Vice Chairman of GRAIL, Inc. GRAIL's mission is to detect cancer early, when it can be cured. Prior to GRAIL, he was a Senior Vice President at Alphabet Inc. (formerly Google Inc.). Over 13 years at Google, Mr. Huber co-founded Google's life sciences efforts in Google[x], and he led development and scaling for Google Maps, Google Apps (Gmail, Calendar, Docs, etc.), and Google Ads. Earlier, Mr. Huber was VP of Architecture and Systems Development at eBay and SVP of Engineering at Excite@Home. He is a board member of both publicly traded and privately held companies, including Mammoth Biosciences, Inc., Manifold Biotechnologies, Inc., Electronic Arts Inc., Upstart Network, Inc., Openwater, Genalyte, Inc., Zapata Computing Inc., Weta FX Ltd, d-Matrix Corp., and the Parker Institute for Cancer Immunotherapy, and is a former board member of GRAIL, Inc., Aldevron LLC, and Illumina, Inc. Mr. Huber holds a B.S. in Computer Engineering from the University of Illinois and an M.B.A. from Harvard Business School. “Jeff’s breadth and depth of experience is unmatched,” added Dr. Maky Zanganeh, Chief Executive Officer, President, and a member of the Board of Directors of Summit. “I am thrilled to be working with Jeff as a member of our board to further propel Team Summit to achieving our goal of bringing ivonescimab to as many patients as possible who can benefit from our innovative bispecific antibody candidate.” “I am excited to join a mission-driven company seeking to make a significant, positive difference in improving the quality and potential duration of patients’ lives,” said Mr. Huber. “An opportunity to join the Board of Directors and to work with Team Summit is a tremendous opportunity to make that difference, and I am confident in Team Summit’s ability to achieve its mission.” About Ivonescimab Ivonescimab, known as SMT112 in Summit’s license territories, the United States, Canada, Europe, Japan, Latin America, including Mexico and all countries in Central America, South America, and the Caribbean, the Middle East, and Africa, and as AK112 in China and Australia, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with higher affinity when in the presence of both PD-1 and VEGF. This could differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Ivonescimab’s tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME with over 18-fold increased binding affinity to PD-1 in the presence of VEGF in vitro, and over 4-times increased binding affinity to VEGF in the presence of PD-1 in vitro (Zhong, et al, SITC, 2023). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days (Zhong, et al, SITC, 2023), is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets. Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials. Over 1,600 patients have been treated with ivonescimab in clinical studies globally. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two Phase III clinical trials, HARMONi and HARMONi-3. HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib). HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic squamous NSCLC. Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. About Summit Therapeutics Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs. Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol "SMMT"). We are headquartered in Miami, Florida, and we have additional offices in Menlo Park, California, and Oxford, UK. For more information, please visit and follow us on X @SMMT_TX. Summit Forward-looking Statements Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, entry into and actions related to the Company’s partnership with Akeso Inc., including the expected benefits of the amendment to the collaboration and license agreement, the intended use of the net proceeds from the private placement, the Company's anticipated spending and cash runway, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, potential acquisitions, statements about the previously disclosed At-The-Market equity offering program (“ATM Program”), the expected use proceeds and uses thereof, and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company’s ability to sell shares of our common stock under the ATM Program, the conditions affecting the capital markets, general economic, industry, or political conditions, including the results of our evaluation of the underlying data in connection with the development and commercialization activities for ivonescimab, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials, the results of such trials, and their success, and global public health crises, that may affect timing and status of our clinical trials and operations, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, whether business development opportunities to expand the Company’s pipeline of drug candidates, including without limitation, through potential acquisitions of, and/or collaborations with, other entities occur, expectations for regulatory approvals, laws and regulations affecting government contracts and funding awards, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the "Risk Factors" section of filings that the Company makes with the Securities and Exchange Commission. Any change to our ongoing trials could cause delays, affect our future expenses, and add uncertainty to our commercialization efforts, as well as to affect the likelihood of the successful completion of clinical development of ivonescimab. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.

The FDA confirmed the accelerated approval pathway for Dizal's sunvozertinib in previously treated non-small cell lung cancer with EGFR exon 20 insertion mutations The FDA in March converted Johnson & Johnson’s Rybrevant use in previously treated EGFR exon20 insertion-mutated non-small cell lung cancer into a full nod. But the door to an accelerated approval in the same indication remains open, according to Dizal Pharma. “The FDA actually encouraged us […] to submit as soon as possible,” Dizal CEO Xiaolin Zhang, Ph.D., told Fierce Pharma on the sidelines of the American Society of Clinical Oncology (ASCO) annual meeting in Chicago early June. Dizal is developing the EGFR tyrosine kinase inhibitor sunvozertinib, which was approved in China in August for pretreated NSCLC with EGFR exon 20 insertion mutations. After a positive global pivotal trial readout and what Zhang described as a successful pre-NDA meeting with the FDA, the AstraZeneca spinout is on the verge of filing for an accelerated approval in the U.S. The FDA confirmed the accelerated approval pathway and then granted breakthrough therapy designation to sunvozertinib as a frontline treatment after the agency had handed J&J’s Rybrevant its full nod, which came hand-in-hand with a first-line approval. “Clearly, the FDA views there are patients’ needs for alternative or better therapies for this disease,” Zhang said. The FDA has in the past turned away accelerated approval applications when a full approval was already in place. Back in 2021, Agenus was forced to pull a cervical cancer submission for balstilimab after the FDA granted full approval to Merck’s Keytruda in the same indication. While both balstilimab and Keytruda are PD-1 inhibitors, sunvozertinib and Rybrevant are different, as the J&J drug is an EGFR-MET bispecific antibody. With an FDA filing around the corner, Dizal has been in discussion with multiple larger pharma companies to team up on sunvozertinib, Zhang said. Many potential partners were waiting for results from the global WU-KONG1B trial presented at ASCO 2024 and were asking questions about the first-line setting, where the drug’s key opportunity lies. Dizal is open to all deal types, Zhang said. As to whether the biotech can take U.S. commercialization in its own hands, the CEO said he’s comfortable with the company’s cash flow, especially now that sunvozertinib has started generating revenue. “We’re going to do the best deal that maximizes that potential of sunvozertinib commercially and benefit our patients,” Zhang said. “We are not going to do a deal for the sake of it.” Sunvozertinib has proven its worth in the single-arm, pivotal WU-KONG1B trial, which enrolled more than 40% non-Asian patients. As of a data cut in March, investigators recorded a best overall response rate (ORR) of 53.3% and a confirmed ORR of 44.9%, including two confirmed complete responses, among 107 patients who received sunvozertinib at the recommended 300mg dose. Notably, the drug showed anti-tumor effect regardless of prior treatment with Rybrevant. The best ORRs for those with or without prior exposure to the J&J drug were similar at 50% and 53.8%, respectively. The median duration of response was not reached, and 57% of patients were in remission for at least nine months. Dizal can’t file just yet because the FDA wants at least six-month follow-up for the last responder. And Dizal could have that additional data late June, Zhang said.  When Rybrevant got its accelerated approval in 2021, the drug’s ORR was 40% with a median response duration of 11.1 months. Sunvozertinib’s tumor shrinkage data also appeared to be far better than Takeda’s disgraced small-molecule drug Exkivity, which got a conditional nod based on a 28% ORR. Takeda has decided to pull Exkivity off the market after failing a confirmatory phase 3 trial in the first-line setting. Dizal designed sunvozertinib in a flexible way to accommodate different types of EGFR exon 20 insertions, as well as some potency against wild-type EGFR, Zhang explained. Other drugs that focus on certain more sensitive insertions may have strong inhibition in those subtypes but may be too weak elsewhere. To shoot for an accelerated approval, the FDA has been requiring that a confirmatory trial be underway. The phase 3 WU-KONG28 trial could serve that purpose, and it’s already 70% enrolled, according to Zhang. The study is evaluating sunvozertinib monotherapy versus platinum-based doublet chemotherapy in first-line EGFR exon 20-mutated NSCLC. J&J’s Rybrevant succeeded in the first line as part of a combination with chemotherapy, while Takeda’s Exkivity flopped as a monotherapy. Still, Zhang believes single-agent sunvozertinib is the right approach because in newly diagnosed patients, quality of life is important. “Our view is that in the first line, the goal of treatment is different from later lines,” Zhang explained. “You want to keep the [progression-free survival] as long as you can, and the patient sill have very good quality of life because these are patients who generally have a reasonable daily life. So, we don’t think, if possible, that first-line combo with chemo is a desirable strategy. Once you have chemo, then that patient’s quality [of life] immediately goes down.” At last year’s European Society of Medical Oncology annual meeting, Dizal unveiled a pooled analysis of early-phase data for sunvozertinib monotherapy in first-line EGFR exon 20 NSCLC, showing a median progression-free survival of 12.4 months. The result compared favorable to Rybrevant-plus-chemo’s 11.4 months from J&J’s phase 3 PAPILLON trial. J&J is also angling Rybrevant for the more common EGFR mutations involving exon 19 and exon 21, which is currently dominated by AstraZeneca’s Tagrisso. Zhang, who previously led AZ’s China innovation center before its spinoff into Dizal, knows Tagrisso very well. Tagrisso has established itself very well in common EGFR mutations, Zhang said, “so we focus on second-line treatment after Tagrisso failure.” And that’s where Dizal will explore combinations with sunvozertinib. These include pairings with chemotherapy and with Dizal’s JAK1 inhibitor golidocitinib, which last week won Chinese approval for peripheral T-cell lymphoma. And the company has DZD6008, an EGFR inhibitor specifically designed for post-Tagrisso treatment.