Summit Therapeutics Unveils Breakthrough Treatment for Autoimmune Disorders: Ivonescimab (SMT112) Ready for Clinical Trials!

Summit Therapeutics Inc. (NASDAQ: SMMT) is thrilled to announce that it has identified two indications in non-small cell lung cancer (NSCLC) where its innovative, potential first-in-class bispecific antibody, ivonescimab, is to be tested in Phase III clinical trials. This marks a significant milestone in the development of a potential breakthrough therapy for this life-threatening condition.

In the first quarter of 2023, Summit held a series of meetings with the US Food and Drug Administration (FDA) to discuss its planned Phase III clinical program. After incorporating the FDA’s feedback, Summit is now ready to launch clinical studies in various indications, such as…

Ivonescimab, when combined with chemotherapy, has been shown to be an effective treatment for patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI). This new therapeutic approach, known as HARMONi, has the potential to improve outcomes in this patient population.

The HARMONi-3 trial is exploring the potential of Ivonescimab in combination with chemotherapy as a first-line treatment for metastatic squamous non-small cell lung cancer (NSCLC). This study could be a game-changer in the treatment of this type of cancer, offering new hope to patients and their families.

Summit is gearing up to dose its first patient in the HARMONi trial during the current quarter (Q2 2023). We are looking forward to dosing the first patient in the HARMONi-3 trial in the second half of 2023, marking an exciting milestone in our progress towards improving the health of patients around the world.

Ivonescimab is a revolutionary, first-of-its-kind bispecific antibody that combines immunotherapy and anti-angiogenesis effects in one single molecule. This groundbreaking tetravalent structure has over 10-fold increased binding affinity to PD-1 in the presence of VEGF in tumor cells, steering the antibody towards tumor tissue and away from healthy tissue. This has the potential to reduce side effects and enhance the anti-tumor activity of both targets, making Ivonescimab a promising new treatment option for cancer patients.

Ivosescimab has been administered to over 750 patients in clinical trials across China and Australia, demonstrating its potential for helping people around the world.

Team Summit is proud to announce that clinical trials for SMT112 are now underway, demonstrating their commitment to developing innovative therapies for those who need it most. With the potential of ivonescimab, Summit is confident in their ability to not only clinically develop and achieve regulatory approvals, but also effectively commercialize a quality product. This milestone is a testament to the speed and efficiency of the Summit team, and further cements their mission to make a difference in the lives of patients around the world.

In just three months, Team Summit has achieved an incredible feat: readying itself to launch the first of two Phase III clinical trials for ivonescimab. This impressive outcome is the result of our agreement with Akeso to in-license the product back in January, as well as our commitment, preparation, diligence, and vision. We are proud and excited to bring this innovative medicine to the world and look forward to its successful future.

Ivonescimab is an exciting new investigational product that has yet to receive approval from any health authorities. While its potential in treating a variety of conditions is yet to be fully evaluated, its promise as a potential game-changer in the medical industry is undeniable. With further research, Ivonescimab may just become the next breakthrough in healthcare.

First Quarter 2023 Earnings Call

Summit is pleased to announce that it will host a live webcast of its first quarter 2023 financial results and operational update on Thursday, May 11, 2023 before the market opens. Join us as we discuss our progress and share our insights on the future of the company at 9:00am ET!

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