On May 3, 2023 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported that it has determined its first two indications in non-small cell lung cancer (NSCLC) in which to pursue Phase III clinical trials for its innovative, potential first-in-class bispecific antibody, ivonescimab (Press release, Summit Therapeutics, MAY 3, 2023, View Source [SID1234630955]).

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Summit has held multiple meetings with the US Food and Drug Administration (FDA) during the first quarter of 2023 regarding its planned Phase III clinical program and incorporated this feedback accordingly. We plan to initiate clinical studies in the following indications:

Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) ("HARMONi")
Ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients ("HARMONi-3")
For the HARMONi trial, Summit intends to dose its first patient during the current quarter (Q2 2023). We intend to dose our first patient in the HARMONi-3 trial in the second half of 2023.

Ivonescimab, known as SMT112 in the United States, Canada, Europe, and Japan, 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. There is higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal, healthy tissue in the body. Ivonescimab’s tetravalent structure enables higher avidity (accumulated strength of multiple binding interactions) with over 10 fold increased binding affinity to PD-1 in the presence of VEGF in vitro in tumor cells.1 This tetravalent structure, the design of the molecule, and bringing these two targets into a single bispecific antibody have the potential to steer ivonescimab to the tumor tissue versus healthy tissue, which are intended to improve side effects and safety concerns associated with these targets and have the potential to focus the antitumor activity of both targets.

Over 750 patients have been dosed with ivonescimab in clinical studies in China and Australia.

"I am immensely proud of the speed and efficiency of our team to enable clinical trials for SMT112," stated Robert W. Duggan, Chairman & Chief Executive Officer of Summit. "I am particularly enthusiastic about the potential of ivonescimab: this shared enthusiasm is the impetus behind Team Summit’s rapid development to enter into multiple Phase III clinical trials with SMT112. With our confidence in our ability to clinically develop, achieve regulatory approvals, and effectively commercialize a quality product, we believe that we have the opportunity to make a significant difference in the lives of those patients who could benefit from this innovative therapy."

"Our agreement to in-license ivonescimab from our high-achieving partner, Akeso, went effective this past January," added Dr. Maky Zanganeh, Co-CEO & President of Summit. "In just over three months’ time, we are preparing to enroll patients in our first Phase III clinical trial, while actively preparing to launch our second Phase III study later this year. The commitment, preparation, diligence, and vision of Team Summit is shining brightly today and reflects the work we have completed to maximize the opportunities for the success of ivonescimab."

Ivonescimab is an investigational product and is not approved for use by any health authority. Its efficacy and safety for the treatment of any indication have not been established.

1 Zhong et al, SITC (Free SITC Whitepaper) 2022

First Quarter 2023 Earnings Call

Summit will host an earnings call to announce its first quarter 2023 financial results and provide an operational update for the Company on Thursday, May 11, 2023, before the market opens. Summit will host a live webcast of the earnings conference call at 9:00am ET. It will be accessible through Summit’s website www.smmttx.com. An archived edition of the session will be available on our website.