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Summit Therapeutics Inc (NASDAQ: SMMT) delivers innovative therapies for high-need medical conditions through focused research in genetic disorders and infectious diseases. This dedicated news hub provides investors and industry observers with essential updates on clinical progress, regulatory milestones, and strategic collaborations.
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Akeso, Inc. (HKEX: 9926.HK) announced two upcoming oral presentations of ivonescimab (PD-1/VEGF bispecific antibody) at the IASLC 2024 World Conference on Lung Cancer (WCLC24). A key presentation will feature results from the HARMONi-2/AK112-303 study, comparing ivonescimab monotherapy to pembrolizumab in patients with PD-L1 positive non-small cell lung cancer (NSCLC).
Ivonescimab has shown significant milestones, including:
- Marketing approval for EGFR-mutated NSCLC treatment in May 2024
- Statistically significant improvement in progression-free survival compared to pembrolizumab
- Acceptance of supplemental New Drug Application by China NMPA for first-line treatment of PD-L1 positive NSCLC
These developments position ivonescimab as a promising treatment option in the field of lung cancer therapy.
Summit Therapeutics (NASDAQ: SMMT) has announced the grant of inducement awards to 14 new employees. The awards consist of options to purchase a total of 453,250 shares of common stock. These options, approved by the Company's Compensation Committee, were granted on August 7, 2024, in accordance with Nasdaq Listing Rule 5635(c)(4).
The options have a ten-year term and an exercise price of $9.40 per share, which was the closing price of Summit's common stock on the grant date. The options will vest in equal annual installments over four years and are subject to the terms of a stock option agreement to be executed by each recipient.
Summit Therapeutics (NASDAQ: SMMT) reported financial results and operational progress for Q2 and H1 2024. Key highlights include:
1. Ivonescimab achieved statistically significant improvement over pembrolizumab in HARMONi-2 Phase III trial for 1L advanced NSCLC.
2. Positive HARMONi-A data presented at ASCO and published in JAMA, supporting ivonescimab's first regulatory approval in China for 2L+ EGFRm advanced NSCLC.
3. Raised $200 million in net proceeds, extending cash runway into Q4 2025.
4. Five-year strategic collaboration with MD Anderson to accelerate ivonescimab development in solid tumors.
5. Q2 2024 financial results: GAAP net loss of $60.4 million ($0.09 per share), Non-GAAP net loss of $34.3 million ($0.05 per share).
Summit Therapeutics (NASDAQ: SMMT) has announced it will host an earnings call on August 6, 2024, to discuss its second quarter 2024 financial results and provide an operational update. The conference call is scheduled for 9:00am ET, before the market opens. Investors and interested parties can access the live webcast through the company's website at www.smmttx.com. An archived version of the session will also be available on the website for those unable to attend the live call.
Summit Therapeutics (NASDAQ: SMMT) and MD Anderson Cancer Center have announced a five-year strategic collaboration to accelerate the development of ivonescimab, a potential first-in-class PD-1 / VEGF bispecific antibody. The partnership aims to explore additional opportunities for ivonescimab in various solid tumors beyond its current development plan.
MD Anderson will lead multiple clinical trials to evaluate ivonescimab's safety and potential clinical benefit, including biomarker identification. Early work may focus on renal cell carcinoma, colorectal cancer, skin cancer, breast cancer, and glioblastoma. The collaboration leverages MD Anderson's clinical infrastructure and research expertise alongside Summit's innovative drug candidate.
Ivonescimab has shown promise in recent Phase III non-small cell lung cancer trials (HARMONi-A and HARMONi-2) and Phase II studies in other solid tumors. The partnership aims to rapidly expand the drug's development program and bring this innovative immunotherapy and anti-angiogenic treatment to patients who may benefit.
Summit Therapeutics (NASDAQ: SMMT) has granted inducement awards of options to purchase up to 330,000 shares of common stock to six new employees. These awards, approved by the Compensation Committee, were given as an incentive for the new hires under Nasdaq Listing Rule 5635(c)(4). The options, granted on June 28, 2024, have a 10-year term with an exercise price of $7.80 per share, matching the closing price on the grant date. The options will vest in equal annual installments over four years and are governed by stock option agreements.
Summit Therapeutics has appointed Jeff Huber to its Board of Directors, effective immediately. Huber brings extensive experience from his roles at Google, GRAIL, and his venture capital firm, Triatomic Capital. His background in healthcare and technology aligns with Summit's focus on ivonescimab, a bispecific antibody candidate aimed at treating solid tumors. Huber's appointment is expected to enhance Summit's leadership as it strives to innovate in cancer treatment.
Summit Therapeutics (NASDAQ: SMMT) announced raising $200 million through the sale of 22,222,222 shares at $9.00 each, above the recent closing price. The funds will support ivonescimab's clinical development, working capital, and general corporate purposes. Additionally, Summit expanded its license territories for ivonescimab to include Latin America, the Middle East, and Africa, adding to its existing regions of the US, Canada, Europe, and Japan. This expansion deal, valued up to $70 million, enhances the collaboration with Akeso by improving data sharing and advancing clinical development and regulatory approval processes. A conference call is scheduled for June 3, 2024, at 8:00am ET.
Summit Therapeutics (NASDAQ: SMMT) announced the publication of a manuscript in JAMA detailing the HARMONi-A clinical trial results. The Phase III study, conducted by Akeso in China, investigated ivonescimab combined with chemotherapy in patients with EGFR-mutated non-small cell lung cancer (NSCLC) who had progressed after EGFR TKI treatment. The results indicate that ivonescimab, a PD-1/VEGF bispecific antibody, shows promise in this clinical setting where PD-1 monoclonal antibodies have previously failed.
The study was highlighted in an oral presentation at ASCO 2024 on May 31, 2024. A conference call to discuss the findings will be held on June 3, 2024, at 8:00 AM ET. The call will be webcast live and archived on Summit's website.
Summit Therapeutics (NASDAQ: SMMT) has announced that its partner, Akeso, has received marketing authorization from China's National Medical Products Administration (NMPA) for ivonescimab in combination with chemotherapy for treating patients with EGFR-mutated non-squamous non-small cell lung cancer (NSCLC). This approval is based on the Phase III HARMONi-A clinical trial, which showed a significant improvement in progression-free survival (PFS) and a positive trend in overall survival (OS). Ivonescimab plus chemotherapy achieved a 54% reduction in disease progression risk compared to chemotherapy alone, with a median PFS of 7.1 months versus 4.8 months for the placebo group. The trial also reported a disease control rate of 93.1% for the combination therapy. Safety profile was manageable, with 5.6% of patients discontinuing ivonescimab due to adverse events. The positive results were presented at the 2024 ASCO Annual Meeting. Summit will host a conference call on June 3, 2024, to discuss these updates.