Summit Therapeutics and MD Anderson Announce Strategic Collaboration to Accelerate Development of Ivonescimab
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) e MD Anderson Cancer Center hanno annunciato una collaborazione strategica quinquennale per accelerare lo sviluppo di ivonescimab, un potenziale anticorpo bispecifico PD-1 / VEGF di prima classe. L'obiettivo della partnership è esplorare ulteriori opportunità per ivonescimab in diversi tumori solidi oltre al piano di sviluppo attuale.
MD Anderson guiderà numerosi trial clinici per valutare la sicurezza e il potenziale beneficio clinico di ivonescimab, compresa l'identificazione di biomarcatori. I primi studi potrebbero concentrarsi su carcinoma a cellule renali, cancro colorettale, cancro della pelle, cancro al seno e glioblastoma. La collaborazione sfrutta l'infrastruttura clinica e l'esperienza di ricerca di MD Anderson insieme al candidato innovativo di Summit.
Ivonescimab ha mostrato risultati promettenti nelle recenti prove di Fase III per il cancro polmonare non a piccole cellule (HARMONi-A e HARMONi-2) e negli studi di Fase II in altri tumori solidi. La partnership mira ad espandere rapidamente il programma di sviluppo del farmaco e a portare questa innovativa immunoterapia e trattamento anti-angiogenico ai pazienti che potrebbero beneficiarne.
Summit Therapeutics (NASDAQ: SMMT) y MD Anderson Cancer Center han anunciado una colaboración estratégica de cinco años para acelerar el desarrollo de ivonescimab, un potencial anticuerpo bispecífico PD-1 / VEGF de primera clase. La asociación tiene como objetivo explorar oportunidades adicionales para ivonescimab en varios tumores sólidos más allá de su plan de desarrollo actual.
MD Anderson liderará múltiples ensayos clínicos para evaluar la seguridad y el posible beneficio clínico de ivonescimab, incluyendo la identificación de biomarcadores. Los primeros trabajos podrían centrarse en carcinoma de células renales, cáncer colorrectal, cáncer de piel, cáncer de mama y glioblastoma. La colaboración aprovecha la infraestructura clínica y la experiencia en investigación de MD Anderson junto con el candidato innovador de Summit.
Ivonescimab ha mostrado promesas en los recientes ensayos de Fase III de cáncer de pulmón no microcítico (HARMONi-A y HARMONi-2) y en estudios de Fase II en otros tumores sólidos. La asociación tiene como objetivo expandir rápidamente el programa de desarrollo del fármaco y llevar esta innovadora inmunoterapia y tratamiento anti-angiogénico a los pacientes que puedan beneficiarse.
서밋 테라퓨틱스 (NASDAQ: SMMT)와 MD 앤더슨 암 센터는 ivonescimab, 잠재적인 첫 번째 클래스 PD-1 / VEGF 바이스페시픽 항체의 개발을 가속화하기 위한 5년 전략적 협력을 발표했습니다. 이 파트너십은 ivonescimab의 현재 개발 계획을 넘어 다양한 고형 종양에 대한 추가 기회를 탐색하는 것을 목표로 합니다.
MD 앤더슨은 ivonescimab의 안전성 및 잠재적 임상 이점을 평가하기 위해 여러 임상 시험을 주도하며, 바이오마커 식별도 포함됩니다. 초기 작업은 신장 세포 암종, 대장암, 피부암, 유방암 및 교모세포종에 집중될 수 있습니다. 이 협력은 MD 앤더슨의 임상 인프라와 연구 전문성을 서밋의 혁신적인 약물 후보와 함께 활용합니다.
ivonescimab은 최근 비소세포 폐암 3상 시험 (HARMONi-A와 HARMONi-2)과 다른 고형 종양에서의 2상 연구에서 유망한 결과를 보였습니다. 이 파트너십은 약물 개발 프로그램을 빠르게 확장하고 이 혁신적인 면역 요법 및 항혈관 치료를 필요로 하는 환자에게 제공하는 것을 목표로 합니다.
Summit Therapeutics (NASDAQ: SMMT) et MD Anderson Cancer Center ont annoncé une collaboration stratégique de cinq ans pour accélérer le développement de ivonescimab, un potentiel anticorps bispécifique PD-1 / VEGF de première classe. Cette partenariat vise à explorer des opportunités supplémentaires pour ivonescimab dans divers cancers solides au-delà de son plan de développement actuel.
MD Anderson dirigera plusieurs essais cliniques pour évaluer la sécurité et l'éventuel bénéfice clinique d'ivonescimab, y compris l'identification de biomarqueurs. Les travaux initiaux pourraient se concentrer sur carcinome à cellules rénales, cancer colorectal, cancer de la peau, cancer du sein et glioblastome. La collaboration s'appuie sur l'infrastructure clinique et l'expertise en recherche de MD Anderson aux côtés du candidat innovant de Summit.
Ivonescimab a montré des promesses lors des récents essais de phase III pour le cancer du poumon non à petites cellules (HARMONi-A et HARMONi-2) et dans des études de phase II sur d'autres cancers solides. Le partenariat vise à étendre rapidement le programme de développement du médicament et à offrir cette immunothérapie innovante et ce traitement anti-angiogénique aux patients qui pourraient en bénéficier.
Summit Therapeutics (NASDAQ: SMMT) und MD Anderson Cancer Center haben eine fünfjährige strategische Zusammenarbeit angekündigt, um die Entwicklung von ivonescimab, einem potenziellen ersten PD-1 / VEGF bispezifischen Antikörper, zu beschleunigen. Ziel der Partnerschaft ist es, weitere Möglichkeiten für ivonescimab in verschiedenen soliden Tumoren über den aktuellen Entwicklungsplan hinaus zu erkunden.
MD Anderson wird mehrere klinische Studien leiten, um die Sicherheit und potenziellen klinischen Nutzen von ivonescimab zu bewerten, einschließlich der Identifizierung von Biomarkern. Frühere Arbeiten könnten sich auf Nierenzellkarzinom, kolorektalen Krebs, Hautkrebs, Brustkrebs und Glioblastom konzentrieren. Die Zusammenarbeit nutzt die klinische Infrastruktur und die Forschungsexpertise von MD Anderson zusammen mit dem innovativen Arzneimittelkandidaten von Summit.
Ivonescimab hat in den jüngsten Phase-III-Studien zu nicht-kleinzelligem Lungenkrebs (HARMONi-A und HARMONi-2) und in Phase-II-Studien zu anderen soliden Tumoren vielversprechende Ergebnisse gezeigt. Die Partnerschaft zielt darauf ab, das Entwicklungsprogramm des Medikaments schnell auszubauen und diese innovative Immuntherapie und anti-angiogene Therapie zu den Patienten zu bringen, die davon profitieren könnten.
- Strategic five-year collaboration with MD Anderson Cancer Center to accelerate ivonescimab development
- Expansion of ivonescimab clinical trials into multiple new tumor types
- Promising Phase III and Phase II data for ivonescimab in non-small cell lung cancer and other solid tumors
- Potential for biomarker identification to enhance treatment efficacy
- None.
Insights
This strategic collaboration between Summit Therapeutics and MD Anderson marks a significant step in accelerating the development of ivonescimab, a potential first-in-class PD-1/VEGF bispecific antibody. The partnership leverages MD Anderson's renowned clinical infrastructure and research expertise, which could substantially expedite the drug's development timeline.
The collaboration's scope is particularly noteworthy. While ivonescimab has shown promise in non-small cell lung cancer trials, this partnership aims to explore its potential in a broader range of solid tumors. The mention of renal cell carcinoma, colorectal cancer, skin cancer, breast cancer and glioblastoma as potential targets suggests a ambitious expansion of the drug's application.
From a research perspective, the most intriguing aspect is the possibility of identifying biomarkers. This could lead to more personalized treatment approaches, potentially improving efficacy and patient outcomes. The combination of immunotherapy (PD-1) and anti-angiogenic (VEGF) mechanisms in a single molecule is an innovative approach that could address multiple aspects of tumor biology simultaneously.
However, it's important to note that while the recent Phase III trials in lung cancer have shown promise, success in one cancer type doesn't guarantee efficacy in others. The diverse range of cancers being explored presents both opportunities and challenges. Each cancer type has unique characteristics that may affect the drug's efficacy and extensive clinical trials will be necessary to establish safety and efficacy in each indication.
Overall, this collaboration has the potential to significantly accelerate and broaden ivonescimab's development program, potentially bringing a novel treatment option to patients across multiple cancer types.
This collaboration between Summit Therapeutics and MD Anderson is a strategic move that could significantly impact Summit's market position and financial outlook. The partnership with a prestigious institution like MD Anderson lends credibility to Summit's research efforts and could potentially attract investor interest.
From a financial perspective, this collaboration could be highly beneficial for Summit. By leveraging MD Anderson's resources and expertise, Summit can potentially accelerate the development of ivonescimab without bearing all the costs typically associated with extensive clinical trials. This could lead to substantial cost savings and faster time-to-market, both of which are important factors in the pharmaceutical industry.
Moreover, the expansion of ivonescimab's potential applications to multiple cancer types could significantly increase its market potential. If successful across various indications, ivonescimab could become a blockbuster drug, potentially generating billions in revenue. This diversification also helps mitigate risk, as success isn't dependent on a single indication.
However, investors should be cautious. While the collaboration is promising, drug development is inherently risky and time-consuming. Many promising candidates fail in later-stage trials and the process from current stage to market approval could still take several years. Additionally, the financial terms of the collaboration aren't disclosed, making it difficult to assess the exact impact on Summit's finances.
In the short term, this news could positively impact Summit's stock price due to increased investor optimism. Long-term impact will depend on the success of the clinical trials and eventual market performance of ivonescimab. Investors should closely monitor the progress of these trials and any updates on the drug's development across various cancer types.
Five Year Collaboration Intended to Advance PD-1 / VEGF Bispecific in Several Solid Tumors across Multiple Clinical Trials
Leveraging MD Anderson’s clinical infrastructure and research expertise together with Summit’s innovative, investigational, potential first-in-class PD-1 / VEGF bispecific antibody, the collaboration is designed to quickly discover additional opportunities for ivonescimab, including several tumors outside of its current development plan. MD Anderson will lead multiple clinical trials in several tumor types to evaluate the safety and potential clinical benefit of ivonescimab, including the possibility of identifying biomarkers through additional research activities.
“We are excited to collaborate with MD Anderson to provide unique insights and expertise to further broaden the development of ivonescimab,” stated Allen S. Yang, MD, PhD, Chief Medical Officer of Summit. “This collaboration will help accelerate the growing clinical development efforts for ivonescimab and help bring this innovative advancement on immunotherapy and anti-angiogenic standards to as many patients who may benefit as possible.”
Early work may include certain types of renal cell carcinoma, colorectal cancer, skin cancer, and breast cancer and glioblastoma, which has the potential to rapidly expand the breadth and depth of the ivonescimab development program. The bispecific antibody has shown significant promise in recent read-outs from the randomized Phase III non-small cell lung cancer clinical trials, HARMONi-A and HARMONi-2, conducted by Summit’s partner, Akeso, in addition to promising Phase II data in other solid tumors.
“Through our extensive clinical research efforts, we are committed to bringing impactful new medicines to patients in need as rapidly as possible,” said Christopher Flowers, M.D., Division Head of Cancer Medicine at MD Anderson. “We are pleased to be collaborating with Summit to broaden the clinical development efforts of ivonescimab and its unique mechanism of action to support our mutual goal to improve the therapeutic options for patients with cancer.”
MD Anderson and Summit will collaborate on the design and conduct of preclinical and clinical studies with oversight from a joint steering committee. This research is expected to begin later this year.
About Ivonescimab
Ivonescimab, known as SMT112 in Summit’s license territories,
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 tumor microenvironment 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 1,800 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 multi-regional 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.
In addition, Akeso has recently had positive read-outs in two single-region (
HARMONi-A was a Phase III clinical trial which evaluated 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 an EGFR TKI.
HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression (PD-L1 TPS >
Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including
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
For more information, please visit https://www.smmttx.com and follow us on X @SMMT_TX.
About MD Anderson
The University of Texas MD Anderson Cancer Center in
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 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.
Appendix: Glossary of Critical Terms Contained Herein
Affinity – Affinity is the strength of binding of a molecule, such as a protein or antibody, to another molecule, such as a ligand.
Avidity – Avidity is the accumulated strength of multiple binding interactions.
Angiogenesis – Angiogenesis is the development, formation, and maintenance of blood vessel structures. Without sufficient blood flow, tissue may experience hypoxia (insufficient oxygen) or lack of nutrition, which may cause cell death.1
Cooperative binding – Cooperative binding occurs when the number of binding sites on the molecule that can be occupied by a specific ligand (e.g., protein) is impacted by the ligand’s concentration. For example, this can be due to an affinity for the ligand that depends on the amount of ligand bound or the binding strength of the molecule to one ligand based on the concentration of another ligand, increasing the chance of another ligand binding to the compound.2
Immunotherapy – Immunotherapy is a type of treatment, including cancer treatments, that help a person’s immune system fight cancer. Examples include anti-PD-1 therapies.3
Intracranial - Within the cranium or skull.
PD-1 – Programmed cell Death protein 1 is a protein on the surface of T cells and other cells. PD-1 plays a key role in reducing the regulation of ineffective or harmful immune responses and maintaining immune tolerance. However, with respect to cancer tumor cells, PD-1 can act as a stopping mechanism (a brake or checkpoint) by binding to PD-L1 ligands that exist on tumor cells and preventing the T cells from targeting cancerous tumor cells.4
PD-L1 – Programmed cell Death Ligand 1 is expressed by cancerous tumor cells as an adaptive immune mechanism to escape anti-tumor responses, thus believed to suppress the immune system’s response to the presence of cancer cells.5
PD-L1 TPS – PD-L1 Tumor Proportion Score represents the percentage of tumor cells that express PD-L1 proteins.
PFS – Progression-Free Survival.
RANO – Response Assessment in Neuro-Oncology, the standard for assessing the response of a brain or spinal cord tumor to therapy.
SQ-NSCLC – Non-small cell lung cancer tumors of squamous histology.
T Cells – T cells are a type of white blood cell that is a component of the immune system that, in general, fights against infection and harmful cells like tumor cells.6
Tetravalent – A tetravalent molecule has four binding sites or regions.
Tumor Microenvironment – The tumor microenvironment is the ecosystem that surrounds a tumor inside the body. It includes immune cells, the extracellular matrix, blood vessels and other cells, like fibroblasts. A tumor and its microenvironment constantly interact and influence each other, either positively or negatively.7
VEGF – Vascular Endothelial Growth Factor is a signaling protein that promotes angiogenesis.8
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1 |
Shibuya M. Vascular Endothelial Growth Factor (VEGF) and Its Receptor (VEGFR) Signaling in Angiogenesis: A Crucial Target for Anti- and Pro-Angiogenic Therapies. Genes Cancer. 2011 Dec;2(12):1097-105 |
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2 |
Stefan MI, Le Novère N. Cooperative binding. PLoS Comput Biol. 2013;9(6) |
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3 |
US National Cancer Institute, a part of the National Institute of Health (NIH). https://www.cancer.gov/about-cancer/treatment/types/immunotherapy. Accessed April 2024. |
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4 |
Han Y, et al. PD-1/PD-L1 Pathway: Current Researches in Cancer. Am J Cancer Res. 2020 Mar 1;10(3):727-742. |
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5 |
Han Y, et al. PD-1/PD-L1 Pathway: Current Researches in Cancer. Am J Cancer Res. 2020 Mar 1;10(3):727-742. |
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6 |
Cleveland Clinic. https://my.clevelandclinic.org/health/body/24630-t-cells. Accessed April 2024. |
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7 |
MD Anderson Cancer Center. https://www.mdanderson.org/cancerwise/what-is-the-tumor-microenvironment-3-things-to-know.h00-159460056.html. Accessed April 2024. |
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8 |
Shibuya M. Vascular Endothelial Growth Factor (VEGF) and Its Receptor (VEGFR) Signaling in Angiogenesis: A Crucial Target for Anti- and Pro-Angiogenic Therapies. Genes Cancer. 2011 Dec;2(12):1097-105. |
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Contact Summit Investor Relations:
Dave Gancarz
Chief Business & Strategy Officer
Nathan LiaBraaten
Senior Director, Investor Relations
investors@smmttx.com
Contact MD Anderson:
Clayton Boldt, Ph.D.
1-713-792-9518
CRBoldt@MDAnderson.org
MD Anderson Public Relations Office
1-713-792-0655
PublicRelations@MDAnderson.org
@MDAndersonNews
Source: Summit Therapeutics Inc.
FAQ
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