Adenocarcinoma of Esophagus

OXFORD, UK I April 9, 2025 I Infinitopes Ltd today announces that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Clinical Trial Application (CTA) approval for the first-in-human Phase I/IIa clinical trial of ITOP1, the company’s lead ‘off-the-shelf’ cancer vaccine. ITOP1 is a precision cancer vaccine, designed to safely and accurately target tumour antigens, leveraging the company’s vector delivery system, aiming to drive strong and durable T-cell protection for patients with surgically resectable oesophageal adenocarcinoma (OAC). The vaccine is designed to stimulate a robust immune response, including activation of CD8+ cytotoxic T cells, to eliminate residual cancer cells expressing the target antigens, reducing the risk of disease recurrence. Tumour antigen targets for ITOP1, Infinitopes’ lead asset from its Precision Immunomics™ platform, are derived using the company’s bespoke AI/ML-driven immunopeptidomics approach and demonstrate high tumour-specificity and inter-patient conservation with potential clinical applicability across multiple cancer types. The VISTA* study is a phase I/IIa double-blind, randomised, placebo-controlled trial to assess the safety, tolerability and anti-tumour activity of ITOP1 in reducing OAC recurrence rates. 60 patients will receive ITOP1 in a prime/boost regimen, in combination with the best standard of care, i.e., a priming dose following neoadjuvant and a boost dose before adjuvant FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) chemotherapy. Infinitopes’ VISTA trial will be one of the first in the world to administer a cancer vaccine in the neoadjuvant setting while the primary tumour remains in situ, unlocking the potential for enhanced protection from epitope spreading. The multicentre VISTA study will be conducted at specialist cancer centres in the UK under the leadership of Prof Mark Middleton, a world-renowned Chief Investigator. The VISTA* study is set to commence in Q2 2025 . For further details, visit the UK Clinical Trials Registry for Integrated Research Application System (IRAS) project 1008088. Prof Mark Middleton, Chief Investigator, Head of Oncology & Co-director, CRUK Oxford Centre, University of Oxford, and Scientific Advisory Board Member for Infinitopes, said: “Half of us will suffer cancer in our lifetimes, so we need better, affordable treatments for the disease. ITOP1 is an exciting new immunotherapy with the potential to make a difference across a wide range of cancers, bringing hope to many patients. This first trial in oesophageal cancer will evaluate ITOP1’s precision targeting, which enables anti-tumour immunity through epitope spreading to tackle residual cancer cells and prevent recurrence. We are particularly excited that, by working with the MHRA, we can test ITOP1 where we believe it will achieve the best protection, in potentially curable disease.” Dr Jonathan Kwok, Chief Executive Officer & Co-Founder at Infinitopes, commented: “We are delighted that we have advanced our lead vaccine candidate, ITOP1, from university research to a groundbreaking clinical programme in just over three years. This marks a major performance milestone for the company, bringing Infinitopes an important step closer to offering lifesaving solutions for patients with oesophageal and other aggressive cancers. This achievement is a testament to the power of our team, across immunopeptidomics, computational biology/AI/ML, immunology, oncology, advanced trial design, and our collaborations with Cancer Research UK and leading centres around the world.” Infinitopes recently strengthened its scientific and clinical team with the appointments of exceptional industry leaders, Dan Menichella and Jo Brewer, PhD, supporting the company’s ambition to advance ITOP1 through clinical development to prolong survival and improve the quality of life for patients. Dan Menichella, Non-Executive Director at Infinitopes, noted: “Infinitopes’ Precision Immunomics approach has the potential to revolutionise cancer treatment as we know it today. I am very excited for the start of our VISTA study, to validate our ITOP1 vaccine and the fundamental enabling technologies.” *VISTA (Vaccination with ITOP1 in resectable oesophageal adenocarcinoma, to evaluate Safety, Tolerability & Anti-tumour activity) About Infinitopes Infinitopes Ltd is now a clinical stage, integrated cancer biotechnology company supported by Cancer Research UK (CRUK) and the University of Oxford. The Company combines two world leading platforms, in precision target discovery and in high efficiency, vector delivery systems, to develop immunologically durable vaccines against multiple solid tumour indications. The lead vaccine candidate is scheduled to begin Phase I/IIa trials in Q2 2025. Infinitopes has gathered together in-house talent across antigen discovery, immunology, vaccinology, oncology, biomanufacturing, clinical trials and regulation, winning an ‘Innovative Licensing and Access Pathway’ (ILAP) innovation passport from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in 2022. Infinitopes has also won two prestigious, maximum size, nondilutive awards from Innovate UK, a Cancer Therapeutics Award (in 2022) and a Future Economy Investor Partnership (in 2023). Since incorporation, the Infinitopes team has raised nearly $20m from sector expert investors including Cancer Research Horizons, Cancer Research Institute, Kindred Capital, Manta Ray Ventures, Martlet, Meltwind, Octopus Ventures, Saras Capital, Wilbe and the Fundación CRIS Contra el Cáncer, fuelling its rapid growth from three academic co-founders to 28 full time equivalents. It is now the largest tenant of Oxford University’s BioEscalator innovation accelerator. For more information, visit www.infinitopes.com About Oesophageal Adenocarcinoma (OAC) Oesophageal cancer is an aggressive tumour. In the UK, approximately 10,000 people are diagnosed annually, resulting in around 8,500 deaths, making it the 12th most common cancer and the sixth leading cause of cancer deaths. Survival rates depend on the stage at diagnosis, with only 20% of patients surviving beyond five years. The disease is often diagnosed late due to a lack of early symptoms and the absence of effective population screening. Infinitopes selected oesophageal cancer as our proof-of-concept indication because of the obviously high unmet clinical need and limited effective treatment options. SOURCE: Infinitopes

Based on the Phase 3 CheckMate-8HW trial, Opdivo plus Yervoy demonstrated reduction in the risk of disease progression or death by 79% vs. chemotherapy in the first-line setting and by 38% vs. Opdivo monotherapy across all lines of therapy 1 The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date PRINCETON, NJ, USA I April 08, 2025 I Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo ® (nivolumab) plus Yervoy ® (ipilimumab) as a first-line treatment of adult and pediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC). 1 This approval is based on the CheckMate-8HW trial, which is the largest Phase 3 trial (n=839) of immunotherapy in patients with MSI-H/dMMR mCRC, evaluating Opdivo plus Yervoy (n=354) vs. Opdivo monotherapy (n=353) in the all-lines setting and Opdivo plus Yervoy (n=202) vs. investigator’s choice chemotherapy (n=101) (mFOLFOX-6 or FOLFIRI with or without bevacizumab or cetuximab) in the first-line setting. 1 Opdivo plus Yervoy met the dual primary endpoints of progression free survival (PFS) when compared to Opdivo monotherapy across all lines of therapy and when compared to chemotherapy in the first-line setting, as assessed by Blinded Independent Central Review (BICR). 1 This approval, granted more than two months ahead of the June 23, 2025 Prescription Drug User Fee Act goal date, follows the FDA’s prior decision to grant the application Breakthrough Therapy Designation and Priority Review status. “There is an unmet need for additional treatment options such as a dual immunotherapy approach for patients with previously untreated MSI-H/dMMR unresectable or metastatic CRC, which is an aggressive form of cancer and can be particularly difficult to treat,” said Heinz-Josef Lenz, MD, CheckMate-8HW investigator and Deputy Director for Research Programs and Head of the Gastrointestinal Cancers Program at the USC Norris Comprehensive Cancer Center. 2,3,4,5,6 “The meaningful outcomes in CheckMate-8HW underscore how initiating treatment with the dual immunotherapy combination of nivolumab plus ipilimumab may result in a notable survival benefit. 1,5 This approval has the potential to redefine traditional approaches of care for patients with this form of CRC.” In the CheckMate-8HW trial, Opdivo plus Yervoy demonstrated a 38% reduction in the risk of disease progression or death vs. Opdivo monotherapy in immunotherapy-naïve patients across all lines of therapy (Hazard Ratio [HR] 0.62; 95% Confidence Interval [CI] 0.48–0.81; P =0.0003). 1 Assessing the dual primary endpoint of PFS, the trial demonstrated that median PFS was not reached with Opdivo plus Yervoy (95% CI: 53.8-Not Estimable [NE]) and was 39.3 months with Opdivo monotherapy (95% CI: 22.1-NE). 1 PFS rates at 12-, 24-, and 36-months were also numerically higher compared to Opdivo monotherapy (76% vs. 63%, 71% vs. 56%, and 68% vs. 51%, respectively). 1 In Kaplan-Meier (KM) curves showing PFS rates with Opdivo plus Yervoy compared to Opdivo monotherapy, an early separation was observed at two months and sustained at three years. 1 Opdivo plus Yervoy also met a key secondary endpoint, demonstrating superior overall response rate (ORR) by BICR compared to Opdivo monotherapy (n=296, 71% vs. n=286, 58%; P =0.0011). 1 Of the most common all-cause adverse reactions (ARs) occurring in ≥10% of patients, similar rates of grade 3-4 ARs were observed between Opdivo plus Yervoy and Opdivo monotherapy. 1 The safety profile for the dual immunotherapy combination remained consistent with previously reported data and the ARs observed were manageable with established protocols, with no new safety signals identified. 1,5 Additional safety information can be found in the U.S. Full Prescribing Information for Opdivo . The Opdivo plus Yervoy vs. chemotherapy arm of the CheckMate-8HW trial showed that the combination regimen reduced the risk of cancer progression or death by 79% compared to chemotherapy in first-line patients (HR 0.21; 95% CI: 0.14-0.32; P <0.0001). 1 This arm also assessed the other dual primary endpoint of PFS, where median PFS was not reached with Opdivo plus Yervoy (95% CI: 38.4-NE) compared to 5.8 months with chemotherapy (95% CI: 4.4-7.8). PFS rates were numerically higher with Opdivo plus Yervoy vs. chemotherapy at 12- and 24-months (79% vs. 21% and 72% vs. 14%, respectively). 1 KM curves comparing PFS with Opdivo plus Yervoy vs. chemotherapy showed an early separation at three months, which was sustained through two years. 1 The regimen of Opdivo plus Yervoy represents the first-ever dual immune checkpoint inhibitor combination to demonstrate significant efficacy benefit compared to Opdivo monotherapy and chemotherapy in MSI-H/dMMR mCRC patients. 1,5 Opdivo and Yervoy are associated with the following Warnings and Precautions: severe and fatal immune-mediated adverse reactions including pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies, nephritis with renal dysfunction, dermatologic adverse reactions, other immune-mediated adverse reactions; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when Opdivo is added to a thalidomide analogue and dexamethasone, which is not recommended outside of controlled clinical trials. 1 Please see the Important Safety Information section below. “This approval marks our ninth indication for an Opdivo -based treatment in the gastrointestinal space. 1 We are witnessing the transformative potential of dual immunotherapy in treating GI cancers,” said Wendy Short Bartie, senior vice president of Oncology Commercialization at Bristol Myers Squibb. 2,3,4,5 “People with MSI-H/dMMR metastatic colorectal cancer face high unmet need, and Opdivo plus Yervoy is an important new approach in the first-line setting. 2,3,4,5 This milestone can offer hope, and it underscores our commitment to continue reaching more patients with new treatment options.” 1 “Colorectal cancer is the third most commonly diagnosed cancer and the second most common cause of cancer-related death for men and women combined in the U.S., and concerning trends show that incidence is increasing in people younger than 50,” said Nicole Sheahan, President of the Global Colon Cancer Association. 6,7 “Despite the prevalence of CRC, there remains a high unmet need, highlighting the urgency for additional treatment options. 2,3,5,6,7 We are thrilled with this FDA approval as Opdivo plus Yervoy offers an exciting new first-line approach for patients with MSI-H/dMMR metastatic colorectal cancer.” 1 Opdivo as a single agent, or in combination with Yervoy , was previously granted accelerated approval in MSI-H/dMMR CRC adult and pediatric patients (12 years and older) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. 1 Today’s FDA decision converts this second-line indication to full approval for Opdivo monotherapy and expands the indication for Opdivo plus Yervoy into the first-line setting based on the CheckMate-8HW trial. 1 About CheckMate-8HW CheckMate-8HW is a Phase 3, randomized, multicenter, open-label trial evaluating Opdivo plus Yervoy compared to Opdivo alone or chemotherapy (mFOLFOX-6 or FOLFIRI with or without bevacizumab or cetuximab) in patients with unresectable MSI-H/dMMR mCRC. 8 In the CheckMate-8HW study, 839 patients were randomized to receive either Opdivo monotherapy ( Opdivo 240 mg Q2W for six doses, followed by Opdivo 480 mg Q4W), Opdivo plus Yervoy ( Opdivo 240 mg plus Yervoy 1 mg/kg Q3W for four doses, followed by Opdivo 480 mg Q4W), or investigator’s choice of chemotherapy. 8 The dual primary endpoints of the trial were PFS for Opdivo plus Yervoy compared to Opdivo alone across all lines of therapy and PFS for Opdivo plus Yervoy compared to chemotherapy in the first-line setting, as assessed by Blinded Independent Central Review (BICR). 8 The study is ongoing to assess various secondary endpoints, including overall survival (OS), and BMS will continue to work with the study investigators to present these data and longer-term follow-up in the future. 8 Select Safety Profile from CheckMate-8HW The safety analysis in CheckMate-8HW included 288 patients, of whom 200 received Opdivo plus Yervoy. 1 Serious adverse reactions occurred in 46% of patients receiving Opdivo plus Yervoy . 1 The most frequent serious adverse reactions reported in ≥1% of patients who received Opdivo plus Yervoy were adrenal insufficiency (2.8%), hypophysitis (2.8%), diarrhea (2.0%), abdominal pain (2.0%), small intestinal obstruction (2.0%), pneumonia (1.7%), acute kidney injury (1.4%), immune mediated enterocolitis (1.4%), pneumonitis (1.4%), colitis (1.1%), large intestinal obstruction (1.1%), and urinary tract infection (1.1%). 1 The most common adverse reactions reported in ≥ 20% of patients treated with Opdivo plus Yervoy were fatigue, diarrhea, pruritis, abdominal pain, musculoskeletal pain, and nausea. 1 Fatal adverse reactions occurred in 2 (0.6%) patients who received Opdivo plus Yervoy ; these included myocarditis and pneumonitis, 1 each. 1 Opdivo and/or Yervoy were discontinued in 19% of patients and were delayed in 48% of patients for an adverse reaction. 1 About Colorectal Cancer Colorectal cancer (CRC) is cancer that develops in the colon or the rectum, which are part of the body’s digestive or gastrointestinal system. 9 With more than 154,000 new cases estimated to be diagnosed in the United States in 2025, CRC is the third most commonly diagnosed cancer. 7,10 Trends show that incidence is increasing in people younger than 50, and mortality rates have increased in people younger than 55 since the mid-2000s. 7 Mismatch repair deficiency (dMMR) occurs when the proteins that repair mismatch errors in DNA replication are missing or non-functional, leading to microsatellite instability-high (MSI-H) tumors. 11,12 Up to 7% of people with mCRC have MSI-H/dMMR tumors and may often have poor outcomes with standard chemotherapy. 5 INDICATIONS OPDIVO ® (nivolumab), in combination with YERVOY ® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC). OPDIVO ® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. OPDIVO ® (nivolumab), in combination with YERVOY ® (ipilimumab), is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. OPDIVO ® (nivolumab) is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. OPDIVO ® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT). OPDIVO ® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC). OPDIVO ® (nivolumab), in combination with YERVOY ® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC). OPDIVO ® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. Please see U.S. Full Prescribing Information for OPDIVO and YERVOY . Clinical Trials and Patient Populations CheckMate-649–previously untreated advanced or metastatic gastric cancer, gastroesophageal junction and esophageal adenocarcinoma; CheckMate-577–adjuvant treatment of esophageal or gastroesophageal junction cancer; 8HW: Previously CheckMate-142–MSI-H or dMMR metastatic colorectal cancer in combination with YERVOY; 8HW: Previously CheckMate-142–MSI-H or dMMR metastatic colorectal cancer, as a single agent; Attraction-3–esophageal squamous cell carcinoma; CheckMate-648—previously untreated, unresectable advanced recurrent or metastatic esophageal squamous cell carcinoma in combination with chemotherapy; CheckMate-648—previously untreated, unresectable advanced recurrent or metastatic esophageal squamous cell carcinoma combination with YERVOY; CheckMate-040–hepatocellular carcinoma, in combination with YERVOY. Bristol Myers Squibb: Creating a Better Future for People with Cancer Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into insights that sharpen their focus. Deep understanding of causal human biology, cutting-edge capabilities and differentiated research platforms uniquely position the company to approach cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future. About Bristol Myers Squibb’s Patient Access Support Bristol Myers Squibb remains committed to providing assistance so that cancer patients who need our medicines can access them and expedite time to therapy. BMS Access Support ® , the Bristol Myers Squibb patient access and reimbursement program, is designed to help appropriate patients initiate and maintain access to BMS medicines during their treatment journey. BMS Access Support offers benefit investigation, prior authorization assistance, as well as co-pay assistance for eligible, commercially insured patients. More information about our access and reimbursement support can be obtained by calling BMS Access Support at 1-800-861-0048 or by visiting www.bmsaccesssupport.com . About the Bristol Myers Squibb and Ono Pharmaceutical Collaboration In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Ono and Bristol Myers Squibb further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan. About Bristol Myers Squibb Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn , X , YouTube , Facebook and Instagram . References SOURCE: Bristol Myers Squibb

Revolutionary 'off-the-shelf' cancer vaccine designed to prevent the recurrence of oesophageal cancer ITOP1 to enter first-in-human Phase I/IIa clinical development in the VISTA study in H1 2025 Multicentre study to be conducted at four university cancer centres, aiming to raise the standard of care by reducing the recurrence of metastases and cancer-related deaths OXFORD, England, April 9, 2025 /PRNewswire/ -- Infinitopes Ltd today announces that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Clinical Trial Application (CTA) approval for the first-in-human Phase I/IIa clinical trial of ITOP1, the company's lead 'off-the-shelf' cancer vaccine. ITOP1 is a precision cancer vaccine, designed to safely and accurately target tumour antigens, leveraging the company's vector delivery system, aiming to drive strong and durable T-cell protection for patients with surgically resectable oesophageal adenocarcinoma (OAC). The vaccine is designed to stimulate a robust immune response, including activation of CD8+ cytotoxic T cells, to eliminate residual cancer cells expressing the target antigens, reducing the risk of disease recurrence. Tumour antigen targets for ITOP1, Infinitopes' lead asset from its Precision Immunomics™ platform, are derived using the company's bespoke AI/ML-driven immunopeptidomics approach and demonstrate high tumour-specificity and inter-patient conservation with potential clinical applicability across multiple cancer types. The VISTA* study is a phase I/IIa double-blind, randomised, placebo-controlled trial to assess the safety, tolerability and anti-tumour activity of ITOP1 in reducing OAC recurrence rates. 60 patients will receive ITOP1 in a prime/boost regimen, in combination with the best standard of care, i.e., a priming dose following neoadjuvant and a boost dose before adjuvant FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) chemotherapy. Infinitopes' VISTA trial will be one of the first in the world to administer a cancer vaccine in the neoadjuvant setting while the primary tumour remains in situ, unlocking the potential for enhanced protection from epitope spreading. The multicentre VISTA study will be conducted at specialist cancer centres in the UK under the leadership of Prof Mark Middleton, a world-renowned Chief Investigator. The VISTA* study is set to commence in Q2 2025 . For further details, visit the UK Clinical Trials Registry for Integrated Research Application System (IRAS) project 1008088. Prof Mark Middleton, Chief Investigator, Head of Oncology & Co-director, CRUK Oxford Centre, University of Oxford, and Scientific Advisory Board Member for Infinitopes, said: "Half of us will suffer cancer in our lifetimes, so we need better, affordable treatments for the disease. ITOP1 is an exciting new immunotherapy with the potential to make a difference across a wide range of cancers, bringing hope to many patients. This first trial in oesophageal cancer will evaluate ITOP1's precision targeting, which enables anti-tumour immunity through epitope spreading to tackle residual cancer cells and prevent recurrence. We are particularly excited that, by working with the MHRA, we can test ITOP1 where we believe it will achieve the best protection, in potentially curable disease." Dr Jonathan Kwok, Chief Executive Officer & Co-Founder at Infinitopes, commented: "We are delighted that we have advanced our lead vaccine candidate, ITOP1, from university research to a groundbreaking clinical programme in just over three years. This marks a major performance milestone for the company, bringing Infinitopes an important step closer to offering lifesaving solutions for patients with oesophageal and other aggressive cancers. This achievement is a testament to the power of our team, across immunopeptidomics, computational biology/AI/ML, immunology, oncology, advanced trial design, and our collaborations with Cancer Research UK and leading centres around the world." Infinitopes recently strengthened its scientific and clinical team with the appointments of exceptional industry leaders, Dan Menichella and Jo Brewer, PhD, supporting the company's ambition to advance ITOP1 through clinical development to prolong survival and improve the quality of life for patients. Dan Menichella, Non-Executive Director at Infinitopes, noted: "Infinitopes' Precision Immunomics approach has the potential to revolutionise cancer treatment as we know it today. I am very excited for the start of our VISTA study, to validate our ITOP1 vaccine and the fundamental enabling technologies." *VISTA (Vaccination with ITOP1 in resectable oesophageal adenocarcinoma, to evaluate Safety, Tolerability & Anti-tumour activity) About Infinitopes Infinitopes Ltd is now a clinical stage, integrated cancer biotechnology company supported by Cancer Research UK (CRUK) and the University of Oxford. The Company combines two world leading platforms, in precision target discovery and in high efficiency, vector delivery systems, to develop immunologically durable vaccines against multiple solid tumour indications. The lead vaccine candidate is scheduled to begin Phase I/IIa trials in Q2 2025. Infinitopes has gathered together in-house talent across antigen discovery, immunology, vaccinology, oncology, biomanufacturing, clinical trials and regulation, winning an 'Innovative Licensing and Access Pathway' (ILAP) innovation passport from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in 2022. Infinitopes has also won two prestigious, maximum size, nondilutive awards from Innovate UK, a Cancer Therapeutics Award (in 2022) and a Future Economy Investor Partnership (in 2023). Since incorporation, the Infinitopes team has raised nearly $20m from sector expert investors including Cancer Research Horizons, Cancer Research Institute, Kindred Capital, Manta Ray Ventures, Martlet, Meltwind, Octopus Ventures, Saras Capital, Wilbe and the Fundación CRIS Contra el Cáncer, fuelling its rapid growth from three academic co-founders to 28 full time equivalents. It is now the largest tenant of Oxford University's BioEscalator innovation accelerator. For more information, visit About Oesophageal Adenocarcinoma (OAC) Oesophageal cancer is an aggressive tumour. In the UK, approximately 10,000 people are diagnosed annually, resulting in around 8,500 deaths, making it the 12th most common cancer and the sixth leading cause of cancer deaths. Survival rates depend on the stage at diagnosis, with only 20% of patients surviving beyond five years. The disease is often diagnosed late due to a lack of early symptoms and the absence of effective population screening. Infinitopes selected oesophageal cancer as our proof-of-concept indication because of the obviously high unmet clinical need and limited effective treatment options. SOURCE Infinitopes WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED