Cancer Therapeutics, Inc.

Collaboration aims to accelerate the development of personalized therapies and transform patient care through the use of precision medicine TAMPA, Fla. & LOS ANGELES--(BUSINESS WIRE)-- Moffitt Cancer Center, a world-renowned cancer treatment and research center, and Fulgent Pharma, a subsidiary of Fulgent Genetics, Inc. (NASDAQ: FLGT) and a leading nanobiotechnology company specializing in innovative cancer therapeutics, announced today a strategic partnership aimed at advancing cancer treatment through clinical development and pre-clinical co-development initiatives. This collaboration combines Moffitt’s cutting-edge clinical capabilities with Fulgent’s groundbreaking nanotherapeutics and genomics platforms in an effort to accelerate the development of personalized cancer therapies. Under the agreement, Moffitt will provide Fulgent with priority access to its clinical expertise and resources, with the aim of expediting the advancement of Fulgent’s clinical pipeline. This priority access at Moffitt includes prioritized clinical trial activation, enhanced patient screening, and data sharing designed to get investigational therapies to patients in need more quickly and efficiently. Fulgent Pharma, a leader in nanoencapsulation technology, has transformed paclitaxel, a chemotherapy drug known for its poor solubility, into a soluble counterpart suitable for intravenous injection called FID-007. In Phase 1 clinical studies conducted with FID-007 to date, substantial tumor reduction across various cancer types, including breast, head and neck, lung, bile duct, and pancreatic cancers, has been observed. Additionally, the partnership will focus on co-developing next-generation personalized treatment options for cancer. Moffitt will leverage its broad scientific and immunology expertise, access to tissue samples and nonclinical research resources, while Fulgent will contribute its novel and proprietary nano-particle-based drug development platform along with its broad spectrum genetic and genomic testing capabilities. “Pooling our unique strengths, Moffitt and Fulgent will strive to create new precision oncology therapies customized to meet the specific needs of each patient, thereby improving future outcomes,” said Fulgent Pharma President and CSO Ray Yin, Ph.D. “This partnership aligns with Moffitt’s mission to contribute to the prevention and cure of cancer. We are looking forward to working with Fulgent to accelerate the translation of scientific discoveries into lifesaving treatments for our patients,” said Moffitt President and CEO Patrick Hwu, M.D. “We are excited to collaborate with Moffitt Cancer Center, a global cancer research and treatment leader,” said Ming Hsieh, CEO of Fulgent Genetics. “By combining Moffitt’s clinical and research expertise with Fulgent’s innovative nanotherapeutic platform and growing patent portfolio, we believe we can make significant strides in advancing personalized cancer treatment options.” About Moffitt Cancer Center Moffitt is dedicated to one lifesaving mission: to contribute to the prevention and cure of cancer. The Tampa-based facility is one of only 57 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt’s scientific excellence, multidisciplinary research, and robust training and education. Moffitt’s expert nursing staff is recognized by the American Nurses Credentialing Center with Magnet® status, its highest distinction. For more information, call 1-888-MOFFITT (1-888-663-3488), visit MOFFITT.org, and follow the momentum on Facebook, Twitter, Instagram and YouTube. About Fulgent Pharma Fulgent Pharma began as part of Fulgent LLC in Temple City, California, established in June 2011. As the company progressed into the sphere of precision medicine, it also started delving into clinical genetic and genomic testing - a natural complement. In 2016, Fulgent LLC split into two separate entities - Fulgent Pharma and Fulgent Genetics - in order to better pursue their independent objectives. In 2022, Fulgent Pharma was acquired by Fulgent Genetics to synergistically advance personalized cancer genomics and precision oncology therapeutics. Today, Fulgent Pharma is fully focused on perfecting drug candidates for treating a broad range of cancers. Its partners in this endeavor include the University of Southern California, Moffitt Cancer Center, and ANP Technologies. For more information visit FulgentGenetics.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements in this press release include statements about, among other things: future performance; Fulgent Pharma’s research and development efforts, including any implications that the results of earlier clinical trials will be representative or consistent with later clinical trials, the expected timing of enrollment and regulatory filings for these trials and the availability of data or results of these trials, including any implication that interim or preliminary data will be representative of final results, the intended benefits of the collaboration, including whether the collaboration expedites development of any of Fulgent Pharma’s product candidates. Forward-looking statements are statements other than historical facts and relate to future events or circumstances or Fulgent Pharma’s future performance, and they are based on management’s current assumptions, expectations, and beliefs concerning future developments and their potential effect on Fulgent Pharma’s business. These forward-looking statements are subject to a number of risks and uncertainties, which may cause the forward-looking events and circumstances described in this press release to not occur, and actual results to differ materially and adversely from those described in or implied by the forward-looking statements. These risks and uncertainties include, among others: the success of Fulgent Pharma’s development efforts, including its ability to progress its candidates through clinical trials on the timelines expected; its compliance with the various evolving and complex laws and regulations applicable to its business and its industry; and its ability to protect its proprietary technology and intellectual property. As a result of these risks and uncertainties, forward-looking statements should not be relied on or viewed as predictions of future events. The forward-looking statements made in this press release speak only as of the date of this press release, and Fulgent Pharma and Fulgent Genetics assume no obligation to update publicly any such forward-looking statements to reflect actual results or to changes in expectations, except as otherwise required by law. Fulgent Genetics, Inc.’s reports filed with the U.S. Securities and Exchange Commission, or the SEC, including its annual report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 28, 2024, and the other reports it files from time to time, including subsequently filed annual, quarterly and current reports, are made available on the Fulgent Genetic’s website upon their filing with the SEC. These reports contain more information about Fulgent Genetics and Fulgent Pharma, their business and the risks affecting their business. View source version on businesswire.com: Contacts Patty Kim Moffitt Cancer Center 813-745-7322 Patty.Kim@Moffitt.org Melanie Solomon The Blueshirt Group melanie@blueshirtgroup.com Source: Fulgent Pharma View this news release online at:

Publication in Human Vaccines and Immunotherapeutics highlights progress in understanding tumour biology and vaccine technologies since the pandemic OXFORD, England, May 9, 2024 /PRNewswire/ -- Infinitopes Precision Immunomics, an integrated cancer biotech combining world leading platforms in precision antigen discovery with vaccine vectors capable of durably stimulating protective immune responses, today announced the publication of a peer-reviewed article in Human Vaccines & Immunotherapeutics (HVI). The article outlines the current cancer vaccine landscape and the challenges facing vaccine technologies for the treatment of solid tumours to explain the advantages of Infinitopes' combined approach to cancer vaccines: incorporating the right targets and the right vectors, for the right patients at the right time. The review, entitled "Unlocking Cancer Vaccine Potential: What are the Key Factors?", was an invited contribution from the editorial team at HVI for inclusion in their special edition on cancer vaccines. The Company co-authored the review in close collaboration with senior academics from the University of Oxford's cancer vaccine programme. The article describes the history of cancer vaccine development, the impact of the SARS-CoV-2 pandemic on vaccine immunology, and the hurdles that face the successful clinical development of vaccines within the solid tumour space. Limited understanding of tumour biology has historically been a major obstacle to progress in cancer vaccine development. Following the announcement of its £12.8m seed funding round in April 2024, Infinitopes is investing in world-leading mass spectrometry equipment to accurately identify the best synergistic tumour targets. This will enable the company to expand the development of its precision-targeted cancer vaccines for five further cancers beyond its lead candidate, which is due to begin phase I/IIa later this year. Dr Jonathan Kwok, Infinitopes CEO, commented: "Infinitopes' team has amassed an enormous wealth of insight into the fundamental immunology required to develop effective cancer vaccines. Over the past decade, we have crystallised our understanding of the building blocks necessary to design precision-targeted, durably stimulating, affordable vaccine therapies. It's an honour to be invited to share our learnings with readers of the prestigious Human Vaccines & Immunotherapeutics journal, and we look forward to the future collaborations this will unlock." Lead author Dr Michael Grant, Executive Medical Director of Infinitopes, commented: "The global burden of cancer is increasing, whilst advances in diagnosis and shifts in lifestyle factors are changing the demographics of patients that we see in clinic. There is a growing need for cost-effective treatments that can be deployed in the earlier stages of disease. Cancer vaccines offer a potential solution to this and, in the past few years alone, we have begun to see some exciting results from different vaccine platforms. However, it is vital that we learn from previous failures – as well as recent successes – to optimise the clinical development of future cancer vaccines." Professor Mark Middleton, Head of the Department of Oncology at the University of Oxford and Scientific Advisory Board member for Infinitopes, added: "As we detect cancers earlier, we need treatments that are cheaper and better tolerated than existing drugs, and cancer vaccines look very promising. Recent trial results show that they work, and they are relatively cheap to make at scale. The challenge now is to understand the rules that govern vaccine activity, so we can give them to the right patients at the right time." "Unlocking Cancer Vaccine Potential: What are the Key Factors?" is available to read online at: Notes to editors About Infinitopes Infinitopes Ltd is a soon to be 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 antigen discovery and in high efficiency, vector delivery systems, to develop immunologically durable vaccines for use against multiple solid tumour indications. The lead vaccine candidate is expected to begin phase I/IIa trials in Q3 2024. Infinitopes has cultivated in-house talent across antigen discovery, immunology, vaccinology, oncology, biomanufacturing, 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). In 2024, the company closed its £12.8 m seed financing. Since incorporation, the Infinitopes team has grown from three co-founders to 28 full time equivalents, and is now the largest tenant of Oxford University's BioEscalator Innovation Building. For more information, visit SOURCE Infinitopes

Funding also supports the start of phase I/IIa study for lead vaccine, ITOP1 OXFORD, England, April 30, 2024 /PRNewswire/ -- Infinitopes Precision Immunomics, an integrated cancer biotech combining world leading platforms in precision antigen discovery with vaccine vectors capable of durably stimulating protective immune responses, today announced the completion of a £12.8m seed funding round led by Octopus Ventures. The round was heavily oversubscribed, also drawing in funds from Cancer Research Horizons, Cancer Research Institute, CRIS Cancer Foundation, Kindred Capital, Manta Ray, Martlet Capital, Meltwind Advisory, Saras Capital, Wilbe Capital, and expert angel investors. The total funds raised combine new equity investment and a prestigious non-dilutive award from Innovate UK's Future Economy Investor Partnership scheme. Right targets, right vectors, right patients, right time Since incorporation in 2021, Infinitopes has moved swiftly to cement its leadership position in cancer vaccines by overcoming three key challenges in the field. Firstly, using its Precision ImmunomicsTM antigen discovery technologies, the Company can identify and rank tumour signatures, without prior bias, enabling the accurate selection of novel, synergistic tumour targets. Secondly, Infinitopes continues to develop safe and effective, proprietary vector delivery systems, capable of stimulating durable T-cell responses necessary to prevent the recurrence of life-threatening cancer metastases. Finally, the Company leverages its deep knowledge of immunology, partnering with disease KOLs, in order to optimally schedule therapies to drive maximal protection for patients. Lead phase I/IIa on schedule to begin this autumn Infinitopes' lead asset, a novel cancer vaccine called ITOP1, is scheduled to commence a phase I/IIa study in first line cancer patients in the third quarter of 2024. This rapid transition into the clinic has become possible after receiving an Innovative Licensing & Access Pathway (ILAP) innovation passport from the UK's Medicines & Healthcare products Regulatory Agency (MHRA) in August 2022. Best-in-class antigen discovery The new investment accelerates the installation of best in class, next generation LC-MS/MS mass spectrometer equipment, enhancing the company's proprietary tumour antigen discovery and computational immunobiology/AI/machine learning techniques, to identify and rank the best target combinations, to treat five more cancers. Supported by Cancer Research UK Infinitopes is a Cancer Research UK (CRUK)-led spinout from Oxford University, combining underlying technologies, know-how, patents and licenses that were developed with CRUK funding across the laboratories of Professor Paul Klenerman and Associate Professor Nicola Ternette, and clinical programmes led by Professor Mark Middleton. Jonathan Kwok, CEO and co-founder of Infinitopes said: "Since founding in September 2021, Infinitopes has established world leading capabilities to design, develop, and clinically evaluate an exciting new class of precision targeted, durable cancer vaccines. Our therapies are emerging at a time when blockbuster checkpoint inhibitors are hitting their peak, capable of preventing tumour recurrence in 30-40 per cent of patients at best. Our preclinical results suggest that our vaccines may significantly outperform them, to transform care for future cancer patients. We're excited to announce this fundraise, which enables us to pursue our uniquely integrated strategy of selecting the right targets, with the right vectors, for the right patients, at the right time in their treatment journey. We continue to seek academic and Big Pharma collaborators, smart technical investors, and passionate new hires and interns to join our mission to cure cancer." Phil Masterson, Associate Director, Cancer Research Horizons commented: "Infinitopes is at the forefront of the cancer vaccine revolution emerging from Covid-era technology advances. Cancer Research Horizons' investment strategy focuses on maximising patient impact – Infinitopes is empowering the immune system to fight the cancer metastases that cause 70 to 90 percent of cancer deaths through better targeting, better delivery mechanisms and better clinical trials. We are delighted to support the building of a leading company based on innovative CRUK-funded foundational science." Hugo Villanueva, Octopus Ventures, said: "At Octopus Ventures, we back the entrepreneurs who are revitalising healthcare. The Infinitopes team is a great example of this ─ their work to design, develop and clinically assess novel cancer vaccines is incredibly important, and we're delighted to support them in their work to combat cancer." John W Cassidy, General Partner, Kindred Capital, added: "At Kindred, we don't just invest; we partner with trailblazers who reimagine the future. Infinitopes exemplifies this spirit, weaving together scientific acumen with technological foresight to architect the next frontier in cancer care. This significant funding milestone underscores our collective commitment to empower healthcare innovation that promises not only to challenge the current paradigms but to redefine them. Infinitopes is charting a bold course towards a world where cancer is no longer a formidable foe but a conquerable condition. We are delighted to support them in this mission." Julia Schrameier, Investor at Manta Ray, added: "Our initial investment in Infinitopes in December 2022 was driven by our strong conviction that they were the right team at the right time to create a leading computational, proteomics-driven antigen discovery platform. Their focus on accessible, non-personalised treatments, combined with the team's deep scientific expertise and remarkable track record, distinctly set them apart from other companies in the space. After observing their impressive progress and growth over the past year, our conviction has only strengthened. Working with Jonathan and his team has been remarkable, and we are excited to follow our initial investment and continue supporting Infinitopes on its journey to cure cancer, one epitope at a time." Infinitopes presented at the 8th Immuno Oncology Europe (London, April 23-25) and Immuno'24 (London, April 25-26) last week, and will attend the 7th European Neoantigen Summit (Amsterdam, April 29-May 1), and BioEquity (San Sebastián, May 12-14). About Infinitopes Infinitopes Ltd is a soon to be 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 antigen discovery and in high efficiency, vector delivery systems, to develop immunologically durable vaccines for use against multiple solid tumour indications. The lead vaccine candidate is expected to begin phase I/IIa trials in Q3 2024. Infinitopes has cultivated in-house talent across antigen discovery, immunology, vaccinology, oncology, biomanufacturing, 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). In 2024, the company closed its £12.8 m seed financing. Since incorporation, the Infinitopes team has grown from three co-founders to 28 full time equivalents, and is now the largest tenant of Oxford University's BioEscalator Innovation Building. For more information, visit SOURCE Infinitopes