H. Lee Moffitt Cancer Center & Research Institute, Inc.

The Annual Conference Fuels Growth with a Focus on Elevating Florida's Position on the Global Stage PONTE VEDRA, Fla., Oct. 16, 2023 /PRNewswire/ -- The 26th BioFlorida Annual Conference united 500+ statewide leaders from Florida's life sciences industry, representing biopharmaceutical, medical technology, digital health, and health systems, globally recognized research universities and research institutions, investors, policymakers, and economic development agencies, to spotlight the momentum and success in science, business, and public policy and spur collaboration and future global growth for Florida's companies. BioFlorida also announced a strategic partnership with BIOQuébec aiming to facilitate collaboration and bolster industry growth in both regions. "Florida's life sciences continue to expand, further establishing Florida as a global life sciences destination – and today our industry represents 8,600 establishments and research organizations that employ nearly 107,000 Floridians," said Nancy K. Bryan, President and CEO of BioFlorida. "The BioFlorida Annual Conference provides us an opportunity to showcase recent innovations, spur collaborations, explore policy solutions to fuel future growth, and drive global excellence, which was front and center with the launch of our strategic partnership with BIOQuébec." Three distinct tracks – BioScience, BioTrends, and BioBusiness – explored topics ranging from inflammation and its impact on diseases; innovation in cell and gene therapies; next generation cancer treatments; advancements in neurodegeneration; breakthroughs in medical devices; drug delivery and pre-clinical testing; AI; post-pandemic workforce and facility planning; and financing insights. State Representative Karen Gonzalez Pittman also joined experts to discuss unlocking the potential of biomarkers and the state legislature's role from her perspective as sponsor of legislation to require insurance coverage for cancer biomarker testing. State Representative Kelly Skidmore also joined life science leaders at the Conference to collaborate on solutions to drive Florida's health care industry forward. All conversations were led by CEOs, executives, and top scientists and researchers from Florida-based companies, universities, research organizations, and health systems. Panels also explored collaborative opportunities to propel growth and innovation throughout the state and strategies for attracting global technology and companies to Florida. Prominent Florida company executives also shared their dos and don'ts for successful commercialization. Attendees heard from keynote speakers who drew from their personal experiences and passion for their work. W. Gregory Sawyer, PhD of the Moffitt Cancer Center discussed strategies for success in today's environment drawing from his work on the original Mars Rover design team at the NASA's Jet Propulsion Laboratory and his own fight with cancer which led to the establishment of his own Cancer Engineering Center at the University of Florida and the creation of Aurita Biosciences, a company connecting the lab to the clinical setting through a platform for 3D bioscience. Alfredo Quiñones-Hinojosa, MD, or Dr. Q, of the Mayo Clinic focused on global growth strategies. Dr. Q's journey took him from a challenging upbringing in Mexico to becoming a world-famous neurosurgeon developing leading, innovative research in brain cancer treatment. In addition to his clinical activities, Dr. Q leads NIH-funded research to find a cure for brain cancer. His cutting-edge research focuses on brain tumors and cell migration, health care disparities and clinical outcomes for neurosurgical patients in which the operating room is used as an extension for his research scenario. He has authored numerous high-impact scientific journal articles, chapters, abstracts, and books. The Spotlight on Innovation session showcased three companies that have exhibited transformational growth: Medtronic (Miami); iTolerance, Inc. (Miami); and Johnson & Johnson Vision (Jacksonville). Seed and early-stage companies competed in BioPitch, an opportunity for some of the state's most innovative companies to pitch to 35+ life sciences investors. Winners will receive cash prize totaling $50,000. BioFlorida received a record number of BioPitch applicants with HEMOTAG (Boca Raton), an innovative medical technology allowing detection of heart disease before symptoms occur, winning the BioPitch competition. Runners-up included EVQLV (Miami); Feldan Therapeutics (Quebec); and PriZm Therapeutics (University of Miami spin-off). K-Lab Therapeutics (Alachua), a company developing novel immunotherapies with the goal of curing advanced and metastatic solid cancers won the newly introduced "Moonshot" award recognizing promising, very early-stage companies. During the Conference, BioFlorida recognized individuals and organizations throughout six unique categories for their incredible achievements. This year's award recipients include: Researcher of the Year Award The Researcher of the Year award recognizes distinguished researchers whose achievements have significantly advanced scientific knowledge with a proven impact on innovation and public health. This year's award was presented to Stephen D. Nimer, M.D., director of the National Cancer Institute (NCI)-designated Sylvester Comprehensive Cancer Center. He is also the executive dean for research and a professor of medicine, biochemistry, and molecular biology at the University of Miami Miller School of Medicine. Dr. Nimer is a physician scientist who has dedicated his career to the study and treatment of leukemia. During the last ten years, the focus of the Nimer lab has been on the epigenetic basis of acute myeloid leukemia (AML) and other myeloid malignancies. In the last year, Dr. Nimer began his second five-year Leukemia & Lymphoma Society Specialized Center of Research program (LLS SCOR) grant working with renowned investigators at Memorial Sloan Kettering Cancer Center and Dana-Farber Cancer Institute. This award supports a breadth of work from basic laboratory research to therapeutics in the clinic. Over the past 37 years, Dr. Nimer has also received continuous funding from the NIH. He has conducted clinical and laboratory research on bone marrow failure states and AML and participated in pivotal clinical trials that led to the FDA approvals of therapeutics for patients with myelodysplastic syndrome (MDS). Therapies are now being tested in patients based on targets identified in his lab. He has authored more than 250 peer-reviewed scientific publications, many in high-impact journals including Cell, Science, Nature, Nature Medicine, and Cancer Cell. Sylvester, which sits at the "gateway" to the Caribbean and Latin America, became an NCI-designated center in July 2019. In his time as director, Dr. Nimer has hired more than 250 world-class physicians and researchers, creating an environment of excellence and collaboration. Dr. Nimer currently holds the Oscar de La Renta Endowed Chair in Cancer Research. Deal of the Year Award The Deal of the Year Award recognizes a deal, whether it be an equity investment, key license agreement, significant grant award, or other agreement, with a significant impact on innovation, public health, and the deal-flow ecosystem within Florida's life sciences industry. The 2023 Deal of the Year Award was presented to Quang Pham, Chief Executive Officer of Cadrenal Therapeutics (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a late-stage novel oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes and deaths due to blood clots in patients with certain rare medical conditions. In 2021, he founded Cadrenal Therapeutics in Ponte Vedra and acquired tecarfarin from Horizon Technology Finance (Nasdaq: HRZN). Tecarfarin was invented by a chemist from the University of Florida. The Deal of The Year is Cadrenal's closing of its initial public offering (IPO) in January 2023, with the Company raising $7 million. Cadrenal Therapeutics was the first biopharma IPO of 2023 and the first-ever in Northeast Florida. Subsequently, the Company raised an additional $7.5 million in a private placement priced at-the-market under Nasdaq rules from a single institutional investor. The two offerings provided capital to the Company to continue to advance tecarfarin through its regulatory and developmental goals. Tecarfarin has FDA orphan drug and Fast Track designations. Quang Pham has significant business, mergers and acquisitions, and fundraising experience, as well as numerous interactions with the FDA and extensive knowledge of the pharmaceutical industry. He previously served as Chief Executive Officer of Espero BioPharma. He has a Bachelor of Arts in Economics from UCLA and served as a U.S. Marine Corps Officer. He is also a past recipient of the EY Entrepreneur of the Year and BioFlorida's Entrepreneur of the Year awards. Weaver H. Gaines Entrepreneur of the Year Award The Weaver H. Gaines Entrepreneur of the Year Award honors an individual who has made extraordinary contributions to the growth of Florida's life sciences industry. The 2023 Weaver H. Gaines Entrepreneur of the Year Award was presented to W. Greg Sawyer, Ph.D., Chief Bioengineering Officer at Moffitt Cancer Center. Dr. Sawyer is an mechanical engineer who started his career working with NASA on the first Mars rover. He later built instruments to evaluate nanocomposites in low Earth orbit as they were exposed to the space environment on the International Space Station. But in 2013 after a surprise late-stage metastatic cancer diagnosis, Dr. Sawyer shifted his focus to cancer bioengineering. His mission became finding a way to 3D print cancer and tumors in a way that could help researchers study how the disease grows and reacts to therapies. In 2015, while a professor at the University of Florida, Dr. Sawyer collaborated with students Jack Famiglietti and Ryan Smolcheck to develop a 3D culture platform to model to mimic human tissues and organs. Together, they founded Aurita Biosciences, which has developed several tools to expand the use of their 3D culture platform. This year, Dr. Sawyer joined Moffitt Cancer Center as the Chief Bioengineering Officer and Chair of its new Bioengineering Department. This new department is the first of its kind for any cancer center. Its goal of the department mimics Dr. Sawyer's focus nearly a decade ago – to accelerate cancer research by providing 3D cancer models to see how cells interact, metastasize and respond to therapies. A full circle moment that will help countless cancer patients here in Florida and beyond. The Department of Bioengineering will be one of the key basic science departments at Moffitt's Center for Innovation, a new 300,000-square-foot research facility in Speros, FL and designed to stimulate entrepreneurship. The cancer center broke ground on the Pasco County project in January. David J. Gury Company of the Year Award The David J. Gury Company of the Year Award honors a company that has achieved significant milestones and has contributed to the growth of Florida's life sciences industry. The 2023 David J. Gury Company of the Year Award was presented to Maurice R. Ferré MD, Chairman and CEO of the Board of Directors at Insightec, a global healthcare company dedicated to using acoustic energy to transform patient care. Founded in Haifa, Israel with headquarters in both Israel and Miami, Insightec has been a pioneer in focused ultrasound (FUS) technology for more than 25 years with a continued focus on realizing the therapeutic power of acoustic energy. The company's Exablate Neuro platform focuses sound waves, safely guided by MRI, to provide tremor treatment to patients with medication-refractory essential tremor and Parkinson's disease. Affecting approximately 60 million people globally, essential tremor is the most common movement disorder in the world and is often misdiagnosed. Essential tremor commonly affects both sides of the body, and in December 2022, Insightec received FDA approval to allow appropriate patients to have their second side treated at least nine months after treatment of the first side, potentially meaning tremor relief on both sides of the body. The technology also received a CE mark for second side treatment in European countries in 2023. Research for future applications in the neuroscience space is underway in partnership with leading academic and medical institutions including a new pivotal trial, known as LIBERATE (Liquid Biopsy with Low Intensity Ultrasound in Brain Tumors), designed to assess for the first time the clinical benefit of using low-intensity focused ultrasound to transiently increase the permeability of the BBB and enable incisionless liquid biopsy in brain tumors. Insightec is also exploring other treatment applications in the body, such as prostate disease and uterine fibroids. BioFlorida Leadership Award The BioFlorida Leadership Award recognizes the BioFlorida volunteer who has taken on a leadership role within the organization, dedicated significant time to BioFlorida's mission, and has acted as a true ambassador to BioFlorida and the industry. Juan Carlos Varela, Vice President and Senior Client Partner at Globant, was honored with the 2023 BioFlorida Leadership Award. With over 25 years of experience in healthcare, life sciences, and MedTech, Varela's strategic leadership at Globant, Medtronic, and Johnson & Johnson has consistently driven high-growth businesses and delivered substantial value for clients. Within BioFlorida, Varela's impact is deeply felt. From Board Member to Chairman of the Board and various other roles, his visionary contributions have been instrumental in shaping the organization's trajectory. His creation of the International Development Committee promises enduring value for BioFlorida, reflecting his forward-thinking vision. Varela's role as a connector of people has furthered the organization's mission, making him an invaluable ambassador, not only for BioFlorida but for the entire industry. BioFlorida Lifetime Achievement Award The BioFlorida Lifetime Achievement Award recognizes an individual's outstanding career achievements, leadership and contributions that have significantly contributed to the growth of his or her respective industry. This year we acknowledge the visionary leadership and remarkable contributions of Patrick J. McEnany, a distinguished co-founder, Chairman, President, and Chief Executive Officer of Catalyst Pharmaceuticals. McEnany has played a pivotal role since the Company's inception in January 2002, serving as CEO and a dedicated board member. His roles as Chairman and President were assumed in March 2006, marking a significant milestone in his exceptional leadership journey. Throughout his illustrious career and leadership journey, McEnany's accomplishments have been truly transformative. He founded Catalyst Pharmaceuticals in 2002 and successfully led the Company to go public in 2016, steering it toward remarkable growth. His consistent demonstration of exceptional vision, dedication, and unwavering commitment to enhancing the quality of life for individuals facing rare and challenging diseases has been remarkable. His pioneering spirit has been a driving force behind the company's success, including achieving a market capitalization of $1.3 billion. Under his guidance, Catalyst Pharmaceuticals has experienced substantial growth through successful product development and strategic acquisitions, enriching the company's product portfolio and contributing to an annual revenue base exceeding $200 million. McEnany's dedication extends well beyond the corporate realm, leaving a positive impact on both his immediate community in Coral Gables and the entire state of Florida. His achievements, exemplified by the well-deserved BioFlorida Lifetime Achievement Award, serve as a testament to his profound influence within the biotechnology field and the broader Florida community. His unwavering commitment to the community is evident through his active involvement in philanthropic ventures. He currently serves on the emeritus board of directors of the Jackson Health Foundation and the board of directors of the Humane Society of Greater Miami. For over three decades, he has generously shared his expertise as a director with numerous public companies, leveraging his extensive knowledge and leadership acumen to help drive their growth and prosperity. The Nancy K. Bryan Organizational Impact Award With the introduction of the Nancy K. Bryan Organizational Impact Award, BioFlorida celebrated the organization's progress but also the guidance of President and CEO, Nancy K. Bryan. Bryan's visionary leadership and commitment to innovation has left a lasting mark on BioFlorida's legacy, a testament to her extraordinary dedication over the past 11 years. Through pioneering initiatives and an unwavering commitment to member value, Bryan has elevated BioFlorida to unprecedented levels of achievement. BioFlorida's President & CEO, Nancy K. Bryan, has announced her retirement. The organization is in the process of identifying her successor. As the organization bids farewell to a chapter marked by Nancy's leadership, BioFlorida looks forward to a future of continued growth and impact. About BioFlorida BioFlorida is the voice of Florida's life sciences industry, representing 8,600 establishments and research organizations in BioPharma, MedTech, Digital Health, and Health Systems that collectively employ nearly 107,000 Floridians (Source: TEConomy/BIO). BioFlorida's member driven initiatives provide a strong business climate for the advancement of innovative products and technology that improve lives and promote economic benefits to the state. SOURCE BioFlorida

- With no dose-limiting toxicities observed, treatment of second dose cohort to begin SAN JOSE, Calif., Oct. 13, 2023 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that, in partnership with Moffitt Cancer Center, it has completed treatment of the first patient cohort in the ongoing clinical trial of Anixa's novel chimeric antigen receptor T-cell (CAR-T) therapy for ovarian cancer. All three patients in the first cohort received the same dose of engineered T-cells, with no dose-limiting toxicities observed. Following the requisite wait time after the last patient was dosed, a comprehensive review of the safety data from this cohort, and confirmation that it is safe to escalate, the trial will begin enrolling patients in the second dose cohort immediately. Patients enrolled in this second cohort will receive three times the cell dose compared to the first cohort. Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, stated, "We are pleased with the positive safety data from the first cohort and look forward to advancing to the next higher dose cohort. We hope to continue observing good safety results as we continue to increase dosage, and eventually objective efficacy data." The study (NCT05316129), which is being conducted at Moffitt Cancer Center, is a dose-escalation Phase 1 trial to evaluate the therapy's safety; determine the maximum tolerated dose of T-cells targeting the follicle stimulating hormone receptor (FSHR); and preliminarily assess clinical activity. All patients being enrolled in the trial have disease that is progressing and have failed at least two, but often more, therapeutic interventions. Dr. Robert Wenham, the Principal Investigator of the trial, and the Head of Gynecological Oncology at Moffitt stated, "We are very pleased with the results to date. The first three patients were dosed through a peritoneal catheter and no patient has had a dose-limiting toxicity. Since most lesions in ovarian cancer are within the peritoneum, we hope the delivered CAR-T cells remain localized and active in the vicinity of the tumors. It's possible that we may see very limited side effects due to this local, as opposed to systemic, delivery. The very selective target also gives us reason to hope that on-target, off-tumor effects will not be prevalent as in other solid tumor studies. Perhaps this delivery approach may enhance efficacy as well. However, we will also test this therapy by intravenous administration, in patients for whom peritoneal administration is not possible." The CAR-T approach used for Anixa's therapy is known as chimeric endocrine receptor T-cell (CER-T) since the target of the engineered T-cells is an endocrine receptor. While CAR-T therapy has shown efficacy in some hematological tumors, reproducing the same results with solid tumors, such as ovarian cancer, has proven challenging. One of the reasons for this difficulty is that effective CAR-T therapy needs to attack a specific antigen present only on targeted cells to avoid negatively affecting healthy cells. The cell therapy being evaluated in Anixa's Phase 1 study differs from traditional CAR-T therapy in that it targets the FSHR, which research indicates is exclusively expressed on ovarian cells in healthy adult females. About Anixa Biosciences, Inc. Anixa is a clinical-stage biotechnology company focused on the treatment and prevention of cancer. Anixa's therapeutic portfolio consists of an ovarian cancer immunotherapy program being developed in collaboration with Moffitt Cancer Center, which uses a novel type of CAR-T, known as chimeric endocrine receptor T-cell (CER-T) technology. The Company's vaccine portfolio includes a novel vaccine being developed in collaboration with Cleveland Clinic to prevent breast cancer – specifically triple negative breast cancer (TNBC), the most lethal form of the disease – as well as a vaccine to prevent ovarian cancer. These vaccine technologies focus on immunizing against "retired" proteins that have been found to be expressed in certain forms of cancer. Anixa's unique business model of partnering with world-renowned research institutions on clinical development allows the Company to continually examine emerging technologies in complementary fields for further development and commercialization. To learn more, visit or follow Anixa on Twitter, LinkedIn, Facebook and YouTube. Forward-Looking Statements Statements that are not historical fact may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect Anixa's current expectations concerning future events and results. We generally use the words "believes," "expects," "intends," "plans," "anticipates," "likely," "will" and similar expressions to identify forward-looking statements. Such forward-looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in "Item 1A - Risk Factors" and other sections of our most recent Annual Report on Form 10-K as well as in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release. Contacts: Stephen Kilmer Investor Relations [email protected] 646-274-3580 Mike Catelani President, COO & CFO [email protected] 408-708-9808 SOURCE Anixa Biosciences, Inc.

Gesund.ai's platform validates medical AI models for safety, effectiveness, and health equity in order to accelerate and improve responsible use of AI in the clinic and in drug development. CAMBRIDGE, Mass., Oct. 5, 2023 /PRNewswire/ -- Gesund.ai, the company ensuring that medical artificial intelligence (AI) is safe and effective for all, today announced it has joined the White House Cancer Moonshot — CancerX — joining hundreds of public, private, and non-governmental organizations to deliver progress on the mission to end cancer as we know it. Gesund will contribute its expertise as a compliant AI Factory that allows companies to train and validate models in order to then secure FDA clearance. As the industry's leading independent third party AI validator, Gesund uses its proprietary technology and partnerships to audit and validate each model to ensure cutting-edge medical AI products can be trusted and are safe for all. Despite more than 10,000 patent filings and countless number of articles trumpeting the emergence of medical AI, only a few hundred AI models have been FDA approved. The conversion of AI models from development to deployment in clinics is (rightly) a cumbersome and rigorous process in order to ensure patient safety and effectiveness. Gesund.ai's mission is to improve that ratio dramatically by reducing risk, increasing speed, and lowering the costs of validating new AI models. This in turn, will unleash a tsunami of clinical impact. CancerX is the inaugural project in The White House's national Cancer Moonshot initiative. The project is co-hosted by Moffitt Cancer Center and the Digital Medicine Society (DiMe), alongside the Office for the National Coordinator for Health Information Technology and Office of the Assistant Secretary for Health. "We are thrilled to be included in CancerX, a critically important initiative with the mission to improve patient outcomes and reduce the cancer death rate," said Enes Hosgor, Ph.D., founder & CEO of Gesund. "Medical AI provides unprecedented precision, accuracy, and scale in the development of new cancer therapies and procedures, but it's essential that any new offering be fully vetted and validated before it's used to treat patients. This is our commitment at Gesund." "We are honored to partner with Gesund.ai and leverage digital innovation in the fight against cancer," said Edmondo Robinson, Chief Digital Officer of Moffitt Cancer Center. "By harnessing our diverse strengths and expertise, we have the ability to impact the lives of every person, caregiver and researcher working on a cancer journey. This partnership offers the potential to bridge the gap between the world of cancer care today and our vision for CancerX and the future." "Multi-stakeholder collaboration is critical to harness the potential of digital innovation in the fight against cancer, and we're honored to partner with Gesund.ai to achieve the ambitious goals of CancerX," said Smit Patel, Associate Program Director of DiMe. "Through this impressive collaboration, we will establish best practices, build capacity, and demonstrate the impact of innovation on the life of every person on a cancer journey." Last year, President Biden and First Lady Dr. Jill Biden reignited the Cancer Moonshot with the goals of reducing the cancer death rate in the United States by at least half—preventing more than 4 million cancer deaths—by 2047 and improving the experience of people who are touched by cancer. In the time since, the Cancer Moonshot has announced roughly 50 new programs, policies, and resources and secured more than 100 commitments from private companies, non-profit organizations, and patient groups. About Gesund.ai Gesund is the world's first compliant AI factory on a mission to help bring clinical-grade AI solutions to market. Gesund uses its platform to deliver industry-leading independent third party validation of medical AI for pharma and medical device companies. Backed by marquee investors including Merck, McKesson, Northpond and 500, Gesund orchestrates the entire AI/ML lifecycle for all stakeholders by bringing models, data and experts together in a no-code environment. Its pioneering AI-native platform can be deployed on-prem, air-gapped, or in the cloud, which enables faster engagement with healthcare providers and board-certified physician experts. To learn more visit . James Christopherson PR Manager Gesund.ai [email protected] This release was issued through WebWire®. For more information, visit . SOURCE Gesund.ai