TGF-β3

AGOURA HILLS, Calif., May 16, 2023 (GLOBE NEWSWIRE) -- Oncotelic Inc. (“Oncotelic” or the “Company”) (OTCQB:OTLC), a pioneering developer of therapeutic interventions for rare and orphan diseases such as Parkinson's Disease and various forms of cancer, is thrilled to announce their participation in the BIO International Convention. The Company's presentation is readily accessible at Key points of the presentation include: The significant role of TGF-β2 as the primary driver of survival, outpacing the influence of TGF-β1 and TGF-β3. The ongoing advancement of clinical trials for OT-101 in conjunction with P201 in Pancreatic Cancer, set to commence in the second half of 2023. Additional combination trials with various checkpoint inhibitors involving multiple cancer types are also slated to begin within the same timeframe. The sustained progress towards the IPO of the joint venture, contingent on favorable market conditions. The evolution of a state-of-the-art AI-driven nanomedicine platform designed to bolster both internal developmental processes and external collaborative endeavors. "Our commitment to innovation is reflected in the development of a cutting-edge AI-driven nanomedicine platform. This platform is anticipated to revolutionize the drug development initiatives within both Oncotelic and the joint venture. We are stand ready to invest in our partners supporting their journey from initial concept to clinical trials and through to commercialization," stated Dr. Vuong Trieu, CEO of Oncotelic and CEO of Sapu. We extend a warm invitation to all interested parties to explore the details of our presentation and discover more about the future of our groundbreaking work in rare and orphan disease therapeutics. About Oncotelic Oncotelic (f/k/a Mateon Therapeutics, Inc.), was formed in the State of New York in 1988 as OXiGENE, Inc., was reincorporated in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic Therapeutics, Inc. in November 2020. Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on rare pediatric cancers. Oncotelic has rare pediatric designation for Diffuse Intrinsic Pontine Glioma (“DIPG” through OT-101) through its 45% joint venture, GMP Biotechnology Limited, melanoma (through CA4P), and Acute Myeloid Leukemia (“AML” through OXi 4503). Oncotelic also acquired PointR Data Inc. in November 2019 to build an AI driven biotechnology company. Further, Oncotelic acquired AL-101, during the 4th quarter of 2021, for the intranasal delivery of apomorphine. We intend to develop AL-101 for the treatment of Parkinson Disease, erectile dysfunction, female sexual disorder and hypoactive sexual desire disorder. All these ailments have a very large population suffering from them and there is a need for treatments for each. For more information on AL-101, refer to our Annual Report on form 10-K/A filed with the SEC on April 19, 2023. Oncotelic's Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position, prospects, plans and objectives of management are forward-looking statements. Words such as "may", "expect", "anticipate" "hope", "vision", "optimism", "design", "exciting", "promising", "will", "conviction", "estimate," "intend," "believe", "quest for a cure of cancer", "innovation-driven", "paradigm-shift", "high scientific merit", "impact potential" and similar expressions are intended to identify forward-looking statements. Forward looking statements contained in this press release include, but are not limited to, statements about future plans related to the operations of the JV, taking the JV into an initial public offering or the success thereof, the progress, timing of clinical development, scope and success of future clinical trials, the reporting of clinical data for the company's product candidates and the potential use of the company's product candidates to treat various cancer indications as well as obtaining required regulatory approval to conduct clinical trials and upon granting of approval by the regulatory agencies, the successful marketing of the products; building and the success of our nanoparticle platform and the related success of launching the platform, the success of the launch of a company with a DAO infrastructure, the success of the entity and the plans surrounding the pet and animal health, the ability for the Company to register the tokens of Pet2Dao, the actual filing of a registration statement and approval of the tokens as registrable securities with the SEC through a registration statement, the ability of the tokens to be tradable or any value such tokens may have if they become tradable.. Each of these forward-looking statements involves risks and uncertainties, and actual results may differ materially from these forward-looking statements or may not occur at all. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes, taking the Company or its affiliates through initial public offerings. These risks are not exhaustive, the company faces known and unknown risks, including the risk factors described in the Company's annual report on Form 10-K filed with the SEC on April 19, 2023 and in the company's other periodic filings. Forward-looking statements are based on expectations and assumptions as of the date of this press release. Except as required by law, the company does not assume any obligation to update forward-looking statements contained herein to reflect any change in expectations, whether because of new information, future events, or otherwise. Contact Information: For Oncotelic Therapeutics, Inc.: Investor Relations ir@oncotelic.com

-The TGFβ1 and TGFβ3 isoforms are predictive --Validation of TGFβ2 as therapeutic target AGOURA HILLS, Calif., March 13, 2023 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc (OTCQB:OTLC) ("Oncotelic", the "Company" or "We"), a developer of treatments for rare and orphan indications, including Parkinson's Disease, pancreatic ductal adenocarcinoma, diffuse intrinsic pontine gliomas (“DIPG”), and COVID-19, today announced the publication of High Intra-Tumor Transforming Growth Factor β2 Level as a Predictor of Poor Treatment Outcomes in Pediatric Cancer of the brainstem. Links to the publication can be found below. Uckun, F.M.; Qazi, S.; Trieu,V. High Intra-Tumor Transforming Growth Factor Beta 2 Level as a Predictor of Poor Treatment Outcomes in Pediatric Diffuse Intrinsic Pontine Glioma. Cancers 2023, 15, 1676. https://doi-org.libproxy1.nus.edu.sg/10.3390/cancers15061676. Pediatric cancer of the brainstem, including DIPGs, is one of the most aggressive and deadliest childhood brain tumors. In spite of numerous clinical trials of chemotherapeutic agents, immune-oncology drugs, and specific targeted therapies aimed at improving the survival outcome of these patients, little progress has been achieved and the prognosis remains dismal, with a median survival time of approximately 10 months and a two-year survival rate of less than 10 percent. The purpose of the present study was to evaluate the clinical significance of amplified expression levels of transforming growth factor beta 2 (TGFβ2) in the tumor tissue specimens from these patients. Our findings provide the first evidence that high level TGFβ2 expression is associated with a poor treatment outcome. The reported results also support the notion that further evaluation of the clinical potential of new strategies targeting TGFβ2 in pediatric cancer of the brainstem is warranted. “OT-101 is the only TGFβ2 inhibitor that is in late clinical development. As TGFβ1 and TGFβ3 are not prognostic, we believe that previous clinical failures, including bintrafusp alfa, could be rectified by targeting TGFβ2 instead” stated Dr. Vuong Trieu, CEO and Chairman of Oncotelic. A clinical study protocol looking at treatment of pediatric cancer of brainstem with OT-101 has been accepted onto the National Institute for Health and Care Research (“NIHR”) portfolio. NIHR is the British government’s major funder of clinical, public health, social care and translational research. About Oncotelic Oncotelic (f/k/a Mateon Therapeutics, Inc.), was formed in the State of New York in 1988 as OXiGENE, Inc., was reincorporated in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and subsequently to Oncotelic Therapeutics, Inc. in November 2020. Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on rare pediatric cancers. Oncotelic has rare pediatric designations for DIPG,through OT-101 through its 45% joint venture GMP Biotechnology Limited (“GMP Bio”), with Dragon Overseas Capital Limited (“Dragon”); for melanoma (through CA4P); and Acute Myeloid Leukemia (through OXi 4503). Oncotelic also acquired PointR Data Inc. in November 2019 to create a biotechnology company with artificial intelligence capabilities. During the 4th quarter of 2021, Oncotelic acquired AL-101 for the intranasal delivery of apomorphine. We intend to develop AL-101 for the treatment of Parkinson Disease ("PD"). Over 60,000 new patients are being diagnosed with PD in the United States and currently there are over 1 million patients in the US and expected to increase to over 1.2 million by 2030. In addition, approximately 10 million suffer from this disease globally. https://www.parkinson.org/Understanding-Parkinsons/Statistics. AL-101 is also being developed for Erectile Dysfunction ("ED"). ED is the most prevalent male sexual disorder globally. The percentages of men affected by ED are as follows: 14.3-70% of men aged 60 years, 6.7-48% of men aged 70 years, and 38% of men aged 80 years (Geerkens MJM et al. (2019). Eur Urol Focus. pii: S2405-4569(19)30079-3). However, with the increasing administration of PDE5 inhibitors in clinical practice, it was found that approximately 30-35% of ED patients are treatment failures (McMahon CN et al. (2006). BMJ, 332: 589-92). AL-101 is designed to target treatment failure ED patients who do not respond to PDE5 inhibitors. Through similar mechanism of action, AL-101 is being developed for Female Sexual Dysfunction ("FSD"). Female sexual dysfunction is a prevalent problem, afflicting approximately 40% of women and there are few treatment options. FSD is more typical as women age and is a progressive and widespread condition. (Allahdadi, KJ et al. (2009) Cardiovascular & hematological agents in medicinal chemistry, 7(4), 260-269). There is no available drug for the treatment of FSD. In June 2019, the U.S. Food and Drug Administration approved Vyleesi (bremelanotide) to treat acquired, generalized hypoactive sexual desire disorder ("HSDD") in premenopausal women. This is the only available drug treatment. Vyleesi has essentially replaced the only other drug for HSDD - however, it has a long list of drug-drug interactions, including commonly used antidepressants, such as fluoxetine and sertraline. In addition, it has a black box warning regarding its use with alcohol, a combination that has been associated with hypotension and syncopal episodes. Therefore, there is an urgent need for effective therapy against FSD and HSDD. About OT-101: Oncotelic jointly owns OT-101 with its joint venture partners Dragon and GMP Bio. OT-101 has completed seven clinical trials including one phase 2 trial in COVID and two phase 2 trials in brain cancer and against pancreatic cancer. It has pediatric designation for a rare form of pediatric brain cancer known as DIPG. There are about 200-300 new cases of DIPG every year in the United States. DIPG most often occurs in children aged 5-10 years old. Treatment options are limited with surgery being contraindicated. Most children do not survive more than 2 years after diagnosis. Currently, the main treatment for DIPG is radiation therapy. Although radiation temporarily improves symptoms in most patients, it is not a cure. Paliative care or quality of life services help patients and families manage pain and other symptoms, promote quality of life, and making difficult decisions including treatment choices and end of life care. When COVID-19 emerged in China, Oncotelic and Golden Mountain Partners, an affiliate of Dragon and GMP, entered into a research and services agreement in February 2020 to develop and test COVID-19 antisense therapeutics. In March 2020, Oncotelic reported the anti-viral activity of OT-101. The anti-viral activity of OT-101, in an in vitro antiviral testing performed by an independent laboratory, OT-101 has a 50% effective concentration (EC50) of 7.6 µg/mL and is not toxic at the highest dose of 1000 µg/mL giving a safety index (SI) value of >130, which is considered highly active and on par or superior to Remdesivir - a Gilead drug. Unlike Remdesivir, OT-101 targets not only the virus replication but also the virus induced pneumonia and fibrosis. Our Phase 2 trial was completed for OT-101 in South America. This was a randomized, double-blind, placebo-controlled Phase 2 study intended to evaluate the safety and efficacy of OT101 in adult patients hospitalized with positive SARS-CoV-2 and pneumonia. As reported in November 2021, the top line data was positive for safety and efficacy. For more information, please visit www.oncotelic.com Oncotelic's Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position, prospects, plans and objectives of management are forward-looking statements. Words such as "may", "expect", "anticipate" "hope", "vision", "optimism", "design", "exciting", "promising", "will", "conviction", "estimate," "intend," "believe", "quest for a cure of cancer", "innovation-driven", "paradigm-shift", "high scientific merit", "impact potential" and similar expressions are intended to identify forward-looking statements. Forward looking statements contained in this press release include, but are not limited to, statements about future plans related to the operations of the JV, taking the JV into an initial public offering or the success thereof, the progress, timing of clinical development, scope and success of future clinical trials, the reporting of clinical data for the company's product candidates and the potential use of the company's product candidates to treat various cancer indications as well as obtaining required regulatory approval to conduct clinical trials and upon granting of approval by the regulatory agencies, the successful marketing of the products; building and the success of our nanoparticle platform and the related success of launching the platform, the success of the launch of a company with a DAO infrastructure, the success of the entity and the plans surrounding the pet and animal health, the ability for the Company to register the tokens of Pet2Dao, the actual filing of a registration statement and approval of the tokens as registrable securities with the SEC through a registration statement, the ability of the tokens to be tradable or any value such tokens may have if they become tradable.. Each of these forward-looking statements involves risks and uncertainties, and actual results may differ materially from these forward-looking statements or may not occur at all. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes, taking the Company or its affiliates through initial public offerings. These risks are not exhaustive and the company faces known and unknown risks, including the risk factors described in the Company's annual report on Form 10-K filed with the SEC on April 15, 2022 and in the Company's other periodic filings. Forward-looking statements are based on expectations and assumptions as of the date of this press release. Except as required by law, the Company does not assume any obligation to update forward-looking statements contained herein to reflect any change in expectations, whether as a result of new information, future events, or otherwise. Contact Information: For Oncotelic Therapeutics, Inc.: Investor Relations ir@oncotelic.com

- Preclinical data showing the rationale for two new pipeline candidates targeting the immunosuppressive effects of Arginase-1 (ARG1) and Transforming Growth Factor Beta 1 (TGFb1) were presented in two posters NEW YORK, Nov. 09, 2022 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), IO Biotech, a clinical-stage biopharmaceutical company developing novel, immune-modulating anti-cancer therapies based on its proprietary T-win® technology, today announced details of the invited oral presentation and two poster presentations at the Society for Immunotherapy of Cancer’s (SITC) 37th Annual Meeting. Information for the invited oral presentation: Title: Utilizing Tumor Microenvironment Antigens for Immune Modulatory Vaccines Session: Concurrent Session 119 – Vaccines: In Situ Agents and Novel Systemic Approaches Presenter: Mads Hald Andersen, Ph.D. – Professor and Director of Center for Cancer Immune Therapy at Herlev University Hospital, IO Biotech Founder and Scientific Advisor Date: Thursday, November 10, 2022 Location and time: TBD – 6:25 p.m. EST “We are pleased that Dr. Andersen has been invited to SITC to give an overview of our Phase 1/2 MM1636 study at SITC and are very encouraged that the long-term follow up data confirm the earlier results reported from this study in front-line PD-1 naïve metastatic melanoma patients,” said Mai-Britt Zocca, Ph.D., President and Chief Executive Officer of IO Biotech. “We are also thrilled to share, for the first time, preclinical data from the next two candidates in our pipeline that target ARG1 and TGFβ1, immunosuppressive antigens found in the tumor microenvironment (TME).” Dr. Zocca continued, “Based on the promising clinical results of our lead asset, IO102-103, which dually targets and disrupts immunosuppressive antigens indoleamine 2,3-dioxygenase (IDO) and anti-programmed death ligand 1 (PD-L1), we believe that targeting suppressive antigens can not only better allow T-cells to directly attack tumor cells, but also modulate the TME as an immunotherapeutic approach. We see the potential of these two new candidates to build on the strength of our T-win® platform and a path forward for Investigational New Drug filings. We look forward to providing additional updates on both our Phase 3 trial with IO102-103 in combination with pembrolizumab for metastatic melanoma and our Phase 2 basket trial in solid tumors in the coming weeks and months.” Highlights from the two preclinical poster presentations include: Title: Modulating the TME by targeting TGFb1 with vaccine-induced immune responses Abstract Number: 1182 Presenter: Brian Weinert, Ph.D., Principal Scientist IO Biotech Date: Friday, November 11, 2022 Location and time: Poster Hall C Poster Hall Hours: 9 a.m.– 8:30 p.m. EST Transforming Growth Factor Beta 1 (TGFb1) is a major immune suppressive element in the tumor microenvironment (TME) of most solid tumors. It is implicated in antagonizing the efficacy of various immune oncology therapies. Developing selective and efficacious modulators of the pathway is an ongoing challenge in the field. IO Biotech has deployed its unique approach to modulate TGFb1 activity in the TME, and the poster details the identification and characterization of highly selective TGFb1 peptide vaccines. These peptides were shown to induce potent and selective immune responses (versus TGFb2 and TGFb3). Murine TGFb1 peptide vaccines were also identified and characterized, and functional activity was preliminarily demonstrated in a relevant murine tumor mouse model (MC38). Translational work detailing content and identity of cells expressing TGFb1 and other immune suppressive antigens in the TME provided the biological rationale to target TGFb1 via a vaccine approach individually and in combination with other TME targets. These preclinical data support further development of a TGFβ1 vaccine as a TME targeted approach for the treatment of a wide range of cancers. Title: An Arginase-1 peptide-based vaccine is an exciting approach to modulate the TME and drive efficacy in preclinical tumor models Abstract Number: 1440 Presenter: Marion Chapellier, Ph.D., Senior Scientist IO Biotech Date: Friday, November 11, 2022 Location and time: Poster Hall C Poster Hall Hours: 9 a.m.– 8:30 p.m. EST Arginase-1 (ARG1) regulates immune escape of tumor cells through various mechanisms in the tumor microenvironment (TME). It is being targeted experimentally in the clinic, but selective and efficacious inhibitors of ARG1 remain elusive. IO Biotech has shown that vaccination against TME targets is an exciting new therapeutic approach and has previously identified and characterized selective ARG1 peptide vaccines. The poster highlights translational data to guide clinical development of the vaccine in the relevant cancer indications and provides a biological rationale to combine an ARG1 vaccine with other TME vaccines (IDO1/PD-L1). In addition, in vivo data demonstrated functional efficacy of the murine ARG1 vaccine in two ARG1 expressing mouse cancer models in combination with other TME vaccines. These preclinical data support further development of an ARG1 vaccine as a TME vaccine targeted approach in combination with an IDO/PD-L1 vaccine for the treatment of a wide range of solid cancers and we anticipate an IND filing for IO112 (ARG1 vaccine) in 2023. About SITC Established in 1984, the Society for Immunotherapy of Cancer (SITC) is a nonprofit organization of medical professionals dedicated to improving cancer patient outcomes by advancing the development, science and application of cancer immunotherapy and tumor immunology. SITC is comprised of influential basic and translational scientists, practitioners, health care professionals, government leaders and industry professionals around the globe. Through educational initiatives that foster scientific exchange and collaboration among leaders in the field, SITC aims to one day make the word “cure” a reality for cancer patients everywhere. Learn more about SITC at sitcancer.org About IO Biotech IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer therapies based on its T-win® technology platform. The T-win® platform is a novel approach to cancer immunotherapy designed to activate naturally occurring T cells to target immunosuppressive mechanisms. IO Biotech is advancing in clinical studies its lead immuno-oncology candidate, IO102-IO103, targeting IDO and PD-L1, and through preclinical development its other pipeline candidates. IO Biotech is headquartered in Copenhagen, Denmark, with its United States headquarters in New York, New York. For further information, please visit . Forward-Looking Statement This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including regarding future clinical trials and results, are based on IO Biotech’s current assumptions and expectations of future events and trends, which affect or may affect its business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Except to the extent required by law, IO Biotech undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise. Company Contact: Amy Sullivan Chief Financial Officer IO Biotech, Inc. asu@iobiotech.com Investor Contact: Corey Davis, Ph.D. LifeSci Advisors 212-915-2577 cdavis@lifesciadvisors.com Media Contact: Raena Mina, Ph.D. LifeSci Communications 646-606-1438 rmina@lifescicomms.com