KRAS

Hamilton, Bermuda, Sept. 27, 2024 (GLOBE NEWSWIRE) -- Certification to ISO 13485 extended to also include production process Supports Bentrio growth strategy together with strategic contract manufacturer and expanding network of international distributors Altamira Therapeutics Ltd. (“Altamira” or the “Company”) (Nasdaq:CYTO) today announced that its associate company Altamira Medica Ltd. obtained extended ISO 13485 certification for its quality management system, including henceforth also production activities. With this extension, the quality management system has been certified for the whole design, development, production and distribution cycle for Altamira Medica’s Bentrio® nasal spray. “We are very proud of passing the required audits for the certification of our quality management system for Bentrio in accordance with the internationally recognized, rigorous ISO 13485 standard,” commented Thomas Meyer, Altamira Medica’s Chairman and CEO. “Our comprehensive and effective quality management system helps to ensure that Bentrio complies with high quality standards and regulatory requirements. Its extension to also include our production processes is an important milestone in our growth strategy for Bentrio, which we are implementing with a strategic contract manufacturer and an expanding network of international distributors.” About Bentrio Bentrio is an “over the counter” drug-free nasal spray for personal protection against airborne allergens and, where approved, against airborne viruses. Upon application into the nose, Bentrio forms a protective gel layer on the nasal mucosa. This thin film is designed to prevent the contact of airborne particles with cells; in addition, the composition serves to bind such particles and help with their discharge. The efficacy and safety of Bentrio has been demonstrated in a total of four clinical trials, of which the largest one (“NASAR” study) enrolled 100 patients suffering from seasonal allergic rhinitis. In NASAR, participants self-administered either Bentrio or saline nasal spray for two weeks 3 times per day. The study showed a statistically significant reduction in the mean daily reflective Total Nasal Symptom Score (rTNSS) for Bentrio compared to saline (p = 0.013), as well as a statistically highly significant improvement in health-related quality of life (Rhinoconjunctivitis Quality of Life Questionnaire, p < 0.001) and superior global ratings of efficacy by patients and investigators alike (p < 0.001). In addition, Bentrio showed good safety and tolerability, similar to saline controls, and fewer Bentrio treated patients used relief medication and more of them enjoyed symptom-free days compared to saline treatment. For more information, visit: www.bentrio.com About ISO 13485 ISO 13485 is an internationally recognized standard for quality management systems in the medical device industry. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device. Certification is achieved based on passing a thorough and comprehensive audit by an independent, accredited organization. ISO (International Organization for Standardization) is a worldwide federation of more than 160 national standards bodies. About Altamira Therapeutics Altamira Therapeutics (Nasdaq: CYTO) is developing and supplying peptide-based nanoparticle technologies for efficient RNA delivery to extrahepatic tissues (OligoPhore™ / SemaPhore™ platforms). The Company currently has two flagship siRNA programs using its proprietary delivery technology: AM-401 for KRAS driven cancer and AM-411 for rheumatoid arthritis, both in preclinical development beyond in vivo proof of concept. The versatile delivery platform is also suited for mRNA and other RNA modalities and made available to pharma or biotech companies through out-licensing. In addition, Altamira holds a 49% stake (with additional economic rights) in Altamira Medica AG, which holds its commercial-stage legacy asset Bentrio®, an OTC nasal spray for allergic rhinitis. Further, the Company is in the process of partnering / divesting its inner ear legacy assets. Founded in 2003, Altamira is headquartered in Hamilton, Bermuda, with its main operations in Basel, Switzerland. For more information, visit: https://altamiratherapeutics.com/ Forward-Looking Statements This press release may contain statements that constitute "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 are statements other than historical facts and may include statements that address future operating, financial or business performance or Altamira’s strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may", "might", "will", "should", "expects", "plans", "anticipates", "believes", "estimates", "predicts", "projects", "potential", "outlook" or "continue", or the negative of these terms or other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, the clinical utility of Altamira’s product candidates, the timing or likelihood of regulatory filings and approvals, Altamira’s intellectual property position and Altamira’s financial position. These risks and uncertainties also include, but are not limited to, those described under the caption "Risk Factors" in Altamira’s Annual Report on Form 20-F for the year ended December 31, 2023, and in Altamira’s other filings with the Securities Exchange Commission (“SEC”), which are available free of charge on the SEC’s website at: www.sec.gov. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated. All forward-looking statements and all subsequent written and oral forward-looking statements attributable to Altamira or to persons acting on behalf of Altamira are expressly qualified in their entirety by reference to these risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and Altamira does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. Investor Contact: Hear@altamiratherapeutics.com

September 25, 2024 – Medigene AG (Medigene or the “Company”, FSE: MDG1, Prime Standard), an oncology platform company focused on the research and development of T cell receptor (TCR)-guided therapies for the treatment of cancer, today announced the filing of a new patent application protecting MDG2021, a T cell receptor engineered T cell (TCR-T) therapy targeting Kirsten rat sarcoma viral oncogene homologue (KRAS) G12D with human leukocyte antigen (HLA)-A*11, for the TCR-T therapy alone as well as in combination with the Company’s PD1-41BB costimulatory switch protein (CSP) technology to the European Patent Office. MDG2021 marks the second candidate within the KRAS library targeting KRAS G12D (HLA-A*11) for which the Company announced lead selection in June 2024. The addition of MDG2021 to Company’s KRAS targeting TCR library significantly impacts the addressable patient population with the combination of KRAS G12V and KRAS G12D mutations comprising ~50% of all KRAS mutations in all tumors (pan-cancer), or even >70% in pancreatic adenocarcinoma. (Yang et al., J Clin Med 2023) “We are pleased to announce the patent filing for MDG2021, our optimal affinity 3S (sensitive, specific and safe) TCR targeting KRAS G12D (HLA-A*11), alone and in combination with our PD1-41BB armoring and enhancement CSP,” said Selwyn Ho CEO at Medigene. “This filing reaffirms our commitment to broaden our intellectual property for TCRs targeting both neoantigens and cancer testis antigens that have potential utility in multiple TCR-guided treatment modalities including TCR-T therapies such as MDG2021, as well as TCR-guided T cell engager therapies (MDG3010) and TCR-natural killer cell therapies.” Medigene continually extends and strengthens its patent portfolio with new technologies and expands existing patents into additional jurisdictions. The Company maintains 29 different patent families worldwide covering applications protecting Medigene’s 3S TCRs as well as its exclusive E2E Platform technologies. Medigene AG (FSE: MDG1) is an immuno-oncology platform company dedicated to developing T cell receptor (TCR)-guided therapies to effectively eliminate cancer. Its End-to-End Platform generates optimal 3S (sensitive, specific and safe) T cell receptors with unique and distinctive attributes that are utilized in multiple therapeutic modalities, such as T cell receptor engineered T cell (TCR-T) therapies, TCR-guided T cell engager therapies and TCR-natural killer cell therapies for both its in-house product pipeline and partnering. Medigene’s lead TCR-T program MDG1015 is a potential best-in-class, TCR-T therapy to treat multiple solid tumor indications. The End-to-End Platform technologies enable armoring and enhancing of these T cells to overcome the immunosuppressive tumor microenvironment (TME) and ensure the T cell drug product composition maximizes safety, efficacy and durability of response. Medigene’s MDG1015 received IND approval in Q3 2024 and is filing for CTA in Q4 2024. For more information, please visit https://medigene.com/ Medigene’s approach to immunotherapy harnesses the immense power of natural T cell receptors. By combining these TCRs with different components of the immune system such as T cells, natural killer (NK) cells or a CD3 complex (TCE, T cell engager), highly specific, sensitive and safe modalities are formed to either complement and/or activate the body’s defense systems against cancer. Medigene’s comprehensive End-to-End (E2E) Platform is built on a foundation of proprietary and cutting-edge technologies, driving the development of highly specific TCR-guided therapies, including the latest advancements in TCR-T, TCR-NK and TCR-TCE drug products. The E2E Platform incorporates sophisticated TCR generation and optimization techniques, such as Allogeneic-HLA TCR Priming, and integrates advanced product armoring and enhancement features like PD1-41BB and CD40L-CD28 Costimulatory Switch Proteins, and iM-TCR. In addition, the E2E Platform offers solutions to developing optimal cell therapy drug products for improved safety, efficacy and durability. Collaborations with partners like BioNTech, Regeneron and WuXi Biologics further underscore the platform’s capabilities and its potential to revolutionize cancer treatment. This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene® is a registered trademark of Medigene AG. This trademark may be owned or licensed in select locations only. The content above comes from the network. if any infringement, please contact us to modify.

On September 27, 2024, Jacobio Pharma (stock code: 1167.HK) attracted a lot of attention in the industry when it officially announced a major cooperation development - the successful acquisition of Shanghai Ellis Pharmaceutical Technology Co., LTD. (stock code: 688578.SH) received up to 172 million yuan in cooperation funds. This payment not only marks the depth and stability of the cooperation between the two parties, but also demonstrates the excellent strength and extensive influence of Gax in the field of innovative drug research and development. The composition of this cooperation is quite remarkable, including a down payment of 150 million yuan, which is a direct reflection of Ellis' high recognition and value of Gax's research and development results. In addition, there is also 22.79 million RMB as research and development cost compensation and other related payments, which will strongly support Gax's continued investment and innovation exploration in subsequent research and development projects. Looking back at the history of cooperation between the two parties, it all began with the signing of a landmark cooperation agreement on August 30, 2024.This initiative not only shows CAx's trust and respect for its partners, but also reflects its firm determination to promote the development of China and even the global medical and health cause. KRAS G12C inhibitor Golelexel, as a star drug in the field of tumor therapy in recent years, has won widespread praise worldwide for its unique mechanism of action and remarkable efficacy. The SHP2 inhibitor JAB-3312 is another effort of GaX in the field of precision medicine, and its precision strike ability for specific targets has brought new hope to many patients with refractory diseases. The introduction of these two drugs will undoubtedly inject new vitality into Ellis' product line and further consolidate its leading position in the pharmaceutical market. It is worth noting that this cooperation not only reflects the depth of cooperation between the two sides in the field of drug research and development, but also indicates that China's pharmaceutical industry is gradually moving toward a new stage of internationalization and high-end. As the global pharmaceutical market continues to integrate and competition intensifies, Chinese pharmaceutical companies are enhancing their core competitiveness by strengthening international cooperation, introducing advanced technology and management experience. The cooperation between Gax and Ellis has undoubtedly set a new benchmark for the internationalization of China's pharmaceutical industry.