Clear Cell Adenocarcinoma

Ladenburg, Germany, 19 March 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), today announced the formal closing of the royalty purchase agreement with HealthCare Royalty (HCRx) for Zircaix®, signed earlier this month. Ladenburg, Germany, 19 March 2024 – Under the terms of the agreement, Heidelberg Pharma has received an upfront, non-refundable cash payment of USD 25 million and is furthermore eligible to receive up to USD 90 million in total from the partial sale of its future royalties on the worldwide sales of Zircaix® (TLX250-CDx, 89Zr-DFO-girentuximab), a radiopharmaceutical Positron Emission Tomography (PET) imaging agent for the diagnosis and management of clear cell carcinomas. Heidelberg Pharma developed the antibody as therapeutic and diagnostic agent up to a first completed Phase III clinical trial prior to licensing it to Telix Pharmaceuticals Limited (Telix), an Australian-headquartered company based in Melbourne, in 2017 for further development. Telix submitted the Biologics License Application submission for Zircaix® in December 2023. Heidelberg Pharma will utilize this funding to further advance its proprietary toolbox of novel payloads and first-in-class Amanitin-based Antibody Conjugate pipeline, including lead candidate HDP-101 which is currently progressing in a Phase I/IIa study for the treatment of multiple myeloma. Dr. George Badescu, Chief Business Officer at Heidelberg Pharma, said: “The funding from the royalty purchase agreement with HealthCare Royalty is enabling us to further advance Heidelberg Pharma’s leading expertise in the field of ADC research and development. The upfront payment strengthens the Company’s liquidity, and along with future anticipated payments, should extend our cash runway. The funds will be used to advance the expansion of our ADC pipeline including our preclinical projects HDP-102, HDP-103 and HDP-201.” Dr. George Badescu, Chief Business Officer at Heidelberg Pharma, said

Melbourne, Australia, 17 October 2023 – Cartherics Pty Ltd (“Cartherics” or “Company”), a biotechnology company developing immune cell therapies for the treatment of cancer, announced today that it has appointed Dr Walid Azar as Chief Scientific Officer (CSO), effective immediately. He holds extensive experience from a diverse scientific background encompassing both academic research and the biotechnology industry. Prior to joining Cartherics three years ago, Dr Azar worked as a molecular biologist at CSL Limited, where he was part of the international R&D team. He brings valuable expertise in cancer research to the CSO role, having completed a PhD in molecular biology and biochemistry at the Murdoch Children’s Research Institute and a postdoctoral research fellowship at the Peter MacCallum Cancer Centre, focusing on clear cell carcinoma, a rare subtype of ovarian cancer. As CSO, Dr Azar will be responsible for overseeing the Company’s scientific activities, building on current capabilities, product pipeline, and platforms. This includes ensuring that the Company remains at the forefront of the latest developments in the immune cell therapy space. He will also be focused on managing and leading the team of highly skilled and committed scientists working at Cartherics. “I am passionate about developing novel treatments for cancer and there is a strong alignment between Cartherics’ mission and my commitment to delivering new options for cancer patients. It is great to be working alongside very talented and committed scientists with the same goal,” said Dr Azar. “CAR-T and CAR-NK cell therapies are yet to reach their potential in solid tumours. With the rapid developments in gene editing technologies and our evolving knowledge of the tumour microenvironment and NK cell biology, there is an opportunity for us to significantly improve the efficacy of CAR-NK therapy in solid tumours,” Dr Azar added. Cartherics CEO, Prof Alan Trounson AO, commented: “We are pleased to promote Walid to this important position. He has a strong background in molecular genomics cancer research, and science management, and will be a valuable addition to the Company’s executive team. Prof Richard Boyd will remain with the Company as Chief Scientific Advisor, a part-time advisory role, and will act as a mentor for Walid. The combination will enable us to maintain excellence in immunology and genomics/gene editing.” About Cartherics Cartherics is a privately held biotechnology company based in Melbourne, Australia that is rearming the body’s immune system to fight cancer.  It is developing cell-based immunotherapies for the treatment of cancer, with a portfolio of CAR-T and CAR-NK cell products.  The Company’s allogeneic (“off-the-shelf”) cell platform is based upon induced pluripotent stem cells (iPSCs) generated from donated cord blood that can be differentiated into NK cells, T cells and other cells of the immune system.  The iPSCs are genetically engineered to provide enhanced function for the derived NK and other immune cells. The Company is also developing autologous CAR-T cell therapies. These use the patient’s own immune system T cells, which are modified to be effective against the patient’s cancer cells. CTH-004 is created by genetically modifying patient T cells to insert a chimeric antigen receptor (CAR) to target a marker (TAG-72) on ovarian cancer cells and delete genes that are involved in suppression of T cell function. Cartherics media contact Christine Filippis Teraze Communications Phone: +61 419 119 866 Email: christine@teraze.com.au

SEATTLE, April 05, 2021 (GLOBE NEWSWIRE) -- SEngine Precision Medicine , a precision oncology company revolutionizing cancer therapies by pre-testing drugs on patient-derived tumor organoids, announced today that the PARIS® Test was utilized in a study to identify novel drug targets and combinations to combat ovarian clear cell carcinoma (OCCC). The study, “Targeting BET proteins BRD2 and BRD3 in combination with PI3K-AKT inhibition as a therapeutic strategy for ovarian clear cell carcinoma,” was recently published in American Association for Cancer Research’s Molecular Cancer Therapeutics and was co-authored by researchers from the Fred Hutchinson Cancer Research Center, SEngine Precision Medicine, Weill Cornell Medicine, and the University of Washington. Ovarian clear cell carcinoma, a relatively uncommon subtype of ovarian cancer, has historically been treated with the same platinum-based chemotherapies as patients with high grade serous carcinoma. However, clear cell carcinoma patients typically display a poorer response to chemotherapies, which leads to lower overall survival for these patients. In this study, researchers identified BET proteins BRD2 and BRD3 as novel targets against ovarian clear cell carcinoma, which could lead to more effective targeted therapies for this subtype. Additional drug sensitivity screening identified the combination of BET protein and PI3K-AKT pathway inhibitors as a promising therapeutic path for further investigation. SEngine’s PARIS® Test, a high-throughput drug sensitivity assay using patient-derived tumor organoids, was utilized in this study to validate the drug-response findings on ovarian cancer cell models. In addition to the PARIS® Test already being utilized as a clinical tool guiding oncologists’ treatment decisions for patients with ovarian cancer, this study demonstrates the power of SEngine’s functional drug sensitivity assay to identify novel therapeutic targets and drug synergies to combat hard-to-treat ovarian cancers. "We are excited to share these new findings that identified two novel BET proteins as candidate therapeutic targets for OCCC and suggest a potential drug combination therapeutic strategy for OCCC,” said Shogo Shigeta, MD, PhD, current Research Associate in the department of gynecology at the Tohoku University Graduate School of Medicine and lead author of the study. “The validation of our study with organoids derived from patient samples will help enable rapid clinical translation." “In this study, SEngine’s PARIS® Test was applied to patient derived tumor cells to identify new therapeutic strategies for hard-to-treat cancers. This is yet another example of the benefit that functional testing brings to oncologists seeking novel treatment options,” commented Carla Grandori, MD, PhD, co-founder and Chief Executive Officer of SEngine Precision Medicine. About PARIS® Test The PARIS® Test is based on the capability to propagate patient-specific cancer cells as organoids outside the body and is applicable to all solid tumors including colon, breast, lung, ovarian and pancreatic cancer. Organoids are cancer-derived cells grown in 3D outside the body, which maintain the functionality of the original tumor as well as its genomic characteristics. For cancers where a treatment path is not clear, such as many metastatic and recurrent cancers, the PARIS® Test provides crucial information to treating physicians to match the right drug to the right patient. About SEngine Precision Medicine SEngine Precision Medicine Inc. is a precision oncology company revolutionizing cancer therapies by pre-testing drugs on patient-derived organoids grown ex-vivo utilizing patient specific tumor cells. As a spin-out from the world-renowned Fred Hutchinson Cancer Research Center, SEngine is leveraging over two decades of R&D in diagnostics and drug discovery. The Company is commercializing the PARIS® Test, a next generation diagnostic test that predicts drug responses integrating knowledge of cancer genomics with organoids, robotics, and AI-driven computational tools. SEngine’s CLIA certified PARIS® Test generates predictive drug sensitivity reports for patients with solid tumors. SEngine is also pursuing drug discovery via strategic collaborations with biopharmaceutical / pharma companies leveraging its precision oncology platform. Discover more at SengineMedicine.com and follow the latest news from SEngine on Twitter at @SEngineMedicine and on LinkedIn . Contact: Stephanie Carrington stephanie.carrington@westwicke.com 646-277-1282