Rasburicase

DOYLESTOWN, Pa., Aug. 24, 2023 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical stage biopharmaceutical company focused on precision oncology through synthetic lethality, today announced it has appointed Dr. Jean-Pierre Bizzari to its Board of Directors and is naming Dr. Richard Peters as its new Chairman of the Board. Dr. Bizzari will replace Mr. Christian Schade, who is stepping down from the Board. “We warmly welcome Dr. Jean-Pierre Bizzari to our Board of Directors. Jean-Pierre is an esteemed industry thought leader and was the Group Head Clinical Development Oncology at Celgene where he was responsible for developing some of the most significant and successful oncology therapeutics,” said Dr. Oren Gilad, President and Chief Executive Officer of Aprea. “Jean-Pierre joins our Board as Chris Schade retires from his role as Chairman and member of the Board to focus on his other commitments. Dr. Richard Peters has served as independent Director of Aprea since June 2020 and Chair of the Compensation Committee since November 2020. Dr. Peters will now also assume the role of Chairman, and we welcome his leadership as he guides our diverse and experienced Board.” Dr. Jean-Pierre Bizzari joins the Aprea Board having led a remarkable and distinguished career in oncology. He has been responsible for numerous global approvals of several billion-dollar therapies, including: Fotomustine, Taxotere, Revlimid, Abraxane, Vidaza, PTCL, Eloxatin, CPT-11, Gliadel, Rasburicase, and Pomalidomide to name a few. He has been involved in acquisition and licensing agreements with several major pharmaceutical companies. Dr. Bizzari is a member and leader on many scientific committees and is currently a member of the Scientific Advisory Board for the National Cancer Institute in France; a Board member of the European Organization of Research and Treatment of Cancer (EORTC) and Chairman of the EORTC New Drug Advisory Committee. He currently is on the Boards of Halozyme, ADC Therapeutics, NETRIS Pharma, and Oxford BioTherapeutics. Most recently, Dr. Bizzari was the Group Head Clinical Development Oncology at Celgene. He led global clinical development conducting over 25 Phase 3 trials, was responsible for global operations of over 950 people and was chairman of the Hematology Oncology development committee. Prior to Celgene, Dr. Bizzari was the VP of clinical development oncology at Sanofi-Aventis where he was responsible for the worldwide clinical development and approvals. He also served as VP of clinical development oncology at Rhone-Poulenc Rorer where he shepherded a deep pipeline of oncology candidates. Dr. Bizzari holds a degree in mathematics, and completed his medical studies in Nice, France. He completed his residency in oncology at Pitie Salpetriere Hospital in Paris. Dr. Bizzari said, “I am excited to join this dedicated Board, and look forward to contributing to the success of their very promising therapeutics at the center of synthetic lethality and DNA Damage Repair drug development.” Mr. Christian Schade noted, “It has been an honor to serve on this dynamic Board. I leave knowing that the Board and Company are in good hands, and that everyone involved is committed to realizing the tremendous potential of this company.” Dr. Richard Peters added, “I thank Chris for his years of service to the Board and astute leadership as we successfully navigated the company through several challenges. I look forward to working closely with our Board and terrific management team as we move towards several meaningful Company milestones.” About ApreaAprea Therapeutics, Inc. is a clinical stage biopharmaceutical company headquartered in Doylestown, Pennsylvania, focused on precision oncology through synthetic lethality. The Company’s lead program is ATRN-119, a clinical-stage small molecule ATR inhibitor being developed for solid tumor indications. Our WEE1 inhibitor is being advanced to IND submission. For more information, please visit the company website at www.aprea.com. The Company may use, and intends to use, its investor relations website at https://ir.aprea.com/ as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Forward-Looking Statement Certain information contained in this press release includes “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 related to our study analyses, clinical trials, regulatory submissions, and projected cash position. We may, in some cases use terms such as “future,” “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “targeting,” “confidence,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Our forward-looking statements are based on current beliefs and expectations of our management team and on information currently available to management that involve risks, potential changes in circumstances, assumptions, and uncertainties. All statements contained in this press release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, including timing considerations and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations. Any or all of the forward-looking statements may turn out to be wrong or be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. These forward-looking statements are submits to risks and uncertainties including, without limitation, risks related to the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials, futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results )including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of our ongoing clinical trials, and the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. For all these reasons, actual results and developments could be materially different from those expressed in or implied by our forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of the date of this press release. We undertake no obligation to update such forward-looking statement for any reason, except as required by law. Investor Contact: Mike MoyerLifeSci Advisorsmmoyer@lifesciadvisors.com

Sanofi to showcase new data from oncology portfolio spanning marketed products and investigational compounds at ASH 2022 Four Sarclisa ® (isatuximab) oral presentations and 11 posters featuring cutting-edge investigational and marketed therapies to be presented December 2 , 2022 . Data featured at the 64 th American Society of Hematology (ASH) Annual Meeting & Exposition from December 10-13, 2022, reinforce Sanofi’s commitment to transforming care for people living with multiple myeloma (MM) and other difficult-to-treat blood cancers. Peter C. Adamson , MD Global Head of Oncology Development “ Data to be presented at this year’s ASH Meeting demonstrate our commitment to improving the outcome for patients with cancer . This includes presentations for Sarclisa , an anti- CD38 antibody of choice for patients with multiple myeloma and a cornerstone of our strategy to broaden our portfolio in hematologic malignancies . W e are proud to be advancing knowledge and the treatment of patients with multiple myeloma , by sharing emerging data from our research efforts . ” The first Sarclisa oral presentation will detail results from a subgroup analysis of the Phase 3 IKEMA trial, which in May 2022 reported updated median progression-free survival results in combination with carfilzomib and dexamethasone. This new analysis compared patients with early versus late relapse. The second Sarclisa oral presentation highlights updated longer-term efficacy data following subsequent therapy in the pivotal Phase 3 ICARIA-MM trial. It is critical to advance scientific understanding of how individuals who relapse early will respond to subsequent lines of therapy because the earlier a person relapses, the more difficult they can be to treat. Sanofi is also presenting multiple abstracts from its investigational early pipeline of cutting-edge compounds, such as an open-label, first-in-human, dose-escalation study of Natural Killer Cell Engager (NKCE) SAR443579 as a monotherapy for the treatment of relapsed or refractory acute myeloid leukemia, B-cell acute lymphoblastic leukemia or high-risk myelodysplasia. Another abstract will highlight the potential of SAR’514, an anti-B cell Maturation Antigen (BCMA) NKCE, for controlling MM tumors in vivo. Since 2019, Sanofi’s oncology pipeline has doubled, with a dozen next-generation, potential first- or best-in-class compounds entering clinical trials. Much of this growth is a result of an acceleration of in-house research and development capabilities, as well as building external partnerships, particularly in early portfolio, including for MM and other hematologic malignancies. A bstracts accepted for presentation at ASH include: Isatuximab Isatuximab Plus Pomalidomide/Low-Dose Dexamethasone Versus Pomalidomide/Low-Dose Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma (ICARIA-MM): Characterization of Subsequent Antimyeloma Therapies Oral presentation Abstract #247 Dec. 10, 2-3:30 p.m. CST Isatuximab Plus Carfilzomib and Dexamethasone in Patients with Early Versus Late Relapsed Multiple Myeloma: IKEMA Subgroup Analysis Oral presentation Abstract #753 Dec. 12, 10:30 a.m.-12 p.m. CST Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone (Isa-KRd) in Patients with High-Risk Newly Diagnosed Multiple Myeloma: Planned Interim Analysis of the GMMG-Concept Trial Oral presentation by GMMG Abstract #759 Dec. 12, 10:30 a.m.-12 p.m. CST Bone Marrow Immune Signatures in Multiple Myeloma Are Linked to Tumor Heterogeneity and Treatment Outcome Oral presentation by GMMG Abstract #860 Dec. 12, 2:45-4:15 p.m. CST Subcutaneous Isatuximab Administration by an On-Body Delivery System (OBDS) in Combination with Pomalidomide and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma: Phase 1b Expansion Study Results Poster Abstract #1923 Dec. 10, 5:30-7:30 p.m. CST Isatuximab Plus Carfilzomib and Dexamethasone in Relapsed Multiple Myeloma: IKEMA Subgroup Analysis By Number of Prior Lines of Treatment Poster Abstract #3176 Dec. 11, 6-8 p.m. CST Isatuximab in Combination with Lenalidomide and Dexamethasone in Patients with High-Risk Smoldering Multiple Myeloma: Updated Safety Run-in Results from the Randomized Phase 3 ITHACA study Poster Abstract #3253 Dec. 11, 6-8 p.m. CST Isatuximab Plus Pomalidomide and Dexamethasone in Patients with Relapsed and/or Refractory Multiple Myeloma in Real-Life Context in France: IMAGE Subgroup Analysis Based on Prior Lines of Therapy and Refractory Status Poster Abstract #4928 Dec. 12, 6-8 p.m. CST Rasburicase Fatalities from Tumor Lysis Syndrome (TLS) After Anti-Hyperuricemic Monotherapy – Nationally Representative, Propensity Score Matched, Retrospective Study Comparison of Rasburicase and Allopurinol Poster Abstract #3632 Dec. 11, 6-8 p.m. CST Pipeline and other MAP4K2 Inhibition Reinforces the Iberdomide Sensitivity in MM Cells by Inducing IKZF1 Degradation Through a CRBN Independent Mechanism (Externally Sponsored Collaboration) Poster Abstract #1838 Dec. 10, 5:30-7:30 p.m. CST Real-World Multiple Myeloma Risk Factors and Outcomes by Race/Ethnicity in the United States Poster Abstract #2285 Dec. 10, 5:30-7:30 p.m. CST High Ex Vivo Response Rates to CD38/CD28xCD3 Trispecific T Cell Engager in Patients Relapsed After Anti-CD38 and Anti-BCMA Targeted Immunotherapies (Externally Sponsored Collaboration) Poster Abstract #3157 Dec. 11, 6-8 p.m. CST Real-World Multiple Myeloma Front-Line Treatment and Outcomes by Transplant in the United States Poster Abstract #3198 Dec. 11, 6-8 p.m. CST An Open-Label, First-in-Human, Dose-Escalation Study of SAR443579 Administered as Single Agent by Intravenous Infusion in Patients with Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-Cell Acute Lymphoblastic Leukemia (B-ALL) or High-Risk Myelodysplasia (HR-MDS) (Trial in Progress) Poster Abstract #3329 Dec. 11, 6-8 p.m. CST The Novel Trifunctional Anti-BCMA NK Cell Engager SAR’514 Has Potent in-Vitro and in-Vivo Anti-Myeloma Effect Through Dual NK Cell Engagement Poster Abstract #4486 Dec. 12, 6-8 p.m. CST Pegathor Lymphoma, a Phase 2 Study of SAR444245 as a Monotherapy or in Combination with Pembrolizumab for the Treatment of Adults and Adolescents with Relapsed or Refractory B Cell Lymphoma (Trial in Progress) Online abstract only About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media Relations Sandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com Sally Bain | + 1 617 834 6026 | sally.bain@sanofi.com Kate Conway | + 1 508 364 4931 | kate.conway@sanofi.com Investor Relations Eva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com Arnaud Delépine | + 33 6 73 69 36 93 | arnaud.delepine@sanofi.com Corentine Driancourt | + 33 6 40 56 92 21 | corentine.driancourt@sanofi.com Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com Priya Nanduri | + 1 617 764 6418| priya.nanduri@sanofi.com Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment PDF