Université Pierre et Marie Curie

Dr. Steve Caffé is an accomplished industry executive with over 25 years of expertise in global product development and regulatory affairsWATERTOWN, Mass., Sept. 19, 2024 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today announced the appointment of Steve Caffé, MD as the company’s Chief Regulatory Officer. Dr. Caffé is an experienced biotech executive with significant expertise in global regulatory leadership across a wide range of therapeutic areas, including hematology, oncology, and rare diseases. “We are excited to welcome an executive as accomplished as Steve to Disc, where his depth of regulatory expertise and experience in global product development will be integral to the company’s growth,” said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc. “Steve’s track record of successful drug approvals across multiple disease areas and geographies will be a significant advantage for Disc as we move into the later stages of development across our portfolio.” “I am excited to be joining Disc at this pivotal moment in the company’s transition to a late-stage hematology company,” said Dr. Caffé. “With significant trial initiations coming in the next year for all three pipeline programs, I look forward to leading global regulatory interactions to support Disc’s mission of delivering novel treatments to patients with high unmet need. I am excited to work with the talented team at Disc and build on the excellent work done to date.” Dr. Caffé has more than 25 years of experience in global product development and regulatory affairs, having held senior leadership positions at several top biotechnology companies. Most recently, he served as Head of Regulatory Affairs at CRISPR Therapeutics where he was involved in the development and approval of Casgevy® (exagamglogene autotemcel) for sickle cell disease and beta thalassemia. Prior to joining CRISPR, Dr Caffé was the Senior Vice President leading Regulatory Affairs, Pharmacovigilance, Quality, and Patient Advocacy at Ra Pharmaceuticals. Before this, Dr. Caffé held senior-level regulatory positions at a number of other biopharmaceutical companies, including Sucampo Pharmaceuticals, AMAG Pharmaceuticals, MedImmune (Biologics Division of AstraZeneca), Baxter, Sanofi-Aventis and Merck. Across these experiences, Dr. Caffé has contributed to over 40 new drug approvals and major new indications worldwide in a wide range of therapeutic areas. Steve received his M.D. at the Université Pierre et Marie Curie in Paris, France. In connection with Dr. Caffé’s appointment, on September 16, 2024, Disc granted to Dr. Caffé an inducement equity award outside of Disc’s Amended and Restated 2021 Stock Option and Incentive Plan in accordance with Nasdaq Listing Rule 5635(c)(4), comprised of (i) an option to purchase 55,000 shares (the “Option Award”) of Disc’s common stock (“Common Stock”), at an exercise price equal to the closing price of the Common Stock on the date of grant, and (ii) a restricted stock unit award for 36,666 shares of Common Stock (the “RSU Award” and, together with the Option Award, the “Inducement Award”). The Option Award shall vest 25% on September 16, 2025, with the remainder vesting in 36 equal monthly installments thereafter. The RSU Award shall vest in equal installments on each of the first, second, third, and fourth anniversaries of the vesting date set by Disc’s company vesting policy. The Inducement Award was approved by the Compensation Committee of Disc’s Board of Directors. About Disc Medicine Disc Medicine (NASDAQ:IRON) is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, potentially first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. For more information, please visit www.discmedicine.com. Disc Cautionary Statement Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, express or implied statements regarding Disc’s expectations with respect to the chief regulatory officer position, upcoming trial initiations in the next year, and Disc’s clinical development plans and related regulatory interactions. The use of words such as, but not limited to, “believe,” “expect,” “estimate,” “project,” “intend,” “future,” “potential,” “look forward,” “continue,” “may,” “might,” “plan,” “will,” “should,” “seek,” “anticipate,” or “could” or the negative of these terms and other similar words or expressions that are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Disc’s current beliefs, expectations and assumptions regarding the future of Disc’s business, future plans and strategies, clinical results and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Disc may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and investors should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements as a result of a number of material risks and uncertainties including but not limited to: Disc’s expectations regarding the chief regulatory officer position; Disc’s expectations regarding leadership and future growth; Disc’s expectations regarding its research and development programs; Disc’s expectations of entering late-stage development; and the other risks and uncertainties described in Disc’s filings with the Securities and Exchange Commission, including in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2023, and in subsequent Quarterly Reports on Form 10-Q. Any forward-looking statement speaks only as of the date on which it was made. None of Disc, nor its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. Media Contact Peg RusconiDeerfield Grouppeg.rusconi@deerfieldgroup.com Investor Relations Contact Christina TartagliaPrecision AQchristina.tartaglia@precisionaq.com

NEW YORK, April 05, 2024 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win® platform, today announced that Faiçal Miyara, Ph.D., has been appointed as the company’s chief business officer. Dr. Miyara, who has more than 17 years of experience in the pharmaceutical industry, will be responsible for global business development activities including strategic partnerships. Dr. Miyara will be based in the United States, report to IO Biotech’s CEO, Mai-Britt Zocca, Ph.D., and be a member of the company’s executive team, effective immediately. “We are very excited to welcome Faiçal to IO Biotech,” said Dr. Zocca. “His deep experience in business development with proven ability to execute strategic transactions will be invaluable as we look at opportunities to advance our wholly owned proprietary T-Win platform. The coming months will be a critical period for the development of our company with the outcome of the pivotal Phase 3 interim analysis of our lead therapeutic cancer vaccine, IO102-IO103, expected in the third quarter of this year, as well as the readout of the primary endpoint of progression free survival estimated to follow in the second half of 2025.” Dr. Miyara added, “I am thrilled to join the IO Biotech team at this important time in the company’s development. I believe the novel dual-mechanism approach of the vaccines being developed is very promising and has the potential to significantly improve the current treatment paradigm for people living with cancer. I look forward to developing new partnerships to further progress the company’s growing portfolio.” Dr. Miyara is a seasoned executive with nearly two decades of experience in the pharmaceutical and biotechnology industry with a track record of successful deals and partnerships across several key therapeutic areas. Most recently, he served as Vice President, Head of Business Development Oncology, then Head of External Innovation Oncology, Lead on Venture Capital Activities at Ipsen Biosciences. Prior to this role, he was Senior Vice President, Head of Business Development and External Research at Kadmon Corporation. Earlier in his career, Dr. Miyara served in leadership roles at Pfizer and Eli Lilly and Company. Dr. Miyara holds a Ph.D. in reproductive, molecular, and cellular biology from the Université Pierre & Marie Curie Paris, and a Master of Engineering of Medical Biology degree from Université Joseph Fourier Grenoble. Inducement Equity Awards In connection with Dr. Miyara’s acceptance of employment with the company, Dr. Miyara will, as of the close of business on April 5, 2024, be granted a non-statutory option to purchase 310,000 shares of the company’s common stock. The option will vest over four years, with 25 percent of the shares vesting on the first anniversary of Dr. Miyara’s hire date and the remainder vesting in equal monthly installments over the following three years. The option will have an exercise price per share equal to the closing price of the company’s common stock on the grant date, have a ten-year term, be granted outside of outside of the company’s 2021 Equity and Incentive Plan, but be governed by the company’s 2023 Inducement Award Plan, and be subject to the terms and conditions of stock option agreement covering the grant. The stock option was granted as an inducement material to the employee entering into employment with the company in accordance with Nasdaq Listing Rule 5635(c)(4). About IO102-IO103 IO102-IO103 is an investigational off-the-shelf therapeutic cancer vaccine designed to kill both tumor cells and immune-suppressive cells in the tumor microenvironment (TME) by stimulating activation and expansion of T cells against indoleamine 2,3-dioxygenase (IDO) and/or programmed death-ligand 1 (PD-L1) cells. The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) investigating IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with advanced melanoma, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) investigating IO102-IO103 in combination with pembrolizumab as first line treatment in patients with solid tumors, and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) investigating IO102-IO103 in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors. The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck, and Merck is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About IO Biotech IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win® platform. The T-win platform is based on a novel approach to cancer vaccines designed to activate T cells to target the immunosuppressive cells in the tumor microenvironment. IO Biotech is advancing its lead cancer vaccine candidate, IO102-IO103, in clinical trials, and additional pipeline candidates through preclinical development. Based on positive Phase 1/2 first line metastatic melanoma data, IO102-IO103, in combination with pembrolizumab, has been granted a breakthrough therapy designation for the treatment of advanced melanoma by the US Food and Drug Administration. IO Biotech is headquartered in Copenhagen, Denmark and has US headquarters in New York, New York. For further information, please visit . Follow us on our social media channels on LinkedIn and X (@IOBiotech). 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 the timing of the interim and primary analyses of the company’s Phase 3 trial, current or future clinical trials, their progress, enrollment or results, or the company’s financial position or cash runway, 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. Contact: Maryann Cimino, Director of Investor Relations IO Biotech, Inc. 617-710-7305 mci@iobiotech.com

BOSTON, Aug. 08, 2023 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a leader in the discovery and development of novel small molecule therapeutics to benefit patients with diseases of the immune system, today announced that Christophe Arbet-Engels, MD, PhD, will be joining the company as its new Chief Medical Officer, bringing more than 25 years’ experience in strategic global drug development across a wide range of therapeutic areas including rare and orphan diseases. “We are thrilled to welcome Christophe to our leadership team at this exciting time at X4,” said Paula Ragan, Ph.D., President and Chief Executive Officer of X4 Pharmaceuticals. “Christophe brings extensive experience in drug development, spanning research, clinical development, launch, and commercialization across global markets, which should further enable our growth as we near the submission of our first U.S. New Drug Application for mavorixafor in WHIM syndrome, prepare for our first potential U.S. commercial launch in 2024, and continue clinical development of mavorixafor in certain chronic neutropenic disorders. We would also like to thank Dr. Murray Stewart, who has been serving as our Interim Chief Medical Officer, for his exceptional contributions and his leadership. We look forward to his continued strategic guidance as an ongoing member of our Board of Directors.” Dr. Arbet-Engels also commented on his appointment: “I am honored to have been appointed to the role of CMO at X4 and excited to help advance the company’s mission to bring innovative therapies to patients with rare diseases of the immune system. The company has made great progress and I look forward to adding to its continued forward momentum. I believe mavorixafor has great potential to improve the lives of a significant number of patients given its oral pro immune-modulating mechanism of action and I look forward to being an integral part of the team maximizing that opportunity for the benefit of patients in need across the world.” Dr. Arbet-Engels previously served as Chief Medical Officer at several life science companies, including Neurogastrx, Millendo Therapeutics, and Poxel Pharmaceuticals, where he provided research and development leadership, advancing multiple candidates from pre-clinical through to late-stage clinical trials. Prior to these roles, he held a variety of senior medical and clinical positions at Biogen, Boehringer-Ingelheim Pharmaceuticals, Hoffmann-La Roche, Merck Research Laboratories, Aventis Pharmaceuticals, and Ligand Pharmaceuticals, where he led clinical development and registration, launch and lifecycle management efforts for several new medicines, including blockbuster therapies such as LANTUS® and JARDIANCE®. Dr. Arbet-Engels has also served in educational roles at The Salk Institute for Biological Studies, University of Paris VI, and the Assistance Publique, Hospitals of Paris, and currently serves as a Member of the Board of Tutors in Biochemical Sciences at Harvard University. He received his MD and PhD in internal medicine/endocrinology-metabolism from the University of Paris, France, and completed his MBA at Rutgers University. About X4 Pharmaceuticals X4 Pharmaceuticals is a late-stage clinical biopharmaceutical company focused on the discovery and development of novel therapies for people with diseases of the immune system. Our lead clinical candidate is mavorixafor, a small molecule antagonist of chemokine receptor CXCR4 that is being developed as an oral, once-daily therapy. Due to its ability to increase the mobilization of mature, functional white blood cells from the bone marrow into the bloodstream, we believe that mavorixafor has the potential to provide therapeutic benefit across a variety of chronic neutropenic disorders, including WHIM (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis) syndrome, a rare, primary immunodeficiency. Following announcement of positive top-line and secondary endpoint data from our global, pivotal, 4WHIM Phase 3 clinical trial, we are currently preparing a U.S. regulatory submission seeking approval of oral, once-daily mavorixafor in the treatment of people aged 12 years and older with WHIM syndrome. We are also currently evaluating mavorixafor in a Phase 2 clinical trial in people with certain chronic neutropenic disorders following positive results from a Phase 1b clinical trial of mavorixafor in people with congenital, idiopathic, or cyclic neutropenia. We continue to leverage our insights into CXCR4 and immune system biology at our corporate headquarters in Boston, Massachusetts and at our research center of excellence in Vienna, Austria. For more information, please visit our website at . Forward-Looking Statements This press release contains forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by the words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target,” or other similar terms or expressions that concern X4's expectations, strategy, plans, or intentions. Forward-looking statements include, without limitation, statements regarding the clinical and regulatory progress of X4’s pipeline development programs, including the anticipated New Drug Application submission for mavorixafor for the treatment of WHIM syndrome and the timing thereof; the potential therapeutic benefits of mavorixafor; and X4’s expectations with respect to future commercialization activities and the timing thereof. Any forward-looking statements in this press release are based on management's current expectations and beliefs. Actual events or results may differ materially from those expressed or implied by any forward-looking statements contained herein, including, without limitation, on account of uncertainties inherent in the initiation and completion of clinical trials and clinical development; the risk that trials and studies may not have satisfactory outcomes; the risk that the outcomes of preclinical studies or earlier clinical trials will not be predictive of later clinical trial results; the risk that initial or interim results from a clinical trial may not be predictive of the final results of the trial or the results of future trials; the potential adverse effects arising from the testing or use of mavorixafor or other product candidates; the risk that the U.S. Food and Drug Administration (“FDA”) may not accept a regulatory submission for mavorixafor; the risk that the FDA may not approve mavorixafor for WHIM syndrome; the risks related to X4’s ability to raise additional capital; the impacts of general macroeconomic and geopolitical conditions, rising inflation, and uncertain credit and financial markets on X4’s business, clinical trials, and financial position; and other risks and uncertainties, including those described in the section entitled “Risk Factors” in X4’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 4, 2023, and in other filings X4 makes with the SEC from time to time. X4 undertakes no obligation to update the information contained in this press release to reflect new events or circumstances, except as required by law. Contacts: Daniel Ferry (investors) Managing Director, LifeSci Advisors daniel@lifesciadvisors.com (617) 430-7576 Brett Whelan (media) LifeSci Communications bwhelan@lifescicomms.com