Caspofungin Acetate

In vivo data demonstrated efficacy of SCY-247 in mouse model of invasive candidiasis caused by Candida glabrataSCY-247 showed in vitro activity against a broad range of pathogenic fungi, including azole-resistant strains of Candida and Aspergillus species JERSEY CITY, N.J., April 30, 2024 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced the presentation of preclinical efficacy data on its second generation fungerp candidate SCY-247 at the ESCMID Global 2024 congress (formerly known as ECCMID) in Barcelona, Spain from April 27-30, 2024. "We continue to be excited about the potential of our second generation fungerp SCY-247 to address the critical need for new antifungal treatments, particularly for invasive fungal infections where current options are limited and resistance is increasing," said David Angulo, M.D., President and Chief Executive Officer of SCYNEXIS. "The positive data presented at ESCMID Global further strengthen our confidence in SCY-247's ability to combat these difficult-to-treat infections, and we look forward to its continued advancement as we aim to enter clinical stage by year end." Nathan Wiederhold, Pharm.D., Professor, Director – Fungus Testing Laboratory, University of Texas Health Science Center, San Antonio, delivered an oral presentation entitled, “The novel second-generation IV/oral triterpenoid SCY-247 is efficacious in an experimental murine model of invasive candidiasis caused by Candida glabrata.” C. glabrata, a high priority fungal pathogen on the World Health Organization fungal priority pathogens list (WHO FPPL), is a major cause of invasive candidiasis with an increasing rate of resistance against current antifungals. In a mouse model of invasive candidiasis caused by C. glabrata, SCY-247 showed promising in vivo efficacy. Following inoculation with C. glabrata, mice were treated with either vehicle control, oral SCY-247 (16, 32, & 48 mg/kg), oral fluconazole 20 mg/kg, or parenteral caspofungin 1 mg/kg for 7 days. In mice treated with SCY-247, dose-dependent reductions of fungal burden in both kidneys and lungs were observed. Fungal burden within the kidneys was significantly lower in each SCY-247 group versus vehicle (p0.01 for all comparisons). Lung fungal burden in the SCY-247 32 mg/kg and 48 mg/kg groups was also significantly lower versus placebo (p0.01 for both comparisons). In contrast, caspofungin significantly lowered fungal burden within the kidneys (p=0.01) but not the lungs, while fungal burden in mice treated with fluconazole was similar to controls in both organs. The findings in this model illustrate the meaningful efficacy of SCY-247 against C. glabrata, its ability to reach efficacious concentrations after oral administration and suggests an improved lung penetration of SCY-247 relative to echinocandins. Dr. Wiederhold also presented a poster entitled, “SCY-247, a novel second-generation IV/oral triterpenoid antifungal, demonstrates in vitro activity against fungal pathogens, including azole-resistant strains of Candida and Aspergillus.” In this study, SCY-247 was tested against 155 clinical isolates of yeasts, molds and dimorphic fungi. SCY-247 demonstrated in vitro activity against a broad range of pathogenic fungi, with the most potent activity observed against Candida species including C. albicans, C. auris, and C. glabrata as well as fluconazole-resistant strains. Potent activity was also observed against Aspergillus species, including voriconazole-resistant isolates, and against the dimorphic fungi Blastomyces dermatitidis, Histoplasma capsulatum, and Coccidioides species. Both studies presented by Dr. Wiederhold have been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contract nos. HHSN272201700039 and 75N93019D00022. A second poster entitled, “Effect of SCY-247, a second-generation triterpenoid antifungal, on growth kinetics and ultrastructure of Candida auris,” was presented by Mahmoud Ghannoum, Ph.D., Professor, Case Western Reserve and Director, Center for Medical Mycology, University Hospitals Cleveland Medical Center. In this study, the antifungal effect of SCY-247 on cell morphology of both susceptible and multi-drug resistant C. auris was evaluated using Scanning Electron Microscopy (SEM) imaging. Results demonstrated that SCY-247 significantly inhibited the growth of both C. auris strains. Importantly, SCY-247 had a prominent effect on fungal cell morphology and significantly reduced fungal growth. About Invasive Fungal Infections Candida auris, a critical priority fungal pathogen in WHO fungal priority pathogens list (WHO FPPL), is an emerging fungal pathogen associated with nosocomial infections and considered a serious global health threat. It is often resistant to commonly used antifungal drugs, with about 90% of U.S. C. auris samples resistant to fluconazole and some C. auris strains resistant to all three main classes of antifungals (azoles, echinocandins and polyenes). Candida glabrata is the most common non-albicans species causing systemic fungal infections. It also has high levels of resistance to fluconazole, and echinocandin resistance appears to be increasing. Patients with Candida infections that are resistant to both fluconazole and echinocandin drugs have very few treatment options. Azole-resistant Aspergillus infections are also difficult to treat, and affected patients are up to 33% more likely to die than patients with infections that can be treated with azoles. About SCY-247 SCY-247 is a second-generation antifungal compound, from a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids (fungerps), being developed to address systemic fungal diseases. The triterpenoid class of antifungals represents the first new class of antifungal compounds since 2001. These agents combine the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. SCY-247 is in pre-IND development stage and has demonstrated in vitro and in vivo broad-spectrum antifungal activity, including in MDR isolates (or spp.). SCYNEXIS anticipates that the U.S. Food and Drug Administration (FDA) may grant SCY-247 Qualified Infectious Disease Product (QIDP) and Fast Track designations for the IV and oral formulations of SCY-247. About SCYNEXIS SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS is developing the company’s proprietary antifungal platform “fungerps”. Ibrexafungerp, the first representative of this novel class, has been licensed to GSK. The U.S. Food and Drug Administration (FDA) approved BREXAFEMME® (ibrexafungerp tablets) in June 2021, for its first indication in vulvovaginal candidiasis (VVC), followed by a second indication in November 2022, for reduction in the incidence of recurrent VVC. Late-stage clinical investigation of ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. Additional antifungal assets from this novel class are currently in pre-clinical and discovery phase, including the compound SCY-247. For more information, visit www.scynexis.com. Forward-Looking Statements Statements contained in this press release regarding expected future events or results are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding: SCYNEXIS’s plans to begin a clinical study in SCY-247 by year end, confidence in SCY-247's ability to combat difficult-to-treat fungal infections, and SCY-247’s potential to be differentiated from currently available antifungals. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks inherent in regulatory and other costs in developing products. These and other risks are described more fully in SCYNEXIS' filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K filed on March 28, 2024, including under the caption "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. CONTACT: Investor RelationsIrina KofflerLifeSci AdvisorsTel: (646) 970-4681ikoffler@lifesciadvisors.com

Approval triggered by positive results from ReSTORE Phase III clinical trial Payment will advance Cidara’s Cloudbreak platform for the development of drug-Fc conjugates (DFCs) SAN DIEGO, Feb. 12, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced receipt of an $11.14 million milestone payment from Mundipharma following the European approval of REZZAYO™ (rezafungin acetate), a novel, once-weekly echinocandin antifungal approved for the treatment of invasive candidiasis in adults. This approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) and is based on results from the pivotal ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority for rezafungin, dosed once weekly, when compared to the standard of care, caspofungin, dosed once daily. The drug was previously approved by the United States Food and Drug Administration (FDA) for the treatment of candidemia and invasive candidiasis in patients with limited or no treatment options. “The European approval of REZZAYO marks a significant milestone for patients who are in need of new treatment options for invasive candidiasis, and we look forward to seeing Mundipharma bring it to the EU market,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “With the payment we’ve received from this milestone, we remain committed to advancing our Cloudbreak platform to develop targeted immunotherapies for cancer patients.” Cidara is currently advancing its Cloudbreak drug-Fc conjugate (DFC) platform to design targeted immunotherapies that inhibit specific diseases while simultaneously engaging the immune system. Its lead oncology DFC, CBO421, is a potential best-in-class inhibitor of CD73, a validated target highly expressed on tumor cells. An IND is anticipated this year. About Cidara Therapeutics Cidara is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs). These targeted immunotherapies offer the unique opportunity to create “single molecule cocktails” comprised of targeted small molecules and peptides coupled to a human antibody fragment (Fc). DFCs are designed to save lives and improve the standard of care for patients facing cancers and other serious diseases by inhibiting specific disease targets while simultaneously engaging the immune system. In addition, Cidara received FDA approval for REZZAYO® (rezafungin for injection), which it has licensed to multiple partners to commercialize in the U.S. and ex-U.S. Cidara is headquartered in San Diego, California. For more information, please visit About REZZAYO® (rezafungin for injection) REZZAYO (rezafungin for injection) is a novel once-weekly echinocandin approved in the United States for the treatment of candidemia and invasive candidiasis in adults. REZZAYO is currently being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic blood and marrow transplantation. The structure and properties of REZZAYO are specifically designed to improve upon a clinically validated mechanism. INDICATIONS AND USE REZZAYO is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data. REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida. IMPORTANT SAFETY INFORMATION REZZAYO is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins. REZZAYO may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion. REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation. Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO therapy. Most common adverse reactions (incidence 5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia. Please see the full Prescribing Information for REZZAYO (rezafungin for injection), available at . Forward-Looking Statements This 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, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to whether an unmet medical need exists for rezafungin, and the likelihood that rezafungin will be prescribed by physicians in the EU or approved for reimbursement by member state authorities. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements. These and other risks are identified under the caption “Risk Factors” in Cidara’s most recent Quarterly Report on Form 10-Q and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise. INVESTOR CONTACT: Brian Ritchie LifeSci Advisors 212-915-2578 britchie@lifesciadvisors.com MEDIA CONTACT: Veronica Eames LifeSci Communications 646-970-4682 veames@lifescicomms.com