1stOncology™: Cancer Intelligence Service – Page 8618 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

CEL-SCI Corporation Reports Third Quarter Fiscal 2021 Financial Results

On August 16, 2021 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended June 30, 2021, as well as key clinical and corporate developments (Press release, Cel-Sci, AUG 16, 2021, View Source [SID1234586650]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

Clinical and Corporate Developments include:

On June 28, 2021, CEL-SCI announced top line results from its 9.5 year global pivotal Phase 3 study for its immunotherapy Multikine (Leukocyte Interleukin, Injection)* in head and neck cancer. The Phase 3 results showed a long-term 5-year overall survival (OS) benefit in the treatment arm receiving Multikine treatment regimen followed by surgery and radiation. This survival benefit was statistically significant, robust and durable, with no safety issues, something not commonly seen with cancer drugs. In fact, the survival benefit increased over time and at 5-years the overall survival benefit reached an absolute 14.1% advantage for the Multikine treated arm over control (n=380, total study patients treated with surgery plus radiation): Multikine arm 62.7%, control arm 48.6% survival.
The OS benefit of 14.1% at 5 years for this treatment arm exceeded the >10% OS benefit set out for the study population as a whole in the protocol. The OS results for this treatment arm were significant (two-sided p=0.0236, HR=0.68) and the survival effect increased over time. The results from the Phase 3 cancer study proved that Multikine met all of the protocol required benefits stated in the study protocol in patients in the treatment arm receiving surgery and radiation as their standard therapies. Based on the results of this pivotal Phase 3 study, CEL-SCI intends to file a Biologic License Application with U.S. Food and Drug Administration (FDA) for approval of this indication. We are assembling the information required to request a pre-BLA (Biologics License Application) meeting with the FDA to discuss the adequacy of the study results to support a license application and receive FDA input on any other issues that would have to be addressed for an approval to be granted.
Worldwide there are approximately 890,000 newly diagnosed head and neck cancer patients of which CEL-SCI’s target population when filing for FDA approval is about 210,000 patients. That would mean that approximately 29,000 patients could be alive at 5-years if all 210,000 eligible patients received the Multikine treatment regimen followed by surgery and radiation compared to receiving surgery and radiation alone, the current treatment paradigm/SOC for these patients.
CEL-SCI is near completion of the expansion of its existing dedicated cGMP manufacturing facility for Multikine. The construction, which began in 2020, will double the current facility’s capacity to accommodate two shifts for increased production of Multikine.
CEL-SCI raised net proceeds of $53.6 million during the nine months ended June 30, 2021 through the sale of common stock and the exercise of warrants and options. As of June 30, 2021, CEL-SCI had $47.1 million in cash, cash equivalents and U.S. Treasury Bills.

"The results of this 10-year landmark study proved our novel concept of cancer treatment, 1) that the use of our investigational cancer immunotherapy Multikine before the usual first cancer treatments (as neoadjuvant treatment) should significantly increase survival and 2) that a cancer drug can have a very favorable safety profile. Our Phase 3 study results are the first sign of real progress in the treatment of advanced primary head and neck cancer in many decades. We estimate about 210,000 patients per year globally who could potentially benefit from this drug once approved. Our goal is to seek FDA approval based on the data from our recently concluded pivotal Phase 3 study," stated CEL-SCI CEO, Geert Kersten.

CEL-SCI reported an operating loss of $27.7 million for the nine months ended June 30, 2021, versus an operating loss of $20.5 million for the nine months ended June 30, 2020. CEL-SCI reported an operating loss of $10.5 million for the quarter ended June 30, 2021, versus an operating loss of $7.0 million for the quarter ended June 30, 2020.

HDT Bio Announces Agreement With Korea’s Quratis to Co-Develop Innovative COVID-19 Vaccine in Asia

On August 16, 2021 HDT Bio Corp., a developer of immunotherapies for oncology and infectious diseases, reported an agreement with Korean biotech Quratis Inc. to co-develop HDT’s revolutionary COVID-19 vaccine (a next generation mRNA vaccine) for distribution in South Korea and neighboring countries (Press release, HDT Bio, AUG 16, 2021, View Source [SID1234586649]). HDT previously established a collaboration with Gennova Biopharmaceuticals in India, and it plans to announce similar deals in China and Brazil soon.

"This agreement will enable Quratis to manufacture our next-generation COVID-19 vaccine and distribute it across much of East Asia," said HDT Bio CEO Steve Reed. "Today, we have advanced both HDT’s business prospects and its global health reach."

HDT Bio’s COVID-19 vaccine uses a proprietary Lipid InOrganic Nanoparticle (LIONTM) formulation to deliver immune-stimulating RNA fragments to targeted cells. The vaccine, currently in clinical trials to establish safety and efficacy, is significantly different from current mRNA vaccines in two ways. First, its RNA payload is designed to amplify itself inside the body. As a result, the vaccine effectively activates the immune system at a much lower dose than current vaccines, enhancing safety and reducing manufacturing costs. Second, the HDT LION formulation system simplifies manufacture and enhances stability.

"Partnering with HDT Bio gives us a unique opportunity to fight COVID-19 with the world’s most advanced mRNA vaccine technology not only in Korea, but also in other nations in our region to help bring an end to this deadly pandemic," said Kwan Goo Cho, President of Quratis.

Quratis got an IND approval from Ministry of Food and Drug Safety for Phase I clinical trial of a COVID-19 vaccine in mid-July and is expected to begin evaluating QTP104 in a Phase 1 clinical trial shortly.

Castle Biosciences Presents New Data on DecisionDx®-Melanoma and DecisionDx®-SCC at the 2021 American Academy of Dermatology (AAD) Summer Meeting

On August 16, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a dermatologic diagnostics company providing personalized genomic information to inform treatment decisions, reported recent presentations on two of its skin cancer gene expression profile tests at the 2021 American Academy of Dermatology (AAD) Summer Meeting, held Aug. 5-8, 2021 (Press release, Castle Biosciences, AUG 16, 2021, View Source [SID1234586648]).

DecisionDx-Melanoma:

DecisionDx-Melanoma is Castle’s gene expression profile test that uses an individual patient’s tumor biology to predict the risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node (SLN) positivity, independent of traditional staging factors.

"Integrating 31-gene expression profiling with clinicopathologic features improves prognostication of recurrence and metastasis in patients with stage I-III cutaneous melanoma" was presented by Nicholas Taylor, M.D., Ph.D., Zitelli and Brodland, P.C., Pittsburgh and Central Dermatology Center, Chapel Hill, N.C. in the Frontiers in Research, Science and Technology (FiRST) session on Saturday, Aug. 7.

"The study demonstrated that DecisionDx-Melanoma added significant prognostic value for a patient beyond traditional staging," said Taylor. "The study further showed that the ability to integrate a patient’s unique tumor biology with their personal clinical and pathologic risk factors helped both patients and clinicians."

Study methods and findings:

DecisionDx-Melanoma’s 31-gene expression profile (31-GEP) has been validated to both identify patients at low risk of sentinel lymph node positivity and refine risk of recurrence prognosis.
A new integrated algorithm (i31-GEP ROR (risk of recurrence) for outcomes prediction) was developed (n=1581) and validated (n=523) using Cox regression and 10×4-fold cross-validation on patients with stage I-III cutaneous melanoma from multiple centers.
The final integrated outcomes prediction algorithm combined DecisionDx-Melanoma’s continuous 31-GEP score and patient-specific clinicopathologic risk factors, including Breslow thickness, ulceration, mitotic rate, age, tumor location, sentinel lymph node (SLN) status and/or the presence of microsatellites.
Compared to American Joint Committee on Cancer Eighth Edition (AJCC8) staging, the i31-GEP ROR algorithm for outcomes prediction significantly improved the classification of overall risk for five-year recurrence-free survival (RFS), distant metastasis-free survival (DMFS) and melanoma-specific survival (MSS).
Integrating DecisionDx-Melanoma’s continuous 31-GEP score with clinicopathologic features improves risk stratification over staging guidelines alone.
Overall, the study demonstrated that DecisionDx-Melanoma’s i31-GEP ROR integrated test result was an independent, significant predictor of five-year RFS, DMFS and MSS, and that the i31-GEP ROR outcomes prediction algorithm provided an individualized risk estimate rather than an average, population-based risk estimate that can help personalize patient management decisions and overall risk assessments beyond standard melanoma staging.
DecisionDx-SCC:

DecisionDx-SCC is Castle’s prognostic 40-gene expression profile (GEP) test for patients diagnosed with high-risk cutaneous squamous cell carcinoma (SCC), designed to use a patient’s tumor biology to predict individual risk of metastasis for patients with SCC and one or more risk factors.

"Risk assessment by the 40-gene expression profile (40-GEP) test further stratifies risk of metastasis in a subset of high-risk cutaneous squamous cell carcinoma (cSCC) patients meeting T1 staging criteria" was presented by Aaron Farberg, M.D., Baylor University Medical Center, Dallas in the Frontiers in Research, Science and Technology (FiRST) session on Saturday, Aug. 7.

"As a physician, it is important that I leverage all of the information available to me to make the best decisions for the care of each patient," said Farberg. "This study demonstrated that by incorporating DecisionDx-SCC into their clinical practice, physicians can more confidently identify patients with a higher risk of metastasis, who may have otherwise been considered low-risk using traditional staging systems alone, which provides the ability to adjust their treatment plans for improved patient outcomes."

Study methods and findings:

Previous validation of the DecisionDx-SCC test in a high-risk SCC cohort (n=420, all high-risk or very- high risk by the National Comprehensive Cancer Network (NCCN) guidelines v1.2021 or meeting Appropriate Use Criteria for Mohs Micrographic Surgery) demonstrated independent prognostic value when the result was incorporated into existing risk assessment methods.
Using this validation cohort, the objective of this study was to determine whether DecisionDx-SCC could identify biologically risky tumors within a subset of NCCN high-risk tumors comprehensively staged as T1 by either American Joint Committee on Cancer Eighth Edition (AJCC8) or Brigham and Women’s Hospital (BWH) staging (AJCC8 cohort n=222; BWH cohort n=200).
Kaplan-Meier analysis demonstrated a statistically significant difference in three-year metastasis-free survival rates between DecisionDx-SCC risk groups:
AJCC8 T1 cases – Class 1: 95.2%, Class 2A: 81.4%, Class 2B: 50%; p<0.001
BWH T1 cases – Class 1: 96.6%, Class 2A: 84.9%, Class 2B: 55.6%; p<0.001
Within these T1 subsets, DecisionDx-SCC accurately identified metastatic cases in approximately 80% of the cases:
AJCC8 T1 cases: 78.6% of metastatic cases received a Class 2A (moderate biological risk of metastasis) or 2B (high biological risk of metastasis) DecisionDx-SCC result
BWH T1 cases: 78.9% of metastatic cases received a Class 2A or 2B DecisionDx-SCC result
Overall, the study demonstrated that DecisionDx-SCC accurately identified tumors at risk of metastasis and can be incorporated into clinical assessments with traditional clinicopathological risk factors to help inform patient surveillance and treatment decisions.
About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. To predict likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithm, i31-GEP, to produce an integrated test result. i31-GEP is an artificial intelligence-based neural network algorithm (independently validated in a cohort of 1,674 prospective, consecutively tested patients with T1-T4 cutaneous melanoma) that integrates the DecisionDx-Melanoma test result with the patient’s traditional clinicopathologic features. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Through June 30, 2021, DecisionDx-Melanoma has been ordered 78,277 times for use in patients with cutaneous melanoma.

More information about the test and disease can be found at www.CastleTestInfo.com.

About DecisionDx-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1 (low), 2A (moderate) or 2B (high) risk category, predicts individual metastatic risk to inform risk-appropriate management.

Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that integrating DecisionDx-SCC with current prognostic methods can add positive predictive value to clinician decisions regarding staging and management.

More information about the test and disease can be found at www.CastleTestInfo.com.

Turning Point Therapeutics Initiates TRIDENT-2 Clinical Study Investigating Repotrectinib-Trametinib Combination in KRAS G12D Mutated Advanced Solid Tumors

On August 16, 2021 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported initiation of the first cohort of its Phase 1b/2 TRIDENT-2 combination study of lead investigational drug repotrectinib (Press release, Turning Point Therapeutics, AUG 16, 2021, View Source [SID1234586647]). The initial cohort will investigate repotrectinib in combination with MEK-inhibitor trametinib in KRAS G12D mutated advanced solid tumors.

"We are pleased to initiate the TRIDENT-2 study and explore a potential new treatment option for patients with KRAS-driven solid tumors," said Mohammad Hirmand, executive vice president and chief medical officer. "With preclinical studies demonstrating repotrectinib’s ability to inhibit JAK2, SRC and FAK, our goal is to help improve the effectiveness of KRAS-targeting agents by suppressing known pathways of tumor resistance."

The Phase 1b portion of the study will examine the safety, tolerability, pharmacokinetics, and any early signals of efficacy of repotrectinib in combination with trametinib in patients with KRAS G12D mutated advanced solid tumors. After determination of a recommended Phase 2 combination dose, the study includes a Phase 2 dose expansion portion with the primary endpoint of objective response rate.

Results from preclinical studies presented at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting found that repotrectinib in combination with trametinib was more effective than single-agent trametinib in patient-derived KRAS mutant G12D lung cancer models. The repotrectinib-trametinib combination suppressed a broad range of downstream mutant KRAS G12D signaling, increased cell cycle arrest and induction of apoptosis, and was more active in multiple KRAS G12D dependent models compared to either single-agent treatment.

The frequently mutated Kirsten Rat Sarcoma (KRAS) viral oncogene is associated with a broad range of human cancers, including approximately 30% of non-small cell lung, 40% of colorectal and more than 90% of pancreatic cancers. KRAS G12D mutations are known to occur across multiple tumors types, including an estimated 30% of pancreatic, 15% of colorectal and 5% of both endometrial and non-small cell lung cancers.

Therapeutic targeting of KRAS has proven challenging, in part due to resistance and adaptive upregulation of alternative signaling pathways that promote tumor cell survival, as well as concurrent secretion of various cytokines and growth factors.

SCYNEXIS Reports Second Quarter 2021 Financial Results and Provides Corporate Update

On August 16, 2021 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, reported financial results for the second quarter ended on June 30, 2021 and provided an update on recent clinical and corporate developments (Press release, Scynexis, AUG 16, 2021, View Source [SID1234586646]).

"We are not slowing down after our June 1, 2021 approval of BREXAFEMME, the first FDA-approved indication from our ibrexafungerp franchise," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "Our commercial team has been deployed to the field to call on their healthcare provider (HCP) customers to communicate the differentiating features and benefits of BREXAFEMME. We also continue to engage in an active dialogue with payers to establish coverage. While it is still too early to assess external demand for BREXAFEMME, I am extremely proud of our team for their strong execution which we believe will translate to more tangible results to drive shareholder value in the next quarter. In addition, our clinical development team remains focused on advancing ibrexafungerp for life-threatening invasive fungal infections in the hospital setting, including work on the new intravenous (IV) formulation currently in Phase 1."

BREXAFEMME Commercial Update

BREXAFEMME (ibrexafungerp tablets) is now FDA-approved. On June 1, 2021 the New Drug Application (NDA) for BREXAFEMME was approved by the FDA, becoming the first drug from a novel antifungal class (triterpenoid) in more than 20 years. BREXAFEMME was also granted a five-year exclusivity extension under the GAIN Act for a total of 10 years of regulatory exclusivity and is also protected by a composition-of-matter patent until 2035.

BREXAFEMME launch update. On June 29, 2021 SCYNEXIS hosted a virtual investor event to outline plans for the commercial launch of BREXAFEMME which began in August. BREXAFEMME is now available at pharmacies and the entire SCYNEXIS sales team is in the field actively engaging HCPs. An Early Experience Program was successfully implemented with key HCPs in July, confirming the need for a new treatment option and their willingness to prescribe BREXAFEMME. The Pharmacy and Therapeutic (P&T) review process with payers continues to rapidly progress with numerous P&T meetings already scheduled.
Ibrexafungerp Clinical Update

Enrollment is complete in the Phase 3 CANDLE study, investigating the efficacy and safety of oral ibrexafungerp for the prevention of recurrent vulvovaginal candidiasis (VVC), for which there is no approved therapy in the U.S. SCYNEXIS expects last-patient/last-visit by the end of 2021 with top-line results and a supplemental NDA submission anticipated in the first half of 2022 with a potential approval in late 2022.

Dosing is ongoing in Phase 1 testing of the liposomal IV formulation of ibrexafungerp. Based on promising pre-clinical data of the company’s liposomal IV formulation of ibrexafungerp, SCYNEXIS is conducting a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of the IV liposomal formulation of ibrexafungerp in healthy subjects. The study is being conducted in South Africa and dosing began in March 2021.

Ibrexafungerp Phase 3 data were presented at a key medical conference, reporting efficacy in non-albicans Candida (NAC) and patients with severe vulvovaginal candidiasis infections. On April 30, 2021 SCYNEXIS presented posters on two data sets from SCYNEXIS’ Phase 3 VANISH program demonstrating the therapeutic potential of ibrexafungerp at the 2021 American College of Obstetricians and Gynecologists (ACOG) Annual Meeting that took place virtually from April 30 – May 2, 2021. The data highlighted ibrexafungerp’s strong activity in treating patients with NAC, which was comparable to that of the total patient population enrolled in the trial. Additionally, ibrexafungerp showed activity in patients with severe VVC, and may provide a treatment alternative where currently available therapies may not be satisfactory.

Key findings from interim data analyses of SCYNEXIS’s ongoing refractory invasive fungal infections (rIFI) program, which is comprised of two open-label Phase 3 studies (FURI and CARES), were presented at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID). On July 12, 2021 presentations examining positive data from the third interim analysis of the FURI study and first interim analysis of the CARES study, showed oral ibrexafungerp’s ability to treat severe fungal infections in the hospital setting. An analysis by an independent data review committee of 33 patients from the Phase 3 FURI study evaluating ibrexafungerp for the treatment of patients with refractory fungal disease found that 23 patients (70%) achieved clinical improvement, defined as complete or partial response. Seven patients (21%) maintained stable disease and 0 patients (0%) progressed. Three patients (9%) were considered as indeterminate. The first interim analysis of the CARES study showed strong clinical activity of oral ibrexafungerp in patients with invasive candidiasis and candidemia due to Candida auris, a high-mortality infection classified by Centers for Disease Control and Prevention as an urgent threat to public health, with eight out of 10 patients (80%) experiencing a complete response. The results support continued enrollment in both open-label Phase 3 studies, with potential future submissions under the LPAD regulatory pathway.
Corporate Developments

In May 2021, SCYNEXIS entered into an agreement with a third party to sell a portion of its unused New Jersey Net Operating Loss (NOL) and research and development credits for approximately $4.1 million.
In May 2021, SCYNEXIS entered into a Loan Agreement with Hercules Capital, Inc. and Silicon Valley Bank for an aggregate principal amount of $60 million. Under the terms of the Loan Agreement, SCYNEXIS received an initial tranche of $20 million from the lenders on the closing date and received an additional $10 million upon FDA approval of ibrexafungerp for the treatment of vaginal yeast infections. Subsequent cash injections will be available upon achieving certain milestones.
In May 2021, SCYNEXIS announced the appointment of Christine Coyne as Chief Commercial Officer. She brings to the team deep anti-infective commercial expertise across hospital and community settings.
Second Quarter 2021 Financial Results

Cash and cash equivalents totaled $112.4 million on June 30, 2021, compared to $93.0 million in cash, and cash equivalents on December 31, 2020. Based upon its existing operating plan, the company believes that its existing cash and cash equivalents, the sale of a portion of its New Jersey NOLs, and the anticipated sales of BREXAFEMME will enable SCYNEXIS to fund its operating requirements into 2023.

Research and Development expense for the three months ended June 30, 2021 decreased to $4.7 million from $8.5 million for the three months ended June 30, 2020. The decrease of $3.8 million, or 44%, for the three months ended June 30, 2021, was primarily driven by a decrease of $1.5 million in chemistry, manufacturing, and controls (CMC) expense, a decrease of $1.4 million in clinical development expense, a decrease of $0.3 million in preclinical expense, a decrease of $0.2 million in regulatory expense, and a net decrease in other research and development expense of $0.4 million.

Selling, General & Administrative expense for the three months ended June 30, 2021 increased to $12.8 million from $3.4 million for the three months ended June 30, 2020. The increase of $9.4 million, or 281%, for the three months ended June 30, 2021 was primarily driven by a $5.8 million increase in commercial related expense associated with the ongoing commercialization of BREXAFEMME, an increase of $1.1 million in salary related costs, an increase of $1.0 million in medical affairs expense, an increase of $0.8 million in expense associated with increased information technology costs, and a net increase of $0.7 million in other selling, general and administrative expense.

Total other income was $15.0 million for the three months ended June 30, 2021, compared to total other income of $2.3 million for the three months ended June 30, 2020. During the three months ended June 30, 2021 and 2020, SCYNEXIS recognized non-cash gain of $15.3 million and $3.6 million, respectively, on the fair value adjustment of the warrant liabilities and during the three months ended June 30, 2021 and 2020, recognized non-cash gains of $0.5 million and $0.7 million on the fair value adjustment of the derivative liabilities, respectively.

Net income for the three months ended June 30, 2021 was $1.7 million, or $0.06 per basic and ($0.22) per diluted share, compared to a net loss of $6.4 million, or ($0.64) per basic and diluted share for the three months ended June 30, 2020.

About Ibrexafungerp
Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an antifungal agent and the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. Ibrexafungerp is in late-stage development for multiple indications, including life-threatening fungal infections caused primarily by Candida (including C. auris) and Aspergillus species in hospitalized patients. It has demonstrated broad-spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains.

The New Drug Application (NDA) for BREXAFEMME (ibrexafungerp tablets) was approved by the U.S. Food and Drug Administration (FDA) on June 1, 2021. FDA also granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the IV and oral formulations of ibrexafungerp for the indications of invasive candidiasis (IC) (including candidemia) and invasive aspergillosis (IA), and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp is formerly known as SCY-078.