On May 11, 2023 Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immuno-oncology company developing novel T cell engagers, reported its financial results for the first quarter ended March 31, 2023 and provided a corporate update (Press release, Harpoon Therapeutics, MAY 11, 2023, View Source [SID1234631596]).

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"Harpoon is executing its business plan in 2023 with a strengthened balance sheet, advancing multiple programs based on the TriTAC platform, and ProTriTAC IND candidates ready for further development," said Julie Eastland, President and Chief Executive Officer of Harpoon Therapeutics. "Following the $25 million preferred equity financing in March 2023, we have the financial strength to fund current operations into the second half of 2024. Additionally, we expect to see a positive impact on our cash burn over the course of the year from the restructuring implemented in the fourth quarter of last year. We also anticipate completion of enrollment for two of our Phase 1 clinical programs, HPN217 and HPN328, and achievement of key data milestones this year. Our clinical and leadership teams remain focused on advancing a rich pipeline of next-generation T cell engagers to address a broad patient population with unmet needs in both solid tumor and blood cancer indications."

Corporate Update / Recent and Upcoming Highlights

Tri-specific T cell Activating Construct (TriTAC) Platform

HPN217 (BCMA) Phase 1 trial for relapsed, refractory multiple myeloma

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Interim results reported at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (cut-off of October 17, 2022) demonstrated continued evidence of clinical activity with 77% (10/13) ORR observed in the two highest target dose levels (12 and 24 mg).

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Overall low incidence of cytokine release syndrome (CRS) across the patient population studied to date.

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Completion of Phase 1 dose exploration is expected in the first half of 2023, with identification of a recommended Phase 2 dose(s) expected by the end of 2023.

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Data presentation anticipated in the second half of 2023.

HPN328 (DLL3) Phase 1/2 trial in small cell lung cancer (SCLC) and neuroendocrine cancers

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Observations in the monotherapy cohorts, as of February 2023, included early signs of anti-tumor activity, with two confirmed partial responses per RECIST in patients with SCLC.

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Phase 1/2 dose and schedule optimization trial ongoing with monotherapy cohorts enrolling at the 24 mg target dose.
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Enrollment in combination therapy of HPN328 with atezolizumab (Tecentriq) in patients with SCLC, as part of the Phase 1/2 dose escalation trial, is anticipated to begin in the second half of 2023.

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Phase 1 dose exploration is expected to complete in the second half of 2023, including the identification of a recommended Phase 2 dose(s) in the monotherapy setting by the end of 2023.

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Data presentation anticipated in the second half of 2023.

ProTriTAC

HPN601 (EpCAM)

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HPN601 is Harpoon’s first conditionally active T cell engager based on the ProTriTAC platform. EpCAM is expressed in a broad range of solid tumors, potentially enabling HPN601 to address multiple indications with high unmet medical need.

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IND filing timeline to enable a Phase 1 dose exploration study dependent on resource allocation.

Two additional candidates

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Two new candidates for potential IND-enabling studies from the ProTriTAC platform have been identified against the targets trophoblast cell surface antigen 2 (TROP2) and Integrin-ß6 (ITGB6).

TriTAC-XR

The proprietary TriTAC-XR extended-release T cell engager platform is designed to minimize on-target CRS, a characteristic of many T cell engagers that can lead to dose limiting toxicities and can reduce the efficacy of these potent anti-tumor drugs.

AACR 2023 – Five Preclinical Posters Presented

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HPN217: Poster presented on April 18, 2023:

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"Anti-tumor activity of HPN217, a BCMA-targeting tri-specific T cell engager, is enhanced by y-secretase inhibitors in preclinical models"

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In preclinical mouse models, y-secretase inhibitors increased the potency of HPN217 in vitro in multiple cell lines.

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Combination therapy with 1mg/kg LY-3039478 and a subtherapeutic dose of 4ug/kg HPN217 led to decreased tumor burden and increased survival in a disseminated MOLP8 xenograft compared to either monotherapy alone.

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HPN328: Two posters presented on April 18, 2023:
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"Long-term anti-tumor immunity induced by HPN328, a DLL3-targeting tri-specific, half-life extended T cell engager, in a preclinical immunocompetent mouse model"

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These results suggest that HPN328 can induce epitope spreading and prolonged anti-tumor immunity, with an increase in memory T cells, suggesting a novel mechanism for its activity and efficacy in vivo.

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These findings suggest that long-term anti-tumor immunity induced by HPN328 can potentially lead to more durable anti-tumor responses in cancer patients

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"Anti-tumor activity of HPN328, a DLL3-targeting tri-specific, half-life extended T cell engager, is enhanced by combining with an anti-PD-L1 antibody in an immunocompetent mouse model"

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These results demonstrate the utility of combining anti-PD-L1 antibodies to enhance the anti-tumor activity of HPN328 and further supports investigation of this combination approach in patients.

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Clinical studies of HPN328 in combination with atezolizumab are planned.

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ProTriTAC: Two posters presented on April 17, 2023 introducing new candidates for IND-enabling studies:

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"TROP2 ProTriTAC, a protease-activated T cell engager prodrug targeting TROP2 for the treatment of solid tumors"
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"ITGB6 ProTriTAC, a protease-activated T cell engager prodrug targeting Integrin-ß6 for the treatment of solid tumors"
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Both data sets support further investigation of Harpoon’s conditionally active next-generation T cell engager platform, ProTriTAC, with demonstrated therapeutic potential in a broad range of TROP2- and ITGB6-expressing solid tumors.

Corporate Update

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$25 million preferred equity financing closed in March 2023, extending cash runway into the second half of 2024.

First Quarter 2023 Financial Results
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Harpoon ended the first quarter of 2023 with $61.4 million in cash and cash equivalents compared to $53.1 million as of December 31, 2022. Following the $25.0 million preferred equity financing and year to date ATM sales, cash and cash equivalents are expected to fund current operations into the second half of 2024.

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Revenue for the quarter ended March 31, 2023 was $8.6 million, compared to $5.9 million for the first quarter ended March 31, 2022. The increase in revenue was primarily due to revenue recognized in first quarter 2023 for research and development services performed on the fourth target under Harpoon’s Restated Collaboration Agreement with AbbVie, and an increase in revenue recognized related to Harpoon’s Development and Option Agreement with AbbVie for research and development services performed.

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Research and development (R&D) expense for the quarter ended March 31, 2023 was $15.2 million, reduced from $20.8 million during the first quarter ended March 31, 2022. The decrease primarily arose from lower personnel-related costs due to corporate restructuring implemented in November 2022 and lower clinical and development costs due to the wind down of the HPN424 and HPN536 programs.

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General and administrative (G&A) expense for the quarter ended March 31, 2023 decreased to $4.2 million, compared to $5.4 million for the first quarter ended March 31, 2022. The decrease was primarily attributable to lower personnel-related expenses, lower legal costs, and lower professional service fees to support Harpoon’s operations.

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Net loss for the first quarter ended March 31, 2023 was $11.3 million, improved from $20.3 million for the first quarter ended March 31, 2022.

On May 12, 2023 Evotec SE (Frankfurt Stock Exchange: Prime Standard, ISIN: DE0005664809; NASDAQ: EVO) reported its Annual Report for the fiscal year 2022, as well as the qualitative Quarterly Statement for the first quarter of 2023 (Press release, Evotec, MAY 11, 2023, View Source [SID1234631595]).

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Evotec’s fully audited Annual Report 2022 "Ahead of the Curve" is now available for downloading on www.evotec.com/financial-reports. Evotec had published preliminary financial results for FY2022 already on 28 March, which have remained unchanged. The publication of the final document had to be postponed after Evotec became the victim of a criminal cyber-attack that was discovered in early April.

Evotec also published a qualitative Quarterly Statement for the first quarter of 2023 today. Since the cyber-attack was discovered after the end of the first quarter, the Company’s Q1 results remain materially unaffected and saw a very strong start to the year with several deal extensions and expansions, e.g. a multi-billion-US$ extension of the Company’s neuroscience partnership with Bristol Myers Squibb, and the announcement of new partnerships, e.g. with Janssen in the field of immune-based therapies. Scale and scope of these transactions were materially larger than in the comparable period 2022.

Guidance for FY2023 remains unchanged. Evotec expects revenues in the range of € 820 – 840 m (€ 835 – 855 m at constant fx-rates) and adj. EBITDA in the range of € 115 – 130 m (€ 125 – 140 m at constant fx-rates).

Supported by the new long-term alliance with Sandoz in the field of biosimilars that was announced earlier this week, Evotec sees itself well positioned to achieve its mid-term targets of "Action Plan 2025", i.e. revenue growth to >€ 1,000 m, adjusted EBITDA of ≥€ 300 m and unpartnered research and development expenses of >€ 100 m by 2025.

In response to the criminal cyber-attack, Evotec took immediate action to contain and remediate the attack by taking its external-facing systems offline. This was deemed necessary to protect all of the Company’s partners and stakeholders. Evotec expects a fast return to full productivity, and business recovery. However, it cannot be ruled out that there could be a potential impact on the aforementioned guidance. Management will continue to monitor the situation and provide updates in subsequent reporting.

The Company will provide the next update on the financials – including an analysis of Q1 2023 developments – with the publication of the Half-Year Report 2023 that will be published on 09 August 2023.

With the publication of the audited Annual Report 2022 made today, Evotec expects to fulfil the criteria to be reinstated by Deutsche Börse/Qontigo in the relevant stock indices (MDAX, TecDAX, Prime All Share, LTecDAX, Technology All Share and CDAX). The Company anticipates the re-entry on 19 June on the grounds of the Fast Entry evaluation due on 05 June.

On 05 June 2023, Evotec will hold an ESG Capital Markets Day and present the Company’s strategic guardrails for a resilient business that remains "ahead of the curve" – even in times of global uncertainty. The ESG Capital Markets Day will be held as a virtual and invitation-only event. A recording of the broadcast will be available on www.evotec.com in the days after the event.

On May 12, 2023 Cellectis (the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, reported an article in Frontiers Bioenginnering, demonstrating the efficacy of its TALEN engineered FAP UCART-cells in cancer-associated fibroblast (CAF) depletion, reduction of desmoplasia and tumor infiltration (Press release, Cellectis, MAY 11, 2023, View Source [SID1234631590]).

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Adoptive cell therapy based on chimeric antigen receptor-engineered T (CAR-T) cells has proven to be lifesaving for many cancer patients.

However, its therapeutic efficacy has so far been restricted to only a few malignancies, with solid tumors proving to be especially recalcitrant to efficient therapy. Poor intra-tumor infiltration by T cells and T cell dysfunction due to a desmoplastic, immunosuppressive microenvironment are key barriers for CAR T-cell success against solid tumors.-

Cancer-associated fibroblasts (CAFs) are critical components of the tumor stroma, evolving specifically within the tumor microenvironment (TME). The CAF secretome is a significant contributor to the extracellular matrix and a plethora of cytokines and growth factors that induce immune suppression. Together they form a physical and chemical barrier which induces a T cell-excluding ‘cold’ TME. CAF depletion in stroma rich solid tumors can thus provide an opportunity to convert immune evasive tumors susceptible to tumor-antigen CAR T-cell cytotoxicity.

Cellectis used its TALEN-based gene editing platform to engineer non-alloreactive, immune-evasive UCAR T-cells targeting the unique CAF marker Fibroblast Activation Protein, alpha (FAP) to test whether FAP UCAR T-cell pre-treatment can make ‘cold’ tumors susceptible to subsequent tumor-antigen targeting CAR T-cells. Cellectis also generated non-alloreactive CAR T-cells against the tumor associated antigen (TAA) Mesothelin which is overexpressed in most solid tumors including mesothelioma and large sub-sets of ovarian, breast, pancreatic and lung adenocarcinomas. The combination treatment strategy was tested in a pre-clinical mouse model of triple-negative breast cancer (TNBC), an aggressive, stroma-rich breast cancer sub-type with poor prognosis and very limited treatment options at present.

"Over 90% of epithelial cancers including breast, colorectal, pancreatic and lung adenocarcinomas express the CAF-specific surface marker, fibroblast activation protein α (FAP), which makes it a promising CAR T-cell target. In this study, we propose a novel and versatile approach of combination CAR T-cell therapy that can be extended to most stroma-rich cold tumors with relevant tumor-antigen targeting CAR T-cells which otherwise are recalcitrant to cell therapy", said Shipra Das, Ph.D., Senior Scientist & Team Leader at Cellectis.

Preclinical data showed that :

In a mouse xenograft model, successful implantation of injected CAFs in the tumors was confirmed by positive staining of spindle-like cells with human-specific FAP antibody, recapitulating a physiologically relevant TNBC tumor with tumor and stromal compartments.
FAP UCART-cells alone significantly reduced tumor growth.
In vitro and in vivo results show that FAP UCART-cells enable the reprogramming of the cold, stroma-rich triple negative breast cancer (TNBC) TME, making the tumor susceptible to subsequent Meso UCAR T infiltration and cytotoxicity and improving the overall antitumor activity of the treatment.
In the context of combination therapy with anti-PD1 checkpoint inhibitor, maximal anti-tumor activity and survival benefits were observed upon FAP UCAR T-cell treatment followed by Meso UCAR T-cell treatment.

On May 11, 2023 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported its financial results for the three months ended March 31, 2023, and provided a business update (Press release, Altimmune, MAY 11, 2023, View Source [SID1234631579]).

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"We are on course for mid-year initiation of IMPACT, our Phase 2b biopsy trial of pemvidutide in subjects with NASH," said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. "In our previous trials in subjects with non-alcoholic fatty liver disease (NAFLD), we observed remarkable reductions in liver fat content and markers of liver inflammation that occurred rapidly after treatment. This leads us to believe that the IMPACT trial has the potential to show a statistically significant impact on the key endpoints of NASH resolution and fibrosis improvement. We also believe pemvidutide may distinguish itself from other candidates in development for NASH because of its demonstrated reductions in both liver fat content and body weight. This is important, because many NASH patients suffer not only from the complications of liver disease but also from the underlying obesity, a principal driver of NASH. In addition, we eagerly await top-line 48-week results from our MOMENTUM obesity trial anticipated in the fourth quarter of 2023, which we expect will demonstrate continued weight loss beyond the robust levels reported at the 24-week interim analysis. We believe pemvidutide could be an important treatment option for patients with obesity, if approved, particularly those with NAFLD and dyslipidemia, conditions that are highly prevalent in these patients. We also look forward to the top-line results of our Phase 2 trial of HepTcell in CHB, which we expect to announce in the first quarter of 2024."

Recent Highlights and Anticipated Milestones

Pemvidutide

Positive interim data readout from 24-week MOMENTUM Phase 2 obesity trial in March 2023
Mean weight loss of 10.7% and 9.4% at the 2.4 mg and 1.8 mg doses, respectively, at Week 24, compared to mean weight loss of 1.0% in the placebo group.
Approximately 50% of subjects achieved 10% or more weight loss and approximately 20% of subjects achieved 15% or more weight loss at both the 2.4 mg and 1.8 mg doses at Week 24.
Robust reductions in waist circumference, serum lipids and blood pressure, surrogates of reduced cardiovascular risk.
Higher adverse event discontinuation rates observed at the 2.4 mg dose can be mitigated by allowance for dose reduction in Phase 3 trials.
Initiation of IMPACT Phase 2b NASH trial expected mid-2023
This Phase 2b biopsy-driven NASH trial will be conducted at approximately 60 sites in the U.S., with Dr. Stephen Harrison, Medical Director, Pinnacle Research, and Adjunct Professor of Medicine, Oxford University, serving as the principal investigator.
190 subjects with and without diabetes are planned to be randomized 1:2:2 to pemvidutide 1.2 mg, pemvidutide 1.8 mg, or placebo.
The key endpoints will be NASH resolution and fibrosis improvement after 24 weeks of treatment, with subjects followed for an additional 24 weeks to a total of 48 weeks for assessment of safety and additional biomarker responses.
Dose reduction will be allowed for subjects who experience GI intolerance.
The trial is expected to commence mid-2023 with top-line results expected in the first quarter of 2025.
HepTcell

Completed enrollment in the Phase 2 clinical trial in CHB
The multicenter clinical trial, which is being conducted at 26 sites in North America, Europe and Southeast Asia, enrolled approximately 80 previously untreated subjects with inactive CHB and low levels of hepatitis B surface antigen (HBsAg).
Subjects were randomized 1:1 to HepTcell or placebo.
The primary endpoint is virological response, defined as a 1-log or greater reduction or clearance of HBsAg; secondary endpoints include changes in the levels of hepatitis B virus (HBV) DNA, pre-genomic RNA and other markers of virologic response.
Data readout is expected in the first quarter of 2024 after all subjects complete the 6-month course of treatment.
Financial Results for the Three Months Ended March 31, 2023

Cash, cash equivalents and short-term investments totaled $165.8 million as of March 31, 2023.
Research and development expenses were $17.2 million for the three months ended March 31, 2023, compared to $15.1 million in the same period in 2022. The expenses for the quarter ended March 31, 2023 included $8.7 million in direct costs related to development activities for pemvidutide and $2.1 million in direct costs related to development activities for HepTcell.
General and administrative expenses were consistent period-over-period at $4.5 million and $4.4 million for the three months ended March 31, 2023 and March 31, 2022, respectively.
Interest income for the three months ended March 31, 2023 was $1.7 million as compared to a negligible amount in the three months ended March 31, 2022.
Net loss for the three months ended March 31, 2023 was $20.1 million, or $0.40 net loss per share, compared to a net loss of $19.4 million, or $0.44 net loss per share, in the same period in 2022.
Conference Call Information:

Date: Thursday, May 11, 2023
Time: 8:30 am EDT
Webcast: To listen, the conference call will be webcast live on Altimmune’s Investor Relations website at View Source
Dial-in: To participate or dial-in, register here to receive the dial-in numbers and unique PIN to access the call.

Following the conclusion of the call, the webcast will be available for replay on the Investor Relations page of the Company’s website at www.altimmune.com. The Company has used, and intends to continue to use, the IR portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.

About Pemvidutide
Pemvidutide is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and NASH. Activation of the GLP-1 and glucagon receptors is believed to mimic the complementary effects of diet and exercise on weight loss, with GLP-1 suppressing appetite and glucagon increasing energy expenditure. Glucagon is also recognized as having direct effects on hepatic fat metabolism, leading to rapid reductions in levels of liver fat. Pemvidutide incorporates the EuPort domain, a proprietary technology that increases its serum half-life for weekly dosing while likely slowing the entry of pemvidutide into the bloodstream, which may improve its tolerability.

About HepTcell
HepTcell is a novel, investigational, immunotherapeutic comprised of nine synthetic peptides representing conserved HBV sequences formulated with IC31, a TLR9-based adjuvant from Valneva SE. The HBV-directed peptides are designed to drive T cell responses against all HBV genotypes towards a functional cure for chronic HBV in patients of diverse genetic backgrounds.

On May 11, 2023 Onconova Therapeutics, Inc. (NASDAQ: ONTX), ("Onconova"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported that the first patient has been dosed in the Company’s Phase 1/2a trial evaluating narazaciclib combined with letrozole in recurrent metastatic low-grade endometrioid endometrial cancer (LGEEC) (Press release, Onconova, MAY 11, 2023, View Source [SID1234631578]). Narazaciclib is a multi-kinase inhibitor targeting CDK 4, CDK 6, and other kinases important for cell proliferation and motility. Preliminary data from the trial’s Phase 1 portion are expected in 4Q 2023.

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Endometrial cancer arises in the uterine lining and is the most common cancer of the female reproductive organs. Endometrioid endometrial cancer is the most common subtype of endometrial cancer, accounting for approximately 75% of cases. Data from prior randomized and single-arm trials have demonstrated the anti-cancer activity of letrozole combined with CDK 4/6 inhibition in recurrent endometrial cancer1-3. Currently, there is no health authority-approved CDK 4/6 inhibitor for the treatment of endometrial cancer.

"Improved treatment options for recurrent LGEEC are urgently needed, as the CDK 4/6 inhibitors currently used off-label for this indication are marked by limitations related to safety, tolerability, and treatment resistance," said Bhavana Pothuri, M.D., Professor, Department of Obstetrics and Gynecology at NYU Grossman School of Medicine and Director, Gynecologic Oncology Research; Perlmutter Cancer Center and Principal Investigator of the trial. "Narazaciclib’s kinase inhibitory profile suggests it can overcome each of these limitations thanks to reduced activity against kinases whose inhibition is associated with bone marrow toxicity and diarrhea, and increased activity against those implicated in pro-tumor immune suppression and cancer cell survival. This hypothesis is supported by data from in vitro and murine cancer models, and I look forward to its continued evaluation in the ongoing Phase 1/2a trial."

Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova, commented, "Our recurrent LGEEC program provides an opportunity to establish narazaciclib as a best-in-class therapy in an indication where clinical proof-of-concept for its mechanism of action has been demonstrated. We, therefore, view the program as a key avenue for value creation and look forward to our Phase 1/2a trial’s preliminary data readout expected later this year."

About the Phase 1/2a Trial

The Phase 1/2a trial is an open-label, multicenter study evaluating narazaciclib in combination with letrozole as a second or third-line treatment for patients with recurrent metastatic LGEEC. Both narazaciclib and letrozole are administered orally with a continuous daily dosing schedule. The trial begins with a Phase 1 dose escalation phase before moving to a Phase 2 expansion cohort designed to enroll approximately 30 patients. The primary objective of the Phase 1 portion of the trial is to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in order to determine a recommended Phase 2 dose (RP2D) of the combination. The primary objective of the Phase 2 portion will be to evaluate the efficacy of the combination at the RP2D, as measured by progression-free survival at 24 weeks. The estrogen/progesterone receptor status of participants will be recorded as part of an exploratory objective. The trial will be conducted at sites including NYU Langone Health, the site of the Principal Investigator of the study, sites affiliated with MD Anderson Cancer Center, and U.S. Oncology Research sites.

References

1. Mirza MR. ESMO (Free ESMO Whitepaper) Virtual Congress 2020. Abstr. LBA28.

2. Konstantinopoulos PA, et al.; 2022 SGO Annual Meeting on Women’s Cancer; March 18-21, 2022. Phoenix, AZ

3. Colon-Otero G, Zanfagnin V, Hou X, et al. ESMO (Free ESMO Whitepaper) Open. 2020 Oct;5(5):e000926. doi: 10.1136/esmoopen-2020-000926.