Nerviano Medical Sciences Announces FDA Clearance of Investigational New Drug (IND) for NMS-03592088 in positive Relapsed or Refractory Acute Myeloid Leukemia

On June 22, 2023 Nerviano Medical Sciences Srl (NMS), a member of NMS Group and a clinical stage company discovering and developing innovative therapies for the treatment of cancer, reported that the FDA Clearance of Investigational New Drug (IND) Application for NMS-03592088 (NMS-088), a novel, potent FLT3 inhibitor (Press release, Nerviano Medical Sciences, JUN 22, 2023, View Source [SID1234632850]).

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!

NMS-088 is poised to transform the landscape of FLT3 inhibitor by addressing a critical unmet medical need. It offers a breakthrough solution that has the potential to improve patient outcomes and significantly enhance quality of life. The IND approval enables NMS to advance to the next stage of clinical development, initiating critical trials to evaluate the safety, efficacy, and therapeutic potential of this next-generation FLT3 inhibitor.

"We are incredibly proud of this IND approval, which underscores our commitment to innovation and improving patient care," said Lisa Mahnke, MD, PhD, CMO of NMS. "This milestone is a testament to the hard work, dedication, and scientific expertise of our talented team. We remain steadfast in our mission to bring forth groundbreaking solutions that make a real difference in the lives of patients."

The forthcoming clinical trial will be conducted in partnership with renowned medical centers and institutions as part of NMS’s global program. This collaborative approach ensures the rigorous evaluation and comprehensive assessment of NMS-088’s safety, efficacy, and potential benefits across diverse patient populations.

As NMS moves forward with clinical trials, the company remains committed to adhering to the highest ethical and regulatory standards. Patient safety and well-being will remain paramount throughout the entire process, with careful monitoring and adherence to strict protocols.

About Acute Myeloid Leukemia
Acute Myeloid Leukemia (AML) is a rapidly progressing hematologic malignancy that most frequently develops in older adults. FLT3 mutations occur in approximately 30% of AML patients and are associated with aggressive disease, higher relapse rates and worse survival. Despite the approval of FLT3 inhibitors midostaurin and gilteritinib the prognosis of patients with relapsed or refractory disease is poor.

About NMS-03592088
NMS-03592088 is a novel, potent inhibitor of FLT3, KIT and CSF1R, all relevant targets in AML. NMS-03592088 showed superior preclinical activity compared with approved FLT3 inhibitors in different FLT3-driven models. In addition, NMS-03592088 is active on FLT3 gatekeeper mutation F691L causing resistance to first generation FLT3 inhibitors. NMS-03592088 is being developed in AML with two studies currently recruiting (MKIA-088-001 and MKIA-088-002)

Inhibikase Therapeutics Announces Selection of the Bioequivalent Dose of IkT-001Pro and Provides Update on the ‘501’ Bioequivalence Study

On June 22, 2023 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson’s disease, Parkinson’s-related disorders and other diseases of the Abelson Tyrosine Kinases, reported that it has selected the bioequivalent dose of IkT-001Pro, the Company’s prodrug formulation of imatinib mesylate designed to enhance the safety and efficacy of imatinib (marketed as Gleevec) in patients with Chronic Myelogenous Leukemia (CML) and provided an update on its ‘501’ bioequivalence study (Press release, Inhibikase Therapeutics, JUN 22, 2023, View Source [SID1234632849]).

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!

The ‘501’ bioequivalence study has evaluated IkT-001Pro at four single ascending doses of 300, 400, 500 and 600 mg, leading to the selection of 600 mg IkT-001Pro as the bioequivalent dose to 400 mg imatinib mesylate. The pivotal phase of the study was dosed with bioequivalent IkT-001Pro in 31 healthy volunteers; one subject was excluded pre-dose due to aberrant clinical laboratory values. The Company expects to complete the pivotal clinical phase of the study by the end of the second quarter.

"Based on the safety signals we have seen at the 600 mg dose of IkT-001Pro relative to 400 mg imatinib mesylate, we believe that we have identified the appropriate go-forward dose for standard-of-care treatment with IkT-001Pro," stated Dr. Milton Werner, President and Chief Executive Officer of Inhibikase Therapeutics. "We plan to add an additional cohort to the ‘501’ trial in the third quarter to evaluate bioequivalence of IkT-001Pro relative to 600 mg imatinib mesylate with repeat dosing. 600 mg imatinib mesylate is commonly used to treat CML, but is poorly tolerated by up to 50% of patients. We believe IkT-001Pro may overcome the poor tolerability of high dose imatinib experienced by many patients, further differentiating the advantage of IkT-001Pro over current standard-of-care."

Following the completion of the ‘501’ trial, Inhibikase will initiate a discussion with the FDA on the parameters for approval of IkT-001Pro under the 505(b)(2) statute.

About IkT-001Pro
IkT-001Pro is a prodrug formulation of imatinib mesylate and has been developed to improve the safety of the first FDA-approved Abelson (Abl) kinase inhibitor, imatinib (marketed as Gleevec). Imatinib is commonly taken for hematological and gastrointestinal cancers that arise from Abl kinase mutations found in the bone marrow or for gastrointestinal cancers that arise from c-Kit and/or PDGFRa/b mutations in the stomach; c-Kit, PDGFRa/b and Abl are all members of the Abelson Tyrosine Kinase protein family. IkT-001Pro has the potential to be a safer alternative for patients and may improve the number of patients that reach and sustain major and/or complete cytogenetic responses in stable-phase CML and/or reduce the relapse rate for these patients. In preclinical studies, IkT-001Pro was shown to be as much as 3.4 times safer than imatinib in non-human primates, reducing burdensome gastrointestinal side effects that occur following oral administration. Imatinib delivered as IkT-001Pro was granted Orphan Drug Designation for stable-phase CML in September 2018.

About Chronic Myelogenous Leukemia
Chronic myeloid leukemia[1] is a slowly progressing cancer that affects the blood and bone marrow. In CML, a genetic change takes place in immature myeloid cells — the cells that make most types of white blood cells. This change creates an abnormal gene product called BCR-ABL which transforms the cell into a CML cell. Leukemia cells increasingly grow and divide in an unregulated manner, eventually spilling out of the bone marrow and circulating in the body via the bloodstream. Because they proliferate in an uncontrolled manner, the excessive production of myeloid cells acts like a liquid tumor. In time, the cells can also settle in other parts of the body, including the spleen. CML is a form of slow-growing leukemia that can change into a fast-growing form of acute leukemia that is difficult to treat.

IGM Announces Pricing of $107.3 Million Upsized Public Offering and Concurrent Private Placement

On June 22, 2023 IGM Biosciences, Inc. (NASDAQ: IGMS) reported the pricing of its upsized underwritten public offering of 3,285,327 shares of its voting common stock and 7,312,500 shares of its non-voting common stock, in each case at a price to the public of $8.00 per share (Press release, IGM Biosciences, JUN 22, 2023, View Source [SID1234632848]). In addition, IGM has granted the underwriters a 30-day option to purchase up to an additional 1,589,673 shares of its voting common stock at the public offering price, less underwriting discounts and commissions. All of the shares in the public offering will be sold by IGM. The public offering is expected to close on or about June 26, 2023, subject to satisfaction of customary closing conditions.

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!

Concurrent with the public offering, IGM intends to sell, subject to the consummation of the public offering and other customary conditions, in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended (the Securities Act), 2,812,500 shares of non-voting common stock to certain institutional and other accredited investors affiliated with or managed by Redmile Group, LLC at a sale price equal to $8.00 per share. However, the consummation of the public offering is not contingent on the consummation of this concurrent private placement.

IGM expects to receive total gross proceeds of approximately $107.3 million from the public offering and the concurrent private placement, before deducting the underwriting discounts and commissions and estimated offering expenses payable by IGM in connection with the public offering and the concurrent private placement.

BofA Securities, Jefferies, Stifel, and Guggenheim Securities are acting as joint book-running managers for the public offering.

The securities in the public offering will be offered by IGM pursuant to a Registration Statement on Form S-3, filed with the Securities and Exchange Commission (SEC) on November 3, 2022 and declared effective on November 14, 2022. A final prospectus supplement and accompanying prospectus relating to the public offering will be filed with the SEC and may be accessed for free through the SEC’s website at www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the public offering may also be obtained from: BofA Securities, Attention: Prospectus Department, NC1-0220-02-24, 201 North Tryon Street, Charlotte, North Carolina 28255-0001, or via email: [email protected]; Jefferies LLC, Attention: Equity Syndicate Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; Stifel, Nicolaus & Company, Incorporated, One Montgomery Street, Suite 3700, San Francisco, CA 94104, Attn: Syndicate, or by phone at (415) 364-2720, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected].

The shares of non-voting common stock to be sold in the concurrent private placement have not been registered under the Securities Act or under any state securities laws and, unless so registered may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws.

This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful before registration or qualification under the securities laws of that state or jurisdiction.

Genmab Announces Epcoritamab Added to National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for ‘B-Cell Lymphomas’

On June 22, 2023 Genmab A/S (Nasdaq: GMAB) reported that epcoritamab, a T-cell engaging bispecific antibody, has been added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) for "B-cell Lymphomas" (Version 4.2023) for third-line and subsequent therapy for patients with diffuse large B-cell lymphoma (DLBCL), including patients with disease progression after transplant or chimeric antigen receptor (CAR) T-cell therapy and as a Category 2A, preferred regimen for patients with histologic transformation of indolent lymphomas to DLBCL and no intention to proceed to transplant, including patients with disease progression after transplant or CAR T-cell therapy (Press release, Genmab, JUN 22, 2023, View Source [SID1234632845]). This recommendation is based on uniform NCCN consensus that the intervention is appropriate.i Epcoritamab is being co-developed by Genmab and AbbVie (NYSE: ABBV) as part of the companies’ oncology collaboration.

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!

Epcoritamab-bysp (EPKINLY) was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory DLBCL, not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma (HGBL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial(s).

"The NCCN Guidelines are a resource for treating various types of cancer and providing healthcare providers with information for making informed treatment decisions," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. "We are pleased that the NCCN has updated its Guidelines to include epcoritamab in a speedy manner."

About Diffuse Large B-cell Lymphoma (DLBCL)
DLBCL is the most common type of B-cell non-Hodgkin’s lymphoma (B-NHL) worldwide, accounting for approximately 30 percent of all NHL cases and comprising an estimated 30,400 U.S. cases in 2022. DLBCL can arise in lymph nodes as well as in organs outside of the lymphatic system, occurs more commonly in the elderly and is slightly more prevalent in men.ii,iii DLBCL is a fast-growing type of NHL, a cancer that develops in the lymphatic system and affects B-cell lymphocytes, a type of white blood cell. For many people living with DLBCL, their cancer either relapses, which means it may return after treatment, or becomes refractory, meaning it does not respond to treatment. Although new therapies have become available, treatment management can remain a challenge.iv,v

About Epcoritamab
Epcoritamab is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology and administered subcutaneously. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response towards target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells and induces T-cell mediated killing of CD20+ cells.vi

In October 2022, a Marketing Authorization Application was submitted for epcoritamab for the treatment of patients with R/R DLBCL after two or more lines of systemic therapy, which was validated by the European Medicines Agency. Additionally, in December 2022, a Japan new drug application was submitted to the Ministry of Health, Labor and Welfare of Japan for epcoritamab for the treatment of patients with R/R LBCL after two or more lines of systemic therapy. Epcoritamab is not approved in the European Union and Japan. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. AbbVie will continue to pursue regulatory submissions for epcoritamab across international markets excluding the U.S. and Japan throughout the year.

Genmab and AbbVie are continuing to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes an ongoing phase 3, open-label, randomized trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL (NCT: 04628494), an ongoing phase 3, open-label, randomized trial evaluating epcoritamab in combination in adult participants with newly diagnosed DLBCL (NCT: 05578976), and a phase 3, open-label clinical trial evaluating epcoritamab in combination in patients with R/R follicular lymphoma (FL) (NCT: 05409066). Epcoritamab is not approved for the treatment of newly diagnosed DLBCL or R/R FL and the safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit clinicaltrials.gov for more information.

U.S. IMPORTANT SAFETY INFORMATION
BOXED WARNINGS

Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving EPKINLY (epcoritamab-bysp). Initiate treatment with the EPKINLY step-up dosing schedule to reduce the incidence and severity of CRS. Withhold EPKINLY until CRS resolves or permanently discontinue based on severity.

Immune effector cell–associated neurotoxicity syndrome (ICANS), including life-threatening and fatal reactions, can occur with EPKINLY. Monitor patients for neurological signs or symptoms of ICANS during treatment. Withhold EPKINLY until ICANS resolves or permanently discontinue based on severity.
Cytokine Release Syndrome (CRS)

EPKINLY can cause CRS, including serious or life-threatening reactions. CRS occurred in 51 percent of patients at the recommended dose in the clinical trial (37 percent grade 1, 17 percent grade 2, and 2.5 percent grade 3). Recurrent CRS occurred in 16 percent of patients. Of all the CRS events, most (92 percent) occurred during cycle 1. In cycle 1, 9 percent of CRS events occurred after the 0.16 mg dose (cycle 1, day 1), 16 percent after the 0.8 mg dose (cycle 1, day 8), 61 percent after the 48 mg dose (cycle 1, day 15), and 6 percent after the 48 mg dose (cycle 1, day 22). The median time to onset of CRS from the most recently administered EPKINLY dose across all doses was 24 hours (range, 0-10 days). The median time to onset after the first full 48 mg dose was 21 hours (range, 0-7 days). CRS resolved in 98 percent of patients; the median duration of CRS events was 2 days (range, 1-27 days).
Signs and symptoms of CRS can include pyrexia, hypotension, hypoxia, dyspnea, chills, and tachycardia. Concurrent neurological adverse reactions associated with CRS occurred in 2.5 percent of patients and included headache, confusional state, tremors, dizziness, and ataxia.
Initiate EPKINLY according to the step-up dosing schedule. Administer pretreatment medications to reduce the risk of CRS and monitor patients for potential CRS. Following administration of the first 48 mg dose, patients should be hospitalized for 24 hours. At the first signs or symptoms of CRS, immediately evaluate patients for hospitalization, manage per current practice guidelines, and administer supportive care as appropriate. Withhold or discontinue EPKINLY based on the severity of CRS.
Patients who experience CRS (or other adverse reactions that impair consciousness) should be evaluated and advised not to drive and to refrain from operating heavy or potentially dangerous machinery until resolution.
Immune Effector Cell–Associated Neurotoxicity Syndrome (ICANS)

EPKINLY can cause life-threatening and fatal ICANS. ICANS occurred in 6 percent (10/157) of patients in the clinical trial (4.5 percent grade 1, 1.3 percent grade 2, 0.6 percent fatal: 1 event). Of the 10 ICANS events, 9 occurred in cycle 1 of treatment. The median time to onset was 16.5 days (range, 8-141 days) from the start of treatment. Relative to the most recent administration, the median time to onset was 3 days (range, 1-13 days). The median duration of ICANS was 4 days (range, 0-8 days), with ICANS resolving in 90 percent of patients with supportive care.
Signs and symptoms of ICANS can include confusional state, lethargy, tremors, dysgraphia, aphasia, and nonconvulsive status epilepticus. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS.
Monitor for potential ICANS. At the first signs or symptoms of ICANS, immediately evaluate patient and provide supportive therapy based on severity. Withhold or discontinue EPKINLY per recommendations and consider further management per current practice guidelines.
Patients who experience signs or symptoms of ICANS or any other adverse reactions that impair cognition or consciousness should be evaluated, including potential neurology evaluation, and patients at increased risk should be advised not to drive and to refrain from operating heavy or potentially dangerous machinery until resolution.
Infections

EPKINLY can cause serious and fatal infections. In the clinical trial, serious infections, including opportunistic infections, were reported in 15 percent of patients treated with EPKINLY at the recommended dose (14 percent grade 3 or 4, 1.3 percent fatal). The most common grade 3 or greater infections were sepsis, COVID-19, urinary tract infection, pneumonia, and upper respiratory tract infection.
Monitor patients for signs and symptoms of infection prior to and during treatment with EPKINLY and treat appropriately. Avoid administration of EPKINLY in patients with active infections.
Prior to starting EPKINLY, provide Pneumocystis jirovecii pneumonia (PJP) prophylaxis and consider prophylaxis against herpes virus.
Withhold or consider permanent discontinuation of EPKINLY based on severity.
Cytopenias

EPKINLY can cause serious or severe cytopenias, including neutropenia, anemia, and thrombocytopenia. Among patients who received the recommended dose in the clinical trial, grade 3 or 4 events occurred in 32 percent (decreased neutrophils), 12 percent (decreased hemoglobin), and 12 percent (decreased platelets). Febrile neutropenia occurred in 2.5 percent.
Monitor complete blood counts throughout treatment. Based on severity of cytopenias, temporarily withhold or permanently discontinue EPKINLY. Consider prophylactic granulocyte colony-stimulating factor administration as applicable.
Embryo-Fetal Toxicity

EPKINLY may cause fetal harm. Advise pregnant women of the potential risk to the fetus. Verify pregnancy status in females of reproductive potential prior to initiating EPKINLY. Advise females of reproductive potential to use effective contraception during treatment with EPKINLY and for 4 months after the last dose.
Adverse Reactions

The most common (≥20 percent) adverse reactions were CRS, fatigue, musculoskeletal pain, injection site reactions, pyrexia, abdominal pain, nausea, and diarrhea. The most common grade 3 to 4 laboratory abnormalities (≥10 percent) were decreased lymphocyte count, decreased neutrophil count, decreased white blood cell count, decreased hemoglobin, and decreased platelets.
Lactation

Advise women not to breastfeed during treatment and for 4 months after the last dose of EPKINLY.
Please see the full Prescribing Information and Medication Guide, including Boxed Warnings.

NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

Compugen Doses First Patient in Triple Immunotherapy Combination COM701, COM902 and Pembrolizumab Platinum Resistant Ovarian Cancer Proof-of-Concept Study

On June 22, 2023 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported that the first patient has been dosed in the triple immunotherapy combination proof-of-concept study evaluating COM701, Compugen’s potential first-in-class anti-PVRIG antibody, with COM902, Compugen’s potential best-in-class anti-TIGIT antibody and pembrolizumab in patients with platinum resistant ovarian cancer (Press release, Compugen, JUN 22, 2023, View Source [SID1234632843]).

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!

"We are very excited that the first patient with platinum resistant ovarian cancer has been dosed with the triple immunotherapy combination of COM701, COM902 and pembrolizumab in our proof-of-concept study. This milestone keeps us on track to report initial findings by the end of this year," said Anat Cohen-Dayag, Ph.D., President, and CEO of Compugen. "The goal of the study is to build on the encouraging data previously reported by us at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2022, with the dual and triple blockade of PVRIG and PD-1 with or without TIGIT. We expect that this study will help us to better understand the contribution of the components and contribute to our ongoing biomarker work to try and identify the patients most likely to respond, with the purpose of building a path to registration."

"Despite recent advances in the treatment of patients with platinum resistant ovarian cancer, there remains a significant unmet need for new treatment options for these patients," said Dr. Manish Sharma, Associate Director of Clinical Research at START Midwest in Grand Rapids, Michigan. "I am very excited to participate in this proof-of-concept study with the novel triple immunotherapy combination of COM701, COM902 and pembrolizumab. Our initial observation is that this combination is well tolerated by patients as observed in our microsatellite stable colorectal cancer proof-of-concept study initiated recently. I hope this differentiated approach of blocking three pathways in the DNAM-1 axis, PVRIG, TIGIT and PD-1 will result in additional treatment options for patients with platinum resistant ovarian cancer."

Details on the study:
This proof-of-concept study (NCT04354246) is an open label study evaluating the combination of COM701 with COM902 and pembrolizumab in up to 40 patients with high grade platinum resistant epithelial ovarian cancer including patients with fallopian tube cancer and primary peritoneal cancer who have received up to 3 lines of prior therapy for platinum resistant ovarian cancer. The study includes patients with all histologies. The initiation of the study is based on Phase 1 cohort expansion data reported at ESMO (Free ESMO Whitepaper)-IO 2022, showing a favorable safety and tolerability profile and durable anti-tumor activity with the combination of COM701 and nivolumab ± BMS-986207 in platinum resistant ovarian cancer patients.