sovipostobart (BMS-986249) / BMS, CytomX - LARVOL DELTA

A Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=356 | Completed | Sponsor: Bristol-Myers Squibb | N=607 ➔ 356

Enrollment change • First-in-human • Hepatocellular Cancer • Melanoma • Oncology • Solid Tumor • Triple Negative Breast Cancer

A Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=607 | Completed | Sponsor: Bristol-Myers Squibb | Active, not recruiting ➔ Completed | N=425 ➔ 607

Combination therapy • Enrollment change • Metastases • Trial completion • Hepatocellular Cancer • Melanoma • Oncology • Solid Tumor • Triple Negative Breast Cancer

CytomX Therapeutics Provides Business Update and Outlines 2023 Company Priorities (GlobeNewswire) - "2023 KEY MILESTONES AND OUTLOOK...CX-2029 (CD71): Determine next steps with AbbVie; BMS CTLA-4: Continued clinical progress on BMS-986249 and BMS-986288; Collaborations: Initiation of R&D activities with our newest collaborators, Regeneron and Moderna."

Pipeline update • Oncology • Solid Tumor

[VIRTUAL] Anti-CTLA-4 probody BMS-986249 alone or in combination with nivolumab in patients with advanced cancers: Initial phase I results. (ASCO 2020) - P1/2 | "Background: Blockade of the CTLA-4 pathway with ipilimumab (IPI) ± nivolumab (NIVO; anti–PD-1) is an effective treatment for a variety of cancers. BMS-986249 ± NIVO displayed a clinically manageable safety profile, allowing assessment of comparably higher BMS-986249 dose intensity (240-1200 mg; ≈ 3-15 mg/kg) + NIVO (480 mg Q4W, full dose) than that tested with IPI + NIVO. The types of TRAEs were consistent with CTLA-4 blockade, and the overall data align with the proposed Pb-Tx mechanism of action. The preclinical and clinical data support the ongoing randomized BMS-986249 + NIVO expansion in pts with adv melanoma, in addition to other adv tumors."

Clinical • Combination therapy • P1 data • Melanoma • Oncology • Solid Tumor

[VIRTUAL] Preclinical characterization of novel anti-CTLA-4 prodrug antibodies with an enhanced therapeutic index (AACR-II 2020) - P1/2 | "Background: Blockade of the CTLA-4 pathway with ipilimumab (IPI) as monotherapy or in combination with nivolumab (anti–PD-1) is an effective treatment for a variety of cancers...Here, we describe the preclinical characterization of 2 novel anti–CTLA-4 PB mAbs: anti–CTLA-4 PB (BMS-986249) is a peptide-masked version of IPI, and anti‒CTLA-4 nonfucosylated (NF) PB (BMS-986288) is a peptide-masked version of anti–CTLA-4 NF, which has enhanced antibody-dependent cellular cytotoxicity (ADCC) and regulatory T-cell (Treg) depletion compared with IPI. Antibody binding to CD16 was studied by surface plasmon resonance... These data demonstrate the potential of the PB-Tx technology platform to improve the therapeutic indices of anti–CTLA-4 PB and anti–CTLA-4 NF PB relative to their parental mAbs. The safety and antitumor activity of anti–CTLA-4 PB (NCT03369223) and anti–CTLA-4 NF PB (NCT03994601) are being investigated in patients with advanced solid cancers in ongoing phase..."

IO Biomarker • Preclinical • Oncology • Solid Tumor • FOXP3 • IL2

A Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=425 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer

Anti-cytotoxic T-lymphocyte antigen-4 (CTLA 4) probody BMS-986249 ± nivolumab (NIVO) in patients (pts) with advanced cancers: Updated phase I results (ESMO 2022) - P1/2 | "Background Ipilimumab (IPI; anti–CTLA-4) ± NIVO (anti–PD-1) has demonstrated clinical activity across many tumor types. Conclusions BMS-986249 demonstrated a tolerable safety profile with no unexpected signals and promising preliminary activity. PK and PD supported unmasking at the tumor site."

Clinical • IO biomarker • P1 data • Oncology

Bristol Myers Squibb Research at ESMO Congress 2022 Highlights Depth of Development Program Across Early- and Late-Stages of Cancer (Businesswire) - "Bristol Myers Squibb...announced the presentation of scientific research across several solid tumors showcasing the breadth of the Company’s oncology development program at the European Society for Medical Oncology (ESMO) Congress 2022 from September 9-13 in Paris, France....Key data highlighting approved or investigational therapies from Bristol Myers Squibb at ESMO 2022 include: Safety, efficacy, pharmacokinetic and pharmacodynamic data from the Phase 1/2 study of BMS-98629 alone and in combination with nivolumab in patients with advanced cancers In addition, Exelixis announces first presentation of results from the COSMIC-313 study evaluating the combination of cabozantinib, nivolumab and ipilimumab vs. the combination of nivolumab and ipilimumab in patients with previously untreated advanced intermediate- or poor-risk renal cell carcinoma."

P1/2 data • P3 data • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer

"$BMY reports "responses in tumor types typically insensitive to immuno-oncology drugs" with $CTMX-partnered masked IPI (BMS-986249); "PK and PD supported unmasking at the tumor site". Large PhII is ongoing. #ESMO22" (@MysteriousMole1)

Oncology

CytomX Therapeutics Announces Phase 1 Data Update for anti-CTLA-4 Probody Therapeutic BMS-986249 (GlobeNewswire) - P1/2 | N=425 | NCT03369223 | Sponsor: Bristol-Myers Squibb | "CytomX Therapeutics...announced that its collaborator, Bristol Myers Squibb, presented updated Phase 1 results with BMS-986249...at the ESMO Congress 2022 in Paris, France. 'BMS-986249 is a conditionally activated CTLA-4-targeting antibody that has shown clinical activity in multiple tumor types, and the safety profile and disease control rate observed in the updated Phase 1 data for BMS-986249 with and without nivolumab is promising....We are encouraged by the report of a complete response in melanoma and a case study of a partial response in microsatellite-stable colorectal cancer. This Phase 1 study set the stage for the ongoing randomized Phase 2 trial of BMS-986249 in melanoma evaluating the potential differentiation of the the Probody from ipilimumab, and we look forward to results from this study in due course'."

P1 data • Colorectal Cancer • Gastrointestinal Cancer • Melanoma • Oncology • Skin Cancer • Solid Tumor

CytomX Therapeutics Reports Second Quarter 2022 Financial Results and Provides Business Update (GlobeNewswire) - "Bristol Myers Squibb plans to present updated Phase 1 results for BMS-986249 at the ESMO Congress 2022 with the poster presentation titled 'Anti–Cytotoxic T Lymphocyte Antigen-4 (CTLA 4) Probody BMS-986249 ± Nivolumab (NIVO) in Patients With Advanced Cancers: Updated Phase 1 Results'."

P1 data

An Investigational Immunotherapy Study of BMS-986249 Alone and in Combination With Nivolumab in Solid Cancers That Are Advanced or Have Spread (clinicaltrials.gov) - P1/2; N=425; Recruiting; Sponsor: Bristol-Myers Squibb; Trial primary completion date: Oct 2022 ➔ Sep 2024

Combination therapy • Trial primary completion date • Oncology • Solid Tumor • Triple Negative Breast Cancer

CytomX Therapeutics Announces Third Quarter 2020 Financial Results and Provides Business Update (GlobeNewswire) - "BMS-986249: Anti-CTLA-4 Probody Immunotherapeutic. Bristol Myers Squibb continues to enroll patients as part of the Part 2a randomized cohort expansion of the ongoing Phase 1/2a trial of BMS-986249 administered in combination with nivolumab (Opdivo®) in patients with metastatic melanoma....BMS-986288: Anti-CTLA-4 Non-Fucosylated Probody Immunotherapeutic. Bristol Myers Squibb continues to enroll patients as part of the Part 1 dose escalation study of the ongoing Phase 1/2a trial of BMS-986288 administered as monotherapy and in combination with nivolumab in patients with selected advanced solid tumors."

Enrollment status • Hematological Malignancies • Melanoma • Oncology • Solid Tumor

CytomX Therapeutics announces presentations at the 2020 American Society of Clinical Oncology Virtual Scientific Program (GlobeNewswire) - "CytomX Therapeutics...announced the selection of seven presentations to be featured as part of the American Society of Clinical Oncology’s (ASCO) ASCO20 Virtual Scientific Program taking place from May 29 - May 31, 2020....7 Abstracts Highlighting CytomX’s Novel Probody Platform Selected for Oral and Poster Presentations."

Clinical data • P1 data • P1/2 data • P2 data • Breast Cancer • Oncology • Solid Tumor

CytomX Therapeutics announces details of presentations at the American Society of Clinical Oncology ASCO20 Virtual Scientific Program (GlobeNewswire, CytomX Therapeutics Inc.) - "CytomX Therapeutics, Inc…announced further details of oral and poster presentations at the American Society of Clinical Oncology’s (ASCO) ASCO20 Virtual Scientific Program taking place from May 29 - May 31, 2020…CytomX’s ASCO20 clinical presentations for CX-072 (Abstract 3005), CX-2009 (Abstract 526) as well as CX-2029 (Abstract 3502), developed in partnership with AbbVie, will have data cutoff dates of approximately five months later than the abstract data cutoff."

P1/2 data • Breast Cancer • Oncology • Solid Tumor

CytomX Therapeutics announces first quarter 2020 financial results and provides business update (GlobeNewswire, CytomX Therapeutics Inc.) - "CytomX and its partners announced presentations at the American Society of Clinical Oncology’s (ASCO) ASCO20 Virtual Scientific Program: CytomX and its partner AbbVie will present data from Phase 1 dose escalation study of the PROCLAIM-CX-2029 Phase 1/2 study of the anti CD71 Probody CX-2029; Bristol Myers Squibb will present data from the Phase 1 dose escalation study of the Phase 1/2a trial of the anti-CTLA-4 Probody BMS-986249; CytomX will present updated data from the Phase 1 dose escalation and dose ranging studies of the PROCLAIM-CX-2009 Phase 1/2 study of the anti CD166 Probody CX-2009; CytomX will present updated data from the Phase 1 dose escalation study, monotherapy expansion studies and combination with ipilimumab studies of PROCLAIM-CX-072 Phase 1/2 study of the anti PD-L1 Probody CX-072."

P1/2 data • Oncology • Solid Tumor

CytomX Therapeutics Announces Preclinical Data from Anti-CTLA-4 Probody Therapeutic Programs Presented by Partner Bristol Myers Squibb at AACR Annual Meeting (GlobeNewswire) - "CytomX Therapeutics, Inc...announced that its partner Bristol Myers Squibb presented preclinical data from BMS-986249 and BMS-986288, anti-CTLA-4 Probody therapeutics generated with CytomX’s novel Probody® technology platform. The electronic poster #4551 titled 'Preclinical characterization of novel anti-CTLA-4 prodrug antibodies with an enhanced therapeutic index' was presented as part of the Therapeutic Antibodies 3 Session at the American Association of Cancer Research’s (AACR) 2020 Virtual Annual Meeting II."

Preclinical • Oncology • Solid Tumor

BMS-986249 + Opdivo + Yervoy: “The safety profile of BMS-986249 allowed for assessment of higher doses as monotherapy and in combination with full dose nivolumab than previously tested”; Solid tumors (CytomX) - ASCO 2020

P1/2 data • Oncology • Solid Tumor

CytomX Therapeutics clinical programs highlighted at American Society of Clinical Oncology ASCO20 Virtual Scientific Program (GlobeNewswire) - P1/2, N=375; NCT03369223; Sponsor: Bristol-Myers Squibb; "Bristol Myers Squibb presented dose escalation data from their Phase 1/2 trial of BMS-986249....The doses of BMS-986249 ranged from 240 mg to 2400 mg (approximately 3 - 30 mg/kg). BMS-986249 was generally well tolerated as monotherapy and in combination with nivolumab. Bristol Myers Squibb has initiated a randomized clinical trial to explore various doses of BMS-986249 in combination with nivolumab in patients with advanced melanoma."

New trial • P1/2 data • Melanoma • Oncology • Solid Tumor

"$CTMX #ASCO20 2/n 3-30 mpk BMS-986249 vs. 3 mpk Ipi -> 23 % vs. 27 % TRAEs Gr. 3/4 3-15 mpk BMS-986249 + Nivo vs. 3 mpk Ipi + Nivo -> 30 % vs. 55 % TRAEs Gr. 3/4 Ipi comparison data comes from old $CTMX presentations." (@GermanBiotech)

BMS-986218: Initiation of clinical study in cancer by early 2018 (CytomX, Cantor Fitzgerald’s 3rd Annual Healthcare Conference)

New trial • Oncology

BMS-986218: Initiation of clinical study in cancer by early 2018 (CytomX, Cantor Fitzgerald’s 3rd Annual Healthcare Conference)

New trial • Oncology

Bristol-Myers Squibb advances CytomX Therapeutics’ anti-CTLA-4 probody therapeutic BMS-986249 into randomized cohort expansion (part 2a) of ongoing clinical trial (GlobeNewswire) - "CytomX Therapeutics, Inc...announced that its partner, Bristol-Myers Squibb, has initiated a randomized Phase 2 cohort expansion in its ongoing first-in-human Phase 1/2a trial of the anti-CTLA-4 Probody BMS-986249 alone and in combination with Opdivo^® (nivolumab)....The randomized cohort expansion is designed to further evaluate the safety and efficacy of BMS-986249 in combination with Opdivo^® in patients with metastatic melanoma, as part of the larger clinical trial (NCT03369223)."

Trial status

CytomX Therapeutics provides updates on lead clinical programs and 2020 portfolio outlook (GlobeNewswire) - "2020 Clinical Outlook Across The CytomX Portfolio...Bristol-Myers Squibb (BMS), anticipates presenting data from the completed Phase 1 portion of the Phase 1/2a study evaluating BMS-986249 alone and in combination with OPDIVO^® (nivolumab) in advanced solid tumors....BMS is initiating the Phase 2 portion of this clinical trial, upon which CytomX is entitled to a $10 million milestone payment."

Enrollment open • P1/2 data

BMS-986249 + Opdivo: Initiation of P2 trial for solid tumors in H2 2019 (CytomX) - Q2 2019 Results

New P2 trial