CTIM-76 / Context Therap, Integral Molecular - LARVOL DELTA

Ongoing Phase 1 trial of CTIM-76 (CLDN6 x CD3) demonstrates encouraging antitumor activity and safety (The Manila Times) - "Context has enrolled 12 patients as of the October 30, 2025 cutoff, and is currently enrolling Cohort 5 with a priming dose of 140 micrograms and a full dose of 560 micrograms. Preliminary signs of anti-tumor activity, including an ongoing RECIST response (Response Evaluation Criteria in Solid Tumors), have been observed beginning at Cohort 3 in the ongoing Phase 1 study. No Cytokine Release Syndrome ('CRS') greater than Grade 1 has been observed in any cohort. No dose limiting toxicity ('DLT') has been observed and a maximum tolerated dose ('MTD') has not been reached."

P1 data • Platinum resistant • Trial status • Endometrial Cancer • Ovarian Cancer • Testicular Cancer

A phase 1, first-in-human study of CTIM-76, a claudin-6 (CLDN6)-directed bispecific antibody, in patients with recurrent ovarian cancer and other advanced solid tumors. (ASCO 2025) - P1 | "This multicenter study has currently five sites open for enrollment. The first patient was dosed in January 2025."

Clinical • Metastases • P1 data • Endometrial Cancer • Genito-urinary Cancer • Oncology • Ovarian Cancer • Solid Tumor • Testicular Cancer • CLDN6

Context Therapeutics Reports First Quarter 2025 Operating and Financial Results (GlobeNewswire) - "...'We expect to report initial clinical data for CTIM-76 in the first half of 2026 and for CT-95 by mid-2026....We also plan to file an IND for CT-202, a potential best-in-class Nectin-4 x CD3 bispecific antibody, in mid-2026 as we continue to advance our portfolio of innovative T cell-engaging therapies for solid tumors'."

IND • P1 data • Solid Tumor

Context Therapeutics Reports Full Year 2024 Operating and Financial Results (Businesswire) - "...'Looking ahead, we anticipate dosing the first patient in our Phase 1 clinical trial of CT-95, targeting mesothelin-expressing cancers, in Q2 2025. Additionally, we expect to share initial clinical data from the CTIM-76 Phase 1 trial in the first half of 2026 and from the CT-95 Phase 1 trial in mid-2026'."

P1 data • Trial status • Endometrial Cancer • Ovarian Cancer • Solid Tumor • Testicular Cancer

Integral Molecular's Out-licensed Bispecific Antibody Enters Clinical Trial for Treating Solid Tumors (PRNewswire) - "Integral Molecular...is pleased to announce that its out-licensed anti-Claudin 6 (CLDN6) bispecific antibody, CTIM-76, has been dosed in the first patient in a Phase 1 clinical trial by its licensing partner, Context Therapeutics Inc. This milestone is part of a Phase 1 dose escalation and expansion trial enrolling patients with advanced or metastatic ovarian, endometrial, and testicular cancers."

Trial status • Endometrial Cancer • Ovarian Cancer • Testicular Cancer

Context Therapeutics Announces First Patient Dosed in the Phase 1 Clinical Trial of CTIM-76 (GlobeNewswire) - "Context Therapeutics...announced that the first patient has been dosed in its Phase 1 clinical trial evaluating CTIM-76, a Claudin 6 ('CLDN6') x CD3 T cell engaging bispecific antibody. The Phase 1 dose escalation and expansion trial is enrolling patients with CLDN6-positive gynecologic and testicular cancers. The Company anticipates sharing initial data for the CTIM-76 Phase 1 trial in the first half of 2026....The Phase 1 clinical trial is an open-label, dose escalation and expansion study to evaluate the safety and efficacy of CTIM-76 in subjects with CLDN6-positive advanced or metastatic ovarian, endometrial, and testicular cancer....The study is expected to enroll up to 70 patients."

P1 data • Trial status • Endometrial Cancer • Ovarian Cancer • Testicular Cancer

Determination of first in human dose of the T cell-redirecting bispecific antibody CTIM-76 targeting Claudin 6 (SITC 2024) - "Therefore, a 22.5 mcg dose in humans would have safety margins of 462 and 393 based on Cmax and AUC, respectively. Conclusions The weight of evidence of these data supports the safety of the proposed clinical starting dose of 22.5 mcg CTIM-76."

P1 data • Oncology • CLDN6

Context Therapeutics Announces Poster Presentation at the Society for Immunotherapy of Cancer’s (SITC) 39th Annual Meeting (GlobeNewswire) - "Context Therapeutics Inc...announced a poster regarding the Company’s clinical asset, CTIM-76, a Claudin 6 x CD3 bispecific antibody will be presented at the Society for Immunotherapy of Cancer’s (SITC) 39th Annual Meeting, being held November 8–10, 2024 at the George R. Brown Convention Center in Houston, TX."

Clinical data • Oncology

Context Therapeutics Reports Second Quarter 2024 Operating and Financial Results (GlobeNewswire) - "...'Our team recently initiated our Phase 1 trial for CTIM-76, a Claudin 6 x CD3 bispecific antibody and looks forward to dosing our first patient in the third quarter'."

Trial status • Solid Tumor

A Phase 1 Study of CTIM-76 in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Context Therapeutics Inc.

Metastases • New P1 trial • Endometrial Cancer • Genito-urinary Cancer • Oncology • Ovarian Cancer • Refractory Ovarian Cancer • Solid Tumor • Testicular Cancer

Context Therapeutics Announces $100 Million Private Placement (GlobeNewswire) - "Context Therapeutics Inc...announced that it has entered into a securities purchase agreement with certain new and existing investors in a private placement that is expected to result in gross proceeds of approximately $100.0 million, before deducting placement agent fees and estimated offering expenses. The private placement is expected to close on May 6, 2024, subject to the satisfaction of customary closing conditions....Context expects that the net proceeds from the private placement, together with the Company’s existing cash and cash equivalents, will extend its cash runway through the estimated duration of the Company’s planned CTIM-76 Phase 1 clinical trial, as well as into 2028."

Financing • Genito-urinary Cancer • Gynecologic Cancers • Oncology • Solid Tumor • Testicular Cancer

Context Therapeutics Announces FDA Clearance of IND Application for a Phase 1 Clinical Trial of CTIM-76 (GlobeNewswire) - "Context Therapeutics Inc...announced that the U.S. Food and Drug Administration ('FDA') has cleared its Investigational New Drug ('IND') application for CTIM-76, a Claudin 6 ('CLDN6') x CD3 T cell engaging bispecific antibody. The IND supports the initiation of a Phase 1 dose escalation and expansion clinical trial of CTIM-76 in patients with CLDN6-positive gynecologic and testicular cancers. The Company anticipates the enrollment of the first patient in the dose escalation portion of its clinical trial in mid-2024."

IND • New P1 trial • Genito-urinary Cancer • Gynecologic Cancers • Oncology • Solid Tumor • Testicular Cancer

Context Therapeutics Submits IND Application to Evaluate CTIM-76 in Claudin 6-Positive Cancers (GlobeNewswire) - "Context Therapeutics...announced that on March 28, 2024, the Company submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration to begin a first-in-human clinical study of CTIM-76. The IND supports the initiation of a Phase 1 dose escalation and expansion clinical trial of CTIM-76 in patients with Claudin 6 (CLDN6)-positive gynecologic and testicular cancers."

IND • Gynecologic Cancers • Testicular Cancer

Context Therapeutics Reports Full Year 2023 Operating and Financial Results (GlobeNewswire) - "...'We look forward to filing an Investigational New Drug Application ('IND') with the U.S. Food and Drug Administration ('FDA') by the end of March 2024 for CTIM-76. We then plan to initiate a Phase 1 clinical trial to focus on CLDN6-positive gynecologic and testicular cancers upon receiving IND clearance from the FDA'....In February 2024, Context amended its collaboration and licensing agreement with Integral Molecular, Inc. ('Integral') to reflect updated financial terms to reduce various payment obligations and narrow the license grant to only cover CTIM-76."

IND • Licensing / partnership • Gynecologic Cancers • Testicular Cancer

Context Therapeutics Reports Third Quarter 2023 Operating and Financial Results - "Research and development (“R&D”) expenses were $4.5 million for the third quarter 2023, as compared to $2.1 million for the same period in 2022. The increase in R&D expenses was driven by higher CTIM-76 contract manufacturing costs and preclinical costs as a result of ongoing IND-enabling studies and activities. This increase was partially offset by a decrease in onapristone extended release (“ONA-XR”) expenses, primarily due to the Company’s decision in March 2023 to discontinue the development of ONA-XR and focus on the development of CTIM-76."

Commercial • Discontinued • Solid Tumor

Context Therapeutics Reports Third Quarter 2023 Operating and Financial Results - "In November 2023, announced encouraging preclinical data presented at the SITC 38th Annual Meeting that demonstrated CTIM-76 was well tolerated and induced dose-proportional tumor regressions in models of CLDN6-positive cancer. Benchmarking studies were conducted to compare CTIM-76 to clones of other CLDN6 clinical-stage compounds, including TORL-1-23 and AMG-794. In these studies, CTIM-76 was potent across a wide-range of CLDN6 expression profiles, whereas TORL-1-23 potency was limited to CLDN6-high expression. In addition, CTIM-76 demonstrated ten-fold higher potency than that of AMG-794 in in vitro cytotoxicity and cytokine activation assays."

Preclinical • Solid Tumor • CLDN6

Development of CTIM-76, a highly specific Claudin 6 bispecific antibody (SITC 2023) - "Methods Starting with a panel of high specificity CLDN6 antibodies, we engineered a large set (> 50) of CLDN6xCD3 bispecific antibodies using multiple bispecific formats and CD3 arms...Conclusions The exquisite specificity of CTIM-76 and potent cell-killing effects suggests it has significant potential as a potent and safe therapeutic against CLDN6-positive cancers. Context Therapeutics will be responsible for the clinical development of CTIM-76, and IND filing for this molecule is anticipated to occur in Q1 2024."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • CLDN3 • CLDN4 • CLDN6

Context Therapeutics Announces Preclinical Data Demonstrating Differentiated and Active Profile of its Claudin 6-Targeted Bispecific Antibody CTIM-76 (GlobeNewswire) - "Context Therapeutics...announced encouraging preclinical data regarding the Company’s preclinical asset, CTIM-76, a Claudin 6 (CLDN6) x CD3 T-cell engaging bispecific antibody....CTIM-76 was shown to have high potency and target selectivity in both binding and cytotoxicity assays. In in vivo xenograft experiments, CTIM-76 induced dose-proportional tumor regressions and was well tolerated....'These findings collectively support CTIM-76 as a promising CLDN6-targeting candidate, and we look forward to filing an Investigational New Drug Application late in the first quarter of 2024'."

IND • Preclinical • Solid Tumor

Context Therapeutics Announces Acceptance of Abstract to be Presented at the Society for Immunotherapy of Cancer’s (SITC) 38th Annual Meeting (GlobeNewswire) - "Context Therapeutics...announced a poster regarding the Company’s preclinical asset, CTIM-76, a Claudin 6 x CD3 bispecific antibody will be presented at the Society for Immunotherapy of Cancer’s (SITC) 38th Annual Meeting taking place November 3-5, 2023, at the San Diego Convention Center in San Diego, CA."

Preclinical • Oncology

Context Therapeutics Reports Second Quarter 2023 Operating and Financial Results (GlobeNewswire) - "Research and development ('R&D') expenses were $3.5 million for the second quarter 2023, as compared to $1.5 million for the same period in 2022. The increase in R&D expenses was driven by higher CTIM-76 contract manufacturing costs and preclinical costs as a result of ongoing IND-enabling studies and activities. This increase was primarily offset by a decrease in onapristone extended release ('ONA-XR') expenses due to the Company’s decision in March 2023 to discontinue the development of ONA-XR and focus on the development of CTIM-76."

Commercial • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Context Therapeutics Reports Second Quarter 2023 Operating and Financial Results (GlobeNewswire) - "...'We believe CTIM-76 is demonstrating unique qualities in preclinical research including potent killing of CLDN6-expressing cells, developability, and manufacturability. We look forward to providing additional preclinical data by the end of 2023 and remain on track to file an Investigational New Drug Application ('IND') in the first quarter of 2024'."

IND • Preclinical • Oncology • Solid Tumor

Context Therapeutics shares ASCO23 data on CLDN-6 targeted treatments and CTIM-76 update (Yahoo Finance) - "Context Therapeutics...to discuss the latest data on clinical cancer target Claudin 6 (CLDN6) presented at ASCO23 and how Context’s CTIM-76 CLDN6 X CD3 bispecific antibody sets itself apart from other CLDN6-targeted clinical candidates....CTIM-76 is currently in preclinical development and is intended to direct activated immune T cells to CLDN6-expressing cancer cells. Preclinical studies of evaluating CTIM-76 demonstrates selective immune-mediated cell death of CLDN6-positive cancer cells."

Preclinical • Oncology

Development of CTIM-76, a Highly Specific Claudin 6 Bispecific Antibody for Treatment of Ovarian Cancer (PEGS 2023) - No abstract available

Oncology • Ovarian Cancer • Solid Tumor • CLDN6

Context Therapeutics Reports First Quarter 2023 Operating and Financial Results (GlobeNewswire) - "CTIM-76 IND filing on track for Q1 2024."

IND • Oncology • Solid Tumor

Context Therapeutics CTIM-76 bispecific antibody preclinical data presented at AACR Annual Meeting (Market Screener) - "Context Therapeutics CEO Marty Lehr joins Proactive's Natalie Stoberman to discuss CTIM-76 preclinical data presented at the American Association for Cancer Research (AACR) Annual Meeting 2023. Lehr noted the latest CTIM-76 bispecific antibody data and developments were shared with investors and colleagues as Context prepares for an Investigational New Drug application filing in early 2024."

IND • Preclinical • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor