On November 10, 2025 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), reported financial results for the third quarter ended September 30, 2025, and provided operational updates.

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"The successful completion of our most recent PIPE financing strengthens our balance sheet and provides the resources to further invest in ZYNLONTA as we anticipate advancing into earlier lines of therapy for DLBCL and into indolent lymphomas," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "We look forward to multiple upcoming clinical catalysts expected across LOTIS-7, LOTIS-5, and the ongoing Phase 2 IITs, starting with LOTIS-7 before the end of this year and continuing with data readouts throughout 2026."

Third Quarter 2025 Operational Updates & Recent Highlights

•Completed private investment in public equity (PIPE) financing. The Company entered into a securities purchase agreement for the sale of its equity securities to certain institutional investors in a $60 million PIPE financing, of which the net proceeds of approximately $57.6 million are anticipated to fund the commercial expansion of ZYNLONTA and strengthen the Company’s balance sheet.
•Updated data from LOTIS-7 expected by the end of the year. Beyond the initial results reported at European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Congress (EHA2025) and at the International Conference on Malignant Lymphoma (ICML) in June from the LOTIS-7 Phase 1b trial evaluating ZYNLONTA in combination with the bispecific antibody glofitamab (COLUMVI) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL), the Company expects to share additional data from the LOTIS-7 trial through a corporate update by the end of the year. Once sufficient data with longer follow-up is available, the Company plans to engage with the U.S. Food and Drug Administration (FDA). In addition, the Company plans to pursue publication and compendia inclusion in the first half of 2027.
•LOTIS-5 topline results anticipated in 1H 2026. The Company expects to provide topline data in the first half of 2026 from the LOTIS-5 Phase 3 confirmatory trial of ZYNLONTA in combination with rituximab in patients with 2L+ DLBCL once the pre-specified number of progression-free survival (PFS) events is reached and data are available. Assuming positive results, a supplemental Biologics License Application (sBLA) submission to regulatory authorities will follow, with potential confirmatory approval in 2L+ DLBCL as well as publication and compendia inclusion in the first half of 2027.
•Updated data from the Phase 2 investigator-initiated trial (IIT) of ZYNLONTA in r/r follicular lymphoma (FL) presented at the 22nd International Workshop on Non-Hodgkin Lymphoma (iwNHL). Juan Pablo Alderuccio, MD, Clinical Site Disease Group Leader, Lymphoma Section, at Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine, presented updated data at iwNHL in September from the Phase 2 IIT evaluating ZYNLONTA in combination with rituximab in r/r FL. Data from the 55 efficacy evaluable patients to date in this trial continue to demonstrate encouraging results with an overall response rate (ORR) of 98.2%, a complete response rate (CR) of 83.6%. After median follow-up of 28th months, median PFS was not reached, and the 12-month PFS was 93.9%. Safety was consistent with the known profile of ZYNLONTA. The trial has been expanded to enroll 100 patients, and the Company plans to assess regulatory and updated compendia pathways as soon as sufficient data are available.
•IND-enabling activities advancing for PSMA-targeting ADC. IND-enabling activities are ongoing for the Company’s exatecan-based, prostate-specific membrane antigen (PSMA)-targeting ADC with completion of these activities expected by the end of 2025.

Third Quarter and Year to Date 2025 Financial Results

•Product Revenues: Net product revenues were $15.8 million for the three months ended September 30, 2025, and $51.2 million for the nine months of 2025 as compared to $18.0 million and $52.9 million for the same periods in 2024. The period-over-period changes were primarily driven by lower sales volume, partially offset by higher sales price and favorability in gross-to-net sales adjustments.
•Research and Development (R&D) Expense: R&D expense was $26.8 million for the three months ended September 30, 2025, as compared to $32.5 million for the same period in 2024. The decrease in R&D costs for the three-month period was driven by a reduction in spending on discontinued programs and timing and enrollment of our ZYNLONTA clinical trials, partially offset by an increase in IND-enabling activities for our PSMA-targeting ADC. R&D expense was $85.8 million for the nine months ended September 30, 2025, as compared to $82.5 million for the same period in 2024. The increase in R&D costs for the nine-month period was driven by an increase in IND-enabling activities for our PSMA-targeting ADC and timing and enrollment of our ZYNLONTA clinical trials, partially offset by a reduction in spending on discontinued programs.
•Selling and Marketing (S&M) Expense: S&M expenses were relatively consistent at $10.7 million for the three months ended September 30, 2024, and 2025, respectively. S&M expense was $31.4 million for the nine months ended September 30, 2025, as compared to $32.8 million for the same period in 2024. The period-over-period decrease was primarily due to a reduction in marketing and advertising expenses.
•General & Administrative (G&A) Expense: G&A expense was $8.3 million and $27.1 million for the three and nine months ended September 30, 2025, respectively, compared to $10.0 million and $32.3 million for the same periods in 2024. The reductions in G&A expense were primarily due to lower external professional fees.
•Restructuring, impairment and other related costs: In connection with the strategic reprioritization and restructuring plan announced in June 2025, the Company incurred $0.4 million and $13.5 million in restructuring, impairment and other related costs for the three and nine months ended September 30, 2025, which consisted of $6.2 million in employee severance and related benefit costs, $6.4 million in non-cash impairment of assets and $0.8 million in retirement costs in connection with the close down of the UK facility.
•Net Loss: Net loss for the three months ended September 30, 2025, was $41.0 million, or a net loss of $0.30 per basic and diluted share, as compared to a net loss of $44.0 million, or a net loss of $0.42 per basic and diluted share, for the same period in 2024. The lower net loss for the three-month period was primarily due to lower R&D and G&A expenses. Net loss for

the nine months ended September 30, 2025, was $136.2 million, or a net loss of $1.14 per basic and diluted share, as compared to a net loss of $127.1 million, or a net loss of $1.35 per basic and diluted share, for the same period in 2024. The higher net loss for the nine-month period was primarily due to the increase in R&D expense, the restructuring, impairment and related costs incurred in connection with the strategic reprioritization and restructuring plan and lower interest income.
•Adjusted Net Loss: Adjusted net loss, which is a non-GAAP financial measure, was $25.5 million, or an adjusted net loss of $0.19 per basic and diluted share for the three months ended September 30, 2025, as compared to adjusted net loss of $29.4 million, or $0.28 per basic and diluted share, for the same period in 2024. Adjusted net loss for the nine months ended September 30, 2025, was $78.2 million, or an adjusted net loss of $0.66 per basic and diluted share, as compared to an adjusted net loss of $84.9 million, or $0.90 per basic and diluted share, for the same period in 2024. The decrease in adjusted net loss for the three-month and nine-month periods was due to lower operating expenses and a higher number of weighted average shares outstanding.
•Cash and cash equivalents: As of September 30, 2025, cash and cash equivalents were $234.7 million, compared to $250.9 million as of December 31, 2024. In October, the Company entered into securities purchase agreements for the sale of its equity securities to certain institutional investors in a $60.0 million PIPE financing. Giving effect to the estimated net proceeds from the PIPE financing of approximately $57.6 million (after deducting placement agent fees and estimated offering expenses), the Company would have had approximately $292.3 million of cash and cash equivalents as of that date.

Conference Call Details

ADC Therapeutics management will host a conference call and live audio webcast to discuss third quarter 2025 financial results and provide a company update today at 8:30 a.m. Eastern Time. To access the conference call, please register here. Registrants will receive the dial-in number and unique PIN. It is recommended that you join 10 minutes before the event, though you may pre-register at any time. A live webcast of the call will be available under "Events & Presentations" in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call.

(Press release, ADC Therapeutics, NOV 10, 2025, View Source [SID1234659699])

On November 9, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company," 6990.HK) reported results from multiple clinical studies on its TROP2 ADC sacituzumab tirumotecan (sac-TMT) as oral presentations. From November 6 to 9, the 2025 Chinese Congress on Holistic Integrative Oncology (CCHIO) was held in Kunming, Yunnan. This conference was jointly organized by the Chinese Anti-Cancer Association (CACA), the Tengchong Science Forum Organizing Committee Office, the World Association for Integrative Oncology (WAIO), and the China Institute for Integrative Medicine Development Strategy. Academicians, experts, and scholars from across the nation gathered to focus on innovations in cancer diagnosis and treatment while sharing scientific breakthroughs.

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KL264-01/MK-2870-001

On November 7, Professor Sheng Jindong from Tianjin Cancer Hospital presented oral results on the efficacy and safety of sacituzumab tirumotecan (sac-TMT) monotherapy for locally advanced or metastatic endometrial cancer (EC) in a Phase II study at the conference. The endometrial carcinoma (EC) cohort in this study enrolled a total of 158 patients, with 114 patients assigned to the sac-TMT 4 mg/kg group and 44 patients to the sac-TMT 5 mg/kg group.

At data cutoff (May 21, 2025), median (range) follow-up was 11.7 months in the 4 mg/kg group and 21.8 months in the 5 mg/kg group. Confirmed objective response rate (ORR) was 30.7% and 34.1% in the 4 mg/kg and 5 mg/kg groups; all responses were partial response (PR). Confirmed and unconfirmed ORR was 35.1% and 36.4% in the 4 mg/kg and 5 mg/kg groups. Median duration of response (DOR) was 9.3 months and 8.7 months in the 4 mg/kg and 5 mg/kg groups. Median progression free survival (PFS) was 6.0 months and 7.3 months in the 4 mg/kg and 5 mg/kg groups.

Grade ≥3 treatment-related AEs (TRAEs) occurred in 59 patients (51.8%) and 34 patients (77.3%) in the 4 mg/kg and 5 mg/kg groups respectively; Treatment-related AEs that led to treatment discontinuation was 2 and 1 patient in each group, respectively.

In patients with advanced EC, sac-TMT monotherapy showed promising antitumor activity in the ≥2L advanced/metastatic setting and manageable safety. Both the 4 mg/kg and 5 mg/kg groups exhibited manageable safety and tolerability profiles consistent with the known safety characteristics of sac-TMT. These data led to initiation of two ongoing global Phase 3 studies of sac-TMT 4 mg/kg Q2W in advanced EC, which were sponsored and led by MSD.

OptiTROP-Lung03

On November 8, Professor Fang Wenfeng from the Cancer Center of Sun Yat-sen University delivered an oral presentation at the conference on preliminary results from a Phase II study evaluating sac-TMT in treating locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring uncommon EGFR mutations in previously treated patients. As of Dec 01, 2024, 42 patients were enrolled, including 23 patients with EGFR uncommon non-ex20ins mutations and 19 patients with EGFR ex20ins. Patients received sac-TMT 5 mg/kg Q2W until disease progression or unacceptable toxicity. After a median follow-up of 9.9 months, the ORR was 35.7% (15/42, 3 pending confirmation). The disease control rate (DCR) was 85.7%. Responses were durable with the median duration of response (mDoR) not yet reached, and the 6-month DoR rate was 90.9%. The median progression-free survival (mPFS) was 9.5 months (95% CI: 5.6, 10.9).

In the subset of patients with uncommon non-ex20ins, the ORR was 34.8% (8/23, 1 pending confirmation); the mPFS was 10.9 months (95% CI: 5.6, NE). In the subset of patients with ex20ins, the ORR was 36.8% (7/19, 2 pending confirmation); the mPFS was 9.0 months (95% CI: 2.4, NE). Grade ≥3 treatment-related adverse events occurred in 52.4% of pts. No TRAE led to treatment discontinuation or death. No cases of interstitial lung disease/pneumonitis were reported.

Sac-TMT monotherapy demonstrated promising clinical activity with a manageable safety profile in previously treated advanced NSCLC patients with uncommon EGFR mutations. These findings warrant further investigation of sac-TMT as a potential therapy for this population.

OptiTROP-Lung01

Professor Fang Wenfeng also presented results from the non-squamous cohort in the Phase II study evaluating the combination of sac-TMT and tagitanlimab (anti-PD-L1) as first-line therapy for advanced NSCLC during the oral presentation session. As of Dec 30, 2024, 81 patients with non-squamous histology were enrolled. Patients receive sac-TMT (5 mg/kg Q3W or Q2W) plus tagitanlimab (1200 mg Q3W or 900 mg Q2W) until disease progression or unacceptable toxicity. After median follow-up of 17.1 months, the confirmed ORR was 59.3%; The DCR was 91.4%; mDOR was 16.5 months (95% CI: 11.7, 22.1); mPFS was 15.0 months (95% CI: 10.8, 24.8). Among pts with PD-L1 TPS< 1%, the confirmed ORR was 47.1%; mPFS was 12.4 months (95%CI: 7.6, 15.4); while for patients with PD-L1 TPS≥ 1%, the confirmed ORR was 68.1%; mPFS was 17.8 months (95%CI: 14.5, NE). Among patients with PD-L1 TPS≥ 50%, the confirmed ORR was 77.8%; mPFS was 17.8 months (95% CI: 10.8, NE). No TRAE led to treatment discontinuation or death.

Sac-TMT in combination with tagitanlimab demonstrated promising antitumor activity in treatment-naive advanced non-squamous NSCLC. The durable clinical activities were observed regardless of PD-L1 expression. This combination therapy showed a tolerable safety profile based on known profiles of the individual agents, with no new safety signals observed.

Currently, two Phase 3 registrational studies of sac-TMT, namely (i) sac-TMT in combination with pembrolizumab (KEYTRUDA1) versus pembrolizumab for first-line treatment of patients with PD-L1 positive locally advanced or metastatic NSCLC, and (ii) sac-TMT in combination with pembrolizumab versus chemotherapy combined with pembrolizumab as first-line treatment for patients with PD-L1 negative locally advanced or metastatic non-squamous NSCLC are in progress.

With the goal of addressing patients’ urgent clinical needs, Kelun-Biotech has initiated over 30 clinical studies across multiple disease areas including lung cancer, breast cancer, and gynecological tumors. Leveraging its proprietary ADC and novel DC platform, OptiDC, the Company will continue developing innovative drugs with significant clinical value. This commitment aims to further enhance patient outcomes and contribute corporate strength to advancing the Healthy China initiative.

About Sac-TMT

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macau, and Taiwan).

To date, three indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting), EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy and EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy. Sac-TMT is the first TROP2 ADC drug approved for marketing in lung cancer globally. In addition, the new indication application for sac-TMT for the treatment of adult patients with unresectable locally advanced, metastatic hormone receptor positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting was accepted by the Center for Drug Evaluation of the NMPA, and was included in the priority review and approval process.

As of today, the Company has initiated 9 registrational clinical studies in China. MSD has initiated 15 ongoing Phase Ⅲ global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.

(Press release, Kelun, NOV 9, 2025, View Source [SID1234659674])

On November 7, 2025 Trained Therapeutix Discovery, Inc., a biotech company training immunity at its origin with nanomedicines, reported preclinical data on RIDE-001, a nanomedicine designed to program myeloid progenitor cells for an anticancer innate immune response, were presented in a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. The data demonstrated that RIDE-001 effectively induced trained immunity in vitro in primary human immune cells, induced anti-tumor immunity in mouse tumor models of melanoma and colorectal cancer, and safely induced innate immune responses in rats and non-human primates. RIDE-001 showed therapeutic activity against solid tumors as a single agent, and it also exhibited synergy in combination with immune checkpoint inhibition.

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"Myeloid cells can promote cancer by suppressing anti-tumor immune responses, enhancing tumor angiogenesis and facilitating metastasis, but due to their plasticity in the tumor microenvironment, they have been considered an unattractive therapeutic target," said Willem Mulder, PhD, Chief Scientific Officer of Trained Therapeutix Discovery. "Our approach with RIDE-001 is a breakthrough in immune-oncology, as it targets myeloid progenitor cells before they differentiate into immune cells. By programing myeloid cells at their naissance, we can deploy the power of the innate immune response against cancer. Based on these promising data demonstrating consistent myeloid cell training and antitumor activity across species, in addition to RIDE-001’s favorable safety profile, we have initiated GMP manufacturing in anticipation of the first clinical studies in patients with solid tumors."

RIDE-001 was developed using Trained Therapeutix Discovery’s proprietary ApoA1-based nanomedicines platform to target the bone marrow where it activates the intracellular pattern recognition receptor NOD2. This triggers epigenetic changes in myeloid progenitor cells, inducing the production of trained myeloid cells to generate durable, anti-tumor responses.

RIDE-001 preclinical data showed:

A dose-dependent rise in NOD2 activation;
Trained immunity as assessed by peripheral blood mononuclear cells (PBMCs);
Trained myeloid cells in rats demonstrating a shift in monocyte phenotype and increased blood neutrophil counts;
Trained myeloid cells in non-human primates with a consistent increase in intermediate monocytes in both males and females following each administered dose;
Single-agent anti-tumor efficacy in the highly immunosuppressive B16F10 melanoma mouse model;
Synergy with a subtherapeutic dose of anti-PD1 in the MC38 colorectal cancer mouse model;
And a favorable safety profile.
A copy of the poster titled "RIDE-001: A well-tolerated innate immunotherapy to treat cancer by targeting and reprogramming bone marrow progenitor cells" (abstract number 1178) is available on the company’s website.

(Press release, Trained Therapeutix Discovery, NOV 7, 2025, View Source [SID1234660997])

On November 7, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported that the Company is presenting evidence of strong immune system engagement and anti-cancer activity of its next generation Bria-OTS+ platform in preclinical models at a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40 th Anniversary Annual Meeting, to be held November 7-9, 2025, in National Harbor, MD.

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Title: Redefining Cancer Vaccines: Bria-OTS+ Integrates Trained Innate Immunity and Adaptive Memory to Overcome Immune Resistance
Abstract Number: 353
Location: Prince George ABC Exhibit Halls, Gaylord National Resort and Convention Center
Date: Friday, November. 7, 2025
Time : 12:15-1:45 PM, and 5:35-7 PM ET

"We are thrilled with the comprehensive, powerful, and long-lasting immune activation demonstrated by Bria-OTS+ in our preclinical studies, which we believe will translate into meaningful anti-cancer immune responses in the clinic," stated Miguel A. Lopez-Lago, PhD, BriaCell’s Chief Scientific Officer. "By training both the innate and adaptive arms of the immune system, Bria-OTS+ represents an important step toward developing more durable and broadly effective cancer immunotherapies."

"These findings add to the growing body of evidence supporting our Bria-OTS+ platform’s unique mechanism of action for novel personalized cancer immunotherapies. We look forward to confirming these encouraging preclinical results in planned clinical trials of Bria-BRES+ for breast cancer and Bria-PROS+ for prostate cancer," commented Dr. William V. Williams, BriaCell’s President and CEO.

Summary of Preclinical Findings

Bria-OTS+ Fast Acting and Potent Anti-Cancer Immune System Activation :
Bria-BRES+ and Bria-PROS+ rapidly activated key components of the immune system in preclinical models. The platform induced coordinated innate and adaptive immune responses, training the immune system to kill cancer cells. These findings are consistent with strong anti-tumor immune activity and support its promise as BriaCell’s next generation cancer immunotherapy platform.

Bria-OTS+ Long Lasting Anti-Cancer Response :
Both Bria-BRES+ and Bria-PROS+ produced sustained, and durable anti-cancer immune responses that may translate into prolonged clinical benefit for patients treated with the Bria-OTS+ platform of whole cell immunotherapies.

Bria-OTS+: Broad Applicability :
Positive results with lead candidates Bria-BRES+ and Bria-PROS+ reinforce the broad applicability of the Bria-OTS+ platform and support possible expansion into other solid tumor indications. These data highlight the platform’s capacity to generate broad and potent immune responses against multiple tumor types that share key immune-recognition features.

(Press release, BriaCell Therapeutics, NOV 7, 2025, View Source [SID1234660840])

On November 7, 2025 TwoStep Therapeutics, a biotechnology company developing innovative, first-in-class, multispecific targeted peptide conjugate therapies for solid tumors, reported it will be presenting a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 40th Annual Meeting, being held November 7–9, 2025, at the Gaylord National Resort and Convention Center in National Harbor, MD.

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Poster Presentation:
Title: A multi-integrin targeting peptide-drug conjugate induces durable tumor regression with a strong preclinical safety profile
Date and Time: Saturday, November 8, 2025
Abstract Number: 948
Authors: Yash Agarwal, Caleb Perez, Joy Geallis, Caitlyn Miller
Recognized among the Top 15% of accepted abstracts.

(Press release, TwoStep Therapeutics, NOV 7, 2025, View Source [SID1234659661])