1stOncology™: Cancer Intelligence Service – Page 307 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Akari Therapeutics Presents Promising Immuno-OncologyData for its Novel Splicing-Targeted ADC Payload Driving ImmuneActivation, Both as Single Agent and in Combination with Anti-PD1 Checkpoint Inhibitors

On November 10, 2025 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing novel payloads for antibody drug conjugates (ADCs), reported the presentation of immune mechanism-of-action data for its novel ADC payload, PH1. The Company will host a live webcast to discuss the presented data on Tuesday, November 18th (details below).

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 abstract titled,A Novel Splicing-Targeted ADC Payload Drives Immune Activation, Synergy with Checkpoint Inhibitors, and Enhanced Therapeutic Potential Beyond Cytotoxicity was presented in oral and poster presentations at the recently held 40th Annual SITC (Free SITC Whitepaper) Meeting by Satyajit Mitra Ph.D., Executive Director, Head of Oncology at Akari Therapeutics.

Dr. Mitra commented, "We were excited to showcase the unique mechanism of action of our novel ADC payload PH1 at the annual meeting for SITC (Free SITC Whitepaper), a premier global immunotherapy conference. It’s not often that one gets to introduce a novel ADC payload class with the unique data we presented. I was thrilled to see our work being received extremely well and the excitement from colleagues to see further clinical development of the PH1 payload as Akari continues to advance its lead ADC molecule, a Trop2 PH1 ADC."

The presented data outlined Akari’s investigation of multiple mechanisms behind preclinical colon tumor regressions induced by a Trastuzumab PH1 ADC as a single agent or in combination with an anti-PD-1 therapy compared to a first-in-class ADC with a microtubule inhibitor payload, Kadcyla, tested also as a monotherapy or in combination with anti-PD1 therapy. A higher rate of complete tumor regressions was seen with Trastuzumab PH1 combined with anti-PD1 therapy (74%) when compared to Kadcyla, combined with anti-PD1 therapy (42%), with statistical significance of p < 0.05. These differentiated results are attributed to a multi-faceted immune response activated by neoantigens induced by the PH1 payload’s ability to disrupt normal RNA splicing. These neoantigens likely trigger the observed multi-modal immune response including a polarization of macrophages to the pro-inflammatory phenotype, an increase in the presence of neutrophils, and importantly, expansion of both B cell clones to produce polyclonal IgM antibodies, and gamma-delta T-cell clones. Notably, these immune system responses were not as prominent in the comparator test arm utilizing Kadcyla, in combination with anti-PD1 therapy. Importantly, these Trastuzumab PH1 results also highlight a synergy between the PH1 ADC payload and the anti-PD1 checkpoint inhibitor. The induction of gamma-delta T-cells by the combination of Trastuzumab PH1 and anti-PD1 is particularly interesting because this subpopulation of T-cells is known to attack cancer through a rapid response and has high cytotoxic activity.

Key Highlights:

Payload diversification is key in the current ADC landscape dominated by 2 ADC payload classes, microtubule inhibitors, and topoisomerase inhibitors.
A payload that disrupts the actions of the spliceosome demonstrates multiple modes of actions to attack cancer, including cytotoxicity and broad immuno-oncology effects.
An ADC of Trastuzumab PH1 induces RNA mis-splicing and subsequently increases neoantigen generation in cancer cells and a subsequent increase in anti-cancer immune cells in the tumor microenvironment.
Trasutuzmab-PH1 in combination with an anti-PD1 agent outperformed Kadcyla in combination with an anti-PD1 agent in complete tumor regressions with statistical significance (74% vs. 42%, p < 0.05) in an immune-competent, HER2-positive colon cancer model.
When combined with anti-PD1 therapy, the MOAs of the two agents complemented each other: Trastuzumab PH1 increased neoantigens, driving an increase in pro-inflammatory macrophages, an increase in pro-inflammatory neutrophils, and the expansion of B cells and resulting IgM antibodies. The anti-PD1 therapy specifically expanded alpha-beta T cell clones as expected, and together, the combination of both therapies drove the unique expansion of gamma-delta T cell clones. The synergy of the Trastuzumab PH1+ anti-PD-1 agent is likely due to each agent’s unique and complementary impact on the immune system.

These unique results seen with both the single agent ADC Trastuzumab-PH1 and the combination therapy with an anti-PD1 agent open up the possibility of creating a new paradigm of an ADC/checkpoint inhibitor therapy that goes beyond today’s regimens using ADCs with traditional payloads. This new potential combination of ADC’s using the PH1 payload with checkpoint inhibitors has the opportunity to set a new standard of care, and the chance to dramatically improve outcomes for cancer patients.

Utilizing its innovative ADC payload platform, Akari is advancing a new class of immuno-oncology ADCs built on the platform of a novel PH1 payload. This payload is designed specifically to target and disrupt the action of the spliceosome and has a unique preclinical efficacy and safety profile with the potential to address an unmet need for oncology patients as a monotherapy or used in combination with checkpoint inhibitors. Akari’s lead candidate, AKTX-101, targets the Trop2 receptor on cancer cells with a proprietary linker and delivers its novel PH1 payload directly into the tumor. Akari is currently initiating IND-enabling studies with the plan to advance this lead ADC into clinical trials in the near future. For more information, visit www.akaritx.com.

Webcast Details

Members from the Akari management team will host a live webcast to discuss the presented data for investors, analysts and other interested parties on Tuesday, November 18, 2025 at 11:00 AM ET.

Interested participants can access the webcast here or on the Presentations page under the Investors section of the Company’s website, akaritx.com. A replay of the webcast will be accessible two hours after the live event and archived for 90 days.

(Press release, Akari Therapeutics, NOV 10, 2025, View Source [SID1234659702])

AIM ImmunoTech Details New UPMC Abstract on Completed Clinical Trial Involving Ampligen’s Synergistic Potential in the Treatment of Advanced Recurrent Ovarian Cancer

On November 10, 2025 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported a recent abstract containing data from the completed Phase 2 advanced recurrent ovarian cancer clinical study utilizing Ampligen (rintatolimod), which was presented at the 40th Annual SITC (Free SITC Whitepaper) Meeting on November 7, 2025, at National Harbor, MD.

Platinum-sensitive patients with measurable peritoneal disease were eligible for combination therapy with up to six treatment cycles at 3-week intervals of intraperitoneal cisplatin, intravenous pembrolizumab (also known as Merck’s Keytruda) and intraperitoneal Ampligen. Of the 27 patients included in the trial, 24 were evaluable for response and of those 24 there were 5 patients with complete response and 7 patients with partial response, for an Objective Response Rate ("ORR") of 50%. In contrast, a previous study titled Keynote-100 found ORRs of 7.4% and 9.9% in two arms of a pembrolizumab-only study in advanced recurrent ovarian cancer.

Read the full abstract titled "A Phase II Trial of Combination Locoregional Chemoimmunotherapy in Recurrent Platinum-Sensitive Ovarian Cancer Triggers a T Lymphotactic Response Correlating with Clinical Outcomes."

Read more about the study at ClinicalTrials.gov: NCT03734692

These new ovarian cancer study results are consistent with AIM’s belief that Ampligen can act as a synergistic agent when combined with checkpoint inhibitors. This could be especially encouraging for refractory patients whose cancers do not respond to checkpoint inhibitors alone, such as in the Keynote-189 study in non-small cell lung cancer, which found that approximately 52% of study subjects did not respond in the pembrolizumab-combination group.

"Ampligen’s demonstrated ability to enhance the effectiveness of traditional cancer treatments could make it a difference maker that dramatically improves tumor immune responses and significantly prolongs the lives of people who have otherwise few effective options for prolonged remission and even possible cure," said Robert Edwards, MD, Milton Lawrence McCall Professor and Chair, Department of Obstetrics, Gynecology and Reproductive Sciences at the University of Pittsburgh School of Medicine.

AIM’s "synergistic" patents include a U.S. patent (expires August 9, 2039) for methods involving use of Ampligen as part of a combination oncology therapy when paired with an anti-PD-L1 antibody; a patent in Japan (expires December 20, 2039) for the use of Ampligen in combination with checkpoint inhibitors (anti-PD-1 or anti-PD-L1 antibodies) for the treatment of cancer; and a patent in the Netherlands (expires December 19, 2039) for the use of Ampligen as a combination cancer therapy with checkpoint blockade inhibitors, such as Keytruda (pembrolizumab), Opdivo (nivolumab) and Imfinzi (durvalumab).

For more information about the SITC (Free SITC Whitepaper) Annual Meeting, please visit sitcancer.org.

(Press release, AIM ImmunoTech, NOV 10, 2025, View Source [SID1234659701])

Agenus Reports Q3 2025 Results Showcasing Clinical and Regulatory Advances

On November 10, 2025 Agenus Inc. (Nasdaq: AGEN) reported quarterly results for the period ended September 30, 2025, and provided a business update. Highlights include government‑funded, reimbursed compassionate access (AAC) in France for botensilimab plus balstilimab (BOT/BAL), new survival data presented at ESMO (Free ESMO Whitepaper) and ESMO (Free ESMO Whitepaper)‑GI across more than 400 patients spanning more than five refractory cancers, and initiation of the global Phase 3 BATTMAN trial.

Access & Regulatory

•
France authorizes reimbursed AAC for BOT/BAL. In September, France’s medicines agency (ANSM) authorized reimbursed compassionate access (Accès Compassionnel, AAC) for BOT/BAL in refractory MSS mCRC without active liver metastases—the first government-funded access for this population and the first reimbursed access provided for BOT/BAL by a regulatory agency. link

Clinical Highlights

BOT/BAL has demonstrated durable, long-term survival in patients with advanced solid tumors, reinforcing its potential to expand the reach of immunotherapy to those historically unresponsive to treatment.

•
MSS metastatic colorectal cancer (ESMO‑GI 2025): In 123 heavily pretreated MSS mCRC patients without active liver metastases, BOT/BAL achieved 42% two‑year overall survival (OS) and 20.9‑month median OS. Median OS benchmarks in this third‑line‑plus setting is 8-14 months with current standards of care. link
•
Pan‑tumor cohort (ESMO 2025): Updated Phase 1b results in >400 patients demonstrated 39% two‑year OS across more than five refractory cancers, including colorectal, ovarian, sarcoma, lung, and hepatocellular tumors. Important to note that responses were seen after prior checkpoint inhibitor failure; immune‑related AEs were treatable and reversible. link

Phase 3 Program

•
Global registrational trial initiated. The BATTMAN (CCTG CO.33) Phase 3 trial conducted with the Canadian Cancer Trials Group and supported by AGITG (Australasia), and PRODIGE (France)—is launching in Q4 2025 across 100+ sites in Canada, France, Australia, and New Zealand to evaluate BOT/BAL versus best supportive care in refractory, unresectable MSS/pMMR colorectal cancer. link

Q3 2025 Financial Highlights

•
Zydus transactions: In October, Agenus and Zydus agreed to a $10 million bridge facility ahead of the anticipated $91 million upon closing of the transaction which also includes an equity investment at $7.50 per share.

•
MiNK deconsolidation: In July 2025, Agenus’ ownership of MiNK fell below 50%, resulting in deconsolidation in Q3 2025. This generated approximately $100.9 million gain, resulting in net income for the three‑month and nine-month period ended September 30, 2025.

Upcoming Catalysts

•
BATTMAN patient enrollment to commence before year-end 2025
•
BOT/BAL paid access programs: government reimbursed in France and self-pay in several European countries as well as other regions – patients currently under treatment in both pathways.
•
Investigator‑initiated trials: Neoadjuvant and frontline data updates expected 1H 2026
•
France AAC: Will generate real world evidence

Webcast and Conference Call Information

As part of Agenus’ newly launched webcast series, the Company will host a Stakeholder Briefing Webcast in late November, featuring internal and external experts. Additional details will be announced prior to the event.

(Press release, Agenus, NOV 10, 2025, View Source [SID1234659700])

ADC Therapeutics Reports Third Quarter 2025 Financial Results and Provides Operational Update

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.

"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])

Kelun-Biotech Presented TROP2 ADC Sacituzumab Tirumotecan Results From Multiple Clinical Studies at the 2025 CCHIO Congress

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.

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])