On November 4, 2025 Defence Therapeutics Inc. ("Defence" or the "Company"), a leading biotechnology company specialized in drug delivery technologies, reported at the World ADC Conference in San Diego, USA, highly encouraging results from its latest preclinical in vivo study evaluating Accum-Kadcyla, a novel version of Genentech/Roche’s marketed ADC Kadcyla (ado-trastuzumab emtansine), in mouse models of HER2-positive breast cancer.

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Study Results: 20-Fold Increased Potency at Equivalent Dose

In the comparative in vivo study, Accum-Kadcyla demonstrated a ~20-fold higher anti-tumor efficacy than Kadcyla alone when administered at the same dose (0.5 mg/kg). Tumor growth was significantly halted in the Accum-Kadcyla-treated group, resulting in a durable and near-complete response in most mice while Kadcyla at the same dose (0.5 mg/kg) had no effect on tumor growth. Importantly, 100% of the animals survived throughout the duration of the study with no signs of toxicity, underscoring the excellent tolerability of the treatment.

Implications for Patients and the Industry

These results confirm that Defence’s Accum platform can dramatically enhance the intracellular delivery and potency of ADCs by overcoming endosomal entrapment—a known bottleneck in ADC performance. By increasing the therapeutic payload’s reach inside cancer cells, Accum enables a more efficient drug release and tumor killing, even at lower doses.

This finding is particularly meaningful for patients: the ability to achieve the same or better efficacy at reduced doses translates into a potential reduction in toxicity and side effects, addressing one of the main limitations of current ADC therapies. Practically, it could potentially bring this current second line of treatment to a first line of treatment for the benefit of the patients.

Dr. Maxime Parisotto, Chief Scientific Officer of Defence Therapeutics, commented:

"These results further validate the power of Accum as a transformative technology for ADCs. By amplifying the potency of a clinically proven ADC like Kadcyla by 20 times at the same dose, we demonstrate that Accum can unlock a new generation of safer and more effective targeted therapies for cancer patients."

Next Steps and Commercial Outlook

Following these promising results, Defence Therapeutics plans to expand its Accum-ADC program to additional HER2-positive and HER2-low tumor models and to advance discussions with potential pharmaceutical partners.

(Press release, Defence Therapeutics, NOV 4, 2025, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-demonstrates-strong-preclinical-in-vivo-efficacy-results-evaluating-accum-kadcyla-in-breast-cancer-models [SID1234659633])

On November 4, 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 will be showing evidence of strong immune system engagement inducing potent anti-cancer cell 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. The details are listed below.

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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 very excited with this opportunity to showcase the activity of our novel Bria-OTS+ platform which is designed to reinvigorate the body’s immune system to powerfully and selectively attack cancer cells while sparing normal tissues," commented Miguel A. Lopez-Lago, PhD, BriaCell’s Chief Scientific Officer.

"We will present extensive immune system activation and cytotoxicity data at the upcoming poster session on November 7, 2025. Our data further validates the promise of our personalized cancer immunotherapy platform in advancing new treatments for cancer," stated Dr. William V. Williams, BriaCell’s President and CEO. "We look forward to evaluating these encouraging results in upcoming clinical studies of Bria-BRES+ for breast cancer and Bria-PROS+ for prostate cancer, as we strive to bring new hope to patients with unmet medical needs."

(Press release, BriaCell Therapeutics, NOV 4, 2025, View Source [SID1234659459])

On November 4, 2025 NEOK Bio, Inc., a biotechnology company focused on the development of novel antibody drug conjugates (ADCs) for improving outcomes for cancer patients, reported that it has emerged from stealth mode with $75 million in Series A financing. The company’s principal investor is ABL Bio, Inc., a leading Korean biotech company and a proven leader in antibody engineering. The funding will be used to advance two bispecific ADC programs into the clinic. The company aims to be a leading bispecific ADC company in the U.S.

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Leveraging ABL’s innovative ADC platform technology, NEOK is building a pipeline of bispecific ADCs by pursuing validated targets, while balancing high expression, selectivity, and target-related safety signals. NEOK utilizes a proprietary, linker-payload technology (SYNtecan E) that enables ADC generation with strong linker stability and superior biophysical properties. The company aims to overcome the efficacy and safety limitations of conventional ADCs through its bispecific approach which targets unique pairs of cancer targets.

"ADCs are a proven modality in treating select cancers, but historically have had limitations related to stability, selectivity, and therapeutic window. We believe our dual-targeting strategy has the potential to overcome drug resistance, target a wider range of tumors, increase internalization rates and cell killing, and improve the safety profile of ADCs by increasing selectivity and reducing off-tumor toxicity," said Mayank Gandhi, Chief Executive Officer of NEOK Bio. "The financing is a critical step in our journey to a clinical-stage company and enables the execution of a robust and efficient clinical development plan for our bispecific ADCs."

"Our investment in the formation of NEOK Bio underscores our commitment to deliver transformative therapeutic innovation to the dynamic and growing ADC landscape," said ABL Bio CEO Dr. Sang Hoon Lee. "We are excited to support an outstanding and experienced NEOK team as they aim to fulfill the significant untapped potential of bispecific ADCs to improve the lives of people with cancer."

The financing will support the initiation of clinical studies for NEOK’s two lead ADC candidates, which target proteins that are broadly expressed in multiple tumor types with significant unmet needs. They include NEOK001 (previously ABL206), a bispecific ADC targeting ROR1 and B7-H3, and NEOK002 (previously ABL209), a bispecific ADC targeting EGFR and MUC1 proteins. Both assets have the potential to demonstrate enhanced efficacy and safety over monovalent ADCs in large patient populations across thoracic, gastrointestinal, and gynecological cancers.

NEOK plans to file an Investigational New Drug (IND) application for both programs by early 2026 and initiate Phase 1 clinical trials in mid-2026 in the U.S. First data readouts from both programs are expected in 2027.

(Press release, Neok Bio, NOV 4, 2025, View Source [SID1234659407])

On November 4, 2025 Ensoma, an in vivo hematopoietic stem cell (HSC) engineering company with a mission to advance the future of medicine through one-time therapies, reported new preclinical data demonstrating proof-of-concept for its in vivo, HSC-derived CAR-M, NK, and T cell platform, including its potential to durably generate lineage-restricted CAR cells in solid tumors. The data will be presented in two poster sessions this week at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Annual Meeting, taking place November 5-9 in National Harbor, Md.

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"While ex vivo CAR-T therapies have transformed treatment for blood cancers, use in solid tumors has been limited by multiple factors, including poor T cell infiltration and persistence in the immunosuppressive tumor microenvironment, as well as manufacturing cost and complexity," said Jim Burns, CEO of Ensoma. "By engineering HSCs in vivo, we can develop off-the-shelf therapies that turn the body into its own cell factory—capable of continuously producing multiple CAR immune cell types that work together against solid tumors. These data move us closer to realizing this vision as we advance toward our first in vivo, HSC-derived CAR-M, NK, and T development candidate early next year."

Ensoma SITC (Free SITC Whitepaper) poster presentations:

In vivo HSC engineering with Ensoma’s virus like particles (VLPs) generates lineage-restricted, multiplexed CAR-M, NK, and T cells to cooperatively mediate solid tumor control in pre-clinical models

Abstract Number: 302

Poster Presentation Time/Date: Saturday, November 8, 5:10-6:35 pm EST

Location: Gaylord National Resort and Convention Center – Lower Level Atrium – Prince George’s ABC

Presenter: Yiwen Zhao, Ph.D., Ensoma

This study in HER2-positive orthotopic tumor-bearing mouse models, validates proof-of-concept for anti-tumor activity driven by in vivo CAR therapy via HSC engineering. Administration of VLPs encoding lineage-specific HER2 CARs successfully generated durable CAR-expressing myeloid, NK, and T cells from HSCs that:

Exhibited tumor suppression in vivo and ex vivo
Remodeled the cold solid tumor microenvironment, marked by macrophage M1 polarization, increased lymphocyte recruitment, and production of inflammatory cytokines and chemokines.
Discovery of lineage specific regulatory elements for development of in vivo CAR immune cell therapy via hematopoietic stem cell engineering

Abstract Number: 1019

Poster Presentation Time/Date: Friday, November 7, 5:10-6:35 pm EST

Location: Gaylord National Resort and Convention Center – Lower Level Atrium – Prince George’s ABC

Presenter: Alvin Pratama, Ph.D., Ensoma

This research supports the ability of the Ensoma platform to precisely identify and validate genetic regulatory elements that have the potential to drive robust lineage-restricted CAR expression in effector immune cells, potentially improving safety and functional control. Using Ensoma’s HSC-targeted VLPs to deliver lineage-restricted CAR payloads, the team achieved stable integration and selective CAR expression across myeloid, NK and T cells in human CD46 transgenic mouse models. The lineage-restricted CAR cells displayed potent, antigen-dependent cytotoxicity and cytokine production comparable to ubiquitous CAG-driven CARs, supporting the platform’s potential for precise, scalable and lineage-controlled in vivo CAR delivery.

(Press release, Ensoma, NOV 4, 2025, View Source [SID1234659406])

On November 4, 2025 Dispatch Bio, a biotechnology company developing a universal treatment for solid tumors, reported preclinical data supporting its first therapeutic program planned to enter the clinic, DISP-10, and its first-in-class Flare platform, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2025 Annual Meeting.

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Immunotherapies have had limited success in solid tumors due to the lack of tumor-specific targets and a profoundly immunosuppressive microenvironment. Dispatch’s Flare platform addresses these barriers by systemically delivering a tumor-specific virus that paints a universal synthetic antigen (Flare) on tumor cells, enabling precise recognition by T cells, while reshaping the tumor microenvironment to support immune activity. Data presented at SITC (Free SITC Whitepaper) (Abstract 394) demonstrate strong and consistent tumor labeling, iterative viral amplification and tumor cell clearance across multiple epithelial tumor models.

"These data show that delivering engineered targets specifically to tumor cells allows us to control antigen specificity, while also reprogramming the tumor microenvironment," said Lex Johnson, Ph.D., Co-Founder and Chief Platform Officer. "We are excited to start with CAR T as our first program, and because the Flare approach is modular and not restricted to CAR T cells, it can be extended across multiple immunotherapy modalities."

The company also presented preclinical findings from DISP-10, its first therapeutic candidate (Abstract 393). DISP-10 pairs DV-10, a tumor-targeted virus expressing a modified BCMA antigen (dBCMA) and the immune-stimulatory cytokine IL-18 and chemokine CXCL9, with a clinically validated BCMA-directed CAR T. The viral component installs the target and drives local immune activation, enabling robust CAR T function in solid tumors. DISP-10 demonstrated potent anti-tumor responses in numerous in vitro and in vivo models, with no activity observed in healthy cells. Dispatch plans to initiate a first-in-human Phase 1 study in 2026 to evaluate DISP-10 across multiple solid tumor types.

"DISP-10 creates the right biological context for CAR T cells to function in solid tumors," said Barbra Sasu, Ph.D., Chief Scientific Officer. "The consistency of activity seen with various BCMA-targeted therapies across tumor models gives us confidence in its clinical potential."

(Press release, Dispatch Bio, NOV 4, 2025, View Source [SID1234659405])