BriaCell Confirms 100% Resolution of Lung Metastasis with Bria-OTS(TM)

On April 24, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported the sustained complete resolution of the lung metastasis, first reported in February 2025 , two months after initial treatment in the ongoing Phase 1/2 Bria-OTS study (Press release, BriaCell Therapeutics, APR 24, 2025, View Source [SID1234652431]). The latest data at four months also demonstrates stable disease elsewhere.

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The patient, a 78-year-old woman with metastatic breast cancer (hormone receptor positive, HER2 negative), had failed several prior lines of therapy and received the lowest dose level in the Phase 1/2a Bria-OTS study. At enrollment on November 21, 2024, she had extensive metastases including bone, lymph node and lung involvement. Following Bria-OTS intradermal injections every 2 weeks for six weeks (4 total doses), and subsequent dosing every 3 weeks, the lung metastasis completely resolved with stable disease elsewhere. This response is now confirmed and shows the potentially promising activity of the Bria-OTS platform as monotherapy.

"Despite recent advancements with Antibody-drug-conjugates (ADCs) and immune check point inhibitors (CPIs), many patients, including those with HR+ disease, like BriaCell’s first OTS patient, have very few options," stated Neal S. Chawla MD, Director at the Sarcoma Oncology Center, Santa Monica, Ca., and Principal Investigator for the Bria-OTS study. "We are thrilled with our initial data with single agent Bria-OTS showing rapid and strong anti-tumor activity in an HR+ patient and look forward to continuing this novel approach in patients with MBC, and other cancers."

"This unprecedented anti-cancer response in the first patient dosed with Bria-OTS is an important milestone for us and provides early validation of BriaCell’s personalized immunotherapy approach," stated Dr. William V. Williams, BriaCell’s President and CEO.

Bria-OTS is a personalized off-the-shelf immunotherapy, currently under investigation in a Phase 1/2a dose escalation study (ClinicalTrials.gov identifier: NCT06471673 ) in metastatic recurrent breast cancer. Bria-OTS represents a personalized, next generation, advancement of BriaCell’s lead candidate Bria-IMT which is currently in a pivotal Phase 3 study for metastatic breast cancer. The Phase 1/2a clinical trial in metastatic breast cancer is a dose escalation study initially evaluating the safety and efficacy of Bria-OTS as monotherapy and will be followed by Bria-OTS in combination with an immune checkpoint inhibitor.

Flagship Pioneering Unveils Etiome to Pioneer Preemptive Healthcare

On April 24, 2025 Flagship Pioneering, the bioplatform innovation company, reported that it unveiled Etiome, a company redefining how we detect and preempt disease progression (Press release, Flagship Pioneering, APR 24, 2025, View Source [SID1234652210]). Etiome’s Temporal Biodynamics platform is the first end-to-end technology to characterize disease with increased resolution over time and accelerate the development of preemptive medicines that promise better health outcomes for people at risk of chronic or progressive diseases. The AI-powered platform makes it possible to forecast how individuals are likely to progress along the disease continuum, confirm disease biostages with temporally relevant markers, and develop Biostaged Medicines to halt or reverse disease before it becomes debilitating and irreversible. Flagship has initially committed $50 million to Etiome to advance the Temporal Biodynamics platform and develop an initial pipeline of preemptive medicines. Etiome was founded from Flagship Pioneering’s Preemptive Health and Medicine Initiative, which is pioneering a new field to protect, maintain, or improve people’s health before they get sick.

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"By combining expansive, multimodal population-level data and single cell omics with artificial intelligence, we have, for the first time, revealed unprecedented insights into the complex dynamics of disease biology over the course of progression," said Avak Kahvejian, Ph.D., Founding CEO of Etiome and General Partner at Flagship Pioneering. "In doing so, with our Temporal Biodynamics platform we have unlocked the ability to accurately characterize the biostages of disease progression, selectively identify and engage patients across stages, and create targeted medicines designed to alter the course of disease, even at its earliest stages, ensuring the right patient gets the right medicine at the right time."

Etiome designed the Temporal Biodynamics platform based on an understanding that the underlying biology of disease is dynamic and will mandate stage-specific interventions to effectively impact progression. To pioneer these targeted preemptive medicines, the platform first leverages expansive clinical, cellular, and molecular data and artificial intelligence to develop a deeper, time-based understanding of disease biology and forecast when individuals are likely to progress further into disease. With proprietary phenotype-aware AI, the platform then isolates and uncovers underlying temporal shifts in thousands of genes and proteins specific to each disease, revealing unique Biostage Markers—stage-specific biomarkers that indicate where a patient resides along the disease journey—and potential stage-appropriate therapeutic targets. Finally, temporally tuned, translational assays allow for target validation and the development of Biostaged Medicines.

"Until now, healthcare practices for serious and progressive diseases have often been reactive, treating diseases after they have caused significant damage and resulting in patient decline that can be irreversible," said Raj Panjabi, M.D., MPH, Senior Partner and Head of Flagship Pioneering’s Preemptive Health and Medicine Initiative and board director of Etiome. "Etiome is redefining how we think about disease progression and developing interventions precisely designed for critical intervention windows, at the earliest stages of disease – helping to slow, stop or even reverse it. This represents a significant shift towards preemptive medicine—a future where people can live healthier and longer lives."

Etiome is initially focused on developing Biostaged Medicines to address serious and progressive metabolic, neurodegenerative, pre-cancerous and autoimmune diseases, all of which impact large populations and have clear unmet needs. With these targeted therapeutics, Etiome aims to reduce morbidity, lower healthcare burdens and costs, and extend healthy and productive lifespans.

Scott Lipnick, Ph.D., Co-Founder and President of Etiome and Flagship Pioneering Origination Partner, added, "We envision a world where patients can be treated for a disease when it is still possible to slow, stop, or entirely preempt its progression. Doing so can prevent suffering, save lives, and lower healthcare costs. Over the last four years we have been building Etiome around this vision and look forward to making meaningful and rapid progress towards this future."

Etiome’s team includes leaders with extensive expertise in biology, omics, and artificial intelligence. In addition to Kahvejian and Lipnick, Etiome’s founding team includes Noubar Afeyan, Ph.D., Founder and CEO of Flagship Pioneering; Torben Straight Nissen, Ph.D., Chairman of the Board for Etiome, Flagship Pioneering Executive Partner and CEO of Repertoire Immune Medicines; Yann Echelard, Ph.D., Chief Operating Officer of Etiome and Flagship Pioneering Operating Partner; and Katharine von Herrmann, Ph.D., Chief Innovation Officer of Etiome and Flagship Pioneering Principal. Additionally, the Etiome board includes Gregory J. Moore M.D., Ph.D., a Senior Advisor at Gates Ventures and the former Corporate Vice President at Microsoft leading Health and Life Sciences.

Agilent Showcases Solutions and Partnerships Transforming Cancer Research and Therapeutics at AACR 2025

On April 24, 2025 Agilent Technologies Inc. (NYSE: A) reported its participation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting on April 25-30, 2025 in Chicago, Illinois (Press release, Agilent, APR 24, 2025, View Source [SID1234652127]). Innovative Agilent products and partnerships playing a crucial role in transforming cancer research, diagnostics, and therapeutics will be featured, including:

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Agilent Avida DNA Cancer Panels – Based on cutting-edge next-generation sequencing (NGS) target enrichment solutions that enable simultaneous DNA and methylation profiling from a single sample, the Avida product portfolio has expanded to include three new DNA panels*. Optimized based on the requirements of the European OncNGS Consortium, these catalog panels deliver ultra-sensitive and rapid detection of cancer-related genomic alterations from circulating cell-free DNA (cfDNA) in liquid biopsy samples. The streamlined DNA workflow generates sequencing-ready libraries in just five hours, enabling scientists to go from cfDNA samples to sequencing in a single day shift. These DNA panels can be paired with an Avida methylation panel to provide deep multiomic insights.
Agilent SureSelect Cancer CGP Assay and Tagomics InterlaceTM Multiomics Assay – Agilent has partnered with Tagomics to gain early access to a novel, unbiased approach for epigenetic profiling. The combined workflow of the Tagomics Interlace Multiomics assay with the Agilent SureSelect Cancer CGP assay offers a comprehensive genomic profiling solution, delivering genome-wide epigenetic signatures alongside targeted DNA variant detection. This enables novel and informative multiomic insights into cancer biology to accelerate disease understanding and diagnosis.
Agilent SureSelect Cancer Pan Heme Assay – Co-developed with the Roswell Park Comprehensive Cancer Center, this new assay interrogates DNA and RNA to provide comprehensive genomic profiling for hematologic malignancies. It is the first kitted assay with walkaway automation via the Agilent Magnis NGS Prep System, and an integrated, optimized secondary and tertiary data analysis software powered by QIAGEN Clinical Insight (QCI). This significantly improves laboratory productivity, efficiency, and turnaround time.
Agilent and Abcam Strategic Collaboration for (IHC) Companion Diagnostics (CDx) – This collaboration establishes a seamless paradigm for Agilent to develop a novel IHC CDx using Abcam’s extensive portfolio of over 10,000 high-quality, extensively validated, and stringently manufactured recombinant monoclonal antibodies, RabMAbs. The collaboration enables Agilent to expedite the development of custom assays for drug development and accelerates the use of assays in early clinical trials.
"At Agilent, we are dedicated to pushing the boundaries of cancer research and diagnostics," states Simon May, president of Agilent’s Life Sciences and Diagnostics Markets Group. "Our innovative solutions and strategic partnerships are at the forefront of transforming cancer care, enabling us to deliver comprehensive multiomic insights and cutting-edge diagnostic tools that empower researchers and clinicians to make more informed decisions and ultimately improve patient care."

AACR attendees are invited to join Agilent at the Exhibitor Spotlight Theater on Sunday, 27 April from 1:30 to 2:30 p.m. for an educational session titled "Revolutionizing Multiomic Profiling: Tagomics’ Interlace Platform and Agilent’s SureSelect Cancer Pan Heme Assay."

Presenter Dr. Robert Neely, PhD, Co-founder, Director, and Chief Scientific Officer at Tagomics, will explore their Interlace platform. This platform revolutionizes multiomic profiling with a single sample input and minimal sequencing. Combining Agilent’s SureSelect reagents with Tagomics’ unique approach to methylation profiling delivers comprehensive genome-wide genetic and epigenomic insights.

Following this, Dr. Sean Glen, PhD, Vice Chair of Molecular Pathology at the Roswell Park Comprehensive Cancer Center, will present on the Agilent SureSelect Cancer Pan Heme Assay. This assay is a breakthrough in hematological malignancy testing. It provides a long-term solution by targeting relevant mutation types across all heme-related genes and integrating automated lab and analysis solutions for expedited reporting.

AACR attendees can also explore multiple Agilent research posters and a plethora of posters and platform presentations by customers highlighting Agilent instruments and solutions. For more details about these events, visit the Agilent booth #2306.

*Agilent Avida DNA Onco LB, Avida DNA Onco LB Plus, and Agilent Avida DNA Lymphoma panels were developed as part of the oncNGS Project, which received funding from the European Union’s Horizon 2020 Research and Innovation Programme.

Iksuda to Present Growing ADC Pipeline at AACR

On April 24, 2025 Iksuda Therapeutics (Iksuda), the developer of class leading, clinically validated antibody drug conjugates (ADCs) reported that it will present three posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago, Illinois (25-30 April) (Press release, Iksuda Therapeutics, APR 24, 2025, View Source [SID1234652126]). The posters cover the Company’s new payload class, the ProAlk series, its CA242-directed ADC, IKS04, being developed for the treatment of gastrointestinal (GI) cancers, and its proprietary PermaLink conjugation chemistry.

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Iksuda will introduce its new ProAlk payload class which has a novel protein alkylating mechanism and is incorporated in ADCs in a prodrug format for enhanced targeting precision. ProAlk is active across a broad range of tumours and has been designed for optimal ADC relevance. It is associated with potent bystander activity and is MDR-resistant. Its novel mechanism will help to address the growing and significant challenge of ADC sequencing, where differentiation from tubulin and topoisomerase I inhibitor payloads will become imperative. Iksuda is building a pipeline of ProAlk driven ADCs which incorporate its proprietary PermaLink conjugation chemistry for ADC stability and tumour-selective payload activation and release for enhanced precision and safety.

The Company will also present a poster on IKS04, its CA242-directed ADC for the treatment of GI cancers and which is in IND-enabling studies. IKS04 uses a pro-drug approach for the tumour-specific delivery of a highly potent pyrrolobenzodiazepine (PBD) payload, avoiding the typical toxicity profile seen in traditional PBD ADCs. In preclinical trials, IKS04 is associated with in vivo efficacy which is substantially improved over benchmark ADCs in all tumour models, and a superior therapeutic index over all other PBD-based solid tumour ADC programs. IKS04 will be administered via pre-administration of naked antibody – a novel dosing regimen in the ADC field – to overcome high expression abundance and enable higher tumour penetration and consistent levels of efficacy across tumours. IKS04 is expected to enter clinical development in GI cancers by the end of 2025.

In addition, Iksuda will highlight its proprietary PermaLink conjugation chemistry, which is used across its early-stage ADC platform alongside the Company’s glucuronide linker formats and novel ProAlk payload. PermaLink offers a simple, scalable and highly stable bioconjugation method as an alternative to maleimide-based conjugation, enabling highly stable ADCs with favourable anti-tumour activity and safety.

Dr Dave Simpson, Chief Executive Officer, Iksuda Therapeutics, said:

"These three poster presentations at AACR (Free AACR Whitepaper) demonstrate Iksuda’s leadership in ADC innovation as we unveil our novel ProAlk payload class, overcoming the challenges in ADC sequencing and which will drive Iksuda’s deepening pipeline. With two clinical-stage programs, a growing pipeline of class leading ADCs and our expanding, innovative platforms, we are strongly positioned to progress new and promising ADCs to deliver improved outcomes for patients living with cancer. We look forward to progressing IKS04 into clinical development for GI cancers later this year, an area of high unmet need with limited effective treatment options and poor five-year survival rates for the significant number of patients with advanced disease."

Poster Presentation details:

ProAlk

Abstract Title:

PA289, a prodrug linker-payload with a novel mechanism of action for the development of antibody drug conjugates

Session Title:

Antibody-Based Cancer Therapeutics 1

Date/Time:

April 28, 2025 9:00 AM – 12:00 PM

Location:

Poster Section 15

Poster Number:

1579/28

IKS04

Abstract Title:

IKS04, an antibody drug conjugate with a highly potent DNA crosslinker payload for the treatment of gastrointestinal cancers

Session Title:

Antibody-Based Cancer Therapeutics 2

Date/Time:

April 28, 2025 2:00 PM – 5:00 PM

Location:

Poster Section 15

Poster Number:

2885/24

PermaLink

Abstract Title:

PermaLink, a stable and scalable bioconjugation platform as an alternative to maleimide-based conjugation

Session Title:

Antibody-Based Cancer Therapeutics 1

Date/Time:

April 28, 2025 9:00 AM – 12:00 PM

Location:

Poster Section 15

Poster Number:

1570/19

Innate Pharma Announces €15M Investment by Sanofi

On April 24, 2025 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported a €14,999,998.59 capital increase subscribed by Sanofi (Press release, Innate Pharma, APR 24, 2025, View Source [SID1234652125]).

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As announced on April 23, 2025, and given the satisfactory market conditions, Sanofi has agreed to subscribe to 8,345,387 new ordinary shares of Innate, at a price of €1.7974 per share, representing a total capital increase of €14,999,998.59 (€417,269.35 in nominal amount and €14,582,729.24 of issue premium).

The subscription price of €1.7974 per share (€0.05 in nominal amount and €1.7474 of issue premium) is equal to the daily volume-weighted average price of the ordinary shares of Innate on the regulated market of Euronext in Paris on April 23, 2025.

"We welcome Sanofi’s strategic investment in Innate, which further reinforces the strength of our collaboration. The proceeds from this capital increase will be used for general corporate purposes, including extending our cash runway to support continued pipeline execution and long-term value creation", said Jonathan Dickinson, Chief Executive Officer of Innate Pharma.

This capital increase is to be completed pursuant to the 22nd resolution of the combined general meeting of shareholders of Innate held on 23 May 2024.

Closing of the capital increase is expected to take place on April 25, 2025. The newly issued shares will be admitted to trading on the regulated market of Euronext in Paris on the same day.

The tables below set out the Company’s shareholding, based on the information available to Innate as of the date of this press release, before and after the closing of the capital increase:

Before closing

Shareholder

Nb of Shares*

%

Nb of voting rights†

%

Novo Nordisk A/S

9,817,546

11.71%

9,817,546

11.60%

Medimmune Limited

7,485,500

8.93%

7,485,500

8.85%

Bpifrance Participations

6,389,406

7.62%

6,389,406

7.55%

Members of the Executive Board, Supervisory Board and Leadership Team

846,944

1.01%

911,444

1.08%

Treasury shares

18,575

0.02%

0

0%

Public

59,286,440

70.71%

59,995,085

70.92%

Total

83,844,411

100%

84,598,981

100%

After closing

Shareholder

Nb of Shares*

%

Nb of voting rights†

%

Novo Nordisk A/S

9,817,546

10.65%

9,817,546

10.56%

Sanofi-Aventis Participations

8,345,387

9.05%

8,345,387

8.98%

Medimmune Limited

7,485,500

8.12%

7,485,500

8.05%

Bpifrance Participations

6,389,406

6.93%

6,389,406

6.87%

Members of the Executive Board, Supervisory Board and Leadership Team

846,944

0.92%

911,444

0.98%

Treasury shares

18,575

0.02%

0

0%

Public

59,286,440

64.31%

59,995,085

64.55%

Total

92,189,798

100%

92,944,368

100%