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

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%

On April 24, 2025 Debiopharm Research & Manufacturing S.A. (Debiopharm, www.debiopharm.com), a Swiss-based global biopharmaceutical company aiming to cure cancer and infectious diseases, and Oncodesign Services (www.oncodesign-services.com), a leading CRO specialized in drug discovery and preclinical services, reported the execution of a license agreement for the use of the AbYlink technology for preclinical services (Press release, Debiopharm, APR 24, 2025, View Source [SID1234652124]).

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AbYlink is a regio-selective bioconjugation technology ideally suited for preparing conjugates for use in therapeutic and non-invasive diagnostic applications. Oncodesign Services will use this cutting-edge technology to prepare antibody chelator conjugates for use in preclinical studies to gain insights into the predictive effectiveness of novel treatment approaches in Molecular Radiotherapy, and particularly Radioimmunotherapy in the context of cancer. A joint poster will be presented at the AACR (Free AACR Whitepaper) Annual Meeting 2025 to demonstrate the use of the non-invasive technology in Radioimmunotherapy, targeting animal models bearing HER2+ tumors.

"We have demonstrated the effectiveness of this powerful technology to rapidly and covalently conjugate any off-the-shelf antibody in a single step with an imaging agent. Our strategic collaboration with Oncodesign Services allows broader access to and usage of non-invasive imaging applications and provides an innovative solution to biotech and pharma partners to integrate imagery in the development of new antibody- and ADC-based therapeutics," commented Frédéric Lévy, Chief Scientific Officer at Debiopharm.

Aidan Synnott, CEO of Oncodesign Services, said, "We are pleased to integrate this cutting-edge technology into our portfolio for our clients. The AbYlink technology gives the advantage of generating reproducible batches of bioconjugated antibodies and ADCs that secure specificity and efficacy of targeted radiotherapy."

About AbYlink

AbYlink is a versatile and rapid regio-selective chemical conjugation technology for use to prepare diagnostic or therapeutic conjugates. This one-step method results in stable conjugation at defined and invariable sites on the Fc domain of an antibody or the like, with no impact on antigen-binding regions. It enables a seamless and reproducible conjugation of payloads (e.g., a chelator for radiolabeling, a fluorescent dye or a drug) to antibodies or ADCs. The universal applicability of the technology has been demonstrated for various antibody isotypes and payloads.

On April 24, 2025 Mosaic Therapeutics, Ltd (‘Mosaic’, or ‘the Company’) a targeted oncology therapeutics company dedicated to resolving cancer’s complexity with new combination therapies for patients, reported the in-licensing of two clinical-stage oncology programs from Astex Pharmaceuticals (‘Astex’), a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd (Press release, Mosaic Therapeutics, APR 24, 2025, View Source [SID1234652123]). Mosaic has identified proprietary combinations incorporating the licensed products and their targets and this agreement gives Mosaic the exclusive rights to develop those combination products for patients for whom there are no, or limited, treatment options.

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As part of the agreement, Astex has taken an equity stake in Mosaic equating to a fully-diluted ownership stake of 19% equity upfront and a further 3% dependent on clinical milestones, which will consolidate the partnership between these two innovation-driven businesses. Astex will also receive potential future revenue shares. Dr. Harren Jhoti, co-founder, president and chief executive officer of Astex, will also take an observer role on the Mosaic Board. Other financial details have not been disclosed.

Mosaic’s platform identifies combinations of pairs of oncology drugs predicted to have synergistic activity in biomarker-defined patient populations and expected to lead to greater efficacy and durability of response than achieved as monotherapy. The development strategy for each combination product is to seek a broad, biomarker-defined label across multiple tumour types. The two small molecule assets from Astex are ASTX029, an ERK1/2 inhibitor discovered by Astex that has completed a Phase 2 clinical study and ASTX295 an MDM2 antagonist discovered by Astex in collaboration with the Cancer Research UK Drug Discovery Unit at Newcastle University, that has completed a Phase 1 clinical study. Each of the two licensed compounds has been studied in more than 100 patients and demonstrated differentiated safety profiles within their target class and single-agent activity as monotherapies, enabling use in combination therapies.

"Mosaic’s mission is to bring novel targeted combination medicines to patients who need them," said Dr. Edward Hodgkin, Managing Partner of Syncona Investment Management Limited and Chair of Mosaic. "The in licensing of these two clinical-stage assets provides a step change in our development pipeline, allowing Mosaic to progress targeted drug combinations in novel biomarker-defined settings and enabling the delivery of precision medicines for patients who currently have few therapeutic options. Excitingly the deal significantly accelerates Mosaic’s development path, with the first clinical combination study expected to commence in 2026."

"We recognise the significance of Mosaic’s platform, which has identified these two assets as anchor components of a pipeline of potential combination products," said Dr. Harren Jhoti, co-founder, president and chief executive officer of Astex. "Both drug targets are well-characterised drivers of many cancers, and we are excited to be working with the experienced team at Mosaic to expand the Company’s pipeline in combination therapies with high unmet medical need."

On April 24, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, reported that its ultra-sensitive Signatera Genome assay is now broadly available to physicians in the United States (Press release, Natera, APR 24, 2025, View Source [SID1234652122]).

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This launch is supported by a large genome-based molecular residual disease (MRD) study, which was accepted and will be presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. In this clinical validation study of more than 3,000 samples from multiple cancer types – including breast cancer, colorectal cancer, non-small cell lung cancer, melanoma, and renal cell carcinoma – Signatera Genome was able to detect circulating tumor DNA (ctDNA) significantly ahead of clinical recurrence with excellent performance. In addition, postsurgical Signatera-positive patients had inferior recurrence-free survival compared to Signatera-negative patients, consistently across the different cancers that were evaluated. Additional clinical utility data on the Signatera Genome assay, including predictive data, will be presented at the conference.

Signatera Genome is available in CLIA, IUO and RUO and was designed to improve patient management as an ultra-sensitive assay for the detection of ctDNA. The test’s bespoke assay is designed from a whole genome sequence of a patient’s tumor and matched normal DNA. It benefits from Natera’s patented multiplex polymerase chain reaction and next generation sequencing technology (mPCR-NGS), using a targeted and deep sequencing approach to detect tiny traces of tumor DNA at frequencies as low as 1 part per million (PPM). An RUO version of the assay is available that detects below 1 PPM.

"We are extremely pleased with the emerging evidence for our Signatera Genome assay, providing an ultrasensitive MRD detection tool for physicians," said Alexey Aleshin, M.D., general manager of oncology and corporate chief medical officer. "We look forward to sharing the results of this study, which further demonstrates the clinical utility of Signatera across disease indications."

About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and has coverage from Medicare across a broad range of indications. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 100 peer-reviewed papers.