On March 26, 2025 Linnaeus Therapeutics, Inc. ("Linnaeus"), a privately held biopharmaceutical company focused on the development and commercialization of novel small molecule oncology therapeutics, reported it has been awarded its fourth competitive Small Business Innovation Research ("SBIR") Award by the National Cancer Institute ("NCI") of the National Institutes of Health ("NIH") (Press release, Linnaeus Therapeutics, MAR 26, 2025, View Source [SID1234651480]).

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This $2,000,000 SBIR award was granted to the company after yet another highly competitive peer-review process. The award will help fund the clinical development of its lead compound, LNS8801, which targets a G protein-coupled receptor (GPER), for the treatment of metastatic cutaneous melanoma as a monotherapy in patients who cannot tolerate immunotherapy.

"This award marks the fourth time that Linnaeus has received a competitive award from NCI for LNS8801 development and brings the total non-dilutive contribution by NCI to LNS8801 development to $8.3 million. NCI’s continued support provides a strong peer-reviewed validation of the core science that is the basis of LNS8801, its target GPER, and the clinical data seen in LNS8801-treated patients with cancer," said Patrick Mooney, MD, Chief Executive Officer of Linnaeus. "This award will allow us to further advance LNS8801 as a potentially safe and effective oral therapeutic for the treatment of melanoma and will augment the data seen from our ongoing clinical studies of LNS8801. We thank the NCI and NIH for their ongoing support of LNS8801 to help patients with cancer."

Linnaeus anticipates initiating a randomized controlled clinical trial in unresectable, treatment refractory cutaneous melanoma in Q2 of this year. This study will randomize 135 biomarker-positive patients to receive LNS8801 monotherapy, LNS8801 and pembrolizumab, or physician’s choice therapy. The study will assess progression-free survival and overall survival between the groups.

About LNS8801

LNS8801 is an orally bioavailable and highly specific and potent agonist of GPER whose activity is dependent on the expression of GPER. GPER activation by LNS8801 rapidly and durably depletes c-Myc protein levels. In preclinical cancer models, LNS8801 displays potent antitumor activities across a wide range of tumor types, rapidly shrinking tumors and inducing immune memory.

In the ongoing clinical study in humans, LNS8801 monotherapy has been safe and well tolerated. Additionally, LNS8801 has demonstrated target engagement, c-Myc protein depletion, and durable clinical benefit in patients with advanced cancers, and a predictive biomarker has been identified.

On March 26, 2025 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that an abstract regarding IPH4502, its novel and differentiated topoisomerase I inhibitor Antibody Drug Conjugate (ADC) targeting Nectin-4, has been selected for the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025, taking place April 25-30 in Chicago, Illinois (Press release, Innate Pharma, MAR 26, 2025, View Source [SID1234651496]).

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In addition, Jonathan Dickinson, CEO of Innate Parma, will present in a showcase session at the AACR (Free AACR Whitepaper) Oncology Industry Partnering Event, to give an update on Innate’s pipeline and strategy.

Presentation details

AACR 2025 ANNUAL MEETING

IPH4502, a differentiated Nectin-4 exatecan antibody-drug conjugate

Abstract Number: 5443

Session Type: Poster session

Session Category: Experimental and Molecular Therapeutics

Session Title: Antibody-Based Cancer Therapeutics 3

Session Date/Time: Tuesday Apr 29, 2025 2:00 PM – 5:00 PM

More information can be found on the AACR (Free AACR Whitepaper) website.

AACR ONCOLOGY INDUSTRY PARTNERING EVENT

Showcase Session 2 | W192

Presenter: Jonathan Dickinson, Chief Executive Officer

Date and Time: Thursday Apr 24, 2025 4:50 PM

Location: McCormick Place Convention Center West Building, Chicago, Illinois

More information can be found on the AACR (Free AACR Whitepaper) Oncology Industry Partnering Event website.

About IPH4502

IPH4502 is a novel and differentiated topoisomerase I inhibitor Antibody Drug Conjugate (ADC) conjugated to exatecan targeting Nectin-4, a cell adhesion molecule that is overexpressed in several types of solid tumors, such as urothelial carcinoma, breast cancer, non-small cell lung cancer or gastro-intestinal tract cancer.

IPH4502 is currently investigated in a Phase 1 trial in advanced solid tumors. The Phase 1 trial includes a dose escalation part 1 and a dose optimization part 2 and will assess the safety, tolerability, and preliminary efficacy of IPH4502 in different solid tumors known to express Nectin-4, including but not limited to urothelial carcinoma, non-small cell lung, breast, ovarian, gastric, esophageal, and colorectal cancers. The study plans to enroll approximately 105 patients.

In preclinical models, IPH4502 demonstrates strong bystander killing effect, and efficient internalization, enabling a potent anti-tumor activity in models with various Nectin-4 expression levels. Additionally, IPH4502 shows efficacy in models resistant to MMAE-ADC. These results support its potential for development beyond UC and in cancer patients treated with MMAE-based ADCs.

On March 26, 2025 Bayer and Suzhou Puhe BioPharma Co.,Ltd., a clinical-stage biotechnology company, reported that they have entered into a global license agreement for Puhe BioPharma’s oral, small molecule PRMT5 inhibitor that selectively targets MTAP-deleted tumors (Press release, Bayer, MAR 26, 2025, View Source [SID1234655501]). Under the agreement, Bayer obtains an exclusive worldwide license to develop, manufacture and commercialize the MTA-cooperative PRMT5 inhibitor. Bayer has enrolled the first participant in a Phase I first-in-human dose escalation study investigating MTA-cooperative PRMT5 inhibitor under the development name BAY 3713372 for the treatment of MTAP-deleted solid tumors.

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"We are looking forward to explore the potential of the PRMT5 inhibitor, which could improve outcomes for patients with MTAP-deleted tumors who often have a poor prognosis," said Juergen Eckhardt, M.D., Head of Business Development and Licensing at Bayer’s Pharmaceuticals Division. "The highly selective targeting of cancer cells while sparing healthy cells, based on the innovative mechanism of action is very promising. This will support our mission to build one of the most transformative and differentiated precision oncology pipelines in the industry."

"We see great potential in MTA-cooperative PRMT5 inhibitors in treating MTAP-deleted tumors. Our MTA-cooperative PRMT5 inhibitor, PH020, now named BAY 3713372, has demonstrated competitive selectivity for PRMT5 bound to MTA and activity in preclinical studies, as well as brain penetration capabilities," said Yongqi Guo, CEO of Puhe BioPharma. "We are excited to partner with Bayer, a global leader in the field of life sciences, to advance our PRMT5 inhibitor into the clinic. Together with Bayer, we look forward to bringing this therapeutic option to patients worldwide."

PRMT5 (protein arginine methyltransferase 5) and a specific gene called MTAP (metabolic enzyme 5’-deoxy-5′-methylthioadenosine phosphorylase) play important roles in cell metabolism and are critical for cell survival. MTAP deletions, which occur in approximately 10 to 30 percent of all cancers1, lead to elevated levels of MTA in tumor cells and BAY 3713372 is designed to bind the PRMT5-MTA complex thus specifically exploiting tumor vulnerability.

"Loss of the MTAP gene occurs in a variety of tumor types, including those with few treatment options and poor prognosis, such as pancreatic cancer and glioblastoma," said Dominik Ruettinger, M.D., Ph.D., Global Head of Research and Early Development for Oncology at Bayer’s Pharmaceuticals Division. "We look forward to advancing this program as we are driven by our ambition to develop innovative medicines that improve and extend the lives of cancer patients we serve, focusing on areas of high unmet medical need."

Financial terms are not disclosed.

About BAY 3713372 (MTA-cooperative PRMT5 inhibitor)
BAY 3713372 is an investigational agent and has not been approved by any health authority for use in any country, for any indication. It is an oral, potent selective MTA-cooperative PRMT5 inhibitor being evaluated as a potential new targeted treatment option for patients with MTAP-deleted solid tumors. BAY 3713372 has unique characteristics including brain penetrance, which allows targeting of central nervous system (CNS) metastases and primary brain tumors.

Protein arginine N-methyltransferase 5 (PRMT5) plays a crucial role in modifying proteins that control the cell cycle. The metabolic enzyme 5’-deoxy-5′-methylthioadenosine phosphorylase (MTAP) is involved in the methionine salvage pathway which recycles methionine from methylthioadenosine (MTA).This targeted approach takes advantage of the unique relationship between MTA and PRMT5, creating a specific vulnerability that can be exploited to effectively treat MTAP deficient cancer cells.

About the clinical phase I study
BAY 3713372 is investigated in a global Phase I first-in-human dose escalation study in patients with MTAP-deleted solid tumors. The clinical program aims to evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics and preliminary clinical activity of BAY 3713372, a novel cancer cell specific PRMT5 inhibitor.

On March 26, 2025 AbbVie (NYSE: ABBV) reported that new data from its early oncology research will be showcased across multiple presentations at the upcoming American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, April 25-30, 2025 (Press release, AbbVie, MAR 26, 2025, View Source [SID1234651481]). Presentations include data from novel investigational molecules, ABBV-969 and ABBV-514, across a range of hard-to-treat tumor types.1,2 Additionally, new insights on treatment resistance and novel biomarker identification based on real-world-data analyses are to be presented.3,4,5

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"As we seek to advance innovative therapies for people living with difficult-to-treat cancers, our early-stage oncology research helps lay the scientific foundation for future innovation that may address profound unmet needs that many patients experience," said Theodora S. Ross, M.D., Ph.D., vice president, early oncology research and development, AbbVie. "By harnessing the latest scientific breakthroughs in translational research, we are advancing novel therapeutic approaches such as ABBV-969 and ABBV-514, aiming to improve cancer care for patients worldwide."

Data on ABBV-969, a novel, dual-targeted ADC, with a proprietary, cytotoxic topoisomerase 1 inhibitor (Top1i) payload will be presented in an oral presentation at the meeting.1 ABBV-969 is designed to target tumor cells expressing STEAP1 and/or PSMA antigens.1 Prostate cancer cells may overexpress STEAP1, PSMA or both, and their expression is associated with tumor growth and survival.1 ABBV-969 is currently in a Phase 1 clinical trial for men with metastatic castration-resistant prostate cancer (mCRPC) (NCT06318273).6

Data from AbbVie’s immuno-oncology platform highlight the potential of a novel CCR8-targeting antibody, ABBV-514, in driving anti-tumor immunity.2 CCR8 is a promising target due to its enhanced expression on tumor-infiltrating regulatory T cells (Tregs) and a higher prevalence of these CCR8+ Tregs is associated with poor clinical outcomes in several solid tumor types.2 Preclinical data show that ABBV-514 depletes CCR8+ Tregs inside the tumor and has strong monotherapy activity in a variety of in vivo tumor models, including models that are insensitive to anti-PD-1 treatment.2 ABBV-514 is currently being evaluated in a Phase 1 clinical trial in non-small cell lung cancer (NSCLC), head and neck cancer and other solid tumors, both as a monotherapy and in combination with budigalimab, a PD-1-blocking antibody (NCT05005403).2,7,8

Additional presentations at the AACR (Free AACR Whitepaper) annual meeting will include real-world-data analyses in two key areas of cancer research – treatment resistance and biomarker discovery:

An analysis to characterize the overlap of folate receptor alpha (FRa) expression, a biomarker found in 90 percent of ovarian cancers, with other biomarkers that could potentially help support the development of novel precision medicines.4,9,10 This study provides new insights that could aid treatment matching for patients and inform treatment sequencing and combination therapy options.4
A new study that employed multi-omics approaches to real-world-data analysis, to identify clinical features and molecular mechanisms of long-term response and acquired resistance to immunotherapy in non-small cell lung cancer.3
Data showcasing a novel approach for investigating relationships between germline variants, cancer patient prognosis and treatment responses, using electronic health record-linked genomics data across a range of solid tumor types.5 The study shows that certain germline variants may serve as predictive biomarkers and help advance precision medicine R&D efforts.5
Further information on AbbVie clinical trials is available at View Source

Additional details on key presentations at AACR (Free AACR Whitepaper) are available below and the full AACR (Free AACR Whitepaper) Annual Meeting 2025 abstracts are available here.

Title

Date/Time

Session

Abstract number

ABBV-969: A first-in-class dual-targeting
PSMA-STEAP1 drug conjugate for the
treatment of metastatic castrate-resistant
prostate cancer

April 27, 1:45 –

2:00 PM CT

Oral Presentation

Session: New Drugs on the Horizon: Part 1

ND03

Investigating clinical features and
molecular mechanisms of long-term
response and acquired resistance to
immunotherapy in non-small cell lung
cancer by applying real-world-data

April 28, 2:00 –
5:00 PM CT

Poster

Poster Board 15

Session: Real-World Data and Real-World Evidence: Clinico-Genomics

3395

ABBV-514: an afucosylated CCR8
specific antibody that targets and
eliminates key immunosuppressive
tumor regulatory T cells

April 29, 2:00 –
5:00 PM CT

Poster

Poster Board 20

Session: Therapeutic Antibodies,

Including Engineered

Antibodies 2

6025

Characterizing spatial expression
patterns and prevalence of folate
receptor alpha in relation to other
existing and emerging ovarian cancer
biomarkers

April 29, 2:00 –
5:00 PM CT

Poster

Poster Board 2

Session: Predictive Biomarkers 6 /Diagnostic Biomarkers 3

5910

Identifying cancer germline variants
associated with patient prognosis and
response by applying clinico-genomics
data

April 30, 09:00 AM –
12:00 PM CT

Poster

Poster Board 19

Session: Genomic Profiling of Tumors 3

6638

ABBV-969 and ABBV-514 are investigational medicines and are not approved by any health authority worldwide. Their safety and efficacy are under evaluation as part of ongoing clinical studies.

About ABBV-969
ABBV-969 is an investigational, novel antibody-drug conjugate (ADC) targeting prostate-specific membrane antigen (PSMA) and six transmembrane epithelial antigen of the prostate 1 (STEAP1), being investigated to treat metastatic castration-resistant prostate cancer (mCRPC).1,6 ABBV-969 was designed using a dual variable domain immunoglobulin (DVD-Ig) with a proprietary topoisomerase-1 (Top1) inhibitor linker-drug format.1

About ABBV-514
ABBV-514 is an investigational anti-chemokine C-C motif receptor 8 (CCR8) antibody that is being investigated for the treatment of relapsed non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC) both as a monotherapy and in combination with a PD-1 inhibitor.

On March 26, 2025 SOTIO Biotech, a clinical-stage biopharmaceutical company owned by PPF Group, reported it will present new data from two of its antibody-drug conjugate (ADC) programs for the treatment of solid tumors, showcasing advancements in its innovative pipeline (Press release, SOTIO, MAR 26, 2025, View Source [SID1234651497]). The presentations will take place at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago, IL from April 25-30, 2025.

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SOT106 is being developed for the treatment of patients with sarcomas and other LRRC15-positive tumors. The oral presentation at AACR (Free AACR Whitepaper) will feature new preclinical in vitro and in vivo data. SOT106 targets leucine-rich repeat containing protein 15 (LRRC15), a protein that is commonly overexpressed in mesenchymal malignancies.

SOT109 is being developed for the treatment of colorectal cancer and other gastrointestinal cancers. It targets cadherin-17 (CDH17), a protein homogenously overexpressed in more than 90% of colorectal cancers. The poster presentation at AACR (Free AACR Whitepaper) will showcase preclinical data on the efficacy and safety of SOT109 across various models.

Presentation details are as follows:

Oral Presentation Title: "SOT106, a novel best-in-class antibody-drug conjugate targeting LRRC15, to treat sarcomas and other advanced solid cancers"
Abstract Number: 1164
Session: Experimental and Molecular Therapeutics / Antibody-Based Cancer Therapeutic Agents
Presenting Author: Michaela Fojtu
Date & Time: April 27, 2025, 3:00 p.m. – 5:00 p.m. CT

Poster Title: "Preclinical safety and efficacy of SOT109, an antibody-drug conjugate targeting Cadherin 17 (CDH17) for the treatment of colorectal and other gastrointestinal tract tumors"
Abstract Number: 5469
Session: Experimental and Molecular Therapeutics
Presenting Author: Nataliia Kalynovska
Date & Time: April 29, 2025, 2:00 p.m. – 5:00 p.m. CT
Location: Poster Section 15, Board Number 27

Presentation materials will be made available here after presentations at AACR (Free AACR Whitepaper) conclude.