On April 21, 2025 Axcynsis Therapeutics that is at the forefront of developing cutting-edge Antibody Drug Conjugate (ADC) therapies, reported two upcoming poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 (Press release, Axcynsis Therapeutics, APR 21, 2025, View Source [SID1234651989]). This meeting will be held in Chicago from April 25th to 30th 2025.

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The company will present the following two assets:

AT65474 is a highly selective anti-CLDN6 ADC with a proprietary payload
Session Category: Experimental and Molecular Therapeutics

Session Title: Antibody-Based Cancer Therapeutics 4

Session Date and Time: April 30, 2025, 9:00 AM to 12:00 PM (Local Time)

Location: Poster Section 16

Poster Board Number: 7

Published Abstract Number: 6741

CLDN6 is a membrane-bound oncofetal protein and a promising target for cancers such as ovarian and testicular cancer. AT65474 is an antibody drug conjugate (ADC) candidate composed of a highly selective humanized anti-CLDN6 antibody conjugated to a proprietary payload, namely TCS132, with a drug-to-antibody (DAR) ratio of 4. The antibody is engineered to incorporate AxcynCYSTM technology for site-specific conjugation which can reproducibly achieve high DAR4 ratios of greater than 97% by HIC analysis.

The payload, TCS132, is derived from an FDA approved drug and when compared to the parent drug, demonstrates increased potency with broad sub-nanomolar activities across a wide range of cancer cell lines including those resistant to paclitaxel, DM1, MMAE and DXd. Additionally, TCS132 was chemically optimized for better PK properties and demonstrates a much-improved safety profile despite its increased potency over the parent drug.

AT2604 is a highly efficacious ADC targeting alkaline phosphatases ALPP and ALPPL2​
Session Category: Experimental and Molecular Therapeutics

Session Title: Antibody-Based Cancer Therapeutics 4

Session Date and Time: April 30, 2025, 9:00 AM to 12:00 PM (Local Time)

Location: Poster Section 16

Poster Board Number: 17

Published Abstract Number: 6751

Placental alkaline phosphatases, ALPP and ALPPL2, are highly homologous, membrane-bound proteins involved in fetal development. Despite having limited expression in normal tissues, they are highly differentiated in multiple tumor cells making them ideal targets for antibody drug conjugate (ADC) development.

AT2604 is an ADC incorporating an anti-ALPP/ALPPL2 antibody conjugated to monomethyl auristatin E (MMAE) with high DAR 4 homogeneity; and displays strong tumor growth inhibition at low doses in CDX models of gastric and pancreatic cancer. In patient-derived xenograft models of gastric cancer with moderate- and low-antigen expression, AT2604 achieves near-complete tumor regression at 3 and 6 mg/kg (QWx3), respectively. A preliminary toxicity assessment in non-human primates concluded a well-tolerated dose of 10 mg/kg (Q3Wx3) without exhibiting any non-reversible adverse effects and good plasma stability; implying that AT2604 possesses an improved safety profile over other vedotin-based ADCs.

On April 21, 2025 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company working to develop a new class of drugs based on targeted protein degradation, reported that new preclinical combination data for ARV-393 will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual meeting, April 25-30, 2025 in Chicago, Illinois (Press release, Arvinas, APR 21, 2025, View Source [SID1234651988]). The poster highlights the potential for ARV-393 to be combined with various standard of care lymphoma treatments.

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ARV-393 is Arvinas’ investigational PROteolysis TArgeting Chimera (PROTAC) degrader targeting the B-cell lymphoma 6 protein (BCL6), a transcriptional repressor and major driver of B-cell lymphomas.

Presentation details are as follows:

Poster Title: ARV-393, a PROteolysis TArgeting Chimera (PROTAC) BCL6 Degrader, Combined With Biologics or Small-Molecule Inhibitors Induces Tumor Regressions in Diffuse Large B-Cell Lymphoma Models

Abstract: 1655
Session Title: Degraders and Glues 2
Session Type: Experimental and Molecular Therapeutic
Location: Poster Section 18
Poster Board Number: 15
Date: Monday, April 28, 2025
Lecture Time: 9:00 a.m. – 12:00 p.m. CT

The full abstract can be accessed via the AACR (Free AACR Whitepaper) 2025 online interactive program.

About ARV-393
ARV-393 is an investigational PROteolysis TArgeting Chimera (PROTAC) designed to degrade B-cell lymphoma 6 protein (BCL6), a transcriptional repressor and major driver of B-cell lymphomas. The BCL6 protein facilitates B cell tolerance of rapid proliferation and somatic gene recombination via repressing cell cycle checkpoints, terminal differentiation, apoptosis, and the DNA damage response. PROTAC-mediated degradation has the potential to address the traditional undruggable nature of BCL6. ARV-393 is currently in a Phase 1 clinical trial in patients with relapsed/refractory non-Hodgkin lymphoma.

On April 18, 2025 Ymmunobio AG (YB), a Swiss-based global biotech company dedicated to the development of new cancer therapeutics, reported that its two-antibody drug conjugate (ADC) assets, YB-800ADC1 and YB-800ADC2, have completed the preclinical proof of concept studies (Press release, Ymmunobio, APR 18, 2025, View Source [SID1234651987]). Both in vivo and in vitro studies have reached this important milestone by demonstrating the anti-tumor efficacy of both ADCs.

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The ADCs are derived from YB’s lead antibody YB-800 which targets a novel and first in class tumor marker. They utilize established payloads and a third-generation linker, demonstrating a tumor growth inhibition of 90%.

"These excellent results allow YB to move forward swiftly to prepare for the pivotal toxicology studies. This is a major step towards the clinical development of our ADCs in solid tumors and demonstrates the potential for YB’s ADCs to address unmet needs for cancer patients expressing the new novel tumor marker. In addition, the proof-of-concept data support the preclinical development of the two YB-800 based radiopharmaceuticals developed in collaboration with the Paul Scherer Institute," said Peter Schiemann, CEO.

On April 18, 2025 SparX Biopharmaceutical Corp. reported that it will present clinical updates on its lead asset, SPX-303, a first-in-class anti-LILRB2/PD-L1 bispecific antibody, during the Trial-in-Progress poster session at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting on April 28, from 2:00 PM to 5:00 PM (Press release, Sparx Therapeutics, APR 18, 2025, View Source [SID1234651986]). The presentation marks the one-year anniversary of the first patient dosing of this novel bispecific antibody in its ongoing Phase 1 clinical trial.

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A more comprehensive overview of SPX-303’s dual mechanism, which targets both myeloid and T-cell immune checkpoints, will be featured at a Satellite Symposium themed "Harnessing Super Immunotherapy and ADCs to Redefine the Standard of Care." Co-hosted by the University of Illinois at Chicago Cancer Center and Yao Yuan—Academy for Pharma Innovation, the symposium will convene expert clinicians, academic investigators, and industry leaders to discuss how next-generation immuno-oncology, known as "Super IO," can be synergized with antibody-drug conjugates (ADCs). This innovative approach combines the tumor-targeting precision of ADCs with the immune-activating power of checkpoint inhibitors, aiming to deliver deeper and more durable anti-tumor responses.

SPX-303, a first-in-class bispecific antibody targeting LILRB2 and PD-L1, is currently enrolling patients with resistant or refractory solid tumors at a dose level of 20 mg/kg. "This innovative program represents a significant advancement in macrophage checkpoint blockade and T cell co-engagement strategies," said Dr. Gui-Dong Zhu, CEO of SparX. "It holds promise as a potential next-generation immuno-oncology therapy—or ‘Super IO’ booster—for patients with limited treatment options."

The SPX-303 poster will be presented at Poster #CT116-11 in the Phase I Clinical Trials in Progress session at McCormick Place, Chicago, on April 28, from 2:00 to 5:00 PM. The Satellite Symposium will be held at the Trump International Hotel & Tower Chicago (401 N Wabash Ave, Chicago, IL 60611). SparX welcomes attendees to visit its exhibition booth during the symposium and strongly encourages early registration via the [registration portal] to secure a seat.

About SPX-303

SPX-303 is a first-in-its-class bispecific antibody therapy designed to simultaneously inhibit LILRB2 and PD-L1, two critical immune checkpoint proteins often hijacked by cancer cells. The program represents a novel immunotherapy approach aimed at activating both myeloid and lymphoid immune responses.

On April 17, 2025 Calidi Biotherapeutics Inc. (NYSE American: CLDI) ("Calidi"), a clinical-stage biotechnology company pioneering targeted antitumor virotherapies, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CLD-201 (Press release, Calidi Biotherapeutics, APR 17, 2025, View Source [SID1234653210]). This investigational, allogeneic stem cell-based immunotherapy is set to advance into clinical development for the treatment of solid tumors in adults, focusing on breast cancer, head & neck cancer and soft tissue sarcoma.

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The IND application included preclinical data demonstrating the potential of CLD-201 to evade viral inactivation by the patient’s immune system and effectively target and kill cancer cells. The upcoming clinical trials will assess the safety, tolerability, and preliminary efficacy of CLD-201 in patients with these difficult-to-treat tumors, addressing significant unmet medical needs.

"This FDA-cleared IND is a monumental milestone for Calidi Biotherapeutics and for patients worldwide. This allogeneic virotherapy product can transform how we treat cancer. It’s a one-of-a-kind product that has never been manufactured before using adipose tissue-derived stem cells in combination with oncolytic vaccinia virus. Its versatility in being able to treat solid tumors is remarkable," said Allan Camaisa, CEO and Chairman at Calidi. "I am proud of our executives and staff that have worked tirelessly to make this application possible."

"This remarkable achievement underscores the innovative approach and dedication of our exceptional team. The potential of CLD-201 to revolutionize the treatment of multiple solid tumors is truly exciting. We are eager to see its clinical application in providing new hope and improved outcomes for patients battling these challenging cancers," said Boris Minev, MD, President, Medical and Scientific Affairs at Calidi.

"This milestone is a testament to the comprehensive and robust pre-clinical, CMC, and development package supporting the clinical advancement of CLD-201. It highlights the expertise and dedication of Calidi’s teams in pushing forward innovative immunotherapies," said Antonio F. Santidrian, PhD, Chief Scientific Officer & Head of Technical Operations at Calidi.