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Vivesto strengthens Cantrixil program with new preclinical results and patent application

On December 19, 2024 Vivesto AB, an oncology-focused development company, reported that positive results were obtained from preclinical studies with combination treatments within the company’s Cantrixil program, supporting continued development in hematological cancer (Press release, Vivesto, DEC 19, 2024, View Source [SID1234649208]). Vivesto also announced that a new patent application covering the treatment of hematological cancer with Cantrixil was filed, with the aim to strengthen the IP position.

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The drug candidate Cantrixil has been evaluated in further combination treatments with other anti-cancer drugs generating new in vitro data in hematological cancer cell lines. The results demonstrate clear positive effects of Cantrixil in combination with other anti-cancer drugs. The positive results confirm previous preclinical efficacy results and support continued development in hematological cancer. New results from hematological cancer models are expected to be presented throughout 2025.

"Hematological cancer is one of Vivesto’s priority focus areas, and we are pleased to report successful results from yet another preclinical study supporting the further development of the Cantrixil program. We believe that Cantrixil can play a key role in the treatment of hematological cancer and look forward to reporting new data from additional ongoing studies early next year that will be of great importance as the program is developed towards clinical phase," said Erik Kinnman, CEO of Vivesto. "Vivesto also filed a new patent application for the treatment of hematological cancer with Cantrixil as a robust patent portfolio is fundamental for value creation in clinical development, and eventually, commercialization of the product."

Cantrixil has previously shown strong cytotoxic effects at low doses in cell lines derived from patients with hematological cancer. The recently generated data provides important input to the dosing selection and treatment regime in upcoming preclinical and clinical studies.

Applied DNA Customer ÚHKT Initiates Phase I Clinical Trial for Rapidly Manufacturable CAR T-cell Therapy Produced from LineaDNA

On December 18, 2024 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, reported that the State Institute for Drug Control of the Czech Republic (SÚKL) approved an application for a Phase I clinical trial of an investigational CD123-specific autologous CAR T-cell therapy by the Institute of Hematology and Blood Transfusion (ÚHKT/Eng: IHBT) in Prague for the treatment of relapsed and/or refractory acute myeloid leukemia (AML) (Press release, Applied DNA Sciences, DEC 18, 2024, View Source [SID1234650780]). UHKT-CAR123-01 utilizes Applied DNA’s synthetic DNA, Linea DNA, as a critical component in its manufacture.

AML is a hematologic malignancy with a high rate of treatment failure for which current treatment options are often restricted to palliative approaches. Novel emerging methods leveraging advancements in genetic medicines, such as CAR T-cell therapies, can potentially improve outcomes of patients after relapse but have been difficult to establish for clinical use due to high costs and long manufacturing times predominantly attributable to the use of viral vectors.

UHKT-CAR123 seeks to address these issues by generating CD123-specific CAR T-cells in a non-viral workflow utilizing Linea DNA to reduce manufacturing costs and timelines. Preclinical data showed that ÚHKT’s Linea DNA-empowered non-viral workflow resulted in the rapid production of substantial and cost-efficient CAR T-cell yields with high potency[1].

"The use of Linea DNA illustrates our innovative approach to finding new and best-in-class treatments for patients with relapsed or refractory AML," stated Dr. Jan Vydra, principal investigator of the UHKT-CAR123 clinical trial.

Added Pavel Otáhal, Ph.D., scientific project leader at ÚHKT, "The Linea DNA platform enables the very rapid abiotic production of expression vectors usable for highly effective electroporation-based CAR-T manufacturing compared to plasmid-based vectors. The decreases in complexities and costs of developing autologous CAR-T technologies offer an innovative approach for the rapid clinical testing of novel types of CAR-T products. This is an incredible milestone for ÚHKT and one that we could not have achieved without the commitment of the Applied DNA team."

Applied DNA CEO Dr. James A. Hayward, said, "We congratulate ÚHKT on their progress into the clinic. Their accomplishment is also a significant milestone for Linea DNA as we look to support additional customers expected to initiate clinical trials in calendar 2025."

About Linea DNA
Linea DNA is an enzymatically produced, linear DNA manufactured by the Company’s proprietary, large-scale polymerase chain reaction ("PCR") based manufacturing platform, the Linea DNA platform. As an alternative to plasmid-based DNA, Linea DNA can be used to manufacture of a wide range of nucleic acid-based therapies and in vitro diagnostics, including mRNA therapies, DNA vaccines, cell and gene therapies, and molecular and genetic diagnostic tests.

General Proximity Gets $8M for Drug Discovery

On December 18, 2024 General Proximity reported the company has raised an $8 million seed to grow its drug discovery platform, CEO Armand Cognetta tells Axios exclusively (Press release, General Proximity, DEC 18, 2024, View Source [SID1234649817]).

Why it matters: The company’s approach shows promise in identifying drug candidates for difficult-to-treat conditions like dementia.

How it works: The company’s platform uses proximity therapeutics to take an "undruggable" protein or enzyme and force it in proximity with a drug target.
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"Cells can simplistically be thought of as containers to hold things together to drive chemical reactions," he says.
The company’s platform is a tool to discover which of these "proximity events" are the most therapeutically useful. It’s currently focused on cancer, neurodegeneration and longevity.
"These insights then guide our development of precision therapeutics that recapitulate these interactions," he adds.
Zoom in: The round was led by Aydin Senkut, founder of VC firm Felicis.
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Other investors include Y Combinator, age1, Modi Ventures and Wilson Sonsini, alongside several angel investors.
Catch up quick: The San Francisco company has received five "Golden Ticket" awards from major pharma pitch competitions, which grant startups access to lab space and mentorship.

Yes, but: General Proximity struggled for years until it found a lead for its seed round and "almost ran out of money a few times," Cognetta says.

What they’re saying: "It happens in biotech — where early on, they don’t get the benefit of the doubt and you really have to grind," says Senkut.

Most VCs looking at Cognetta’s proximity approach might think, "’For 30 years, no one has figured this out, so what makes this different?’ We believe in this method and are willing to take the leap of faith with him," Senkut says.

Agenus Announces Five Presentations at ASCO GI Highlighting BOT/BAL Activity Across Colorectal and Gastric Cancers

On December 18, 2024 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, reported five presentations featuring botensilimab (BOT, an Fc-enhanced anti-CTLA-4 antibody) plus balstilimab (BAL, an anti-PD-1 antibody) at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers (ASCO GI) Symposium (Press release, Agenus, DEC 18, 2024, View Source [SID1234649207]). The conference will take place on January 23-25, 2025, in San Francisco, California.

The presentations will showcase BOT/BAL’s activity across three distinct colorectal cancer settings—late-line metastatic, first-line, and neoadjuvant treatment. The studies demonstrate BOT/BAL’s consistent activity in microsatellite stable (MSS) colorectal cancer (CRC), which accounts for over 80% of CRC cases and has limited treatment options, as well as its efficacy in microsatellite instability-high (MSI-H) CRC. Additionally, one presentation will feature BOT/BAL and invariant natural killer T cells (iNKTs) in patients with refractory gastric cancer.

"These presentations will highlight BOT/BAL’s potential to benefit patients across colorectal cancer treatment settings, including the neoadjuvant, late-line, and first-line settings," said Dr. Garo Armen, Chairman and CEO of Agenus. "We aim to transform outcomes at every stage of disease and deliver renewed hope for patients worldwide."

Presentation Details

Abstract Title: Preliminary results from a randomized, open-label, phase 2 study of botensilimab (BOT) with or without balstilimab (BAL) in refractory microsatellite stable metastatic colorectal cancer with no liver metastases (MSS mCRC NLM)*
Abstract Number: 23
Presenting Author: Dr. Marwan Fakih
Session: Rapid Oral Abstract Session C: Cancers of the Colon, Rectum, and Anus
Session Date and Time: 1/25/2025, 9:15 AM-10:00 AM PST

Abstract Title: Preoperative botensilimab (BOT) with or without balstilimab (BAL) for patients with resectable locally advanced pMMR or dMMR colon cancer: Results from the UNICORN trial by GONO
Abstract Number: 158
Presenting Author: Dr. Filippo Ghelardi
Session: Poster Session C: Cancers of the Colon, Rectum, and Anus
Session Date and Time: 1/25/2025, 7:00 AM-7:55 AM PST

Abstract Title: A phase II study of agenT-797 (invariant natural killer T-cells), botensilimab (Fc-enhanced CTLA-4 inhibitor) and balstilimab (anti-PD-1) in patients with advanced, refractory gastroesophageal adenocarcinoma
Abstract Number: TPS515
Presenting Author: Dr. Samuel Cytryn
Session: Trials in Progress Poster Session A: Cancers of the Esophagus and Stomach and Other Gastrointestinal Cancers
Session Date and Time: 1/23/2025, 11:30 AM-1:00 PM PST

Abstract Title: Neoadjuvant botensilimab (BOT) plus balstilimab (BAL) in resectable mismatch repair proficient (pMMR) and deficient (dMMR) colorectal cancer (CRC): NEST clinical trial update
Abstract Number: 207
Presenting Author: Dr. Erika Hissong
Session: Poster Session C: Cancers of the Colon, Rectum, and Anus
Session Date and Time: 1/25/2025, 7:00 AM-7:55 AM PST

Abstract Title: A phase 1 trial of folinic acid, fluorouracil, oxaliplatin, bevacizumab, botensilimab, balstilimab (FOLFOX-3B) in microsatellite stable metastatic colorectal cancer.
Abstract Number: 180
Presenting Author: Dr. Marwan Fakih
Session: Poster Session C: Cancers of the Colon, Rectum, and Anus
Session Date and Time: 1/25/2025, 7:00 AM-7:55 AM PST

Complete abstracts will be released at 5:00 PM ET on January 21st, 2025. Data presented at the conference will be available to view in the publications section of the Agenus website (View Source) following the ASCO (Free ASCO Whitepaper) GI Meeting.

Iambic Therapeutics to Present at the 43rd Annual JP Morgan Healthcare Conference

On December 18, 2024 Iambic Therapeutics, a clinical-stage biotechnology company developing novel therapeutics using its unique AI-driven discovery platform, reported that Tom Miller, Ph.D., Iambic’s Chief Executive Officer and Co-Founder, will present at the 43rd Annual JP Morgan Healthcare Conference (Press release, Iambic Therapeutics, DEC 18, 2024, View Source [SID1234649206]). The presentation will take place on Tuesday, January 14th, at 5 p.m. PT at the Westin St. Francis Hotel in San Francisco.

Dr. Miller will detail progress and anticipated milestones for Iambic’s emerging pipeline of development candidates, as well as advances to its AI drug discovery platform. The Company’s pipeline currently includes IAM1363, a highly selective, brain penetrant small molecule inhibitor of both wild-type and oncogenic HER2 mutants currently in a Phase 1/1b study, as well as a potential first-in-class selective dual CDK2/4 inhibitor for multiple cancer indications, an allosteric inhibitor for KIF18A, and additional new programs.