On May 6, 2025 Formosa Pharmaceuticals, Inc. ("Formosa"; 6838.TW ticker-symbol on the Taiwan Stock Exchange) and Almac Discovery reported a global licensing agreement for development and commercialisation of ALM-401, a first-in-class engineered bispecific Antibody-Drug Conjugate (ADC), addressing the high unmet needs of cancer patients worldwide suffering with intractable and aggressive solid tumours (Press release, Almac, MAY 6, 2025, View Source [SID1234652564]).

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The agreement facilitates the next phases of CMC and drug development by Formosa, including IND submission and early clinical proof-of-concept in international clinical trials.

ALM-401 has been the culmination of a multi-year R&D programme at Almac Discovery deploying their proprietary OmniaScape informatics platform, protein engineering and medicinal chemistry capabilities.

The design of ALM-401 has built upon the recent clinical successes within the ADC field, including selection of a linker-payload matched to potential clinical cancer indications, and the molecule also benefits from being approximately half the size of conventional ADCs, thereby facilitating enhanced solid tumour penetration. The main features of ALM-401 include:

Innovative bi-specific target-pairing based on co-expression and functional analysis of specific, aggressive solid tumours
Sustained high-efficacy in vivo in PDX models; as presented at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) (AACR; Chicago) annual meeting
Half-the-size of conventional ADCs for enhanced solid tumour penetration and optimised manufacturing.
Formosa Pharmaceuticals, Inc. (6838.TW) is a clinical stage biotechnology company with primary focus in the areas of ophthalmology and oncology, with particular CMC and manufacturing expertise for specialist ADC therapeutics. "Formosa Pharma is pleased to have this opportunity to bring ALM-401 into our development pipeline. This novel, next-generation ADC complements our corporate strategy and resources and promises to deliver a differentiated therapy to cancer patients worldwide. We look forward to collaborating closely with Almac Discovery in advancing this exciting program through clinical trials, commercialization, and beyond." said Dr. Erick Co, President and CEO of Formosa Pharmaceuticals.

"We are pleased to have met Formosa’s exacting selection requirements for Next Generation ADC candidates," said Dr Stephen Barr, President and Managing Director of Almac Discovery. "This agreement allows the seamless progression of the molecule into clinical evaluation, driven by Formosa."

"In addition to an excellent preclinical efficacy profile, high-quality, robust and scalable CMC and manufacturing is a key competitive advantage for ADCs in the fast-moving race for effective cancer therapeutics" commented Dr Graham Cotton, Vice-President of Protein Therapeutics, Almac Discovery.

On May 6, 2025 Alector, Inc. (Nasdaq: ALEC), a late-stage clinical biotechnology company focused on developing therapies to counteract the devastating progression of neurodegeneration, reported that management will participate in the following upcoming investor conferences (Press release, Alector, MAY 6, 2025, View Source [SID1234652563]):

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Bank of America Securities Health Care Conference (Las Vegas, Nevada)
Tuesday, May 13, 2025, at 2:20 p.m. PT, corporate presentation
H.C. Wainwright 3rd Annual BioConnect Investor Conference (New York, New York)
Tuesday, May 20, 2025, at 12:00 p.m. ET, fireside chat
A webcast of each conference presentation will be available on the "Events & Presentations" page within the Investors section of the Alector website at View Source Replays of the webcasts will be available on the Alector website for 90 days following the presentation dates.

On May 6, 2025 Alchemab Therapeutics (Alchemab), the next generation biopharmaceutical company which uses the power of human immune evolution to identify and develop naturally occurring therapeutic antibodies from resilient individuals, reported that it has entered into a licensing agreement with Eli Lilly and Company (Lilly) for ATLX-1282, Alchemab’s first-in-class IND-ready programme for amyotrophic lateral sclerosis (ALS) and other neurodegenerative conditions (Press release, Alchemab Therapeutics, MAY 6, 2025, View Source [SID1234652562]).

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The transaction is worth up to a total of $415m, including an undisclosed upfront payment, potential discovery, development, and commercialisation payments and royalties. Under the terms of the agreement, Alchemab will be taking the programme through early Phase 1 clinical trials after which Lilly will lead all further development and commercialisation.

Alchemab’s unique platform uses state-of-the-art machine learning and AI to analyse the complexities of the human immune response and identify antibodies that are uniquely associated with resilience to untreatable diseases. This is achieved using over 6,000 carefully selected and highly curated patient samples across neurodegeneration, immunology, oncology and healthy aging. Weaving together lab-based protein science and biology with machine learning, human samples and proprietary data analysis, and leveraging Nvidia’s supercomputer in Cambridge, Alchemab has sequenced and analysed millions of antibody sequences to unveil novel targets and antibodies with unique mechanisms of action.

Through its research, Alchemab has identified an antibody in people with mutations that normally lead to frontotemporal dementia (FTD), but who remain well into old age. These samples were sourced from a collaboration with the Genetic Frontotemporal Initiative (GENFI) consortium, which has built the largest global cohort of FTD patients.

Starting from the antibody sequence, Alchemab was able to identify the target and has subsequently demonstrated its importance in neuroprotection, and across multiple neurodegenerative conditions including ALS and FTD.

Alchemab’s Chief Executive Officer, Jane Osbourn, commented: "As the first programme from our highly novel platform, this is a landmark transaction for Alchemab. With Lilly’s deep expertise in neurological conditions, they are ideally placed to speedily advance ATLX-1282 through the clinic, and maximise the potential to help patients. We believe this innovative programme has enormous promise and look forward to working with Lilly to bring this to fruition.

"Today’s announcement is also a tremendous endorsement for Alchemab’s unique approach to drug discovery. Our revolutionary computational and wet lab-based workflow has enabled us to sift through millions of antibodies to identify this target. We think this is a powerful story demonstrating both the discovery of a novel antibody to treat neurogenerative diseases and the development of a unique platform which has great potential to provide innovative treatments across many disease settings. The transaction will support our work to progress our pipeline, which includes metabolic, immunology and oncology programmes, towards the clinic and we look forward to unveiling highly differentiated assets in these areas in due course."

This transaction builds on a separate discovery collaboration agreement with Lilly announced in January 2025 to discover, develop and commercialise up to five novel therapeutic candidates for ALS.

On May 5, 2025 Actuate Therapeutics, Inc. (NASDAQ: ACTU) ("Actuate" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), reported that elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) met the primary endpoints and achieved statistical significance in topline results from its ongoing Phase 2 (Actuate-1801 Part 3B) trial in first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) (Press release, Actuate Therapeutics, MAY 6, 2025, View Source [SID1234652561]).

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The topline results, which demonstrate a substantial improvement in median overall survival benefit in the elraglusib/GnP combination arm compared to the results announced in December 2024, will be presented on May 31, 2025, at the Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).

"Pancreatic cancer is one of the most aggressive and difficult-to-treat malignancies, where patients urgently need new therapeutic options," said Daniel Schmitt, President & Chief Executive Officer of Actuate. "There have been no major advances in improving survival in first-line treatment of metastatic pancreatic cancer in over a decade. Demonstrating statistically significant increases in both median overall survival and percent of patients reaching one-year survival and beyond, along with a favorable risk-benefit profile in this Phase 2 trial, further demonstrates elraglusib’s potential to shift the treatment paradigm in mPDAC. We are incredibly excited to present the topline data at ASCO (Free ASCO Whitepaper). Based on the significant improvement in survival we have seen to date in the combination arm, we look forward to working with US and EU regulators in the second half of this year to map out the path to advancing elraglusib to NDA and registration and making the drug available to patients as expeditiously as possible."

ASCO Presentation Details:

Abstract Title: Preliminary results from the randomized phase 2 study (1801 part 3B) of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) versus GnP alone in patients (pts) with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC).

Abstract Number: 4006

Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Presenter: Devalingam Mahalingam, MD, PhD

Oral Presentation Date and Time: Saturday, May 31, 2025, 4:48 PM CDT

About Actuate-1801 Part 3B Study

The Actuate-1801 Part 3B study (NCT03678883) is a randomized, controlled Phase 2 trial of elraglusib with GnP versus GnP alone in first-line mPDAC. The trial enrolled 286 mPDAC patients with no prior systemic treatment for metastatic disease, who were randomized 2:1 to the elraglusib treatment arm (elraglusib + GnP) or the control arm (GnP alone). Elraglusib is administered at a dose of 9.3 mg/kg by IV infusion on Day 1 of each week of a 28-day cycle. The primary endpoint for this study is median overall survival, with OS summarized throughout the study by estimates of 1-year survival. Secondary endpoints are DCR, ORR, PFS, and AE.

About GSK-3β

Inhibition of GSK-3β may inhibit tumor growth and improve survival through several complimentary mechanisms that include enhancement of chemotherapy activity, activation of innate anti-tumor immunity, and regulation of gene expression, leading to alterations in tumor metabolism and Epithelial-to-Mesenchymal Transition (EMT).

On May 6, 2025 Circio Holding ASA (OSE: CRNA), a biotechnology company developing powerful circular RNA technology for next generation nucleic acid medicine, reported that it will present new and strengthened circVec circular RNA in vivo data at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) annual meeting 2025 taking place in New Orleans, USA, 13-17 May 2025 (Press release, Circio, MAY 6, 2025, View Source [SID1234652505]).

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In the poster presentation, Circio will showcase the latest in vivo results for the circVec synthetic DNA and AAV gene therapy platform. circVec circular RNA-based vectors have the potential to substantially boost protein expression level and durability for both viral and non-viral gene and cell therapy. Recently generated in vivo data further validates and strengthens the circVec system in specific settings, and provides important context to prioritize development areas and partnering strategy.

Title of presentation:
CircVec: a powerful circular RNA expression platform to enhance viral and non-viral gene and cell therapies

Time and poster number:
13 May 2025, 18:00-19:30hrs CDT, poster #655

Location:
Ernest N. Morial Convention Center, New Orleans, Louisiana, USA

The poster will be made available on Circio´s webpage after the presentation