On July 11, 2024 Resolute Science, Inc., a preclinical-stage biotechnology company developing a novel class of pan-cancer therapeutics for the treatment of aggressive and hard-to-treat solid tumors, reported the National Cancer Institute (NCI) has issued a Notice of Award for the Phase 2 portion of its Fast Track Small Business Innovation Research (SBIR) grant (Press release, Resolute Science, JUN 11, 2024, View Source [SID1234656394]). This $2.1 million grant supports the advancement of Resolute’s lead asset, RS-5, a novel synthetic, pan-cancer drug conjugate for treating soft tissue sarcomas (STS) and other aggressive, hard-to-treat solid tumors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This NCI grant will enable Resolute to accelerate its IND-enabling activities as it advances RS-5 toward clinical trials. RS-5 is a first-in-class pan-cancer therapeutic leveraging the company’s proprietary MAC-TAC (Macrophage Targeted Conjugate) drug-delivery technology platform. RS-5 demonstrates powerful anti-cancer efficacy across multiple CDX and PDX murine tumor models while being well-tolerated. This proof-of-concept data supports the continued development of RS-5 for soft tissue sarcomas and a broad range of solid tumors.

"We are grateful for the continued support from the NCI," said Faith H. Barnett, MD, PhD, Founder and CEO of Resolute Science. "These funds will allow us to continue translating MAC-TAC therapeutics toward the clinic. Our goal is to bring effective and safe therapeutics to cancer patients, particularly those with limited or no treatment options".

The MAC-TAC platform has broad functionality for the targeted delivery of various anti-cancer payloads to tumors, including cytotoxins and radioisotopes, as well as molecules for tumor visualization (e.g., MRI) and precise surgical resection (via fluorescein isothiocyanate [FITC] fluorescence).

Resolute targets a highly abundant non-cancerous cell population within tumors called TAMs (tumor-associated macrophages). These cells process MAC-TACs to deliver cytotoxic drugs to adjacent cancer cells. By targeting stable and non-dividing TAMs rather than rapidly dividing and mutating cancer cells, Resolute may avoid the resistance mechanisms intrinsic to targeting cancer cells, as seen with cancer cell-targeting therapeutics such as Antibody Drug Conjugates (ADCs) and small molecules.

On June 11, 2024 Moleculent AB, a company pioneering technology to study the communication between cells in human tissue, reported the closing of its oversubscribed $26 million Series A financing (Press release, Moleculent, JUN 11, 2024, View Source [SID1234644273]). The round was led by ARCH Venture Partners (ARCH) and co-led by Eir Ventures with participation from the company’s existing investors. ARCH’s Patrick Weiss has been appointed Chairman. Sean Kendall from ARCH, together with Magnus Persson from Eir Ventures, have also joined the company’s Board of Directors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Moleculent’s functional biology platform detects cell-cell interactions and profiles their communication directly within their tissue environment. This novel approach allows scientists to see how healthy cells function and how diseased cells differ at a complex, networked level. A complete picture of the cell-cell communication in a tumor, for example, offers a practical understanding of the signaling pathways and molecular mechanisms involved in drug response. Studying cell-cell interactions between many different receptors and ligands, in a tissue context, represents a paradigm shift in understanding biological systems by enabling scientists to see a more comprehensive picture and to decode the cell-cell conversations and disease pathways.

"Analysis of DNA, as well as RNA and protein expression inform us about the building blocks of a cell but do not directly measure how cells are working together. Understanding cell-cell communication networks in tissues has the potential to bring us into a new era of understanding functional biology and human disorders," said Olle Ericsson, PhD, co-founder and Chief Executive Officer of Moleculent. "The Moleculent platform has been designed to allow scientists to uncover radical new insights into the cellular level of human biology and pathology. We are very happy to partner with ARCH Venture Partners and Eir Ventures to bring this enabling platform to the scientific community."

Moleculent is led by a team of industry veterans with expertise in developing and globally commercializing life science tools at leading companies including Halo Genomics (acquired by Agilent), Vanadis Diagnostics (acquired by Perkin Elmer), and Spatial Transcriptomics (acquired by 10x Genomics).

"Spatial mapping technologies transformed our understanding of cellular neighborhoods, and the next frontier is to measure the critical communications between networks of individual cells. Moleculent will enable scientists to decipher this communication to better understand functional human biology," said Weiss. "I am honored to chair the Moleculent Board and look forward to working with this exceptional team of experienced entrepreneurs and technology developers to change how we understand and diagnose disease in the coming decade."

On June 11, 2024 Incyte Corporation (Nasdaq: INCY) ("Incyte" or the "Company") reported the preliminary results of its modified "Dutch auction" tender offer to purchase up to $1.672 billion in value of shares of its common stock, which expired at 12:00 midnight, at the end of the day, New York City time, on June 10, 2024 (Press release, Incyte, JUN 11, 2024, View Source [SID1234644271]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Based on the preliminary count by Computershare Trust Company, N.A., the depositary for the tender offer, a total of approximately 29.8 million shares of Incyte’s common stock were properly tendered and not properly withdrawn at or below the purchase price of $60.00 per share, including approximately 14.8 million shares that were tendered through notice of guaranteed delivery. Incyte has been informed by the depositary that the preliminary proration factor for the shares to be purchased by Incyte pursuant to the tender offer is approximately 93.4 percent.

In accordance with the terms and conditions of the tender offer and based on the preliminary count by the depositary, the Company expects to purchase approximately 27.9 million shares of its common stock through the tender offer at a purchase price of $60.00 per share, for a total cost of approximately $1.672 billion, excluding fees and expenses relating to the tender offer. These shares represent approximately 12.4 percent of the Company’s total outstanding shares of common stock as of June 7, 2024.

As previously announced, on May 12, 2024, Incyte entered into a separate stock purchase agreement with Julian C. Baker (a member of Incyte’s Board of Directors), Felix J. Baker, and entities affiliated with Julian C. and Felix J. Baker, including funds advised by Baker Bros. Advisors LP (collectively, the "Baker Entities"), under which the Baker Entities agreed not to tender or sell any shares in the tender offer and instead agreed to sell to the Company, following completion of the tender offer, a pro rata number of shares at the same price per share as will be paid by the Company in the tender offer, such that the Baker Entities’ aggregate percentage ownership in the Company will be substantially the same as prior to the tender offer. As such, the Company expects to repurchase a total of approximately 33.3 million shares of its common stock through the tender offer and the stock purchase agreement at a price of $60.00 per share, for a total cost of approximately $2.0 billion, excluding fees and expenses. These shares represent approximately 14.8 percent of the Company’s total outstanding shares of common stock as of June 7, 2024.

The number of shares expected to be purchased in the tender offer and under the stock purchase agreement and the purchase price per share are preliminary and subject to change. The preliminary information contained in this press release is subject to confirmation by the depositary and is based on the assumption that all shares tendered through notice of guaranteed delivery will be delivered within the required one business day period. The final number of shares to be purchased in the tender offer and the final purchase price per share will be announced following the expiration of the guaranteed delivery period and the completion by the depositary of the confirmation process. Payment for the shares accepted for purchase pursuant to the tender offer, and the return of all other shares tendered and not purchased, will occur promptly following the completion of the confirmation process. The Company expects to fund the purchase of shares in the tender offer and pursuant to the stock purchase agreement with the Baker Entities, together with all related fees and expenses, with cash on hand.

The dealer manager for the tender offer is Goldman Sachs & Co. LLC. D.F. King & Co., Inc. is serving as information agent for the tender offer. Stockholders who have questions or would like additional information about the tender offer may contact D.F. King & Co., Inc. toll-free at (866) 864-4943.

On June 11, 2024 Eilean Therapeutics AU Pty Ltd, a biopharmaceutical company dedicated to discovering and developing best-in-class and first-in-class small molecule inhibitors to target escape mutations in hematologic and solid malignancies, reported that it has joined The Leukemia & Lymphoma Society (LLS) in the groundbreaking collaborative Beat AML Master Clinical Trial (Press release, Eilean Therapeutics, JUN 11, 2024, View Source;lymphoma-societys-groundbreaking-beat-aml-master-clinical-trial-302168959.html [SID1234644270]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Eilean’s investigational agent, lomonitinib (ZE46-0134) has been selected for a new trial arm for patients with FLT3 mutated relapsed/refractory (R/R) acute myeloid leukemia (AML). Lomonitinib is a highly potent and selective pan-FLT3/IRAK4 inhibitor that targets clinically relevant FLT3 mutations and putative escape pathways. Given the excellent safety profile (with no cytological changes) and ability to rapidly reach steady state, target engagement exposures in a healthy volunteer study, it is anticipated that lomonitinib will have a deeper response (i.e. more CR/CRh) and longer duration of response in R/R AML patients and eventually expand to be the best-in-class FLT3 inhibitor. This will be Beat AML’s first phase 1 sub study, as well as its first precision medicine study in patients whose AML has relapsed or not responded to previous therapies.

"The Beat AML Master Trial provides a unique opportunity to contribute to the advancement of science in AML and evaluate the potential of lomonitinib in FLT3 mutated relapsed refractory AML," commented Iain Dukes, Chief Executive Officer of Eilean Therapeutics.

Beat AML is among the first cancer clinical trials to be sponsored by a nonprofit. It brings together a broad global collaboration of the best and brightest clinicians, cancer centers, pharmaceutical companies, and operational and technology partners, all unified to fundamentally change the treatment approach to AML. The trial has generated impressive results, showing superior survival rates and better quality of life when patients receive targeted treatment matched to the genetic mutations or their blood cancer in place of standard-of-care chemotherapy treatment.

"This partnership with Eilean is exactly what LLS envisioned when we began the Beat AML trial," said Ashley Yocum, Ph.D., LLS executive research lead for Beat AML. "Working with partners like Eilean to evaluate their new and potentially breakthrough approaches to AML treatment in the Beat AML framework will speed the process of bringing new treatments to both newly diagnosed patients and those previously treated with other therapies."

About Lomonitinib
Lomonitinib is a highly potent and selective inhibitor of FLT3 ITD, TKD and other clinically relevant FLT3 mutations, as well as IRAK4. FLT3 mutations are the most frequently identified mutations in AML. There are two main mechanisms of resistance to FLT3 inhibitors: the FLT3-ITD-F691L mutation deemed the "gatekeeper" mutation that confers resistance to all currently approved FLT3 inhibitors and the activation of the IRAK4 escape pathway. Lomonitinib inhibits both resistance mechanisms.

On June 11, 2024 Laminar Pharmaceuticals S.A., a clinical-stage biotechnological company developing novel therapies to treat diverse pathologies with unmet clinical needs, reported the recruitment of patients for the CLINGLIO (NCT04250922) study has been closed after 140 adult patients have been successfully enrolled (Press release, Laminar Pharma, JUN 11, 2024, View Source [SID1234644269]). The CLINGLIO study is a multinational, phase 2b/3, randomized, placebo-controlled, double-blind clinical trial evaluating idroxioleic acid in combination with Standard of Care (combined tumour resection and chemoradiotherapy) for the treatment of newly diagnosed glioblastoma patients. The CLINGLIO trial, funded by a European Commission Grant (H2020) is being carried out in 21 hospitals in Spain, Italy, France, and United Kingdom. The investigational study drug, idroxioleic acid (LAM561, sodium; 2-OHOA) is a synthetic fatty acid with a novel therapeutic approach, administrated orally to treat this devastating type of cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased to announce that the pivotal phase 2b/3 trial recruitment is completed, as this means that the results and outcome of the trial will be soon available," said Adrian McNicholl, Chief of Clinical Operations at Laminar Pharmaceuticals. The trial is expected to reach the trigger event for interim analysis in July 2024, which would provide an unblinded readout the last quarter of this year. "If idroxioleic acid is able to show compelling evidence demonstrating significant progression free survival benefit with overall survival, it could imply the first addition to the Standard of Care for glioblastoma patients since the approval of Temozolomide in 2005, 19 years ago." These unblinded results will be submitted for EMA evaluation for Conditional Marketing Authorization in early 2025, and the trial will continue until final analysis of survival in 2026.

Pablo Escribá, CEO of Laminar Pharmaceuticals, said: "The completion of the recruitment is a huge milestone in our clinical trial and in the development of this potential new therapy for glioblastoma patients. We are excited about the possibility of offering a new treatment available for this fatal disease, which has some of the clearer unmet needs across the oncology field".

The CLINGLIO trial, which was initiated in December 2019, has enrolled 140 participants across 4 countries in Europe. Those patients were randomized 1:1 versus placebo. Idroxioleic acid or placebo is added to Standard of Care, and continued for as long as the tumour does not progress. Idroxioleic acid has shown a favorable safety profile in pre-clinical and clinical trials so far. Additionally, no safety concerns were raised by an Independent Data Monitoring Committee (IDMC) who recommended "continue without modifications" after unblinded reviews of the available safety and efficacy data. The trial will continue until the final analysis of overall survival.

The CLINGLIO trial is considered pivotal in that results showing significant clinical benefit could be sufficient for a request for conditional marketing authorization in the EU late this year; and potential full marketing authorization in 2026, for which enabling pre-submission interactions with the EMA have been initiated.