On May 16, 2024 OneChain Immunotherapeutics S.L. (OneChain) and NanoCell Therapeutics Inc. (NanoCell), reported a strategic collaboration to develop a novel in vivo CAR-T therapy targeting B-cell lymphomas (Press release, NanoCell Therapeutics, MAY 16, 2024, View Source [SID1234643397]). This partnership combines OneChain’s advanced CD22 CAR technology with NanoCell’s innovative in vivo CAR-T technology platform, opening a new course for treatment in this disease area with persisting unmet need.

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NanoCell’s non-viral, DNA-based CAR-T technology platform has demonstrated compelling results in pre-clinical proof of concept studies, durable CAR-T expression and robust tumor control. This new approach offers a viable alternative to conventional viral methods, potentially establishing a new standard in the field.

OneChain’s proprietary CD22 CAR molecule was developed and optimized by Professor Pablo Menendez, founder of OneChain and Professor at the Josep Carreras Institute for Leukemia. Preclinical validation of this CD22 CAR has been published in multiple peer-reviewed academic journals1.

"Partnering with NanoCell allows us to integrate our CD22 CAR with their innovative in vivo CAR-T technology, aiming to enhance treatment options for B-cell lymphoma", said Stefanos Theoharis, CEO of OneChain Immunotherapeutics.

"We look forward to collaborating with OneChain Immunotherapeutics, and potentially offering innovative treatments beyond traditional CD19 therapies for patients with B-cell malignancies", added Maurts Geerlings, CEO of NanoCell Therapeutics.

To learn more about our work and stay updated about our latest developments, please visit our websites at View Source and View Source

On May 16, 2024 Monte Rosa Therapeutics, Inc. ("Monte Rosa") (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, reported the pricing of an underwritten public offering of 10,638,476 shares of its common stock at a public offering price of $4.70 per share and, in lieu of common stock to certain investors, pre-funded warrants to purchase 10,638,524 shares of common stock at a public offering price of $4.6999 per pre-funded warrant, which represents the per share public offering price of each share of common stock less the $0.0001 per share exercise price for each pre-funded warrant (Press release, Monte Rosa Therapeutics, MAY 16, 2024, View Source [SID1234643396]). The gross proceeds to Monte Rosa from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be approximately $100 million. All of the shares and pre-funded warrants in the offering are to be sold by Monte Rosa. The offering is expected to close on or about May 20, 2024, subject to satisfaction of customary closing conditions.

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The financing was led by Dimension and a life-sciences focused institutional investor, with participation from other new and existing investors.

TD Cowen and Wedbush PacGrow are acting as joint book-running managers for the offering.

The shares and pre-funded warrants are being offered by Monte Rosa pursuant to an effective shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (SEC) on July 1, 2022 and declared effective by the SEC on July 13, 2022 (File No. 333-266003). The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov.

The final prospectus supplement relating to and describing the final terms of the offering will be filed with the SEC and may be obtained, when available, from TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, NY 10017, by telephone at (855) 495-9846 or by email at [email protected] or Wedbush Securities Inc., Attn: ECM Department, 600 Montgomery Street, 29th Floor, San Francisco, CA 94111 or via email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On May 16, 2024 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, reported its abstract has been accepted for poster presentation at the EHA (Free EHA Whitepaper)2024 Hybrid Congress being held June 13-16, 2024 in Madrid, Spain and virtually (Press release, Moleculin, MAY 16, 2024, View Source [SID1234643395]).

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Details for the poster presentation are as follows:

Abstract: P537
Session: Acute myeloid leukemia – Clinical
Title: LIPOSOMAL ANNAMYCIN (L-ANN) IN COMBINATION WITH CYTARABINE FOR TREATMENT OF PATIENTS WITH ACUTE MYELOID LEUKAEMIA (AML) REFACTORY TO OR RELAPSED (R/R) AFTER INDUCTION THERAPY (MB-106 STUDY)
Presenting Author: Wolfram C. M. Dempke, MD, PhD, MBA, European Chief Medical Officer of Moleculin

For more information about the EHA (Free EHA Whitepaper)2024 Hybrid Congress, visit the event website.

On May 15, 2024 Galapagos NV (Euronext & NASDAQ: GLPG) and Blood Centers of America (BCA) reported that they have entered into a strategic collaboration for the decentralized manufacturing of Galapagos’ CAR-T cell therapies through BCA’s network in the U.S (Press release, Galapagos, MAY 16, 2024, View Source [SID1234643392]).

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Under the terms of the collaboration agreement, BCA will provide access to its extensive network of over 50 community blood centers in 43 states for Good Manufacturing Practice compliant manufacturing for Galapagos’ CAR-T hemato-oncology clinical program. This agreement complements existing collaborations between Galapagos and Landmark Bio and Thermo Fisher Scientific.

Galapagos will leverage BCA’s network to initiate technology transfer to multiple sites in parallel for the decentralized manufacturing of its CAR-T product candidates, close to cancer treatment centers, while also accessing apheresis capacity at BCA sites when required. In addition, BCA will play a crucial coordinating role by supporting site initiation and onboarding to accelerate Galapagos’ efforts and ensure consistent quality.

Galapagos’ innovative, decentralized manufacturing platform could address many of the limitations that currently available CAR-T production is facing. It has the potential to offer greater speed and scalability, with the delivery of fresh, fit cells with a vein-to-vein time of seven days and the possibility for greater physician control and improved patient experience.

"Our collaboration with Blood Centers of America marks a major milestone for Galapagos’ U.S. expansion by establishing centers for support of our pivotal studies, with the potential to be used for commercial introduction. Working with BCA’s extensive nationwide network allows us to efficiently scale up decentralized CAR-T therapy manufacturing across the U.S., while their established infrastructure helps us harmonize operations and access apheresis capacity," said Dr. Paul Stoffels1, CEO and Chairman of the Board of Directors of Galapagos. "This agreement complements the existing collaborations between Galapagos and Landmark Bio and Thermo Fisher Scientific and translates to a significant step forward in our aspiration to bring CAR-T therapies to more patients with a vein-to-vein time of just seven days."

"We are very pleased to partner with Galapagos in expanding their nationwide CAR-T manufacturing network," said Delisa English, BCA Board Chair. "Our decades of experience and advanced capabilities in regulatory compliant biologic processing across the U.S. will facilitate seamless technology transfer across multiple sites. We strongly believe that the combination of Galapagos’ decentralized manufacturing platform and our national cell therapy manufacturing footprint will ultimately benefit patients by providing convenient access to our local facilities for apheresis and local healthcare providers within their communities."

On May 16, 2024 Flamingo Therapeutics ("Flamingo") reported that the first patient has been dosed in an Investigator-initiated Trial (IIT) evaluating the safety and efficacy of danvatirsen in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) who have relapsed or are refractory to frontline therapy (Press release, Flamingo Therapeutics, MAY 16, 2024, View Source;utm_medium=rss&utm_campaign=flamingo-therapeutics-announces-first-patient-dosed-in-investigator-initiated-trial-iit-evaluating-danvatirsen-in-phase-1-for-aml-mds-cancers [SID1234643391]). The IIT is being conducted by leading researchers at Montifore Einstein Comprehensive Cancer Center (MECCC; New York, USA) and MD Anderson Cancer Center (MDACC; Houston, USA). In the Phase 1 trial, the STAT3 inhibiting oligonucleotide danvatirsen, discovered by Ionis, will be evaluated as a monotherapy and also in combination with venetoclax, an approved frontline treatment in relapsed/refractory MDS and AML.

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AML and MDS—two related blood diseases that disproportionally impact older adults—are notoriously difficult to treat and associated with high relapse rates. Although new therapies have improved survival, treatment options remain limited, and the prognosis for the 50% of people who experience disease relapse remains poor. STAT3 protein, which danvatirsen is designed to inhibit, has been associated with worse prognosis.

"We are excited to dose the first patient and initiate a potentially ground-breaking study to evaluate a novel therapeutic strategy targeting STAT3 with danvatirsen for patients suffering from AML and MDS. This clinical trial builds upon the work that my team has done in the research lab over the past decade, and is a good example of a bench to bedside partnership between academic medical centers and industry," said Aditi Shastri, M.D., Principal Investigator of the IIT, Member of MECCC’s Stem Cell & Cancer Biology Research Program and Blood Cancer Institute, and Associate Professor of Oncology, Medicine, and Developmental and Molecular Biology at Albert Einstein College of Medicine. "I look forward to working with the Flamingo team to continue generating promising results in the ongoing clinical trial."

The IIT is being funded by a multi-year grant awarded by the US FDA Office of Orphan Products Development (OOPD) to MECCC, with Dr. Aditi Shastri as the principal investigator, and was one of only 10 grants awarded by the FDA OOPD in 2023. MD Anderson Cancer Center (MDACC) is also participating in the trial with Dr.Naval Daver being the principal investigator at the MDACC site.

"Drs. Shastri and Daver are recognized among the world’s leading experts in AML and MDS and we couldn’t be more pleased to collaborate with them, MECCC, and MDACC," said Andrew Denker, MD, PhD, Chief Medical Officer of Flamingo. "We have tremendous momentum right now with danvatirsen, with ongoing clinical programs in head and neck cancer (PEMDA-HN) and in AML/MDS. The IIT announced today is very important to broaden Flamingo’s danvatirsen clinical development program, and advance our therapy towards patients who can benefit from novel treatments."

The IIT is a Phase I study (NCT05986240) investigating danvatirsen as both a monotherapy and in combination with venetoclax in patients with AML or intermediate/high/very high risk MDS who have relapsed or are refractory to frontline therapy. The sequential dose escalation design seeks to assess safety, efficacy, pharmacokinetics and pharmacodynamics, to inform a recommended phase 2 dose and further investigations.

More information on the IIT study can be found here.