On April 23, 2024 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported that it has entered into definitive agreements for the purchase and sale of an aggregate of 494,096 shares of common stock at a purchase price of $2.034 per share, in a private placement to accredited investors and certain Company directors (Press release, MAIA Biotechnology, APR 23, 2024, View Source [SID1234642260]). Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $2.26 per share, which price represents the greater of the book or market value of the stock on the date the definitive agreements were executed (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing six months following issuance and have a term of five years from the initial exercise date. The securities being sold to the Company directors participating in the offering are being issued pursuant to the Company’s 2021 Equity Incentive Plan. The private placement is expected to close on or about April 25, 2024, subject to the satisfaction of customary closing conditions.

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The gross proceeds from the offering are expected to be approximately $1.00 million, prior to offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for to fund research and development activities, such as to fund the first third of the pivotal accelerated approval Part C of the THIO-101 trial in non-small cell lung cancer (NSCLC).

The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

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 other 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 other jurisdiction.

On April 23, 2024 Aubex Therapeutics Inc., a pioneering biotechnology firm, reported its official launch, heralding a new era in the battle against cancer (Press release, Aubex Therapeutics, APR 23, 2024, View Source [SID1234642259]). Under the guidance of Board Member and Interim CEO, Jeffrey Glazer, Aubex’s initial program is focused on novel compounds aimed at transforming the treatment of solid tumor malignancies through a unique approach to modifying the tumor microenvironment (TME).

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Aubex’s R&D program shows promise, particularly in cancers where fibrosis drives progression, such as HER2+ and triple-negative (TN) breast cancers, pancreatic cancer, esophageal squamous cell carcinoma (SCC), colon cancer, and non-small cell lung cancer. These solid tumors are notable for their pronounced fibrotic response, which impedes effective immune responses.

Jeffrey A. Glazer expressed his excitement about the company’s mission, stating, "Aubex Therapeutics is thrilled to launch with a unique R&D program addressing the TME. This innovative program demonstrates promising early activity in altering the tumor microenvironment, marking a significant milestone in immuno-oncology. We are eager to lead the way in developing therapies that hold the potential to dramatically improve outcomes for cancer patients by reducing fibrosis and boosting a patient’s immune response."

The launch of Aubex Therapeutics marks a pivotal moment in the ongoing effort to develop more effective cancer treatments. With a focus on achieving groundbreaking progress in the therapy of solid tumors, Aubex is dedicated to improving patient outcomes through innovative research.

On April 23, 2024 Red Arrow Therapeutics Inc. reported the company closed a $4.5M Seed Extension round, raising from four, top-tier institutional investors in Japan (Press release, Red Arrow Therapeutics, APR 23, 2024, View Source [SID1234642258]).

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Participants of this round are:

Beyond Next Ventures Inc.
The University of Tokyo Edge Capital Partners Co., Ltd.
Keio Innovation Initiative, Inc.
OSAKA University Venture Capital Co., Ltd.
This boosts the accumulative funding raised by Red Arrow Therapeutics to nearly $5.5M, along with previous funding from The University of Tokyo Edge Capital Partners Co., Ltd., University of California, Berkeley’s accelerator SkyDeck , and other non-dilutive funding.

Emerging from the University of Tokyo’s Cabral Lab in 2021, Red Arrow Therapeutics Inc. develops pH-sensing nanomedicine drug delivery technologies for multiple therapeutic areas such as oncology. Headquartered in Boston, Massachusetts, the company is committed to delivering cutting-edge technology for patients in need worldwide.

The Seed extension round will allow Red Arrow Therapeutics to obtain key preclinical data on safety and efficacy of their lead compound, IL-12-loaded nanopolymeric micelles. The funding will also enable manufacturing initiation in collaboration with external partners.

On April 23, 2024 Medivir AB (NASDAQ: MVIR) (STO: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported an update from a Type C meeting with the FDA, regarding the company’s plans for a global phase 2b study and opening of an IND for fostroxacitabine bralpamide (fostrox) in the US (Press release, Medivir, APR 23, 2024, View Source;lenvima-continue-302124266.html [SID1234642257]).

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The key outcome of the Type C meeting was that Medivir’s preparations for the randomized phase 2b study, comparing fostrox + Lenvima with Lenvima alone, continues with two key adjustments to the study design.

Firstly, as Medivir plans to use the improved capsule formulation of fostrox in the upcoming phase 2b study, an initial dose run-in as the first part of the study will be added. This means including 20-25 additional patients in an arm with a lower dose, in addition to the 30 mg dose used in the currently ongoing phase 1b/2a study. This change will also further strengthen the study design in relation to FDA’s Project Optimus.

Secondly, Objective Response Rate (ORR) is a validated surrogate endpoint for Overall Survival. In prior HCC studies, ORR has supported accelerated approvals. Therefore, the primary endpoint in the enhanced study design will be changed to ORR with key secondary endpoints, including duration of response, progression free survival and overall survival.

The aim of the study, as well as size and study length, remain similar as previously planned and communicated phase 2b design.

The FDA guidance has been discussed with Scientific Advisory Council members and regulatory experts. The next step is to finalize the study design and study protocol before submitting an IND in the US to enable study start in the beginning of 2025.

– "With the outcome of the Type C meeting, we are confidently moving forward with the enhanced phase 2b study design, including the adjustments informed by the discussion with FDA. Our current phase 1b/2a study, in a similar patient population, is still ongoing and patients are staying on treatment longer than expected. With the planned phase 2b study, we are excited to move forward with the development of a promising treatment alternative to second line HCC patients," says Pia Baumann, CMO at Medivir.

– "We continue to accelerate the development plan for fostrox. Engaging with FDA, to ensure best possible study design for the next phase, is critical for the program and is an important element in partnering discussions. Clarity on study design for phase 2b also allows us to move forward and perform study feasibility with speed as well as finalize CMC preparations," says Jens Lindberg, CEO at Medivir.

Medivir will provide additional details regarding the updated study design at the Quarterly Results webcast on April 30.

On April 23, 2024 Factor Bioscience Inc., a Cambridge-based biotechnology company focused on developing mRNA and cell-engineering technologies, reported its participation in the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 27th Annual Meeting to be held in Baltimore, MD from May 7-11, 2024 (Press release, Factor Bioscience, APR 23, 2024, View Source;cell-therapy-asgct-27th-annual-meeting-302124039.html [SID1234642256]). Factor will deliver seven presentations, representing the company’s most expansive presentation of data to date.

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"2024 marks the fifth year that Factor will present our latest data at the Annual Meeting of the ASGCT (Free ASGCT Whitepaper)," said Dr. Matt Angel, Co-Founder, Chairman and CEO of Factor. "This year promises to be particularly exciting, as we present our progress on deploying the powerful mRNA cell-engineering technologies that we have built at Factor over the last decade."

Dr. Kyle Garland, Director of Translational Science at Factor, commented, "We have been working hard over the last year to address several critical needs in our industry, including tissue-targeted delivery of nucleic acids, durable allogeneic cell therapies, and effective approaches for targeting solid tumors. We look forward to presenting our results in these and other areas next month at the ASGCT (Free ASGCT Whitepaper) Annual Meeting."

Details of the presentations are below:

"iMSCs Derived from mRNA-Engineered B2M-KO iPSCs Exhibit Enhanced Immunosuppressive Activity and Stealthing Features." -to be presented by Raven Hinkel on May 11 at 10:30 am, Novel Immune Effector Cell Manufacturing Oral Abstract Session, Ballroom 2.

"Sustained Transgene Expression in Engineered iPSC-Derived Tissue-Specific Cells." -to be presented by Taeyun Kim on May 10 from 12:00-7:00 pm, Targeted Gene Insertion Poster Session.

"Chromatin Opening Elements Mitigate Silencing of Transgenes During iPS Cell to Macrophage or Lymphocyte Differentiation." -to be presented by Claire Aibel on May 10 from 12:00-7:00 pm, Gene Targeting and Gene Correction New Technologies Poster Session.

"Targeted Insertion of HLA-E at the B2M Locus of mRNA-Reprogrammed iPSCs Facilitates the Development of Allogenic Cell Therapies with Enhanced Safety Features." -to be presented by Elizabeth Belcher on May 10 from 12:00-7:00 pm, Targeted Gene Insertion Poster Session.

"iPS-Derived Macrophages Engineered to Express IL-12 Enhance Cancer Cell Killing of a Multi-Cell Type Therapeutic Platform." -to be presented by Ian Hay on May 10 from 12:00-7:00 pm, Immune Targeting and Approaches with Genetically-Modified Cells and Cell Therapies Poster Session.

"A Library of Novel Polyvalent Ionizable Lipids for Targeted Co-Delivery of mRNA and DNA." -to be presented by Joey Pisano, Ph.D. on May 10 from 12:00-7:00 pm, Nonviral Therapeutic Gene Delivery and Synthetic/Molecular Conjugates Poster Session.

"Novel Polyvalent Ionizable Lipids Enable Targeted Delivery of mRNA to T Cells and Monocytes." -to be presented by Ariadna Lubinus on May 10 from 12:00-7:00 pm, Nonviral Therapeutic Gene Delivery and Synthetic/Molecular Conjugates Poster Session.
For more information about the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting, visit annualmeeting.asgct.org.