On April 23, 2024 TME Pharma N.V. (Euronext Growth Paris: ALTME), a biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), reported a positive update on survival at two years for newly diagnosed glioblastoma patients receiving NOX-A12, TME Pharma’s CXCL12 inhibitor, with the VEGF inhibitor bevacizumab and radiotherapy (Press release, TME Pharma, APR 23, 2024, View Source [SID1234642262]).

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Two out of the six glioblastoma patients in this expansion arm of the GLORIA Phase 1/2 trial have survived for more than 24 months since the start of therapy. These two patients had tumors which, at one point during treatment, either disappeared completely or reached near-complete reduction (>99%) in size. The first patient to cross the two-year survival milestone had maintained a physical and cognitive condition within the norm, displaying only minimal disease-specific symptoms at this timepoint. This translates to a preserved quality of life, as evidenced by the patient’s continued ability to engage in hobbies, leisure activities, and social interaction. The second patient’s clinical status at the last assessment at 23 months was stable, although certain neurological functions had been partially affected. This patient’s course is also remarkable in that they received no therapy expected to prolong survival in the last 18 months since they decided to end treatment with the NOX-A12 combination following a near-complete reduction of tumor as assessed by MRI.

In February, TME Pharma announced the final median overall survival (mOS) for this NOX-A12 cohort had reached an unprecedented 19.9 months. This survival rate compares very favorably to a matched standard of care reference cohort,1 which achieved an mOS of approximately 10 months, and exceeds what TME Pharma believes to be all relevant competitor therapy trials in newly diagnosed glioblastoma patients resistant to standard chemotherapy.2

"This positive update from the GLORIA trial underlines the exceptional survival achieved by this cohort of patients with measurable tumors after surgery that are resistant to standard of care chemotherapy and gives more support for the potential of this NOX-A12 treatment regimen to prolong survival while preserving quality of life in patients suffering from this aggressive adult brain cancer," said Aram Mangasarian, CEO of TME Pharma. "This latest announcement adds to the significant clinical and regulatory progress we have made in recent months with our lead asset, putting us in an excellent position for our upcoming Phase 2 evaluation and our discussions with potential pharmaceutical and financial partners, as we endeavor to deliver NOX-A12 for the benefit of glioblastoma patients as quickly and efficiently as we can."

TME Pharma recently announced two key regulatory milestones with the clearance by the US Food and Drug Administration (FDA) in March of the company’s Investigational New Drug (IND) application for NOX-A12 in glioblastoma, allowing TME Pharma to proceed with the continued clinical development of NOX-A12 in a new Phase 2 study. This was followed by the FDA’s award of Fast Track designation to NOX-A12 in glioblastoma in April. Fast Track designation aims to facilitate the development of therapies intended to treat serious conditions and address unmet medical needs, and could support an accelerated pathway to US regulatory approval. Preparatory steps for the NOX-A12 Phase 2 in glioblastoma are ongoing, and TME Pharma is aiming to initiate the new study as soon as the necessary resources from financial and industrial partners have been secured.

On April 23, 2024 Incyte (Nasdaq:INCY) and Escient Pharmaceuticals, a clinical-stage drug discovery and development company advancing novel small molecule therapeutics for systemic immune and neuro-immune disorders, reported to have entered into a definitive agreement under which Incyte has agreed to acquire Escient, including EP262, a first-in-class, potent, highly selective, once-daily small molecule antagonist of Mas-related G protein-coupled receptor X2 (MRGPRX2) and EP547, a first-in-class oral MRGPRX4 antagonist (Press release, Incyte, APR 23, 2024, View Source [SID1234642261]).

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"As a company dedicated to innovation and the discovery of transformative medicines, we are excited to add EP262 and EP547 to our portfolio. This acquisition builds on our strategy to develop differentiated and first-in-class medicines with high potential," said Hervé Hoppenot, Chief Executive Officer, Incyte. "EP262 and EP547 are complementary additions to our portfolio, providing an opportunity to leverage our expertise, address the needs of patients with inflammatory diseases and additional potential launch opportunities starting in 2029."

By blocking MRGPRX2 and degranulation of mast cells, EP262 has the potential to effectively treat multiple mast cell-mediated diseases including atopic dermatitis (AD), chronic inducible urticaria (CIndU) and chronic spontaneous urticaria (CSU). Preclinical studies presented at the American Academy of Dermatology annual meeting in March 2023 showed that EP262 improved AD-like skin lesions and markers of type 2 inflammation. Additionally, in a Phase 1 study of 64 healthy volunteers, EP262 was safe and well tolerated at all doses tested, with no serious or severe adverse events, no adverse events leading to discontinuation and no clinically meaningful adverse changes in safety laboratory parameters, vital signs or ECG parameters. Treatment-emergent adverse events for EP262 were mild, with an incidence that was lower than placebo (33.3% vs. 62.5%) and did not increase with dose.

"These drug candidates are the result of the highly innovative research performed by Escient’s employees and scientific collaborators," said Joshua A. Grass, President and Chief Executive Officer, Escient. "With its experienced development and commercial teams in Inflammation and Autoimmunity and portfolio of commercial and development stage products, Incyte is well positioned to translate this new science into valuable medicines for patients."

Under the terms of the agreement, Incyte will acquire Escient and its assets for $750 million plus Escient’s net cash remaining at the close of the transaction, subject to customary adjustments. The acquisition is subject to clearance under the Hart-Scott-Rodino Act, among other customary conditions, and will become effective promptly following the satisfaction or waiver of these conditions which is currently anticipated to be by the third quarter of 2024.

Centerview Partners LLC and Goldman Sachs & Co. LLC advised Escient on the transaction and Fenwick & West LLP acted as legal counsel for Escient. Covington & Burling LLP acted as legal counsel for Incyte.

Incyte Conference Call and Webcast

Incyte will hold a conference call and webcast this morning at 8:00 a.m. ET. To access the conference call, please dial 877-407-3042 for domestic callers or +1 201-389-0864 for international callers. When prompted, provide the conference identification number: 13746287. If you are unable to participate, a replay of the conference call will be available for 90 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is +1 201-612-7415. To access the replay, you will need the conference identification number: 13746287.

The conference call will also be webcast live and can be accessed at investor.incyte.com.

About EP262

EP262 is a potent, highly selective once-daily small molecule antagonist of MRGPRX2, a receptor expressed on mast cells that is activated by numerous ligands, including many peptides released from sensory neurons as well as other cell types. In response to MRGPRX2 activation, mast cells release histamine, tryptase, chymase, chemokines and cytokines, which can cause itchy hives, angioedema, type 2 inflammation (through engagement of the adaptive immune system) and chronic pruritus and pain. Preclinical data demonstrate that, by blocking activation of MRGPRX2, EP262 has the potential to effectively treat a broad range of mast cell-mediated conditions, with an initial focus on chronic urticarias and atopic dermatitis.

About EP547

EP547 is a potent, highly selective antagonist that blocks the activation of MRGPRX4 by various bile acids, bilirubin and urobilin. By virtue of this disease-specific mechanism of action, EP547 has the potential to be a highly targeted and efficacious treatment for cholestatic and uremic pruritus.

About Chronic Urticaria

Chronic urticaria, defined as urticaria persisting for more than 6 weeks, manifests with very itchy hives that may vary in size and can significantly impact a patient’s quality of life by interfering with sleep and daily activities. Some patients with chronic urticaria may also develop swelling deeper under the skin or in other tissues (angioedema). There are two main forms of chronic urticaria. In chronic spontaneous urticaria (CSU), hives occur spontaneously, without known triggers. In chronic inducible urticaria (CIndU), hives are induced by specific triggers, such as cold exposure (cold urticaria) or touch (symptomatic dermographism), among others.

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.