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Pasithea Therapeutics Announces PAS-004 Abstract Accepted for Poster Presentation at 2024 ASCO Annual Meeting

On April 29, 2024 Pasithea Therapeutics Corp. (NASDAQ: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor for the treatment of neurofibromatosis type 1 (NF1) and other indications, reported the acceptance of an abstract for poster presentation at the American Society of Cancer Oncology ("ASCO"), which will be held in Chicago from May 31 – June 4, 2024 (Press release, Pasithea Therapeutics, APR 29, 2024, View Source [SID1234642430]).

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Session titles and information for the abstract are listed below and now available on the ASCO (Free ASCO Whitepaper) online program planner.

PAS-004: A novel macrocyclic MEK inhibitor to inhibit cancer cell growth in vitro and tumor growth in mouse xenograft studies.

Session Type and Title: Poster Session – Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Session Date and Time: 6/1/2024, 9:00 AM – 12:00 PM CDT
Abstract Number: 3126
Speaker / lead author: Graeme Currie, PhD

The poster will be available at www.pasithea.com/publications following the presentation.

PAS-004 is the first macrocyclic MEK inhibitor to enter human clinical trials, with an expected extended half-life which may provide better compliance rates, as well as improved efficacy in NF1. Macrocycles are known to exhibit stronger binding, better solubility and longer half-life with more selectivity and less off target effect as compared to acyclic small molecules.

About PAS-004

PAS-004 is a small molecule allosteric inhibitor of MEK 1/2, which are dual-specificity protein kinases, in the MAPK signaling pathway. The MAPK pathway has been implicated in a variety of diseases, as it functions to drive cell proliferation, differentiation, survival and a variety of other cellular functions that, when abnormally activated, are critical for the formation and progression of tumors, fibrosis and other diseases. MEK inhibitors block phosphorylation (activation) of extracellular signal-regulated kinases (ERK). Blocking the phosphorylation of ERK can lead to cell death and inhibition of tumor growth. Existing FDA approved MEK inhibitors are marketed for a range of diseases, including certain cancers and neurofibromatosis type 1 (NF1). We believe these MEK inhibitors suffer from certain limitations, including known toxicities. Unlike current FDA approved MEK inhibitors, PAS-004 is macrocyclic, which we believe may lead to improved pharmacokinetic and safety (tolerability) profiles. Cyclization offers rigidity for stronger binding with drug target receptors. PAS-004 was designed to provide a longer half-life with what we believe is a better therapeutic window. Further, we believe the potency and safety profile that PAS-004 has demonstrated in preclinical studies may also lead to stronger and more durable response rates and efficacy, as well as better dosing schedules. PAS-004 has been tested in a range of mouse models of various diseases and has completed preclinical testing and animal toxicology studies. Additionally, PAS-004 has received orphan-drug designation from the FDA for the treatment of NF1.

Oncotelic Therapeutics, Inc. to Sell Its Necroptosis Cancer Therapy Assets to Mosaic ImmunoEngineering, Inc.

On April 29, 2024 Oncotelic Therapeutics, Inc. (OTCQB:OTLC) ("Oncotelic", the "Company" or "We" or "Our"), reported that it has entered into a binding term-sheet with Mosaic ImmunoEngineering, Inc. (OTCPK: CPMV) ("Mosaic") under which Mosaic will acquire rights to Oncotelic’s clinical-stage necroptosis cancer therapies (Press release, Oncotelic, APR 29, 2024, View Source [SID1234642429]). Oncotelic’s necroptosis therapeutics work by disrupting tumor blood flow resulting in immunogenic tumor cell death through "death receptor" activation which can result in a robust anti-cancer immune response. In addition to the clinical stage assets, Mosaic will have access to Oncotelic’s proprietary Artificial Intelligence ("AI") technologies for identifying immunotherapy combinations.

Pursuant to the binding term-sheet, Mosaic will issue to Oncotelic $15 million in CPMV shares upon execution of the definitive purchase agreement along with additional milestones allowing Oncotelic to earn up to an additional $15 million in shares of CPMV. The Mosaic team, which has broad experience in bringing oncology and orphan drug products to market with a combined experience including well over 30 FDA and worldwide product approvals, will be responsible for advancing the development of the technologies. Both companies will work closely together to ensure a smooth transfer of the technologies from Oncotelic to Mosaic. Oncotelic will provide short-term financial support for the program while the teams work together to achieve both short-term and long-term financing goals. Pursuant to the binding term sheet, the parties agreed to negotiate in good faith towards the execution of the Definitive Agreements and the closing of the transactions contemplated thereby, which will be subject to customary due diligence and other conditions as described in the binding term sheet.

"This will be the second transaction for capitalizing on our assets and building shareholder value. The first being the successful transition of OT-101 to our joint venture ("JV") with Dragon Capital Overseas, Limited. The JV is expected to list for an IPO, as well as the completion of establishing a research and manufacturing facility headquartered in San Diego, California." expressed Dr. Vuong Trieu, CEO of Oncotelic.

"We are very pleased to have this opportunity to bring these clinical stage assets that have promise for the treatment of multiple types of cancer into Mosaic. We anticipate that the initial application of the technology will be in areas with high unmet medical need such as uveal melanoma and retinoblastoma. We look forward to working with the Oncotelic team to advance the program." said Steven King, President and CEO of Mosaic.

INOVIO to Participate in Upcoming Investor Conferences in May

On April 29, 2024 INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, reported that management will participate in the following investor conferences during the month of May (Press release, Inovio, APR 29, 2024, View Source [SID1234642428]):

The Citizens JMP Life Sciences Conference
Date: Tuesday, May 14, 2024
Time: 11:30 AM ET
Presenter: Dr. Jacqueline Shea, President & CEO
Format: Fireside Chat

RBC Capital Markets 2024 Global Healthcare Conference
Date: Wednesday, May 15, 2024
Time: 10:00 AM ET
Presenter: Dr. Jacqueline Shea, President & CEO
Format: Fireside Chat

H.C. Wainwright 2nd Annual BioConnect Investor Conference at NASDAQ
Date: Monday, May 20, 2024
Time: 12:30 PM ET
Presenter: Dr. Jacqueline Shea, President & CEO
Format: Fireside Chat

During the conferences, Dr. Shea and members of INOVIO’s management team will conduct one-on-one meetings with registered investors.

Webcasts of the fireside chats will be available on the INOVIO Investor Relations Events page at View Source Replays of the webcasts will be available for 90 days after the date of the presentation.

Immix Biopharma Awarded European Union Orphan Drug Designation for NXC-201 in Multiple Myeloma

On April 29, 2024 Immix Biopharma, Inc. ("Immix Biopharma", "Company", "We" or "Us", Nasdaq:IMMX), a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease, reported that the European Commission (EC) has granted orphan drug designation to NXC-201 for the treatment of multiple myeloma (Press release, Immix Biopharma, APR 29, 2024, View Source [SID1234642427]).

"Frail patients, heavily represented in our NEXICART-1 clinical trial, remain an area of unmet medical need and are a significant portion of the relapsed/refractory multiple myeloma population," said Ilya Rachman, MD PhD, Chief Executive Officer, Immix Biopharma. "We believe EU orphan drug designation for NXC-201 affirms the potential clinical impact of NXC-201 in this sizable population."

Gabriel Morris, Chief Financial Officer, Immix Biopharma added, "We believe NXC-201’s observed favorable tolerability profile and ‘Single Day CRS’ across a robust clinical dataset could enable an attractive option for frail relapsed/refractory multiple myeloma patients in addition to our lead indication, relapsed/refractory AL Amyloidosis, and our active NXC-201 expansion into other autoimmune diseases."

According to Davis et al., 2023 Transplantation and Cellular Therapy, commercial CAR-Ts produced 6.9 months median progression free survival in frail relapsed/refractory multiple myeloma patients in a real-world setting. 61% of patients in the dataset were considered frail.

Orphan drug designation in the European Union (EU) is granted by the EC based on a positive opinion issued by the European Medicines Agency (EMA) Committee for Orphan Medicinal Products. To qualify for orphan drug designation, a candidate therapy must be intended for the treatment, prevention or diagnosis of a life-threatening or chronically debilitating disease that occurs in not more than five in 10,000 people in the EU. The designation provides regulatory, financial and commercial incentives to develop therapies for rare diseases where there are either no satisfactory treatment options or significant benefit to those affected by the disease.

Deciphera Pharmaceuticals to be Acquired by ONO Pharmaceutical For $2.4 Billion

On April 29, 2024 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, reported that it has entered into a definitive merger agreement with ONO Pharmaceutical Co., Ltd. (ONO), under which ONO will acquire all outstanding shares of Deciphera common stock for $25.60 per share in cash through a tender offer followed by a merger of Deciphera with a wholly-owned subsidiary of ONO (the "Acquisition"), for a total equity value of $2.4 billion (Press release, Deciphera Pharmaceuticals, APR 29, 2024, View Source [SID1234642426]). The boards of directors of both companies have unanimously approved the transaction.

Together, ONO and Deciphera will accelerate their shared vision to deliver innovative new drugs and serve patients around the world. Deciphera brings specialized research and development capabilities in kinase drug discovery, well-established commercial and sales platforms in the United States and Europe, and global clinical development capabilities. In addition to QINLOCK – Deciphera’s switch-control inhibitor for the treatment of fourth-line gastrointestinal stromal tumor (GIST), which is approved in the United States and over 40 other countries, Deciphera also brings a mature, diverse pipeline of best-or-first in class potential medicines, including vimseltinib, DCC-3116 (an ULK inhibitor) and multiple additional oncology candidates. Vimseltinib is a highly selective switch-control kinase inhibitor with successful pivotal clinical data for the potential to be a best-in-class and first-in-class agent for the treatment of tenosynovial giant cell tumor (TGCT), and potentially other indications. The Acquisition is expected to enable ONO to build a robust presence in oncology, one of its key priority areas, and also support ONO’s efforts to become a Global Specialty Pharma company.

Steven L. Hoerter, President and Chief Executive Officer of Deciphera, said, "Deciphera and ONO share a deep commitment to improve the lives of people living with cancer, and the transaction announced today enables us to make even greater impact for patients. Together, we expect to advance and accelerate each organization’s important work through combined research and development capabilities and a global commercial footprint. Importantly, this acquisition delivers for all of Deciphera’s stakeholders. It provides immediate, compelling value for our shareholders, provides greater opportunities for our world-class team, and ultimately, greater hope for patients. I am excited about the future of the combined organization, and we are honored to contribute to the continued growth of ONO in the U.S. and around the world."

Gyo Sagara, Representative Director, Chairman of the Board and Chief Executive Officer of ONO, said, "We expect that this acquisition of Deciphera will not only expand ONO’s target oncology portfolio, but also accelerate ONO’s business development in the United States and Europe, and strengthen kinase drug discovery research. Deciphera’s mission statement ‘Inspired by Patients: Defeat Cancer’ is aligned with ONO’s corporate philosophy ‘Dedicated to the Fight against Disease and Pain.’ We respect the innovative culture of Deciphera and look forward to working together to drive further growth for both ONO and Deciphera."

Transaction Details

The Acquisition is structured as a tender offer and subsequent merger of Deciphera with a wholly-owned subsidiary of ONO. Under the terms of the definitive merger agreement, ONO will acquire all outstanding shares of Deciphera for $25.60 per share in cash for a total equity value of approximately $2.4 billion. The purchase price represents a premium of 74.7% to Deciphera’s closing share price of $14.65 on April 26, 2024, and a premium of 68.8% to Deciphera’s 30-trading-day volume weighted average price as of April 26, 2024.

ONO will promptly commence the tender offer, and it will expire 20 business days after its commencement, unless otherwise extended. If the tender offer conditions are not satisfied, ONO may be required to extend the tender offer under certain circumstances. Upon the successful completion of the tender offer, ONO’s wholly-owned subsidiary will merge with and into Deciphera, with Deciphera continuing as the surviving corporation and a wholly-owned subsidiary of ONO, and any shares of common stock of Deciphera not tendered into the offer will receive the same USD per share price payable in the tender offer. The Acquisition is expected to close in the third quarter of 2024, subject to customary closing conditions, including U.S. antitrust clearance and the tender of a majority of Deciphera’s outstanding shares of common stock.

In connection with the execution of the merger agreement, certain stockholders of the Company owning approximately 28% of the outstanding shares of Deciphera Common Stock have entered into Tender and Support Agreements pursuant to which they will tender all of their owned shares in the offer.

Upon completion of the Acquisition, Deciphera will operate as a standalone business of ONO Group, from its headquarters in Waltham, Massachusetts.

In light of the Acquisition, Deciphera will not host a first quarter 2024 earnings call. The Company will file a Form 10-Q in the ordinary course.

Advisors

J.P. Morgan Securities LLC is serving as exclusive financial advisor to Deciphera and Goodwin Procter LLP is serving as legal counsel. BofA Securities is serving as financial advisor to ONO and Greenberg Traurig is serving as legal counsel.