On February 13, 2024 CSL reported its Results Presentation for the Half-year ended 31 December 2023 (Presentation, CSL, FEB 13, 2024, View Source [SID1234642335]).

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On February 13, 2024, CRISPR Therapeutics AG (the "Company") reported to have entered into an investment agreement (the "Investment Agreement") with certain institutional investors relating to the issuance of 3,916,082 shares of the Company’s common shares, par value of CHF 0.03 per share (the "Common Shares"), to such investors (the "Offering") (Filing, CRISPR Therapeutics, FEB 13, 2024, View Source [SID1234641108]). The Common Shares will be issued to the investors at an issue price of $71.50 per share. The Investment Agreement contains customary representations and warranties, conditions to closing, termination provisions and indemnification obligations, including for liabilities under the Securities Act of 1933, as amended.

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The gross proceeds from the Offering will be approximately $280 million, before paying estimated offering expenses. The Offering is being made pursuant to the automatically effective shelf registration statement on Form S-3 (File No. 333-258274) previously filed by the Company with the Securities and Exchange Commission on July 29, 2021.

The form of Investment Agreement is filed as Exhibit 10.1 to this Current Report on Form 8-K. The foregoing description of the respective terms of the Investment Agreement is not intended to be complete and is qualified in its entirety by reference to such exhibit. A copy of the opinion of Walder Wyss AG relating to the legality of the issuance and sale of the shares in the Offering is filed as Exhibit 5.1 to this Current Report on Form 8-K.

On February 13, 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 cancer indications, reported the activation of four clinical trial sites in the United States (Press release, Pasithea Therapeutics, FEB 13, 2024, View Source [SID1234640978]). These U.S. clinical trial sites in Texas and Virginia are now open and actively enrolling patients.

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This announcement follows the approval from the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for PAS-004, and FDA review of the protocol for the Company’s Phase 1 multicenter, open-label trial of PAS-004 in patients with MAPK pathway-driven advanced solid tumors with a documented RAS, NF1 or RAF mutation or patients who have failed BRAF/MEK inhibition.

The objective of the Phase 1 study is to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PAS-004 as well as to evaluate the preliminary anticancer activity (efficacy) of PAS-004 and to define the preliminary recommended Phase 2 dose.

The Company’s clinical development plan for PAS-004 following the Phase 1 study is to begin a Phase 2 clinical trial in NF1 pediatric and adult patients as soon as safety and PK are established.

Pasithea has selected Novotech as the clinical research organization (CRO) for the Phase 1 trial and will be collaborating in the U.S. with NEXT Oncology, led by Dr. Anthony Tolcher M.D., along with Dr. Ildefonso Rodriguez M.D., acting as principal investigator for the San Antonio, TX site. There are also three other clinical trial sites in Eastern Europe that are expected to open in the coming months.

"Activating our four clinical trial sites in the U.S. is a significant milestone in Pasithea’s mission towards developing PAS-004 as a potential best-in-class next-generation MEK inhibitor. We recognize the significant unmet needs and limited treatment options for patients with MAPK pathway-driven advanced solid tumors as well as NF1. We are ready to screen and enroll subjects in the coming month and look forward to gaining insight into the safety, tolerability and initial efficacy of PAS-004." said Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea.

PAS-004 is the first macrocyclic MEK inhibitor to enter human clinical trials, with an expected extended half-life in humans 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), which 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, which may provide seven years of marketing exclusivity upon approval of an NDA.

On February 13, 2024 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported the initiation of its ALISertib in CAncer (ALISCA-Lung1) Phase II trial (PUMA-ALI-4201; NCT06095505) of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (Press release, Puma Biotechnology, FEB 13, 2024, View Source [SID1234640056]). The ALISCA-Lung1 trial will enroll up to 60 patients with extensive stage small cell lung cancer who have progressed on or after first-line platinum-based chemotherapy and immunotherapy. Patients must provide tissue specimens so that biomarkers can be analyzed. Alisertib is dosed at 50 mg BID on days 1-7 of every 21-day cycle.

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The primary endpoint of the trial is objective response rate, with secondary endpoints of duration of response, disease control rate, progression-free survival and overall survival. Puma will also be looking at each of these endpoints within selected pre-specified biomarker subgroups and will assess whether there is enhanced efficacy in any biomarker subgroup. Puma will be performing its biomarker analysis of the ALISCA-Lung1 trial in parallel with the execution of the clinical trial. Puma plans to perform an initial interim analysis for the evaluation of the biomarkers as well as an evaluation of efficacy. Based upon the outcomes of the study, Puma anticipates meeting with the U.S. Food and Drug Administration to explore the potential for an accelerated approval pathway for alisertib in small cell lung cancer.

"Treatment options for patients with small cell lung cancer that has progressed on or after platinum-based chemotherapy are limited, and there is an urgent need for new drugs to treat this patient population," said Taofeek K. Owonikoko, MD, PhD, Marlene and Stewart Greenbaum Professor of Oncology in the Department of Medicine at the University of Maryland, Baltimore. "The results from the previous clinical trials of alisertib in small cell lung cancer suggest that the drug may represent a potentially promising treatment option for these patients and, more specifically, for patient subsets whose tumors harbor potential molecular markers that are likely associated with the clinical activity of an aurora kinase A inhibitor such as alisertib," said Dr. Owonikoko.

Alan H. Auerbach, Chief Executive Officer, President and Founder of Puma, stated, "We are pleased to initiate this Phase II trial, and we hope that the study will provide much needed insight into the clinical activity of alisertib in small cell lung cancer and, more specifically, in patients with molecularly defined tumors that may be targetable with an aurora kinase A inhibitor like alisertib."

On February 13, 2024 Immunome, Inc. ("Immunome") (Nasdaq: IMNM), a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies, reported the pricing of an underwritten public offering of 10,000,000 shares of its common stock at a price to the public of $20.00 per share (Press release, Immunome, FEB 13, 2024, View Source [SID1234640055]). All of the shares are to be sold by Immunome.

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The gross proceeds to Immunome from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be $200.0 million. In addition, Immunome has granted the underwriters a 30-day option to purchase up to an additional 1,500,000 shares of its common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on February 16, 2024, subject to the satisfaction of customary closing conditions.

J.P. Morgan, TD Cowen, Leerink Partners and Guggenheim Securities are acting as joint book-running managers for the offering. Wedbush PacGrow is acting as lead manager for the offering.

The offering is being made pursuant to a shelf registration statement on Form S-3 that was filed with the U.S. Securities and Exchange Commission (the "SEC") on February 13, 2024 and automatically became effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to the proposed offering were filed with the SEC and are available for free on the SEC’s website located at View Source A final prospectus supplement and accompanying prospectus relating to the proposed offering will be filed with the SEC and will be available for free on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Cowen and Company, LLC, 599 Lexington Avenue, New York, NY 10022, by email at [email protected] or by telephone at (833) 297-2926; Leerink Partners LLC, Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525 ext. 6105, or by email at [email protected]; or Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-9544, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, 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 registration or qualification under the securities laws of any such state or jurisdiction.