On January 25, 2023 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson’s disease ("PD"), Parkinson’s-related disorders and other diseases of the Abelson Tyrosine Kinases, reported that it has entered into definitive agreements for the issuance and sale of 6,744,187 of its shares of common stock (or common stock equivalents) at a purchase price of $0.86 per share (or common stock equivalent) in a registered direct offering (Press release, Inhibikase Therapeutics, JAN 25, 2023, View Source [SID1234626541]). In a concurrent private placement, Inhibikase has also agreed to issue and sell 4,883,721 of its shares of common stock (or common stock equivalents), at the same purchase price as in the registered direct offering. In addition, the Company has agreed to issue in the offerings unregistered warrants to purchase up to an aggregate of 11,627,908 shares of common stock. The registered direct offering and the private placement were priced at a premium to market under Nasdaq rules. The offerings are expected to close on or about January 27, 2023, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offerings.

The warrants will have an exercise price $0.75 per share, will become exercisable immediately upon issuance and will have a term of five years from the date of issuance.

The aggregate gross proceeds to the Company from the concurrent offerings is expected to be approximately $10 million, before deducting the placement agent’s fees and other offering expenses payable by Inhibikase. The Company currently intends to use the net proceeds from the offerings for general corporate purposes, including clinical trials, product candidate development and manufacturing activities for product candidates, and to meet working capital needs.

The shares of common stock (or common stock equivalents) offered in the registered direct offering (but excluding the securities offered in the private placement and the shares of common stock underlying the unregistered warrants) are being offered and sold by the Company pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-262551), including a base prospectus, previously filed with the Securities and Exchange Commission (SEC) on February 7, 2022 and declared effective by the SEC on February 11, 2022. The offering of the shares of common stock (or common stock equivalents) to be issued in the registered direct offering are being made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and an accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the final prospectus supplement and accompanying base prospectus may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The offer and sale of the securities in the private placement and the unregistered warrants described above are being made in a transaction not involving a public offering and have not been registered under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act") and/or Rule 506(b) of Regulation D promulgated thereunder and, along with the shares of common stock underlying the unregistered warrants, have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities in the private placement, the unregistered warrants and underlying shares of common stock may not be reoffered or resold in the United States except pursuant to an effective registration statement with the Securities and Exchange Commission (the "SEC") or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

The Company has agreed to file an initial registration statement with the SEC covering the resale of the securities to be issued in the private placement no later than 10 days following the date of the agreement.

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 January 25, 2023 ArcticZymes Technologies, reported that the Company will host a Q4 2022 presentation, followed by an extended investor presentation for investors, analysts and media at 08:30 CET on Thursday, 02 February 2023 at Høyres Hus, Stortingsgata 20, Oslo (Press release, Biotec Pharmacon, JAN 25, 2023, View Source [SID1234626539]).

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The presentation will be given by the Chairman of the board, Marie Roskrow, CFO Børge Sørvoll, VP Business Development and Marketing, Dirk Hahneiser, VP of Operations Marit Sjo Lorentzen and CSO Darren Ellis. CEO Jethro Holter is currently on sick leave and will not participate.

The presentation can also be followed as a live webcast from Hegnar TV on www.arcticzymes.com or https://channel.royalcast.com/landingpage/hegnarmedia/20230202_2/. It will be possible to post questions through the webcast console.

The report for the fourth quarter 2022 and the extended investor presentation will be available on www.newsweb.no and on the company’s homepage www.arcticzymes.com from 07.00 CET on Thursday, 02. February 2023.

On January 24, 2023 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported the expiration of the waiting period under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 with respect to the previously reported expansion of its collaboration with Sanofi (Press release, Innate Pharma, JAN 25, 2023, View Source [SID1234626535]). The licensing agreement is now effective.

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As announced on December 19, 2022, Sanofi is licensing a Natural Killer (NK) cell engager program targeting B7H3 from Innate’s ANKET (Antibody-based NK Cell Engager Therapeutics) platform. Sanofi will also have the option to add up to two additional ANKET targets. Upon candidate selection, Sanofi will be responsible for all development, manufacturing and commercialization. Under the terms of the agreement, Innate will receive €25m upfront payment and up to €1.35bn total in preclinical, clinical, regulatory and commercial milestones plus royalties on potential net sales.

About ANKET

ANKET (Antibody-based NK cell Engager Therapeutics) is Innate’s proprietary platform for developing next-generation, multi-specific natural killer (NK) cell engagers to treat certain types of cancer.

This versatile, fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer. It leverages the advantages of harnessing NK cell effector functions against cancer cells and also provides proliferation and activation signals targeted to NK cells.

Our latest innovation, the tetra-specific ANKET molecule, is the first NK cell engager technology to engage activating receptors (NKp46 and CD16), a tumor antigen and an interleukin-2 receptor (via an IL-2 variant, IL-2v) via a single molecule.

On January 25, 2023 Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, reported that the National Comprehensive Cancer Network (NCCN) has updated its clinical practice guidelines for Adolescent and Young Adult (AYA) Oncology to include PEDMARK (sodium thiosulfate injection) to help reduce the risk of ototoxicity (hearing loss) associated with cisplatin use in pediatric patients with localized, non-metastatic solid tumors (Press release, Fennec Pharmaceuticals, JAN 25, 2023, View Source [SID1234626533]).

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"The use of cisplatin chemotherapy, an indispensable treatment of choice in many pediatric cancer cases, can be toxic to the ears and frequently causes permanent and irreversible bilateral hearing loss. In fact, permanent hearing loss occurs in approximately 60 percent of children treated with cisplatin and can be as high as 90 percent2," said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals. "We applaud NCCN for not only recognizing the importance of routine monitoring for hearing loss – which can have a profound impact on children’s learning and development at all ages – and also for providing a clear recommendation for the routine use of PEDMARK, a recently approved FDA therapeutic that may help reduce this unfortunate treatment-related side effect. Moreover, the FDA has directed that PEDMARK is not substitutable with other sodium thiosulfate products as part of the approved prescribing label.3"

The update to the Clinical Guidelines for AYA Oncology follows the U.S. Food and Drug Administration (FDA) approval of PEDMARK in September 2022, which was based upon safety and efficacy data from two pivotal open-label, randomized Phase 3 trials (Clinical Oncology Group [COG] Protocol ACCL0431 and SIOPEL 6), which compared PEDMARK plus a cisplatin-based regimen to cisplatin-based regimens alone for the reduction of cisplatin-induced hearing loss in pediatric patients. Fennec Pharmaceuticals commercially launched PEDMARK in the U.S. in October 2022.

"As a parent community, we are enthusiastic about the long-awaited approval of PEDMARK for the treatment of hearing loss associated with cisplatin. Anytime there is an opportunity to safely increase the long-term quality of life for a young patient, it should be considered a top priority in both therapeutic and supportive care," said Kimberly Buff, founder & executive director of the non-profit community organization, Momcology. "With many of our survivors now thankfully living to experience adult lives, we must take every action possible now to gift them the opportunity for the best future possible."

"Rigorously tested FDA-approved drugs offer parents a blanket of security and peace of mind when they are navigating the many unknowns after diagnosis, and as parents of children with cancer, we deserve all the security we can get," Bluff added.

The goal of the NCCN Guidelines for AYA Oncology is to identify issues specific to the AYA population; recommend interventions unique to the AYA population; educate physicians regarding the prevalence of cancer in AYAs; discuss long-term consequences; explain considerations related to the management in AYA patients that aims to improve treatment tolerance, compliance and clinical outcome; and promote participation in clinical trials.

About Cisplatin-Induced Ototoxicity

Cisplatin and other platinum compounds are essential chemotherapeutic agents for the treatment of many pediatric malignancies. Unfortunately, platinum-based therapies can cause ototoxicity, or hearing loss, which is permanent, irreversible, and particularly harmful to the survivors of pediatric cancer.4

The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids or cochlear implants, which can be helpful for some, but do not reverse the hearing loss and can be costly over time.5 Infants and young children that are affected by ototoxicity at critical stages of development lack speech and language development and literacy, and older children and adolescents often lack social-emotional development and educational achievement.6

PEDMARK (sodium thiosulfate injection)

PEDMARK is the first and only U.S. Food and Drug Administration (FDA) approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients with localized, non-metastatic, solid tumors. It is a unique formulation of sodium thiosulfate in single-dose, ready-to-use vials for intravenous use in pediatric patients.7 PEDMARK is also the only therapeutic agent with proven efficacy and safety data with an established dosing paradigm, across two open-label, randomized Phase 3 clinical studies, the Clinical Oncology Group (COG) Protocol ACCL0431 and SIOPEL 6.

In the U.S. and Europe, it is estimated that, annually, more than 10,000 children may receive platinum-based chemotherapy. The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventive agent for this hearing loss and only expensive, technically difficult, and sub-optimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children that suffer ototoxicity at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.

PEDMARK has been studied by co-operative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, COG ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, medulloblastoma, and other solid tumors. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

Indications and Usage

PEDMARK (sodium thiosulfate injection) is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.

Limitations of Use

The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.

Important Safety Information

PEDMARK is contraindicated in patients with history of a severe hypersensitivity to sodium thiosulfate or any of its components.

Hypersensitivity reactions occurred in 8% to 13% of patients in clinical trials. Monitor patients for hypersensitivity reactions. Immediately discontinue PEDMARK and institute appropriate care if a hypersensitivity reaction occurs. Administer antihistamines or glucocorticoids (if appropriate) before each subsequent administration of PEDMARK. PEDMARK may contain sodium sulfite; patients with sulfite sensitivity may have hypersensitivity reactions, including anaphylactic symptoms and life-threatening or severe asthma episodes. Sulfite sensitivity is seen more frequently in people with asthma.

PEDMARK is not indicated for use in pediatric patients less than 1 month of age due to the increased risk of hypernatremia or in pediatric patients with metastatic cancers.

Hypernatremia occurred in 12% to 26% of patients in clinical trials, including a single Grade 3 case. Hypokalemia occurred in 15% to 27% of patients in clinical trials, with Grade 3 or 4 occurring in 9% to 27% of patients. Monitor serum sodium and potassium levels at baseline and as clinically indicated. Withhold PEDMARK in patients with baseline serum sodium greater than 145 mmol/L.

Monitor for signs and symptoms of hypernatremia and hypokalemia more closely if the glomerular filtration rate (GFR) falls below 60 mL/min/1.73m2.

Administer antiemetics prior to each PEDMARK administration. Provide additional antiemetics and supportive care as appropriate.

The most common adverse reactions (≥25% with difference between arms of >5% compared to cisplatin alone) in SIOPEL 6 were vomiting, nausea, decreased hemoglobin, and hypernatremia. The most common adverse reaction (≥25% with difference between arms of >5% compared to cisplatin alone) in COG ACCL0431 was hypokalemia.

On Janaury 25, 2023 Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company, reported that an independent Data and Safety Monitoring Board (DSMB) has completed its prespecified data review for the first cohort of patients in the Company’s ongoing Phase I/II cell therapy clinical trial of AllocetraTM in patients with advanced-stage solid tumors (clinicaltrials.gov Identifier: NCT05581719) (Filing, 6-K, Enlivex Therapeutics, JAN 25, 2023, View Source [SID1234626532]). The Israeli Ministry of Health (IMOH) also reviewed the data and provided regulatory clearance to continue the study and open the study’s additional cohorts.

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The DSMB based its review on available safety data for the three enrolled patients in the first cohort in which three, once-weekly, low starting doses of AllocetraTM were administered as monotherapy. The dose-limiting toxicity period extended for one week following the last administration with an overall follow-up of 21 days. The primary purpose of the dosing regimen for the first cohort was to establish a safety profile that may enable an increase in the AllocetraTM dosing level administered to additional patients in the study and potentially associate dose levels with indications of effect.

There were no mortalities nor DSMB-identified safety signals in the first cohort, and the DSMB recommended that the study continue as designed. Following the DSMB recommendation, the IMOH reviewed the safety data for the first cohort and provided a regulatory clearance to initiate the recruitment of patients into the two following cohorts in the study, both of which will be administered higher AllocetraTM doses – one as monotherapy and the other in combination with anti-PD1 therapy.

Oren Hershkovitz, Ph.D., CEO of Enlivex, commented, "We are pleased with the safety profile of AllocetraTM as demonstrated in the first three patients in this trial. We look forward to initiating the next two cohorts in which higher doses of AllocetraTM will be administered in patients, allowing Enlivex to obtain additional safety data as well as a potential indication of effect."

ABOUT THE PHASE I/II TRIAL

The Phase I/II trial is a multicenter, open-label, dose escalation trial that is expected to enroll up to 48 patients with advanced solid tumors across two trial stages. Stage 1 of the trial will examine escalating doses of Allocetra monotherapy administered intravenously (IV) or intraperitoneally (IP) once a week for three consecutive weeks. Stage 2 will evaluate escalating doses of Allocetra administered IV or IP and combined with anti-PD1 therapy. Patients in Stage 2 will receive three injections of Allocetra concomitantly with the studied anti-PD1 agent. The primary objective of the study is to evaluate safety and tolerability throughout the treatment period and through one week after the last administration of Allocetra. Key secondary endpoints include efficacy assessments, such as best overall response rate, progression-free survival, and overall survival. Changes in immune cell/cytokine profiling in peritoneal fluid will also be assessed as an exploratory endpoint. The study population encompasses adult patients with advanced, unresectable or metastatic solid tumors that have relapsed or have been refractory to available approved therapies, or patients who are not eligible for, or have declined additional standard-of-care systemic therapy.

ABOUT ALLOCETRA

Allocetra is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as "unmet medical needs", as a stand-alone therapy or in combination with leading therapeutic agents.