Chugai Files for Additional Indication of Actemra for Cytokine Release Syndrome Induced by Cancer Treatment in Japan

On February 28, 2023 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it filed regulatory applications with the Ministry of Health, Labour and Welfare for the humanized anti-human IL-6 receptor monoclonal antibody, "Actemra Intravenous Infusion 80mg, 200mg, and 400mg" [generic name: tocilizumab (genetical recombination)] for the treatment of cytokine release syndrome induced by cancer treatment. This application is based on the clinical study results of an antineoplastic agent (Press release, Chugai, FEB 28, 2023, View Source [SID1234627922]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are very pleased to file for regulatory application of Actemra for the additional indication of cytokine release syndrome induced by cancer treatment in Japan," said Chugai’s President and CEO, Dr. Osamu Okuda. "Cytokine release syndrome, a common adverse reaction in CAR-T cell therapy and some antibody drugs, can be life-threatening in severe cases. We are closely working with the Japanese health authority to ensure that proper treatment is provided to patients on cancer therapies other than CAR-T cell therapy."

About Actemra
Actemra is the first therapeutic antibody created in Japan by Chugai. It is designed to block the activity of IL-6, a type of inflammatory cytokine. First launched in June 2005, the intravenous injection is approved for seven indications in Japan: Castleman’s disease, rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, cytokine release syndrome induced by tumor-specific T cell infusion therapy, adult Still’s disease, and SARS-CoV-2 pneumonia. In addition, Actemra subcutaneous injection is approved for three indications in Japan: rheumatoid arthritis, Takayasu arteritis, and giant cell arteritis. Actemra has obtained regulatory approval in more than 110 countries worldwide.

Entry into a Material Definitive Agreement.

On February 28, 2023 Applied DNA Sciences, Inc. (the "Company") reported that it has entered into that certain Amended and Restated Lease Agreement with Long Island High Technology Incubator, Inc. (the "Landlord") with respect to the Company’s office space consisting of 30,000 gross rentable square feet in the building known as LIHTI 2 located at 50 Health Sciences Drive, Stony Brook, New York 11790 (the "Office Lease" ) (Filing, 8-K, Applied DNA Sciences, FEB 28, 2023, View Source [SID1234627920]). Also on February 24, 2023, the Company entered into that certain Amended and Restated Lease Agreement with the Landlord with respect to the Company’s laboratory space consisting of an aggregate of 2,500 gross rentable square feet located at 25 Health Sciences Drive, Stony Brook, New York 11790 (the "Laboratory Lease").

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The term of the Office Lease commenced on February 1, 2023 and expires on January 31, 2026, unless terminated prior to such expiration date as provided in the Office Lease. The term of the Laboratory Lease commenced on February 1, 2023 and expires on January 31, 2024, unless terminated prior to such expiration date as provided in the Laboratory Lease.

Under the Office Lease, beginning on February 1, 2023 and ending on January 31, 2024, the base rent will be $48,861.17 per month. Beginning on February 1, 2024, the base rent under the Office Lease shall be increased in February of each year by a percentage equal to the percentage change in the Consumer Price Index statistics published by the United States Bureau of Labor Statistics. Under the Laboratory Lease, beginning on February 1, 2023 and ending on January 31, 2024, the base rent will be $8,750 per month.

The foregoing descriptions of the Office Lease and the Laboratory Lease contained in this Current Report on Form 8-K do not purport to be complete and are qualified in their entirety by reference to the Office Lease and Laboratory Lease, copies of which are filed as Exhibit 10.1 and Exhibit 10.2, respectively.

Item 2.03 Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.

The descriptions of the Office Lease and the Laboratory Lease in "Item 1.01 Entry into a Material Definitive Agreement" of this Current Report on Form 8-K are incorporated by reference in their entirety into this Item 2.03.

Puma Biotechnology to Participate in a Panel Discussion at Cowen’s 43rd Annual Health Care Conference

On February 28, 2023 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will attend Cowen’s 43rd Annual Health Care Conference, which will be held March 6 – 8, 2023 at the Boston Marriott Copley Place in Boston (Press release, Puma Biotechnology, FEB 28, 2023, View Source [SID1234627919]). Mr. Auerbach will participate in a Breast and Lung Cancer Panel Discussion on March 7 at 10:30 a.m. ET.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the Breast and Lung Cancer Panel Discussion will be available at https://wsw.com/webcast/cowen132/panel8/2250192, and a replay will be available on Puma’s website for 30 days following the presentation at View Source

Adicet Bio Reports Inducement Grants under Nasdaq Listing Rule 5635(c)(4)

On February 28, 2023 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, reported it granted inducement awards on February 28, 2023 (Press release, Adicet Bio, FEB 28, 2023, View Source [SID1234627918]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Four individuals hired by Adicet in February 2023 received, in the aggregate, non-qualified stock options to purchase 105,400 shares of Adicet’s common stock with an exercise price of $7.88 per share, the closing price of Adicet’s common stock as reported by Nasdaq on February 28, 2023. One-fourth of the shares underlying each employee’s option will vest on the one-year anniversary of each recipient’s start date and thereafter the remaining three-fourths of the shares underlying each employee’s option will vest in thirty-six substantially equal monthly installments, such that the shares underlying the option granted to each employee will be fully vested on the fourth anniversary of the recipient’s start date, in each case, subject to each such employee’s continued employment with Adicet on such vesting dates.

All of the above-described awards were granted outside of Adicet’s stockholder-approved equity incentive plans pursuant to Adicet’s 2022 Inducement Plan (the Inducement Plan), which was adopted by the board of directors in January 2022 and subsequently amended in January 2023. The awards were authorized by the compensation committee of the board of directors, which is comprised solely of independent directors, as a material inducement to the employees entering into employment with Adicet in accordance with Nasdaq Listing Rule 5635(c)(4).

AngioDynamics to Participate in Three Investor Conferences in March

On February 28, 2023 AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving quality of life for patients, reported that Jim Clemmer, President and Chief Executive Officer, and Stephen Trowbridge, Executive Vice President and Chief Financial Officer, will participate in the following three investor conferences in March (Press release, AngioDynamics, FEB 28, 2023, View Source [SID1234627917]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Raymond James Institutional Investors Conference
Format: In-person Presentation
Date: Monday, March 6, 2023
Time: 8:05 a.m. ET
Location: Orlando, FL

Oppenheimer Virtual Healthcare Conference
Format: Fireside Chat
Date: Monday, March 13, 2023
Time: 9:20 a.m. ET

KeyBanc Virtual Life Sciences & MedTech Investor Forum
Format: Fireside Chat
Date: Tuesday, March 21, 2023
Time: 4:30 p.m. ET

A live webcast of each presentation will be accessible through the "Investors" section of the Company’s website at www.angiodynamics.com and will be available for replay following each event.