On June 6, 2022 Checkpoint Therapeutics, Inc. (Checkpoint) (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported the presentation of data from its pivotal trial of cosibelimab in metastatic cutaneous squamous cell carcinoma (cSCC) during the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Checkpoint Therapeutics, JUN 6, 2022, View Source [SID1234615709]). Positive top-line results were previously announced in January 2022 .

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Poster Presentation Title: Efficacy and safety of cosibelimab, an anti-PD-L1 antibody, in patients with metastatic cutaneous squamous cell carcinoma: Results from pivotal cohort

This registration-enabling clinical trial enrolled 78 patients with metastatic cSCC at 24 sites in 8 countries, including Australia/New Zealand (58%), Europe (24%), South Africa (10%), and Thailand (8%), and is being conducted under an Investigational New Drug application with the U.S. Food and Drug Administration. The trial is investigating the safety and efficacy of cosibelimab administered as a fixed dose of 800 mg every two weeks in patients with metastatic cSCC (lymph nodal or distant metastatic disease). Data from this study is expected to support a Biologics License Application for cosibelimab planned for submission in the fourth quarter of 2022.

Data highlights from the poster include:

Efficacy

Confirmed objective response rate (ORR) by independent central review in the modified intent to treat population of 48.7% (95% CI, 37.0-60.4)
13.2% of patients achieved a complete response in target lesions
Median duration of response (DOR) had not yet been reached at time of analysis; 76% of responses were ongoing
The Kaplan-Meier-estimated probability of maintaining a response at six and 24 months was 88.1% and 72.5%, respectively
Safety

Cosibelimab was generally well tolerated with no unexpected safety signals
The most common adverse events associated with cosibelimab were fatigue (11.5%) and rash (10.3%)
Seven patients (9.0%) experienced a grade 3 treatment-related adverse event (TRAE); no grade 4 or 5 TRAEs were reported
A copy of the poster can be found on the Publications page of the Checkpoint Therapeutics website.

Cosibelimab was licensed by Checkpoint in 2015 from the Dana-Farber Cancer Institute.

About Cutaneous Squamous Cell Carcinoma
Cutaneous squamous cell carcinoma (cSCC) is the second most common type of skin cancer in the United States, with an estimated annual incidence of approximately one million cases according to the Skin Cancer Foundation. While most cases are localized tumors amenable to curative resection, approximately 40,000 cases will become advanced and an estimated 15,000 people will die from their disease. In addition to being a life-threatening disease, cSCC causes significant functional morbidities and cosmetic deformities based on tumors commonly arising in the head and neck region and invading blood vessels, nerves and vital organs such as the eye or ear.

About Cosibelimab
Cosibelimab (formerly referred to as CK-301) is a potential best-in-class, high affinity, fully-human monoclonal antibody of IgG1 subtype that directly binds to programmed death ligand-1 (PD-L1) and blocks the PD-L1 interaction with the programmed death receptor-1 (PD-1) and B7.1 receptors. Cosibelimab’s primary mechanism of action is based on the inhibition of the interaction between PD-L1 and its receptors PD-1 and B7.1, which removes the suppressive effects of PD-L1 on anti-tumor CD8+ T-cells to restore the cytotoxic T cell response. Cosibelimab is potentially differentiated from the currently marketed PD-1 and PD-L1 antibodies through sustained >99% target tumor occupancy to reactivate an antitumor immune response and the additional benefit of a functional Fc domain capable of inducing antibody-dependent cell-mediated cytotoxicity (ADCC) for potential enhanced efficacy in certain tumor types.

On June 7, 2022 Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that it has released the results from its Phase I first-in-human (FIH) study of the company’s novel FAK inhibitor and third-generation ALK/ROS1 tyrosine kinase inhibitor (TKI) APG-2449 in patients with second-generation TKI-resistant ALK/ROS1+ non-small-cell lung cancer (NSCLC) or mesothelioma in a Poster Presentation at the 58th American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Ascentage Pharma, JUN 7, 2022, View Source;ascentage-pharma-releases-for-the-first-time-results-of-its-fakalkros1-inhibitor-apg-2449-demonstrating-safety-and-efficacy-in-patients-with-advanced-nsclc-301563283.html [SID1234615727]). APG-2449 is the first China-developed third-generation ALK inhibitor entering clinical studies.

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Entering the fifth consecutive year in which its abstracts were selected for presentations by the ASCO (Free ASCO Whitepaper) Annual Meeting, Ascentage Pharma showcased results from multiple clinical trials of its five drug candidates, including the first-time results of APG-2449 highlighting the company’s promising pipeline in solid tumors. APG-2449 demonstrated preliminary efficacy in TKI-naïve patients or those whose disease was resistant to second-generation TKIs, with 4 partial responses (PRs) observed in the 14 patients with second-generation-TKI resistant and ALK-positive NSCLC. In the 10 TKI-naïve ALK/ROS1+ patients, the objective response rate (ORR) was 80%, and the disease control rate (DCR) was 100%.

Discovered and developed by Ascentage Pharma, APG-2449 is a novel, orally-available FAK/ALK/ROS1 inhibitor and the first China-developed third-generation ALK inhibitor entering clinical studies.

Prof. Hongyun Zhao of Sun Yat-sen University Cancer Center, who is the principal investigator of this study, said, "APG-2449 is a potent FAK/ALK/ROS1 inhibitor that can address drug resistance to second-generation ALK TKIs. In this FIH study, APG-2449 demonstrated favorable safety and antitumor activity in patients with advanced NSCLC, and showed on-target pharmacodynamic effects. Building on results from this Phase I study, we look forward to further evaluate APG-2449’s efficacy in advanced NSCLC patients resistant to second-generation ALK inhibitor.

Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, commented, "APG-2449 is one of our key drug candidates, outside our pipeline of apoptosis-targeting assets. The data presented at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting demonstrated APG-2449’s therapeutic potential in patients with advanced NSCLC and are indicative of our progress in the field of solid tumors. We will continue to take firm steps to advance this clinical development program. Furthermore, we are proud to be able to present clinical development progress for a number of Ascentage Pharma’s drug candidates at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting, which highlight our capabilities in global innovation. Honoring our mission of addressing unmet clinical needs in China and around the world, we are now accelerating our clinical programs to bring more safe and effective therapeutics to patients in need."

The highlights of this abstract on APG-2449 are as follows:

First-in-human phase I results of APG-2449, a novel FAK and third-generation ALK/ ROS1 tyrosine kinase inhibitor (TKI), in patients (pts) with second-generation TKI-resistant ALK/ROS1 non-small-cell lung cancer (NSCLC) or mesothelioma.

Abstract: #9071

This dose-escalation and dose-expansion study was designed to assess the safety, tolerability, recommended Phase II dose (RP2D), pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of APG-2449 in patients with second-generation TKI-resistant ALK/ROS1+ NSCLC or mesothelioma.
As of December 30, 2021, 84 Chinese patients with NSCLC or mesothelioma enrolled were treated with APG-2449 at doses ranging from 150 to 1,500 mg. APG-2449 was administered orally once daily on a 28-day cycle using a "3+3" dose escalation design.
4 PRs were observed in 14 ALK+ patients resistant to second-generation TKIs treated at the RP2D. Among 8 patients with brain metastases, 1 complete response (CR) and 3 PRs were observed intracranially. In 10 TKI-naïve patients, the ORR was 80% (ALK+, 6/8; ROS1+, 2/2) and the DCR was 100%.
In addition, AGP-2449 demonstrated a favorable safety profile. The preliminary biomarker data showed decreased FAK phosphorylation in peripheral blood mononuclear cells and increased IFN-γ levels in serum after multiple doses of APG-2449.
Conclusions: APG-2449 has a favorable safety and PK profile. Preliminary efficacy was observed in patients whose disease was resistant to second-generation or TKI-naïve. Biomarker data indicated potential target engagement on FAK and the immunomodulatory effects of APG-2449.

On June 7, 2022 Ashvattha Therapeutics ("Ashvattha"), a clinical stage company developing novel hydroxyl dendrimer therapeutics, reported a poster presentation of preclinical data demonstrating its hydroxyl dendrimer-based therapeutics reduce toxicity in targeted delivery to plexiform neurofibroma, a slow growing tumor associated with neurofibromatosis type 1 (NF1), at the 2022 Neurofibromatosis (NF) Conference hosted by the Children’s Tumor Foundation and taking place at Loews Philadelphia Hotel in Philadelphia, PA, June 18 – 21, 2022 (Press release, Ashvattha Therapeutics, JUN 7, 2022, View Source [SID1234615694]).

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Poster presentation details can be found below:

Title: Hydroxyl Dendrimer Therapeutics Reduce Toxicity in Targeted Delivery to Plexiform Neurofibroma
Presenter: Emma C. Mazurek
Date: Sunday, June 19, 2022
Time: 5:40 – 7:40 p.m. ET
Location: Loews Philadelphia Hotel, Millennium Hall, Second Floor

On June 7, 2022 TC Biopharm (Holdings) PLC ("TC Biopharm" or the "Company") (NASDAQ: TCBP) (NASDAQ: TCBPW), a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer indications, reported the closing of its previously announced underwritten public offering of 10,000,000 American Depositary Shares (the "ADSs"), each ADS representing one ordinary share of the Company, at a public offering price of $0.40 per ADS, for aggregate gross proceeds of $4 million, prior to deducting underwriting discounts and commissions, and other offering expenses (Press release, TC Biopharm, JUN 7, 2022, View Source [SID1234615729]). In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 1.5 million ADSs at the public offering price per share, less the underwriting discounts and commissions, to cover over-allotments, if any.

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EF Hutton, division of Benchmark Investments, LLC, acted as sole book-running manager for the offering.

A registration statement on Form F-1 (File No. 333-265159), was filed with the Securities and Exchange Commission ("SEC") and was declared effective on June 2, 2022. A final prospectus relating to the offering was filed with the SEC and is available on the SEC’s website at View Source Electronic copies of the final prospectus relating to this offering may be obtained from EF Hutton, division of Benchmark Investments, LLC, 590 Madison Avenue, 39th Floor, New York, NY 10022, Attention: Syndicate Department, or via email at [email protected] or telephone at (212) 404-7002.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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.

On June 7, 2022 Bristol Myers Squibb (NYSE: BMY) reported that the company will take part in a fireside chat at Goldman Sachs’ 43rd Annual Global Healthcare Conference in Rancho Palos Verdes, California on Wednesday, June 15, 2022 (Press release, Bristol-Myers Squibb, JUN 7, 2022, View Source [SID1234615695]). Adam Lenkowsky, Senior Vice President and General Manager, U.S. Commercialization, will answer questions about the company at 9:20 a.m. PT/12:20 p.m. ET.

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Investors and the general public are invited to listen to a live webcast of the session at View Source Material related to the company’s presentation will be available at the same website at the start of the live webcast. An archived edition of the session will be available later that day.