On August 2, 2023 Arbele, a clinical-stage biotechnology company developing novel immunotherapies targeted for advanced gastrointestinal cancers, reported early safety data from its first-in-class CDH17xCD3 bispecific T-cell engager antibody, ARB202, at the ASCO (Free ASCO Whitepaper) Breakthrough conference in Yokohama, Japan (Press release, ARBELE, AUG 2, 2023, View Source [SID1234633673]).

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Preliminary data from Phase 1a study indicate ARB202 tolerability up to 150ng/ml Cmax in circulation, suggesting no clinically significant off-target T-cell activation at these levels. A total of ten (10) [6 colorectal carcinoma; 2 cholangiocarcinoma; 1 gastric cancer; 1 gastrointestinal adenocarcinoma] have completed dosing across the first 3 dose-level cohorts ranging from 0.0003 to 0.003 mg/kg by single IV doses. The Cmax measured within 1 hour of dosing confirms the circulating PK range of 10-20 ng/ml for the 2nd cohort and 40-50 ng/ml in the 3rd cohort, which are consistent with the expected PK. As of 29 Jun 2023, the safety review committee and an independent data monitoring committee, DMC, had approved the trial to continue without modification.

These data allow for continued dose escalation with the aim of identifying the optimal dose where ARB202 mediates CDH17-specific immunological synapse formation between target cancer cells and T-cells in solid tumors with minimal on-target effects on normal cells. As these data mature, Arbele intends to present more findings at an appropriate scientific meeting.

"We are excited by the current safety profile of ARB202 and indications of clinical activity. They are consistent with us entering the therapeutic window which is competitive and perhaps even more specific than other T-cell engagers directed at solid tumors." said Dr Dennis Wong, Chief Medical Officer at Arbele.

About ARB202

ARB202 is a first-in-class bispecific antibody based on Arbele’s patented CDH17 biomarker. It targets both CDH17 on GI cancer as well as CD3 on T cells. The unique differential binding affinities of ARB202 toward CDH17 and CD3 allows it to have high specificity and cytotoxicity, while avoiding the "off-target" overactivation of T cells. Preclinical data showed that ARB202 can facilitate T-cell activation and release of IL-2, thereby demonstrating target engagement and cytotoxicity. The Phase 1 trial is currently enrolling patients in Australia and Hong Kong (NCT05411133).

On August 2, 2023 Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, reported that it is going to release results from two clinical studies at the 2023 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (Press release, Ascentage Pharma, AUG 2, 2023, View Source;ascentage-pharma-to-present-results-from-two-clinical-studies-including-one-oral-presentation-at-2023-esmo-congress-301892332.html [SID1234633672]). These presentations include a Mini Oral featuring the latest data from a study of pelcitoclax (APG-1252), a Bcl-2/BcL-xL dual-targeted inhibitor, combined with osimertinib in patients with EGFR-mutant non-small cell lung cancer (NSCLC); and a Poster on a study evaluating olverembatinib (HQP1351), the first and only China-approved third-generation BCR-ABL inhibitor, in patients with tyrosine kinase inhibitor (TKI)-resistant succinate dehydrogenase- (SDH-) deficient gastrointestinal stromal tumor (GIST).

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As one of the most authoritative and influential congresses in oncology globally, the ESMO (Free ESMO Whitepaper) Congress showcases the latest results from some of the most cutting-edge research from around the world. This year, the ESMO (Free ESMO Whitepaper) Congress will take place on October 20 to October 24, local time, in Madrid, Spain.

"We are pleased that results from the study of pelcitoclax combined with osimertinib in patients with NSCLC and that from the study evaluating olverembatinib in patients with succinate dehydrogenase- (SDH-) deficient gastrointestinal stromal tumor (GIST) have been selected for presentations at the 2023 ESMO (Free ESMO Whitepaper) Congress," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "These presentations highlight Ascentage Pharma’s robust capabilities in clinical development and global innovation, as well as our strong potential in solid tumors. Remaining steadfastly committed to our global innovation roadmap, we will expeditiously advance the global clinical development of our lead drug candidates with the hope to bring benefit to patients in China and around the world as soon as possible."

These two clinical studies to be presented at the ESMO (Free ESMO Whitepaper) Congress this year are as follows:

Pelcitoclax

Updated study results of pelcitoclax (APG-1252) combined with osimertinib in patients (pts) with EGFR-mutant non-small cell lung cancer (NSCLC)

Format: Mini Oral
Abstract#: 5586
Category: NSCLC, Locally Advanced
First Author: Yuxiang Ma, MD, Sun Yat-sen University Cancer Center
Olverembatinib

Antitumor activity of olverembatinib (HQP1351) in patients (pts) with TKI-resistant succinate dehydrogenase- (SDH-) deficient gastrointestinal stromal tumor (GIST)

Format: Poster
Abstract#: 5746
Category: Sarcoma
First Author: Haibo Qiu, MD, PhD, Sun Yat-sen University Cancer Center
*Pelcitoclax is an investigational drug that has not been approved in any country and region.

*Olverembatinib is an investigational drug that has not been approved for any indication outside the Chinese mainland. This drug is jointly commercialized in China by Ascentage Pharma and Innovent Biologics.

On August 2, 2023 Theriva Biologics (NYSE American: TOVX), ("Theriva" or the "Company"), a clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported key progress in VIRAGE, a multinational, Phase 2b, randomized, open-label, controlled clinical trial evaluating VCN-01 in combination with standard-of-care chemotherapy (gemcitabine/nab-paclitaxel) as a first-line therapy for patients with metastatic pancreatic ductal adenocarcinoma (PDAC) (Press release, Theriva Biologics, AUG 2, 2023, View Source [SID1234633671]). Patient dosing has initiated in the U.S. and with four sites open in the U.S. and eight sites open in Spain the trial remains on track to be fully-enrolled in the first quarter of 2024. Dosing in Spain initiated in January 2023 and the first patients have now received their second doses of intravenous VCN-01, which were well tolerated with a safety profile consistent with prior clinical trials.

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VCN-01 is Theriva’s systemic, selective, stroma-degrading oncolytic adenovirus. VCN-01 has been granted Orphan Drug designations from the US Food and Drug Administration and the European Medicines Agency for the treatment of pancreatic cancer.

"Initiating dosing in the U.S., and the completion of the second VCN-01 doses for the first patients in Spain, are important accomplishments that add to the strong momentum for VIRAGE, which remains on track to complete enrollment in the first quarter of 2024," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "With a dearth of novel therapies available and a five-year survival rate for metastatic PDAC of only 3%, pancreatic cancer is an indication that is ripe for innovation. Through VIRAGE’s advancement, we aim to demonstrate VCN-01’s ability to address the unmet needs of pancreatic cancer patients by synergistically combining with standard-of-care chemotherapy. We are extremely encouraged by the favorable safety profile following the advancement to the second dose that further differentiates and positions VCN-01 as a leading oncolytic adenovirus. More broadly, this trial will enable us to determine the feasibility of repeated dosing of VCN-01, which could shift the paradigm for standardized treatment cycles that are well established in cancer chemotherapy and immunotherapy, and thereby lead to improved clinical outcomes for patients with PDAC and other solid cancers."

About VIRAGE

VIRAGE is a two-arm Phase 2b open-label, randomized, controlled, multicenter clinical trial in patients with histologically confirmed, newly-diagnosed metastatic PDAC. VIRAGE is expected to enroll up to 92 adult participants at up to 25 sites across the US and Spain. In both the control and treatment arms, patients will receive gemcitabine/nab-paclitaxel standard-of-care chemotherapy over 28-day cycles. In the treatment arm only, patients will also receive systemically administered VCN-01 seven-days prior to the first and fourth cycles of gemcitabine/nab-paclitaxel treatment. Primary endpoints for the trial include overall survival and VCN-01 safety/tolerability. Additional endpoints include progression free survival, objective response rate, and measures of biodistribution, VCN-01 replication, and immune response. Since this is an open-label trial, progress will be monitored very closely and steps to accelerate the clinical program may be implemented if supported by the emerging data. More information about the trial is available on Clinicaltrials.gov (NCT05673811), through the Spanish Clinical Trials Registry and European Union Drug Regulating Authorities Clinical Trials Database (EudraCT Number: 2022-000897-24).

About VCN-01

VCN-01 is a systemically administered oncolytic adenovirus designed to selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. This unique mode-of-action enables VCN-01 to exert multiple antitumor effects by (i) selectively infecting and lysing tumor cells; (ii) enhancing the access and perfusion of co-administered chemotherapy products; and (iii) increasing tumor immunogenicity and exposing the tumor to the patient’s immune system and co-administered immunotherapy products. Systemic administration enables VCN-01 to exert its actions on both the primary tumor and metastases. VCN-01 has been administered to over 80 patients in Phase 1 and investigator-sponsored clinical trials of different cancers, including PDAC (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection).

On August 2, 2023 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body, reported that it will host a conference call and webcast to provide a business and clinical update on Wednesday, August 9, 2023 at 4:30 p.m. EDT (Press release, Cue Biopharma, AUG 2, 2023, View Source [SID1234633670]). Live and archived versions of the event can be accessed via the Company’s website.

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The company will provide a clinical update from its ongoing Phase 1 trial evaluating CUE-101, the company’s lead interleukin 2 (IL-2)-based biologic from the CUE-100 series, in combination with pembrolizumab (KEYTRUDA) for patients with recurrent/metastatic HPV+ head and neck cancer, as well as clinical progress from the Phase 1 monotherapy dose escalation trial of the company’s second clinical drug asset, CUE-102, for the treatment of patients with Wilms’ Tumor 1 (WT1)-positive recurrent/metastatic cancers. Additional clinical, pipeline and business updates will also be addressed.

Webcast Details

Wednesday, August 9 at 4:30 p.m. EDT

Investors: 1-888-886-7786
International: 1-416-764-8658
Conference ID: 92073568
Request a return call via the Call me link: View Source;
Participants can use the guest dial-in numbers above and be answered by an operator or click the Call me link for instant telephone access. The link will be active 15 minutes prior to the scheduled start time.
Webcast: View Source;tp_key=38376b8c08

On August 2, 2023 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a commercial-stage biopharmaceutical company, reported the pricing of its public offering of 5,930,000 units at a public offering price of $1.35 per unit (Press release, Adamis Pharmaceuticals, AUG 2, 2023, View Source [SID1234633669]). Each unit consists of one share of common stock (or a prefunded warrant in lieu thereof) and one warrant to purchase one share of common stock. The common warrants will be immediately exercisable at an exercise price of $1.35 per share and will expire five years from the date of issuance. The shares of common stock (or pre-funded warrants in lieu thereof) and accompanying common warrants can only be purchased together in this offering, but will be issued separately and will be immediately separable upon issuance.

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Gross proceeds, before deducting placement agent fees and other offering expenses, are expected to be approximately $8.0 million. The offering is expected to close on August 4, 2023, subject to the satisfaction of customary closing conditions.

Maxim Group LLC is acting as sole placement agent in connection with this offering.

The securities described above are being offered pursuant to a registration statement on Form S-1, as amended (File No. 333-273233) (the "Registration Statement"), previously filed with and subsequently declared effective by the Securities and Exchange Commission (the "SEC") on August 1, 2023. The offering is being made only by means of a prospectus which is a part of the Registration Statement. A preliminary prospectus relating to the offering has been filed with the SEC. Copies of the final prospectus relating to this offering, when available, will be filed with the SEC and will be available on the SEC’s website at View Source Copies of the final prospectus relating to this offering, when available, may be obtained from Maxim Group LLC, 300 Park Avenue, 16th Floor, New York, NY 10022, at (212) 895-3745.

This press release shall not constitute an offer to sell or a 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 other 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 other jurisdiction.