On March 16, 2021 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products reported its financial results for the first quarter ended January 31, 2021 and provides a business update (Press release, Advaxis, MAR 16, 2021, View Source [SID1234576706]).

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First Quarter Ended January 31, 2021 Financial Results and Recent Key Accomplishments:

Presented updated clinical data from the ongoing Phase 1/2 trial of ADXS-503 as a monotherapy and in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in non-small cell lung cancer (NSCLC) at the 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting
° Disease control rate of 67% and overall response rate of 17% in first six evaluable patients with immediate prior progression on KEYTRUDA. The first two patients treated in Part B combination arm that had achieved stable disease (SD) and partial response (PR) remain on treatment for 10 and 8 months, respectively
° Biomarker data across 9 patients across trial arms confirmed on-mechanism activation of innate and adaptive immune responses to ADXS-503 with transient elevation of immune-modulatory cytokines, activation of cytotoxic -and/or memory CD8+ T cells as well as 100% efficient priming by ADXS-503
° Across trial arms, ADXS-503 appeared safe and well tolerated as a monotherapy and in combination with KEYTRUDA with no added toxicities from combination therapy
Announced upcoming presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual meeting, in collaboration with Precision for Medicine, on the development of a novel immunophenotyping assay to accurately evaluate PD-1 expression as a pharmacodynamic marker during PD-1 blockade treatment with pembrolizumab, and the correlation of changes in T cell populations with observed clinical activity in the ongoing ADXS-503 clinical trial
Announced receipt of funding milestone payment under ADXS-HER2 licensing agreement with OS Therapies
Announced closing of $9.2 million public offering of common stock and warrants, with proceeds being used to fund continued development and expansion of our product pipeline
Management Commentary

"We are encouraged by the growing body of evidence that suggest ADXS-503 has the potential to synergistically enhance and/or restore sensitivity to checkpoint inhibitors," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "Based on our encouraging data, we are prioritizing the ongoing and recently expanded ADXS-503 trial in diverse treatment settings for NSCLC, and will remain focused on continued clinical execution. We look forward to our presentation at AACR (Free AACR Whitepaper), which will further expand upon the previously reported on-mechanism innate and adaptive immune stimulation which we believe are driving meaningful and durable clinical benefit for patients treated with ADXS-503. Our strengthened balance sheet leaves us well positioned to continue progress with our off-the-shelf neoantigen immunotherapy ADXS-HOT program, including our planned expansion into prostate cancer with ADXS-504, and we look forward to providing study updates in the coming months."

First Quarter Ended January 31, 2021 Financial Results

Research and development expenses for the first quarter of fiscal year 2021 were $2.6 million, compared with $4.9 million for the first quarter of fiscal year 2020. The reduction of $2.3 million was primarily attributable to the substantial reduction in costs associated with the winding down of clinical studies that have been discontinued.

General and administrative expenses for the three months ended January 31, 2021 were approximately unchanged at $3 million, compared to $3 million in the same three-month period in 2020.

As of January 31, 2021, the Company had approximately $33.3 million in cash and cash equivalents. The Company believes this is sufficient capital to fund its obligations, as they become due, in the ordinary course of business until May 2022.

On March 16, 2021 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported it has signed an exclusive distribution agreement with Switzerland-based Ewopharma for Piclidenoson in the treatment of psoriasis and Namodenoson in the treatment of liver diseases namely, hepatocellular carcinoma (HCC) the most common form of liver cancer and nonalcoholic steatohepatitis (NASH) (Press release, Can-Fite BioPharma, MAR 16, 2021, View Source [SID1234576703]). Under the terms of the distribution agreement, Ewopharma will pay to Can-Fite $2.25 million upfront with up to an additional $40.45 million payable upon the achievement of regulatory and sales milestones plus 17.5% royalties on net sales. In exchange, Ewopharma will have the exclusive right to market and sell Piclidenoson in Central Eastern European (CEE) countries and Namodenoson in CEE countries and Switzerland. Ewopharma has the right to extend the distribution agreement to new indications that Can-Fite may identify for its drug candidates.

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Ewopharma is a pharmaceutical marketing organization that helps pharma companies access markets in CEE and Switzerland. In addition to Can-Fite, Ewopharma has distribution agreements with many leading healthcare companies worldwide.

"We are very pleased to enter into this distribution agreement with Ewopharma, a leader in pharmaceutical distribution in Eastern Europe. This is a high-value deal that brings Can-Fite non-dilutive funding, and upon regulatory approval, it gives our products immediate access and distribution in the European market," stated Can-Fite VP Business Development Dr. Sari Fishman.

Dr. Shila Schneider, Business Development Manager Ewopharma Group, added, "We are honored to partner with Can-Fite and help bring their innovative and much needed new treatments to patients in our market in Central Eastern Europe and Switzerland. This is a key strategic deal with therapies complementing our portfolio in gastroenterology, oncology and immunology and reinforcing Ewopharma’s long-standing commitment to its entire region."

About Piclidenoson

Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with a favorable therapeutic index demonstrated in Phase II clinical studies. It is currently being evaluated in a multinational Phase III study as a treatment for moderate to severe psoriasis and a Phase II U.S. study for the treatment of moderate to severe COVID-19.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

On March 16, 2021 AstraZeneca reported that it has completed the divestment of its 26.7% ownership in Viela Bio, Inc. (Viela), as part of the proposed acquisition of Viela by Horizon Therapeutics plc (Press release, AstraZeneca, MAR 16, 2021, View Source [SID1234576702]). This follows the agreement to divest the shareholding on 1 February 2021.

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Financial considerations
AstraZeneca has received cash proceeds and profit of c.$775m. This will be accounted for in other operating income in the Company’s financial statements. The divestment does not impact the Company’s financial guidance for 2021.

On March 16, 2021 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, reported the first patients have been dosed in its global Phase 1 clinical trial of ADG126 for the treatment of various advanced solid tumors (Press release, Adagene, MAR 16, 2021, View Source [SID1234576701]). ADG126 is a fully-human, antagonistic monoclonal antibody (mAb) targeting a novel epitope of CTLA-4 and is Adagene’s lead SAFEbody product candidate.

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"Dosing the first patients in our Phase 1 clinical trial of ADG126 is an exciting milestone for the development of our SAFEbody technology platform," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. "SAFEbody technology is designed to mask antibody binding sites, which will be activated specifically within the tumor microenvironment (TME), to provide favorable safety and efficacy with significantly enhanced therapeutic windows. Our most advanced SAFEbody candidate, ADG126 targets a conserved epitope of CTLA-4 with broad species cross-reactivity for potent Treg depletion via strong antibody-dependent cellular cytotoxicity (ADCC) in TME versus peripheral tissue. Our preclinical studies provide proof-of-concept for the potential of ADG126 in leveraging our SAFEbody platform to overcome standing issues associated with existing anti-CTLA-4 therapies by limiting on-target off-tumor toxicities in normal tissues."

"Existing cancer therapies that target CTLA-4 are associated with safety concerns, creating an unmet need for new anti-CTLA-4 therapies that are both safe and potent," said Anthony W. Tolcher, M.D., FRCPC, FACP, medical oncologist, co-founder of NEXT Oncology , Adagene advisor and study investigator. "ADG126 demonstrated an impressive safety margin while maintaining its potent antitumor efficacy in pre-clinical studies, and I look forward to its evaluation in patients with advanced solid tumors."

The global Phase 1 open-label, dose-escalation clinical trial is investigating the tolerability and anti-tumor activity of ADG126 in patients with advanced/metastatic tumors in multiple clinical sites in Australia. Adagene has also received approval from the FDA to initiate the Phase 1 clinical trial of ADG126 in the United States. The dose escalation trial will test five doses at 0.1, 0.3, 1.0, 3.0 and 10 mg/kg, with dose-limiting toxicities (DLT) evaluation for 3 weeks. Additional information about this clinical trial is available at ClinicalTrials.gov using the identifier: NCT04645069.

About ADG126
ADG126 is a fully human antagonistic mAb targeting a novel epitope of CTLA-4 and has been shown to specifically deplete regulatory T-cells in tumors. ADG126 is Adagene’s lead SAFEbody product candidate. The SAFEbody technology, developed using Adagene’s AI-powered platform, enables binding of an antibody to a specific target only after conditional activation of the antibody in target tissues.

In preclinical studies, ADG126 was well tolerated in cynomolgus monkeys in a four-week repeat-dose GLP toxicology study at doses up to 200 mg/kg, and demonstrated an encouraging antitumor response in multiple immune-competent mouse tumor models in a dose-dependent manner both as a single agent and in combination with anti-PD1 and other therapies.

Unlike anti-PD1/PD-L1 check point inhibitors, anti-CTLA-4 is known for its dose-dependent clinical response in single and combination therapies, which is severely limited by the narrow therapeutic window available to current anti-CTLA-4 therapies. The large safety margin shown by ADG126 GLP toxicology studies of up to 200 mg/kg in targeting CTLA-4 will make it possible to dose patients for their optimal clinical benefits in single and combination therapies.

On March 15, 2021 Peptomyc reported that the company has reached another major milestone obtaining the approval from the Spanish authorities (AEMPS) to initiate the First in Human Phase I/II trial with its first compound OMO-103 in patients with advanced solid tumors (Press release, Peptomyc, MAR 15, 2021, View Source [SID1234576695]). Peptomyc will soon start treating the first patients with this disruptive Myc inhibitor in selected clinical sites in Barcelona and Madrid. The company could achieve this key milestone thanks to an outstanding team, great collaborators and consultants.

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The Chief Medical Officer of Peptomyc, Manuela Niewel, MD, PhD, comments: "Now we will be able to translate the good preclinical results into hopefully great benefit for the patients".