On January 19, 2023 Advaxis, Inc. (OTCQX: ADXS), a biotechnology company devoted to the discovery, development and commercialization of immunotherapies based on a technology which uses engineered Listeria monocytogenes (Lm), reported the completion of a previously reported merger with Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare tumors and aggressive cancers (Press release, Advaxis, JAN 19, 2023, View Source [SID1234626370]).

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While the stock will continue to trade on OTC under the symbol ADXS, the merged company will operate under the name Ayala Pharmaceuticals. The merged company will be focused primarily on the development and commercialization of Ayala’s lead program AL102 for the treatment of desmoid tumors. As previously disclosed, the company is seeking to uplist to Nasdaq in the near future, but there is no guarantee that this effort will be successful.

Management and Board of Directors

Kenneth A Berlin, President and Chief Executive Officer of Advaxis, will be President, Chief Executive Officer and a Director of the company; Andres Gutierrez, M.D., Ph.D., will be the Chief Medical Officer; and Igor Gitelman will be the Interim Chief Financial Officer. The board of directors consists of David Sidransky, M.D., as chairman, Roni Appel, Samir Khleif, M.D., Vered Bisker-Leib, M.D., Murray A. Goldberg, Robert Spiegel, M.D., and Ken Berlin.

On January 19, 2023 Addex Therapeutics Ltd (SIX: ADXN, Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, reported a corporate update, including a review of its pipeline and financial guidance (Press release, Addex Therapeutics, JAN 19, 2023, View Source [SID1234626369]).

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"We ended 2022 with CHF7.0 million of cash and expect to be able to finance our operations until Q3 2023. We continue to focus on entering into collaborative arrangements across our pipeline to secure the financial resources to advance their development and strengthen our balance sheet," said Tim Dyer, CEO of Addex. "We also look forward to our Partner Janssen completing part 1 of the Phase 2 epilepsy study this quarter and reporting progress under our collaboration with Indivior."

Corporate Update:

Cash and cash equivalents at December 31, 2022 of CHF7.0 million

ADX71149, our mGlu2 PAM, licensed to Janssen Pharmaceuticals Inc., a Johnson and Johnson company: continues to advance in a Phase 2 study in epilepsy patients with completion of part 1 on track for Q1 2023. Under our agreement with Janssen, we are eligible to receive up to €109 million in success-based development and regulatory milestone, and low double-digit royalties on net sales.

Dipraglurant, our mGlu5 NAM: we continue discussions with potential strategic partners to reinitiate Phase 2 development of dipraglurant in PD-LID or an alternative indication, including pain, substance use disorders (SUD) and stroke recovery.

GABA B PAM strategic partnership with Indivior: we recently extended the research term of the agreement until March 31, 2023, securing CHF 850,000 (approx. US $900,000) of additional funding. The program is currently in clinical candidate selection phase, with IND enabling studies expected to be initiated in late 2023. Under the agreement with Indivior, in addition to research funding, we are eligible to receive $330 million in development, regulatory and sales milestones as well as the right to select drug candidates for development in certain exclusive indications outside of SUD. We plan to develop our selected drug candidate in chronic cough, pain and CMT1A.

mGlu7 NAM for the treatment of stress related disorders, including PTSD: lead drug candidate ready to start IND enabling studies.

mGlu2 NAM for the treatment of mild neurocognitive disorders and depression: drug candidates in clinical candidate selection phase.

M4 PAM for the treatment of schizophrenia and other psychotic disorders: novel series of compounds have rapidly progressed into lead optimization; scheduled to enter clinical candidate selection phase in H2 2023.

On January 19, 2023 PreciseDx, a leading innovator in AI-powered, patient-specific disease analysis, reported its recent publication in Breast Cancer Research, demonstrating the ability of its digital AI platform to enrich breast cancer grading and improve risk categorization (Press release, PreciseDx, JAN 19, 2023, View Source [SID1234626359]). The paper, entitled ‘Development and Validation of an AI-Enabled Digital Breast Cancer Assay to Predict Early-Stage Breast Cancer Recurrence Within 6 Years,’ illustrates an industry-changing advancement in cancer diagnosis and outcome predictions.

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Despite advances in breast cancer screening and diagnosis, there continues to be an opportunity to significantly improve accuracy in histologic characterization, grading and prognosis. Once breast cancer is detected, pathologists and oncologists are tasked to set a course for an effective treatment plan which is currently limited by the subjectivity of a visual interpretation of the invasive disease.

PreciseDx’s Platform, which leverages its Morphology Feature Array, has proven the ability to enhance pathology interpretation with objective, quantifiable, and highly accurate data. This provides more robust information regarding patient disease status, representing the next generation of pathology analysis.

"There still remains an inherent subjectiveness in the cancer classification, grading and prognosis," said PreciseDx CEO, Wayne Brinster. "Our platform was designed to set a new standard of information and accuracy without interrupting workflows. I am proud to lead an organization that is truly transforming the way cancer is staged and graded worldwide."

The population-based longitudinal clinical development and validation study examined more than 2,000 patients from Mount Sinai Hospital with infiltrating ductal carcinoma of the breast. Following patients retrospectively for a median of six years, the study determined the PreciseDx Platform improved risk stratification and prediction of disease recurrence over standard histologic grade and clinical features and, furthermore, demonstrated the ability to supplement molecular genomic tests.

"The recent publication in Breast Cancer Research on the clinical validation of our AI-enabled digital assay to predict early-stage breast cancer recurrence represents a key milestone in advancing our automated AI-driven platform to phenotype and grade invasive breast cancer with just an Hematoxylin and Eosin (H&E) image and readily available clinical data," said Michael Donovan, MD, PhD, Co-Founder and Chief Medical Officer at PreciseDx. "Additional extended validation studies are underway to enrich our current results and ultimately broaden access to this platform throughout the breast cancer community."

On January 19, 2023 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that it will host a virtual key opinion leader event to discuss the current treatment landscape for patients suffering from acute myeloid leukemia (AML) and the potential for galinpepimut-S (GPS) as a treatment solution (Press release, Sellas Life Sciences, JAN 19, 2023, View Source [SID1234626353]).

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The webinar event will feature Omer Jamy, MD who is principal investigator of the Phase 3 REGAL study at the University of Alabama at Birmingham (UAB), one of the highest enrolling REGAL sites. He is currently Assistant Professor of Medicine at UAB in the Division of Hematology and Oncology and Associate Scientist, Experimental Therapeutics at the O’Neal Comprehensive Cancer Center. Dr. Jamy is principal investigator on several clinical trials in addition to REGAL, focusing on AML, chronic myelogenous leukemia, and allogeneic stem cell transplantation. Dr. Jamy completed his internal medicine residency at the University of Tennessee in Memphis followed by fellowship training at UAB in hematology/oncology, bone marrow transplantation and cellular therapy.

The SELLAS management team will provide a corporate update on GPS, their lead pipeline candidate, which is currently being evaluated in a Phase 3 registrational clinical trial in AML patients who have achieved complete remission following second-line salvage therapy. GPS targets malignancies and tumors characterized by an overexpression of the WT1 antigen, one of the most widely expressed cancer antigens in multiple malignancies.

On January 19, 2023 Seagen Inc. (Nasdaq: SGEN) reported that it will report its fourth quarter and full year 2022 financial results on Wednesday, February 15, 2023 after the close of U.S. financial markets (Press release, Seagen, JAN 19, 2023, View Source [SID1234626352]). Following the announcement, Company management will host a conference call and webcast at 4:30 p.m. Eastern Time to discuss the results and provide a business update.

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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

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Conference call and webcast information:

Telephone 844-763-8274 (U.S.) or +1 412-717-9224 (international). Ask for the Seagen conference call.
Webcast with slides can be accessed at investor.seagen.com. A webcast replay will be archived on the Company’s website.