PharmaCyte Biotech to Present at H.C. Wainwright BioConnect Conference

On January 6, 2022 PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it will be featured as a presenting company at the H.C. Wainwright BioConnect Conference (Press release, PharmaCyte Biotech, JAN 6, 2022, View Source [SID1234598364]). The Conference is being held virtually on January 10-13, 2022.

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During the presentation, the Chief Executive Officer of PharmaCyte Biotech, Kenneth L. Waggoner, will provide an overview of the Company’s business and product pipeline.

Over 500 corporate presentations and panels are available on-demand from January 10-13, 2022. The pre-recorded presentation by PharmaCyte will be available on Monday, January 10, 2022, on the News & Media tab of PharmaCyte’s website at View Source

PharmaCyte’s presentation will also be available at View Source

Additionally, PharmaCyte will be publishing a press release in the coming weeks to update its shareholders on the progress PharmaCyte has made to lift the clinical hold the U.S. Food and Drug Administration placed on PharmaCyte’s planned Phase 2b clinical trial for the treatment of locally advanced, inoperable pancreatic cancer.

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced, inoperable pancreatic cancer, we encourage you to watch PharmaCyte’s documentary video complete with medical animations at View Source

Fortress Biotech to Participate in the H.C. Wainwright BioConnect Virtual Conference

On January 6, 2022 Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), an innovative revenue-generating company focused on acquiring, developing and commercializing or monetizing promising biopharmaceutical products and product candidates cost-effectively, reported that Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer, will participate in the H.C. Wainwright BioConnect Virtual Conference scheduled to take place from Monday, January 10 through Thursday, January 13, 2022 (Press release, Fortress Biotech, JAN 6, 2022, View Source [SID1234598363]). The company’s presentation will be available for on-demand viewing on Fortress’ website beginning Monday, January 10, 2022, at 7:00 a.m. EST and will remain available on the Events page under the News & Media section of Fortress’ website: www.fortressbiotech.com for approximately 30 days following the presentation.

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Knight Therapeutics Inc. Announces Approval of Halaven® in Colombia

On January 6, 2022 Knight Therapeutics Inc. (TSX:GUD) ("Knight" or "the Company") reported that its Colombian affiliate, Biotoscana Farma S.A. has obtained INVIMA approval for Halaven (eribulin) injection (Press release, Knight Therapeutics, JAN 6, 2022, View Source;Announces-Approval-of-Halaven174–in-Colombia-1-6-2022 [SID1234598361]).

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Halaven (eribulin) injection is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer which has continued to spread after at least two previous treatment for advanced cancer. Previous treatment should have included anthracyclines and a taxane in either the adjuvant or metastatic setting, unless these treatments were not suitable. Halaven(eribulin) injection is also used to treat patients with advanced or metastatic liposarcoma that cannot be surgically removed. It is used in patients who have already been treated with an anthracycline, unless deemed unsuitable.

Halaven (eribulin) injection has shown to significantly improve overall survival in patients with advanced or metastatic breast cancer after anthracycline and taxane treatment. Halaven (eribulin) injection indicated extended overall survival (OS) of 2.5 months (OS of 13.1 months versus 10.6 months, respectively; Hazard Ratio (HR) 0.81; p=0.041) when compared to selected, major existing therapies1. Also, Halaven (eribulin) injection demonstrated a statistically significant extension in overall survival over the comparator treatment dacarbazine in patients with locally advanced/recurrent or metastatic soft tissue sarcoma (liposarcoma or leiomyosarcoma) who had disease progression following standard therapies 2.

Breast cancer is now the most frequently diagnosed cancer in Colombian women. In 2020, an estimated 15,509 patients were diagnosed with breast cancer3. Further, approximately 1,500 patients in Colombia are diagnosed with soft tissue sarcoma each year, and liposarcoma, an area with high unmet medical need, represents the most common form of soft tissue sarcoma4.

"We’re pleased to announce the approval of Halaven (eribulin) injection in Colombia as it provides a new treatment option for metastatic breast cancer and liposarcoma," said Samira Sakhia, President & Chief Executive Officer. "Our Colombian team is focused on our oncology launches with the approval of Halaven (eribulin) injection and Lenvima (lenvatinib) and will be coordinating launch efforts with our teams throughout the region."

Knight has an exclusive license from Eisai to commercialize Lenvima (lenvatinib), Halaven (eribulin) injection, Fycompa (perampanel), and Inovelon (rufinamide) throughout Latin America, with the exception of Mexico where Eisai retains the rights to Halaven (eribulin) injection and Lenvima (lenvatinib).

About Halaven (eribulin) injection

Discovered and developed by Eisai, eribulin is a synthetic analog of halichondrin B, a natural product that was isolated from the marine sponge Halichondria okadai. First in the halichondrin class, eribulin is a microtubule dynamics inhibitor. Eribulin is believed to work primarily via a tubulin-based mechanism that causes prolonged and irreversible mitotic blockage, ultimately leading to apoptotic cell death. Additionally, in preclinical studies of human breast cancer, eribulin demonstrated complex effects on the tumor biology of surviving cancer cells, including increases in vascular perfusion resulting in reduced tumor hypoxia, and changes in the expression of genes in tumor specimens associated with a change in phenotype, promoting the epithelial phenotype, opposing the mesenchymal phenotype5-6. Eribulin has also been shown to decrease the migration and invasiveness of human breast cancer cells5-6.

Galectin Therapeutics to Present at the H.C. Wainwright BioConnect Conference

On January 6, 2022 Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, reported the Company will be participating in the H.C. Wainwright BioConnect Conference being held virtually January 10-13, 2022 (Press release, Galectin Therapeutics, JAN 6, 2022, View Source/news-releases/news-release-details/galectin-therapeutics-present-hc-wainwright-bioconnect" target="_blank" title="View Source/news-releases/news-release-details/galectin-therapeutics-present-hc-wainwright-bioconnect" rel="nofollow">View Source [SID1234598360]). Mr. Joel Lewis, President and Chief Executive Officer, and Dr. Pol F. Boudes, Chief Medical Officer, will be presenting on behalf of the Company.

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A webcast of this presentation will be available on the "Investor Relations" section under "Events and Presentations" of the Company’s website, View Source, at 7:00 a.m. ET on January 10, 2022. A replay will be accessible on Galectin’s website for 90 days following the event.

Sapience Therapeutics Announces First Patient Dosed in Phase 2 Clinical Trial of ST101

On January 6, 2022 Sapience Therapeutics, Inc., a biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, reported the initiation of Phase 2 and dosing of the first patient in the glioblastoma (GBM) expansion cohort in the ongoing Phase 1-2 Study of ST101 (Press release, KemPharm, JAN 6, 2022, View Source [SID1234598359]).

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The expansion cohorts in the study include patients with refractory, locally advanced and metastatic cutaneous melanoma, hormone-receptor-positive breast cancer, castrate-resistant prostate cancer, and GBM, and are designed to determine proof-of-concept efficacy of ST101 and provide further insights into safety, pharmacokinetics (PK) and pharmacodynamics (PD).

"Following successful conclusion of dose escalation, we are pleased to expand our ST101 program with the initiation of Phase 2 and dosing of the first patient in the GBM cohort at Columbia University Irving Medical Center," commented Dr. Alice Bexon, Sapience’s Chief Medical Officer. "ST101 has shown very encouraging efficacy and safety in Phase 1, with demonstrated clinical proof-of-concept with a durable clinical response and evidence of long-lasting stable disease in several patients with refractory solid tumors. We are excited about the potential of ST101 to treat these four aggressive cancers."

Dr. Barry Kappel, Sapience’s founder, CEO and President, added, "Moving to Phase 2 and testing ST101 in our tumor specific expansion cohorts is a great moment for us at Sapience. Having the first patient be treated at Columba University, where Sapience licensed its initial intellectual property from, makes this significant milestone even more meaningful for us."

About ST101 and the Phase 1-2 Study
ST101, a peptide antagonist of C/EBPβ, is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). This is an open-label, two-part, Phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 in patients with advanced solid tumors. The study consists of two phases: a Phase 1 dose escalation/regimen exploration phase and a Phase 2 expansion phase. In the ongoing study, ST101 has demonstrated clinical proof-of-concept with a RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. Sapience has initiated Phase 2 and has dosed the first patient in the GBM expansion cohort. Sapience also plans to initiate dosing in the additional expansion cohorts in refractory, locally advanced or metastatic hormone-receptor-positive breast cancer, metastatic cutaneous melanoma and castrate-resistant prostate cancer. ST101 has been granted Fast Track designation for recurrent GBM and advanced cutaneous melanoma in patients who have disease progression on or after anti-PD-1/anti-PD-L1 therapy, as well as Orphan designation from the U.S. Food and Drug Administration and the European Commission for the treatment of glioma.