Palleon Pharmaceuticals Announces First Patient Dosed in Phase 1/2 Study of Lead Glyco-Immunology Drug Candidate for Oncology

On March 8, 2022 Palleon Pharmaceuticals, a company pioneering the field of glyco-immunology to treat cancer and inflammatory diseases, reported dosing of the first patient in the company’s Phase 1/2 study of E-602 in patients with advanced cancers (Press release, Palleon Pharmaceuticals, MAR 8, 2022, View Source [SID1234609700]). The study, called GLIMMER-01 (Glycan-Mediated Immune Regulation), is the first clinical study of Palleon’s novel approach to cancer immunotherapy which targets immunosuppressive sialoglycans.

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E-602 is Palleon’s lead program in oncology and the first candidate generated from the company’s EAGLE platform. E-602 is composed of two engineered human sialidase molecules fused to a human monoclonal antibody. Preclinical studies have demonstrated that E-602 degrades terminal sialic acids on immunosuppressive sialoglycans on both tumor cells and immune cells, restoring both innate and adaptive antitumor immunity.

"We’re very excited to bring our first therapeutic candidate into the clinic. This milestone is significant not just for Palleon, but for the broader immuno-oncology community, as we test a bold new approach to releasing immune suppression by modifying cancer cell-surface glycans," said Jim Broderick, M.D., Chief Executive Officer and Founder of Palleon. "We continue to pursue research at the forefront of glyco-immunology to advance other novel therapies for cancer and inflammatory diseases into the clinic and ultimately to patients."

The GLIMMER-01 trial (NCT05259696) is an open-label, dose-escalation, and dose-expansion study. It will evaluate safety, pharmacodynamic effects, and antitumor activity of E-602, both as a single agent and in combination with pembrolizumab (anti-PD-1). The study will enroll patients with previously treated non-small cell lung cancer, colorectal cancer, melanoma, pancreatic cancer, and ovarian cancer.

"First generation immune checkpoint inhibitors demonstrated remarkable efficacy for patients with many types of cancer. However, only a minority of patients benefit from these therapies," said David Feltquate, M.D., Ph.D., Chief Medical Officer of Palleon. "Novel approaches to overcoming immune resistance are needed. Today marks an important milestone for the nascent field of glyco-immunology as we explore the potential of altering the immune suppressing effects of inhibitory sialoglycans."

Bicycle Therapeutics Announces Interim BT8009 Phase I Clinical Trial Results Selected for an Oral Presentation at the 2022 AACR Annual Meeting

On March 8, 2022 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that interim Phase I results from the Phase I/II trial of BT8009, a second-generation BTC targeting Nectin-4, has been selected for an oral presentation at the upcoming 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, being held April 8-13, 2022 in New Orleans, LA (Press release, Bicycle Therapeutics, MAR 8, 2022, View Source [SID1234609718]). The Company will host a conference call to discuss the data from the presentation on Monday, April 11, 2022 at 8:30 a.m. ET.

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Oral Presentation Details

Title: BT8009-100 Phase I/II Study of Novel Bi-Cyclic Peptide and MMAE Conjugate BT8009 in Patients with Advanced Malignancies Associated with Nectin-4 Expression
Abstract #: 7971
Presenter: Meredith McKean, Sarah Cannon Research Institute at Tennessee Oncology
Session Title: Biomarker Advances in Clinical Trials
Date/Time: Sunday, April 10, 2022 at 4:00 p.m. ET

Poster Presentation Details

Title: Development of a CD137 Receptor Occupancy Assay to Support the Phase I/II Study of BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist (Bicycle TICA)
Abstract #: 5555
Presenter: Heather Cohen, Bicycle Therapeutics
Session Title: Immune Response to Therapies / Immune Monitoring and Clinical Correlates
Date/Time: Monday, April 11, 2022 at 2:30 p.m. ET

Title: Activity of the Erythropoietin-Producing Hepatocellular A2 Receptor (EphA2) Targeting Bicycle Toxin Conjugate (BTC) BCY6033 in EGFR Inhibitor Resistant Non-Small Lung Cancer (NSCLC) Patient Derived Xenografts
Abstract #: 333
Presenter: Kenneth Ngo, Belfer Center for Applied Cancer Science, Dana-Farber Cancer Institute
Session Title: Biological Therapeutic Agents and Novel Drugs
Date/Time: Sunday, April 10, 2022 at 2:30 p.m. ET

Title: Modeling the cDC1 Ex Vivo and In Vitro: Development and Characterization of a Conventional Dendritic Cell Culture System to Support Drug Discovery
Abstract #: 4230
Presenter: Laura Goodfield, Bicycle Therapeutics
Session Title: Immunomodulatory Agents and Interventions 3
Date/Time: Wednesday, April 13, 2022 at 10:00 a.m. ET

Title: Generation of a Bicycle NK-TICA, a Novel NK Cell Engaging Molecule Designed to Induce Targeted Tumor Cytotoxicity
Abstract #: 4233
Presenter: Fay Dufort, Bicycle Therapeutics
Session Title: Immunomodulatory Agents and Interventions
Date/Time: Wednesday, April 13, 2022 at 10:00 a.m. ET

The posters and a copy of the presentation will be available on the Publications section of bicycletherapeutics.com following presentation.

Conference Call Details

Bicycle Therapeutics will host a conference call and webcast on Monday, April 11, 2022 at 8:30 a.m. ET to review the data being presented. To access the call, please dial (800) 377-9118 (domestic) or (409) 937-8920 (international) and provide the Conference ID 2775710. A live webcast of the presentation will be available on the Investors & Media section of the Bicycle website, bicycletherapeutics.com.

Cowen Health Care Conference Presentation, dated March 8, 2022

On March 8, 2022 Molecular Templates Presented the corporate Presentation (Presentation, Molecular Templates, MAR 8, 2022, View Source [SID1234609736]).

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AbbVie Resolves HUMIRA® (adalimumab) U.S. Litigation with Alvotech

On March 8, 2022 AbbVie (NYSE: ABBV) reported that it has resolved all U.S. HUMIRA (adalimumab) litigation with Alvotech (Press release, AbbVie, MAR 8, 2022, View Source [SID1234609635]).

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Under the terms of the resolution, AbbVie will grant Alvotech a non-exclusive license to its HUMIRA-related patents in the United States, which will begin on July 1, 2023. AbbVie will make no payments of any form to Alvotech, and Alvotech will pay royalties to AbbVie for licensing its HUMIRA patents and acknowledges the validity and enforceability of the licensed patents. The resolution includes dismissal of the patent and trade secret litigation between AbbVie and Alvotech.

Panbela Schedules Conference Call on 3/24/22 to Report 2021 Fourth Quarter Financial Results

On March 08, 2022 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer, reported that it will host a conference call on March 24, 2022 at 4:30 PM Eastern Time to discuss results for its fourth quarter ended December 31, 2021 (Press release, Panbela Therapeutics, MAR 8, 2022, View Source;utm_medium=rss&utm_campaign=panbela-schedules-conference-call-on-3-24-22-to-report-2021-fourth-quarter-financial-results [SID1234609652]).

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Conference Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

About SBP-101

SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 12.0 months which is not yet final, and an objective response rate (ORR) of 48%, both exceeding what is seen typically with the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source .