On April 8, 2021 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company developing onvansertib to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, pancreatic cancer and castrate-resistant prostate cancer, reported that it will host a key opinion leader (KOL) webinar on onvansertib for the treatment of KRAS-mutated metastatic colorectal cancer on Monday, April 12, 2021 at 11 a.m. Eastern Time (Press release, Cardiff Oncology, APR 8, 2021, View Source [SID1234577725]).

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The webinar will feature presentations by KOLs Daniel H. Ahn, D.O., M.S. (Mayo Clinic Arizona), and Manish R. Sharma, M.D. (START Midwest), who will discuss the current treatment landscape and unmet medical need in KRAS-mutated metastatic colorectal cancer (mCRC), as well as the ongoing Phase 1b/2 clinical trial and observations from the Expanded Access Program evaluating onvansertib in combination with FOLFIRI/Avastin in KRAS-mutated mCRC.
During the webinar, Cardiff Oncology’s CEO, Mark Erlander, Ph.D., will give a corporate update and outlook for the year. Dr. Erlander and Drs. Ahn and Sharma will be available to answer questions following the conclusion of the formal presentations.

About the KOLs
Daniel H. Ahn, D.O, M.S. is a GI Medical Oncologist and Assistant Professor in the Division of Hematology/Medical Oncology at the Mayo Clinic. He conducts clinical and translational research focused on developing anti-cancer agents for patients with gastrointestinal cancers. Dr. Ahn collaborates extensively with various scientists and industry partners to design and execute innovative clinical trials, including many first-in-human studies. He is the Lead for the GI Oncology Translational Research Disease Working Group at Mayo Clinic Arizona. He also serves on the Board of Directors for the Mayo Clinic-supported cancer research consortium Academic and Community Cancer Research United (ACCRU) and is an Alliance for Clinical Trials in Oncology GI Committee member, a National Cancer Institute (NCI)-supported cooperative research group.
Dr. Ahn’s research includes a large focus on the incorporation of agents that target the multiple facets of cancer, including genetic and epigenetic drivers, as well as the feeding microenvironment and the immune milieu. His research has also led to the launch of a number of clinical trials, including recent studies investigating novel agents targeting DNA repair mechanisms, sequencing treatment strategies in colorectal cancer as well as various targeted therapies in advanced colorectal cancer.

Manish R. Sharma, M.D. is the Associate Director of Clinical Research at START Midwest and is a medical oncologist in Grand Rapids, Michigan. He graduated with honors from the University of Michigan Medical School in 2004. He completed his residency in Internal Medicine at the University of California – San Francisco, where he also served as chief resident. He completed a combined fellowship training in Hematology/Oncology and Clinical Pharmacology & Pharmacogenomics at the University of Chicago.
He subsequently spent six years on the faculty as an Assistant Professor of Medicine at the University of Chicago, where he had a Career Development Award from the National Institutes of Health and was very involved in the teaching and mentorship of trainees. Dr. Sharma developed expertise in oncology drug development, gastrointestinal cancers, clinical pharmacology, pharmacogenomics, and pharmacometrics. He is board certified in Medical Oncology and Clinical Pharmacology.
Dr. Sharma joined START Midwest and Cancer & Hematology Centers of Western Michigan in 2018. Throughout his clinical oncology practice, Dr. Sharma has specialized in the treatment of gastrointestinal cancers. His clinical research interests include early phase drug development and clinical pharmacology trials for patients with advanced solid tumors. He has been the principal investigator on more than 25 phase I clinical trials involving immunotherapies, targeted therapies, chemotherapy, antibody-drug conjugates, drug-drug interactions, and food effect. He has co-authored more than 20 peer-reviewed papers related to oncology drug development and has served as a reviewer for many oncology and clinical pharmacology journals.

On April 8, 2021 Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the "Company"), an international biopharmaceutical company, reported preliminary, unaudited revenue for the first quarter 2021 (Press release, Biofrontera, APR 8, 2021, View Source [SID1234577724]).

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The Company’s preliminary unaudited revenue for the period January 1 to March 31, 2021 amounts to approximately EUR 5.6 million compared to EUR 6.5 million in the same period last year, a decline of 14%.

Preliminary revenues from product sales in the US were around EUR 3.9 million, compared to EUR 4.2 million in Q1 2020, which corresponds to a decline of 6%. In Germany, revenues from product sales amounted to approximately EUR 1.4 million, compared to EUR 1.3 million in Q1 2020, a gain of 7%. In the rest of Europe, the Company generated product sales of around EUR 0.3 million, compared to EUR 0.8 million in the same period last year, a decline of 69%.

While sales in Germany remained relatively stable over the quarter compared to the previous year, revenues in the USA for the months of January and February 2021 were well below those of the previous year due to the pandemic. Starting in the second half of March last year, our sales were significantly impacted by the pandemic, and this is where we already saw a significant upturn this year in the USA compared to last year. In March 2021, our sales in the USA increased by around 46% year-on-year, indicating a significant recovery of the situation in the USA, presumably also due to the high vaccination rates.

On April 8, 2021 Aptose Biosciences Inc. (Nasdaq: APTO; TSX: APS), a clinical-stage company developing highly differentiated therapeutics that target the underlying mechanisms of cancer, reported that William G. Rice, Ph.D., Chairman, President and Chief Executive Officer, will participate in Canaccord Genuity’s 2021 Horizons in Oncology Virtual Conference (Press release, Aptose Biosciences, APR 8, 2021, View Source [SID1234577723]):

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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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Canaccord Genuity’s 2021 Horizons in Oncology Virtual Conference

Panel: Opportunities in BPDCN and AML
Date: Thursday, April 15, 2021
Time: 3:00 – 3:55 PM EDT
Format: Panel Moderated by John Newman, Ph.D., Managing Director, Biotechnology Analyst

Conference Information: Link
The Aptose management team also will be hosting 1×1 meetings during the event.

On April 8, 2021 Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, reported that Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex, will present at the 20th Annual Needham Virtual Healthcare Conference on Thursday, April 15, 2021 at 8:45 a.m. EDT (Press release, Anavex Life Sciences, APR 8, 2021, View Source [SID1234577722]).

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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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A live audio webcast will be available on View Source or in the Investors section of the Company’s website at www.anavex.com. An audio archive of the session will also be available on the website.

On April 8, 2021 Portage Biotech Inc. (NASDAQ: PRTG) (CSE: PBT.U) ("Portage" or the "Company"), a clinical-stage immuno-oncology company focused on the development of therapies and treatments targeting cancer treatment resistance, reported that the first patient has been dosed in the Phase 1 portion of the PRECIOUS-01 open-label, dose-escalation and expansion clinical trial assessing the safety, tolerability, efficacy and dosing of PORT-3 in the treatment of cancer (Press release, Portage Biotech, APR 8, 2021, View Source [SID1234577721]).

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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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PORT-3 is a nanoparticle co-formulation of the invariant natural killer T-cell (iNKT) agonist IMM60 and NY-ESO-1 immunogenic peptides developed for the treatment of NY-ESO-1 positive solid tumors.

"Today’s initiation of the PRECIOUS trial marks an important milestone in the clinical development of Portage’s iNKT agonists, including both PORT-2 and PORT-3," said Dr. Ian Walters, chief executive officer of Portage Biotech. "Preclinical studies of both compounds have shown that treatment can lead to a broad reprogramming of the immune system. We are excited to begin first-in-human trials of PORT-3 to test the proof-of-concept of this approach. If the trial is successful with NY-ESO-1, it will open the door to a multitude of opportunities to design more formulations with other tumor-specific antigens."

The trial is based on preclinical data for PORT-3, which was recently published in Frontiers in Immunology. The preclinical data demonstrated good tolerability and a strong cancer-specific B and T-cell response. Importantly, preclinical data also showed that co-formulation of other cancer antigen vaccines and iNKT agonists resulted in up to 2-5x increases in potency. This has the potential to increase the specificity of treatment, including targeting specific tumor markers, and increasing the effectiveness of treatment. The phase 1 part of the trial is expected to enroll 15 patients.

"In the cancer treatment landscape, solid tumors represent an area of significant unmet need as many patients, including those with NY-ESO-1 positive tumors, have been unable to find an effective therapeutic solution," said Dr. Jolanda de Vries, Professor at the Department of Tumor Immunology at the Radboud Institute for Molecular Life Sciences at Radboud University Medical Center, Netherlands. "We are encouraged by the preclinical data for the PORT-3 iNKT agonists and are excited to explore how this novel co-formulation approach may offer a new treatment paradigm with the potential to target a broad array of solid tumor types in patients with few other options."

The study is supported by a grant from the EU Horizon 2020 program. The trial is actively recruiting at Radboud University, Netherlands. For more information, please visit www.clinicaltrials.gov#NCT04751786.

About iNKT agonists PORT-2 and PORT-3

PORT-2 and PORT-3 contain small molecule agonists (IMM60) of invariant natural killer T-cells (iNKT cells) developed by Oxford University, which play an important role in anti-tumor immune responses. iNKT cells are a distinct class of T lymphocytes and recognize lipid antigens on the surface of the tumor. Our synthetic iNKT agonists are designed to optimally engage the T-cell receptor on the iNKT and facilitate its binding to dendritic cells, resulting in the secretion of a large amount of pro-inflammatory cytokines. This leads to the activation and expansion of important immune system components and primes and boosts an adaptive immune attack against cancer. We see that monotherapy treatment with iNKT agonists shows a heightened immune response and better cancer control in animal models that are resistant to PD-1 antibody treatment. Combination therapy with PD-1 antibodies is synergistic with iNKT agonists and restores sensitivity to PD-1 blockade. While treatment with iNKT agonists alone shows promising preclinical activity against cancer, data suggests that when an iNKT agonist is co-packaged with tumor-specific antigens, potency is increased by up to 5x. PORT-2 is a liposomal formulation of our IMM60 iNKT agonist while PORT-3 is a co-formulation of our IMM60 iNKT agonist with an NY-ESO-1 peptide vaccine, co-packaged into a nanoparticle.