On April 2, 2021 Taiho Oncology, Inc. reported that Phase 2 clinical data, along with preclinical and Phase 1 clinical data for futibatinib (TAS-120) will be presented during the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021 Week 1, taking place virtually from April 10-15, 2021 (Press release, Taiho, APR 2, 2021, View Source [SID1234577548]). Futibatinib is a covalently-binding FGFR inhibitor being investigated for the potential treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements including gene fusions. Key presentations include:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Primary results of phase 2 FOENIX-CCA2: the irreversible FGFR1-4 inhibitor futibatinib in intrahepatic cholangiocarcinoma (iCCA) with FGFR2 fusions/rearrangements: Lipika Goyal, MD, MPhil, Massachusetts General Hospital Cancer Center (Presentation Number CT010). Results will be shared online as an oral plenary presentation from 2:00 – 3:45 PM ET on April 11, 2021.
Acquired resistance to ATP-competitive and irreversible FGFR inhibitors (FGFRi’s): A library-based approach: Hiroshi Sootome, MS, Manager, Translational Research Planning & Management group, Taiho Pharmaceutical Co., Ltd. (1117). Results will be shared online as a poster presentation from 8:30 AM – 11:59 PM ET on April 10, 2021.
Effect of futibatinib on QT/QTc interval: a randomized, controlled, double-blind study: Ikuo Yamamiya, PhD, Associate Director, Bioanalytics & DMPK, Taiho Oncology, Inc. (CT128). Results will be shared online as a poster presentation from 8:30 AM – 11:59 PM ET on April 10, 2021.
Evaluation of potential drug-drug interactions (DDIs) between futibatinib and CYP3A inhibitors/inducers, CYP3A substrates, or proton pump inhibitors (PPIs): Ikuo Yamamiya, PhD, Associate Director, Bioanalytics & DMPK, Taiho Oncology, Inc. (CT125). Results will be shared online as a poster presentation from 8:30 AM – 11:59 PM ET on April 10, 2021.
Please visit Taiho Oncology’s virtual Medical Booth when the exhibit opens on April 10, 2021.

"We are pleased to present these clinical and pre-clinical data for futibatinib in patients with advanced intrahepatic cholangiocarcinoma (iCCA) who have failed at least one line of therapy, including primary results from the Phase 2 FOENIX-CCA2 trial," said Martin J. Birkhofer, MD, Senior Vice President and Chief Medical Officer, Taiho Oncology, Inc. "These data add to the body of evidence for futibatinib and support this investigational compound as a potential treatment option for patients with iCCA whose disease has progressed following previous therapies."

The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) for futibatinib for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements, including gene fusions, in February 2021 based on efficacy and safety results from the FOENIX-CCA2 study. The FDA Office of Orphan Drug Development granted futibatinib orphan drug status for the treatment of cholangiocarcinoma in May 2018.

About Futibatinib (TAS-120)
Futibatinib (TAS-120) is an investigational, oral, potent, selective, and irreversible small-molecule inhibitor of FGFR1, 2, 3 and 4 being studied as a potential treatment for patients with advanced solid tumors with FGFR1-4 genetic aberrations, including cholangiocarcinoma, who were previously treated with chemotherapy or other therapies. Futibatinib selectively and irreversibly binds to the ATP binding pocket of FGFR1-4 resulting in the inhibition of FGFR-mediated signal transduction pathways, reduced tumor cell proliferation and increased tumor cell death in tumors with FGFR1-4 genetic aberrations.

About Cholangiocarcinoma
Cholangiocarcinoma (CCA), also known as bile duct cancer, is not common. About 8,000 people in the U.S. are diagnosed with CCA each year.1 This includes both intrahepatic (inside the liver) and extrahepatic (outside the liver) cancers. CCA can occur at younger ages, but it is seen mainly in older people. The average age of people in the U.S. diagnosed with cancer of the intrahepatic bile ducts is 70, and for cancer of the extrahepatic bile ducts it is 72.1 The five-year survival rates of intrahepatic CCA (all SEER stages combined) is 9%.2

The main treatment for CCA is surgery. Radiation therapy and chemotherapy may be used if the cancer cannot be entirely removed with surgery and in cases where the edges of the tissues removed at the operation show cancer cells (also called a positive margin). Both stage III and stage IV cancers cannot be completely removed surgically. Currently, standard treatment options are limited to radiation, palliative therapy, liver transplantation, surgery, chemotherapy and interventional radiology.3

On April 2, 2021 Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), a leading computational biology company focused on revolutionizing product discovery and development in multiple life-science based industries, reported that it has filed its annual report on Form 20-F for the fiscal year ended December 31, 2020 with the U.S. Securities and Exchange Commission (the "SEC") (Press release, Evogene, APR 2, 2021, View Source [SID1234577547]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The annual report, which contains the Company’s audited consolidated financial statements, can be accessed on the SEC website at View Source as well as via the Company’s website at View Source The Company will deliver a hard copy of its annual report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request to the Company Media Contact: [email protected].

On April 2, 2021 Veracyte, Inc. (Nasdaq: VCYT), a global genomic diagnostics company, reported that Bonnie Anderson, chairman and chief executive officer, will participate in a fireside chat at the 20th Annual Needham Virtual Healthcare Conference on Tuesday, April 13, 2021 at 2:15 p.m. Eastern Time (Press release, Veracyte, APR 2, 2021, View Source [SID1234577546]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The link to the live audio webcast of the company’s presentation will be available by visiting Veracyte’s website at View Source A replay of the webcast will be available for 90 days following the conclusion of the live presentation broadcast.

On April 2, 2021 Pfizer Inc. (NYSE: PFE) reported investors and the general public to access a live video webcast of a presentation and conference call with investment analysts at 10 a.m. EDT on Friday, April 9, 2021 (Press release, Pfizer, APR 2, 2021, View Source [SID1234577545]). Pfizer Oncology leadership will provide an update on the Oncology pipeline progress, specifically how the company is applying its capabilities to move quickly and utilize cutting-edge science to key programs such as LORBRENA (lorlatinib) in ALK-positive metastatic lung cancer, elranatamab (PF-06863135) in multiple myeloma and our next generation breast cancer portfolio.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

To access the live webcast, including audio, video and presentation slides, visit our web site at www.pfizer.com/investors. Information on accessing and registering for the webcast will be available at www.pfizer.com/investors beginning today. Participants are advised to register in advance.

Participants will also have an opportunity to ask questions in a live Q&A session with speakers. Those participants who would like to ask a question can dial either (833) 741-0115 in the United States and Canada or (818) 488-5731 outside of the United States and Canada. The password is "Pfizer Oncology".

Visitors to www.pfizer.com/investors will be able to view and listen to an archived copy of the webcast following the conclusion of the event.

On April 2, 2021 Allarity Therapeutics A/S ("Allarity" or the "Company") reported the submission of a premarket approval application (PMA) to the U.S. Food and Drug Administration (FDA) for DRP-Dovitinib, the Company’s validated companion diagnostic for the drug dovitinib (Press release, Allarity Therapeutics, APR 2, 2021, View Source [SID1234577544]). Dovitinib is a small molecule, pan-tyrosine kinase inhibitor licensed from Novartis, and is Allarity’s most advanced clinical asset. This milestone marks the first time that Allarity has sought regulatory approval for one of its drug-specific DRPs used to guide patient therapy.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Allarity’s unique DRP biomarker technology makes it possible to predict whether a particular cancer patient is likely to benefit from treatment with dovitinib, in addition to a broad range of anti-cancer drugs. DRP drug response assessments of the individual patients are done based on a biopsy from the patients’ tumors. The DRP-Dovitinib is intended to be used to identify patients, suffering from renal cell carcinoma (RCC), who by the gene expression signature of their tumor are found to have a high likelihood of responding to dovitinib.

Allarity plans to file a New Drug Application ("NDA") with the FDA for the approval of dovitinib for the treatment of renal cell carcinoma (kidney cancer) during 2021. If the FDA provides the anticipated premarket approval of the dovitinib DRP as a companion diagnostic, as well as an NDA approval for dovitinib, Allarity will be able to market dovitinib to DRP-selected RCC patients as an effective new therapy to treat their disease. The DRP for dovitinib, if approved, will be the first complex, gene expression signature approved by the U.S. FDA as a companion diagnostic to guide patient selection for cancer therapy.

Allarity’s CEO, Steve Carchedi, noted "Our current goal for dovitinib is to make it available to the group of RCC patients for whom a treatment with this particular therapeutic will be the most efficacious treatment for their disease. Today, marks a milestone for the advancement of our unique DRP biomarker technology for dovitinib, and approval of our PMA will enable oncologists to select those patients who are high likelihood responders to this drug." Mr. Carchedi further stated: "Later this year, I look forward to announcing our expected filing of a New Drug Application for dovitinib itself. Ultimately, if both of these filings are approved by the FDA, our Company will be positioned to significantly change how treatment of RCC will be conducted in the future, and help realize the promise of personalized medicine for these patients."

Steen Knudsen, Ph.D., CSO and Co-Founder of the Company, further stated, "I am extremely pleased to reach the milestone event of our first regulatory approval application for a DRP companion diagnostic, following our extensive work, over the past 15 years, developing, validating, and perfecting our DRP technology. I look forward to our Company advancing dovitinib, in combination with the Dovitinib-DRP, through approval and to market, and to similarly advancing the rest of our oncology therapeutics pipeline with DRP companion diagnostics in a true personalize medicine approach."

In October 2020 Allarity announced that the United States Patent and Trademark Office (USPTO) had issued a notice of allowance to the Company on its patent application no 16/444,881 titled "METHODS FOR PREDICTING DRUG RESPONSIVENESS IN CANCER PATIENTS" – directed to a DRP biomarker for dovitinib.

About the Drug Response Predictor – DRP Companion Diagnostic
Allarity uses its drug specific DRP to select those patients who, by the genetic signature of their cancer, are found to have a high likelihood of responding to the specific drug. By screening patients before treatment, the response rate can be significantly increased. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including genomic information from cell lines combined with clinical tumor biology and prior clinical trial outcomes. DRP is based on messenger RNA from the patient’s biopsies. DRP has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in nearly 40 clinical studies that were examined, including an ongoing, prospective Phase 2 trial. The DRP platform can be used in all cancer types and is patented for more than 70 anti-cancer drugs.