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Mirati Therapeutics to Participate at the Morgan Stanley 21st Annual Global Healthcare Conference

On August 29, 2023 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a commercial stage biotechnology company, reported that it will participate at the Morgan Stanley 21st Annual Global Healthcare Conference on September 12 at 12:35 p.m. P.T. / 3:35 p.m. E.T. Ben Hickey, chief commercial officer, and Jamie Christensen, Ph.D., chief scientific officer, will represent the company in a fireside chat at the conference (Press release, Mirati, AUG 29, 2023, View Source [SID1234634757]).

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Investors and the general public are invited to listen to a live webcast of the session through the "Investors and Media" section on Mirati.com. A replay of the webcast will be made available following the event.

INOVIO to Present at the H.C. Wainwright 25th Annual Global Investment Conference

On August 29, 2023 INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, reported that Dr. Jacqueline Shea, President and CEO will present at the H.C. Wainwright 25th Annual Global Investment Conference (Press release, Inovio, AUG 29, 2023, View Source [SID1234634756]).

H.C. Wainwright 25th Annual Global Investment Conference
Date: Tuesday, September 12, 2023
Time: 4:30 PM ET
Format: Company Presentation

During the conference, Dr. Shea and members of INOVIO’s management team will conduct one-on-one meetings with registered investors.

A webcast of the presentation will be available on the INOVIO Investor Relations Events page at View Source A replay of the webcast will be available for 90 days after the date of the presentation.

Halozyme Announces Approval of Roche’s Tecentriq® Subcutaneous (SC) with ENHANZE® in Great Britain

On August 29, 2023 Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") reported the approval of Roche’s Tecentriq SC (atezolizumab), using Halozyme’s ENHANZE drug delivery technology, by the Medicines and Healthcare Products Regulatory Agency (MHRA) in Great Britain (Press release, Halozyme, AUG 29, 2023, View Source [SID1234634755]). Tecentriq subcutaneous (SC) is co-formulated with Halozyme’s proprietary recombinant human hyaluronidase enzyme, rHuPH20, allowing for subcutaneous delivery, which takes approximately seven minutes, compared with 30-60 minutes for intravenous (IV) infusion. Tecentriq SC will be available to patients in Great Britain for certain types of lung, bladder, breast, and liver cancer.7

Multiple oncology studies suggest that most cancer patients prefer to receive their treatments via subcutaneous delivery, instead of intravenous infusion because of reduced discomfort, ease of administration, and shorter duration of treatment.2,4,11

"We are delighted that Roche has received approval of Tecentriq SC in Great Britain. Subcutaneous delivery of Tecentriq provides cancer patients a faster and more flexible treatment option and may alleviate pressure on healthcare system resources," said Dr. Helen Torley, president and chief executive officer of Halozyme. "We look forward to additional regulatory approvals of our partner products utilizing ENHANZE."

Tecentriq SC is the first subcutaneous anti-PD-(L)1 cancer immunotherapy available to patients in Great Britain and is Roche’s fourth subcutaneous cancer therapy using Halozyme’s ENHANZE drug delivery technology.8-10 The approval is based on clinical data from the Phase IB/III IMscin001 study, which showed comparable levels of Tecentriq in the blood when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation.12 While the IMscin001 trial was conducted within the hospital setting, the SC formulation may be suitable for out-of-hospital administration by a healthcare professional.

The U.S. Food and Drug Administration (FDA) is currently evaluating Tecentriq SC for regulatory approval.

Veracyte to Participate in the Morgan Stanley 21st Annual Global Healthcare Conference

On August 29, 2023 Veracyte, Inc. (Nasdaq: VCYT) reported that Marc Stapley, chief executive officer, and Rebecca Chambers, chief financial officer, will participate in a fireside chat at the Morgan Stanley 21st Annual Global Healthcare Conference on Tuesday, September 12, at 4:15 p.m. Eastern Time (Press release, Veracyte, AUG 29, 2023, View Source [SID1234634754]).

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

Taiho Pharmaceutical Announces the Launch of FGFR Inhibitor LYTGOBI® Tablets 4mg in Japan

On August 29, 2023 Taiho Pharmaceutical Co., Ltd. (hereinafter "Taiho") reported that the FGFR inhibitor "LYTGOBI tablets 4mg" (generic name: futibatinib) has been listed on the National Health Insurance (NHI) reimbursement price list. The new product is scheduled for launch on September 7, 2023, in Japan (Press release, Taiho, AUG 29, 2023, View Source [SID1234634752]).

LYTGOBI, discovered by Taiho, is an FGFR inhibitor. LYTGOBI binds covalently to FGFR 1, 2, 3 and 4, and inhibits FGFR-mediated signal transduction pathways selectively and irreversibly, resulting in reduced tumor cell proliferation and increased tumor cell death in tumors with FGFR1-4 genetic aberrations. Based on the results of the FOENIX-CCA2* phase 2 trial, LYTGOBI was approved in Japan in June 2023 for unresectable biliary tract cancer harboring FGFR2 gene fusions that has progressed after chemotherapy.
*FOENIX-CCA2 trial: PHASE 1/2 STUDY OF TAS-120 IN PATIENTS WITH ADVANCED SOLID TUMORS Harboring FGF/FGFR Aberrations; FGFR Oral SElective Novel Inhibitor X [across] tumors

In September 2022, the U.S. Food and Drug Administration (FDA) approved LYTGOBI for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 gene fusions or other rearrangements. In July 2023, the European Commission (EC) granted conditional marketing authorization for LYTGOBI monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma (CCA) with a FGFR2 fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

Taiho believes that LYTGOBI will make a positive contribution as a new treatment option for patients with biliary tract cancer.

About Biliary Tract Cancer
Biliary tract cancer is a general term for cancer that develops in the biliary tract and is classified into bile duct cancer, gall bladder cancer, and papillary cancer, depending on the site of origin. Intrahepatic cholangiocarcinoma, which occurs in the bile ducts within the liver, is included as biliary tract cancer. According to the National Cancer Center, the annual incidence of biliary tract cancer, including intrahepatic and extrahepatic cholangiocarcinoma, gallbladder cancer, and papillary cancer, is approximately 25,000 in Japan.1

About FGFR (Fibroblast Growth Factor Receptor)
FGFRs belong to a family of receptor-type tyrosine kinases involved in angiogenesis, wound healing and embryonic development. Fibroblast growth factors (FGFs) and their receptors (FGFR 1, 2, 3 and 4) are expressed on diverse cell types and regulate cell growth, survival, migration and differentiation. Recently, FGF/FGFR gene abnormalities have been reported in several types of cancer, and have attracted attention as candidate driver genes for cancer.