On August 1, 2022 AnHeart Therapeutics ("AnHeart"), a clinical-stage global biopharmaceutical company committed to developing novel precision oncology therapeutics, reported the appointment of Shuanglian (Lian) Li, M.D., Ph.D., as the company’s Senior Vice President and Chief Medical Officer (US) (Press release, AnHeart Therapeutics, AUG 1, 2022, View Source [SID1234617217]). In this role, Dr. Li will oversee and direct all U.S.-based clinical programs.

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!

Dr. Li is an accomplished clinical development physician with over 15 years of drug development experience from preclinical drug safety to late-stage drug development and post-marketing clinical research. Her clinical development expertise has specialized in precision medicine and adoptive cellular therapy.

Prior to joining AnHeart, Dr. Li was SVP, Clinical Development at Ansun Biopharma, where she led and drove the overall clinical development strategy of the company’s oncology pipeline and clinical development plan. She also led clinical and regulatory strategy as Head of Clinical Development at Skyline Therapeutics, a gene therapy company headquartered in Shanghai.

Dr. Li was also the Global Clinical Lead for mobocertinib, a first-in-class EGFR inhibitor that targeted EGFR exon 20 insertions, at Takeda Pharmaceuticals. Prior to its acquisition by Takeda, Dr. Li was Medical Director at ARIAD Pharmaceuticals and the medical lead for several oncology programs. Dr. Li has held various positions with increasing responsibilities at Biogen, Pfizer and Sugen.

"We’re delighted to welcome Dr. Li to AnHeart Therapeutics. She brings more than 15 years of experience leading high-performing teams in clinical development, and has a proven track record of success with multiple FDA approvals in oncology," said Junyuan (Jerry) Wang, Ph.D. CEO & Co-Founder, AnHeart Therapeutics. "Dr. Li is precisely the type of high-quality individual we are recruiting as we grow our company. She will be an invaluable asset to AnHeart and our leadership team as we advance our clinical pipeline focused on ROS1-directed therapeutics."

"I am excited to join AnHeart at such a dynamic time. The company is developing multiple cancer therapies including lead asset taletrectinib targeting ROS1-fusion and resistant mutations. AnHeart’s mission to transform the lives of cancer patients with breakthrough medicines and exciting programs attracted me to the role, and I look forward to working with the management and scientific teams to bring innovative therapies to cancer patients," said Dr. Li.

Dr. Li received her Ph.D. in Pharmaceutical Sciences & Pharmacogenomics, from the University of California, San Francisco and an M.D. from Beijing Medical University. She also obtained an M.S. in Pharmacology & Toxicology from the University of Mississippi.

On August 1, 2022 Ono reported its consolidated financial results for the First Quarter of the fiscal year ending March 31, 2023 (Filing, 3 mnth, JUN 30, Ono, 2022, AUG 1, 2022, View Source [SID1234618753]).

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!

On August 1, 2022 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported that it has initiated a bridging study of tazemetostat in China. The first patient received their first dose on July 29, 2022 (Press release, Hutchison China MediTech, AUG 1, 2022, View Source [SID1234617169]).

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 bridging study is a multicenter, open-label, Phase II study to evaluate the efficacy, safety and pharmacokinetics of tazemetostat for the treatment of patients with relapsed/refractory follicular lymphoma ("R/R FL"). The primary objective is to evaluate the efficacy of tazemetostat for treatment of patients with R/R FL who have mutations in EZH2[1] (Cohort 1). The secondary objectives are to evaluate the efficacy of tazemetostat for treatment of patients with R/R FL who have EZH2 wild-type (Cohort 2) and to evaluate the safety and the pharmacokinetics of tazemetostat for treatment of patients with R/R FL. The lead principal investigator is Dr Junning Cao of Shanghai Fudan University Cancer Center. Additional details may be found at clinicaltrials.gov, using identifier NCT05467943.

Tazemetostat is a methyltransferase inhibitor of EZH2 developed by Epizyme, Inc. ("Epizyme"). It is approved by the U.S. Food and Drug Administration ("FDA") for the treatment of certain patients with advanced epithelioid sarcoma ("ES") and certain patients with R/R FL under the FDA accelerated approval granted in January and June 2020, respectively.

In August 2021, HUTCHMED entered into a strategic collaboration with Epizyme to research, develop, manufacture and commercialize tazemetostat in China, Hong Kong, Macau and Taiwan.

In May 2022, tazemetostat was approved by the Health Commission and Medical Products Administration of Hainan Province of China to be used in the Hainan Boao Lecheng International Medical Tourism Pilot Zone ("Hainan Pilot Zone"), under the Clinically Urgently Needed Imported Drugs scheme, for the treatment of certain patients with ES and FL consistent with the label as approved by the FDA.

About FL and ES
FL is a subtype of non-Hodgkin’s lymphoma ("NHL"). FL accounts for approximately 17% of NHL. In 2020, there were an estimated 16,000 and 13,000 new cases of FL in China and the U.S., respectively. [2],[3],[4]

ES is a rare, slow-growing type of soft tissue cancer. Radical tumor resection is the primary treatment for patients with ES. However, ES is known for its high propensity for locoregional recurrence and distant metastases. The survival of patients with ES is often unsatisfactory with very limited treatment options.[5]

About TAZVERIK (tazemetostat)
TAZVERIK is a methyltransferase inhibitor indicated in the United States for the treatment of:

Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval by the U.S. FDA based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.

View the U.S. Full Prescribing Information here: www.tazverik.com

TAZVERIK is a registered trademark of Epizyme, Inc.

About Tazemetostat Clinical Development in China
HUTCHMED and Epizyme are developing tazemetostat in various hematological and solid tumors in Greater China, with HUTCHMED leading the China portion of Epizyme’s SYMPHONY-1 study. HUTCHMED and Epizyme also intend to conduct additional global studies jointly.

SYMPHONY-1 (EZH-302) is an international, multicenter, randomized, double-blind, active-controlled, 3-stage, biomarker-enriched, confirmatory Phase 1b/3 study, which is designed to evaluate the safety and efficacy of tazemetostat in combination with R2 in patients with relapsed or refractory FL after at least one prior line of therapy (clinicaltrials.gov identifier: NCT04224493).

We intend to initiate several combination studies of tazemetostat with HUTCHMED assets.

On August 1, 2022 Amgen (NASDAQ:AMGN) reported that it will report its second quarter financial results on Thursday, August 4, 2022, after the close of the U.S. financial markets (Press release, Amgen, AUG 1, 2022, View Source [SID1234617186]). The announcement will be followed by a conference call with the investment community at 2:00 p.m. PT. Participating in the call from Amgen will be Robert A. Bradway, chairman and chief executive officer, and other members of Amgen’s senior management team.

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!

Live audio of the conference call will be simultaneously broadcast over the internet and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On August 1, 2022 ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, reported that the U.S. Food and Drug Administration ("FDA") has granted Fast Track designation to evorpacept, a next generation CD47 blocker, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, for the first-line treatment of adult patients with PD-L1 positive advanced head and neck squamous cell carcinoma ("HNSCC") (Press release, ALX Oncology, AUG 1, 2022, View Source [SID1234617202]).

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 FDA’s decision is informed by the results of ALX Oncology’s phase 1 clinical trial, ASPEN-01, that showed preliminary antitumor activity and a favorable safety profile in checkpoint inhibitor-naïve patients with second-line or greater advanced HNSCC treated with evorpacept and pembrolizumab (n=10). The preliminary objective response rate of 40% in this limited population represents an improvement over historical anti-PD-1 monotherapy activity in a similar population and supported the initiation of the ASPEN-03 (NCT04675294) study in May 2021 in collaboration with Merck (known as MSD outside the US and Canada). ASPEN-03 is a randomized phase 2 multi-center study to investigate the anti-tumor efficacy of evorpacept plus pembrolizumab in patients with first-line metastatic or unresectable, recurrent PD-L1 positive HNSCC.

"The FDA’s Fast Track designation for the first-line treatment of HNSCC with evorpacept in combination with pembrolizumab builds upon evorpacept’s prior Fast Track designation in the first-line HNSCC population in combination with pembrolizumab and standard chemotherapy highlighting the potential clinical utility of evorpacept in this difficult-to-treat disease," said Sophia Randolph, M.D., Ph.D., Chief Medical Officer, ALX Oncology. "We are pleased by the patient enrollment progress being made across our HNSCC phase 2 program (NCT04675294; NCT04675333) as we seek to advance evorpacept to help patients living with this disease."

About FDA Fast Track Designation
The FDA’s Fast Track program is designed to facilitate the development and expedite the review of medicines that may treat serious or life-threatening conditions and address significant unmet medical needs. The designation provides the opportunity for more frequent meetings with the FDA over the course of drug development. In addition, the Fast Track program allows for eligibility for Accelerated Approval and Priority Review if relevant criteria are met, as well as for Rolling Review, which enables a drug company to submit portions of the Biologic License Application to the FDA as they are completed.

About HNSCC
HNSCC is a serious and life-threatening disease with poor prognosis despite current available standard of care therapies. According to the Global Cancer Observatory, HNSCC was the 6th most common cancer globally in 2018 and the incidence of HNSCC is expected to increase 30% by 2030. For 2022, the National Cancer Institute estimates about 54,000 new cases of HNSCC will be diagnosed and nearly 11,230 of men and women will die from HNSCC in the United States.