On May 20, 2021 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM) reported that new analyses and updates on the ongoing studies of savolitinib, surufatinib, fruquintinib and HMPL-306 will be presented at the upcoming ASCO (Free ASCO Whitepaper)21 Virtual Scientific Program, taking place on June 4-8, 2021 (Press release, Hutchison China MediTech, MAY 20, 2021, View Source [SID1234580343]).

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Aspects of these clinical data disclosures, alongside its PD-1/L1 combination study strategy and corporate update will be discussed part of the previously announced call. For more details, please visit: View Source

SAVOLITINIB

Title:

Clinical activity of durvalumab and savolitinib in MET-driven, metastatic papillary renal cancer

Lead Author:

Cristina Suárez, MD, Hospital Univ. Vall D Hebron General

Session:

Poster Discussion Session: Genitourinary Cancer—Kidney and Bladder

Abstract Number:

4511

SURUFATINIB

Title:

Interim analysis results of surufatinib in U.S. patients with neuroendocrine tumors (NETs).

Lead Author

Scott Paulson, MD, Baylor Sammons Cancer Center

Session:

Poster Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Abstract Number:

4114

Title:

Surufatinib in combination with toripalimab in patients with advanced neuroendocrine carcinoma: results from a multicenter, open-label, single-arm, phase II trial

Lead Author

Lin Shen, MD, Peking University Cancer Hospital & Institute

Session:

Online publication only

Number:

e16199

Title:

Phase II trial of surufatinib plus toripalimab for disease progression after first-line chemotherapy with platinum and fluoropyrimidine in advanced gastric or gastroesophageal junction adenocarcinoma

Lead Author

Lin Shen, MD, Peking University Cancer Hospital & Institute

Session:

Online publication only

Number:

e16040

Title:

A single-arm, multi-center, open-label phase 2 trial of surufatinib in patients with unresectable or metastatic biliary tract cancer.

Lead Author

Yuxian Bai, MD, PhD, Harbin Medical University Cancer Hospital

Session:

Online publication only

Number:

e16123

Title:

Subgroup analysis by Ki-67 and baseline CgA of the randomized, placebo-controlled phase 3 study of surufatinib in advanced well-differentiated pancreatic neuroendocrine tumors (SANET-p)

Lead Author

Xianjun Yu, MD, Fudan University Shanghai Cancer Center

Session:

Poster Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Abstract Number:

4111

Title:

An open-label phase 1b/2 study of surufatinib in combination with tislelizumab in subjects with advanced solid tumors

Lead Author

Arvind Dasari, MD, MS, MD Anderson Cancer Center

Session:

Poster Session: Developmental Therapeutics—Immunotherapy

Abstract Number:

TPS2677

FRUQUINTINIB

Title:

Preliminary results of a phase 1b study of fruquintinib plus sintilimab in advanced colorectal cancer

Lead Author

Ye Guo, MD, Shanghai East Hospital

Session:

Poster Discussion Session: Gastrointestinal Cancer—Colorectal and Anal

Abstract Number:

2514

Title:

A phase Ib trial of assessing the safety and preliminary efficacy of a combination therapy of Geptanolimab (GB 226) plus Fruquintinib in patients with metastatic colorectal cancer (mCRC)

Lead Author

Yanzhi Cui, MD, Tumour Institute, Fourth Hospital of Hebei Medical University

Session:

Online publication only

Number:

e15551

HMPL-306

Title:

A multicenter open-label phase 1 study evaluating the safety and tolerability of HMPL-306 in patients with locally advanced or metastatic solid tumors with IDH mutations.

Lead Author

Filip Janku, MD, MD Anderson Cancer Center

Session:

Poster Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

Abstract Number:

TPS3159

About Savolitinib

Savolitinib is an oral, potent, and highly selective small molecule inhibitor of MET, a receptor tyrosine kinase which has been shown to function abnormally in many types of solid tumors promoting tumor growth, angiogenesis, and metastasis. Savolitinib has been studied in over 1,100 patients to date. In clinical studies, it has shown promising clinical efficacy in patients with MET gene alterations in multiple tumor types with an acceptable safety profile.

In 2011, HUTCHMED entered into a global licensing and joint development and commercialization agreement with AstraZeneca PLC (LSE/STO/NYSE: AZN) for savolitinib. Savolitinib’s global development plan includes non-small cell lung cancer (NSCLC) and kidney cancer, and additional MET-driven tumors are being explored.

About Surufatinib

Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor ("VEGFR") and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.

HUTCHMED currently retains all rights to surufatinib worldwide.

About Fruquintinib

Fruquintinib is a highly selective and potent oral inhibitor of VEGFRs -1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may also be highly suitable for combinations with other anti-cancer therapies.

HUTCHMED retains all rights to fruquintinib outside of China. In China, HUTCHMED is partnered with Eli Lilly and Company and is responsible for development and execution of all on-the-ground medical detailing, promotion and local and regional marketing.

About HMPL-306

HMPL-306 is HUTCHMED’s ninth innovative oncology drug candidate that it has discovered that has entered clinical development and the sixth to enter global clinical development. Cytoplasmic mutant IDH1 and mitochondrial mutant IDH2 have been known to switch to the other form when targeted by an inhibitor of IDH1 mutant alone or IDH2 mutant alone. By targeting both IDH1 and IDH2 mutations, HMPL-306 could potentially provide therapeutic benefits in cancer patients harboring either IDH mutation, and may address acquired resistance to IDH inhibition through isoform switching.

HUTCHMED currently retains all rights to HMPL-306 worldwide.

On May 20, 2021 GlaxoSmithKline reported that it has agreed with Innoviva, Inc ("Innoviva") – a royalty management company – to sell all of its approximately 32 million shares of common stock of Innoviva back to Innoviva at a price of $12.25 per share, raising gross proceeds of approximately $392 million (Press release, GlaxoSmithKline, MAY 20, 2021, View Source [SID1234580360]). Following settlement of the transaction, GSK will no longer hold any Innoviva stock.

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The terms of GSK’s long-standing and successful respiratory collaboration with Innoviva remain unchanged. Under this agreement GSK pays royalties to Innoviva on TRELEGY ELLIPTA, RELVAR/BREO ELLIPTA and ANORO ELLIPTA. In 2020, TRELEGY ELLIPTA sales were £819m (+59% CER (constant exchange rates)); RELVAR/BREO ELLIPTA sales were £1.1bn (+17% CER) and ANORO ELLIPTA sales were £547m (+8% CER).

This equity disposal releases capital to enable GSK to make further investment behind the Group’s strategic priorities.

Innoviva’s most recent closing share price was $12.29. The five-day volume weighted average price was $12.67.

On May 20, 2021 Purple Biotech Ltd. ("Purple Biotech", or the "Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective and durable therapies by overcoming tumor immune evasion and drug resistance, reported that it will present new data from the ongoing Phase 1/2 clinical trial of NT219 on Friday, June 4, 2021, at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting, which will be held virtually from June 4-8 (Press release, Purple Biotech, MAY 20, 2021, View Source [SID1234580376]).

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NT219 is a dual inhibitor, novel small molecule that simultaneously targets IRS1/2 and STAT3. The Phase 1/2 trial is evaluating NT219 as monotherapy treatment of advanced solid tumors, as well as in combination with cetuximab, an epithelial growth factor receptor (EGFR) blocking monoclonal antibody, for the treatment of recurrent and/or metastatic solid tumors and head and neck cancer or colorectal adenocarcinoma.

"We are excited to present interim data from our ongoing Phase 1/2 clinical trial of NT219 as monotherapy for the treatment of solid tumors that has the potential to help people living with hard-to-treat cancers," said Bertrand Liang, M.D., Ph.D., Chief Medical Officer of Purple Biotech. "We are excited to have clinical data for our NT219 program and we continue to expect the availability of further top-line data from the first part of this study in the second half of this year."

Details of the presentation are as follows:

Title: A Phase 1/2 study with open-label, dose escalation phase followed by single-arm expansion at the maximum tolerated dose to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of NT219 injection alone and in combination with Cetuximab in Adults with Advanced Solid Tumors and Head and Neck Cancer.

Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

Location: ASCO (Free ASCO Whitepaper) Meeting Library

On May 20, 2021 Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company developing a new class of potent and selective precision oncology medicines, which it refers to as Pentarin miniature drug conjugates, reported that the company will present data from its Phase 2 clinical trial of PEN-221 at the 2021 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting occurring virtually June 4-8, 2021 (Press release, Tarveda Therapeutics, MAY 20, 2021, View Source [SID1234580393]).

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PEN-221 is a miniature drug conjugate consisting of a peptide ligand that is highly selective in targeting the somatostatin receptor 2 (SSTR2), joined through a cleavable linker to the potent cytotoxic payload DM1. The Phase 2 trial assessed the safety, tolerability, pharmacokinetics, and preliminary efficacy of PEN-221 in well differentiated neuroendocrine tumors (NETs) and small cell lung cancer. The data being presented include safety and efficacy outcomes for patients enrolled in the gastrointestinal mid-gut NETs cohort.

"We are encouraged by the safety and efficacy results of our Phase 2 trial, which showed that PEN-221 was well tolerated and exceeded its clinical efficacy goals in patients with GI mid-gut neuroendocrine tumors," said Brian Roberts, President and Chief Executive Officer of Tarveda. "We look forward to presenting the results of the study at this year’s ASCO (Free ASCO Whitepaper) Annual meeting and to further evaluating PEN-221 in GI mid-gut neuroendocrine tumors."

Details of the poster presentation are as follows:

Title: The safety and efficacy of PEN-221 somatostatin analog (SSA)-DM1 conjugate in patients (PTS) with advanced GI mid-gut neuroendocrine tumor (NET): Phase 2 results.
Abstract Number: 4110
Date: Poster presentation available on demand beginning on June 4, 2021 at 9:00 AM ET

On May 20, 2021 Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products in Greater China and other parts of Asia, reported that sacituzumab govitecan-hziy (SG) was granted Priority Review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) (Press release, Everest Medicines, MAY 20, 2021, View Source [SID1234580409]).

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This marks another progress following the Company’s announcement published on 17 May 2021 that the NMPA accepted its Biologics License Application (BLA) for SG for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.

"We are very pleased by the NMPA’s decision to grant Priority Review for SG, reinforcing its potential to serve as a novel and important treatment option to people in China suffering the devastating effects of metastatic triple-negative breast cancer," said Yang Shi, Chief Medical Officer for Oncology at Everest Medicines. "We look forward to working closely with local regulatory bodies to bring this innovative treatment to patients in China as quickly as possible."

"This exciting milestone is one of many recent global clinical and regulatory advances that further enables us to accelerate the pace at which we work to bring this first-of-its-kind therapy to patients in need," said Kerry Blanchard, MD, PhD, CEO of Everest Medicines.

In October 2020, SG was included in the updated 2020 China Guidelines for the Standardized Diagnosis and Treatment of Advanced Breast Cancer, compiled by the Breast Cancer Expert Committee of the National Cancer Control Center, the Breast Cancer Professional Committee of the Chinese Anti-Cancer Association, and the Cancer Drug Clinical Research Professional Committee of the Chinese Anti-Cancer Association.

Under the trade name Trodelvy, the U.S. Food and Drug Administration (FDA) previously granted accelerated approval to SG in April 2020 and full approval to SG in April 2021 for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease.

About Triple-Negative Breast Cancer

Triple-negative breast cancer (TNBC) is a highly aggressive disease and accounts for approximately 15% of all breast cancer types worldwide. The median age of breast cancer diagnoses tends to be younger in Asian than western countries, and the percentage of the TNBC molecular subtype has been increasing in the past 10 years. TNBC cells lack sufficient estrogen, progesterone or HER2 receptor expression to benefit from the use of hormonal or HER2-directed therapy. Overall survival among patients with this form of breast cancer has not changed in the past 20 years, which highlights the need for advances in therapeutic options for these patients.

About Sacituzumab Govitecan-hziy

Sacituzumab govitecan-hziy (SG) is a first-in-class, antibody and topoisomerase inhibitor conjugate directed at TROP-2, a protein frequently expressed in multiple types of epithelial cancers. SG is approved in the United States under the trade name Trodelvy.

Under a licensing agreement with Gilead Sciences, Inc., Everest Medicines has exclusive rights to develop, register, and commercialize SG for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries.

The Ministry of Food and Drug Safety (MFDS) in South Korea has granted Fast Track Designation and Orphan Drug Designation (ODD) to SG for the treatment of metastatic TNBC. In addition, Everest announced in January 2021 that it submitted a New Drug Application (NDA) to the Health Sciences Authority (HSA) of Singapore for SG for the treatment of patients with metastatic TNBC who have received at least two prior therapies for metastatic disease. That application is currently under review.