On September 27, 2021 AnHeart Therapeutics Co., Ltd ("AnHeart"), a clinical-stage biopharmaceutical company committed to developing novel first-in-class or best-in-class precision oncology therapeutics, together with Innovent Biologics, Inc. ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, reported that interim clinical data from a Phase Ⅱ trial (TRUST) evaluating taletrectinib (AB-106), an investigational next-generation ROS1/NTRK inhibitor in ROS1-positive non-small cell lung cancer (NSCLC) (Press release, AnHeart Therapeutics, SEP 27, 2021, View Source [SID1234590324]). The data was announced as a keynote presentation at the Chinese Society of Clinical Oncology (CSCO) 2021 Annual Meeting on September 25-29, 2021.

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 scientific presentation entitled: "Taletrectinib (AB-106): Preliminary results from TRUST, Phase Ⅱ trial of a new generation of potent ROS1/NTRK inhibitors in ROS1-positive non-small cell lung cancer (NSCLC)," summarized preliminary data from an ongoing Phase Ⅱ trial of taletrectinib (NCT04395677).

As of June 16, 2021, 21 crizotinib treatment-naïve patients and 16 crizotinib pre-treated patients were confirmed to be ROS1 fusion-positive. The key results are as follows:

In the crizotinib treatment-naïve patient group (n=21), the confirmed objective response rate (ORR) was 90.5% (19/21) and the disease control rate (DCR) was 90.5% (19/21).
In the crizotinib pre-treated patient group (n=16), the confirmed ORR was 43.8% (7/16); and the DCR was 75.0% (12/16).
Among the crizotinib pre-treated patient group (n=16), ROS1 G2032R resistant mutations were identified in three patients and all three patients experienced tumor regression, 2 patients reported a partial response (PR), and 1 patient stable disease (SD).
In patients with assessable brain metastasis pre-enrollment, intracranial objective response rate (assessed by investigator) was 83.3% (5/6).
Taletrectinib was well-tolerated and treatment-related adverse events primarily included gastrointestinal adverse events and reversible aspartate aminotransferase (AST) and alanine aminotransferase (ALT) increased.
"We are pleased with the interim Phase Ⅱ data, which have shown taletrectinib to be safe and tolerable, a very promising novel therapy for patients with ROS1 fusion positive lung cancer," said Dr. Caicun Zhou, Director of the Department of Oncology, Shanghai Pulmonary Hospital. "Responses appear particularly impressive in crizotinib treatment-naïve patients, and while the number of crizotinib pre-treated patients is limited, so far, most patients continue to show benefit from the drug."

"Our team is focused on completing patient enrollment for our Phase Ⅱ TRUST trial," said Bing Yan, MD, Co-founder and Chief Medical Officer at AnHeart Therapeutics. "The interim data presented builds a strong foundation for our ongoing global pivotal taletrectinib clinical program. We sincerely thank the patients, their families and investigators in the TRUST trial and look forward to advancing development of taletrectinib for all ROS1 fusion positive patients with NSCLC, an area of significant unmet medical needs."

"We are glad to see the interim Phase Ⅱ data of taletrectinib presented at the CSCO meeting, one of the most authoritative clinical oncology conferences in China," said Dr. Hui Zhou, Senior Vice President of Innovent, "In China, ROS1-positive patients currently have limited treatment options. Novel therapies are urgently needed, and taletrectinib has good efficacy and safety results, which offers hope to patients with ROS1 fusion-positive NSCLC."

About Taletrectinib

Taletrectinib is an investigational next-generation tyrosine kinase inhibitor (TKI) designed to effectively target ROS1 and NTRK fusion mutations with potential to treat TKI-naïve or pre-treated patients. ROS1 rearrangement is estimated to be an oncogenic driver in approximately 2 to 3 percent of patients with advanced NSCLC, and NTRK rearrangement is estimated to be an oncogenic driver in approximately 0.5 percent of patients with other advanced solid tumors. More information about the ongoing TRUST (Taletrectinib ROS1 LUng STudy) trial and the basket trial in NTRK fusion positive solid tumors of taletrectinib may be found by searching clinical trial identifiers NCT04395677 and NCT04617054, respectively at View Source

On September 27, 2021 Sihuan Pharmaceutical Holdings Group Ltd., together with its subsidiaries and SignalChem Lifesciences Corporation reported that Sihuan Pharmaceutical Holdings Group Ltd subsidiary company Xuanzhu Biopharmaceutical Co., Ltd. ("Xuanzhu") and SignalChem Lifesciences Corporation ("SignalChem") have entered into an exclusive collaboration and licensing agreement for the clinical development and commercialization of SLC-391, a potent and selective AXL targeting inhibitor, in the Greater China region (Press release, Lifescience Newswire, SEP 27, 2021, View Source [SID1234590366]).

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!

Under the terms of the agreement, Xuanzhu will pay to SignalChem an upfront fee of thirteen million US dollars (US$13,000,000). Additional development milestones and royalties have also been committed. The exclusive rights for SLC-391 for the field of oncology is for the Greater China region (Mainland China, Hong Kong, Macau and Taiwan).

AXL is a member of TAM (Tyro3, AXL, Mer) family of receptor tyrosine kinases. AXL along with its ligand GAS6 (growth arrest-specific gene 6) is highly expressed and activated in many malignant tumors, such as acute myeloid leukemia, kidney, pancreatic, breast, lung and ovarian cancer, etc. As one of the crucial signaling pathways promoting tumor growth and metastasis, immune escape and drug resistance, GAS6-AXL pathway is considered to be an attractive target for cancer treatment and has attracted widespread attention.

"The agreement with SignalChem will further advance Xuanzhu’s pipeline in the solid tumor and hematoma space. The results from preclinical and phase 1 clinical development demonstrated SLC-391 superiority not only as SLC-391 has prominent single-agent activities in multiple solid and hematological tumors but also can potentially be administered with a variety of drugs under development at Xuanzhu. Both parties will use their respective resources to accelerate the clinical approval of SLC-391 in China," said Ms. Xu Yanjun, Chairman of Xuanzhu. "Xuanzhu will continue to expand its efforts to develop and commercialize innovative drugs in the oncology field."

"Xuanzhu Biopharmaceutical, a subsidiary of Sihuan Pharmaceutical, is a highly innovative and progressive company," commented by Mr. Jun Yan, the Chairman and President of SignalChem, "We are very pleased to establish a partnership with Xuanzhu. This licensing agreement is of great significance for SignalChem to further validate and expand SLC-391’s clinical superiority. This agreement will accelerate SLC-391’s development timeline to reach the market and provide more effective treatment alternatives for patients with cancer." Mr. Jun Yan added, "the size of the agreement, including upfront, milestone and royalties, with Xuanzhu may be one of the largest agreements signed in Canada with a Chinese bio-pharma company for the Chinese territory rights, and we are looking forward to reaching all anticipated objectives. Furthermore, SignalChem will continue its efforts to expand and accelerate clinical development with SLC-391 for wider indications in even more geographic territories."

About SLC-391

SLC-391 is a potent, highly selective and orally bioavailable small molecule AXL inhibitor. Preclinical investigational data shows SLC-391 is a superior AXL inhibitor and has the potential to become a first-in-class inhibitor. Phase I clinical study is currently underway in Canada. SignalChem has established a collaboration with Merck (MSD) to evaluate the efficacy of SLC-391 in combination with Keytruda (pembrolizumab) for the treatment of advanced non-small cell lung cancer (NSCLC). In pre-clinical studies, SLC-391 demonstrated strong efficacy as a single agent or in combination with other approved drugs in multiple animal models for cancer. SLC-391 will be developed to undisclosed cancer indications as a single agent or in combination with other therapies.

On September 27, 2021 Sarah Cannon reported that recently opened its newest drug development unit (DDU) in collaboration with Florida Cancer Specialists & Research Institute (FCS) and The University of Central Florida College of Medicine (UCF) in Lake Nona, Fla (Press release, Sarah Cannon Research Institute, SEP 27, 2021, View Source [SID1234590434]). The unit, located in the Sarah Cannon | UCF Lake Nona Cancer Center, is led by Cesar Augusto Perez, MD, a recognized expert in Phase 1 oncology research. The first of its kind in Lake Nona, the DDU focuses exclusively on oncology clinical trials at the earliest phases of research and was designed to meet the specialized needs of patients seeking advanced cancer treatment options. The first patient was treated on a clinical trial at the new unit earlier this month.

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!

"Lake Nona is known for building a community of collaborators, and by working together with our colleagues at FCS and UCF – we are proud to open a drug development program that is offering greater access to novel therapies that are essential to advancing science and transforming cancer care for patients," said Howard A. "Skip" Burris, III, MD, President of Clinical Operations and Chief Medical Officer, Sarah Cannon. "Dr. Perez has dedicated his career to translational oncology research and we are looking forward to his leadership over this new program."

Cesar Perez, MD most recently served as an Associate Professor of Medicine at the University of Miami where he also was one of the leaders for Phase 1 oncology clinical research. He was previously an Assistant Professor of Medicine at the University of Louisville, where he received the Best Faculty Teacher Award in 2015 and 2017. After completing a hematology and oncology fellowship at the University of Miami, Dr. Perez received the Peter A. Cassileth, MD Award as an outstanding fellow, and served as Chief Fellow.

"It is an honor to join Florida Cancer Specialists and lead Sarah Cannon’s newest drug development program in Lake Nona so that we can advance therapies for patients who vitally need them," said Dr. Perez. "By having our unit aligned to FCS’s medical oncology practice and located in UCF’s center focused on delivering cutting-edge offerings, we are offering a more comprehensive care experience."

As Director of Drug Development for Sarah Cannon Research Institute at FCS – Lake Nona, Dr. Perez works with a team that includes Sarah Canon and FCS research nurses, pharmacists, and patient support members that provide patients with access to the latest research and compassionate care without needing to travel far from home.

"Over the last two decades, FCS has partnered with Sarah Cannon to bring new treatment options to patients facing cancer throughout the state," said Lucio Gordan, MD, President & Managing Physician, Florida Cancer Specialists & Research Institute. "The DDU, which is co-located with one of our newest medical oncology practices, ensures patients can access specialized oncology care in a purposefully-designed space that brings together essential oncology services under one roof."

Located on the Sarah Cannon | UCF Lake Nona Cancer Center campus, the new 10,000 square-foot Sarah Cannon Research Institute at FCS drug development unit is a part of a new treatment facility, which combines medical oncology services and Phase 1 clinical trial options for cancer patients in one convenient location, 6400 Sanger Road, Suite A-2400, Orlando, Florida 32827. Radiation oncology will also be offered at this location later this year in collaboration with Sarah Cannon and HCA Healthcare’s UCF Lake Nona Medical Center. Additionally, departments for the UCF College of Medicine and HCA Healthcare Center for Clinical Advancement are located within the center.

"The UCF College of Medicine welcomes partnership with Sarah Cannon and FCS as new members of Lake Nona’s growing health and life sciences cluster," said Deborah German, MD, Founding Dean and VP for Health Affairs at the UCF College of Medicine. "By partnering with Sarah Cannon and FCS, we are able to make greater strides for people facing cancer from the bench to the bedside."

Currently, Sarah Cannon and FCS offer clinical trials through more than 36 locations in the state, including existing drug development programs in Sarasota and Lake Mary. All three units will work closely to increase early phase trial options for patients.

On September 27, 2021 Sorrento Therapeutics, Inc. (NASDAQ: SRNE, "Sorrento"), reported that it will participate in the Cantor Virtual Healthcare Conference (Press release, Sorrento Therapeutics, SEP 27, 2021, View Source [SID1234590296]).

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 Henry Ji, Chairman and CEO will be presenting on Wednesday September 29th at 9:20 AM EST.

Interested parties can access a link to the live webcast of the presentations from the Events & Presentations section of the Company’s website. The webcast replay may be accessed at the same location for 14 days following the live presentation.

On September 27, 2021 Bio-Thera Solutions, Ltd. (688177.SH, "Bio-Thera") and Intract Pharma ("Intract") reported a global collaboration and licensing agreement that gives Bio-Thera access to Intract’s Soteria and Phloral drug delivery technologies to develop novel oral monoclonal antibody (mAb) treatments for chronic gastrointestinal (GI) inflammatory diseases (Press release, BioThera Solutions, SEP 27, 2021, View Source [SID1234590325]). Bio-Thera is a global pharmaceutical company developing innovative therapeutics and biosimilars for oncology, autoimmune diseases, cardiovascular diseases, and other serious unmet medical needs.

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!

Under the terms of the agreement, Intract has granted Bio-Thera a worldwide license to Intract’s oral biologics drug delivery platform for a single undisclosed mAb product. Intract will receive an undisclosed upfront payment, with potential development and commercial milestone payments along with royalties on product sales. Intract will lead preclinical research of the product and Bio-Thera will have the option to expand development of the product for multiple GI indications and will be responsible for manufacturing and commercialization of any approved products.

Intract’s oral biologics delivery platform includes Soteria a technology which protects proteins such as mAbs from degradation in the intestinal lumen. The platform also includes Phloral, a clinically- validated technology that utilizes both pH and the enzymes produced by colonic bacteria as a trigger mechanism to allow accurate release of payloads in the colon, a suitable site in the GI tract for targeting of biologics for local and systemic delivery.

"Developing oral biologics is the next step in advancing compliance and access to innovative monoclonal antibodies for chronic diseases," said Dr. Shengfeng Li, CEO of Bio-Thera Solutions. "We believe that combining Bio-Thera’s antibody expertise with Intract’s oral delivery platform will lead to a great advance in the treatment of gastrointestinal disease."

"Intract Pharma is delighted to be partnering with Bio-Thera to address the significant challenge of delivering powerful biologics orally" said Dr Bill Lindsay, CEO of Intract. "We believe that our technologies will allow development of a more effective therapeutic for the treatment of IBD, while also increasing drug safety and reducing cost."