On June 2, 2021 Naveris reported that A new clinically-validated saliva test has been shown to detect HPV-associated head and neck cancer with high accuracy, a first-of-its-kind study result (Press release, Naveris, JUN 2, 2021, View Source [SID1234583411]).

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!

Researchers at Washington University School of Medicine in St. Louis used the Naveris, Inc. test to analyze saliva for sequences of the human papilloma virus (HPV) genome that are specific for HPV DNA released from malignant tumors. The test successfully distinguishes this tumor-tissue modified virus from non-cancerous sources of HPV DNA and precisely measures the number of tumor-tissue modified viral HPV (TTMV-HPV) DNA strands present in a saliva sample.

The study results point to the potential for a significant improvement in early detection of the most common type of head and neck cancer, HPV-associated oropharyngeal squamous cell carcinoma.

"Naveris’ patient-friendly saliva test has the potential to radically advance early detection of HPV-positive head and neck cancer, which has been growing rapidly among men in the United States. Early detection of these cancers would make a dramatic difference in patient outcomes," said Piyush Gupta, PhD, CEO of Naveris.

The study quantified participants’ tumor-tissue modified viral HPV DNA in saliva samples and compared it to the levels found in their blood by utilizing Naveris’ NavDx test. The results showed that TTMV-HPV DNA was commonly found in the saliva of HPV-associated head and neck cancer patients (44/46 cases), and at 18 times higher levels in the saliva samples than in the blood samples. One sample had undetectable TTMV-HPV and one was indeterminate for HPV DNA.

Washington University researchers are presenting an abstract of the study at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 annual meeting.

"The results of our study highlight the potential of accurately analyzing saliva to improve the early detection of HPV-associated oropharyngeal squamous cell carcinoma. If validated in larger studies, this test could lead to earlier diagnosis and treatment," said the study’s principal investigator Jose P. Zevallos, MD, chief of the division of Head and Neck Surgery in the Department of Otolaryngology at Washington University School of Medicine.

Naveris’ new saliva test is based upon the proprietary technology employed by the NavDx blood test that is in use at centers of excellence treating HPV-associated oropharyngeal cancer across the United States. NavDx is a liquid biopsy test that detects HPV-associated head and neck cancer earlier than is possible with imaging and is provided exclusively in the United States through the Naveris national reference CAP-accredited laboratory.

About Oropharyngeal Cancer:

Oropharyngeal cancer, which can develop at the base of the tongue, tonsils, and the middle part of the throat, used to be closely associated with smoking and heavy drinking. Today, however, oropharyngeal cancer is primarily caused by human papillomavirus (HPV) infection, the most common sexually transmitted virus and infection in the United States. More than one of five U.S. adults are infected with a high-risk strain of HPV that can potentially develop into cancer.1

Cases of HPV-positive oropharyngeal cancer have been increasing at an exponential rate among men in the United States over the last two decades2. About 54,000 cases of oropharyngeal and oral cavity cancer are expected in the nation this year and more than 10,000 deaths.3

Oropharyngeal cancers usually are not identified early because they grow slowly in locations that are not easy to see. By the time the cancers are recognized they frequently have spread to the lymph nodes and are difficult to treat. Early detection, however, enables highly effective treatment.

On June 2, 2021 Porton Biologics Ltd. (hereinafter referred to as Portonbio) reported a strategic cooperation with Nanjing KAEDI Biotech, Inc. (hereinafter referred to as KAEDI). Portonbio will offer CMC services for KAEDI’s CAR-T cell therapies with its end-to-end CDMO platform for gene and cell therapies to help accelerate their development process (Press release, Porton Biopharma, JUN 2, 2021, View Source [SID1234583427]).

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!

According to the agreement, Portonbio, as an exclusive CDMO partner, will provide KAEDI with CMC services for multiple CAR-T projects, including the process development and manufacturing of plasmids, viral vectors and CAR-T cells and IND filling (CMC part) support services. The indication of the first project of our collaboration, KD-025 CAR-T, is liver cancer and glioma. The results of its preclinical research have been published in the leading international journal of tumor immunotherapy and ASCO (Free ASCO Whitepaper) (American Society of Clinical Oncology). At present, a multi-center clinical trial of KD-025 CAR-T POC is being carried out and a number of cases of clinical infusion have been completed with no obvious toxicities and side effects being observed. At the same time, the product is being applied for IND at home and abroad.

Dr. Hongjiu Dai, Chairman and CEO of KAEDI, said: "We are very pleased to have a strategic cooperation with Portonbio. KAEDI has successfully developed a pipeline of several CAR-T new drug candidates for malignant solid tumors. We believe that Portonbio’s excellent technical team and professional CDMO platform can help KAEDI quickly and efficiently promote the drug candidates in our pipeline and accelerate the development process of our cell therapy drugs."

"We are very honored to contribute to KAEDI’s innovative research in the field of cell therapy", said Mr. Nianfeng Ju, Chairman and CEO of Portonbio, "Portonbio has established an integrated CDMO service platform for plasmids, viral vectors and cell therapy products, and has an experienced expert team and unique technical advantages. We hope to accelerate the marketing process of KAEDI CAR-T products through this cooperation, jointly promote the breakthrough of cell therapy products in the field of solid tumor, and enable the patients’ early-access to the therapies."

On June 2, 2021 Cytokinetics, Incorporated (Nasdaq: CYTK) reported that Robert I. Blum, President and Chief Executive Officer, is scheduled to participate in three virtual fireside chats at the following investor conferences (Press release, Cytokinetics, JUN 2, 2021, View Source [SID1234583461]):

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!

42nd Annual Goldman Sachs Healthcare Conference on Wednesday, June 9, 2021 at 3:00 PM EDT
JMP Securities Life Sciences Conference on Wednesday, June 16, 2021 at 4:00 PM EDT
Raymond James Human Health Innovation Conference on Monday, June 21, 2021 at 2:00 PM EDT
Interested parties may access the live webcasts of each presentation by visiting the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The replay of each presentation will be archived on the Presentations page within the Investors & Media section of Cytokinetics’ website for 90 days following the conclusion of the event.

On June 2, 2021 Lyra Therapeutics, Inc. (Nasdaq: LYRA), a clinical-stage therapeutics company leveraging its proprietary XTreo platform to enable precise, sustained, and local delivery of medications to ear, nose and throat (ENT) passages and other diseased tissues, and LianBio, a biotechnology company dedicated to bringing paradigm-shifting medicines to patients in China and other major Asian markets, reported a strategic partnership and exclusive license agreement for the development and commercialization of LYR-210 in Greater China (mainland China, Hong Kong, Taiwan, and Macau), South Korea, Singapore and Thailand (Press release, LianBio, JUN 2, 2021, View Source [SID1234583510]). LYR-210 is an anti-inflammatory, intra-nasal drug matrix in late-stage development that is designed to treat chronic rhinosinusitis (CRS), a debilitating inflammatory disease of the nasal passages.

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, Lyra will receive an upfront payment of $12 million and is eligible to receive up to $135 million in future payments based upon the achievement of specified development, regulatory and commercialization milestones. Upon commercialization on a region-by-region basis, Lyra also will be entitled to receive low double-digit royalties based on net sales of LYR-210 in the licensed territories. LianBio will be responsible for the clinical development and commercialization of LYR-210 in the licensed territories, and Lyra will retain all rights to LYR-210 in all other geographies. As part of the agreement, LianBio will also have the first right to obtain development and commercial rights in the licensed territories to Lyra’s LYR-220, an anti-inflammatory, intra-nasal, drug matrix in development for the treatment of CRS patients who have undergone a prior sinus surgery but continue to have persistent disease.

"We are delighted to enter into this strategic alliance with LianBio to expand the global reach of LYR-210 for millions of CRS patients who need new and innovative treatment alternatives to surgery," said Maria Palasis, Ph.D., CEO of Lyra. "The LianBio team has deep expertise in drug development and is well positioned to successfully commercialize LYR-210 in these Asian territories. The introduction of our novel, integrated ENT drug and delivery solution to the large patient populations in Asian markets supports our planned global commercialization strategy."

"CRS patients who have failed medical management are currently left with limited and invasive options to manage their disease," said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. "In clinical studies conducted to date, LYR-210 has demonstrated six months of clinically meaningful symptom improvement following a single administration in patients with and without polyps. With an estimated 88 million adult CRS patients in China alone, we believe LYR-210 has the potential to address a significant unmet medical need and meaningfully improve the standard of care for patients in Asia."

About LYR-210

LYR-210 is an investigational product candidate that utilizes Lyra’s proprietary XTreo platform to enable six months of local anti-inflammatory therapy from a single treatment for chronic rhinosinusitis (CRS). LYR-210 is designed as a non-invasive alternative to sinus surgery for the millions of CRS patients who have failed medical management. In the LANTERN Phase 2 clinical trial, LYR-210 (7500mcg) demonstrated rapid, clinically meaningful and durable symptom improvement in symptom scores over six months.

On June 2, 2021 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported that it has completed the acquisition of ACEA Therapeutics Inc. ("ACEA") (Press release, Sorrento Therapeutics, JUN 2, 2021, View Source [SID1234583395]).

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 merger was completed on June 1, 2021 and at such time, ACEA became a wholly owned subsidiary of Sorrento. The total value of the consideration payable to the holders of securities of ACEA in the merger was $38,000,000, subject to certain adjustments for interest expenses, indebtedness, transaction expenses and cash. In total, 5,519,469 shares of Sorrento common stock were issued at closing in satisfaction of certain outstanding indebtedness of ACEA. In addition to the foregoing consideration, and subject to the achievement of certain clinical and sales milestones (as described below), Sorrento will pay the ACEA equity holders (i) up to $450,000,000 in additional payments, subject to the receipt of certain regulatory approvals and achievement of certain net sales targets with respect to the assets acquired in the merger and (ii) with respect to specified royalty-bearing products, five to ten percent of the annual net sales thereof, in each case in accordance with the terms of an earn-out agreement. The amount referenced in clause (i) of the preceding sentence includes the amounts that would have otherwise been due to ACEA under that certain License Agreement, dated July 13, 2020, which agreement terminated in its entirety at the effective time of the merger.

"This is a value-inflection acquisition for Sorrento as we bring in multiple NCE drug product candidates, including the previously licensed Abivertinib as an anchoring small molecule drug product for treating many different cancers and autoimmune diseases," said Henry Ji, Ph.D., Chairman and Chief Executive Officer of Sorrento. "With broad-spectrum and synergistic infrastructures and expertise in pharmaceutical and biological drug discovery, development and manufacturing, and expanded geographic coverage in China and North America, we envision Sorrento becoming a leading biopharmaceutical company to develop and commercialize innovative medicines that will save and improve lives globally."

"With perfectly aligned missions, ACEA and Sorrento are both committed to developing innovative drugs and providing therapeutic solutions for unmet medical needs. The successful integration of ACEA small molecule drug pipelines to Sorrento large molecule and cell therapy platforms will significantly strengthen and facilitate the innovative drug development in the field of cancer and autoimmune diseases," said Xiao Xu, M.D, President of ACEA Therapeutics.