1stOncology™: Cancer Intelligence Service – Page 12091 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

bridgebio pharma expands reach into china and other major asian markets through strategic collaboration with perceptive advisors-founded company, lianbio

On August 11, 2020 BridgeBio Pharma, Inc. (NASDAQ: BBIO), a clinical-stage biopharmaceutical company focused on genetic diseases and cancers with clear genetic drivers, reported that it is partnering with Shanghai-based LianBio, a new company founded by Perceptive Advisors, to expand its global reach into China, the second-largest pharmaceutical market in the world (Press release, BridgeBio, AUG 11, 2020, View Source [SID1234576225]). The partnership marks the first major expansion of BridgeBio’s pipeline into Asian markets.

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!

This strategic relationship will initially focus on two of BridgeBio’s targeted oncology drug candidates, FGFR inhibitor infigratinib, currently in Phase 3 development for FGFR-driven tumors and Phase 1-ready SHP2 inhibitor BBP-398, for tumors driven by RAS and receptor tyrosine kinase mutations. The agreement also provides LianBio with preferential future access in the territory to more than 20 drug development candidates currently owned or controlled by BridgeBio. This collaboration is designed to advance and accelerate BridgeBio’s programs in China and other major Asian markets, allowing BridgeBio to quickly bring innovation to large numbers of patients with high unmet need.

"Tremendous patient need and a fast-developing healthcare infrastructure make China a strategic priority. We are eager to not only expand late-stage therapies to the broader patient population there, but also to accelerate our clinical development efforts in Asia and better understand and address the needs of patients there – early. We are grateful to be deepening our relationship with Perceptive Advisors through this agreement with LianBio and look forward to a lasting partnership focused on expanding our reach to patients," said BridgeBio CEO and founder Neil Kumar, Ph.D.

"We value our relationship with BridgeBio and are happy to be enabling the entry of important programs to LianBio’s territories," said Adam Stone, CIO of Perceptive Advisors. "BridgeBio and its affiliate companies exemplify the commitment to science-driven, precision medicine that we believe is a key driver to innovation in healthcare. We are excited about this opportunity to leverage their promising pipeline and LianBio’s local expertise to accelerate both global development and local access to leading edge therapeutics."

Under the terms of the agreements, LianBio will receive commercial rights in China and selected Asian markets and participate in clinical development activities for infigratinib (housed in BridgeBio affiliate QED) and BBP-398 (housed in BridgeBio affiliate Navire). BridgeBio’s near-term economics includes a total of $26.5 million in upfront and milestone payments. BridgeBio will receive up to $505 million in future milestone payments, tiered royalty payments from single- to double-digits on net sales of both products in licensed territories. Additionally, BridgeBio will increase its equity interest via investment in LianBio and BridgeBio CEO Neil Kumar has been appointed to the LianBio board of directors.

LianBio is participating in the ongoing Phase 3 study of infigratinib in first line cholangiocarcinoma (PROOF) in mainland China and further plans to initiate a Phase 2a study of infigratinib in gastric cancer and other FGFR-driven tumors. Additionally, LianBio will contribute to clinical development of BBP-398 in combination with various agents in solid tumors such as non-small cell lung cancer (NSCLC), colorectal and pancreatic cancer, in mainland China and other major Asian markets.

Northwest Biotherapeutics Announces $8 Million Financing: Financing On Favorable Terms; Further Broadening of Warrant Lock-Up

On August 11, 2020 Northwest Biotherapeutics (OTCQB: NWBO)("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, reported that the Company has completed a financing on favorable terms for approximately $8 million (Press release, Northwest Biotherapeutics, AUG 11, 2020, View Source [SID1234569918]). The Company anticipates that this financing will help maintain the Company’s momentum, and will provide some prudent protection in the midst of the current global economic uncertainties. The financing also further broadens the lock-up of warrants that the Company has been building.

The financing comprised:

Approximately $7 million from an offering at 32 cents per share of newly registered common stock of approximately 21.8 million shares with warrants averaging 21% (predominantly 20%, with a couple larger investors at 35%) exercisable at 34 cents per share for approximately 5.3 million shares, with an exercise period ranging from 18 to 30 months, and
$1 Million from a convertible note (the "Note") which is convertible at 34.5 cents. The Note contains no warrants unless it is converted. If, and only to the extent the Note is converted, it will carry 35% warrants exercisable at 34 cents per share.
The financing also broadened the warrant suspensions that the Company has been building and the Company plans to continue expanding:

An additional approximately 75.5 million existing warrants, outstanding prior to this financing and held by investors in this financing, have been suspended until December 15, 2020 as part of this financing. These warrant suspensions were compensated on a similar basis as the warrant suspensions previously reported. In addition, all new warrants in this financing are suspended until December 15, 2020.
As the Company approaches the read-out of its Phase III trial of DCVax-L for Glioblastoma brain cancer, the Company is working with a growing team of technical experts and regulatory advisers on various readiness preparations, including manufacturing related preparations. This financing will help the Company maintain its momentum in these very important activities.

"With this significant financing, we believe we are well positioned to execute on our near-term plans and to support the next critical phase of our business strategy," commented Linda Powers, Chairman and CEO of the Company. "We look forward to sharing more detail on these initiatives."

The majority of this financing involved no fees or placement expenses. On the remainder of the financing, the Company paid fees of 6% cash and 4% warrants.

Tiziana Life Sciences to Present at BTIG’s Virtual Biotechnology Conference

On August 11, 2020 Tiziana Life Sciences plc (Nasdaq: TLSA / AIM: TILS) ("Tiziana" or the "Company"), a clinical stage biotechnology company developing targeted drugs for cancer, inflammatory diseases and COVID-19, reported that members of its management team will participate virtually in the BTIG Biotechnology Conference on Tuesday, August 11, 2020 at 2:30 p.m. EDT (Press release, Tiziana Life Sciences, AUG 11, 2020, View Source [SID1234568594]).

To access a live webcast of the fireside chat please register for the BTIG Biotechnology Conference, using the link here. The investor presentation can be found on the Tiziana website, here. A replay of the webcast will be archived on Tiziana’s website for approximately 45 days following the presentation.

Leica Biosystems Unveils its Aperio GT 450 DX Digital Pathology Scanner and Delivers Excellence to Leeds Teaching Hospitals NHS Trust, UK

On August 11, 2020 Leica Biosystems, a global leader in pathology workflow solutions, reported the European launch of its Aperio GT 450 DX digital pathology scanner (Press release, kreatech, AUG 11, 2020, View Source [SID1234563692]). This next generation imaging system was unveiled at the highly successful Leica Biosystems Digital Pathology Virtual Summit and is already installed at the Centre of Excellence at Leeds Teaching Hospitals NHS Trust NHS, UK.

During the summit, nearly 3,000 virtual attendees joined thought leaders from around the globe to hear about the latest topics and advances in digital pathology. The featured attraction: the Aperio GT 450 DX Scanner. Combining patented real-time focusing with custom-designed Leica objectives, it delivers excellent image quality and rapid scanning. This breakthrough technology enables laboratories to scale up digital pathology for high-throughput, routine diagnostics.

Dr. Darren Treanor, Consultant Pathologist, Leeds Teaching Hospitals NHS Trust, UK and Director of Northern Pathology Imaging Co-operative (NPIC), was a presenter at the summit, discussing Digital Pathology and Artificial Intelligence in the NHS, and also spearheads digital pathology in NPIC, Leeds, who are the recipient of the first Aperio GT 450 DX Scanner in Europe.

"Our goal with the Aperio GT 450 DX System is to have a platform for high quality, standardised, 100% scanning for NPIC across 6 hospitals linked by a central PACS system," stated Dr. Treanor. "Digital Pathology will lead in the application of Artificial Intelligence (AI) in healthcare, improving the quality and speed of pathology services for patients globally. The NHS is an ideal environment for the development of AI – the NPIC vision is to be at the forefront of digital pathology and AI adoption, while maintaining strong foundations in routine clinical practice."

"Artificial intelligence and digital pathology for clinical diagnosis have long been an integral part of our strategic roadmap," said Colin White, Global Vice President, Advanced Staining and Imaging at Leica Biosystems. "The practice of pathology will be transformed with the integration of whole slide images, advanced algorithms, and big data integrated into the PACS. We are excited that the Aperio GT 450 DX delivers the technology that will allow healthcare professionals to realize their long-term vision, while providing immediate benefits in primary diagnosis such as improved throughput, reduced turnaround times and high-quality images."

Leica Biosystems Virtual Digital Pathology Summit – On-Demand Presentations:
Leeds Teaching Hospital presentations (in the auditorium): Chloe Knowles will discuss Laboratory quality assurance and ISO accreditation for DP, Bethany Williams will touch upon Maintaining Lab and Clinical Quality With Digital Diagnosis and Darren Treanor will exchange ideas on digital pathology and artificial intelligence in the NHS. Fourteen additional On-Demand digital pathology presentations are available.

The clinical use claims described for the products in the information supplied have not been cleared or approved by the U.S. FDA or are not available in the United States.

COMBAT STUDY PRELIMINARY RESULTS SHOW RESPONSE OF 32% IN TREATMENT OF PANCREATIC TUMORS

On August 11, 2020 Working with an international team of researchers, HonorHealth Research Institute and the Translational Genomics Research Institute (TGen), an affiliate of City of Hope,reported that were instrumental in one of the first clinical trials showing how pancreatic cancer patients can benefit from immunotherapy, according to a four-year study published in a premier scientific journal, Nature Medicine (Press release, TGen, AUG 11, 2020, View Source [SID1234563691]).

The "COMBAT trial" (NCT02826486) is a prospective, open label, phase IIa clinical trial for patients with metastatic pancreatic cancer, meaning their cancer had spread to other parts of the body. Patients were given pembrolizumab, an immune therapy drug, in combination with BL-8040, an agent that makes the tumor microenvironment more receptive to immune therapy.

The study was conducted in Arizona at the HonorHealth Research Institute and at 30 other locations in the U.S. and across the globe, including Spain, Israel and South Korea.

The two-part clinical trial began in September 2016:

Cohort 1, a group of 37 patients whose cancer had already progressed on other therapies, were treated with pembrolizumab and BL-8040. Importantly, it appeared this combination therapy made pancreatic cancer more "hot," meaning it could work in tandem with the body’s own immune system. Previous studies have shown pancreatic tumors to be "cold," meaning immune therapies like pembrolizumab were not able to act on the cancer.
Preliminary results of Cohort 2 were reported in the manuscript on a group of 22 patients (out of approximately 40 patients in total expected in the cohort), who had previously received one line of chemotherapy. These patients received pembrolizumab and BL-8040, as well as chemotherapy drugs 5-fluorouracil and nano-liposomal irinotecan.
"The percentage of meaningful tumor shrinkage was 32% in Cohort 2, which is double what is available for individuals with pancreatic cancer with traditional chemotherapy. While the study is small, these preliminary results are encouraging and there is hope that we will be able to do larger trials to see if the response to therapy is high and if it is better in comparison to traditional treatment," said Erkut Borazanci, M.D., M.S., a medical oncologist and physician-investigator at HonorHealth Research Institute, a clinical associate professor at TGen, and one of the paper’s authors.

This clinical trial is currently in a follow-up phase of the study.

Pancreatic cancer is an aggressive disease that carries a high mortality rate. It is the third-leading cause of cancer death in the U.S., following lung and colorectal cancers. In 2020, the five-year survival rate for pancreatic cancer is 10%, which has increased from 6% in 2014.

Next steps for this research would be to compare this COMBAT combination therapy in future studies to other treatment options, such 5-fluorouracil, leucovorin and nano-liposomal irinotecan.

COMBAT derives its name from letters in one of the study’s descriptions: Combination of BL-8040 and Pembrolizumab in Patients with Metastatic Pancreatic Cancer.

The COMBAT treatment continues at the HonorHealth Research Institute. For more information, please go to HonorHealth.com/research, call 480-323-1339 or email [email protected].

This research is supported by BioLineRx Ltd.

The study – BL-8040, a CXCR4 antagonist, in combination with pembrolizumab and chemotherapy for pancreatic cancer: the COMBAT trial – was published May 25, 2020, in Nature Medicine.