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Bristol Myers Squibb and ConcertAI Advance Novel Oncology Accelerated Digital Clinical Trial Solution

On September 29, 2022 ConcertAI, LLC (ConcertAI) reported the launch of its new Digital Trial Software-as-a-Service solution (Press release, Bristol-Myers Squibb, SEP 29, 2022, View Source [SID1234621760]). Powered by ConcertAI’s deep and broad real-world data, IT infrastructure, digital technology and a broad network of leading research sites, Digital Trial Solution integrates clinical research and clinical practice seeking to simplify patient identification, consent, IRB approval and contract negotiations . This offering seeks to ultimately reduce or eliminate duplicative data entry and constant data monitoring so clinical research staff can focus their resources on patient care.

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"As an industry leader in discovering, developing and delivering medicines to help patients prevail over serious diseases, we are employing digital innovation to redesign and redefine how pre- and post-approval studies are conducted and, together with ConcertAI, we are fundamentally changing the way we do clinical research from study design, through enrollment and execution," said Venkat Sethuraman, senior vice president, Global Biometrics and Data Sciences, Bristol Myers Squibb. "The Digital Trial Solution will allow us to accelerate access to innovative, lifesaving cancer medicines to patients. And we anticipate this approach will become BMS’ gold standard for oncology studies in the future."

The Digital Trial Solution helps researchers rethink the who, what, where and how to design trials, recruitment criteria and data collection standards needed to launch trials that take less time to execute, cost less and are more diverse across patients and sites. The Digital Trial Solution is advancing us towards the industry goal of digital-only trials and clinical studies that are more directly generalizable to the community settings where most patients receive their care.

"Traditional methods are failing trial sponsors, cancer patients and their providers, and the lack of adequate technologies to implement more effective and efficient digital clinical development solutions has been painfully exposed during the COVID-19 pandemic," said Jeff Elton, PhD, chief executive officer, ConcertAI. "Our mission is to build the most advanced technologies and AI solutions for the future of digital oncology clinical development to meet and exceed the regulatory appetite for diversity and digital enablement."

ConcertAI is developing the first digital research solutions and clinical trials network that will make it easier for providers to screen patients for trials and gather the necessary clinical data to execute a study once the patient has enrolled. This modular set of technology re-envisions how clinical research can be entirely integral to healthcare provider workflows, while enabling an end-to-end digital solution for the biopharma sponsor that delivers enormous benefits in accuracy, reliability, time and cost when executing a clinical trial. SaaS tools and real-world data provide the differential performance benefit for study sponsors, research clinics and, most importantly, community-based patients.

"We are extremely proud to have worked with ConcertAI for the past two years to help them shape this highly innovative digital solution," said Marisa Co, vice president, R&D Business Insights & Analytics, Bristol Myers Squibb. "Achieving our first participant enrolled through the Digitally Accelerated Clinical Trial (DACT) model has been a tremendous cross-functional effort and demonstrates BMS’ commitment to use data and technology to simplify and accelerate the clinical research process."

The Digital Trial Solutions use digitalization technologies that reduce the time, complexity and burden of finding participants and conducting trials. The solution is designed for healthcare practices by integrating directly into the practices’ clinical workflows including electronic medical records, imaging and lab systems, assisting them with more efficient ways to identify patients that may be candidates for clinical trials, which research sites benefit from through a set of integrated applications that makes patient screening easier. The solution can also help reduce errors-over manual entry of trial data. This benefits the healthcare community through broader clinical trial access to patients. ConcertAI’s first deployments are underway with a schedule of network expansions over the coming months creating the largest digitally enabled oncology, hematology and urology research capacity in the industry.

Provectus Biopharmaceuticals Establishes Research Collaboration with University of Texas Medical Branch at Galveston to Investigate Pharmaceutical-Grade Small Molecule Immunotherapy Rose Bengal for Wound Healing

On September 29, 2022 Provectus (OTCQB: PVCT) reported that the Company has initiated a new sponsored research program with Amina El Ayadi, PhD, Assistant Professor, Surgical Sciences Division and Jayson Jay, PhD, Postdoctoral Research Fellow and Jeane B. Kempner Scholar of the Burn, Trauma, and Critical Care Research Laboratory in the Department of Surgery at the University of Texas Medical Branch at Galveston (UTMB) to characterize the effects of Provectus’ proprietary pharmaceutical-grade rose bengal sodium (RBS) on full-thickness cutaneous wounds and during the subsequent phases of wound healing (Press release, Provectus Biopharmaceuticals, SEP 29, 2022, View Source [SID1234621586]). RBS is the lead member of a class of small molecules called halogenated xanthenes that is entirely owned by Provectus.

Starting from the Texas City Disaster of 1947, the deadliest industrial accident in U.S. history and one of history’s largest non-nuclear explosions, UTMB clinicians and researchers in the Department of Surgery have developed treatments that improve the survival chances of patients with massive burns, reduce scar formation, and accelerate patient recovery. Many novel treatments discovered by UTMB researchers have been adopted by specialist burn centers around the world. The Department of Surgery’s Burn, Trauma, and Critical Care Research Laboratory is equipped with an array of cutting-edge equipment and technologies that support its research activities, including a dedicated cell culture suite, confocal microscope, flow cytometer, Comprehensive Lab Animal Monitoring System (CLAMS), and bioprinter for 3D cell culture.

Drs. El Ayadi and Jay plan to examine the safety of topically-applied, multi-dosed RBS over the wound healing periods of inflammation and cellular proliferation, determine the efficacy of RBS in a pre-clinical model of wound healing, and elucidate a spatiotemporal immune activation signature over wound healing time in a large animal model of burn and full-thickness cutaneous trauma.

YS BIOPHARMA TO MERGE WITH NASDAQ-LISTED SUMMIT HEALTHCARE ACQUISITION CORP.

On September 29, 2022 YishengBio Co., Ltd. (to be renamed as YS Biopharma Co., Ltd., and herein referred to as "YS Biopharma" or the "Company"), a global biopharmaceutical company dedicated to discovering, developing, manufacturing and commercializing new generations of vaccines and therapeutic biologics for infectious diseases and cancer, and Summit Healthcare Acquisition Corp. (Nasdaq: SMIH) ("Summit"), a publicly traded special purpose acquisition company, reported that they have entered into a definitive agreement for a business combination of Summit and the Company (the "Transaction") (Press release, Yisheng Biopharma, SEP 29, 2022, View Source [SID1234621582]). Upon closing of the Transaction, the combined company will be renamed as YS Biopharma Co., Ltd. and become a publicly traded company on the Nasdaq.

YS Biopharma’s YSJATM rabies vaccine is one of the leading products in the human use rabies vaccine market in China with a total product sales of approximately RMB503 million in the fiscal year ended March 31, 2022. Supported by strong sales & marketing infrastructure, over 90 million doses of YSJATM rabies vaccine have been administered with excellent protection efficacy and safety for post-exposure protection against rabies.

YS Biopharma has also developed a broad pipeline powered by its proprietary PIKA immunomodulating technology platform, including four clinical stage candidates, targeting a wide range of clinical indications with significant market potential, such as rabies, COVID-19, hepatitis B, cancer, shingles and influenza.

Over the years, YS Biopharma has made significant advancements in commercialization expertise and manufacturing infrastructure. It has completed the construction of three state-of-art manufacturing plants for YSJATM rabies vaccine, PIKA adjuvanted rabies vaccine and PIKA adjuvanted recombinant COVID-19 vaccine.

Upon closing of the Transaction, YS Biopharma will continue to be led by Mr. Yi Zhang, its founder and chairman, Dr. Hui Shao, its president and chief executive officer, and the current management team. YS Biopharma has over 800 employees with business operations in China, Singapore, the United States, the United Arab Emirates and the Philippines.

Mr. Yi Zhang, the founder and chairman of YS Biopharma, commented, "YS Biopharma has always been the trailblazer and at the forefront in developing new technology and products for vaccine and immunological therapeutics. This transaction will fuel our strategy for future business expansion and execution and allow shareholders to participate in significant upside potential created by the partnership with Summit."

Dr. Hui Shao, the president and the chief executive officer of YS Biopharma, stated, "Today’s announcement on strategic combination between YS Biopharma and Summit represents a major milestone in our journey to become a global leader in transformative vaccine and therapeutic biologics arena. We anticipate the closing of the business and financial transactions will further accelerate the commercialization endeavor of our promising pipeline in many countries and create shareholder values for both YS Biopharma and Summit."

Mr. Bo Tan, the chief executive officer, co-chief investment officer and director of Summit, stated, "Summit is missioned to identify high-quality growth companies in global healthcare industry. YS Biopharma is clearly a differentiated vaccine platform with growing revenue and robust pipelines. With sponsor’s firm commitment, support from our shareholders and Forward Purchase Investors and further enhanced by a bonus share structure in the transaction, we believe YS Biopharma will be well positioned to achieve the next series of milestones and the business combination will create meaningful value for our shareholders."

YS Biopharma Investment Highlights

A global commercialization-stage biopharmaceutical company focusing on innovative vaccines and therapeutic biologics with over 800 employees and business operations in China, Singapore, the United States, the United Arab Emirates and the Philippines
A leading human use rabies vaccine manufacturing company in China, with approximately RMB503 million product sales in the fiscal year ended March 31, 2022, over 1,700 local Centers for Disease Control and Prevention sales coverage, as well as over 90 million doses administered with excellent safety and efficacy profile for post-exposure protection against rabies
An in-house developed and proprietary PIKA immunomodulating technology platform in immunological and therapeutic innovation, having established strong intellectual franchise evidenced by over 70 patents granted by over 30 jurisdictions covering both technology and product innovations
PIKA adjuvanted rabies vaccine candidate is expected to enter into a multi-center Phase III clinical trials in Singapore, the Philippines, Vietnam and Pakistan in the fourth quarter of 2022, with the potential to become "best in class," and cited as a novel vaccine with dose reduction and accelerated regimen by the Background Paper of World Health Organization (WHO)
PIKA recombinant COVID-19 vaccine in Phase II/III clinical development in the United Arab Emirates, the Philippines and Pakistan with potentially differentiated immunological profile as compared to mRNA-based vaccines, including two-year sustainable immune response, cellular immuno response, broad neutralization against all the prevalent COVID-19 virus mutants such as Omicron variants, and additional therapeutic treatment benefits
Established track record, technical expertise and infrastructure in mass production of vaccine and biologics, providing strong execution support in clinical development and commercialization objectives
Transaction Overview

The pre-money equity value of YS Biopharma in the proposed Transaction is approximately $834 million. YS Biopharma shareholders will become the majority owners immediately after the closing of the Transaction. The business combination is expected to provide up to approximately $230 million in gross proceeds to YS Biopharma, including $30 million from Forward Purchase Investors and up to approximately $200 million currently held in Summit’s trust account, assuming no redemption from Summit’s existing public shareholders. Proceeds from the Transaction will allow YS Biopharma to fund its ongoing and planned clinical trials, future commercial launch of PIKA adjuvanted rabies vaccine, the construction of new GMP-compliant manufacturing plants as well as developing other product candidates.

Each of the board of directors of YS Biopharma and Summit has unanimously approved the proposed Transaction. The shareholders of YS Biopharma have also approved the proposed Transaction at its extraordinary general shareholders meeting. Completion of the proposed Transaction is still subject to the approval of Summit’s shareholders and certain other customary closing conditions, including, among others, a registration statement on Form F-4 (the "Registration Statement"), of which the proxy statement/prospectus forms a part, being declared eﬀective by the U.S. Securities and Exchange Commission (the "SEC"), and the approval by the Nasdaq Stock Market LLC on the listing application of the combined company. The Transaction is targeted to be completed in the first quarter of 2023.

Additional information about the proposed Transaction, including copies of the business combination agreement and related agreements, will be provided in a Current Report on Form 8-K to be filed by Summit with the SEC and available at www.sec.gov. YS Biopharma intends to file the Registration Statement, which will contain a proxy statement and a prospectus, with the SEC in connection with the Transaction.

Advisors

Wilson Sonsini Goodrich & Rosati, Jingtian & Gongcheng and Maples and Calder (Hong Kong) LLP are serving as legal advisors to YS Biopharma in connection with the Transaction.

Cooley LLP and Ogier are serving as legal advisors to Summit in connection with the Transaction.

Investor Presentation

An investor presentation with more detailed information regarding the proposed Transaction will be filed by Summit as an exhibit to a Current Report on Form 8-K, which can be viewed on the SEC’s website at www.sec.gov.

Kintor Pharma Announces Publication of Phase Ib Data from Pruxelutamide for AR+ mBC in EJC

On September 29, 2022 Kintor Pharmaceutical Limited ("Kintor Pharma", HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecules and biological therapeutics, reported that the results from a phase Ib study of pruxelutamide (used to be called proxalutamide, GT0918) for the treatment of patients with androgen receptor positive (AR+) metastatic breast cancer (AR+ mBC) in China have been published in the international journal, European Journal of Cancer (2021 Impact Factor: 10.002, EJC) on September 28, 2022, further demonstrating the efficacy and safety of pruxelutamide in patients with AR+ mBC (Press release, Suzhou Kintor Pharmaceuticals, SEP 29, 2022, View Source [SID1234621572]).

Highlights

Pruxelutamide showed promising activity in heavily pretreated AR+ mBC patients.
Pruxelutamide showed an acceptable safety profile in heavily pretreated AR+ mBC.
Recommended phase II dose of pruxelutamide was defined as 200mg orally once daily.
AR expression, cell-free DNA yield, CNV might be associated with response.
Patients with PIK3CA pathogenic mutation showed longer progression-free survival.
Metastatic breast cancer (mBC) remains a largely incurable disease in most patients, resulting in approximately 0.5 million deaths every year worldwide. At present, the primary goals of mBC therapy are to prolong patient survival and maintain their quality of life. Any novel therapy likely to provide a survival advantage in patients is valuable.

Pruxelutamide is an oral, newly-generation AR antagonist, developed by Kintor Pharma. Results from this study of pruxelutamide were published in a paper titled "Proxalutamide in patients with AR-positive metastatic breast cancer: Results from an open-label multicentre phase Ib study and biomarker analysis". This phase Ib study was designed to evaluate the preliminary efficacy and safety of pruxelutamide monotherapy in patients with pretreated AR+ mBC and to determine the RP2D of pruxelutamide. The corresponding author of the paper, Professor Huiping Li of Peking University Cancer Hospital & Institute, was the principal investigator of the phase I clinical trial in China.

In this open-label, dose-expansion, multicentre phase Ib trial, patients with AR+ mBC (immunohistochemistry [IHC] AR≥1%) received pruxelutamide orally once daily. Two pruxelutamide dose cohorts (cohort A: 200mg; cohort B: 300mg) were sequentially investigated. Primary endpoints were disease control rate (DCR) at 8 and 16 weeks and recommended phase II dose (RP2D).

Finally, 45 eligible patients were enrolled and treated. 30 eligible patients were enrolled in cohort A (200mg orally once daily) from April 19, 2018, to March 7, 2019. 15 patients were enrolled into cohort B (300mg orally once daily) from March 11, 2019, to April 16, 2019.

Among 39 evaluable patients, DCR at 8 and 16 weeks was 25.6% (95% confidence interval [CI], 11.9–39.4%), with 26.9% in cohort A and 23.1% in cohort B. The 6-month progression-free survival (PFS) rate was 19.6% (95% CI, 10.2–37.5%). In the triple-negative subgroup, DCR at 8 weeks was 38.5%, with median PFS of 9.1 months (95% CI, 7.8–NA) in those who achieved response at 8 weeks (n = 5).

All 45 patients were evaluable for safety. Overall, pruxelutamide demonstrated a good safety profile. The most common grade 3 or 4 AEs were AST increase (8.9%) and γ-glutamyltransferase increase (8.9%). No treatment-related deaths or dose reductions occurred in either cohort.

This study conducted another exploratory analysis to identify potential predictive biomarkers of treatment response. By biomarker analysis, patients with moderate AR expression of IHC (26%–75%), PIK3CA pathogenic mutations, or <60 ng/ml cell-free DNA yield showed longer PFS.

In conclusion, pruxelutamide demonstrated promising anti-tumour activity with an acceptable safety profile in patients with heavily pretreated AR+ mBC, particularly in the TNBC subgroup. And, this study determined the RP2D to be 200mg orally once daily. Furthermore, we identified that AR expression, CNVs, and cfDNA yield may be associated with the response to pruxelutamide, highlighting the importance of conducting genomic profiling in patients with AR+ mBC to identify those likely to benefit from pruxelutamide treatment. The data supports further clinical development of pruxelutamide on treating breast cancer patients.

Kling Biotherapeutics Announces First Patient Dosed in Phase 1b Clinical trial of KBA1412 in Patients with Advanced Solid Tumors

On September 29, 2022 Kling Biotherapeutics, BV, (Kling Bio) a clinical stage biotechnology company focused on developing novel antibody-based therapeutics for cancer and infectious diseases generated through its proprietary discovery platform, reported the dosing of the first patient with KBA1412 in its Phase 1b trial (KBA1412-101, NCT05501821), an open-label, multi-center study evaluating the safety, tolerability, PK/PD, and potential efficacy of KBA1412 in adult patients with advanced solid tumors not responding to standard of care (Press release, Kling Biotherapeutics, SEP 29, 2022, View Source [SID1234621571]).

KBA1412 is a first in class fully human anti-CD9 antibody based on an antibody produced by circulating B cells in the blood of a cancer survivor. "KBA1412 has remarkable properties identified in preclinical studies including efficacy as monotherapy mediated by two anti-cancer mechanisms (cell-mediated cytotoxicity and enhanced immune cell infiltration into tumors), synergy with PD-1 blockade, and a very favorable preclinical safety profile not seen previously with anti-CD9 antibodies" said Timothy M. Wright, MD, Kling Bio co-founder and interim CEO.

The Phase 1b study will involve dose escalation followed by several expansion cohorts in patients with selected solid tumor types. The expansion cohorts will study KBA1412 alone and in combination with a PD-1 checkpoint inhibitor to further define the dose for future Phase 2 studies and to evaluate secondary endpoints for preliminary assessment of clinical efficacy. "This study marks an important milestone for Kling Bio and demonstrates the potential to leverage the ‘human-to-human’ approach from discovery to clinical development for advancing novel cancer treatments," said Sohail Ahmed, MD, MBA, Chief Medical Officer at Kling Bio.