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CASI Pharmaceuticals To Present At The Jefferies 2020 Healthcare Conference

On June 2, 2020 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported that Dr. Wei-Wu He, Chairman & CEO will present an overview of the company and provide a business update at the Jefferies 2020 Healthcare Conference on Thursday, June 4, 2020, at 4:00 p.m. ET (Press release, CASI Pharmaceuticals, JUN 2, 2020, View Source [SID1234560774]). The conference will be held in a virtual meeting format.

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To access the live webcast presentation, or the subsequent archived recording, please visit the "Investor Center" section of the CASI website at www.casipharmaceuticals.com.

RenovoRx Announces Orphan Drug Designation Granted for Treating Bile Duct Cancer

On June 2, 2020 RenovoRx, an innovator in targeted cancer therapy, reported the U.S. Food and Drug Administration (FDA) has granted the Company orphan drug designation for treating bile duct cancer —- also known as cholangiocarcinoma — with intra-arterial gemcitabine (Press release, Renovorx, JUN 2, 2020, View Source [SID1234560773]). The Company’s proprietary FDA cleared medical device system, RenovoCath, employs a dual-balloon infusion catheter, enabling the Trans-Arterial Micro-Perfusion (TAMPTM) approach for targeted delivery of gemcitabine to the tumor site.

In April 2018, RenovoRx received FDA orphan drug designation for treatment of pancreatic cancer with intra-arterial gemcitabine. RenovoRx’s proprietary TAMP delivery of gemcitabine is being utilized in the TIGeR-PaC Phase III trial evaluating extended median survival and improved Quality of Life for pancreatic cancer patients.

In the United States, more than 8,000 people develop cholangiocarcinoma annually.i However, research suggests the incidence is higher due to misdiagnosis.ii The disease is nearly five times more common in Asia and the Mideast, largely due to parasitic liver fluke infections.iii,iv

According to Cancer.net, the 5-year survival rate ranges between 2 and 24%, depending on when the cancer is found. Two-thirds of patients are 65 or older.

"Receiving a second orphan drug designation from the FDA is a significant milestone as we build the TAMP platform for solid tumor treatment. This new orphan drug indication builds on the momentum of the TIGeR-PaC Phase III clinical trial currently treating pancreatic cancer patients in the U.S. and Europe," said RenovoRx CEO Shaun Bagai. "To help bile duct cancer patients, we are designing a Phase I/II clinical trial that will launch by early next year. This expansion of the RenovoRx platform, beyond pancreatic cancer, could improve outcomes for more cancer patients."

Bagai added, "Our team is evaluating market opportunities in Asia since it is estimated more than 100,000 patients are diagnosed annually with bile duct cancer that could be treated with RenovoRx’s TAMP delivery of intra-arterial gemcitabine."

The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for underserved patient populations, or rare disorders, affecting fewer than 200,000 people in the U.S. Orphan drug designation provides RenovoRx certain benefits, including market exclusivity upon regulatory approval if received, exemption of FDA application fees and tax credits for qualified clinical trials.

Prescient Metabiomics and the Harvard Chan Microbiome in Public Health Center Collaborate to Advance Research in Colon Cancer Screening

On June 2, 2020 Prescient Metabiomics, a subsidiary of Prescient Medicine Holdings, Inc., reported a research collaboration with the Harvard Chan Microbiome in Public Health Center (HCMPH Center), a group at Harvard T.H. Chan School of Public Health dedicated to expanding research on the microbiome to improve public health (Press release, Prescient Metabiomics, JUN 2, 2020, View Source [SID1234560772]). The aim of the collaboration is to study microbial biomarkers to identify the presence of precancerous adenomas and carcinomas in the colon. The initial collaboration will investigate prevalent gut microbial biomarkers for colorectal cancer (CRC) by analyzing known, recent CRC cases across populations with which the HCMPH Center works and applying cutting-edge statistical and bioinformatic techniques for microbiome meta-analysis.

"The ongoing research collaboration will further enhance diagnostic screening for colon cancer," said Keri Donaldson, M.D, chief executive officer at Prescient Medicine. "Offering a non-invasive alternative to colonoscopies that screen for colorectal adenomas and carcinomas could represent a paradigm shift in CRC screening driven by the microbiome. Therefore, research to better understand the microbiome’s role in CRC is needed at this time."

Curtis Huttenhower, Ph.D., professor of computational biology at Harvard Chan School and co-director of the HCMPH Center, said, "The mission of the HCMPH Center is to improve population health via microbiome science, and there are few chronic disease conditions as well-positioned to benefit from microbiome screening as colorectal cancer. It is one of the most common causes of cancer deaths, but also one of the most preventable cancers if detected early. It’s exciting to embark on this collaboration to advance the latest science and, I hope, eventually deploy our findings to the clinic."

The past decade has seen a dramatic expansion of research on the human microbiome, including investigation into the role of microbes and microbiota in the gastrointestinal track in the origin and development of CRC. The advancements in this field parallel the preceding decade’s growth in personalized genetic medicine, with the microbiome offering opportunities for both therapeutic and diagnostic biomarker discovery.

According to the American Cancer Society, colorectal cancer is the third leading cause of cancer-related deaths in both men and in women. The U.S. spends approximately $14 billion each year for the diagnosis and treatment of CRC with costs largely due to delayed detection. There is a lack of non-invasive screening tests that can accurately detect precancerous polyps as effectively as a colonoscopy, the current standard of care. Screening recommendations currently suggest a colonoscopy for average-risk patients starting at age 45 every 10 years and earlier for high-risk patients, but approximately one in three patients are not in compliance with these recommendations. Research indicates that early detection of precancerous adenomas and carcinomas could lead to significantly better patient outcomes

NW Bio Provides Update On Projected Timing For Data Lock For Phase 3 Trial of DCVax®-L for Glioblastoma Brain Cancer

On June 2, 2020 Northwest Biotherapeutics (OTCQB: NWBO)("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, reported progress toward data lock for the Phase 3 trial of DCVax-L for Glioblastoma brain cancer (Press release, Northwest Biotherapeutics, JUN 2, 2020, View Source [SID1234560771]).

The Company reported that the final data collection process has been progressing steadily despite ongoing difficulties due to coronavirus-related limitations on operations and restrictions at trial sites. The coronavirus-related difficulties have impacted most aspects of the process, including review processes at sites and even logistical matters such as the shipping of tissue slides.

The completion process includes final data collection, identification and resolution of queries, data checking and confirmation, and site sign-offs. All of these functions are performed by independent service firms (not by the Company), with oversight by the Company. The service firms have completed the final monitoring visits to the trial sites (including a number of them virtually). The service firms are in the process of resolving the queries from those final monitoring visits (each monitoring visit can generate new queries), and the firms have completed most of the data confirmations. After the query resolution and data confirmation are finished for a trial site, the site’s investigator needs to sign off on the data before it can be locked.

In light of the current status of the completion process, and the experience over recent months, the Company currently anticipates that the process may be completed by about mid-June or shortly thereafter – i.e., within a couple of weeks after the Company’s anticipated schedule at the time of the Annual Meeting in April.

If some of the information that currently remains outstanding cannot be obtained by mid-June, the Company may consider proceeding with a "soft lock" of the data at that time, if arrangements can be made for the rest of the data to be included when it is obtained later. The Company plans to obtain advice from its regulatory counsel, its Scientific Advisory Board and the Steering Committee of the trial in regard to such possibilities.

It is too early to determine what effect this update of the anticipated timing of data lock may have on the anticipated timing of the public announcement of data. There may be a similar update to the timing of the announcement of the data as to the timing of the data lock.

The steps that will take place after data lock remain the same as were outlined at the Company’s Annual Meeting. Initially following data lock, only the statisticians will be unblinded (i.e., will be given access to the database containing all of the raw data from the trial). The statisticians will need several weeks to carry out all the relevant analyses and calculations. Then the statisticians will deliver the results to the Company, and that is when the Company will become unblinded. The Company will then discuss the data with key advisors, such as its Scientific Advisory Board and the Steering Committee of the trial, and will address any comments or questions from its advisors as part of preparing the data for public announcement.

The timing of such processes cannot be predicted with precision even in normal times, and especially not in the current unprecedented circumstances. However, the Company and the independent service firms that are carrying out these processes are committed to proceeding quickly. If the anticipated timing becomes significantly different than currently anticipated, the Company plans to provide additional update bulletins.

Innovent Announces the Preliminary Results of the Anti-CTLA-4 Monoclonal Antibody IBI310 in a Phase 1 Clinical Study

On June 2, 2020 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 the preliminary results of a Phase 1 clinical study (NCT03545971) of the recombinant fully human anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) monoclonal antibody (IBI310) in the form of online publication at the 56th American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Innovent Biologics, JUN 2, 2020, View Source [SID1234560770]). (Online publication, Abstract # 302489)

The NCT03545971 study is an open-label study and was consisted of two parts, namely Phase 1a study and Phase 1b study, which were designed to evaluate the tolerability, safety and anti-tumor activity of IBI310 and its combination with TYVYT (sintilimab injection) in the treatment of subjects with advanced malignant tumors, respectively. In the Phase 1a study, subjects with advanced solid tumors who have progressed from standard treatment were dosed with IBI310; while in the Phase 1b study, subjects with advanced melanoma were treated with IBI310 in combination with TYVYT (sintilimab injection). The main clinical data includes:

As of November 12, 2019, a total of 10 subjects were enrolled in Phase 1a study and 17 subjects were enrolled in Phase 1b study. There were no dose limiting toxicities (DLTs) in both phases, and the dose expansion in Phase 1b is currently ongoing. The most common treatment related adverse event (TRAE) was pruritus in both Phase 1a and Phase 1b studies, and no Grade 3 or higher adverse events occurred in Phase 1a and only one subject in Phase 1b experienced a grade 3 or higher TRAE (AST increased). There were no TEAE caused death.
In Phase 1b study, three subjects in the 3mg combination dose group had at least one tumor assessment and one of these subjects had objective response.
Professor Jun Guo, Vice President of Peking University Cancer Hospital and Director of the Department of Melanoma Medicine of Renal Cancer, said: "In recent years, several breakthroughs achieved in melanoma have brought more treatment methods for patients with melanoma. The 1-year survival rate of patients with advanced melanoma has been prolonged from 25% ~ 35% in the 1990s to 75% by today, and immunotherapy is one of the most critical breakthroughs for this improvement. The results of Checkmate-067 study showed that double immunotherapy for first-line treatment of advanced melanoma can significantly improve the prognosis compared to single immunotherapy. The preliminary results of NCT03545971 study show that IBI310 have acceptable safety profile and preliminary efficacy. We hope to see more positive data in the next studies."

Dr. Hui Zhou, Vice President of Medical Science and Strategic Oncology of Innovent, said: "CTLA-4 is an important immunosuppressive receptor, and there are a number of CTLA-4 related clinical studies on-going both in domestic and abroad, while currently only one has been approved. IBI310 is the CTLA-4 monoclonal antibody of fastest progress in China. The preliminary clinical results of IBI310 in combination with sintilimab show acceptable safety and anti-tumor activity, suggesting a synergistic enhancement effect. Currently, Phase 2/3 clinical studies of IBI310 in combination with sintilimab are on-going in multi tumors. We hope to evaluate the clinical results of IBI310 in combination with sintilimab and bring this therapy to more patients in need as soon as possible. "

About IBI310 (Anti-CTLA-4 Monoclonal Antibody)

IBI310 is a fully human monoclonal antibody blocking Cytotoxic T Lymphocyte-associated Antigen-4 (CTLA-4). CTLA-4 inhibits the immune escape of tumor cells and improves the body’s own immune response against tumor cells by up-regulating the anti-tumor immune response mediated by human effector T cells and weakening the immunosuppressive activity mediated by regulatory T cells, so as to achieve the purpose of treating a variety of tumors.