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AngioDynamics to Report Fiscal 2021 First Quarter Financial Results on September 29, 2020

On September 17, 2020 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported that it will report financial results for the first quarter of fiscal year 2021 before the market open on Tuesday, September 29, 2020 (Press release, AngioDynamics, SEP 17, 2020, View Source [SID1234565314]). The Company’s management will host a conference call at 8:00 a.m. ET the same day to discuss the results.

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To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13710506.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Tuesday, September 29, 2020, until 11:59 p.m. ET on Tuesday, October 6, 2020. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13710506.

Brii Biosciences Appoints Rogers Luo, Ankang Li To Leadership Positions

On September 17, 2020 Brii Biosciences ("Brii Bio"), a multi-national company developing innovative therapies for diseases with significant unmet medical needs and large public health burden,reported the appointments of Rogers Yongqing Luo, B.M., MBA, as President of the company and General Manager for greater China, and Ankang Li, Ph.D., J.D., CFA, as Chief Financial Officer of the company. Both executives are based in Shanghai (Press release, Brii Biosciences, SEP 17, 2020, View Source [SID1234565313]).

Dr. Luo will play a central role in running Brii Bio’s business in China while supporting company’s growth in the United States. He will also lead the partnership with Tsinghua University and Shenzhen 3rd People’s Hospital to develop, manufacture and commercialize COVID-19 antibody therapies in China. Dr. Li is responsible for corporate finance & transactions, financial reporting and accounting, and internal control & audit.

"The appointments of Dr. Luo and Dr. Li mark a pivotal step for Brii Biosciences, as we advance clinical research, accelerate growth and prepare for the new and evolving healthcare marketplace in China and around the globe," said Zhi Hong, Ph.D., CEO of Brii Bio. "Dr. Luo has extraordinary knowledge of the science, proven leadership track record, and commercial expertise in patient access. Dr. Li’s broad financial credentials, supported by scientific and legal qualifications, also are a significant addition to our already strong capabilities. I am delighted that they have brought their expertise and energy to Brii Bio at this critical time of growth."

"I am excited to join a company with Brii Bio’s deep commitment to meeting the most urgent healthcare needs in China and to supporting global public health," said Dr. Luo. "The environment is changing rapidly in China, with a need for companies to anticipate and respond with deep insight, disruptive access technologies, novel purchasing and healthcare delivery strategies – at the national, regional and local level. Doing well as a business while doing good for the health and well-being of people and society is core to my decision to join Brii Bio."

Dr. Luo has more than 25 years of experience in healthcare industry. He joined Brii Bio from Gilead Sciences, where he was a global vice president and general manager of China. In four years with Gilead, as an early employee in China, he has built Gilead’s presence in China from beginning. Dr. Luo led the development, regulatory review and launch of eight innovative products, gaining rapid access across China. He led the team and established a unique business model encompassing science, commercialization and patient access. Prior to Gilead, he was Vice President of Roche China, pioneering novel strategies for patient access to oncology therapies. Before joining Roche, he was the General Manager of Novartis North China and Associate Marketing Director in Novartis global headquarter in Switzerland. Dr. Luo received his medical education from Xiangya School of Medicine, Central-South University, and served for three years as a surgeon at St. Luke’s Hospital, Shanghai. He also holds an EMBA from China Europe International Business School.

Dr. Li commented: "I am impressed by Brii Bio’s infectious disease pipeline and commitment to addressing the tremendous health challenges worldwide. Having worked with many multi-national research-based companies, I am inspired by Brii Bio’s focus on breakthrough innovation and insight with an entrepreneurial esprit de corps. I am honored to be a member of this remarkable team and looking forward to leading the company’s finance organization to accelerate the growth of Brii Bio."

Dr. Li brings more than 10 years of experience in investment banking, business development, legal transaction and biomedical research. He joined Brii from Terns Biopharmaceuticals, where he was CFO, developing and deploying financial and corporate strategies and budget. Prior to Terns, Dr. Li was the Executive Director of the Corporate Finance department division at Goldman Sachs, where he was responsible for investment banking in Asia outside Japan. Dr. Li also worked in Merck Asia Pacific Innovation Hub, overseeing business development and licensing transactions in the region. Before that Dr. Li worked at two prominent law firms, Davis Polk & Wardwell LLP and Ropes & Gray LLP as attorney, advising clients on capital markets and M&A transactions. His working career started in the Salk Institute as a biomedical researcher. Dr. Li received a Juris Doctor degree from The University of Chicago Law School, a Ph.D. in Biomedical Sciences from The Baylor College of Medicine, a Master of Science degree from The National University of Singapore, and a Bachelor of Science degree in Biochemistry from The Fudan University. He is also a Chartered Financial Analyst (CFA).

Cullinan Pearl Announces Presentation of Preliminary Safety and Efficacy of CLN-081 in EGFR Exon 20 NSCLC Patients at ESMO Virtual Congress 2020

On September 17, 2020 Cullinan Pearl, a Cullinan Oncology company, reported that an abstract detailing the ongoing Phase 1/2a clinical trial evaluating CLN-081 for the treatment of EGFR exon 20 insertion mutant non-small cell lung cancer (NSCLC) will be presented as a poster presentation at the ESMO (Free ESMO Whitepaper) Virtual Congress 2020 (Press release, Cullinan Oncology, SEP 17, 2020, View Source [SID1234565312]).

Poster Title: Preliminary Safety and Activity of CLN-081 in NSCLC with EGFR Exon 20 Insertion Mutations (Ins20)
Abstract Number: 2133
Poster Number: 1345P
Session Date & Time: From 09:00 Thursday, 17 September 2020 until 20:00 Monday, 21 September 2020.

The poster presentation will summarize the initial Phase 1 experience with CLN-081 up to the data cutoff of September 1, 2020, including data on 22 patients treated at dose levels ranging from 30-150 mg administered orally twice daily. CLN-081 demonstrated acceptable safety, with no dose-limiting toxicities (DLT) and no Grade 3 or greater drug-related adverse events. The most common drug-related adverse events included rash and dry skin, with only one case of Grade 1 drug-related diarrhea being observed.

In this group of heavily pretreated patients with EGFR exon-20 mutant NSCLC (over 80% with 2 or more prior lines of systemic therapy), encouraging preliminary antitumor activity was observed across multiple dose levels, including the initial dose level of 30 mg twice daily. Of the initial 22 patients, 17 were evaluable for objective response at the time of data cutoff, and 5 had not yet reached their initial scan. Of the 17 response evaluable patients, 6 experienced an objective response, including 2 patients with a confirmed partial response, 3 patients with ongoing partial responses not yet reaching a confirmatory scan, and 1 with an unconfirmed partial response. Among the 11 remaining response evaluable patients with a best response of stable disease, the change in target lesions ranged from +3% to -21%. Of these 11 patients, 9 patients remained on treatment with stable disease at the data cutoff.

Commenting on the preliminary data, Jon Wigginton, Cullinan Oncology’s Chief Medical Officer (CMO) stated, "We are encouraged with CLN-081’s initial safety and efficacy data in this very difficult to treat patient population, with antitumor activity across a broad range of doses tested to date and an acceptable safety profile. Guided by this data, we look forward to defining the recommended phase 2 dose of CLN-081, and initiating discussions with regulators regarding the future clinical development path for the program."

The accepted abstract is now available on the ESMO (Free ESMO Whitepaper) conference website HERE. The poster can be viewed on the Cullinan Oncology website HERE.

VBI Vaccines Announces Biomarker Data From VBI-1901 Phase 1/2a Study in Recurrent GBM Presented at ESMO Virtual Congress 2020

On September 17, 2020 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported additional biomarker data from its ongoing Phase 1/2a study evaluating VBI-1901, the company’s cancer vaccine immunotherapeutic candidate in recurrent glioblastoma (GBM) patients presented in an e-poster at The European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 (Press release, VBI Vaccines, SEP 17, 2020, View Source [SID1234565310]).

Expanding the biomarker analysis of the six tumor responders seen to-date in the study, including a confirmed durable partial response, the e-poster highlighted data that further assessed correlates of tumor response and clinical benefit. Specifically, human leukocyte antigen (HLA) restriction and T cell receptor (TCR) repertoires were evaluated.

"We continue to broaden the analysis around tumor responders in our ongoing Phase 1/2a study of VBI-1901 to enable us to identify GBM patients most likely to benefit from the vaccine immunotherapeutic in the next phase of clinical development," said Dr. David E. Anderson, VBI’s Chief Scientific Officer. "This analysis suggests that VBI-1901 is able to induce a CMV antigen-specific immune response to target a broader set of CMV antigens beyond what is expressed in VBI-1901, evident by HLA analysis and functional T cell assays. As with the previously announced CD4+/CD8+ ratio, a biomarker which may reflect the immunologic fitness of CD4+ T cells in recurrent GBM patients, these biomarkers will continue to be evaluated throughout the study."

In parallel to the ongoing biomarker analysis, enrollment in the Phase 1/2a Part B study arm of VBI-1901 in combination with GSK’s AS01B adjuvant system continues, with initial immunologic and tumor data expected in Q4 2020.

The e-poster is available on the "Events/Presentations" page in the "Investors" section of the VBI Vaccines website.

About the Phase 1/2a Study Design

VBI’s two-part Phase 1/2a study is a multi-center, open-label, dose-escalation study of VBI-1901 in up to 38 patients with recurrent GBM:

Phase 1 (Part A)
Dose escalation phase that defined the safety, tolerability, and optimal dose level of VBI-1901 adjuvanted with granulocyte-macrophage colony-stimulating factor (GM-CSF) in recurrent GBM patients with any number of prior recurrences.
This phase enrolled 18 recurrent GBM patients across three dose cohorts of VBI-1901: 0.4 µg, 2.0 µg, and 10.0 µg.
Enrollment completed in December 2018.
Phase 2a (Part B)
Subsequent extension of the optimal dose level, 10.0 µg, as defined in the Part A dose escalation phase.
This phase is a two-arm study, enrolling 10 first-recurrent GBM patients in each arm, assessing 10.0 µg of VBI-1901 in combination with either GM-CSF or GSK’s proprietary AS01B adjuvant system as immunomodulatory adjuvants.
Enrollment of the 10 patients in the GM-CSF arm is complete. Enrollment of the 10 patients in the AS01B arm is ongoing.
VBI-1901 is administered intradermally when adjuvanted with GM-CSF and intramuscularly when adjuvanted with the AS01B adjuvant system. Patients in both phases of the study receive the vaccine immunotherapeutic every four weeks until tumor progression.

About VBI-1901 and GBM

VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using VBI’s enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including glioblastoma (GBM). GBM is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, 12,000 new cases are diagnosed each year. The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses rapidly and is exceptionally lethal.

Patient recruitment starts for the international PRO-SID study evaluating Panzyga® for primary prophylaxis in patients with chronic lymphocytic leukaemia and secondary immunodeficiency

On September 17, 2020 Octapharma reported that the first site for the international PRO-SID (Primary Infection Prophylaxis with Panzyga in Secondary Immunodeficiency in Chronic Lymphocytic Leukaemia) study was initiated in Milan, Italy, and patient recruitment is underway (Press release, Octapharma, SEP 17, 2020, View Source [SID1234565309]). Additional sites across Europe (Italy, Poland, Denmark, Hungary, Germany and Russia) and the USA are expected to begin recruitment soon. PRO-SID is the first randomised, placebo-controlled study to systematically evaluate the efficacy and safety of IVIG for primary prophylaxis for infection control in patients with chronic lymphocytic leukaemia (CLL).

Secondary immunodeficiency (SID) is a common complication in patients with haematological malignancies such as CLL. Up to 85% of CLL patients develop hypogammaglobulinemia during the course of the disease, either due to the underlying disease or as a side effect of their treatment.1 For example, in one study, 39% of CLL patients developed hypogammaglobulinaemia after treatment with a B-cell depleting therapy.2 Patients with hypogammaglobulinaemia are more likely to develop infections, which are not only a major cause of morbidity but also account for up to 60% of deaths in patients with CLL.3 The use of intravenous immunoglobulins (IVIG) is well established as secondary prophylaxis to reduce the rate of infections in patients with haematological malignancies. However, there are insufficient data from well-designed, randomised, controlled studies to recommend IVIG as primary prophylaxis, before occurrence of the first major infection.4 For more information on SID and haematological malignancies, please visit View Source

The double-blind, randomised, placebo-controlled, prospective, multicentre phase III PRO-SID study (NCT04502030) was designed to assess the efficacy and safety of Panzyga, a human immunoglobulin for intravenous administration, as primary prophylaxis in patients with CLL and SID. The study plans to recruit at least 240 adult patients with CLL and hypogammaglobulinaemia (IgG levels < 5 g/L) who are receiving antineoplastic treatment. The primary outcome is the occurrence of at least one major infection over 52 weeks in patients receiving Panzyga compared with placebo. Both treatment groups will also receive standard of care infection prophylaxis. Secondary outcomes include the overall infection rate and the frequency and duration of prophylaxis with anti-infectives.

Wei Ding, M.B.B.S, PhD, Mayo Foundation for Medical Education and Research, member of the PRO-SID study steering committee, commented that: "Despite improved therapy options in CLL patients, infections are still one of the major causes of morbidity and mortality. Primary prophylaxis with IVIG before severe infections occur has the potential to reduce infection rates and the burden on patients and the healthcare system. There is a need for robust data on the efficacy and safety of this approach, and insights from the PRO-SID study may prove highly valuable for informing treatment decisions

Dr. Olaf Walter, Board Member at Octapharma, added: "There remains a significant need to reduce the burden of the disease in managing patients with haematological malignancies and secondary immunodeficiency. Initiation of the PRO-SID study represents a key milestone in Octapharma’s efforts to improve the care of patients with CLL."

About the PRO-SID study
The PRO-SID study (NCT04502030) is a prospective, double-blind, randomised, multi-centre, placebo-controlled, interventional, phase III study investigating the efficacy and safety of Panzyga in patients with chronic lymphocytic leukaemia (CLL) and hypogammaglobulinaemia (IgG < 5 g/L) who are receiving antineoplastic treatment. The study will be conducted at multiple sites across Europe (Italy, Poland, Denmark, Hungary, Germany and Russia) and the USA and plans to recruit at least 240 patients.

About Panzyga
Panzyga is a 10% human normal immunoglobulin solution ready for intravenous administration. Panzyga is approved for use in treatment of primary immunodeficiency and idiopathic thrombocytopenic purpura in the USA, Europe and Canada. It is also approved for secondary immunodeficiencies and Guillain Barré syndrome in Europe and Canada and for CIDP in Europe.