On December 17, 2020 Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, reported the company has reached a licensing agreement with Biomm S.A. for BAT1706, its bevacizumab biosimilar, under which Biomm will have exclusive rights to distribute and market the drug in Brazil (Press release, BioThera Solutions, DEC 17, 2020, View Source [SID1234572998]).

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BAT1706 is a proposed bevacizumab biosimilar for the treatment of patients with metastatic colorectal cancer, metastatic or locally recurrent breast cancer, locally advanced, metastatic or recurrent non-small cell lung cancer, metastatic renal cell carcinoma, persistent, recurrent, or metastatic cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Bio-Thera’s BAT1706 has successfully completed a global Phase III comparative clinical study which was a multicenter, randomized, double blind, study evaluating the efficacy, safety, pharmacokinetics and immunogenicity of BAT1706 versus EU-bevacizumab plus chemotherapy in patients with advanced non squamous non-small cell lung cancer.

Bio-Thera has filed the commercial license application for BAT1706 with the China National Medical Products Administration (NMPA) and also more recently with the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA). Biomm will be responsible for filing the dossier in Brazil.

This partnership will leverage Biomm’s strong local presence, sales and marketing capabilities in Brazil. Bio-Thera will be responsible for full development, and commercial supply of BAT1706 out of its manufacturing facilities in Guangzhou, China.

"Bio-Thera is pleased to partner with Biomm to commercialize our bevazcizumab biosimilar program in Brazil", said Dr. Shengfeng Li, CEO of Bio-Thera. "This partnership is the first to expand Bio-Thera’s presence into Brazil, an important pharmaceutical market for biosimilars and innovative drugs."

"Biomm is committed to expanding its portfolio in biotechnology with a long-term vision, especially in ​​oncology where is critical to expand the access to modern treatments", says Heraldo Marchezini, CEO of Biomm. "We are pleased to partner with Bio-Thera Solutions, given its expertise in research and development of such important biopharmaceuticals."

On December 17, 2020 KIYATEC, Inc. reported the first clinical use of its response-prediction test to improve outcomes in relapsed brain cancer patients (Press release, KIYATEC, DEC 17, 2020, View Source [SID1234572996]). Test results that measure the effect of cancer drugs on a patient’s live cancer cells are available in just seven days, thereby enabling oncologists to select drugs informed by patient-specific evidence of response before treatment begins.

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Lindsay Lipinski, MD, Assistant Professor of Oncology and a neurosurgeon at Roswell Park Comprehensive Cancer Center (Buffalo, NY), presented her and her colleagues’ findings at the 2020 Society of Neuro-Oncology meeting in November. A case series of seven patients with recurrent high-grade gliomas – six with glioblastoma multiforme (GBM) and one with anaplastic astrocytoma – was detailed.

"In this early experience, tools that can predict a tumor cell’s responsivity to a variety of chemotherapy or other therapeutic agents have already been extremely valuable in guiding treatment decision-making for patients with recurrent high-grade gliomas at our center," said Dr. Lipinski. "Our results show that we are far along in the paradigm shift toward individualized medicine."

Today, when these cancers return following a patient’s initial treatment, oncologists do not have evidence-based guidelines to choose which drug therapy to use next. Across several drug options, the typical expectation for the time in which these recurrent patients will remain cancer-free (i.e., median progression free survival or PFS) is only 4 months. The use of KIYATEC’s test results to inform drug selection approximately doubled the typical expectation, achieving a group median PFS of 7.9 months, a significant improvement over expected PFS in these patients.

KIYATEC’s test results informed two of the seven patients’ successful treatment with dabrafenib, a targeted agent. Notably, neither had a typically associated genetic mutation, demonstrating that the test can uncover effective drug options that would have normally been missed.

"Our vision is to successfully translate these study findings into the GBM population at large, including newly diagnosed patients – a population that we’re also actively enrolling and testing in our study," said Matthew Gevaert, PhD, CEO of KIYATEC. "Today’s positive results in relapsed patients, with a median age of 60 and some having had two or even three relapses, paves the way to do this."

This first release of data from KIYATEC’s active 3D-PREDICT (ClinicalTrials.gov ID NCT03561207) clinical study coincides with the continued addition of new sites at which high-grade glioma patients can enroll, bringing this study to nine institutions across the United States.

On December 17, 2020 Humanigen, Inc. (Nasdaq: HGEN) ("Humanigen"), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab, reported that the Company’s management will present and host meetings with investors and potential partners at the J.P. Morgan Healthcare Conference, held virtually from January 11 to 14, 2021 (Press release, Humanigen, DEC 17, 2020, View Source [SID1234572995]).

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Cameron Durrant, MD, MBA, chief executive officer of Humanigen, Dale Chappell, MD, MBA, chief scientific officer, and Timothy Morris, chief operating and financial officer, will provide an update on enrollment for its Phase 3 clinical trial of lenzilumab in patients hospitalized with COVID-19, an update on the commercial preparation ahead of a potential Emergency Use Authorization (EUA) for lenzilumab as well as an overview of the Company’s other programs.

Details for the upcoming virtual investor conference are below:

J.P. Morgan Healthcare Conference

Date: Wednesday, January 13, 2021
Presentation Time: 8:20 AM ET
Event Link: View Source;kiosk=true

On December 17, 2020 Cullinan Oncology, LLC, a biopharmaceutical company focused on developing a diversified pipeline of targeted oncology and immuno-oncology therapies with transformative potential for cancer patients, reported the closing of an oversubscribed $131.2 million Series C financing (Press release, Cullinan Oncology, DEC 17, 2020, View Source [SID1234572994]). The financing was led by Foresite Capital with participation from additional new investors: Boxer Capital of Tavistock Group; Eventide Asset Management; Nextech Invest; OrbiMed; Venrock Healthcare Capital Partners; Rock Springs Capital; BVF Partners, L.P.; and Logos Capital. Existing investors, including MPM Capital, F2 Ventures, Cowen Healthcare Investments, The Baupost Group, Schooner Capital, as well as other institutions and individuals, also participated in the round.

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"We appreciate the confidence of both our existing as well as new investors in our team and portfolio of assets," stated Owen Hughes, Cullinan’s CEO.

SVB Leerink is acting as exclusive placement agent to the company in connection with the private placement.

On December 17, 2020 Humanigen, Inc. (NASDAQ: HGEN) ("Humanigen"), a clinical stage biopharmaceutical company developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases, reported completing enrollment in its Phase 1 bioimaging study of ifabotuzumab in patients with recurrent glioblastoma multiforme (GBM) (Press release, Humanigen, DEC 17, 2020, View Source [SID1234572993]). Ifabotuzumab, or ifab, is the Company’s proprietary anti-EphA3 monoclonal antibody. This trial is supported by funding from the Cure Brain Cancer Foundation. Results from the study, being conducted at the Olivia Newton-John Cancer Research Institute in Heidelberg, Victoria, Australia, are expected in the first half of 2021.

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"GBM represents an extremely aggressive form of cancer that has historically eluded effective treatment, and we remain committed to investigating ifabotuzumab as a potential new approach to treat this devastating disease as well as other solid tumors," said Prof. Andrew Scott, Head, Tumor Targeting Laboratory, Olivia Newton-John Cancer Research Institute, Professor, School of Cancer Medicine, La Trobe University and a member of the Australian Brain Cancer Mission Strategic Advisory Group.

GBM is the most frequent and lethal type of primary brain cancer, with only 10% of patients surviving five years,1 and preclinical research has shown that EphA3 is responsible for maintaining less differentiated, tumor-initiating cells.2 Ifabotuzumab is a non-fucosylated IgG1K antibody designed to bind to EphA3,2 which is expressed in 38-40% of GBM and 100% of the tumor vasculature and is widely expressed in the tumor stroma and tumor vasculature of other solid tumors.3,4

The primary goal of the Phase 1 study is to evaluate safety of ifabotuzumab and to recommend a dose for a potential Phase 2 study either with ifabotuzumab or an antibody drug conjugate (ADC) based on ifabotuzumab. Led by Prof. Andrew Scott and Prof. Hui Gan, the study uses radiolabelled ifabotuzumab followed by sequential positron emission tomography (PET) imaging to determine biodistribution, frequency of in situ EphA3 expression and quantitative tumor uptake of ifabotuzumab. Subsequently, patients were enrolled into one of three cohorts evaluating escalating doses of ifabotuzumab administered on a weekly basis, allowing for an assessment of receptor occupancy, response rate and overall survival.

"The study has now completed recruitment and we are very excited at having shown that ifabotuzumab is able to target the brain tumor in all the patients tested without binding to healthy tissue," said Prof. Hui Gan, Clinical Research Lead, Olivia Newton-John Cancer Research Institute and Director, Cancer Clinical Trials Center, Austin Health. "We saw some signs that ifabotuzumab was affecting the blood vessels that feed the tumors and may halt their ability to grow in some patients."

"There is a tremendous need to advance new therapies for solid tumors and we look forward to progressing the clinical development of ifabotuzumab," said Cameron Durrant, MD, MBA, Chief Executive Officer, Humanigen. "Ifabotuzumab represents an important part of our immuno-oncology arsenal as we advance our pipeline to target a wide-range of cancers."