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3S Sunshine Guojian Partner Numab Therapeutics Closes Series B Financing

On March 9, 2020 Numab reported the closing of its Series B financing round at a total volume of CHF 22M (approximately USD 22.6M) (Press release, Numab, MAR 9, 2020, View Source [SID1234637794]). New investors in this round included 3SBio Group’s subsidiary Sunshine Guojian Pharmaceutical（Shanghai）Co., Ltd., Mitsubishi UFJ Capital Co., Ltd. and Eisai Co., Ltd. as well as Numab’s board member Dr. Daniel Vasella. Numab’s existing shareholders also contributed to the financing round. Sunshine Guojian invested CHF15M in this series B financing in December 2019. Dr. Zhenping Zhu, MD, PhD, President of Research and Development, Chief Scientific Officer of 3SBio, has joined the Numab’s board of directors. With the financing secured, Numab plans to further broaden its proprietary pipeline and accelerate the development for a number of programs towards the clinic. The company also plans to initiate a clinical trial for its lead oncology program ND021 during the course of 2020.

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Mitsubishi UFJ Capital is one of Asia’s leading venture capital firm focusing on life science, information and communications technology and high technology investments. Numab and Eisai entered into a global research and option agreement to discover and develop a portfolio of multi-specific antibody immunotherapies for cancer in October 2019. In December 2019, Numab added a regional alliance with Sunshine Guojian to its growing roster of pharmaceutical partnerships.

"We are very pleased to have attracted a renowned institutional investor in Mitsubishi UFJ Capital to the Numab story and likewise appreciate the additional display of confidence in our platform and pipeline strategy by our partners as well as by our existing Series A investors and our board member Dr. Daniel Vasella," commented Dr. David Urech, Chief Executive Officer of Numab Therapeutics.

"3SBio is committed to developing innovative cancer cures. The investment and collaboration with Numab are consistent with our strategies. we are looking forward to collaborating with the Numab team to explore cutting edge immunotherapies in oncology." said Dr. Jing Lou, Chairman and Chief Executive Officer of 3SBio。

Multi-specific antibodies have the potential to unlock entirely novel modes-of-action aiming at superior benefit-to-risk profiles relative to conventional cancer immune therapies. Numab’s proprietary MATCH technology platform represents one of the most versatile and flexible sources for multi-specific antibodies. MATCH molecules can incorporate up to six binding specificities in true plug-and-play fashion. The individual antibody Fv building blocks are designed for maximum stability and developability.

U.S. FDA Accepts Biologics License Application (BLA) for Mylan and Biocon’s Proposed Biosimilar Bevacizumab for Review

On March 9, 2020 Biocon Ltd. (BSE code: 532523, NSE: BIOCON) and Mylan N.V.(NASDAQ: MYL) reported that the U.S. Food and Drug Administration (FDA) has accepted Mylan’s Biologics License Application (BLA) for MYL-1402O, a proposed biosimilar to Avastin (bevacizumab), for review under the 351(k) pathway (Press release, Biocon, MAR 9, 2020, View Source [SID1234594758]).

The BLA seeks approval of bevacizumab for first-line and second-line treatment of patients with metastatic colorectal cancer in combination with fluorouracil-based chemotherapy; first-line use for patients with non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma in combination with interferon alfa; and persistent, recurrent or metastatic cervical cancer.

The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Dec. 27, 2020.

Biocon and Mylan’s proposed biosimilar bevacizumab is expected to be the third biosimilar from the partnered portfolio for the cancer patients in the U.S. It is currently available in India and other developing markets.

Dr Christiane Hamacher, CEO, Biocon Biologics, said: "The US FDA’s acceptance of our BLA for a proposed biosimilar bevacizumab co-developed by Biocon Biologics and Mylan is an important milepost in our journey of enabling access to affordable cancer therapies for patients. Once approved, our proposed biosimilar bevacizumab will provide an affordable alternative to the branded biologic for the approved indications. Biocon Biologics’ strong R&D and manufacturing capabilities have enabled us to offer two key biosimilars to cancer patients in the U.S. and bevacizumab will further expand our oncology portfolio."

Mylan President Rajiv Malik commented: "As we continue toward our goal of expanding access to cancer treatments for oncology patients, the FDA acceptance of our application for proposed biosimilar bevacizumab is another important step forward to increase competition, drive health system savings and expand our growing oncology portfolio to provide a broad range of offerings. We’re encouraged by the results of our scientific program to date and look forward to advancing the review of our application."

The BLA is supported by a global randomized, controlled phase 3 clinical trial to evaluate the efficacy, safety and immunogenicity of proposed biosimilar bevacizumab versus Avastin.

The study included patients diagnosed with stage 4 non-squamous non-small cell lung cancer. Eligible patients were randomised to receive either the proposed biosimilar bevacizumab or Avastin along with carboplatin and paclitaxel for up to six cycles (18 weeks). After which the patients continued to receive monotherapy until week 42. Additionally, patients benefitting from the treatment continued on bevacizumab monotherapy. The primary endpoint was overall response at week 18, using RECIST 1.1. Secondary endpoints included safety, progression free survival and overall survival at week 18 and 42.

A total of 671 patients were randomized. At week 18, the study met the primary endpoint and the 90% confidence interval for the best ORR (objective response rate) ratio was within the pre-specified equivalence margin. The safety which included immunogenicity was found to be similar to Avastin.

About the Biocon and Mylan Partnership
Mylan and Biocon Biologics are exclusive partners on a broad portfolio of biosimilar and insulin products. Our proposed biosimilar bevacizumab is one of the 11 biologic products being co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for the product in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.

U.S. FDA Accepts Biologics License Application (BLA) for Mylan and Biocon’s Proposed Biosimilar Bevacizumab for Review

On March 9, 2020 Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) reported that the U.S. Food and Drug Administration (FDA) has accepted Mylan’s Biologics License Application (BLA) for MYL-1402O, a proposed biosimilar to Avastin (bevacizumab), for review under the 351(k) pathway (Press release, Mylan, MAR 9, 2020, View Source [SID1234565288]).

The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Dec. 27, 2020.

Mylan and Biocon’s proposed biosimilar bevacizumab is expected to be the third biosimilar from the partnered portfolio for cancer patients in the U.S. It is currently available in India and other developing markets.

The BLA is supported by a global randomized, controlled phase 3 clinical trial to evaluate the efficacy, safety and immunogenicity of proposed biosimilar bevacizumab versus Avastin. The study included patients diagnosed with stage 4 non-squamous non-small cell lung cancer. Eligible patients were randomised to receive either the proposed biosimilar bevacizumab or Avastin along with carboplatin and paclitaxel for up to six cycles (18 weeks). After which the patients continued to receive monotherapy until week 42. Additionally, patients benefitting from the treatment continued on bevacizumab monotherapy. The primary endpoint was overall response at week 18, using RECIST 1.1. Secondary endpoints included safety, progression free survival and overall survival at week 18 and 42.

Abbisko Therapeutics Announces Receiving of the IND Approval by the China NMPA for ABSK-011, A Novel FGFR4 Inhibitor

On March 9, 2020 Abbisko Therapeutics, a clinical-stage biopharmaceutical company, reported that it has received the regulatory approval by the National Medical Products Administration (NMPA) of China to initiate its phase 1 trial for ABSK-011, a novel FGFR4 inhibitor in advanced solid tumors (Press release, Abbisko Therapeutics, MAR 9, 2020, View Source;article_id=138&brd=1 [SID1234556285]).

ABSK-011 is independently discovered and developed by Abbisko Therapeutics with full intellectual property rights worldwide. It is an orally administrated, highly potent, and selective small molecule inhibitor of FGFR4 with best-in-class drug-like properties. Through disruption of FGF19-FGFR4 pathway activities, ABSK-011 offers a potential novel therapeutic approach to treat cancers such liver cancers harboring aberrant FGFR4 pathway alterations. Liver cancer in China accounts for ~50% of the global incidence with poor survival rate and limited treatment options, representing a major unmet clinical needs in the territory and around the world. To date, no FGFR4-targeted therapies have been approved worldwide.

ABSK-011 is the first program of Abbisko Therapeutics to be approved for clinical studies in China. In December 2019, Abbisko has also received the IND approval in Taiwan to conduct first-in-human studies of ABSK-011.

Founded in April 2016, Abbisko Therapeutics Co., Ltd. is a biopharmaceutical company dedicated to discovering and developing innovative therapeutics to treat cancer and other diseases with unmet medical needs. The founders and core team of Abbisko are industrial veterans with strong leadership and managerial experiences from top international pharmaceutical companies. Over three years, Abbisko has established a strong oncology pipeline with multiple programs entering the clinic.

Immutep Receives Second IND approval for Efti from US FDA

On March 9, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported the approval of its Investigational New Drug ("IND") application by the United States Food and Drug Administration ("FDA") for eftilagimod alpha ("efti" or "IMP321") (Press release, Immutep, MAR 9, 2020, View Source [SID1234555341]).

The FDA approval of the IND allows Immutep to initiate its planned AIPAC-002 Phase I clinical study in metastatic breast cancer (MBC) patients. Immutep will commence the study, subject to the completion of other preparatory steps and pending positive results from its larger AIPAC Phase IIb study, which are expected to be reported by the end of March 2020.

Immutep CEO, Marc Voigt stated: "Receiving our second IND approval for efti from the FDA is a crucial step forward for Immutep. The IND allows us to initiate, effectively, a small bridging study called AIPAC-002 that enables us to further interact with the FDA in terms of efti in metastatic breast cancer. The results of our larger AIPAC trial will be reported this month. If they are positive, we will proceed with the final preparations and more importantly, will advance our discussions with regulators in order to make key strategic decisions about efti."

Overview of AIPAC-002

AIPAC-002 is a Phase I trial evaluating efti in combination with a taxane-based standard of care chemotherapy, called paclitaxel, in 24 patients with MBC in the US and the EU to boost the T-cell immune responses against tumours. This is the same combination therapy being investigated in Immutep’s Phase IIb AIPAC study. The trial forms part of Immutep’s strategy to expedite the possible use of efti for MBC patients in the US.

The IND application allows Immutep to ship efti across US state borders to US clinical investigators participating in the AIPAC-002 clinical study.