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.

On March 9, 2020 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported financial results for the year ended December 31, 2019 and provided a corporate update (Press release, Cellectar Biosciences, MAR 9, 2020, View Source [SID1234555315]).

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Fourth Quarter and Recent Corporate Highlights

·Announced CLR 131 achieved primary efficacy endpoints from its Phase 2 CLOVER-1 study in relapsed/refractory B-cell lymphomas and completion of the Phase 1 relapsed/refractory multiple myeloma Dose Escalation study. The data showed:

o42.8% overall response rate (ORR) in median 6th line treatment of multiple myeloma at the 75mCi total body dose

o81.8% of the multiple myeloma patients across all therapeutic doses tested experienced tumor reduction with a strong dose response

o100% ORR and 25% complete response (CR) seen in lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinemia (LPL/WM) patients

o42.0% ORR and 11% CR in all non-Hodgkin’s lymphoma (NHL) patients

·Received Orphan Drug Designation for CLR 131 in lymphoplasmacytic lymphoma (LPL) from the U.S. Food and Drug Administration

·Oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Conference entitled "Fractionated Dosing of CLR 131 in Patients with Relapsed or Refractory Multiple Myeloma"

·Oral presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress entitled "Interim Evaluation of a Targeted Radiotherapeutic, CLR 131, in Relapsed/Refractory Diffuse Large B-cell Lymphoma Patients"

·Scientific conference poster presentations during the quarter included:

oAmerican Association for Cancer Research (AACR) (Free AACR Whitepaper) San Antonio Breast Cancer Symposium entitled "Phospholipid ether delivery vehicle shows specificity for a broad range of tumor cells and provides a novel and improved approach for targeted therapy"

oAACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference entitled "CLR 180099, a lipid raft targeted phospholipid-drug conjugate, shows potent improved safety and efficacy against colorectal tumors"

oUK-AACR Joint Conference on Engineering and Physical Sciences in Oncology entitled "Preclinical evaluation of a novel phospholipid drug conjugate, CLR 2000045 with a combretastatin A-4 analogue for improved breast cancer therapy"

·Strengthened the management team with the appointment of Dr. Igor Grachev, Chief Medical Officer

"Data from our CLR 131 Phase 1 dose escalation study and the Phase 2 CLOVER-1 study demonstrated a unique safety profile and an encouraging response rate of nearly 43% as a sixth-line treatment for relapsed/refractory multiple myeloma," said James Caruso, President and CEO of Cellectar. "Importantly, the 75mCi dose demonstrated excellent activity in very challenging to treat subpopulations, high-risk, triple class refractory and penta-refractory. We plan to enroll additional patients at 100mCi of CLR 131 in the two-cycle dosing optimization regimen, which we believe will further increase response rates, the durability of responses and will likely be used in our pivotal study planned for initiation in Q4 of this year."

2019 Financial Highlights

Cash and Cash Equivalents: As of December 31, 2019, the company had cash, cash equivalents and restricted cash of $10.6 million compared to $13.3 million at December 31, 2018. Cash provided by financing activities was $9.0 million, offset by cash used in operating activities of $11.7 million. Consistent with prior guidance, the company believes its cash on hand is adequate to fund operations into the first quarter of 2021.

Research and Development Expense: Research and development expense for the year ended December 31, 2019 was $9.0 million, compared to $6.8 million for the year ended December 31, 2018. The overall increase in research and development expense of approximately 32% was primarily attributable to an increase in clinical project costs largely related to the startup of the pediatric study, as well as an increase in patient recruitment for the ongoing clinical studies.

General and Administrative Expense: General and administrative expense for the year ended December 31, 2019 was $5.2 million, compared to $4.8 million for the year ended December 31, 2018. The increase of 8% in general and administrative costs was primarily related to an increase in personnel and consulting costs and an increase related to public company expenses, rent and depreciation. These costs were offset by a decrease in accounting fees and restructuring charges.

Net Loss: The net loss attributable to common stockholders for the year ended December 31, 2019 was ($14.1) million, or ($1.84) per share, compared to ($15.5) million, or ($5.23) per share, in 2018.

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]).

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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.

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]).

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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.

On March 9, 2020 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, reported financial results for the fourth quarter and year ended December 31, 2019 and provided a corporate update (Press release, Crinetics Pharmaceuticals, MAR 9, 2020, View Source [SID1234555317]).

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"Crinetics made significant progress in 2019 advancing our development programs, as highlighted by the initiation of the ACROBAT Phase 2 clinical trials for acromegaly with our lead product candidate paltusotine," said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. "Paltusotine is a first-in-class nonpeptide small molecule, which demonstrates our ability to develop novel drugs for diseases and patients that have not seen truly innovative therapies in a long time. We anticipate that 2020 will be a year of additional important milestones as our pipeline continues to advance. Importantly, we plan to provide guidance on timing of our acromegaly and neuroendocrine tumor programs early in the second quarter. In addition, we are advancing our ACTH antagonist development candidate for Cushing’s disease and congenital adrenal hyperplasia as well as our sst5 agonist development candidate for congenital hyperinsulinemia towards the clinic as IND enabling activities for both programs are underway."

Full Year 2019 Highlights

Dosed first patients in Phase 2 clinical trials of paltusotine (formerly CRN00808) for acromegaly. In March 2019, Crinetics dosed the first patients in the ACROBAT EDGE and EVOLVE trials for paltusotine in patients with acromegaly. EDGE is an open label exploratory study designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine, an oral selective nonpeptide somatostatin receptor type 2 (sst2) biased agonist, in patients with acromegaly whose disease is not biochemically controlled by octreotide LAR or lanreotide depot alone. EVOLVE is a double-blind, placebo-controlled, randomized withdrawal study designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine in patients with acromegaly whose disease is biochemically controlled by octreotide LAR or lanreotide depot monotherapy.

Initiated Phase 1 trial of CRN01941. In May 2019, Crinetics initiated a Phase 1, double blind, randomized, placebo-controlled, single- and multiple-dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CRN01941 in healthy volunteers. Like paltusotine, CRN01941 is an oral nonpeptide sst2 biased agonist. CRN01941 is initially in development as a potential treatment for neuroendocrine tumors (NETs) that originate from neuroendocrine cells commonly found in the gut, lung, or pancreas. Upon analysis of the cumulative data from the paltusotine and CRN01941 preclinical, nonclinical and clinical programs, Crinetics intends to decide whether to advance CRN01941 or paltusotine into a later stage trial in NETs.

Expanded management team and board of directors. In March 2019, Crinetics appointed Gina Ford, R.Ph., MBA, as Vice President, Corporate Strategy and Commercial Planning. Ms. Ford joined Crinetics from One Joule, LLC a commercial and corporate strategy consulting company she founded, where she provided biopharmaceutical clients with strategic advice on corporate, commercial, marketing and global market access strategy. Among her prior roles, Ms. Ford served as Head of Endocrinology with Ipsen Pharmaceuticals, where she led the endocrine franchise, which included the commercial leadership of a drug to treat acromegaly and neuroendocrine tumors. In July 2019, Crinetics appointed Stephanie S. Okey, M.S. to its board of directors as an independent board member. Ms. Okey brings extensive leadership and management experience in senior commercial roles including, most recently, Head of North America and U.S. General Manager of Rare Diseases at Genzyme.

Fourth Quarter and Full Year 2019 Financial Results

Research and development expenses were $12.1 million and $41.5 million for the three months and full year ended December 31, 2019, respectively, compared to $7.7 million and $24.5 million for the same periods in 2018. The increases were primarily attributable to clinical development and manufacturing activities for paltusotine and CRN01941 as well as the company’s preclinical programs.

General and administrative expenses were $3.4 million and $13.5 million for the three months and full year ended December 31, 2019, compared to $2.6 million and $6.7 million for the same periods in 2018. The increases were primarily due to costs to operate as a public company, as well as personnel costs to support the company’s growth.

Net loss for the three months ended December 31, 2019 was $14.5 million, compared to a net loss of $8.5 million for the same period in 2018. For the year ended December 31, 2019, the company’s net loss was $50.4 million compared to a net loss of $27.1 million for the year ended December 31, 2018.

Unrestricted cash, cash equivalents and investments totaled $118.4 million as of December 31, 2019, compared to $131.7 million as of September 30, 2019 and $163.9 million as of December 31, 2018. Crinetics expects that its cash, cash equivalents and investments will fund its current operating plan into the second half of 2021.

As of February 28, 2020, the company had 24,566,896 common shares outstanding.