On June 5, 2020 Everest Medicines, a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, reported that it has successfully completed US$310 million in Series C financing (Press release, Everest Medicines, JUN 5, 2020, View Source [SID1234560865]).

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The US$310 million Series C financing includes two preferred equity financing tranches, a US$260 million Series C-2 and a US$50 million Series C-1. The Series C-2 was led by Janchor Partners and co-led by RA Capital Management and Hillhouse Capital with additional support from new investors, including Decheng Capital, GT Fund, Janus Henderson Investors, Rock Springs Capital, Octagon Investments and a large, reputable long-term investor. Existing investors, including CBC Group, Cormorant, Pavilion Capital and HBM Healthcare Investments also participated. The Series C-1 comprised of a US$50 million investment from the Jiashan SDIC, which was part of a broader strategic partnership with Jiashan National Economic and Technological Development Zone and Jiashan SDIC announced on March 17, 2020.

Proceeds from the financing will be used to advance clinical development of Everest Medicines’ robust pipeline of novel therapeutic candidates and build out a strong commercial infrastructure to support the next phase of growth. To date, the Company has made important progress with its broad pipeline.

– TrodelvyTM (sacituzumab govitecan-hziy) is a first-in-class anti-Trop-2 antibody-drug conjugate (ADC) approved in the US for patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies. The Company received a Clinical Trial Application (CTA) approval in China for sacituzumab govitecan in mTNBC in April 2020, with plans to initiate clinical development in multiple solid tumor indications.
– XeravaTM (eravacycline) is a novel, fully synthetic, broad-spectrum parenteral antibiotic of the tetracycline class that has shown broad in vitro activity against Gram-negative pathogens that have acquired multidrug resistance (MDR) and are prevalent in China. Xerava is currently approved for the treatment of complicated intra-abdominal infections (cIAI) in the US and EU. The Company received approval in Singapore for eravacycline in cIAI in April 2020. The Company is conducting a Phase 3 clinical trial in China for cIAI to support regulatory approval.
– Etrasimod is a potential best-in-class oral modulator of the sphingosine 1-phosphate receptor (S1PR). The Company is conducting a multi-center Phase 3 clinical trial in ulcerative colitis in Mainland China, South Korea and Taiwan.
– Taniborbactam is a parenteral, potential best-in-class, cyclic boronate compound that inhibits both serine and metallo-ß-lactamases. The Company and its licensing partner, Venatorx Pharmaceuticals, are conducting a global Phase 3 clinical trial for patients with complicated urinary tract infections.
– Ralinepag XR is a potential best-in-class extended release agonist of the IP receptor that allows convenient oral dosing for the treatment of pulmonary arterial hypertension (PAH). The Company is conducting a global Phase 3 clinical trial in PAH in collaboration with its licensing partner United Therapeutics.
– Nefecon is a potential first-in-disease product for the treatment of IgA nephropathy (IgAN). In December 2019, the Company received a CTA approval for Nefecon in IgAN. The Company will join the global Phase 3 clinical trial in collaboration with its licensing partner Calliditas Therapeutics.
– FGF401 is a potential first-in-class, ATP-competitive, reversible-covalent inhibitor of FGFR4 for which the Company obtained global rights from Novartis. The CTA for a Phase 1b/2 trial in China in patients with hepatocellular carcinoma was approved in March 2020.
– SPR206 is a potential best-in-class, novel polymyxin derivative that was designed to reduce the kidney toxicity that is seen clinically with polymyxin B and colistin.
"This is an important milestone for Everest Medicines that reinforces our deep industry expertise and strategic business model to in-license global innovation for the development of critical therapies in Greater China and Asia. We are well-positioned to advance the clinical development of our robust therapeutics pipeline, which spans a number of important diseases, and we look forward to building a strong foundation on which we will grow our commercial business," said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines.

"Everest Medicines has made remarkable progress securing strategic partnerships with established industry leaders to build and develop its promising therapeutics pipeline," said John Ho, Founder and Chief Industrialist Investor of Janchor Partners. "We are excited to partner with Everest to support its mission to deliver innovative therapies to patients with life-threatening diseases in China."

"We are proud of what Everest has achieved in such a short period since its inception in late 2017," said Wei Fu, Chairman of Everest Medicines and Chief Executive Officer of CBC Group, which incubated the Company. "The strong network of investors validates Everest Medicines’ early achievements, as well as their confidence in Everest’s potential to grow into a leading innovative drug platform company in the region."

"We are pleased to be joined by this exceptional group of leading global biopharma institutional investors and look forward to partnering with them during this exciting and important period of growth for Everest Medicines," said Ian Woo, President and Chief Financial Officer of Everest Medicines.

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies.

Everest Medicines has built a portfolio of eight potentially global first-in-class or best-in-class molecules, many of which are in late stage clinical development. The Company’s therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases. Currently, four assets are in clinical trials designed for registration in China and two additional assets will start registrational trials in 2020.

On June 5, 2020 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to margetuximab, an investigational, Fc-engineered monoclonal antibody targeting HER2 for the treatment of gastric and gastroesophageal junction cancer (Press release, MacroGenics, JUN 5, 2020, View Source [SID1234560863]).

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Margetuximab is currently being evaluated in the Phase 2/3 MAHOGANY clinical trial in combination with checkpoint inhibition, with or without chemotherapy, as a potential first-line treatment for patients with HER2-positive gastric cancer (GC) or gastroesophageal junction (GEJ) cancer. The MAHOGANY study is based on results from an ongoing Phase 2 study of margetuximab plus pembrolizumab, an anti-PD-1 monoclonal antibody, for patients with advanced HER2-positive GC or GEJ cancer who have previously been treated with chemotherapy and trastuzumab in the metastatic setting. Data were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress in September 2019.

"We are pleased that the FDA has granted orphan status to margetuximab," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We believe that our immune-enhancing antibody targeting HER2 has the potential to improve upon the clinical activity of existing standard of care for patients with gastric or gastroesophageal cancer."

The FDA grants ODD to medicines intended for the treatment, diagnosis or prevention of rare diseases of disorders that affect fewer than 200,000 people in the U.S. The designation provides certain incentives, which may include seven years of marketing exclusivity for the orphan indication, certain federal grants, tax credits and waiver of certain FDA fees.

About Gastric and Gastroesophageal Junction Cancer

Cancer of the stomach (gastric cancer) or the gastroesophageal junction (where the esophagus joins the stomach) is collectively known as gastroesophageal adenocarcinoma. According to the American Cancer Society, approximately 27,600 new cases of gastric cancer will be diagnosed in the U.S in 2020 and more than 11,000 people will die from the disease. Both GC and GEJ cancer are often diagnosed at an advanced stage and therefore have very poor prognosis, with a 5-year survival of 5-20%. Chemotherapy is the standard of care for first-line therapy and may be combined with trastuzumab for the approximately 20% of patients whose tumors are HER2-positive.

About Margetuximab

Margetuximab is an Fc-engineered, monoclonal antibody that targets the HER2 oncoprotein. HER2 is expressed by tumor cells in breast, gastroesophageal and other solid tumors. Margetuximab was designed to provide HER2 blockade and has similar HER2 binding and antiproliferative effects as trastuzumab. In addition, margetuximab has been engineered to enhance the engagement of the immune system through MacroGenics’ Fc Optimization technology. A Biologics License Application (BLA) for margetuximab for the treatment of patients with metastatic HER2-positive breast cancer in combination with chemotherapy is under review by the FDA, with a Prescription Drug User Fee Act (PDUFA) goal date of December 18, 2020. Margetuximab is also being evaluated in combination with checkpoint blockade. The Phase 2/3 MAHOGANY trial for the treatment of patients with HER2-positive gastroesophageal cancer is ongoing (NCT04082364). For more information please visit www.clinicaltrials.gov.

On June 5, 2020 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported that Ron Peck, M.D., Chief Medical Officer, will participate in a fireside chat at the Goldman Sachs 41st Annual Global Healthcare Conference on Thursday, June 11 at 4:40 p.m. ET (Press release, Arvinas, JUN 5, 2020, View Source [SID1234560862]).

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A live audio webcast of the presentation will be available here and on the Company’s website at www.arvinas.com. A replay of the webcast will be archived on the Arvinas website for 30 days following the presentation.

On June 5, 2020 hugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it filed an application with the Ministry of Health, Labour and Welfare for the expanded use of FoundationOne CDx Cancer Genomic Profile as a companion diagnostic for the PARP inhibitor, Lynparza (generic name: olaparib), for the treatment of homologous recombination repair mutated (HRRm) metastatic castration-resistant prostate cancer (mCRPC) (Press release, Chugai, JUN 5, 2020, View Source [SID1234560861]).

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"Currently, various approaches are progressing to investigate new treatments for patients with mCRPC who are resistant to hormonal therapy and genomic medicine could become an important treatment option," said Dr. Osamu Okuda, Chugai’s President and COO. "Since HRR gene alterations are recognized to be identified in multiple genes, we believe FoundationOne CDx Cancer Genomic Profile will be a useful tool that can support physicians to identify patients who may benefit from treatment with Lynparza by comprehensively understanding patients’ genomic profiles."

The filing aims to expand the use as a companion diagnostic to identify patients who could benefit from Lynparza for the treatment of mCRPC with HRR related gene alterations, and have progressed following prior treatment with enzalutamide or abiraterone by detecting HRR related gene alterations. The efficacy and safety of Lynparza in mCRPC patients were investigated in the Phase III PROfound study. Lynparza is jointly developed and commercialized by AstraZeneca (LSE/STO/NYSE: AZN) and MSD (MSD: known as Merck & Co. inside the US and Canada).

Developed by Foundation Medicine Inc., FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. The program is available as a companion diagnostic for multiple molecular-targeted drugs approved in Japan.

As a leading company in the field of oncology, Chugai is committed to realize advanced personalized oncology care and contribute to patients and healthcare professionals through improving access to comprehensive genomic profiling.

Trademarks used or mentioned in this release are protected by laws.

On June 4, 2020 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors, reported that it has entered into a collaboration agreement with the Explorations in Global Health (ExGloH) Division of Leidos to evaluate the potential of using ONCOS oncolytic adenoviruses as a vector to encode Microtide checkpoint inhibitor peptides (Press release, Targovax, JUN 4, 2020, View Source [SID1234564001]).

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Targovax’s clinical program is focused on combining ONCOS viruses with checkpoint inhibitors. This combination is promising since checkpoint inhibition complements oncolytic virotherapy by blocking the tumor’s main defense mechanism against the anti-tumor immune response generated by the oncolytic virus.

ExGloH has developed a unique, proprietary portfolio of microbially-derived peptides, called MicrotideTM, that act as immune checkpoint inhibitors. The simple structure and small size of Microtide peptides make them well-suited for delivery by DNA vectors, and the parties will explore whether this capability can be extended to ONCOS viruses. If successful, this could potentially circumvent the need to combine ONCOS with classical systemically delivered checkpoint inhibitors.

Under the agreement, Leidos and Targovax will investigate the technical feasibility, in vitro and in vivo immune modulatory, and anti-cancer properties of encoding Microtide checkpoint peptides in the ONCOS adenovirus backbone. If successful, the combined ONCOS and Microtide constructs may serve as a platform where additional functionality can be built in to stimulate multiple complementary anti-tumor mechanisms.

Dr. Erik Digman Wiklund, Chief Business Officer of Targovax, said: "We are continuously looking for new strategies to enhance the immune activation potential and explore novel payloads for our ONCOS viruses. In ExGloH we have found a collaborator with a unique class of checkpoint inhibitors that we believe perfectly complements ONCOS. We are very excited to jointly explore whether the ONCOS and Microtide combination can enhance the second generation of ONCOS viruses and serve as a platform for future clinical product candidates to fulfil important medical needs."