On September 25, 2020 Accord Healthcare reported that it has launched Zercepac (trastuzumab), a biosimilar of Roche’s Herceptin, in the UK after winning approval from the European Commission in July (Press release, Accord Healthcare, SEP 25, 2020, View Source [SID1234567633]).

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The biosimilar is indicated for use as a treatment of certain patients with HER2-positive early and metastatic breast cancer, as well as previously untreated HER2-positive metastatic gastric cancer.

The European Commission approval of Zercepac was based on a number of clinical studies including comparative quality studies, preclinical and clinical studies. The results confirmed the biosimilarity between the products, demonstrating comparable efficacy and safety to Herceptin.

"We are proud to launch Zercepac in the UK and offer healthcare professionals an additional option of this vital oncology medicine," said Anup Sidhu, speciality brands director at Accord.

"This is the launch of our first monoclonal antibody, reinforcing our commitment to ensuring improved patient access whilst also helping to alleviate some of the pressures on overstretched health systems," he added.

Zercepac is the fourth biosimilar to be launched in Europe by Accord, among a 30-strong portfolio of oncology treatments.

On September 25, 2020 M2GEN reported that it has entered into an agreement with Discovery Life Sciences, a global leader in biospecimen solutions, genomic, cell, and immunohistochemistry (IHC) services, to provide M2GEN’s recently launched oncology-focused bioinformatics support services (Press release, M2Gen, SEP 25, 2020, View Source [SID1234567625]).

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Under the agreement, M2GEN will provide pipeline analyses for paired tumor/normal and tumor-only somatic mutation identification from Whole Exome Sequencing (WES), and gene expression and fusion detection from tumor RNA Sequencing (RNA-Seq).

M2GEN’s bioinformatics analysis pipelines leverage results and interpretation gained from its cancer knowledge base including, ORIEN AVATAR, a comprehensive ever-expanding clinico-genomic database. M2GEN’s Bioinfomatics Support Services key differentiators include applying one of the largest Panel of Normals (PoN) available for high-quality somatic mutation calling. Over 20,000 germline samples from cancer patients with a wide range of oncology diagnoses inform the segregation of somatic and germline variants, and identify recurrent sequencing artifacts. In addition, germline data from ORIEN AVATAR patients are leveraged as a Virtual Normal (VN) cohort during tumor-only analysis, allowing for superior somatic mutation classification when patients’ matched normal biospecimens are unavailable.

Over the last four years, M2GEN and Discovery Life Sciences have collaborated to establish a standardized workflow combining preanalytical and sequencing solutions to analyze precious clinical liquid and solid biospecimens. Discovery Life Sciences has sequenced tens of thousands samples from oncology patients using its harmonized Whole Exome and RNA-Seq platforms. This effort significantly contributed to building M2GEN’s ORIEN AVATAR database which has recently been launched to the global pharma, biopharma and molecular and companion diagnostic industry to enhance oncology research, improve protocol design for and support patient identification and enrollment to clinical trials, thus, accelerating the discovery and development of new diagnostics, medicines and targeted therapies for cancer patients.

"M2GEN’s best in class bioinformatics services, combined with the ability to annotate data against M2GEN’s longitudinal clinical and molecular databases, perfectly complement the suite of genomic sequencing services offered by HudsonAlpha Discovery ," said Shawn Levy, PhD, Chief Scientific Officer at HudsonAlpha Discovery.

"We are excited to expand our long-standing successful collaboration with Discovery Life Sciences by providing our oncology focused bioinformatics services and solutions to Discovery," said Oliver Hampton PhD, Vice President of Bioinformatics & Biostatistics at M2GEN. "This agreement demonstrates the power of our multi-disciplinary expertise to access, curate, harmonize and interpret complex clinical and molecular data sets and to leverage our high-depth database for the benefit of interpreting and adding value to information generated by third parties", adds Helge Bastian, PhD, M2GEN’s President & CEO.

On September 25, 2020 Rakuten Medical Inc. reported that its wholly owned subsidiary Rakuten Medical Japan K.K. has received marketing approval in Japan from the Ministry of Health, Labour and Welfare for Akalux IV Infusion 250mg (cetuximab saratolacan sodium) to treat unresectable locally advanced or recurrent head and neck cancer. BioBlade Laser System, the medical device used in the combination with Akalux, was also approved on September 2nd. This combination was developed under the Rakuten Medical Illuminox platform. Akalux received Sakigake Designation in April 2019, and application for approval under the Conditional Early Approval System was made in March 2020. Outside of Japan, Rakuten Medical does not have approval of its investigational therapies and is currently running a global Phase 3 trial.

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Hiroshi Mikitani, Representative Director and Chairman of Rakuten Medical Japan K.K. commented, "In my search for a treatment for my father who was diagnosed with cancer, I encountered a treatment developed by a Japanese researcher. Now, we are moving forth to deliver this treatment to patients fighting with cancer, as soon as possible. Today, we are deeply moved to receive approval in Japan ahead of the world. However, this is just the beginning of Rakuten Medical’s mission. We are dedicated to contribute to cancer treatment and improving the quality of life of as many patients as possible around the world. By bringing everyone together, we will continue to aspire to achieve our corporate mission ‘to conquer cancer.’" (Press release, Rakuten Medical, SEP 25, 2020, View Source [SID1234567624])

On September 25, 2020 Novo Seeds, the early stage investment and company creation team of Novo Holdings, reported that its portfolio company Galecto Inc. (Galecto), a privately-held biotechnology company focused on the development of novel treatments for fibrosis and cancer, successful completed a USD 64 million equity financing (Press release, Novo, SEP 25, 2020, View Source [SID1234567623]).

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Galecto was first incubated through the pre-seed grant programme of the Novo Nordisk Foundation in 2009, and subsequently Novo Seeds led its first seed investment round in 2010. Novo Seeds was instrumental in recruiting the Chief Executive Officer (CEO) Hans Schambye who has been driving the progress since the start. Novo Seeds also led the company’s last fundraise in 2018, when it became its largest shareholder.

Søren Møller, Managing Partner at Novo Seeds, commented: "As the original incubators and first investor in Galecto, we are very proud of the company’s accomplishments to date. This solid financing positions this Nordic company as global leader in diseases with high unmet medical need and validates Novo Seeds’ investment strategy of building the next-generation of life sciences companies and continue financing as they build value. As one of the largest company creator teams in Europe, we are encouraged by this international syndicated fundraise and we look forward to continuing playing a prominent role in shaping the Nordic biotech ecosystem."

Hans Schambye, CEO of Galecto, said: "We are delighted to once again count on Novo Seeds’ support and look forward to continue working with this group of renowned investors in shaping the future of the company. Together with our existing cash balance, this raise will enable the continuing development of Galecto, including advancing our promising GB0139 product candidate, which has orphan drug designation in both the U.S. and EU, towards market. This financing will also support the further expansion of our clinical development as we aim to have three Phase 2 studies running by the end of 2020. We are looking forward to advancing our products through clinical development and potentially to market to address significant unmet medical needs."

Galecto intends to use the funds to prepare for a potential conditional approval of GB0139 for the treatment of Idiopathic Pulmonary Fibrosis (IPF) in the European Union in 2022 and to further expand and advance its clinical development pipeline. Galecto is currently conducting a Phase 2b trial of GB0139 in IPF and intends to initiate Phase 2 studies of GB1211 in liver fibrosis related to Non-Alcoholic SteatoHepatitis (NASH) and GB2064 in Myelofibrosis by the end of this year.

The financing was led by Soleus Capital and co-led by Eir Ventures, with the participation of Novo Holdings, and new and existing investors including: OrbiMed, Ysios Capital, HBM Healthcare Investments, Sunstone Capital, Bristol Myers Squibb, Seventure, Maverick Ventures,Cormorant Asset Management, Janus Henderson Investors, Hadean Capital, Sphera, Asymmetry Capital Management and Canica.

On September 25, 2020 RemeGen Co., Ltd. ("RemeGen") reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for disitamab vedotin (RC48), a novel humanized anti-HER2 antibody drug conjugate (ADC), for the second-line treatment of patients with HER2 positive locally advanced or metastatic urothelial cancer (UC) who have also previously received platinum-containing chemotherapy treatment (Press release, RemeGen, SEP 25, 2020, View Source [SID1234567622]). Earlier this year, RemeGen announced the FDA’s clearance of an Investigational New Drug (IND) application for a Phase II clinical study in the United States and the grant of Fast Track designation for disitamab vedotin.

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A drug development program with Breakthrough Therapy designation is eligible for all Fast Track designation features, intensive guidance on an efficient drug development program beginning as early as Phase I, and organizational commitment involving senior managers. This process is designed to expedite the development and review process.

"An estimated 81,400 new cases of urothelial cancer and 17,980 deaths are predicted in the United States in 2020i," said Jianmin Fang, Ph.D., founder, CEO and CSO of RemeGen. "The high prevalence of metastatic urothelial cancer underscores the need for effective and accessible treatment methods for patients. This Breakthrough Therapy designation will bring RemeGen one step closer to finding a safe and effective treatment for this devastating disease. We look forward to working with the FDA to advance the clinical development of disitamab vedotin."

Urothelial cancer represents the ninth most common cancer worldwide and the fourth most common cancer in men in the United States.ii

About RC48
RC48 was developed to treat HER2 expressing solid tumors. It has a novel antibody with a higher affinity to HER2 compared to standard of care, and superior anti-tumor activity compared to other treatments in animal models. RC48 was the first ADC drug approved for human clinical trials in China and favorable safety profile has been observed in clinical trials. It is currently being studied in multiple late-stage clinical trials across solid tumor types.