19 June 2019

Japan first to approve Roche’s tumour-agnostic medicine Rozlytrek

Roche’s move into personalised cancer medicines has hit a milestone after Japan approved the company’s Rozlytrek (entrectinib) as a treatment for neurotrophic tyrosine receptor kinase (NTRK) fusion-positive, advanced recurrent solid tumours.

Rozlytrek’s approval for adult and paediatric patients was granted by Japan’s Ministry of Health, Labour and Welfare (MHLW).

Rozlytrek targets NTRK gene fusions in a wide range of solid tumour types, including pancreatic, thyroid, salivary gland, breast, colorectal and lung tumours.

The MHLW granted Sakigake designation and orphan drug designation to Rozlytrek, which is undergoing regulatory review for the treatment of ROS1 fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

Roche chief medical officer and Global Product Development head Sandra Horning said: “Today’s approval of Rozlytrek represents a new chapter in personalised healthcare, applying advanced diagnostics to deliver precision medicines that target cancers based on their molecular drivers instead of their location in the body.

“We are proud to be at the forefront of personalised medicine with this novel treatment approach, and we look forward to working with regulatory agencies around the world to bring Rozlytrek to more patients with NTRK fusion-positive cancer, as well as to those with ROS1 fusion-positive NSCLC, as soon as possible.”

Approval was supported by data from the pivotal Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA-372-001 trials, in addition to data from the Phase I/II STARTRK-NG study in paediatric patients.

18 June 2019

Sanofi and Google partner to set up healthcare innovation lab

Sanofi and Google will establish a virtual innovation lab to tap emerging data technologies.

Under the project, both companies will use deep analytics to better understand key diseases and extract related patient insights, allowing Sanofi to develop more personalised approaches to treatment.

The innovation lab is expected to help transform the delivery of future medicines. The collaboration will improve the understanding of diseases, increase Sanofi’s operational efficiency, and improve the experience of Sanofi’s patients and customers.

The companies will use Sanofi’s database to understand what treatments work for patients. The objective is to improve personalised treatment, optimise patient care and reduce healthcare costs.

Sanofi chief digital officer, chief medical officer and executive vice-president of medical Ameet Nathwani said: “We stand on the forefront of a new age for biology and human health, with the opportunity to transform healthcare through partnerships with pioneering technology and analytics companies.

“Combining Sanofi’s biologic innovations and scientific data with Google’s industry-leading capabilities, from Cloud computing to state-of-the-art artificial intelligence, we aspire to give people more control over their health and accelerate the discovery of new therapies.”

Sanofi and Google intend to use artificial intelligence (AI) across datasets to forecast sales and inform marketing and supply chain efforts. By using AI, the companies will be able to take into account real-time information, including geographic, logistic and manufacturing constraints to help the accuracy of these activities.

Sanofi IT will migrate some business applications to the Google Cloud platform. The company intends to accelerate and simplify legacy management while providing easy integration into business plans via automation, scalability and agility.

The transition to the Google Cloud platform is expected to maximise operational cost efficiency and support business objectives, including the innovation lab.

Google Cloud CEO Thomas Kurian said: “Life sciences companies are looking to data-driven, digital innovation to help fuel the creation of accessible healthcare solutions. We look forward to collaborating with Sanofi to help accelerate the cycle of healthcare innovation to populations throughout the world.”

17 June 2019

Upsher-Smith to buy migraine drugs from Dr Reddy’s

Upsher-Smith Laboratories has signed a definitive asset purchase agreement to acquire neurology products from Dr Reddy’s Laboratories.

The deal includes the rights to 3mg Zembrace Symtouch (sumatriptan injection) and 10mg Tosymra (sumatriptan nasal spray) in the US and other select territories. The drugs are commercialised by Dr Reddy’s subsidiary Promius Pharma.

Prescription medicine Zembrace SymTouch and serotonin (5-HT1B/1D) receptor agonist Tosymra (triptan) are indicated for the treatment of acute migraine headaches with or without aura in adults. Zembrace SymTouch is available as a single-use, disposable pen.

As per the agreement, Upsher-Smith will make an upfront payment of $70m, along with $40.5m in near-term milestones and other financial considerations, including existing contractual obligation and inventory. Dr Reddy’s is eligible for sales-based royalties on a quarterly basis.

Promius Pharma head and proprietary products senior vice-president Anil Namboodiripad said: “Tosymra and Zembrace were designed and developed with the goal of addressing unmet needs of large but discrete segments of patients suffering from episodic migraine who need options other than their current therapies. We are excited to partner with Upsher-Smith which has established a strong presence in neurology.”

Upsher-Smith expects the acquisition to support its pipeline with products that are considered as a strategic fit.

Upsher-Smith Laboratories president and CEO said: “This agreement underscores Upsher-Smith’s commitment to significantly expanding its pipeline and diversifying its product portfolio through both internal development and targeted acquisition.

“These two products are a great strategic fit for our company, and we look forward to working with Promius Pharma to ensure a smooth product transition.”

The transaction is subject to customary closing conditions.

14 June 2019

Synlogic and Ginkgo Bioworks to develop biotic drugs

Synlogic has entered a platform collaboration with biotech company Ginkgo Bioworks to support its synthetic bionic medicines pipeline.

The alliance builds on the partners’ pilot programme, which was launched in 2017. It is intended to support Synlogic’s synthetic biotic strain optimisation capabilities.

Synlogic will leverage Ginkgo’s cell programming platform to build and test several microbial strains to quickly advance early preclinical leads.

As part of the collaboration, Synlogic expects to efficiently progress candidate strains, as well as access the technology and resources required to support its pipeline expansion and existing clinical programmes.

Synlogic president and CEO Aoife Brennan said: “Ginkgo has built a world-class infrastructure for programming and optimising microbial strains at a large scale which will be instrumental in the development of our portfolio of synthetic biotic medicines.”

The deal includes an $80m equity investment by Ginkgo, which has acquired 6,340,771 shares of Synlogic common stock along with pre-funded warrants for up to 2,548,117 shares, both at $9 per share. These transactions have been executed and closed.

At the completion, Synlogic made a $30m payment to Ginkgo for synthetic biology services over five years. This period may be extended.

Ginkgo Bioworks co-founder and CEO Jason Kelly said: “The ability to programme living cells to sense and respond to treat complex diseases has great potential.

“Synlogic’s platform for designing and developing living medicines that can treat a wide range of dynamic diseases has the potential to be transformative to the next generation of pharmaceuticals.”

Under the deal, Synlogic will have exclusive rights to any synthetic biotic medicines resulting from the collaboration and to intellectual property covering such products.

14 June 2019

GSK and University of California team up on CRISPR research

UK-based GlaxoSmithKline (GSK) has partnered with the University of California to carry out genomic research for drug discovery applications.

The partners will build the Laboratory for Genomics Research (LGR) facility, which will study links between gene mutations and disease, as well as create clustered regularly interspaced short palindromic repeat (CRISPR) technologies to drive discovery of medicines.

The partners will also conduct research for the development of medical technologies and the discovery of biological mechanisms.

Investigators at the University of California’s San Francisco and Berkeley campuses will be able to leverage the new laboratory for their biological research, enabling them to develop tools for gene analysis.

The University of California Berkeley professor Jennifer Doudna said: “Over the last seven years, CRISPR has transformed academic research, but until the LGR, we haven’t had a focused effort to catalyse the kind of research we know will lead to new innovation using this CRISPR tool.

“LGR is about building that space where creative science is partnered with the development of robust technology that will help develop tomorrow’s drugs.”

Over five years, the genomic research laboratory will receive funding of up to $67m from GSK, including facilities for 24 full-time university employees and up to 14 full-time GSK employees.

LGR will be located near the UCSF Mission Bay campus in San Francisco. It will focus on the immunology, oncology and neuroscience fields. It aims to automate existing CRISPR techniques.

An artificial intelligence (AI) and machine learning group from GSK will work to create the computational pipelines required to analyse data.

A joint steering committee will oversee the alliance, which will build on GSK’s existing partnerships with companies such as 23andMe.

The partners expect AI and machine learning to enable detection of correlations between genetic variants and disease, thereby facilitating selection of trial participants who are most likely to benefit. This is in turn intended to accelerate drug development.

13 June 2019

Sobi to acquire emapalumab drug from Novimmune

Swedish Orphan Biovitrum (Sobi) has agreed to buy a newly established firm from Novimmune for a consideration of SEK4,897m ($517.9m).

The new entity owns assets such as anti-interferon-gamma monoclonal antibody (mAb) emapalumab, which is designed to bind to and neutralise interferon gamma (IFNγ). The drug holds US regulatory approval to treat paediatric and adult patients with refractory, recurrent or progressive primary haemophagocytic lymphohistiocytosis (HLH) that are intolerant to standard HLH therapy.

Primary HLH is a rare hyperinflammation disease that commonly develops within the first year of life and could rapidly become fatal unless diagnosed and treated.

As part of the acquisition, Sobi will gain all emapalumab-related assets, including intellectual property (IP), patent rights and data. The agreement also covers employees involved in the clinical and biopharmaceutical development of the drug.

In addition, the deal provides Sobi with options for the shared financial rights of immuno-oncology product candidates NI-1701 and NI-1801.

This acquisition will suspend a previous exclusive licence agreement, which was signed by Sobi last year for the worldwide rights to emapalumab.

Sobi president and CEO Guido Oelkers said: “The acquisition of emapalumab and related assets is an important step in the transformation of Sobi in becoming a global leader in rare diseases.

“This will allow us to realise the full potential of emapalumab as an important treatment in the area of Immunology and address a significant unmet medical need.”

The company announced plans to reorganise its research and development (R&D) activities to increase focus on haematology and immunology fields. Sobi intends to further develop core assets across these therapeutic areas while building two centres of excellence in Switzerland to support research.

Oelkers added: “This planned structural alignment will sharpen the focus of the company on our two main areas: haematology and immunology. The integration of the emapalumab organisation makes this alignment possible.”

The company revealed its intention to terminate discovery / early research and partner R&D projects outside its core focus areas. Sobi expects the reorganisation to allow annual savings of SEK200-300m ($21.1- 31.7m) on a full-year basis in 2020.

In addition, the company estimates charges of approximately SEK100-200m ($10.5- 21.1m) in restructuring costs relating to the reorganisation and redundancies equivalent to about 90 positions in 2019.

13 June 2019

Merck’s Keytruda secures expanded indications in US

The US Food and Drug Administration (FDA) has approved two indications for Merck’s Keytruda, expanding its application to the oncology market.

This humanised monoclonal antibody (mAb) can now be used as a monotherapy in patients with programmed cell death protein 1 (PD-1) expressing tumours, or in combination with platinum and fluorouracil (FU) as first-line treatment of metastatic / unresectable recurrent head and neck squamous cell carcinoma (HNSCC).

The drug is designed to block the interaction between PD-1 and its PD-L1 and PD-L2 ligands to trigger T-lymphocytes, which may affect both tumourous and healthy cells. It holds approvals in multiple tumour types, including melanoma, classical Hodgkin lymphoma and gastric, cervical and lung cancers.

The drug received initial approval for recurrent or metastatic HNSCC patients that progressed on or after platinum-containing chemotherapy in 2016.

This latest approval is based on data from the pivotal Phase III KEYNOTE-048 clinical trial in 882 subjects with metastatic HNSCC that did not receive prior systemic therapy and were considered incurable by local treatments.

Keytruda led to a significant improvement in overall survival (OS) when compared to the cetuximab plus carboplatin or cisplatin plus FU combination, as well as when used as a monotherapy in patients with PD-L1 expressing tumours and in combination with chemotherapy in the total study population.

During the trial, Merck’s drug was discontinued due to adverse reactions (AR) in 12% of participants in the monotherapy arm. The most common adverse reactions that led to permanent discontinuation were sepsis and pneumonia.

In the combination, the drug was discontinued for ARs in 16% of subjects, with the most common resulting in permanent discontinuation being pneumonia, pneumonitis and septic shock.

Merck Research Laboratories clinical research vice-president Dr Jonathan Cheng said: “The results of KEYNOTE-048, which support this approval, demonstrated that Keytruda monotherapy for patients whose tumours expressed PD-L1 CPS greater than or equal to one and Keytruda in combination with chemotherapy regardless of PD-L1 expression significantly prolonged survival for patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma in the first-line setting.”

Currently, Keytruda is being studied in more than 1,000 trials across several cancers and treatment settings.

12 June 2019

Deciphera licenses cancer drug ripretinib to Zai Lab in China

US-based Deciphera Pharmaceuticals has signed an exclusive licence agreement with biopharmaceutical company Zai Lab to develop and commercialise cancer therapeutic ripretinib in Greater China.

Ripretinib is an investigational, oral kinase switch control inhibitor being developed to treat gastrointestinal stromal tumours (GIST) and other solid tumours driven by KIT or platelet-derived growth factor receptor A (PDGFRα).

It was specifically designed to inhibit a broad spectrum of KIT and PDGFRα mutations in order to allow better treatment of GIST patients.

The compound blocks initiating and secondary KIT mutations in exons 9, 11, 13, 14, 17 and 18 associated with GIST, as well as the primary D816V exon 17 mutation involved in systemic mastocytosis (SM).

It also inhibits primary PDGFRα mutations in exons 12, 14 and 18, including the exon 18 D842V mutation linked to a GIST subset.

Deciphera discovered and developed the therapeutic. The latest alliance is intended to advance its development and potential commercialisation into the Greater China region.

Deciphera Pharmaceuticals president and CEO Steve Hoerter said: “Zai Lab’s strong track record of rapidly progressing the development of innovative product candidates will be a major asset in accelerating the development of ripretinib in this area of the world.

“We are excited to be working with Zai Lab to potentially offer patients in Greater China what we believe is a much needed therapeutic option for the treatment of GIST.”

As part of the deal, Zai Lab will gain exclusive regional development and commercialisation rights for ripretinib in Greater China.

Zai Lab will make an upfront cash payment of $20m to Deciphera, which will be additionally eligible for up to $185m in potential development and commercial milestones. Zai Lab will also pay royalties on annual net sales of ripretinib in Greater China.

Deciphera plans to expand the global Phase III INTRIGUE clinical trial being performed to compare ripretinib to sunitinib in second-line GIST patients.

The company is currently considering the addition of clinical trial sites in China.

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