On June 3, 2020 Epigenetics company Base Genomics reported that it has launched with a team of leading scientists and clinicians to set a new gold standard in DNA methylation detection (Press release, Base Genomics, JUN 3, 2020, View Source [SID1234560814]). The company has closed an oversubscribed seed funding round of $11 million USD (£9 million GBP) to progress development of its TAPS technology, initially focusing on developing a blood test for early-stage cancer and minimal residual disease. The funding round was led by Oxford Sciences Innovation and also included investors with industry expertise in genomics and oncology.

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DNA methylation is an epigenetic mechanism involved in gene regulation and has been shown to be one of the most promising biomarkers for detecting cancer through liquid biopsy. The existing industry standard for mapping DNA methylation degrades DNA and reduces sequence complexity, however, limiting scientific discovery and clinical sensitivity. Base Genomics’ new technology, TAPS, overcomes these issues and generates significantly more information from a given sample, creating new opportunities in research and the clinic.

"In order to realize the potential of liquid biopsies for clinically meaningful diagnosis and monitoring, sensitive detection and precise quantification of circulating tumour DNA is paramount," said Base Genomics CMO Anna Schuh. "Current approaches are not fit for purpose to achieve this, but Base Genomics has developed a game-changing technology which has the potential to make the sensitivity of liquid biopsies a problem of the past."

First developed at Ludwig Institute for Cancer Research Branch at the University of Oxford, TAPS is a novel chemical reaction that converts methylated cytosine to thymine under mild conditions. Unlike the industry standard technology, bisulfite sequencing, TAPS does not degrade DNA, meaning that significantly more DNA is available for sequencing. TAPS also better retains sequence complexity, cutting sequencing costs in half and enabling simultaneous epigenetic and genetic analysis.

"Genomic technologies with the power, simplicity and broad applicability of TAPS come along very infrequently," said Base Genomics CTO Vincent Smith. "It has the potential to have an impact on epigenetics similar to that which Illumina’s SBS chemistry had on Next Generation Sequencing."

Base Genomics is led by a highly experienced team of scientists and clinicians, including Dr Vincent Smith, a world-leader in genomic product development and former Illumina VP; Dr Anna Schuh, Head of Molecular Diagnostics at the University of Oxford and Principal Investigator on over 30 clinical trials; Drs Chunxiao Song and Yibin Liu, co-inventors of TAPS at the Ludwig Institute for Cancer Research, Oxford; and Oliver Waterhouse, previously an Entrepreneur in Residence at Oxford Sciences Innovation and founding team member at Zinc VC.

"The ability to sequence a large amount of high-quality epigenetic information from a simple blood test could unlock a new era of preventative medicine," said Base Genomics founder and CEO Oliver Waterhouse. "In the future, individuals will not just be sequenced once to determine their largely static genetic code, but will be sequenced repeatedly over time to track dynamic epigenetic changes caused by age, lifestyle, and disease."

On June 3, 2020 Q2 Solutions, a leading clinical trial laboratory services organization resulting from an IQVIA and Quest Diagnostics joint venture, reported its partnership with Thermo Fisher Scientific to use the Ion Torrent Genexus System, the first fully integrated, next-generation sequencing (NGS) platform, to deliver clinical trial lab results economically with unprecedented speed (Press release, Q2 Solutions, JUN 3, 2020, View Source [SID1234560813]).

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"Clinical trial oncology patients require lab testing before they can receive potential life-saving treatments, which makes lab testing turnaround time critical," said Brian O’Dwyer, chief executive officer at Q2 Solutions. "Our efforts in developing assays and tests to identify and target different aspects of diseases are critical to drug discovery for pharma clients. Adding the capabilities of the Ion Torrent Genexus System has the potential to drastically reduce our time to deliver clinical reports to trial sites, thereby enabling patients’ access to investigational drugs faster."

The Ion Torrent Genexus System improves turnaround time and minimizes human error for genome profiling, resulting in better delivery of services and further differentiating the Q2 Solutions service offering. With 70 percent of oncology drugs in development relying on genome profiling to uncover specific disease-causing mutations, this significant advancement in genomic technologies may help get the right therapy gets to the right patient quickly.

"Access to the latest technology to help meet the stringent demands from pharmaceutical clients has become essential in the age of genomic-driven medicine," said Peter Silvester, senior vice president and president of Life Sciences Solutions at Thermo Fisher Scientific. "We are proud of this strategic relationship with Q2 Solutions and the opportunity it provides for Thermo Fisher to move healthcare forward."

Genomic profiling is a laboratory method that is used to learn about the genes in a person or in a specific cell type and the way those genes interact with each other and with the environment. Genomic profiling is done in a privacy-protective manner and may be used to discover why some patients are diagnosed with certain diseases while others are not, or why patients react in different ways to the same drug. It may also be used to help develop new ways to diagnose, treat, and prevent diseases, such as cancer.

Q2 Solutions is committed to implementing transformational technology that has the potential to revolutionize how complex diseases are managed. In November 2019, Q2 Solutions announced a national U.S. expansion of its Genomics Center of Excellence in North Carolina to enhance its ability to provide innovative genomic testing in North America and to further enable harmonized genomic testing globally.

Q2 Solutions is further committed to protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes.

On June 3, 2020 NorthShore University HealthSystem (NorthShore) neurosurgeon, Julian Bailes, MD, reported that it is the first in Illinois to begin offering GammaTile Therapy, a new approach to treating malignant brain tumors (Press release, GT Medical Technologies, JUN 3, 2020, View Source [SID1234560812]). The FDA-cleared, Surgically Targeted Radiation Therapy (STaRT) is designed to delay tumor regrowth for patients with high grade gliomas, meningiomas and brain metastases. The FDA most recently approved GammaTile for the initial surgery and treatment of glioblastoma multiforme — the most common malignant tumor. The first patient in the state was treated by Dr. Bailes, who is chairman of the department of neurosurgery and co-director of the NorthShore Neurological Institute. Neuro-oncologist Ryan Merrell, MD, will also be participating in this new surgical therapy at NorthShore.

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Aggressive brain tumors tend to be resistant to current treatments and have a high likelihood of recurrence. Smaller than a postage stamp (2cm x 2cm), the GammaTile is a 3D-collagen tile embedded with Cesium-131 radiation that can be placed at the tumor site after the tumor is surgically removed. It immediately begins to target any microscopic residual tumor with radiation while limiting the impact on healthy brain tissue. It adds just five to ten minutes to surgery time and is absorbed in the body within two months.

"We are excited to offer this new treatment that protects healthy brain tissue while providing immediate, targeted therapy directly to the area that’s most at risk for recurrence," said Dr. Bailes. "Most patients report fewer side effects and better quality of life since this eliminates the wait time and procedures typically associated with standard treatment after the removal of a tumor."

GammaTile Therapy is a radiation therapy specifically designed for implantation in the brain and offers advantages for patients undergoing surgery for brain tumors. GammaTile begins targeting residual tumor cells immediately at the time of tumor removal surgery, rather than waiting several weeks for surgical wound healing before beginning other treatment. GammaTile protects healthy brain tissue while delivering a targeted dose to any remaining tumor cells. The unique design also limits side effects typically associated with radiation therapy, including hair loss. These patients receive their course of internal, focused radiation while going about their daily lives, requiring no additional trips to the hospital or clinic for radiation therapy.

A male patient in his thirties was the first patient in Illinois to receive this treatment. He had brain surgery and standard chemotherapy and radiation last spring. Dr. Bailes says GammaTile therapy shows great promise for prolonging survival and improving quality of life for this patient and others.

Research has shown that patients who received surgery plus GammaTile Therapy had approximately two times improvement in median time to tumor recurrence. Data supporting the efficacy and safety profile of the therapy for patients with recurrent, previously treated meningioma’s was published in the Journal of Neurosurgery (JNS), the official journal of the American Association of Neurological Surgeons.

"We are honored to be working with the brain tumor specialists at NorthShore to deploy GammaTile Therapy for the purpose of improving the lives of patients with brain tumors," said Matt Likens, president and CEO of GT MedTech. "We are excited to begin expanding the availability of GammaTile Therapy to other leading brain tumor treatment centers across the U.S."

On June 3, 2020 Shorla Pharma Limited (‘Shorla’), an Irish specialty pharmaceutical company, reported the completion of a Series A investment of $8.3 million (Press release, Shorla Pharma, JUN 3, 2020, View Source [SID1234560811]). The financing was led by Seroba Life Sciences (‘Seroba’), a European Venture Capital firm headquartered in Dublin, Ireland with additional investment from Irish and Canadian based family offices and participation from Enterprise Ireland.

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Shorla has developed innovative oncology drugs with a focus on rare, orphan and pediatric cancers, delivering more effective products in indications where existing treatments are sub-optimal for the target patients.

The company was founded by Sharon Cunningham and Orlaith Ryan (‘Shorla’ is a combination of both first names), both formerly with EirGen Pharma (‘EirGen’) in Waterford, Ireland. Shorla is based in Questum, a Clonmel, Ireland based acceleration center.

Together with a strong team of scientists, clinicians and an extensive industry network, the company has an advanced pipeline of innovative drug products to treat a number of unmet patient needs. The funding will support the advancement of the product pipeline, along with expansion of technical and commercial operations in both Ireland and the US.

Alan O’Connell, a Partner at Seroba who has joined the Shorla board, said, "We’re delighted to support an Irish company with such a promising pipeline of products designed to improve treatment options for cancer patients. Shorla is led by experienced founders with a track record of success in the sector and we look forward to working with them to grow the company and bring their products to market."

Speaking about the investment, Orlaith Ryan of Shorla said, "This significant investment will provide the necessary resource to further advance the product pipeline through health authority registration and commercialization which will ultimately create valuable and clinically impactful treatments that improve patient outcomes."

Commenting about the support from Seroba, Sharon Cunningham added, "Seroba is a leading venture capital firm in the global life sciences industry and they, along with other participants in the investment syndicate bring invaluable experience to Shorla and have a proven track record in the pharmaceutical sector. We’re confident that we have the right partners to support us in executing our vision."

Julie Sinnamon, CEO, Enterprise Ireland, said, "We are delighted to support Shorla and to be part of this investment round. Ireland is widely recognised as a center for the global life sciences industry as well as a leader in medtech and pharmaceutical manufacturing. Helping to maintain that reputation, Shorla, led by two female founders, is a highly innovative company developing new solutions to critical issues in the oncology area. It is also particularly heartening to see this company starting in a regional location. Earlier this year, the Enterprise Ireland ‘Action Plan for Women in Business’ cited that less than 10 percent of VC funding is going to companies with women founders. This investment is consistent with that action plan in terms of developing a larger number of companies of scale led by female founders. It is fantastic to have a role model like Shorla to demonstrate what’s possible. I wish the team luck with the project and congratulate the company on its success to date."

On June 3, 2020 Specialised Therapeutics Asia reported that NOVEL marine-derived drug to treat Small Cell Lung Cancer (SCLC) has been granted a provisional designation by the Therapeutic Goods Administration (TGA), based on encouraging results from an international trial evaluating its safety and efficacy in several solid tumours, including SCLC (Press release, Specialised Therapeutics Asia, JUN 3, 2020, View Source [SID1234560810]).

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Data from a key Phase 2 study of the drug Lurbinectedin demonstrated a 35% overall response rate in second-line patients, with a median overall survival of 9.3 months (95% CI 6.3-11.8), which is a clinically meaningful advantage over current standard of care in patients in second-line SCLC therapy.[1]

These results also underpin a decision by the US Food and Drug Administration (FDA) granting Lurbinectedin a priority and accelerated review. Lurbinectedin will now be reviewed concurrently by the FDA and other international regulators, including the TGA, under the ‘Project Orbis’ initiative.

This multi-country collaboration between international regulators is designed to streamline approvals where there is a strong unmet medical need, predominantly in oncology and haematology. This project may enable cancer patients to receive expedited access to new therapies.

In tandem with the provisional designation, Lurbinectedin is now being investigated in patients at five cancer centres in Sydney, Melbourne and Queensland. All study subjects are SCLC patients who have relapsed after being treated with standard platinum-based chemotherapy, with or without immunotherapy.

A principal investigator on the new Australian study, Associate Professor Tom John at the Peter MacCallum Cancer Centre, said patients had few treatment options after failure of first-line therapy.

Associate Professor John commented: "The initial Lurbinectedin data are encouraging, and we will be collecting local data to see if it matches that seen in the international study. There is still a significant medical unmet need in Small Cell Lung Cancer. We welcome new treatment options for this difficult to treat patient population."

Lurbinectedin is being made available in Australia and Singapore by independent pharmaceutical company Specialised Therapeutics Asia (STA) under exclusive license from Spanish biopharmaceutical company PharmaMar.

STA Chief Executive Officer Mr Carlo Montagner described the TGA’s provisional designation for Lurbinectedin and review under the Project Orbis collaboration as "extremely encouraging".

"We welcome the provisional designation that acknowledges the encouraging data demonstrated to date and the high unmet medical need in patients with refractory SCLC," he said.

"We look forward to progressing Lurbinectedin through relevant regulatory channels in South East Asia and Australia / New Zealand as expeditiously as possible."

In the interim, STA will continue to make this compound available to eligible patients under a named co-pay Patient Access Program in our region."

Up to 1900 Australians[2] and 1100 Singapore residents are diagnosed with SCLC every year, representing approximately 15% of all lung cancers.[3]