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Daiichi Sankyo and Gustave Roussy Enter Innovative Research Collaboration for DXd ADCs DS-1062 and Patritumab Deruxtecan

On July 22, 2020 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and Gustave Roussy reported a multi-year, multi-study research collaboration to enrich and further enable the development of DS-1062 and patritumab deruxtecan (U3-1402), two of Daiichi Sankyo’s lead DXd antibody drug conjugates (ADCs), in lung and breast cancer (Press release, Daiichi Sankyo, JUL 22, 2020, View Source [SID1234562222]).

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The collaboration will focus on clinical and translational research, including potential combination strategies for DS-1062, a TROP2 directed DXd ADC, in patients with advanced non-small cell lung cancer (NSCLC), and for patritumab deruxtecan, a HER3 directed DXd ADC, in patients with metastatic breast cancer.

"We look forward to engaging and collaborating with the deep expertise and cutting-edge oncology research capabilities of Gustave Roussy, the premier European Cancer Center, to further advance clinical development of DS-1062 and patritumab deruxtecan," said Antoine Yver, MD, MSc, AIHP, ACCA Paris, Global Head, Oncology R&D, Daiichi Sankyo. "This innovative research program includes two precision-medicine rich phase 2 trials designed with an adaptive approach to help determine which patients are most likely to benefit from our ADCs with optimal speed and efficiency. Combination therapy strategies will also be explored in other studies."

"This partnership is strategic for Gustave Roussy and it brings together all the skills which are essential for top quality research in oncology. Launching clinical trials to test two promising molecules in advanced non-small cell lung cancer and metastatic breast cancer is essential for diseases which unfortunately have an increasing incidence and for which there is an urgent need to make progress," said Prof. Jean-Charles Soria, General Director of Gustave Roussy. "It is by pushing the boundaries of innovation that we will further improve the quality of care for our patients."

About the Collaboration
Under the agreement, Daiichi Sankyo, Inc. will provide funding and support to Gustave Roussy for a comprehensive, integrative research program including clinical, translational and preclinical studies for DS-1062 and patritumab deruxtecan in lung and breast cancer, respectively.

Two adaptive phase 2 trials will be conducted, including a multicenter, open-label study to evaluate efficacy, safety and markers of response and resistance to DS-1062 in patients with advanced NSCLC who have progressed on anti-PD-1/PD-L1 therapy and platinum-doublet chemotherapy.

The second multicenter, open-label phase 2 study will evaluate the efficacy, safety and biomarkers of response and resistance to patritumab deruxtecan in patients with HER3 expressing metastatic breast cancer.

Each study will enroll up to 100 patients and will be conducted in several sites in France.

The primary endpoint for both studies is objective response rate as assessed by independent central review. Secondary endpoints include clinical benefit rate, progression-free survival, duration of response, overall survival and safety measures. The studies also will primarily be conducted to analyze biomarker expression and tumor sensitivity; the role of receptor biology in the pharmacological activity of the Daiichi Sankyo DXd ADC platform, as well as factors contributing to treatment resistance; immunogenicity and mechanism of action.

The adaptive trial design includes ongoing clinical and biomarker assessments to identify factors associated with individual patient response and the ability to fine-tune development accordingly.

Additional research to be conducted under the collaboration includes several studies exploring multiple therapeutic combinations for each ADC.

QIMR Berghofer licenses potential new cancer immunotherapies to Merck

On July 22, 2020 QIMR Berghofer Medical Research Institute reported that it has licensed novel cancer immunotherapies to leading science and technology company Merck, headquartered in Darmstadt, Germany (Press release, QIMR Berghofer Medical Research Institute, JUL 22, 2020, View Source [SID1234562187]).

The immunotherapeutic antibodies were developed against a target discovered by the head of QIMR Berghofer’s Molecular Immunology Laboratory, Associate Professor Michelle Wykes.

Under the agreement, Merck will be responsible for further optimisation of the antibodies, IND enabling studies, and the clinical development and, in case of positive clinical outcomes, registration and commercialisation of the immunotherapeutic antibodies.

Queensland’s Health Minister, Steven Miles, said it was reaffirming to see Queensland scientists collaborating with leading pharmaceutical companies.

"This deal with Merck shows that QIMR Berghofer – with the support of the Queensland Government – is producing world-leading research in the area of cancer immunotherapy," Mr Miles said.

"These promising discoveries start in the lab, but they can’t become available to patients unless our scientists collaborate with industry to develop and trial these new treatments.

"This agreement between QIMR Berghofer and Merck brings us one step closer to developing a new immunotherapy we can offer cancer patients around Australia and the world."

QIMR Berghofer’s Director and CEO, Professor Fabienne Mackay, said the immunotherapeutic antibodies appeared to be very promising.

"Associate Professor Wykes and her team have seen very positive responses to these antibodies in pre-clinical models," Professor Mackay said.

"Over the last decade, immunotherapies have significantly improved survival rates in a number of cancers – particularly some, like melanoma, that didn’t respond well to chemotherapy.

"However, not all cancers or patients respond to the immunotherapies available. We hope this collaboration between Associate Professor Wykes and Merck will ultimately give doctors another weapon in their arsenal against cancer."

Associate Professor Wykes has welcomed the agreement.

"This agreement is the culmination of 10 years of work by my team and me to develop these immunotherapeutic antibodies," Associate Professor Wykes said.

"We are looking forward to working with Merck to move this promising research closer to the hospital bedside."

The terms of the agreement are commercial-in-confidence.

Genor Biopharma Announced the Acceptance of New Drug Application for Geptanolimab and the Appointment of Mr. CHEN Wende as Chief Operation Officer

On July 21, 2020 Genor Biopharma Co. Inc, a pre-commercial stage biopharmaceutical company focused on developing and commercializing oncology and autoimmune therapeutics, reported that the new drug application (NDA) for Geptanolimab, a novel PD-1 mAb drug candidate, has been accepted by the National Medical Products Administration ("NMPA") for the treatment of Peripheral T cell Lymphoma (PTCL) (Press release, Genor Biopharma, JUL 21, 2020, View Source [SID1234594761]).

On the same day, Genor Biopharma announced the appointment of Mr. CHEN Wende as Chief Operation Officer. In this role, Mr. CHEN will oversee commercialization and prepare for launches of late-stage drug candidates.

Mr. CHEN brings over 20 years of experience in biopharmaceutical industry, focusing on sales and marketing and business operation at Roche, AstraZeneca, and Pfizer in China. Mr. CHEN was most recently Chief Commercial Officer at a well-known biotech company. Before that, Mr. CHEN served as Vice President at Roche China, overseeing Corporate Affairs, Market Access and Channel Management for a number of key drugs including Herceptin, MabThera, Avastin, Tarceva and Zelboraf. Mr. CHEN also served as Senior Vice President at AstraZeneca from 2010 and as Senior Sales Director at Pfizer from 2000.

"We are excited to appoint Mr. CHEN as COO of Genor Biopharma. We are looking to file NDAs for a number of our late-stage drug candidates in the near term," commented Dr. GUO, Chief Executive Officer of Genor Biopharma, "With over 20 years of experience in drug commercialization and deep insight of the landscape, Mr. CHEN will build our in-house commercialization team and lead our drug launches with differentiated strategy and drive our transformation into a biopharma company."

March 2021 – QUANTRO Therapeutics delighted to join BIOTECH AUSTRIA as a member

On July 21, 2020 QUANTRO Therapeutics GmbH reported that the company has established its operations with seed financing from Boehringer Ingelheim Venture Fund (BIVF) and Evotec (Press release, QUANTRO Therapeutics, JUL 21, 2020, View Source;utm_medium=rss&utm_campaign=quantro-therapeutics-delighted-to-join-biotech-austria [SID1234578387]). As a research-based company, QUANTRO will combine and exploit innovative functional genetics and transcriptomics technologies to generate an unprecedented drug discovery pipeline transforming the precision and scope of cell-based compound screens. By introducing ‘Transcriptional Fingerprinting’ to drug discovery, QUANTRO intends to revamp the scope of pharmacologic interventions in a variety of cellular, target and disease contexts. A prime focus will be the discovery and development of drug candidates blocking the activity of oncogenic transcription factors, a class of particularly promising therapeutic targets that has so far remained largely unamenable to pharmacological intervention.

The company was founded by Dr. Stefan Ameres and Dr. Johannes Zuber as a spin-off of the Institute of Molecular Biotechnology (IMBA) and the Research Institute of Molecular Pathology (IMP), both located in Vienna, Austria. Bringing together expertise in time-resolved transcriptomics and functional genomics, the founders have pioneered innovative methods to study gene regulatory functions of oncogenic transcription factors and drugs in a variety of cellular models. Supported by two Proof-of-Concept grants of the European Research Council (ERC), they explored new applications of these cutting-edge technologies, thereby laying the groundwork for QUANTRO’s discovery pipeline. Meanwhile, the team has been reinforced by extensive pharma R&D and senior executive experience with Dr. Dieter Nachtigall, who is a chemist by training and has been appointed CEO of QUANTRO. Boehringer Ingelheim Venture Fund and Evotec acquired equal minority stakes in QUANTRO and will be represented on the Company’s Supervisory Board by Dr. Sebastian Kreuz and Dr. Dirk Ullmann, respectively. Furthermore, Evotec will provide hit identification services for QUANTRO’s proprietary anti-tumor projects.

Dr. Dieter Nachtigall, Chief Executive Officer of QUANTRO, said: "QUANTRO Therapeutics has designed and set up a new discovery approach and technology platform based on world-leading scientific expertise by our founders and excellent support from our highly committed corporate venture partners. We are extremely motivated and ambitious to start operations in our facilities at the Startup Labs Vienna Biocenter and turn our vision of identifying and developing new anti-cancer agents with breakthrough potential into a reality."

Dr. Sebastian Kreuz, Boehringer Ingelheim Venture Funds, added: "The BIVF focuses on groundbreaking therapeutic approaches and technologies that have the potential to advance patient care in areas of high unmet medical need. We are looking forward to supporting QUANTRO and its dedicated founders to apply time-resolved RNA sequencing in an industrialized setting with the aim to unlock transcription factors as a highly promising target class for drug discovery in oncology and other disease areas."

Dr. Werner Lanthaler, Chief Executive Officer of Evotec, commented: "QUANTRO is a very promising academic spin-off company with great potential to lead the way in time-resolved RNA sequencing with a potentially ground-breaking technology to address ‘undruggable’ drug targets. Through our partnership and equity investment, we will further validate QUANTRO’s approach and hope to be able to open many new doors across a broad range of therapeutic modalities together in the future."

Dr. Stefan Ameres, Founder and Scientific Advisor of QUANTRO, commented: "The definition of direct transcription factor targets and, more generally, the unbiased detection of direct transcriptional effects has remained challenging due to the limited time resolution of conventional techniques for gene perturbation and transcriptional profiling. Overcoming this hurdle adds great possibilities for new therapeutic interventions with previously inaccessible targets in different cancer types and disease contexts."

Dr. Johannes Zuber, Founder and Scientific Advisor of QUANTRO, added: "Transcription factors shape and maintain the identity of cancer cells and have long been recognized as promising therapeutic targets. After studying these factors and their therapeutic potential for many years, QUANTRO’s discovery pipeline takes an unprecedented approach to finally exploit transcription factors for cancer therapy."

QUANTRO Management Board and Team
Dr. Dieter Nachtigall, CEO of QUANTRO, holds a PhD in Analytical Chemistry and contributes 23 years in pharmaceutical research and development experience to QUANTRO. Additionally, he brings more than 10 years in senior executive roles at Boehringer Ingelheim.

Dr. Stefan Ameres, Founder and Scientific Advisor of QUANTRO, is a distinguished expert in RNA biology and transcriptomics and has since 2012 held the position of group leader at the IMBA, Vienna. Dr. Ameres has a track-record of highly ranked publications in Nature, Cell, Science and other peer-reviewed journals.

Dr. Johannes Zuber, also Founder and Scientific Advisor of QUANTRO, is a licensed MD and renowned expert in functional cancer genetics. He has been a group leader at the IMP, Vienna, since 2011, and his outstanding scientific accomplishments are documented in more than 160 publications in highly ranked journals.

Glytherix seeks AUD 7M Series A funding after securing grant – CEO

On July 21, 2020 Glytherix, an unlisted public Australian immuno-oncology company, reported that it is actively seeking AUD 7m (USD 5m) in a Series A equity round, after securing up to AUD 6m in non-dilutive funding, said CEO Brad Walsh (Press release, Glytherix, JUL 21, 2020, View Source [SID1234565156]).

The Sydney-based company has secured AUD 3m in grant funding from Round 9 of the Federal Government’s Cooperative Research Centres Projects (CRC-P) program, as announced last week (16 July), with Sydney-based R&D Capital Partners agreeing to provide another AUD 3m once the AUD 7m is raised, Walsh said.

Glytherix, which is fielding interest from potential investors in Australia, the US, Hong Kong and China, including family offices and institutions, welcomes approaches from other interested investors, Walsh said. Its advisors are New York-and Melbournebased Biosynergy Partners and Sydney-based private placement firm Litmus Equity.

While the novel coronavirus (COVID-19) pandemic initially made it more difficult for the company to engage with potential investors, people are now used to the ‘new normal’ and it is proving easier to connect with people in their home offices, Walsh said.

Glytherix is confident of closing the raise in the next four to eight weeks with the credibility boost provided by the grant funding and on the back of advances made since the 2018 spin-off from its parent, Sydney-based non-invasive prostate cancer diagnostic developer Minomic, Walsh said.

It has completed a 12-patient first-in-human study for its Miltuximab antibody, which reached its primary endpoint of safety and tolerability, and its secondary endpoint of tumour targeting. The company now plans other pre-clinical work including a glioblastoma (brain cancer) study, he noted.

Equity capital raised will be used to support a Phase I trial in patients with prostate, pancreatic, bladder and glioblastoma cancers and will also be used to make more clinical-grade antibodies to prepare for a US Food and Drug Administration (FDA) Investigational New Drug (IND) application and a US Phase I trial, Walsh said.

The equity funding is expected to last two years, with financing options for a Phase II US trial including a NASDAQ listing, licensing deals or trade sales, he added. The company has some 200 shareholders comprising management and high net worth investors.

In collaboration with other Australian companies and research bodies, Glytherix will use grant funding to develop Miltuximab as a flagship molecule for radio-immunotherapies (RITs), which are combinations of radiation therapy and immunotherapy using antibodies to selectively deliver radiation to kill cancer cells, while limiting damage to healthy cells.

This is one of the most dynamic new areas in nuclear and radiochemistry with robust research and commercial interest globally, Walsh said, noting that Novartis [SWX:NOVN] paid some USD 6bn for both Advanced Accelerator Applications [NASDAQ:AAAP] and Endocyte [NASDAQ:ECYT] in 2018. Domestically, Telix [ASX:TLX] is also developing RITs, although for different disease indications to the ones Glytherix is targeting, he said.

Miltuximab is also being used for both imaging and immunotherapy applications, with this pairing of a precision diagnostic and a corresponding precision therapeutic having the potential to treat a wide range of cancers and position both Glytherix and Australia at the forefront of the theranostics industry, Walsh added.

by Louise Weihart in Sydney

Published by Acuris Mergermarket, an ION Group company