On November 4, 2019 Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, reported funding agreements with Royalty Pharma and its affiliate Pharmakon Advisors that, in aggregate, could bring in up to $270 million in capital, significantly strengthening Epizyme’s financial position and extending its operating runway into at least 2022 (Press release, Epizyme, NOV 4, 2019, View Source [SID1234550263]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"These funding transactions support our strategy of becoming a fully integrated, commercial biopharmaceutical company, and provide us significant optionality for the future," said Robert Bazemore, president and chief executive officer of Epizyme. "We are well capitalized to fully fund the anticipated launches of tazemetostat for epithelioid sarcoma and follicular lymphoma next year, and further invest in both the continued development of tazemetostat and our epigenetic pipeline. Royalty Pharma has an outstanding reputation for investing in promising, late-stage companies, and we are thrilled to have their support as we head into the next phase of our evolution."

As part of the agreements, Royalty Pharma will make an upfront payment of $100 million for shares of Epizyme common stock based on a price of $15 per share, representing a 27% premium to the prior trading day’s closing price. Epizyme also has an 18-month option to sell an additional $50 million of its common stock to Royalty Pharma at then prevailing prices, not to exceed $20 per share, and Royalty Pharma has a three-year option to purchase an additional 2.5 million shares of Epizyme common stock at $20 per share.

Epizyme and Royalty Pharma have also agreed to reduce the existing royalty rates owed by Epizyme to Royalty Pharma on worldwide sales of tazemetostat outside Japan at specified annual net sales levels. This reduction follows Royalty Pharma’s acquisition of certain future royalty streams on sales of tazemetostat in all regions except for Japan, which Epizyme previously owed to Eisai as part of their April 2015 amended and restated agreement. In addition, Epizyme has assigned to Royalty Pharma the future royalty streams on tazemetostat sales in Japan previously owed to Epizyme by Eisai.

"We are very pleased to partner with Epizyme, particularly given the tremendous progress in advancing tazemetostat over the course of 2019," stated Pablo Legorreta, founder and chief executive of Royalty Pharma. "With impressive data in treating both solid tumors and hematologic malignancies, we share the company’s excitement for tazemetostat’s broad therapeutic potential and are committed to supporting tazemetostat’s further development and anticipated launches to fully maximize its commercial opportunity. We look forward to working closely with this talented team as they transition into a commercial-stage organization."

As part of the transactions, Mr. Legorreta will be appointed to Epizyme’s Board of Directors.

Under a separate agreement, Epizyme has established a $70 million loan facility with Pharmakon Advisors, an affiliate of Royalty Pharma, which will fund the regulatory milestones owed to Eisai for the NDA submissions and U.S. approvals for tazemetostat for epithelioid sarcoma and follicular lymphoma. The facility may be drawn down in up to three tranches in conjunction with achievement of the milestones and is expandable by up to $300 million following approval of tazemetostat in follicular lymphoma, subject to mutual agreement.

For a further description of terms of the transaction agreements, please refer to Epizyme’s Form 8-K filed today.

Wilmer Cutler Pickering Hale and Dorr LLP acted as legal advisor to Epizyme; Goodwin Procter LLP, Dechert LLP and Maiwald Patentanwalts- und Rechtsanwalts GmbH acted as legal advisors to Royalty Pharma; and, Akin Gump Strauss Hauer & Feld LLP acted as legal advisor to Pharmakon Advisors.

On November 4, 2019 Tmunity Therapeutics, Inc., a private clinical-stage biotherapeutics company focused on saving and improving lives by delivering the full potential of next-generation T-cell immunotherapy, reported it has entered into a strategic collaboration with Oncora Medical to access Oncora’s proprietary real-world data platform to support the design of future clinical programs with cell therapy (Press release, Tmunity Therapeutics, NOV 4, 2019, View Source [SID1234550262]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Oncora brings to this collaboration a suite of intuitive analytics software that collects and deploys real-world clinical data that can be used to drive better decision making and treatment options and ultimately improve patient outcomes. Tmunity brings expertise in clinical oncology and clinical trial design, regulatory strategy and cell therapy. Together, this collaboration has the potential to innovate the way clinical trials for cell therapy are executed to bring treatments to patients more efficiently. Tmunity will leverage Oncora’s data and analytics capabilities to refine, customize and validate a real-world evidence strategy. Tmunity hopes to validate the strategy in a clinical program selected from its highly innovative pipeline.

"Partnering with Oncora Medical to utilize real-world data in clinical development puts Tmunity at the forefront of innovation. This project has the potential to help us more effectively design and execute our clinical trials to advance the next-generation of CAR-T therapies," said Usman "Oz" Azam, MD, President and Chief Executive Officer of Tmunity. "We are excited to begin our relationship with Oncora Medical to revolutionize the way clinical trials are designed with the ultimate goal of reducing the time to deliver targeted T-cell therapies to patients in need."

"We believe that use of real-world data and evidence has the potential to change the way cancer therapies are developed and to further personalize outcome predictions that will guide treatment decisions," said Oncora Medical co-founder and CEO, David Lindsay. "We hope our partnership with Tmunity will innovate the way clinical trials are designed and thereby, to bring important cancer treatments to patients more efficiently."

On November 4, 2019 PhoreMost Limited, the UK-based biopharmaceutical company dedicated to drugging ‘undruggable’ disease targets, and Sentinel Oncology, reported an expansion of their collaboration to accelerate the progression of SOL686, a novel allosteric Polo-like kinase 1 (PLK1) inhibitor through preclinical development and IND enabling studies for the treatment of Glioma (Press release, PhoreMost, NOV 4, 2019, View Source [SID1234550261]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Mitotic PLKs are widely recognised as playing crucial roles in disease causing pathways, including K-Ras mutant cancers. Traditional approaches to drugging PLK enzymes have focused on targeting their active site; however this tactic has been hindered by toxicity-associated adverse events. Sentinel Oncology’s allosteric PLK1 inhibitor takes the novel approach of targeting the Polo-box domain (PBD) of the PLKs, thereby aiming to mitigate adverse events seen by active site inhibitors.

The programme has demonstrated a promising combination of specific drug-like properties, mode of action and target validation data obtained so far. Originating from the laboratory of Prof Ashok Venkitaraman at the University of Cambridge, PhoreMost subsequently developed the lead chemical series. Sentinel Oncology then optimised drug-like properties for the series and guided therapeutic positioning. Both PhoreMost and Sentinel Oncology received funding from Innovate UK for the drug discovery programme.

Dr Chris Torrance, CEO of PhoreMost, said: "We are delighted to deepen our long-standing association with Sentinel Oncology, and excited to be progressing this drug discovery programme towards the clinic. This lead compound exemplifies the value of PhoreMost’s strategy to use functional protein-protein interactions to drive the development of novel therapies, and to capitalise on its SITESEEKER platform to change the model of drug discovery through innovation, strategic partnerships and collaboration."

Robert Boyle, CEO of Sentinel Oncology, commented: "We are very excited about the prospects for this programme, and to be collaborating with PhoreMost to advance our allosteric PLK1 inhibitor. The programme adds to our NeuroOncology pipeline, has started formal preclinical studies and is well positioned to enter clinical development as a glioma treatment by 2021."

On November 4, 2019 NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for translational research and molecular diagnostic products, reported the availability of its new GeoMx Cancer Transcriptome Atlas through the Technology Access Program (TAP) for the GeoMx Digital Spatial Profiler (DSP) (Press release, NanoString Technologies, NOV 4, 2019, View Source [SID1234550260]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This new high-plex RNA expression profiling panel provides the most informed view of the cancer transcriptome based on evidence from the Cancer Genome Atlas Program as well as important immuno-oncology biology. The assay is compatible with both fresh frozen (FF) and Formalin-Fixed Paraffin-Embedded tissue (FFPE) enabling researchers to access more samples to power their studies. NanoString’s GeoMx DSP is used to prepare the sample for spatial analysis using a read-out chemistry designed to be compatible with Illumina’s next-generation sequencing instruments.

"Over the last year we’ve generated strong demand for our GeoMx Digital Spatial Profiler in the translational medicine market," said Brad Gray, president and CEO of NanoString. "The launch of this high-plex RNA assay marks the next phase of our market development activities in which we plan to expand into the large market for discovery applications by leveraging next-generation sequencing read-out to achieve an unprecedented level of multiplex profiling with spatial context."

The GeoMx Cancer Transcriptome Atlas expands on the nCounter PanCancer series of gene expression panels by combining the content from the PanCancer Pathways, PanCancer Immune Profiling and the IO 360 panels with additional gene content. Under the program, a TAP partner can submit FFPE tissue sections to NanoString and NanoString will run the GeoMx Cancer Transcriptome Atlas and provide the analysis report back to the partner.

Researchers interested in participating in NanoString’s technology access program should contact us at [email protected].

On November 4, 2019 RhoVac AB ("RhoVac") reported that the first patient has been screened for the company’s clinical phase IIb study in prostate cancer, a study entitled RhoVac-002 ("BRaVac") (Press release, RhoVac, NOV 4, 2019, View Source [SID1234550259]). The screening took place at the Odense University Hospital.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

BRaVac is a randomized, placebo-controlled and double-blinded study in prostate cancer, with the primary end-point of evaluating if and to what extent treatment with the drug candidate RV001 can prevent or limit the development of cancer measured as a more limited development of PSA (prostate specific antigen) in treated patients compared to the control group (placebo group). The clinical phase IIb study is an international, multicenter study, which is expected to recruit over 175 patients in six European countries (Denmark, Finland, Sweden, United Kingdom, Belgium and Germany), as well as the United States. The first patient is now screened for the study and the ambition is that all patients will be recruited in Q3 2020. The study results on the primary end-points are expected to be reported in 2021.

Anders Ljungqvist, COO: "It has been a challenge to start this large clinical phase IIb study in the summer holiday period, and it is therefore particularly gratifying that the first patient is now screened at Odense University Hospital. Other clinical sites in Denmark are ready to screen patients and Finland is the next country to open up for screening."

Anders Månsson, CEO: "The last few months have been very intense at RhoVac – we have received approval from the Danish authorities to start the clinical phase IIb study, and FDA has also stated, in a pre-IND, a positive opinion on starting the clinical phase IIb trial in the United States. We have also received approval to start the study in Finland. In addition, only a few months ago we completed a new rights issue that will fund the current clinical study, and we applied for and also received a grant of EUR 2.5 million from the EU Research and Innovation Fund Horizon2020. In July 2019, we presented the 12-month follow-up study from the clinical phase I/II-study showing good and stable results over time. The fact that we now have screened our first patient for the clinical phase IIb trial is an extremely important milestone for RhoVac! I would also like to extend my gratitude to all employees and consultants who have worked tirelessly to take the project to the point where it is today. Phase IIb is extremely well prepared, and with this, RhoVac is entering its last development phase, and as a result of this the partnering discussions will advance further."