On November 12, 2020 Denovo Biopharma, a pioneer in applying precision medicine to development of innovative therapies, reported that its international Phase 3 registrational study for DB102 has fully enrolled (Press release, Denovo Biopharma, NOV 12, 2020, View Source [SID1234570849]). The ENGINE study is a randomized, double-blind, placebo-controlled, international multi-center Phase 3 pivotal clinical trial evaluating the efficacy of DB102 in combination with R-CHOP versus R-CHOP alone in newly-diagnosed high-risk (IPI >=3) DLBCL patients with the biomarker DGM1 (Denovo Genomic Marker 1).

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Denovo utilized its deep expertise in the fields of genomics, big data analysis, and drug development to establish a platform technology that can use residual clinical samples to find biomarkers that can predict drug efficacy, creating a new model for developing innovative drugs at a lower cost and in a shorter timeframe through precision medicine. The novel biomarker DGM1 utilized in the ENGINE study was developed using this platform. This clinical trial aims to verify that high-risk DLBCL patients who are DGM1 positive can benefit significantly from DB102 treatment in combination with current standard of care, R-CHOP.

Denovo Biopharma announced that its international Phase 3 registrational study for DB102 has fully enrolled.

DLBCL is the most common type of non-Hodgkin lymphoma (NHL), accounting for about half of the total number of cases. While the current international standard of care, R-CHOP, is curative for the majority of low-risk patients with DLBCL, up to 40% of high-risk patients will fail first-line therapy. DB102 is the world’s first oral small-molecule kinase inhibitor targeting PKC-β. A retrospective analysis found that it has significant curative effects in high-risk DLBCL patients who are DGM1 positive. Mr. Joe Zimmerman, Head of Global Clinical Operations at Denovo , said,"Through the joint efforts of our Chinese and American teams, we successfully completed the enrollment of all subjects. We hope that DB102 can bring new treatment options to patients with high-risk DLBCL, thereby reversing the dearth of new treatments for this group of patients over the past two decades."

About DB102
DB102 (enzastaurin) is an orally available investigational first-in-class small molecule, serine/threonine kinase inhibitor of the PKC beta, PI3K, and AKT pathways that has been studied in more than 3,000 patients across a range of solid and hematological tumor types. DB102 was originally developed by Eli Lilly and for which Denovo has acquired worldwide rights. DB102 received orphan drug designation in DLBCL and glioblastoma multiforme (GBM) from the FDA and EMA. In July 2020 the US FDA granted DB102 Fast Track qualification for the first-line treatment of GBM with DB102.

On November 12, 2020 Bridge Medicines, a pioneering drug discovery company focused on advancing promising early technologies from concept to clinic,reported the additional funding of $10 million to advance its current pipeline of products as well as expand with additional in-licensed technologies (Press release, Bridge Medicines, NOV 12, 2020, View Source [SID1234570848]).

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Bridge Medicines, launched in 2016 by Memorial Sloan Kettering Cancer Center, The Rockefeller University, Weill Cornell Medicine and Takeda Pharmaceutical Company Ltd., in partnership with Deerfield Management Company and Bay City Capital, is a groundbreaking initiative that extends the work of the independent, non-profit Tri-Institutional Therapeutics Discovery Institute.

Bridge Medicines is currently developing novel inhibitors of ENL-YEATS for the treatment of acute leukemias such as acute myelogenous leukemia and a series of orally active small molecule inhibitors of activated factor XII for the treatment of hereditary angioedema and other inflammatory disorders. In addition, Bridge Medicines is in discussions on and evaluating several other in-licensing opportunities from our institutional partners.

"Bridge Medicines was founded four years ago on a mission to discover and develop promising therapeutic technologies emerging from the cutting-edge science discovered on the campuses of our renowned academic partners," said Bill Polvino, MD, Chief Executive Officer of Bridge Medicines. "We are privileged and pleased to benefit from the continued strong support of our investor partners who have provided financial and strategic support for our efforts from day one. Without the commitment of capital, and industry-savvy executives, the opportunity to develop highly innovative products is lost. Our partners share in our passion to meet the challenge of addressing unmet medical needs and creating a vibrant New York City biotech ecosystem."

On November 12, 2020 Immunovia reported that it published third quarter interim report for January – September 2020 (Press release, Immunovia, NOV 12, 2020, View Source;september-2020-301172071.html [SID1234570847]). It is available on Immunovia’s website.

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"The most important event during Q3 was that we announced positive results from the IMMray PanCan-d verification study. The analysis from the verification study showed results in line with the previous commercial test model study (CTMS) and was the beginning of the last stage towards CLIA-CAP accreditation in the USA, the final blind validation study.

Q3 started with a virtual presentation by Immunovia’s Thomas King, MD, Ph.D. and Laura Chirica, Ph.D., at the annual meeting of the International Association of Pancreatology (IAP) at the European Pancreatic Club (EPC) on July 2, 2020, one of the most important events in the world in the field of pancreatic cancer.

In July, we launched the "Immunovia Walk Around the World to Raise Awareness for Pancreatic Cancer", an initiative to raise awareness of pancreatic cancer.

In early September, the second webinar in the IMMray PanCan-d series was hosted with Linda Mellby, Ph.D., Thomas King, MD, Ph.D. and Laura Chirica, Ph.D., who gave a more detailed presentation of the results of the Commercial Test Model Study (CTMS).

We announced the appointment of Patrik Dahlen as our new CEO starting on November 1, 2020, and that Mats Grahn will continue as a board member.

I am pleased to hand over the baton to Patrik Dahlen, who I have known for a long time and who is one of the most experienced leaders in the international diagnostics industry. Patrik is not only a highly respected business leader with wide-ranging international experience and knowledge of the international diagnostics industry, but he also knows Immunovia well, from the ground up, as he was one of our board members during the initial years," commented, Mats Grahn, outgoing CEO and current board member of Immunovia AB.

"I am honored to join Immunovia during this pivotal and exciting time in the company’s history. I believe that Immunovia is in a position to evolve into a dominating market leader for the blood-based diagnosis of pancreatic cancer and I look forward to the exciting times to come in the company’s development.

I would like to emphasize that Immunovia continues to have the goal of a long-term market penetration of 30% after reimbursement and widespread coverage has been achieved. The current size of the addressable market for IMMray PanCan-d is estimated to exceed USD 4 billion in the EU and the USA, across the three risk groups the company targets: hereditary/familial, differential diagnosis of early symptoms and newly diagnosed diabetes in individuals over 50. We look forward to continuing to work with healthcare operators around the world.

On behalf of the Board and the entire Immunovia team, I thank you for your continued support of Immunovia’s efforts to contribute to having a positive impact on the lives of those at risk from pancreatic cancer, "Patrik Dahlen, CEO, Immunovia.

– Excerpt from the CEO comments from the report

Third Quarter Interim Report January – September 2020 Call Details:

Immunovia invites to a teleconference (in English) for investors, analysts and media on Thursday, November 12, 2020 at 16:30 CET.

Patrik Dahlen, CEO will present Immunovia and comment on the interim report for the period January – September 2020 followed by a Q&A session.

Please call in a few minutes in advance. To attend, please dial-in at one of the numbers below and provide the conference code Immunovia to the operator:

Conference Code: (to provide to the operator) Immunovia

Immunovia Webcast: https://channel.royalcast.com/immunovia/#!/immunovia/20201112_1

For more information, please contact:

Julie Silber, Director of Investor Relations, Immunovia

Email: [email protected]

There will be an MP3-file available at Immunovia’s webpage under Investors/Financial Reports (View Source) for those who want to listen to the telephone conference afterwards. The file will be available within two hours after the conference has ended.

On November 12, 2020 IsoPlexis, the leader in single-cell functional proteomics, reported that biomarker and translational data from the PIVOT-02 study using IsoPlexis’ functional proteomics platform was presented at the 2020 SITC (Free SITC Whitepaper) conference (Press release, IsoPlexis, NOV 12, 2020, View Source [SID1234570846]). The presented data from the clinical trial examines T cell response to Nivolumab (Nivo) immunotherapy in combination with Nektar’s bempegaldeskleukin (NKTR-214, BEMPEG) IL-2 pathway agonist.

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IsoPlexis’ technology identified a non-invasive, blood-based biomarker predicted response to the doublet. IsoPlexis began its collaboration with Nektar Therapeutics in June of 2018. IsoPlexis’ functional immune landscaping has been used to profile the effects of BEMPEG in both monotherapy and combination immunotherapies in a clinical setting.

The presentation titled "Progression-free survival and biomarker correlates of response with BEMPEG plus NIVO in previously untreated patients with metastatic melanoma: results from the PIVOT-02 study," was presented on November 11th.

"We are excited to demonstrate that predictive blood-based biomarkers in cancer immunology are possible by harnessing powerful T-cell responses using IsoPlexis’ single-cell functional proteomics," said IsoPlexis’ CEO, Sean Mackay. "Predictors of durable immune response against cancers, like our data demonstrate, are important to continue to move precision immune medicine forward."

"We are pleased to partner with IsoPlexis in support of our translational research for a range of Nektar clinical studies," said Dr. Jonathan Zalevsky, Chief Research and Development Officer at Nektar Therapeutics. "IsoPlexis’ single-cell system provides a uniquely high degree of resolution into the functional impacts of our therapeutics. Through the use of this system, we identified a non-invasive on-treatment biomarker as one that could allow us to predict response to the combination, well before radiographic evidence."

On November 12, 2020 Discovery Life Sciences (Discovery), a global leader in biospecimen solutions, genomic, cell, and immunohistochemistry (IHC) services, reported the addition of Illumina’s TruSight Oncology 500 (TSO500) technology to HudsonAlpha Discovery, Discovery’s highly recognized and regarded sequencing and bioinformatics laboratory (Press release, Discovery Life Sciences, NOV 12, 2020, View Source [SID1234570845]).

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Illumina’s TSO500 solid Tumor (FFPE) and cfDNA technology enables genomic characterization across a broad range of tumor types through the identification of germline and somatic variants from DNA and RNA, including critical immuno-oncology SNV, InDel, CNV, and fusion biomarkers, as well as microsatellite instability (MSI) and tumor mutational burden (TMB). HudsonAlpha Discovery’s TSO500 platform combined with Discovery Life Sciences’ comprehensive biospecimen solutions will accelerate immuno-oncology and liquid biopsy biomarker studies through delivery of actionable NGS data across patient-matched tumor and plasma biospecimens. The result will be a significant enhancement of the information derived from cancer diagnostic studies and immunotherapeutic clinical research programs.

"HudsonAlpha Discovery’s TSO500 services are optimized for efficiency to enable rapid delivery of the valuable NGS data that only TSO500 provides across matched FFPE and plasma samples at any scale," said Dr. Shawn Levy, PhD, Chief Scientific Officer at Discovery Life Sciences. "We are confident these new services will advance biomarker programs and allow researchers to more quickly develop and validate new immunotherapeutics, liquid biopsy diagnostics and companion diagnostics."

"HudsonAlpha Discovery’s addition of our TSO500 platform is a significant step forward in the wider adoption of our innovative pan-cancer technology," said Mark Van Oene, Illumina’s Chief Commercial Officer. "We are excited to see our technology in Discovery’s expert hands. The combination of our technology with Dr. Levy and his team will provide HudsonAlpha Discovery’s clients a unique and valuable resource to accelerate the development of new precision medicine treatments and diagnostic tools."

Discovery’s sequencing and bioinformatics laboratory, HudsonAlpha Discovery, provides a suite of long-read, short-read and single cell sequencing technologies – including Illumina, 10x Genomics, Pacific Biosciences and Oxford Nanopore platforms, and variant discovery bioinformatic pipelines.