OmniSeq and LabCorp Extend Exclusive Distribution Pact and Complete Follow-On Investment Agreement

On April 23, 2019 OmniSeq, a CAP-accredited, molecular diagnostics spin-out of Roswell Park Comprehensive Cancer Center, and LabCorp (NYSE: LH), a leading global life sciences company, reported an extension of their exclusive distribution agreement as well as an additional investment by LabCorp (Press release, OmniSeq, APR 23, 2019, View Source [SID1234535323]). The distribution agreement and LabCorp’s initial investment in OmniSeq’s Series B financing round were first announced in August 2017.

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The distribution agreement originally provided LabCorp with exclusive distribution rights for the OmniSeq Comprehensive and Immune Report Card clinical assays. The agreement’s extension adds OmniSeq Advance, as well as the OmniSeq MSI NGS test. Together, OmniSeq’s next-generation sequencing (NGS)-based assays provide comprehensive genomic and immune profiling to enable oncologists to select the most appropriate therapies or clinical trials for each patient. Pursuant to the agreement, OmniSeq’s suite of advanced tests will be exclusively offered by LabCorp to U.S.-based physicians through Integrated Oncology, a member of the LabCorp Specialty Testing Group, and globally to biopharmaceutical customers through Covance, LabCorp’s drug development business.

Proceeds from LabCorp’s additional investment will be used by OmniSeq to pursue FDA approval or clearance of its proprietary NGS-based comprehensive genomic and immune profiling panels, to continue the development of new panels intended to predict the response to checkpoint inhibitors and other immune-therapies, and to support the expansion of testing operations.

According to Mark Gardner, CEO of OmniSeq, "We are honored to extend our partnership with LabCorp to expand access to OmniSeq’s advanced testing methodologies to help provide more precise guidance in the selection of the right therapy or clinical trial for patients diagnosed with a broad range of cancers. With LabCorp’s continued collaboration and support, we will have the funding to augment the clinical utility of our testing services, and to make the best of precision medicine more readily available to physicians and patients across the U.S. and to biopharmaceutical companies around the globe."

"OmniSeq has been an excellent partner for us in both clinical studies and clinical diagnostics," said Marcia Eisenberg, chief scientific officer of LabCorp Diagnostics, and a member of OmniSeq’s board of directors. "Working together, we have brought advanced NGS-based diagnostics to market, supporting more informed clinical decisions for targeted and immuno-oncology therapies. By combining the clinical trials capabilities of Covance, the single-source lab solutions services of Integrated Oncology, and the testing services of OmniSeq, LabCorp is uniquely positioned to bring precision medicine to oncology patients across the country."

To learn more about OmniSeq Comprehensive, Immune Report Card, OmniSeq AdvanceSM, or OmniSeq MSI NGS, call 1-800-781-1259 or visit www.omniseq.com.

Zymeworks to Present at Bloom Burton & Co. Healthcare Investor Conference 2019

On April 23, 2019 Zymeworks Inc. (NYSE/TSX:ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that management will present at the upcoming Bloom Burton & Co. Healthcare Investor Conference taking place April 30-May 1, 2019 in Toronto, Canada (Press release, Zymeworks, APR 23, 2019, View Source [SID1234535322]).

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The Company’s presentation will be April 30, 2019 at 10:00 a.m. ET.

Interested parties can access a live webcast of the presentation via a link from Zymeworks’ website at View Source, which will also host a recorded replay available afterwards.

BerGenBio to present NSCLC and AML clinical data from Phase II development programme with selective AXL inhibitor bemcentinib at ASCO 2019

On April 23, 2019 BerGenBio ASA (OSE: BGBIO) a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, reported that the company and its collaborators will present new interim clinical and biomarker data from its extensive Phase II clinical development programme with bemcentinib, a selective, oral AXL inhibitor, at the 2019 annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) at McCormick Place in Chicago, Illinois (31 May – 4 June 2019) (Press release, BerGenBio, APR 23, 2019, View Source [SID1234535320]).

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Abstract titles have been announced online at View Source and details of the presentations are below.

The posters presented at ASCO (Free ASCO Whitepaper) will be made available on www.bergenbio.com in the Investors / Presentations section at the time of presentation.

Sunday 2 June, 8:00 AM – 11:00 AM Central Daylight Time

A phase II study of bemcentinib (BGB324), a first-in-class highly selective AXL inhibitor, with pembrolizumab in pts with advanced NSCLC: OS for stage I and preliminary stage II efficacy.

Enriqueta Felip et al
Session: Lung Cancer – Non-Small Cell Metastatic
Location: Hall A, poster board #421, abstract 9098
Monday 3 June, 8:00 AM – 11:00 AM Central Daylight Time

First-in class selective AXL inhibitor bemcentinib (BGB324) in combination with LDAC or decitabine exerts anti-leukaemic activity in AML pts unfit for intensive chemotherapy: Phase II open-label study.

Dr Sonja Loges et al
Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Location: Hall A, poster board #418, abstract 7043

Elpiscience and Bio-Techne Announce Strategic Collaboration

On April 22, 2019 Elpiscience BioPharma and Bio-Techne Corporation reported that the companies have entered into a strategic collaboration for the development of anti-cancer therapeutics (Press release, Elpiscience, APR 22, 2019, View Source;id=1313 [SID1234536921]). Under the terms of the agreement, Elpiscience will have access to multiple antibodies from Bio-Techne’s antibody library for use in preclinical, clinical and commercial pharmaceutical development.

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As a biotech company committed to leading the innovation and development of the next generation of cancer immunotherapy, Elpiscience, in collaboration with Bio-Techne, a global leader in life sciences and molecular diagnostics, will expand mutual capabilities in the field of cancer immunotherapy. This strategic collaboration also aims to accelerate the development of new biologics to address unmet medical needs in Oncology.

Dr. Darren Ji, CEO of Elpiscience, said: "We are very happy to enter into a strategic collaboration with Bio-Techne in therapeutic antibody research and development. This collaboration will leverage the strengths of both companies in the field of anti-cancer therapeutics and speed up the development of new cancer immunotherapies in order to bring more efficient treatment to cancer patients worldwide."

David Eansor, President of Bio-Techne’s Protein Sciences Segment commented "We are extremely excited to partner with Elpiscience in the development of novel cancer immunotherapies. It is our goal to increase our partnerships with therapeutics developers to unleash the potential of our vast library of high-quality antibodies towards the development of next generation immunotherapies."

Poseida Therapeutics Raises $142 Million in Series C Financing

On April 22, 2019 Poseida Therapeutics Inc., a clinical-stage biopharmaceutical company leveraging proprietary non-viral gene engineering technologies to create life-saving therapeutics, reported closing of a Series C financing round, raising $142 million led by a $75 million equity investment from Novartis Pharma AG, and joined by several new investors including Aisling Capital Management, Pentwater Capital Management, Perceptive Advisors as well as additional undisclosed institutional investors (Press release, Poseida Therapeutics, APR 22, 2019, View Source [SID1234536252]). Current investors Malin Corporation plc., Longitude Capital, Vivo Capital and Boxer Capital, LLC also participated in the financing.

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"We welcome the support and investment from Novartis, a leader in the cell and gene therapy field," said Eric Ostertag M.D., Ph.D., chief executive officer of Poseida. "They are joined by an impressive group of new investors whose commitment enables us to accelerate the pursuit of our bold vision to create gene therapy product candidates that could result in single-treatment cures for numerous oncologic indications and orphan genetic diseases, with an initial focus on chimeric antigen receptor T cell (CAR-T) therapies."

The company’s CAR-T product candidates are manufactured with Poseida’s non-viral piggyBac DNA Modification System, resulting in a high percentage of stem cell memory T cells (TSCM). Tscm cells are the only T cell that is self-renewing and long-lived, potentially resulting in product candidates that are more efficacious, less toxic and more durable. Poseida is currently developing the following CAR-T product candidates:

P-BCMA-101 is an autologous CAR-T therapy for the treatment of relapsed/refractory multiple myeloma, currently enrolling patients for a Phase 2 registrational trial with initial dosing expected in the first half of 2019.

P-PSMA-101 is an autologous CAR-T product candidate targeting PSMA-specific cancer cells in castrate resistant prostate cancer, with filing of an IND anticipated in the second half of 2019.

P-BCMA-ALLO1 is an allogeneic, or universal donor, CAR-T product candidate, manufactured using Poseida’s proprietary Cas-CLOVER site specific gene editing system and is being developed as a treatment for relapsed/refractory multiple myeloma, with an IND filing anticipated by late 2019 or early 2020.

P-MUC1C-101 is an autologous CAR-T product candidate in late-stage preclinical development for numerous solid tumor indications, including ovarian, breast, lung, colorectal, pancreatic and renal cancers, with filing of an IND anticipated in 2020.

Poseida plans to broadly advance its current CAR-T programs and emerging pipeline programs, including gene therapies for orphan genetic diseases.