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

On April 23, 2019 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that it will webcast its Quarterly Update Conference Call for the first quarter 2019 on Tuesday, May 7 at 4:30 p.m. ET / 1:30 p.m. PT (Press release, Halozyme, APR 23, 2019, View Source [SID1234535337]). Dr. Helen Torley, president and chief executive officer, will lead the call. On the same date, Halozyme will release financial results for the first quarter ended March 31, 2019 following the close of trading.

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The call will be webcast live through the "Investors" section of Halozyme’s corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit the Investors page of www.halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. The live call may be accessed by dialing (866) 393-4306 (domestic callers) or (734) 385-2616 (international callers). A telephone replay will be available after the call by dialing (855) 859-2056 (domestic callers) or (404) 537-3406 (international callers) using replay ID number 3076769.

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.

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.

On April 23, 2019 ExCellThera Inc., an advanced clinical stage biotechnology company delivering molecules and bioengineering solutions to expand stem and immune cells for therapeutic use, reported that the U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to its lead technology, ECT-001, in the treatment of hematologic malignancies (Press release, ExCellThera, APR 23, 2019, View Source [SID1234535340]). The RMAT designation is based on strong data from Phase I/II clinical trials using ECT-001 to expand stem and immune cells for the treatment of blood cancers.

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RMAT designation is granted by the FDA under the 21st Century Cures Act for cell therapies, tissue-engineered or similar products intended to treat or cure a serious disease, and which demonstrate preliminary evidence to address an unmet clinical need. It accords all the benefits of the FDA’s fast track and breakthrough therapy designation programs, including an ability to interact with the agency to discuss the potential acceleration of regulatory approval. Under the auspices of the RMAT designation, FDA will work closely with ExCellThera and provide advice on generating the evidence needed to support approval of ECT-001 in an efficient manner.

"The FDA’s RMAT designation is a clear signal of confidence in the potential of our lead cell therapy drug product, ECT-001, to treat patients with hematologic malignancies," said Dr. Guy Sauvageau, CEO and founder of ExCellThera. "We look forward to working with the FDA within the RMAT framework to advance ECT-001 through the final phases of clinical development in an expedited manner."

Various clinical studies using ECT-001 are currently ongoing in the treatment of multiple myeloma, high-risk leukemia and other hematologic malignancies. In addition, ExCellThera plans to initiate additional clinical trials, including a pivotal trial in the United States and Canada, in the coming months. ECT-001 has also received FDA orphan drug designation for the prevention of graft-versus-host disease.

About ECT-001
The ECT-001 technology is a combination of a small molecule, UM171, and an optimized culture system. The technology, capable of expanding the number of stem and immune cells exponentially in as little as seven days, is used in novel curative cord blood transplant therapies for patients with blood cancers, allowing rapid engraftment, greatly reduced incidence of transplant-related mortality, low risk of chronic graft-versus-host disease and low risk of relapse, resulting in better outcomes for patients.