On May 16, 2019 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that GSK has expanded its 2016 licensing and collaboration agreement with Zymeworks for the research, development, and commercialization of bispecific antibodies across multiple disease areas (Press release, Zymeworks, MAY 16, 2019, View Source [SID1234536442]). Under the expanded agreement, GSK will now have access to Zymeworks’ unique heavy-light chain pairing technology, part of its proprietary Azymetric platform. Zymeworks’ Azymetric platform enables the development of bispecific and multifunctional therapeutics while maintaining the characteristics of naturally-occurring human antibodies.

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"We are pleased to see GSK broaden their technology license and believe that it reflects their increased commitment to develop differentiated bispecific therapeutics," said Ali Tehrani, Ph.D., President and CEO of Zymeworks. "As part of this expansion, GSK expects to use our Azymetric technology to develop bispecifics for the treatment of infectious diseases, which highlights the utility of our platform beyond traditional indications like oncology and inflammatory disease."

Under the updated terms of the expanded agreement, GSK will have the option to develop and commercialize bispecific drugs across different disease areas and Zymeworks will be eligible to receive increased preclinical, development and commercial milestone payments. If all six programs are developed and commercialized, the new potential value of the collaboration would be up to US$1.1 billion. Additionally, Zymeworks is eligible to receive increased tiered royalties on worldwide sales.

About the Azymetric Platform

The Azymetric platform enables the transformation of monospecific antibodies into bispecific antibodies, giving the antibodies the ability to simultaneously bind two different targets. Azymetric bispecific technology enables the development of multifunctional biotherapeutics that can block multiple signaling pathways, recruit immune cells to tumors, enhance receptor clustering degradation, and increase tumor-specific targeting. These features are intended to enhance efficacy while reducing toxicities and the potential for drug resistance. Azymetric bispecifics have been engineered to retain the desirable drug-like qualities of naturally occurring antibodies, including low immunogenicity, long half-life, and high stability. In addition, they are compatible with standard manufacturing processes with high yields and purity, potentially significantly reducing drug development costs and timelines.

On May 16, 2019 Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, reported the presentation of updated clinical data for its potent and highly selective investigational medicines avapritinib and BLU-667 (Press release, Blueprint Medicines, MAY 16, 2019, View Source [SID1234536441]).

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At the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and 24th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), Blueprint Medicines plans to present:

Data from the expansion portion of the registration-enabling ARROW trial of BLU-667 in patients with RET-altered non-small cell lung cancer (NSCLC) and thyroid cancers
Data from the registration-enabling NAVIGATOR trial of avapritinib in patients with PDGFRA Exon 18 mutant and fourth-line gastrointestinal stromal tumors (GIST), which will be used for planned marketing applications in the United States and Europe
Data from the registration-enabling EXPLORER trial of avapritinib in patients with advanced systemic mastocytosis (SM)
"Our upcoming presentations highlight data supporting our plans for multiple marketing applications in the United States and Europe over the next 18 months and demonstrate continued progress on our ‘2020 Blueprint’ strategy," said Andy Boral, M.D., Ph.D., Chief Medical Officer of Blueprint Medicines. "The datasets reflect the rapid development of avapritinib and BLU-667, including in four indications that have received Breakthrough Therapy Designation from the FDA. These presentations for avapritinib and BLU-667 highlight the breadth and speed of development of our portfolio, as well as our commitment to rapidly deliver new precision therapies to cancer patients with limited or no effective treatment options."

The accepted abstracts are listed below and are now available online on the ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) conference websites, respectively: View Source and View Source

2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting
May 31-June 4, 2019; Chicago, Illinois

Oral Presentation

Presentation Title: Clinical activity and tolerability of BLU-667, a highly potent and selective RET inhibitor, in patients (pts) with advanced RET-fusion+ non-small cell lung cancer (NSCLC)
Session Title: Lung Cancer—Non-Small Cell Metastatic
Session Date & Time: Monday, June 3, 2019 from 8:00 a.m. – 11:00 a.m. CT (9:00 a.m. – 12:00 p.m. ET)
Abstract Number: 9008

Poster Discussion Presentations

Presentation Title: Activity and tolerability of BLU-667, a highly potent and selective RET inhibitor, in patients with advanced RET-altered thyroid cancers
Session Title: Head and Neck Cancer
Poster Session Date & Time: Saturday, June 1, 2019 from 1:15 p.m. – 4:15 p.m. CT (2:15 p.m. – 5:15 p.m. ET)
Poster Discussion Session Date & Time: Saturday, June 1, 2019 from 4:30 – 6:00 p.m. CT (5:30 p.m. – 7:00 p.m. ET)
Abstract Number: 6018

Presentation Title: Clinical activity of avapritinib in ≥ fourth line (4L+) and PDGFRA Exon 18 gastrointestinal stromal tumors (GIST)
Session Title: Sarcoma
Poster Session Date & Time: Saturday, June 1, 2019 from 8:00 a.m. – 11:00 a.m. CT (9:00 a.m. – 12:00 p.m. ET)
Poster Discussion Session Date & Time: Saturday, June 1, 2019 from 3:00 p.m. – 4:30 p.m. CT (4:00 p.m. – 5:30 p.m. ET)
Abstract Number: 11022

24th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper)
June 13-16, 2019; Amsterdam, The Netherlands

Oral Presentation

Presentation Title: Avapritinib, a potent and selective inhibitor of KIT D816V, induces complete and durable responses in patients (pts) with advanced systemic mastocytosis (AdvSM)
Session Title: New Agents in MPN
Presentation Date & Time: Saturday, June 15, 2019 from 12:00 p.m. – 12:15 p.m. CEST (6:00 a.m. – 6:15 a.m. ET)
Abstract Number: S830

Investor Event and Webcast Information

Blueprint Medicines will host an investor event on Monday, June 3, 2019 beginning at 6:30 p.m. CT (7:30 p.m. ET) in Chicago to provide a portfolio update, including a review of updated clinical data from the ongoing ARROW trial of BLU-667 in patients with RET-altered cancers and the ongoing registration-enabling NAVIGATOR trial in patients with PDGFRA Exon 18 mutant and fourth-line GIST. The event will be webcast live and can be accessed under the "Investors & Media—Events & Presentations" section of Blueprint Medicines’ website at www.BlueprintMedicines.com. A replay of the webcast will be available approximately two hours after the event and will be available for 30 days following the event.

On May 16, 2019 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported data presentations on its investigational anti-PD-1 antibody tislelizumab and its investigational BTK inhibitor zanubrutinib from four posters at the 24th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), taking place June 13-16, 2019 in Amsterdam (Press release, BeiGene, MAY 16, 2019, View Source [SID1234536440]).

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Poster Presentations:

Title: Tislelizumab (BGB-A317) for relapsed/refractory classical Hodgkin lymphoma: updated follow-up efficacy and safety results from a Phase 2 study
Abstract Code: PF469
Session Title: Hodgkin lymphoma – Clinical
Date: Friday, June 14
Time: 17:30 – 19:00 (CEST)
Lead Author: Yuqin Song, M.D., Ph.D.

Title: Major responses in MYD88 wildtype (MYD88WT) Waldenström Macroglobulinemia (WM) patients treated with Bruton Tyrosine Kinase (BTK) inhibitor zanubrutinib (BGB-3111)
Abstract Code: PF487
Session Title: Indolent and mantle-cell non-Hodgkin lymphoma – Clinical
Date: Friday, June 14
Time: 17:30 – 19:00 (CEST)
Lead Author: Meletios A. Dimopoulos, M.D.

Title: Updated safety and efficacy data in a Phase 1/2 trial of patients with Waldenström Macroglobulinaemia (WM) treated with the Bruton Tyrosine Kinase (BTK) inhibitor zanubrutinib (BGB-3111)
Abstract Code: PF481
Session Title: Indolent and mantle-cell non-Hodgkin lymphoma – Clinical
Date: Friday, June 14
Time: 17:30 – 19:00 (CEST)
Lead Author: Judith Trotman, MBChB, FRACP, FRCPA

Title: Pooled analysis of safety data from monotherapy studies of the Bruton Tyrosine Kinase (BTK) inhibitor, zanubrutinib (BGB-3111), in B-cell malignancies
Abstract Code: PS1159
Session Title: Chronic lymphocytic leukemia and related disorders – Clinical
Date: Saturday, June 15
Time: 17:30 – 19:00 (CEST)
Lead Author: Constantine S. Tam, M.D.
About BeiGene

BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team

On May 16, 2019 Exelixis, Inc. (Nasdaq: EXEL) reported that it has entered into an exclusive option and license agreement with Iconic Therapeutics, Inc. (Iconic), a private biopharmaceutical company focused on cancer and retinal disease, to advance an innovative next-generation antibody-drug conjugate (ADC) program for cancer (Press release, Exelixis, MAY 16, 2019, View Source [SID1234536439]). This collaboration reflects Exelixis’ ongoing strategy to build a pipeline beyond its lead product, CABOMETYX, through both internal drug discovery and external business development. This agreement with Iconic is Exelixis’ second strategic collaboration focused on novel biologics, following the company’s collaboration with Invenra, Inc. announced in May 2018. This exclusive agreement is Iconic’s first strategic collaboration in oncology and leverages the company’s innovative Tissue Factor antibody expertise.

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This press release features multimedia. View the full release here: View Source

Under the terms of the agreement, Exelixis will gain an exclusive option to license ICON-2, Iconic’s lead oncology ADC program, in exchange for an upfront option payment to Iconic of $7.5 million and a commitment of preclinical development funding. Exelixis would exercise its option at the time of a potential IND application, and upon doing so would make an option exercise payment to Iconic and assume responsibilities for all subsequent clinical development and commercialization activities. Should Exelixis elect to exercise its option, Iconic will become eligible for future development, regulatory and commercialization milestone payments, as well as royalties on potential sales.

"Iconic Therapeutics is pursuing an innovative approach to targeting Tissue Factor, a promising target with early clinical validation and potential applicability across a wide variety of cancers," said Peter Lamb, Ph.D., Executive Vice President and Chief Scientific Officer of Exelixis. "This agreement provides Exelixis with an attractive entry into the antibody-drug conjugate space, and reflects our preference for success-based terms that reward our partners for long-term shared success. We’re looking forward to working with the Iconic team to advance this exciting program, which is complementary to Exelixis’ small molecule and emerging biologics capabilities."

ICON-2 represents a potential best-in-class program targeting TF in solid tumors. TF is highly expressed on tumor cells and in the tumor microenvironment. TF overexpression, while not oncogenic itself, facilitates angiogenesis, metastasis and other processes important to tumor development and progression. ICON-2 is a rationally designed second-generation ADC with potential for an improved therapeutic index and safety profile.

"We believe this partnership with a premier oncology company provides further validation of our novel approach," said William L. Greene, M.D., Chief Executive Officer of Iconic Therapeutics. "Exelixis’ clinical development and commercialization expertise, evidenced by the growing success of the cabozantinib franchise, make it the ideal partner as we advance this promising program towards the clinic. Iconic Therapeutics’ deep expertise in Tissue Factor biology and antibody-drug conjugate design sets the ICON-2 program apart from other approaches to this historically challenging target," Dr. Greene added.

On May 16, 2019 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, reported that it will host a conference call on Wednesday, May 22, 2019 at 8:30 a.m. ET to discuss its first quarter 2019 financial results and recent corporate developments (Press release, Affimed, MAY 16, 2019, View Source [SID1234536438]).

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The conference call will be available via phone and webcast. To access the call, please dial +1 631 510 7495 for U.S. callers, or +44 (0) 2071 928000 for international callers, and reference conference ID 1083705 approximately 15 minutes prior to the call.

An audio webcast of the conference call can be accessed in the "Webcasts" section on the "Investors" page of the Affimed website at View Source A replay of the webcast will be available on Affimed’s website shortly after the conclusion of the call and will be archived for 30 days following the call.