On June 5, 2018 Foundation Medicine, Inc. (NASDAQ:FMI) reported that members of the company’s management team will present at the following upcoming investor conferences (Press release, Foundation Medicine, JUN 5, 2018, View Source [SID1234527172]):

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Goldman Sachs Annual Healthcare Conference on Tuesday, June 12, 2018 at 1:20 p.m. P.T. in Rancho Palos Verdes, California.

William Blair Growth Stock Conference on Thursday, June 14, 2018 at 8:40 a.m. C.T. in Chicago.

A live, listen-only webcast of the presentation may be accessed by visiting the investors section of the company’s website at investors.foundationmedicine.com. A replay of the webcast will be available shortly after the conclusion of each presentation and will be archived on the company’s website for 90 days.

On June 5, 2018 The Institute for Research in Immunology and Cancer – Commercialization of Research (IRICoR) and its host institution, the Université de Montréal (UdeM) reported that they have entered into a research collaboration with AbbVie, a global research and development-driven biopharmaceutical company, in order to identify Tumor-Specific Neoantigens (TSNA) based on a novel proprietary platform developed by Drs. Claude Perreault and Pierre Thibault, both of whom are Principal Investigators at the Institute for Research in Immunology and Cancer (IRIC) of the Université de Montréal (Press release, IRICoR, JUN 5, 2018, View Source [SID1234626500]).

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Under the terms of the agreement, AbbVie will fund certain research activities at the IRIC to identify TSNA in a specific cancer indication. AbbVie will obtain an option to secure an exclusive worldwide license on the intellectual property arising from the collaboration.

"We are very pleased to have been able to successfully conclude an agreement with AbbVie around the identification of TSNA that are of mutual interest to both AbbVie and to IRICoR," stated Dr. Steven Klein, Vice-President, Business Development of IRICoR. "Having a partner such as AbbVie validates the novel approach that Drs. Perreault and Thibault have developed to identify TSNA across multiple tumor types, and demonstrates the value of IRICoR in initially funding this unique platform. This is the second platform technology supported by IRICoR and developed by Drs. Perreault and Thibault that has been advanced towards commercialization. The first one is based on the identification of Minor Histocompatibility Antigens which has been licensed to SpecificiT, a Montreal-based immunotherapy-focused company."

"AbbVie is truly excited about this partnership because it provides a real opportunity to identify new antigens that are produced in cancer cells, which the immune system can recognize. Drs. Perreault’s and Thibault’s work consists of developing technologies to identify these specific proteins at the surface of cancer cells and their approach is quite novel. It’s an area of immuno-oncology we are eager to investigate in order to accelerate and discover new therapies," explains Dr. Thomas Hudson, VP, Head of Oncology Discovery and Early Development, AbbVie.

"Drs. Perreault’s and Thibault’s research will undoubtedly have a remarkable impact on how we treat cancer. Ultimately, AbbVie looks for innovative partnerships and partners who are pushing the boundaries of science in order to tackle the toughest challenges in oncology," says Stéphane Lassignardie, General Manager, AbbVie Canada.

On June 5, 2018 Verastem, Inc. (President and CEO: Robert Forrester)(NASDAQ:VSTM) and Yakult Honsha Co., Ltd. (President: Takashige Negishi)(Tokyo:2267), reported their entry into an exclusive licensing agreement for Yakult to develop and commercialize Verastem’s duvelisib, a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, for the treatment, prevention or diagnosis of all oncology indications in Japan (Press release, Verastem, JUN 5, 2018, View Source;p=RssLanding&cat=news&id=2353165 [SID1234527168]). Verastem’s New Drug Application (NDA) for duvelisib is currently under review with the U.S. Food and Drug Administration (FDA) and is seeking full approval for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and accelerated approval for the treatment of relapsed or refractory follicular lymphoma (FL). On April 9, 2018, Verastem announced that the FDA had accepted the NDA for filing with Priority Review.

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Under the terms of the agreement, Verastem will receive a one-time upfront payment of $10 million from Yakult. Verastem is eligible to receive up to an additional $90 million if certain future pre-specified development and commercialization milestones are successfully achieved by Yakult, plus double-digit royalties based on future net sales of duvelisib in Japan. In exchange, Yakult will receive exclusive rights to develop and commercialize duvelisib in Japan, at its own cost and expense. Yakult will also fund certain global development costs on a pro-rata basis. Verastem will retain all rights to duvelisib outside of Japan.

"In Japan, current therapies to treat CLL/SLL and FL are extremely limited and duvelisib has robust clinical data supporting its efficacy and safety in both indications, which we can build upon," said Masanori Ito, Head of Pharmaceutical Business Division/Managing Executive Officer, Member of the Board of Yakult. "We are eager to collaborate with Verastem to develop duvelisib in these initial hematologic malignancies, and then plan to later expand development to include the additional indications of PTCL and DLBCL. We believe this collaboration underscores our commitment to innovation, growing our oncology franchise, and commercializing medicines that positively impact the lives of patients in Japan."

"This agreement is an important, validating achievement for both duvelisib and Verastem Oncology and speaks to the significant global potential of this novel therapeutic for a broad range of hematologic malignancies," said Robert Forrester, President and Chief Executive Officer of Verastem. "Yakult is an established oncology leader in Japan that successfully markets several branded anti-cancer therapies, including Elplat and Campto. We look forward to working with the world-class development, regulatory and commercial teams at Yakult as they advance oral duvelisib toward commercialization in Japan."

About Duvelisib

Duvelisib is a first-in-class investigational oral, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells and T-cells. PI3K signaling may lead to the proliferation of malignant B- and T-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 Duvelisib was evaluated in late- and mid-stage extension trials, including DUO, a randomized, Phase 3 monotherapy study in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL),4 and DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL).5 Both DUO and DYNAMO achieved their primary endpoints. Verastem Oncology’s New Drug Application (NDA) requesting the full approval of duvelisib for the treatment of patients with relapsed or refractory CLL/SLL, and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma (FL) was accepted for filing by the U.S. Food and Drug Administration (FDA), granted Priority Review and assigned a target action date of October 5, 2018. Duvelisib is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), and is being investigated in combination with other agents through investigator-sponsored studies.6 Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

On June 5, 2018 Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical-stage biopharmaceutical company developing novel oncology therapeutics, reported that positive data from the SL-701 and SL-801 clinical trials were presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in Chicago, IL (Press release, Stemline Therapeutics, JUN 5, 2018, View Source [SID1234527186]). The presentations are available on Stemline’s website (www.stemline.com) under the Scientific Presentations tab.

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SL-701 – Clinical Highlights

The Phase 2 trial of SL-701 in previously treated GBM patients met its primary endpoint of 12-month overall survival (OS-12)

Long-term survivors: 50% OS-12 with SL-701 + bevacizumab

Major responses, including complete responses (CRs), in second-line GBM

Well-tolerated, with very manageable side effect profile

Long-term survivors were comprised largely of patients with target-specific CD8+ T-cell responses

Median OS of target-specific CD8+ T cell responders not reached

Given the major unmet medical need in GBM and promising safety and efficacy data generated to date with SL-701 + bevacizumab, Stemline is considering next steps including leveraging potential immune-related biomarker in registration-directed trial designs
SL-801 – Clinical Highlights

Manageable safety and tolerability profile, largely grade 1-2 adverse events (AEs), to date
Multiple cases of stable disease (SD) in a heavily pretreated solid tumor patient population
Pharmacokinetic (PK) analyses suggest dose-dependent increases in exposure
Ideal therapeutic dose not yet determined as dose escalation continues
Ivan Bergstein, M.D., Stemline’s CEO, commented, "Our BPDCN disease awareness campaign is kicking into high gear as we approach the end of ASCO (Free ASCO Whitepaper), and we believe that our key messages around BPDCN and CD123 are resonating. Our SL-401 regulatory and pre-launch activities continue to progress, and our timelines remain on track." Dr. Bergstein continued, "Additionally, our SL-701 and SL-801 clinical presentations were very well-received at the conference, and our investigators are excited and engaged. The SL-701 + bevacizumab combination has been well-tolerated and has shown activity, including the emergence of long-term survivors comprised largely of target-specific CD8+ T cell responders. Given the major unmet medical need in GBM and SL-701’s promising safety and efficacy data, we are considering next steps, including applying these immune data in registration-directed trial designs. Additionally, we are encouraged by SL-801’s tolerability profile as we continue to dose escalate in a heavily pretreated solid tumor patient population of unmet medical need. Enrollment is ongoing, and we look forward to further updates later this year."

On June 5, 2018 Verastem, Inc. (President and CEO: Robert Forrester)(NASDAQ:VSTM) and Yakult Honsha Co., Ltd. (President: Takashige Negishi)(Tokyo:2267), reported their entry into an exclusive licensing agreement for Yakult to develop and commercialize Verastem’s duvelisib, a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, for the treatment, prevention or diagnosis of all oncology indications in Japan (Press release, Verastem, JUN 5, 2018, View Source;p=RssLanding&cat=news&id=2353165 [SID1234527169]). Verastem’s New Drug Application (NDA) for duvelisib is currently under review with the U.S. Food and Drug Administration (FDA) and is seeking full approval for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and accelerated approval for the treatment of relapsed or refractory follicular lymphoma (FL). On April 9, 2018, Verastem announced that the FDA had accepted the NDA for filing with Priority Review.

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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

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Under the terms of the agreement, Verastem will receive a one-time upfront payment of $10 million from Yakult. Verastem is eligible to receive up to an additional $90 million if certain future pre-specified development and commercialization milestones are successfully achieved by Yakult, plus double-digit royalties based on future net sales of duvelisib in Japan. In exchange, Yakult will receive exclusive rights to develop and commercialize duvelisib in Japan, at its own cost and expense. Yakult will also fund certain global development costs on a pro-rata basis. Verastem will retain all rights to duvelisib outside of Japan.

"In Japan, current therapies to treat CLL/SLL and FL are extremely limited and duvelisib has robust clinical data supporting its efficacy and safety in both indications, which we can build upon," said Masanori Ito, Head of Pharmaceutical Business Division/Managing Executive Officer, Member of the Board of Yakult. "We are eager to collaborate with Verastem to develop duvelisib in these initial hematologic malignancies, and then plan to later expand development to include the additional indications of PTCL and DLBCL. We believe this collaboration underscores our commitment to innovation, growing our oncology franchise, and commercializing medicines that positively impact the lives of patients in Japan."

"This agreement is an important, validating achievement for both duvelisib and Verastem Oncology and speaks to the significant global potential of this novel therapeutic for a broad range of hematologic malignancies," said Robert Forrester, President and Chief Executive Officer of Verastem. "Yakult is an established oncology leader in Japan that successfully markets several branded anti-cancer therapies, including Elplat and Campto. We look forward to working with the world-class development, regulatory and commercial teams at Yakult as they advance oral duvelisib toward commercialization in Japan."

About Duvelisib

Duvelisib is a first-in-class investigational oral, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells and T-cells. PI3K signaling may lead to the proliferation of malignant B- and T-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 Duvelisib was evaluated in late- and mid-stage extension trials, including DUO, a randomized, Phase 3 monotherapy study in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL),4 and DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL).5 Both DUO and DYNAMO achieved their primary endpoints. Verastem Oncology’s New Drug Application (NDA) requesting the full approval of duvelisib for the treatment of patients with relapsed or refractory CLL/SLL, and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma (FL) was accepted for filing by the U.S. Food and Drug Administration (FDA), granted Priority Review and assigned a target action date of October 5, 2018. Duvelisib is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), and is being investigated in combination with other agents through investigator-sponsored studies.6 Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.