On January 9, 2018 Amgen Astellas BioPharma K.K. (Headquarters Tokyo; President and Representative Director Steve Sugino "Amgen Astellas BioPharma") and Astellas Pharma Inc. (Headquarters Tokyo; President and CEO Yoshihiko Hatanaka "Astellas") reported that an application was submitted in Japan for the marketing authorization for bispecific CD19-directed CD3 T cell engager (BiTE) antibody construct blinatumomab (Genetically Recombination) (generic name, development code: AMG 103, "blinatumomab") to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) (Press release, Astellas, JAN 8, 2018, View Source [SID1234522970]). In Japan, blinatumomab is jointly developed by Amgen Astellas BioPharma and Astellas.

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ALL affects approximately 5,000 patients in Japan1, out of which an estimated 670 per year have relapsed or refractory ALL2,3,4. There are several limitations to current treatment options, including their limited efficacy in adult and pediatric patients with relapsed or refractory ALL and dependency on a limited number of drugs with similar mechanisms of action. Improved outcomes for relapsed or refractory ALL patients calls for the development of drugs such as blinatumomab which demonstrate efficacy as a monotherapy and have mechanisms of action dissimilar to cytotoxic agents.

The submission of application for marketing approval in Japan was based on the results from multiple global clinical studies including the Phase 3 randomized study (TOWER study), and the Japanese Phase 1b/2 study. In the TOWER study, blinatumomab was shown to extend overall survival compared to standard-of-care (SOC) chemotherapy in adult patients with relapsed or refractory ALL. Blinatumomab is considered to have the potential to address the serious unmet medical needs of ALL patients.

Blinatumomab received Orphan Drug designation from the Ministry of Health, Labour and Welfare effective September 29, 2017.

About Blinatumomab

Blinatumomab (genetically recombinant antibody) is a bispecific CD19-directed CD3 T cell engager (BiTE) antibody construct that binds specifically to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T cells. Blinatumomab was granted breakthrough therapy and priority review designations by the U.S. Food and Drug Administration, and is now approved in the U.S. for the treatment of relapsed or refractory B-cell precursor ALL in adult and pediatric patients. In November 2015, the EU granted conditional marketing authorization for blinatumomab for the treatment of adults with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor ALL. AmgenInc. is seeking to gain approval for blinatumomab in countries around the world.

TOWER Study

The TOWER study was a Phase 3 randomized study investigating the efficacy of blinatumomab versus SOC chemotherapy in 405 adult patients with Ph- relapsed or refractory B-cell precursor ALL. The study enrolled a difficult-to-treat patient population, which included patients from several stages of relapse. In the blinatumomab arm, this included 35% of patients that had relapsed post-allogenic hematopoietic stem cell transplant (alloHSCT), and excluded those with late first relapse (≥ 12 months after initial remission). Patients were randomized in a 2:1 ratio to receive blinatumomab (n = 271) or one treatment with investigator’s choice out of 4 types of SOC chemotherapy regimens (n = 134). The determination of efficacy was based on overall survival. Per the recommendation of the data monitoring committee, the study was ended early for evidence of superior OS in the blinatumomab arm vs SOC chemotherapy from the pre-specified interim analysis.

These results are published in the New England Journal of Medicine.5

About BiTE Technology

Bispecific T cell engager (BiTE) antibody constructs are being investigated for fighting cancer by helping the body’s immune system to detect and target malignant cells. The modified antibodies are designed to engage two different targets simultaneously, thereby juxtaposing T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. BiTE antibody constructs help place the T cells within reach of the targeted cell, with the intent of allowing T cells to inject toxins and trigger the cancer cell to die (apoptosis). BiTE antibody constructs are currently being investigated for their potential to treat a wide variety of cancers. For more information, visit www.biteantibodies.com.

About Amgen’s Commitment to Oncology

Amgen Oncology is committed to helping patients take on some of the toughest cancers, such as those that have been resistant to drugs, those that progress rapidly through the body and those where limited treatment options exist. Amgen’s supportive care treatments help patients combat certain side effects of strong chemotherapy, and our targeted medicines and immunotherapies focus on more than a dozen different malignancies, ranging from blood cancers to solid tumors. With decades of experience providing therapies for cancer patients, Amgen continues to grow its portfolio of innovative and biosimilar oncology medicines.

On January 8, 2018 Incyte Corporation (NASDAQ:INCY) and Syros Pharmaceuticals, Inc. (NASDAQ:SYRS) reported that the companies have entered into a target discovery, research collaboration and option agreement (Press release, Syros Pharmaceuticals, JAN 8, 2018, View Source [SID1234523027]). Under the agreement, Syros will use its proprietary gene control platform to identify novel therapeutic targets with a focus in myeloproliferative neoplasms (MPNs), and Incyte will receive options to obtain exclusive worldwide rights to intellectual property resulting from the collaboration for up to seven validated targets. Incyte will have exclusive worldwide rights to develop and commercialize any therapies under the collaboration that modulate those validated targets.

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"The discovery and development of novel therapeutic approaches to treat MPNs is an important area of focus at Incyte," said Reid Huber, Ph.D., Chief Scientific Officer of Incyte. "Through this collaboration, we believe that Syros’ gene control platform will allow us to advance our understanding of the underlying biology of MPNs and potentially uncover new molecular targets for drug discovery."

"Our gene control platform has broad applicability across diseases," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "By working with Incyte, a leader in the discovery, development and commercialization of therapies for MPNs, we aim to leverage the promise of our platform to benefit patients with diseases beyond our current areas of focus. Meanwhile, we can continue advancing our own pipeline to achieve our long-term goal of building a fully integrated company with therapies that make a profound difference for patients."

Terms of the Agreement

Under the terms of the agreement, Incyte will pay Syros $10 million upfront – including $2.5 million in cash and $7.5 million in prepaid research and development (R&D) – and purchase a total of $10 million in Syros common stock at $12.61 per share.

Should Incyte exercise all of its options under the agreement, Syros could receive up to $54 million from Incyte in target selection and option exercise fees. For products resulting from the collaboration against each of the up to seven selected and validated targets, Syros could receive up to $50 million in development and regulatory milestones, as well as up to $65 million in commercial milestones. Syros would also be eligible to receive low single-digit royalties on sales of products resulting from the collaboration.

The transaction is effective immediately.

About Incyte Corporation

Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit the Company’s website at www.incyte.com.

Follow @Incyte on Twitter at View Source

On January 8, 2018 Teneobio, Inc., a next generation multi-specific antibody therapeutics company announced today the initiation of a research collaboration and licensing agreement with TESARO, Inc., an oncology-focused biopharmaceutical company, to develop novel multi-specific antibodies for up to six undisclosed oncology targets (Press release, TeneoBio, JAN 8, 2018, View Source [SID1234585553]).

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Under the terms of the agreement, Teneobio will generate product candidates using its proprietary UniRat transgenic human antibody ‘heavy-chain only’ rodent platform and its state-of-the-art sequence-based discovery engine, TeneoSeek. TESARO will have exclusive licenses to the antibodies for clinical development and commercialization on a global basis.

Teneobio Inc. will receive an upfront of $10 million and is eligible for research fees and up to $50M in development milestones per product. Teneobio would also receive royalties on world–wide net sales of each multi-specific product. Additional terms of the agreement were not disclosed.

Roland Buelow, CEO of Teneobio, added, "We are excited to embark on a productive research collaboration with TESARO. The rapid, sequence-based discovery of UniRat-derived modular human variable heavy-chain antibody domains (UniDabs), enables the assembly of robust, optimized multi-specific therapeutics with excellent manufacturability. Complementing our internal pipeline, our strategic alliance with TESARO further leverages the bandwidth and efficiency of Teneobio’s state-of-the-art discovery platforms to advance specific biotherapeutics to the clinic. TESARO’s track record and focus on immuno-oncology are a great match to our interests and our goal to address unmet medical needs with novel mechanisms of action that are now afforded by breakthrough multi-specifics."

"Single domain antibodies have emerged as a leading platform that enables targeted immune activation," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "This strategic research collaboration with Teneobio will allow us to develop biologic drug candidates with novel mechanisms of action. We look forward to working with the Teneobio team, which has a strong track record of success in designing biologic drug candidates."

On January 8, 2018 Vericel Corporation presented Investor presentation on January 8, 2018 (Presentation, Vericel, JAN 8, 2018, View Source [SID1234522981]).

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On January 6, 2018 Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company pioneering the development of medicines to control the expression of genes, reported its strategic plan and expected milestones for 2018 (Press release, Syros Pharmaceuticals, JAN 6, 2018, View Source [SID1234523023]). In a presentation at the 36th Annual J.P. Morgan Healthcare Conference on Thursday, January 11, 2018, at 10:30 a.m. PST (1:30 p.m. EST), the Company will detail its three strategic priorities for the year:

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Aggressively advancing its two clinical-stage programs with planned data readouts on two combinations with SY-1425, a first-in-class selective retinoic acid receptor alpha (RARα) agonist, from the ongoing Phase 2 trial in genomically defined acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) patients, and with the first clinical data for SY-1365, a first-in-class selective cyclin-dependent kinase 7 (CDK7) inhibitor, from the Phase 1 trial in advanced solid tumors.
Leveraging its leading gene control platform to fuel its discovery and preclinical pipeline in oncology, including immuno-oncology, and the recent expansion into monogenic diseases, keeping the Company on track to achieve its goal of delivering one Investigational New Drug (IND) application every other year on average.
Building on its strong fundamentals to continue its evolution toward a fully integrated biopharmaceutical company with therapies that transform patients’ lives.
Syros also announced today that it has entered into a strategic collaboration and option agreement with Incyte Corporation to identify novel targets for myeloproliferative neoplasms (MPNs), a group of blood cancers in which the body makes too many white or red blood cells or platelets. Under the agreement, Syros will use its proprietary gene control platform for target discovery and validation and Incyte will be responsible for drug discovery, development and commercialization. Syros will receive $10 million upfront and a $10 million equity investment at a premium to the current market price. Syros could receive up to $54 million from Incyte in target validation and option exercise fees. Syros could receive up to $115 million in potential development, regulatory and commercial milestone payments per target for up to seven validated targets, plus low single-digit royalties on sales of products that result from the collaboration.

"We have made great strides over the past year, with data validating the ability of our platform to enrich for patients most likely to respond to SY-1425, the advancement of a second program into clinical development, the initiation of our first program in monogenic diseases and a strategic collaboration around our leading gene control platform," said Nancy Simonian, M.D., chief executive officer of Syros. "These accomplishments position us for a transformative year in 2018 with the opportunity for multiple clinical data readouts for SY-1425 and SY-1365, a robust and growing discovery and preclinical pipeline and the continued evolution of our team and capabilities. In 2018, we are focused on continuing to execute with excellence as we strive to build a great and sustainable company that translates our leadership in gene control into therapies that provide a profound and durable benefit for patients."

Expected 2018 Milestones

SY-1425

Report clinical data in second half of 2018 on SY-1425 in combination with azacitidine in biomarker-positive newly diagnosed AML patients who are not suitable candidates for standard chemotherapy.
Report clinical data in second half of 2018 on SY-1425 in combination with daratumumab in biomarker-positive relapsed or refractory AML and higher-risk MDS patients. Janssen Research and Development, LLC is providing daratumumab for the clinical trial under a clinical supply agreement.
SY-1365

Report clinical data in second half of 2018 from dose escalation phase of Phase 1 trial in advanced solid tumor patients.
Open expansion cohorts in ovarian cancer in mid-2018 exploring SY-1365 as a single agent and in combination with carboplatin. Based on robust anti-tumor activity in multiple relapsed and refractory ovarian cancer patient-derived xenograft models, Syros plans to focus the expansion phase of the ongoing Phase 1 clinical trial on ovarian cancer with cohorts evaluating SY-1365 in multiple ovarian cancer populations as a single agent and in combination with carboplatin.
Platform and Early-Stage Pipeline

Select a new development candidate.
Advance discovery programs in cancer and sickle cell disease. Syros’ drug discovery program in sickle cell disease is the first under its monogenic disease strategy to target gene regulatory elements to modulate the expression of a single known gene.
Execute on target discovery work in MPNs in collaboration with Incyte.
Financial Guidance
Based on its current operating plans, Syros expects that its existing cash, cash equivalents and marketable securities, together with the upfront cash and equity investment from its collaboration with Incyte, will enable the Company to fund its anticipated operating expenses and capital expenditure requirements into 2019. Syros had approximately $81.9 million in cash, cash equivalents and marketable securities as of September 30, 2017.

Presentation at 36th Annual J.P. Morgan Healthcare Conference
Syros will webcast its corporate presentation from the 36th Annual J.P. Morgan Healthcare Conference in San Francisco on Thursday, Jan. 11, 2018, at 10:30 a.m. PST (1:30 p.m. EST). A live webcast of the presentation and question and answer session can be accessed under Events & Presentations in the News and Investors section of the Company’s website at www.syros.com. A downloadable copy of the corporate slide presentation is also available on the News and Investors section of the website. A replay of the webcast will be archived on the website for approximately 30 days following the presentation.