On January 07, 2019 CytoReason, a leader in machine learning for drug discovery and development, reported that it has entered into a collaboration agreement with Pfizer Inc. that will leverage CytoReason’s cell-centered models of the immune system (Press release, CytoReason, JAN 7, 2019, View Source [SID1234619714]).

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CytoReason will receive from Pfizer payments potentially equaling up to low double digit millions of US$ for technology access fees, research support and certain success-based payments.

CytoReason’s proprietary platform helps rebuild lost cellular information from gene expression data and associates genes to specific cells. This information is then integrated with additional omics and literature data to create a cell-based model of the trial-specific immune response. Integration with the CytoReason disease model empowers the study analytics and allows the model to learn and improve, leading to robust target discovery, drug response biomarkers and indication selection.

"We believe that CytoReason’s platform has the potential to offer valuable insights that may be applied to our research into the human immune system," said Michael Vincent, Chief Scientific Officer, Inflammation & Immunology, Pfizer. "Leveraging technologies such as this can help us understand disease and prioritize targets, and support our mission of bringing innovative new therapies to patients who need them."

"The collaboration with Pfizer will further strengthen our models in our core therapeutic areas. This will be our fifth major partnership, which we believe will help make our model unparalleled in its accuracy for assets across the pipeline," said David Harel, CytoReason’s CEO. "CytoReason’s model brings together thousands of samples on a cell-protein-gene level, allowing for fast and accurate insights."

About CytoReason

Based on more than 10 years of research, CytoReason’s technology uses a proprietary data and machine learning model to reconstruct cellular information from bulk tissue, to train an immune-specific NLP engine, and to integrate multi-omics data. The company’s platform organizes and standardizes collaborators’ data (gene, protein, cell, and microbiome) and integrates it into CytoReason’s proprietary disease model to generate mechanistic understanding of the immune system, leading to novel insights.

CytoReason’s technology has yielded 2 pending patents, 10 commercial and scientific collaborations and 16 peer reviewed publications. Fully applicable to cancer immunotherapy, autoimmune, neurodegenerative and infectious disease research, CytoReason is at the cutting edge of society’s boldest attempts to improve health outcomes through better understanding of the immune system.

On January 7, 2019 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported anticipated 2019 milestones for IPI-549, a first-in-class, oral, immuno-oncology product candidate targeting tumor-associated myeloid cells through selective phosphoinositide-3-kinase-gamma (PI3K-gamma) inhibition and provided financial guidance for 2019 (Press release, Infinity Pharmaceuticals, JAN 7, 2019, View Source [SID1234532501]).

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"In the year ahead, we are excited to be moving into earlier lines of therapy, new indications, and novel, potentially transformative immuno-oncology combinations to execute on our strategy to expand the depth and breadth of the development of IPI-549," said Adelene Perkins, Chief Executive Officer of Infinity Pharmaceuticals. "Importantly, we have a cash runway into the second half of 2020, which enables us to advance IPI-549 development in several innovative studies in 2019. We also have the support of tremendous collaborators BMS and Arcus for two of these potentially transformative studies."

"The IPI-549 safety and clinical activity from the MARIO-1 Phase 1b study continues to inform our strategy to expand the depth and breadth of IPI-549 development for cancer patients," said Dr. Sam Agresta, Chief Medical Officer of Infinity. "MARIO-275 is our first global, randomized study of IPI-549 in combination with Opdivo compared to Opdivo monotherapy. This study, in collaboration with BMS, is designed to address an unmet medical need for patients with advanced urothelial cancer and is an important step in advancing IPI-549 development beyond the checkpoint inhibitor refractory setting. In addition, the safety, clinical activity and mechanism of action of IPI-549 allows us to expand the breadth of the program by moving into novel combinations, including in previously treated, advanced triple negative breast cancer patients, with a novel triple therapy study in collaboration with Arcus. And I am particularly excited to initiate our first IPI-549 study in the front-line setting in 2019."

Infinity plans to initiate MARIO-275, a combination study of IPI-549 with Opdivo in I/O naïve urothelial cancer (UC) patients, in the first half of 2019. Opdivo was approved for use by the FDA as a single agent in advanced urothelial cancer based on durable response associated with treatment in CheckMate-275, a Phase 2 single arm clinical trial of Opdivo in subjects with metastatic or unresectable urothelial cancer who have progressed or recurred following treatment with a platinum agent1. Retrospective analyses of this study showed that patients with higher levels of myeloid derived suppressor cells, or MDSCs, had poor outcomes2. IPI-549 has been shown to reduce MDSCs as both a monotherapy and in combination with Opdivo in MARIO-13-6. MARIO-275 is intended to evaluate the benefit of adding IPI-549 to Opdivo in cisplatin-refractory, I/O-naive urothelial cancer patients. Clinical benefit will be assessed in the overall population as well as in subsets of patients with different baseline levels of MDSCs.

Infinity will also be advancing novel triple combination therapies with Arcus, initially evaluating IPI-549 in combination with AB928, Arcus’s dual adenosine receptor antagonist, and chemotherapy in patients with previously treated, advanced triple negative breast cancer, or TNBC. As both macrophages and high adenosine levels are believed to play critical roles in creating a highly immune-suppressive tumor microenvironment in cancer after chemotherapy, the novel immuno-oncology combination being evaluated in this setting represent a potentially promising approach to treating TNBC.

Infinity’s chair and chief executive officer, Adelene Perkins, will discuss the company’s continued execution on its corporate strategy and 2019 priorities as part of a podium presentation at the 37th Annual J.P. Morgan Healthcare Conference on Thursday, January 10, at 9:30 a.m. PST (12:30 p.m. EST). The presentation will be webcast live on Infinity’s website, www.infi.com, and an archived version of the webcast will be available on Infinity’s website for 30 days.

Anticipated Milestones in 2019: Expanding Depth and Breadth of IPI-549 Development

1H2019

Advance into Immuno-Oncology (I/O) Naïve Indications in Combination with Opdivo: Initiate MARIO-275 in I/O naïve UC patients with BMS
Advance into Novel Triple Combinations Beyond CPIs: Initiate Triple Therapy Combination (IPI-549+AB928+Chemo) in previously treated advanced TNBC with Arcus
2H2019

Initiate the first IPI-549 combination study in front-line advanced cancer patients
Complete enrollment of MARIO-1 seven combination expansion cohorts including:
Augmented melanoma expansion cohort (n=40)
TNBC expansion cohort (n=29)
2019 Financial Guidance

Infinity ended 2018 with approximately $58.6 million in cash and investments (unaudited) and plans to report its fourth quarter and full-year 2018 financial results in March. The company is providing the following financial guidance today:

Net loss: $30 million to $40 million
Year-end cash: $20 million to $30 million
Cash runway: Into 2H 2020
Infinity’s 2019 financial guidance is based on its current operating plans, excludes additional financing or business development activities, and includes a $2 million milestone payment from PellePharm, a private company, upon initiation of a Phase 3 study for the hedgehog inhibitor program, which Infinity licensed to PellePharm in 2013.

IPI-549 is an investigational compound, and its safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.

On January 7, 2019 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported a 2019 clinical and corporate outlook (Press release, Syndax, JAN 7, 2019, View Source [SID1234532534]).

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"2019 is slated to be a milestone-rich time for Syndax, with data expected from multiple trials within our ENCORE program of entinostat in combination with checkpoint therapy in platinum resistant ovarian cancer, triple negative breast cancer, and anti-PD-1-pretreated melanoma, all of which we believe represent underserved areas with significant market opportunity," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "We also eagerly anticipate the next interim overall survival analysis in the second quarter from the Phase 3 E2112 trial of entinostat plus exemestane in HR+, HER2- breast cancer and remain highly encouraged by the potential to provide a survival benefit for HR+, HER2- breast cancer patients who have stopped responding to first line treatment with hormone therapy. Any positive overall survival assessment would enable the company to file for full regulatory approval."

Dr. Morrison added, "In addition, we remain on track for an IND filing for our Menin inhibitor, SNDX-5613, in the second quarter of 2019, followed by initiation of the clinical trial program. Acute leukemias characterized by MLL-rearrangements and nucleophosmin mutations represent areas of high unmet medical need, and the preclinical data we’ve generated thus far provide strong support that menin inhibition has the potential to serve as an effective therapy for patients lacking viable options. Finally, we continue to expect initial efficacy results for SNDX-6352 in chronic graft versus host disease in the second half of 2019."

Anticipated Key Milestones for 2019:

Entinostat

Topline results from the randomized Phase 2 portion of the ENCORE 603 trial of entinostat in combination with Pfizer/Merck KGaA’s PD-L1 inhibitor, BAVENCIO (avelumab), in patients with ovarian cancer are expected in the first quarter of 2019.
Presentation of clinical, biomarker and gene analysis data from the anti-PD-1 pretreated melanoma cohort of the Phase 2 ENCORE 601 trial of entinostat in combination with KEYTRUDA (pembrolizumab) is expected in the first quarter of 2019.
A decision on whether to advance to the second stage of the ENCORE 601 cohort of patients with microsatellite stable colorectal cancer (MSS-CRC) naïve to PD-1 therapy is expected in the first quarter of 2019.
Topline results from the randomized Phase 2 portion of the ENCORE 602 trial of entinostat in combination with Genentech’s PD-L1 inhibitor, TECENTRIQ (atezolizumab), in patients with triple negative breast cancer are expected in the second quarter of 2019.
The next interim analysis for the overall survival (OS) primary endpoint of E2112, the Phase 3 registration trial of entinostat plus exemestane in advanced hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer, is expected in the second quarter of 2019. Additional interim analyses will be conducted every six months until either an OS benefit is observed, or the final target number of events occur. Any positive OS assessment would enable the Company to file for full regulatory approval.
Syndax plans to commence a focused, biomarker-driven, randomized registration trial comparing the entinostat-pembrolizumab combination to standard of care chemotherapy in non-small cell lung cancer (NSCLC) patients whose disease has progressed after both platinum-based chemotherapy and PD-1 antagonist therapy in the first half of 2019. The trial will seek to validate peripheral classical monocytes as a marker of response to the combination and to determine whether the combination can improve progression free survival (PFS) over standard of care chemotherapy in the high monocyte population.
SNDX-6352

Topline results and a recommended Phase 2 dose and schedule from the Phase 1/1b trial of SNDX-6352, Syndax’s anti-CSF-1R monoclonal antibody, alone or in combination with IMFINZI (durvalumab), AstraZeneca’s human monoclonal antibody directed against PD-L1, are expected in the second quarter of 2019.
Topline results and a recommended Phase 2 dose and schedule from the Phase 1 trial of SNDX-6352 in patients with chronic graft versus host disease (cGVHD) are expected in the third quarter of 2019.
Menin-MLLr Inhibitor Portfolio

An Investigational New Drug (IND) filing with the FDA for SNDX-5613, the Company’s lead Menin inhibitor compound, is expected in the second quarter of 2019, followed by the initiation of a Phase 1 clinical trial in patients with a genetically defined subset of acute leukemias.
Financial Guidance

Syndax ended 2018 with cash, cash equivalents and short-term investments of approximately $80 million. For 2019, research and development expenses are expected to be $54 to $58 million, and total operating expenses are expected to be $68 to $73 million. Research and development expenses and total operating expenses for 2019 are expected to include approximately $2 million and $6 million, respectively, of non-cash stock compensation. The Company plans to announce financial results from the fourth quarter and full-year 2018 later this quarter.

On January 7, 2019 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported it has acquired drug conjugate linker-toxin and CD3-based bispecific technologies from Agensys, Inc., an affiliate of Astellas Pharma Inc. Under the terms of the agreement, CytomX will pay Astellas a one-time, up-front payment (Press release, CytomX Therapeutics, JAN 7, 2019, View Source [SID1234532550]).

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"The clinical progress we reported throughout 2018 provided initial proof of concept for our Probody therapeutic platform. This transaction with Astellas provides us with novel payloads and CD3 binding moieties for our next wave of potent anti-cancer agents that leverage our technology, including Probody drug conjugates and Probody T cell engaging bispecifics," said W. Michael Kavanaugh, M.D. chief scientific officer and head of research and non-clinical development at CytomX.

On January 7, 2019 Cerus Corporation (Nasdaq:CERS) reported unaudited preliminary product revenue for the fourth quarter and full year 2018 and provided 2019 product revenue guidance (Press release, Cerus, JAN 7, 2019, View Source [SID1234532503]).

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Cerus’ unaudited preliminary product revenue for the fourth quarter of 2018 totaled $16.5 million compared to $16.2 million during the same period the prior year. Based on the fourth quarter unaudited preliminary product revenue, the Company expects full year 2018 product revenue to be $60.9 million, ahead of the top end of the range of the Company’s most recent guidance of $58 million to $60 million. The preliminary product revenue results have not been audited and are subject to change.

Preliminary fourth quarter product revenue would represent the highest quarterly product revenue ever reported by the Company. Cerus expects 2019 product revenue to be in the range of $70 million to $73 million, representing 15% to 20% growth compared to the preliminary 2018 results.

"The revenue growth we generated in 2018 underscores the increasing demand for safer blood components. We finished 2018 strong with quarter-over-quarter and year-to-date growth in disposable kits led by French national conversion and U.S. demand," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer.

"Over the past few months, U.S. customer orders for INTERCEPT platelets have been increasing. With the recent FDA publication of the draft guidance document on bacterial risk control strategies for platelet collection and transfusion, we could potentially experience further acceleration in customer demand in the U.S.," continued Greenman.

Heading into 2019, the Company will continue to advance its mission to make INTERCEPT the standard of care for transfused blood components globally and to enable its customers to deliver safe and effective blood products to patients. In addition to delivering on the stated revenue growth goals, other anticipated 2019 milestones include the planned U.S. regulatory submission on pathogen-reduced cryoprecipitate, additional cryoprecipitate manufacturing partnerships, and progress on the U.S. INTERCEPT red blood cell clinical studies.

Cerus will provide complete fourth quarter and full year 2018 financial results and host a call to discuss both 2018 results and 2019 expectations in late February.