On January 7, 2019 Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company pioneering the use of DARPin therapeutics* to treat serious diseases, reported that it will present at the 37th Annual J.P. Morgan Healthcare Conference on Wednesday, January 9, 2019 at 8:00 AM Pacific Standard Time (11:00 AM Eastern Time; 5:00 PM CET) (Press release, Molecular Partners, JAN 7, 2019, View Source [SID1234532536]). The presentation, followed by a Q&A session, will be hosted by Dr. Patrick Amstutz, CEO of Molecular Partners.

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Beyond highlighting the progress of the clinical DARPin compounds and the evolution of the company’s therapeutic design space in oncology research, the presentation will outline the collaboration and license agreement for the clinical development and commercialization of MP0310 (FAP x 4-1BB) which the company and Amgen (NASDAQ:AMGN) announced on December 19, 2018. MP0310 is a preclinical molecule designed to locally activate immune cells in the tumor by binding to FAP on tumor stromal cells (localizer) and co-stimulating T cells via 4-1BB (immune modulator).

Audio webcast
The presentation will be webcast live. A copy of the presentation handout as well as a replay of the webcast will be made available on the company’s website www.molecularpartners.com under the Investors section. The replay will be available for 30 days following the presentation.

Financial Calendar
February 7, 2019 – Publication of Full-year Results 2018 (unaudited)
March 15, 2019 – Expected Publication of Annual Report 2018
April 16, 2019 – Annual General Meeting
May 9, 2019 – Interim Management Statement Q1 2019
View Source

About the DARPin Difference
DARPin therapeutics are a new class of protein therapeutics opening an extra dimension of multi-specificity and multi-functionality. DARPin candidates are potent, specific, safe and very versatile. They can engage more than 5 targets at once, offering potential benefits over those offered by conventional monoclonal antibodies or other currently available protein therapeutics.
The DARPin technology is a fast and cost-effective drug discovery engine, producing drug candidates with ideal properties for development and very high production yields.

With their good safety profile, low immunogenicity and long half-life in the bloodstream and the eye, DARPin therapeutics have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. Molecular Partners is partnering with Allergan to advance clinical programs in ophthalmology, and is advancing a proprietary pipeline of DARPin drug candidates in oncology and immuno-oncology. The most advanced global product candidate is abicipar, a molecule currently in phase 3, in partnership with Allergan. Several DARPin molecules for various ophthalmic indications are also in development. The most advanced DARPin therapeutic candidate wholly owned by Molecular Partners, MP0250, is in phase 2 clinical development for the treatment of solid tumors and hematological tumors. MP0274, the second-most advanced DARPin drug candidate owned by Molecular Partners, has broad anti-HER activity; it inhibits HER1, HER2 and HER3-mediated downstream signaling via Her2, leading to induction of apoptosis. MP0274 is currently in phase 1. Molecular Partners is also advancing a growing preclinical pipeline that features several immuno-oncological development programs. DARPin is a registered trademark owned by Molecular Partners AG.

On January 7, 2019 Celgene Corporation (NASDAQ: CELG) reported a business update, including confirmation that the company achieved its guidance for full-year 2018; its financial guidance for 2019; and reaffirmation of its expected 2020 financial targets (Press release, Celgene, JAN 7, 2019, View Source [SID1234532535]).

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Based on a preliminary review of its results for the fourth-quarter ended December 31, 2018, Celgene achieved guidance for the full-year 2018 that it provided on October 25, 2018 and which is summarized in the table below. The company will report its results for the fourth-quarter and full-year 2018 on January 31, 2019.

Celgene today also provides guidance for the full-year 2019, including total revenue expected to be $17.0 billion to $17.2 billion, a 12 percent increase year-over-year, based on the mid-point of the range. Based on Generally Accepted Accounting Principles (GAAP) diluted earnings per share (EPS) for the full-year 2019 is expected to be in the range of $8.48 to $9.17. Adjusted diluted EPS for the full-year 2019 is expected to be in the range of $10.60 to $10.80.

"Our 2019 financial guidance reflects continued strong operating performance and momentum," said Mark J. Alles, Chairman and Chief Executive Officer of Celgene Corporation. "Multiple clinical and regulatory milestones are expected in 2019 to advance our late-stage portfolio and accelerate our early-stage pipeline."

*Year-over-year percentage change based on the mid-point of the range.

**Not meaningful as the 2019 measures exclude the impact of any strategic transactions, impairments, loss contingencies, changes in the fair value of equity investments, costs associated with the Bristol-Myers Squibb Company (Bristol-Myers Squibb) and Celgene transaction and non-operating tax adjustments that have not yet occurred.

Reaffirming Expected 2020 Long-Term Financial Targets*

2020 total revenue range of $19.0 billion to $20.0 billion

Adjusted diluted EPS to exceed $12.50

*At constant currency using an average of December 2018 spot rates

Overview of Key Milestones Expected Over the Next 12 Months

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REVLIMID

Approval expected by the U.S. Food and Drug Administration (FDA) on the supplemental New Drug Application (sNDA) for REVLIMID in combination with rituximab in relapsed/refractory indolent lymphoma (AUGMENT)

Approval expected by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for REVLIMID in combination with bortezomib and dexamethasone (RVd) in newly diagnosed multiple myeloma (NDMM)

Data expected from the phase III ROBUST trial with REVLIMID in combination with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate and prednisone (R-CHOP) in patients with first-line ABC-subtype diffuse large B-cell lymphoma (DLBCL) (event-driven)

POMALYST/ IMNOVID

Approval expected by the EMA CHMP and Japan Pharmaceuticals and Medical Devices Agency (PMDA) for POMALYST/IMNOVID in combination with bortezomib and dexamethasone (PVd) in relapsed/refractory multiple myeloma (RRMM)

OTEZLA

Approval expected by the U.S. FDA for the sNDA in Behҫet’s disease with a Prescription Drug User Fee Act (PDUFA) action date of July 21, 2019. Approval by the PMDA in Japan is expected in H2:2019

Submission of the sNDA with label update for moderate to severe scalp psoriasis to the U.S. FDA expected in Q2:2019

ABRAXANE

Data from the phase III apact trial with ABRAXANE as adjuvant therapy in patients with surgically resected pancreatic cancer (event-driven)

PDUFA action date of March 12, 2019 for the supplemental Biologics License Application (sBLA) submission filed by Roche of Tecentriq (atezolizumab) in combination with ABRAXANE for the initial treatment of patients with PD-L1-positive, metastatic triple-negative breast cancer

Milestones Expected for Key Pivotal Assets

Ozanimod

U.S. NDA and EU Marketing Authorization Application (MAA) submissions in relapsing multiple sclerosis (RMS) on-track for Q1:2019

Phase III TRUE NORTH trial in ulcerative colitis (UC) expected to complete enrollment in H1:2019

Fedratinib

U.S. FDA approval expected by year-end 2019

EU MAA submission planned in H1:2019

Phase I/II combination trial with luspatercept planned

Luspatercept

U.S. and EU regulatory applications for transfusion-dependent, lower-risk myelodysplastic syndromes (MDS) with ring sideroblasts (RS+) and transfusion-dependent beta-thalassemia planned for H1:2019

Data expected from the phase II myelofibrosis trial in H2:2019

Liso-cel

Data from the pivotal TRANSCEND trial in relapsed/refractory DLBCL expected in 2019

U.S. BLA submission expected in H2:2019

Pivotal phase II trial in relapsed/refractory chronic lymphocytic leukemia (CLL) to be initiated in H1:2019

bb2121

Data from the KarMMa pivotal trial in RRMM expected in H2:2019

Phase II trial in NDMM to be initiated in H2:2019

Key Milestones Expected for Research & Early Development Pipeline

File at least 5 Investigational New Drug (IND) or Clinical Trial Applications (CTA) for novel assets

·Clinical data expected in 2019 from the following assets:

Asset

Indication

Status

CC-92480 (CELMoD)

RRMM

Phase I trial

CC-93269 (BCMA TCE)

RRMM

Phase I trial

CC-220 (CELMoD)

RRMM

Phase I/II trial

bb21217 (BCMA CAR T)

RRMM

Phase I trial

JCARH125 (BCMA CAR T)

RRMM

Phase I trial

CC-90009 (CELMoD)

Relapsed/refractory acute myeloid leukemia (AML)

Phase I trial

CC-90002 (anti-CD47 mAb)

Non-Hodgkin lymphoma (NHL)

Phase I trial

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 Castle Biosciences, Inc., a skin cancer diagnostics company providing molecular diagnostics to improve cancer management decisions, reported a new publication demonstrating that the DecisionDx-Melanoma gene expression profile (GEP) test can identify high-risk patients who are likely to recur or die from melanoma within groups of patients often considered low risk based on traditional staging metrics (Press release, Castle Biosciences, JAN 7, 2019, View Source [SID1234532533]). Results from this multicenter study of 690 patients demonstrated that the DecisionDx-Melanoma test is an independent predictor of risk for recurrence, metastasis and melanoma-specific death. The study was published in the January 2019 issue of the Journal of the American Academy of Dermatology (JAAD).

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"In this study of a large, contemporary melanoma population, the GEP test identified patients at high risk for recurrence and death from melanoma among groups that are deemed low risk by traditional staging metrics," commented study co-author John Vetto, M.D., Professor of Surgery, Division of Surgical Oncology and Director of the Cutaneous Oncology Program at the Department of Surgery, Oregon Health & Science University. "The 31-gene GEP test provides independent information that improves risk prediction and enables physicians to develop tailored care for their patients with melanoma."

Study Details:

Patients from three previously published DecisionDx-Melanoma validation studies were combined to enable analysis of test performance in the following three clinically important subgroups that are traditionally considered low risk based on current national melanoma guidelines: (1) patients who had a negative sentinel lymph node (SLN) biopsy; (2) those with American Joint Committee on Cancer (AJCC) Stage I-IIA melanoma; and (3) those with thin (≤1 mm) tumors.

The DecisionDx-Melanoma test was performed to determine molecular class for each patient, with a Class 1A result indicating the lowest 5-year risk of metastasis and a Class 2B result indicating the highest risk. Study endpoints included recurrence-free survival (RFS; time to local, regional or distant recurrence), distant metastasis-free survival (DMFS; time to any distant metastasis) and melanoma-specific survival (MSS; time to documented death from melanoma).

In this population of 690 unique Stage I-III patients with at least 5 years of follow-up or a metastatic event, median age was 59 years and median Breslow thickness was 1.3 mm. Seventy percent of patients had Stage I or II melanoma.

Key Study Findings:

In the pooled cohort, patients with Class 1A results had significantly higher RFS, DMFS and MSS rates compared to Class 2B (p<0.0001 for all comparisons).
Seventy percent of the patients who were SLN negative and experienced metastasis were identified as Class 2 by the DecisionDx-Melanoma test. Similarly, 79% of melanoma-specific deaths among those who were SLN negative were identified as having a Class 2 result.
Patients with Stage I-IIA melanoma who received a Class 2B DecisionDx-Melanoma test result had significantly worse RFS, DMFS and MSS rates compared to patients with a Class 1A DecisionDx-Melanoma result (p<0.0001 for all comparisons).
Based on Cox multivariate analysis in the Stage I-IIA subgroup that included tumor thickness, ulceration and mitotic rate, DecisionDx-Melanoma test class was found to be the only significant predictor of all three endpoints (RFS, DMFS and MSS; p<0.05 for all).
For patients with thin tumors (≤1 mm), although most patients were low risk Class 1, 15 patients had the highest risk Class 2B result. Those patients with a Class 2B test result had a significantly reduced RFS of 64.6% compared to those with a Class 1A result (96.8%; p<0.0001).
Results of the study extend previous findings of high prognostic accuracy of the DecisionDx-Melanoma GEP test to subgroups of patients at high risk, yet for whom current national melanoma guidelines recommend low intensity follow-up and surveillance. Additionally, the study’s authors suggest that the results could have an important impact on clinical trials evaluating adjuvant treatment of Stage II disease with immunomodulatory or targeted therapies, as the identification of high-risk Stage II patients may guide appropriate patient enrollment in such trials.

The manuscript can be accessed at View Source(18)32328-4/fulltext

About DecisionDx-Melanoma

The DecisionDx-Melanoma test uses tumor biology to predict individual risk of melanoma recurrence and sentinel lymph node positivity independent of traditional factors and has been studied in over 2,900 patients. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in three multi-center studies that have included 690 patients and have demonstrated consistent results. Performance has also been confirmed in four prospective studies including over 700 patients. The consistent high performance and accuracy demonstrated in these studies, which combined have included over 1,300 patients, provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results.

Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter studies that included over 1,400 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in multi-center and single-center studies. More information about the test and disease can be found at www.SkinMelanoma.com.

On January 7, 2019 Clovis Oncology, Inc. (NASDAQ:CLVS) reported its preliminary, unaudited revenues for the fourth quarter and full year ended December 31, 2018 (Press release, Clovis Oncology, JAN 7, 2019, View Source [SID1234532532]). The financial information presented in this news release may be adjusted as a result of completion of customary quarterly review and audit procedures.

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Unaudited preliminary results include:

$30.3-$30.8M in Rubraca product revenues for the fourth quarter of 2018 compared to $22.8M for Q3 2018 and $17.0M for Q4 2017
$95.3-$95.8M in Rubraca product revenues for the full year 2018 compared to $55.5M for FY2017
Free drug was an additional approximately 25 to 27 percent of overall commercial supply for Q4 and FY2018
$518-$521M in cash, cash equivalents and available-for-sale securities at December 31, 2018
Clovis plans to discuss these results with investors this week at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco.

"We are very pleased with our sales performance in the fourth quarter and the momentum it provides going into this year," said Patrick J. Mahaffy, CEO and President of Clovis Oncology. "Following the recent CHMP recommendation for our second ovarian cancer approval in Europe, Breakthrough Therapy Designation and a potential supplemental NDA in prostate cancer by the end of this year, as well as our successful defense last month of the rucaparib camsylate salt/polymorph patent in Europe, we feel extremely well-positioned for a strong 2019."

Clovis Oncology to Present at 37 th Annual J.P. Morgan Healthcare Conference on January 8, 2019

Clovis’ President and CEO, Patrick J. Mahaffy, will present at the 37th Annual J.P. Morgan Healthcare Conference to be held at the Westin St. Francis hotel in San Francisco on Tuesday, January 8, at 4:30 p.m. PT. A live webcast of the presentation and Q&A session can be accessed through the investor relations section of the Company’s website at clovisoncology.com. Following the live presentation, a replay of the webcast will be available on the Company’s website for 30 days.

Fourth Quarter and Full Year 2018 Financial Results Release Planned for February 26, 2019

The Company plans to report financial results for the fourth quarter and full year ended December 31, 2018, on Tuesday, February 26, 2019, after the close of the U.S. financial markets. Clovis’ senior management will host a conference call and live audio webcast at 4:30 p.m. ET to discuss the company’s results in greater detail.

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. Studies open for enrollment or under consideration include ovarian, prostate, breast, gastroesophageal, pancreatic, lung and bladder cancers. Clovis holds worldwide rights for Rubraca.

In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.

Rubraca is an unlicensed medical product outside of the U.S. and EU.