On March 15, 2019 March 15, 2019 (GLOBE NEWSWIRE) — Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage, immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers, reported financial results and recent corporate highlights for the full year ended December 31, 2018 (Press release, Checkpoint Therapeutics, MAR 15, 2019, http://checkpointtx.com/press-releases/checkpoint-therapeutics-reports-full-year-2018-financial-results-and-recent-corporate-highlights/ [SID1234534375]).

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "During 2018, we continued to advance our lead clinical programs, CK-101, a third-generation epithelial growth factor receptor ("EGFR") tyrosine kinase inhibitor ("TKI"), and CK-301, a fully human anti-PD-L1 antibody, and presented our first interim clinical data for CK-101 in an oral presentation at the World Conference on Lung Cancer. We look forward to presenting our first interim safety and efficacy data from the ongoing CK-301 study in the second quarter as we continue to enroll potential registration-enabling expansion cohorts in endometrial and colorectal cancers, and plan to initiate a registration trial for CK-101 by year-end."

Financial Results:

Cash Position: As of December 31, 2018, Checkpoint’s cash and cash equivalents totaled $22.0 million, compared to $19.2 million at December 31, 2017, an increase of $2.8 million.
R&D Expenses: Research and development expenses for the year ended December 31, 2018 were $33.7 million, compared to $19.1 million for the year ended December 31, 2017, an increase of $14.6 million.
G&A Expenses: General and administrative expenses for the year ended December 31, 2018 were $6.6 million, compared to $5.4 million for the year ended December 31, 2017, an increase of $1.2 million.
Net Loss: Net loss attributable to common stock holders for the year ended December 31, 2018 was $36.4 million, or $1.27 per share, compared to a net loss of $22.7 million, or $1.00 per share, for the year ended December 31, 2017.
2018 and Recent Corporate Highlights:

In March 2018, Checkpoint completed an underwritten public offering that raised net proceeds of $20.8 million.
Also in March 2018, Checkpoint completed the dose escalation portion of the ongoing Phase 1 trial of CK-301, a fully human anti-PD-L1 antibody, in selected recurrent or metastatic cancers, and initiated the first dose expansion cohort, which is evaluating an 800 mg dose of CK-301 administered every two weeks.
In April 2018, preclinical data were presented on Checkpoint’s BET inhibitor, CK-103, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. CK-103 demonstrated combinatorial effects in an in vivo model with anti-PD-1 antibodies, which may support the development of CK-103 as an anti-cancer agent alone and in combination with CK-301.
In September 2018, Checkpoint announced interim safety and efficacy data from its Phase 1/2 clinical trial of CK-101, a third-generation EGFR TKI being evaluated in advanced NSCLC. The data were presented in an oral presentation at the International Association for the Study of Lung Cancer ("IASLC") 19th World Conference on Lung Cancer in Toronto. CK-101 was well tolerated across multiple dose groups and safe. Durable anti-tumor activity was observed, particularly in treatment-naïve EGFR mutation-positive NSCLC patients.
In October 2018, Checkpoint appointed Christian Béchon to its Board of Directors.
In January 2019, Checkpoint announced that the ongoing multi-center clinical trial of anti-PD-L1 antibody CK-301 was expanded to enroll patients in three endometrial and colorectal cohorts intended to support requests for accelerated approval and BLA submissions to the FDA. The ongoing trial is also enrolling cohorts of patients with NSCLC and cutaneous squamous cell carcinoma.
In March 2019, Checkpoint announced two new patent issuances by the U.S. Patent and Trademark Office and the European Patent Office for CK-101. The patents cover CK-101 in the U.S. and Europe through at least August 2034, not including any potential patent term extensions.

On March 15, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported financial results for the quarter ended December 31, 2018. The Company also reviewed recent milestones (Press release, Stemline Therapeutics, MAR 15, 2019, View Source [SID1234534361]):

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ELZONRIS (tagraxofusp) – US Approval and Commercial Launch

ELZONRIS was FDA-approved on December 21, 2018 for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients, two years and older.

ELZONRIS has been commercially available in the U.S. since the end of January 2019, and patients are currently being treated with ELZONRIS in the commercial setting.

A Marketing Authorization Application (MAA) for ELZONRIS seeking marketing approval in Europe was submitted to, and subsequently validated by, the European Medicines Agency (EMA) in January 2019. The MAA has been granted accelerated assessment and is currently under review.
ELZONRIS – Market Expansion Efforts

ELZONRIS is being evaluated in clinical trials in additional indications, including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and acute myeloid leukemia (AML).

Based on the clinical results observed in CMML and MF thus far, we are evaluating potential registrational pathways in these indications. For CMML, we intend to discuss registration-directed plans with the FDA mid-year.

We are also working towards expansion opportunities within the BPDCN universe, including maintenance therapy after stem cell transplant.

In parallel, we plan to expand our clinical efforts later this year and next into subsets of AML patients enriched for CD123+ expression.

We expect to provide periodic updates on these initiatives throughout this year and next at scientific conferences.
ASH Conference

In December 2018, ELZONRIS data were selected for four presentations at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) conference. Presentations included results of the BPDCN pivotal trial, delivered via oral presentation, and updated clinical trial data in patients with CMML and MF.

Additionally, we had an active clinical, medical affairs and pre-commercial presence at ASH (Free ASH Whitepaper) focused on BPDCN disease awareness.
SL-801

In October 2018, data from the ongoing Phase 1 trial of SL-801 in patients with advanced solid tumors were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress 2018. We expect to provide further updates at upcoming conferences.
SL-701

In November 2018, data from the Phase 2 trial of SL-701 in patients with second-line glioblastoma (GBM) were delivered via oral presentation at the 23rd Annual Meeting of the Society of Neuro-Oncology (SNO). We expect to provide further updates on this program later this year.
SL-901

SL-901 is a novel kinase inhibitor that was evaluated in an abbreviated Phase 1 trial of solid tumor patients in Europe. Neither a dose limiting toxicity nor maximum tolerated dose was identified, and there was one partial response (PR) in a patient with advanced non-small cell lung cancer. We plan to re-initiate a Phase 1 study by early 2020.
SL-1001

In March 2019, we announced the in-licensing of SL-1001, a novel, selective RET kinase inhibitor that demonstrated potent preclinical in vitro and in vivo activity. We expect to begin IND-enabling studies this year, with a Phase 1 clinical trial targeted for 2020.
Robert Francomano, SVP and Global Head of Commercial, commented, "2018 was a transformational year for Stemline as we invested in building out a focused, world class, commercial organization ahead of the FDA approval of ELZONRIS. We are excited to bring this important new treatment to patients, and our highly talented team is in the field, excited, engaged, and poised for success in 2019."

Ivan Bergstein, M.D., CEO of Stemline Therapeutics, commented, "We have built a solid foundation for growth in 2019 and beyond, driven by the launch of ELZONRIS in BPDCN. ELZONRIS is the first drug ever approved for BPDCN and brings to patients with BPDCN a new treatment option and hope. In parallel, our team is working diligently with the EMA in an effort to make ELZONRIS potentially available to patients in Europe. We continue to aggressively pursue market expansion efforts with ELZONRIS, while also building out our overall pipeline, with the goal of improving the lives of patients with cancer."

Fourth Quarter 2018 Financial Results Review
Stemline ended the fourth quarter of 2018 with $60.1 million in cash, cash equivalents and investments, as compared to $78.5 million as of September 30, 2018, which reflects cash expenditures of $18.4 million for the quarter. Subsequent to year-end 2018, Stemline completed a follow-on public offering during January 2019 raising $86.1 million in net cash proceeds bringing total cash, cash equivalents and investments to $125.2 million as of March 15, 2019.

For the fourth quarter of 2018, Stemline had a net loss of $26.6 million, or $0.92 per share, compared with a net loss of $21.7 million, or $0.93 per share, for the same period in 2017.

Research and development expenses were $12.1 million for the fourth quarter of 2018, which reflects a decrease of $4.6 million compared with $16.7 million for the fourth quarter of 2017. The higher costs in 2017 were primarily due to manufacturing and regulatory expenses in support of our BLA filing for ELZONRIS.

General and administrative expenses were $14.9 million for the fourth quarter of 2018, which reflects an increase of $9.7 million compared with $5.2 million for the fourth quarter of 2017. The increase in costs were primarily attributable to pre-launch expenses in support of the commercialization of ELZONRIS and compensation costs related to an increase in headcount to support the commercial launch.

On March 15, 2019 Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company pioneering the use of DARPin therapeutics* to treat serious diseases, reported its audited Financial Results for 2018 and the company’s 2018 Annual Report (Press release, Molecular Partners, MAR 15, 2019, View Source [SID1234534327]).

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The Audited Financial Results for 2018 and the company’s 2018 Annual Report are available on the investors section of the company’ website.

Financial Calendar
March 19, 2019 – Expected Publication of Invitation to Annual General Meeting
April 16, 2019 – Annual General Meeting
May 9, 2019 – Interim Management Statement Q1 2019
August 27, 2019 – Publication of Half-year Results 2019 (unaudited)
October 31, 2019 – Interim Management Statement Q3 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 March 14, 2019 Targovax ASA (OSE: TRVX), a clinical stage biotechnology company developing immune activators to target hard-to-treat solid tumors, reported that it has granted a freedom-to-operate (FTO) license to Zelluna Immunotherapy for the development of mutant RAS T cell receptor (mutRAS TCRs) therapies (Press release, Targovax, MAR 14, 2019, View Source [SID1234554018]).

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Through the development of the TG neoantigen vaccine program, Targovax has established a significant patent portfolio and know-how in therapies targeting mutant RAS cancers. In addition to covering the TG vaccine program, these patents and know-how are also highly relevant in T cell therapy.

Zelluna Immunotherapy has built a portfolio of validated mutRAS TCRs isolated from long-term cancer survivors treated with first generation TG mutRAS vaccines. Targovax has agreed to out-license Targovax patents and know-how to Zelluna to enable the development of Zelluna’s mutRAS TCRs and create a stronger joint position in the mutRAS TCR field. In addition, the companies have signed a letter of intent to establish an R&D collaboration for the discovery and development of additional novel mutRAS TCR products.

Under the license agreement, Zelluna has been granted a global, non-exclusive license to relevant Targovax patents and know-how, for which Targovax will be compensated financially. The potential deal value amounts to NOK 100 million in milestones and annual fees, in addition to royalties on sales and sub-licensing revenues. Zelluna will retain full rights to, and freedom to operate (FTO) for, its portfolio of mutRAS TCRs and will be responsible for the development of these.

Øystein Soug, CEO of Targovax, said: "Our unique TG technology has already demonstrated a clinical benefit by generating immune responses to RAS driver mutations, and we remain committed to developing mutRAS vaccines in the currently underserved mutant RAS cancer indications. Additionally, we are confident that our proprietary technology and know-how has potential application in the parallel field of T cell therapy; itself a rapidly evolving novel class of immunotherapies. The intention of joining forces with Zelluna, will be strengthening the ability to develop a portfolio of mutRAS TCR products to be applied in T cell therapy, which will complement our TG vaccine development and further solidify Targovax’s strong position as the leader in mutRAS targeted immunotherapy".

On March 14, 2019 Elpiscience Biopharma, Ltd. reported its first Symposium on "Novel Targets for Cancer Immunotherapy", which will be held on March 24th, at Shanghai Kempinski Hotel (Press release, Elpiscience, MAR 14, 2019, View Source;id=1310 [SID1234536919]).

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The field of Cancer Immunotherapy is advancing in a breathtaking speed. The first generation of immune check point antibodies such as PD1/PD-L1, CTLA4 antibodies have revolutionized clinical practice in many cancer types. However a majority of cancer patients can still not benefit from the first generation of IO drugs. Novel targets and innovative approaches are in urgent demand to meet the unmet medical needs. The symposium brings together world leaders in immuno-oncology, to explore new therapeutic targets and approaches, to inspire and open up game-changing paths for the next generation of cancer immunotherapies.