G1 Therapeutics has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, G1 Therapeutics, 2018, FEB 21, 2018, View Source [SID1234524128]).

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On February 21, 2018 Genmab A/S (Nasdaq Copenhagen: GEN) reported its Annual Report for 2017 (Press release, Genmab, FEB 21, 2018, View Source [SID1234524098]). Below is a summary of business progress and financial performance for the year, and financial outlook for 2018 from the report. The full report is attached as a PDF file and can be found on the investor section of the company’s website, www.genmab.com. An online summary of the report is available at View Source

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2017 ACHIEVEMENTS

Business Progress

Maximize daratumumab progress

EMA decision & launch in 2nd line + multiple myeloma (MM) relapsed / refractory setting – Achieved
FDA decision 3rd line MM setting (daratumumab + pomalidomide) – Achieved
Phase III MM interim efficacy analysis in frontline (ALCYONE trial) – Achieved
Start Phase III subcutaneous trial – Achieved
Start trials in solid tumors and non-MM blood cancers – Achieved
Report non-MM clinical data — Expected in 2018
Optimize ofatumumab value

Phase III refractory FL headline results — Expected in 2018
Strengthen differentiated product pipeline

Phase I/II tisotumab vedotin data – Achieved
Progress HuMax-AXL-ADC Phase I/II clinical trial – Achieved
IND/CTA submission HexaBody-DR5/DR5 – Achieved
IND/CTA submission DuoBody-CD3xCD20 – Achieved
Progress pre-clinical pipeline — Achieved
Strengthen partnership portfolio with next generation technologies

Enter new technology collaborations — Not achieved
Progress partnered programs — Achieved
Disciplined financial management

Execute controlled company growth with selective investments in product pipeline — Achieved
Financial Performance

Revenue was DKK 2,365 million in 2017 compared to DKK 1,816 million in 2016. The increase of DKK 549 million, or 30%, was mainly driven by higher DARZALEX royalties under our daratumumab collaboration with Janssen.
Operating expenses increased by DKK 258 million, or 34%, from DKK 763 million in 2016 to DKK 1,021 million in 2017 driven by the advancement of tisotumab vedotin, the addi­tional investment in our product pipeline, and the increase in employees to support the expansion of our pipeline.
Operating income was DKK 1,344 million in 2017 compared to DKK 1,053 million in 2016. The improvement of DKK 291 million, or 28%, was driven by higher revenue, which was partly offset by increased operating expenses.
2017 year end cash position of DKK 5,423 million, an increase of DKK 1,501 million, or 38%, from DKK 3,922 million as of December 31, 2016.
2018 OUTLOOK

MDKK 2018 Guidance 2017 Actual Result
Revenue 2,700 — 3,100 2,365
Operating expenses (1,400) — (1,600) (1,021)
Operating income 1,300 — 1,500 1,344

Revenue
We expect our 2018 revenue to be in the range of DKK 2,700 — 3,100 million, compared to DKK 2,365 million in 2017. Our projected revenue for 2018 consists primarily of DARZALEX royalties of approximately DKK 1,750 million that are based on an estimated USD 2.0 — 2.3 billion of DARZALEX net sales in 2018. We project DARZALEX milestones of approximately DKK 550 million in 2018, consisting primarily of a commercial net sales-based milestone, compared to DKK 1,109 million in 2017. In addition, the 2018 guidance includes the one-time payment from Novartis of approximately DKK 300 million related to the transition of Arzerra from commercial availability to compassionate use programs in non-US markets. The remainder of the revenue consists of cost reimbursement income, Arzerra royalties, and DuoBody milestones.

The overall increase in revenue compared to 2017 is primarily due to a one-time payment from Novartis combined with higher DARZALEX royalties which were partly offset by a decrease in DARZALEX milestones.

Operating Result
We anticipate that our 2018 operating expenses will be in the range of DKK 1,400 — 1,600 million, compared to 2017 operating expenses of DKK 1,021 million. The increase is driven by the advancement of tisotumab vedotin, HuMax-AXL-ADC, HexaBody-DR5/DR5, DuoBody-CD3xCD20, and an increase in employees to support the expansion of our product pipeline.

We expect the operating income for 2018 to be approximately DKK 1,300 — 1,500 million compared to DKK 1,344 million reported for 2017.

More information on the Risks and Assumptions for the 2018 Financial Guidance can be found in the 2017 Annual Report available on our website www.genmab.com.

Conference Call
Genmab will hold a conference call in English to discuss the results for the full year 2017 today, February 21, 2018 at 6.00 pm CET, 5.00 pm GMT or noon EST. To join the call by phone, dial one of the following numbers and ask for the Genmab conference call:

US: + 1 646 828 8156
UK: + 44 330 336 9411
DK: + 45 35 15 81 21

A live and archived webcast of the call and relevant slides will be available at www.genmab.com.

On February 21, 2018 TG Therapeutics, Inc. (NASDAQ:TGTX) reported the publication of the results from the Phase 1 first-in-human study of umbralisib (TGR-1202), the Company’s novel once-daily PI3K delta inhibitor, in The Lancet Oncology (Press release, TG Therapeutics, FEB 21, 2018, View Source [SID1234524106]). The paper includes safety and efficacy information from 90 patients with relapsed or refractory b-cell malignancies, including patients with Chronic Lymphocytic Leukemia (CLL) and various forms of lymphoma treated with single agent umbralisib. In this study, umbralisib was well tolerated with a favorable safety profile distinct from prior generation PI3K delta inhibitors. Grade 3/4 immune mediated AEs commonly associated with other PI3K delta inhibitors were limited, with transaminitis occurring in 3 patients ( < 3%), and pneumonia and colitis in 2 patients each ( < 2% for each). Notably, both events of colitis occurred at doses exceeding the current Phase 3 dose. Umbralisib was also clinically active with 85% of relapsed or refractory CLL patients achieving an objective response (50% per IWCLL criteria; 35% a partial response with lymphocytosis) and 53% of patients with relapsed or refractory Follicular Lymphoma (FL) achieving an objective response, including 2 patients with a Complete Response (CR).

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These data, in addition to the unique structural attributes and enhanced selectivity profile of umbralisib, are described further in the manuscript entitled, "Umbralisib, a novel PI3K and casein kinase-1 epsilon inhibitor, in relapsed or refractory chronic lymphocytic leukaemia and lymphoma: an open-label, phase 1, dose-escalation, first-in-human study," which was published yesterday in The Lancet Oncology. The online version of the article can be accessed at http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(18)30082-2/fulltext.

Dr. Howard A. Burris, the Chief Medical Officer and Executive Director of the Drug Development Program at the Sarah Cannon Research Institute in Nashville, TN, and lead author stated, "We are pleased to have treated the first patient ever with umbralisib over 5 years ago and believe it has an important place in the treatment landscape for patients with hematologic malignancies. Several patients from this Phase 1 study are still on study today, approaching 5 years of continuous daily therapy, speaking to both the safety and efficacy profile of this unique agent."

Dr. Owen A. O’Connor, Professor of Medicine and Experimental Therapeutics, Director Lymphoid Malignancies at Columbia Presbyterian Medical Center, stated, "Pre-clinically umbralisib has a very unique profile, selectively inhibiting both PI3K delta and CK1 epsilon, as previously described in our Blood paper. The clinical results in this paper support our thesis that the differentiated preclinical profile explains the differences seen in the clinic between umbralisib and the other PI3K delta inhibitors."

"We want to thank Dr. Burris, Dr. O’Connor and all the investigators who participated in this first-in-human Phase 1 trial for umbralisib, which has set the stage for our ongoing pivotal UNITY-CLL and UNITY-NHL trials. With over 1,000 patients treated with umbralisib to date, we and the investigators believe umbralisib is a differentiated, active and more selective PI3K delta inhibitor that exhibits a favorable safety profile as compared to prior generation molecules," stated Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer.

On February 20, 2018 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3 clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, reported that the Company’s scientists, and collaborators from the Mount Sinai School of Medicine, will present two abstracts at the American Chemical Society National Meeting & Expo (Press release, Onconova, FEB 20, 2018, View Source [SID1234524076]). The meeting is being held in New Orleans, LA, on March 18-22, 2018.

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The first abstract relates to the analysis of stability of the clinical product during storage and describes the synthesis and characterization of a de-sulfonylated product of rigosertib, Onconova’s lead phase 3 stage clinical candidate. The second abstract describes a new chemical entity ON 150030, which is a type 1 novel pre-clinical stage inhibitor of FLT3 and Src pathways, believed to be important for targeted therapy of relapsed and refractory AML.

Details for the poster presentations are listed below.

Title: Synthesis and characterization of de-sulfonylated product of rigosertib, a late phase III clinical candidate

Date: 18th March, 2018

Presentation Time: 7.00-9.00 PM CDT

Presenter: Dr. M.V. Ramana Reddy & Dr. Muralidhar Mallireddigari

Location: Ernest N. Morial Convention Center, Hall E.

Title: Discovery of a novel kinase inhibitor ON 150030, a type 1 inhibitor for relapsed and refractory AML

Date: 18th March, 2018

Presentation Time: 7.00-9.00 PM CDT

Presenter: Dr. M.V. Ramana Reddy

Location: Ernest N. Morial Convention Center, Hall E.

On February 20, 2018 Myriad Genetics, Inc. (NASDAQ:MYGN) reported that the National Comprehensive Cancer Network (NCCN) has updated its medical guidelines for prostate cancer treatment to broadly include biomarker testing in prostate cancer (Press release, Myriad Genetics, FEB 20, 2018, View Source [SID1234524056]). The changes to the guidelines include new language supporting Prolaris as standard of care in treatment decision making for patients with low and favorable-intermediate risk prostate cancer. Additionally, the new guidelines support an expansion of hereditary cancer testing for prostate cancer to include all patients with a family history regardless of Gleason score along with all patients with metastatic disease, and new recommendations supporting testing for homologous recombination deficiency (HRD) in patients with metastatic prostate cancer.

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"We view this significant update in guidelines as a clear indication of the increasing importance of molecular biomarkers in guiding prostate cancer care and Myriad is uniquely positioned with its broad portfolio of tests to address these clinical needs," said Nicole Lambert, general manager, Urology. "These new guidelines are critical in our efforts to broaden insurance coverage and increase patient access to Myriad’s entire portfolio of prostate cancer molecular diagnostic tests."

Below are the key updates from the guidelines:

Prolaris: now standard of care for 110,000 patients per year identified as low or favorable-intermediate risk patients.
myRisk Hereditary Cancer: now recommended for approximately 70,000 prostate cancer patients per year including all patients with metastatic prostate cancer and those with a family history of cancer regardless of Gleason score.
myChoice HRD: now recommended for 20,000 patients per year with metastatic prostate cancer to identify tumors with homologous recombination deficiency (HRD) so that these patients can be considered for targeted therapies.
About Prolaris
Prolaris is a novel 46-gene RNA-expression test that directly measures tumor cell growth characteristics for stratifying the risk of disease progression in patients with prostate cancer. Prolaris provides a quantitative measure of the RNA expression levels of genes involved in the progression of tumor growth. Low gene expression is associated with a low risk of disease progression in men who may be candidates for active surveillance and high gene expression is associated with a higher risk of disease progression in patients who may benefit from additional therapy. For more information visit: www.prolaris.com.

About Myriad myRisk Hereditary Cancer
The Myriad myRisk Hereditary Cancer test uses an extensive number of sophisticated technologies and proprietary algorithms to evaluate 28 clinically significant genes associated with the development of eight hereditary cancers including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma. The myRisk Hereditary Cancer test offers physicians several distinct advantages over other commercial tests, including unsurpassed lab accuracy, industry leading variant classification, a medical management tool and exceptional customer service.

Men with prostate cancer can take the Hereditary Cancer Quiz to find out if they might be at risk for an inherited mutation and therefore eligible for myRisk Hereditary Cancer test.

About myChoice HRD
Myriad’s myChoice HRD is the most comprehensive homologous recombination deficiency test, enabling physicians to identify tumors that have lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. The myChoice HRD test is a composite of three proprietary technologies (loss of heterozygosity, telomeric allelic imbalance and large-scale state transitions).

Positive myChoice HRD scores, reflective of DNA repair deficiencies, are prevalent in all breast cancer subtypes, ovarian cancer and most other major cancers. It is estimated that 1.4 million people in the United States and Europe who are diagnosed with cancers annually may be candidates for treatment with DNA-damaging agents. Learn more: View Source