On January 12, 2020 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company expects to report revenue between $294 million and $296 million for the fourth quarter ended Dec. 31, 2019 (Press release, Exact Sciences, JAN 12, 2020, View Source [SID1234553038]).

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"Building off a transformative 2019, Exact Sciences is uniquely positioned to change the way cancer is diagnosed and treated," said Kevin Conroy, chairman and CEO of Exact Sciences. "Following our combination with Genomic Health, we have the leading scientific minds, an experienced commercial team with deep relationships, and the global footprint necessary to support the growth of current and future cancer diagnostics. We’ve never been more excited about the future of Exact Sciences."

Preliminary, Unaudited Fourth-Quarter 2019 Financial Results

For the three-month period ended December 31, 2019, as compared to the same period of 2018 (where applicable):

Expected total revenue between $294 million and $296 million
Expected Screening revenue between $229 million and $230 million, an increase of 61 percent
Expected Precision Oncology revenue between $65 million and $66 million for the period Nov. 8, 2019 through Dec. 31, 2019, following the close of the Genomic Health acquisition
Expected Precision Oncology proforma revenue for the full fourth quarter between $118 million and $119 million, an increase of 13 percent, assuming Genomic Health were a standalone entity
Cologuard test volume was 477,000, an increase of 63 percent
Oncotype DX test volume was 41,000, an increase of 14 percent
Preliminary, Unaudited 2019 Financial Results

For the twelve-month period ended December 31, 2019, as compared to the same period of 2018 (where applicable):

Expected total revenue between $874.5 million and $876.5 million, including Precision Oncology revenue between $65 million and $66 million for the period Nov. 8, 2019 through Dec. 31, 2019, following the close of the Genomic Health acquisition
Expected Screening revenue between $809.5 million and $810.5 million, an increase of 78 percent
Expected Precision Oncology proforma revenue between $455 million and $456 million, an increase of 16 percent, assuming Genomic Health were a standalone entity
Cologuard test volume was 1.68 million, an increase of 80 percent
Oncotype DX test volume was 156,000, an increase of 14 percent
For the fourth quarter and 2019, Screening includes revenue from Cologuard and Biomatrica products. Precision Oncology includes global Oncotype DX product revenue. Proforma revenue figures for Precision Oncology for the three and twelve-month periods ended Dec. 31, 2019 include results prior to the acquisition of Genomic Health by Exact Sciences which closed on Nov. 8, 2019.

Exact Sciences has not completed preparation of its financial statements for the fourth quarter or full year of 2019. The revenue ranges presented in this news release for the fourth quarter of 2019 and for the year ended Dec. 31, 2019 are preliminary and unaudited and are thus inherently uncertain and subject to change as we complete our financial results for the fourth quarter of 2019. We are in the process of completing our customary year-end close and review procedures as of and for the year ended Dec. 31, 2019, and there can be no assurance that our final results for this period will not differ from these estimates. During the course of the preparation of our consolidated financial statements and related notes as of and for the year ended Dec. 31, 2019, we or our independent registered public accountants may identify items that could cause our final reported results to be materially different from the preliminary financial estimates presented herein.

Exact Sciences plans to report 2019 financial results and provide guidance during its February 2020 earnings call.

About Cologuard
Cologuard was approved by the FDA in August 2014, and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016). Cologuard is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use Cologuard if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. Cologuard is not a replacement for colonoscopy in high risk patients. Cologuard performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. Cologuard performance in repeat testing has not been evaluated.

The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for diagnostic colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again.

Medicare and most major insurers cover Cologuard. For more information about Cologuard, visit www.cologuardtest.com. Rx Only.

On January 12, 2020 Mundipharma reported a partnership with Samsung Bioepis to commercialize Samsung Bioepis’ first-wave biosimilar candidates in Taiwan and Hong Kong (Press release, Mundipharma, JAN 12, 2020, View Source [SID1234553037]).

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The partnership covers Samsung Bioepis’ biosimilar candidates in the field of immunology and oncology, including SB5 (adalimumab), SB4 (etanercept), SB3 (trastuzumab), and SB8 (bevacizumab).

Through the partnership, Mundipharma will be the exclusive commercialization partner, while Samsung Bioepis will remain the Marketing Authorisation Holder (MAH), responsible for clinical development, regulatory registration, and manufacture of the biosimilars.

"This partnership brings together Samsung Bioepis’ proven biosimilar development platform with Mundipharma’s commercial acumen and market insight and ability to increase patient access to proven treatments," said Mundipharma CEO, Raman Singh. "This partnership will help to address the patient need in two important territories in Asia for immunology and oncology treatments," he added.

On January 12, 2020 Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, reported a business update for the fourth quarter 2019 and preliminary, unaudited key financials for its financial year 2019 (Press release, Hansa Biopharma, JAN 12, 2020, View Source [SID1234553036]).

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The company will be participating in the JP Morgan Global Healthcare Conference in San Francisco from January 13 to 16, 2020.

2019 Fourth Quarter Business Highlights

The European Medicines Agency (EMA) is reviewing a Marketing Authorization Application for imlifidase in Europe. Hansa Biopharma submitted responses to the Day 120 questions on December 22, 2019 and the review process is on track. An opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected in the second quarter of 2020, followed by a potential decision by the European Commission during the summer 2020.

Hansa Biopharma met with the FDA on November 20th and agreed on a regulatory path forward for imlifidase in kidney transplantation of highly sensitized patients in the United States. Hansa will conduct a randomized, controlled clinical study in a well-defined population of approximately 50 patients with the highest unmet medical need to demonstrate the clinical benefit of imlifidase in the context of the U.S. Kidney Allocation System. It is expected that the outcome of this study will support submission of a Biologic License Application (BLA) by 2023.

"Our primary focus in 2020 is to obtain conditional approval of imlifidase in the EU, ensure a successful launch in Europe, and initiate a randomized, controlled clinical study in the US to support a future filing of a BLA in the United States", says Søren Tulstrup, President and CEO, Hansa Biopharma.

Hansa Biopharma has submitted an abstract with long term outcomes of desensitization with imlifidase to the Cutting Edge of Transplantation, CEOT, an annual congress arranged by the American Society of Transplantation on March 5-7, 2020. The long term data indicate that the graft survival for this study population of highly sensitized and cross match positive population was overall comparable to data reported in the literature with other desensitization methods and the general transplantation patient population. Desensitization with imlifidase may provide highly sensitized patients, who are unlikely to find an HLA compatible donor, access to deceased donor organs, potentially reducing mortality and time on the waiting list.

Clinical pipeline update

Anti-GBM (Anti-Glomerular Basement Membrane antibody disease):

Hansa Biopharma has enrolled 14 of targeted 15 patients to date in a phase 2 study to evaluate the safety and efficacy of imlifidase in patients with severe Anti-GBM.
Anti-GBM is an ultra-rare disease affecting one in a million annually with the majority of the patients losing their kidneys, requiring chronic dialysis and kidney transplantation.
Six patients were recruited during the last six months and the Company expects to complete enrollment during the first quarter of 2020 and data read out in the second half of the year.
GBS (Guillain Barré Syndrome)

The first two patients (out of 30) with Guillain Barré Syndrome, GBS, were treated in a phase 2 study with imlifidase.
GBS is an acute autoimmune attack on the peripheral nervous system, which affects 1 in 100,000. GBS is a severe disease where up to 22 % of the patients end up in ICU needing respiratory support.
Six clinics across France and the UK are open for recruitment and the Company expects to complete enrollment during the first half of 2021.
AMR (Antibody Mediated Rejection)

2 out of targeted 30 patients enrolled in a phase 2 study in Antibody Mediated Rejection, AMR, a challenge to long term graft survival after kidney transplantation.
Six clinics are recruiting across the US, Europe and Australia. The Company expects to complete enrollment towards the end of 2020.
Key Financials (preliminary, unaudited)

For the financial year 2019, total Operating loss is expected at approx. SEK 360 million. As of December 31, 2019 the company had a cash position (incl. short-term investments) of SEK 601 million, which is expected to finance Hansa’s operations at least through 2020.

SEK million

Q4 2019

FY 2019

SG&A expenses

-53

-167

R&D expenses

-58

-193

Operating profit/loss

-110

-360

Cash and short-term investments Dec 31, 2019

601

601

The Q4-2019 interim report including audited financials will be published on February 6, 2020.

On January 12, 2020 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, reported with Eli Lilly and Company ("Lilly",NYSE: LLY) the results of a Phase 3 study in China; the ORIENT-11 trial of Tyvyt (sintilimab injection) in combination with ALIMTA (pemetrexed) and platinum in first-line advanced or recurrent nonsquamous non-small cell lung cancer (nsqNSCLC), without sensitive EGFR mutation or ALK rearrangement, met the predefined primary endpoint of progression-free survival (PFS) in an interim analysis (Press release, Innovent Biologics, JAN 12, 2020, View Source [SID1234553035]).

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Based on the interim analysis conducted by the Independent Data Monitoring Committee (IDMC), sintilimab in combination with ALIMTA and platinum demonstrated a statistically significant improvement in PFS compared with placebo in combination with ALIMTA and platinum, which met the pre-defined efficacy criteria. The safety profile of sintilimab in this trial was consistent with previously reported studies, and no new safety signals were identified.

Relevant data will be presented at an upcoming medical conference. Based on the IDMC recommendations, Innovent and Lilly will initiate regulatory discussions for registration with the National Medical Products Administration (NMPA) in China in the near future.

Professor Li Zhang, Head of Department of Internal Medicine, Sun Yat-sen University Cancer Center, stated: "In 2019, the National Cancer Center published Chinese data on lung cancer from 2015, showing an incidence of 20 percent and a mortality rate of about 27 percent, ranking it first among all cancer types. Patients who have nsqNSCLC without sensitive EGFR mutation or ALK rearrangement need more treatment options. Treatment with an anti-PD-1 monoclonal antibody in combination with chemotherapy may bring a greater survival benefit to this patient population. We are glad to see that these findings from this trial of sintilimab met the predefined primary endpoint in the interim analysis."

"So far, Tyvyt is the only anti-PD-1 monoclonal antibody included in the New Catalogue of the National Reimbursement Drug List. It was officially approved by the NMPA on December 24, 2018 for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after at least second-line system chemotherapy," said Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent. "Currently, we have several phase 3 randomized clinical trials ongoing in lung cancer. With the encouraging result of ORIENT-11 we anticipate that sintilimab has the potential to benefit more patients with lung cancer and provide more time with their families."

"We are excited about these results, which show Tyvyt plus ALIMTA and platinum significantly delayed disease progression in this patient population. This study is another example of the joint commitment from Lilly and Innovent to provide new treatment options to patients with lung cancer," said Dr. Wang Li, Senior Vice-President of Lilly China and Head of Lilly China Drug Development and Medical Affairs. "We would like to thank the patients, investigators and clinical trial sites that are participating in the study, and to our colleagues from Innovent. We look forward to bringing this new treatment option to Chinese lung cancer patients."

About ORIENT-11 Trial

ORIENT-11 is a randomized, double-blind, Phase 3 clinical trial to evaluate the efficacy and safety of Tyvyt (sintilimab injection) or placebo in combination with ALIMTA and platinum as first-line therapy for advanced or recurrent nsqNSCLC without sensitive EGFR mutation or ALK rearrangement (ClinicalTrials.gov, NCT03607539). The primary endpoint is progression-free survival (PFS) assessed by Independent Radiographic Review Committee (IRRC) based on RECIST v1.1. The other secondary endpoints include overall survival (OS) and safety profile.

A total of 397 subjects have been enrolled in ORIENT-11 trial and randomized in a 2:1 ratio to receive either sintilimab 200mg or placebo in combination with ALIMTA and platinum every 3 weeks for up to 4 cycles, followed by either sintilimab or placebo plus ALIMTA maintenance therapy. The subjects will receive treatment until radiographic disease progression, unacceptable toxicity or any other conditions that require treatment discontinuation. Conditional crossover is permitted.

About nsqNSCLC

Lung cancer is a malignancy with the highest morbidity and mortality in China. NSCLC accounts for about 80 percent to 85 percent of lung cancer. Approximately 70 percent of NSCLC are locally advanced or metastatic at initial diagnosis, rendering the patients with no chance of radical resection. Meanwhile, even after radical surgery patients still have a high chance of recurrence and eventually die from disease progression. About 70 percent of NSCLC in China are nonsquamous subtype and 50 percent of nsqNSCLC are without sensitive EGFR mutation or ALK rearrangement. These patients do not respond well to targeted therapy and there are limited treatment options available to them.

About Tyvyt (Sintilimab Injection)

Tyvyt (sintilimab injection), an innovative drug jointly developed in China by Innovent and Lilly, has been granted marketing approval by the NMPA for relapsed or refractory classic Hodgkin’s lymphoma after at least second-line system chemotherapy, and included in the 2019 Guidelines of Chinese Society of Clinical Oncology (CSCO) for Lymphoid Malignancies. Tyvyt is the only PD-1 inhibitor with global quality that has been included in the new Catalogue of the National Reimbursement Drug List (NRDL) in November 2019.

Tyvyt (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies for sintilimab injection to evaluate its safety and efficacy in a wide variety of cancer indications, including eight registration or pivotal clinical trials.

On January 12, 2020 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), an advanced phase biotechnology company developing new T-cell based cancer immunotherapies, and Cellectis (Paris: ALCLS) (NASDAQ: CLLS) (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical phase biopharmaceutical company specializing in the development of immunotherapies based on genetically modified allogeneic CAR-T cells (UCART), reported that they have the signing of a research partnership and an exclusive global license agreement granting at Iovance a license for certain applications of Cellectis TALEN technology to develop tumor infiltrating lymphocytes (TIL) which have been genetically modified to create more powerful cancer therapies (Press release, Iovance Biotherapeutics, JAN 12, 2020, View Source [SID1234553033]).

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This global license grants Iovance Biotherapeutics the exclusive use of TALEN technology targeting several genes to modify TILs for therapeutic purposes in various types of cancer. The financial conditions of this license provide for payments from Iovance Biotherapeutics to Cellectis at the development, regulatory and sales stages, as well as royalties on the net sales of TIL products modified using TALEN technology.

"We are delighted to collaborate with Cellectis to apply the TALEN genome editing technology to Iovance’s TIL products. We believe that we can genetically modify the TILs to obtain an anti-cancer product that is more reactive to tumors, "explains Maria Fardis, President and CEO of Iovance Biotherapeutics. "We plan to bring a modified TIL therapy using TALEN technology to the clinic as soon as possible. "

"We are delighted to work with Iovance and are convinced that the application of our TALEN technology to its TIL-based products will generate better treatments for various types of cancer," added André Choulika, President and CEO of Cellectis. "Patients remain the primary concern of our company and we sincerely hope that this collaboration will find more effective solutions for those who need them." "