On August 31, 2018 Genmab A/S (Nasdaq Copenhagen: GEN) reported that the European Commission (EC) has granted marketing authorization for DARZALEX (daratumumab) in combination with bortezomib, melphalan and prednisone (VMP), for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT) (Press release, Genmab, AUG 31, 2018, View Source [SID1234529235]). The EC approval follows a positive opinion issued for DARZALEX by the CHMP of the European Medicines Agency (EMA) in July 2018. In August 2012, Genmab granted Janssen Biotech, Inc. (Janssen) an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

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Genmab will receive a milestone payment of USD 13 million from Janssen in connection with the first commercial sales of DARZALEX under the expanded label. The sales are expected to occur quickly after the approval. This milestone payment was included in the financial guidance issued by Genmab originally on February 21, 2018 and then reiterated in subsequent quarterly financial reports, most recently on August 8, 2018, and as such there is no change to the company’s financial guidance following this approval.

"Approved in this indication in the U.S. since early May, DARZALEX in combination with bortezomib, melphalan and prednisone will now become an option for newly diagnosed multiple myeloma patients in Europe," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "We are very pleased that many more patients in need will have the opportunity for treatment with this regimen and we look forward to seeing this combination launched in Europe."

The positive opinion of the CHMP was based on data from the Phase III ALCYONE (MMY3007) study that showed a reduction of the risk of disease progression or death by 50 percent (Hazard Ratio [HR] = 0.50; 95 percent CI [0.38-0.65], p<0.0001) in patients with newly diagnosed multiple myeloma ineligible for ASCT when daratumumab is combined with VMP. The safety of DARZALEX combination therapy was consistent with the known safety profiles of DARZALEX monotherapy and of therapy with bortezomib, melphalan and prednisone, respectively. This data was presented as a Late-Breaking Abstract at the 2017 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and simultaneously published in The New England Journal of Medicine in December, 2017.

About the ALCYONE study
This Phase III study (NCT02195479) is a randomized, open-label, multicenter study that included 706 newly diagnosed patients with multiple myeloma who are ineligible for ASCT. Patients were randomized to receive 9 cycles of either VMP [bortezomib (a proteasome inhibitor), melphalan (an alkylating chemotherapeutic agent) and prednisone (a corticosteroid)] combined with daratumumab, or VMP alone. In the daratumumab treatment arm, patients received 16 mg/kg of daratumumab once weekly for six weeks (cycle 1; 1 cycle = 42 days), once every three weeks from cycles 2 to 9, and once every 4 weeks from cycle 9 until disease progression. The primary endpoint of the study is progression free survival (PFS).

About multiple myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.1 Approximately 35,433 new patients were diagnosed with multiple myeloma and approximately 22,060 people died from the disease in Western Europe in 2016.3 Globally, it was estimated that 138,509 people were diagnosed and 98,437 died from the disease in 2016.3 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.4

About DARZALEX (daratumumab)
DARZALEX (daratumumab) injection for intravenous infusion is indicated in the United States in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.5 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX is indicated in Europe for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. In Japan, DARZALEX is approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for treatment of adults with relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market. For more information, visit www.DARZALEX.com.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).5,6,7,8,9

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and frontline multiple myeloma settings and in amyloidosis. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases, such as NKT-cell lymphoma, myelodysplastic syndromes, B and T-ALL. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA, for multiple myeloma, as both a monotherapy and in combination with other therapies.

On August 31, 2018 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small-molecule drugs that address cancer, liver disease and inflammatory diseases, reported financial results for the three months ended June 30, 2018 and provided clinical and corporate updates (Press release, Can-Fite BioPharma, AUG 31, 2018, View Source [SID1234529220]).

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Clinical Development Program and Corporate Highlights of the Second Quarter 2018 and Recent Weeks Include:

Business Development Activities Q

In August 2018, Can-Fite signed a License, Collaboration and Distribution agreement with CMS Medical Venture Investment Limited ("CMS Medical") for the development and commercialization of Can-Fite’s Piclidenoson for the treatment of rheumatoid arthritis and psoriasis and Namodenoson for the treatment of advanced liver cancer and NAFLD/NASH in China (including Hong Kong, Macao and Taiwan). Under the terms of the agreement, CMS Medical made an upfront payment of $2,000,000 to Can-Fite and is required to pay to Can-Fite milestone payments of up to $14,000,000 upon the achievement of certain regulatory milestones and payments of up to $58,500,000 upon the achievement of certain sales milestones. In addition, the agreement provides for double-digit royalty payments on net sales.

This deal adds to the distribution agreements that the Company already has in place with Cipher Pharmaceuticals (for the distribution of Piclidenoson in Canada for rheumatoid arthritis and psoriasis), Kwang Dong Pharmaceutical (for the distribution of Piclidenoson in South Korea for rheumatoid arthritis), Chong Kun Dang (for distribution of Namodenoson in South Korea for treatment of liver cancer) and Gebro Pharma (for the distribution of Piclidenoson in Spain, Switzerland and Austria).

Intellectual Property

Can-Fite has been granted by the Australian and Chinese patent offices a patent for the utilization of A3 adenosine receptor ligands in the treatment of sexual dysfunction, in a patent (Australian, No. 2013301125ZL; Chinese No. 2013800472970) titled, "A3adenosine receptor ligands for use in treatment of a sexual dysfunction." The Company has been investigating compounds that target the A3 adenosine receptor (A3AR) and the Company’s CF602 drug candidate previously demonstrated a robust positive effect in the treatment of erectile dysfunction in preclinical studies.

Clinical Development Activities

Piclidenoson (CF101)

Psoriasis – In August 2018, Can-Fite enrolled and dosed the first patient in its Phase III Comfort trial for the treatment of moderate-to-severe plaque psoriasis, which makes up about 90 percent of cases. The study, is designed to evaluate the efficacy and safety of daily Piclidenoson, administered orally compared to Apremilast (Otezla) and placebo, in 407 patients. The study will be conducted in 5 countries in Europe, Israel and Canada. The first patient has been dosed in Israel.

Study initiation prompts a milestone payment of 300,000 Euro that is due under the distribution agreement recently entered into with Gebro.

Rheumatoid Arthritis – The Company continues to enroll patients in its Phase III Acrobat trial that is evaluating Can-Fite’s lead drug candidate Piclidenoson as a first line treatment and replacement for the current standard of care, Methotrexate (MTX). The trial will enroll approximately 500 patients in Europe, Canada and Israel.

Namodenoson (CF102)

Advanced Liver Cancer

In August 2017, Can-Fite completed enrollment of its global Phase II advanced liver cancer study of Namodenson. In June 2018, the Company reported that the accumulated safety data continues to indicate a favorable safety profile, with no clinically significant novel or emerging events attributed to chronic treatment with Namodenoson. The Company continues to follow up on patients’ overall survival.

In July 2018, the Company announced that key opinion leaders from the University of Texas MD Anderson Cancer Center, Houston, TX, USA, published scientific findings recommending development of anti-liver cancer drugs based on a mechanism of action utilized by Namodenoson. The latter inhibits a specific molecular signaling pathway in the liver cancer cells, designated as the Wnt/β-catenin, and is responsible for the development and progression of hepato-cellular carcinoma (HCC).

NAFLD/NASH

The Company is continuing to enroll patients for its Phase II trial of Namodenoson for the treatment of 60 patients with nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH).

"We continue to make progress with our drug candidates. We also signed a significant development and commercialization agreement with CMS Medical for both Piclidenoson and Namodenoson for the Chinese market with significant regulatory and sales’ milestone payments. We look forward to providing updates on our Phase II study of Namodenoson towards the end of year," stated Can-Fite CEO Dr. Pnina Fishman.

Financial Results

Revenues for the six months ended June 30, 2018 were $0.9 million compared to $0.1 million in the first six months of 2017. The increase in revenue was mainly due to the recognition of a portion of the U.S. $2.2 million advance payment received in January 2018 under the distribution agreement with Gebro.

Research and development expenses for the six months ended June 30, 2018 were $2.6 million compared with $2.4 million for the same period in 2017. Research and development expenses for the first six months of 2018 comprised primarily of expenses associated with the Phase II studies for Namodenoson as well as expenses for ongoing studies of Piclidenoson. The increase is primarily due to increased costs associated with the initiation of the Phase III clinical trial of Piclidenoson for the treatment of rheumatoid arthritis. We expect that the research and development expenses will increase through 2018 and beyond.

General and administrative expenses were $1.8 million for the six months ended June 30, 2018, compared to $1.3 million for the same period in 2017. The increase is primarily due to an increase in professional services and investor relations expenses. We expect that the annual general and administrative expenses for 2018 will be higher compared to 2017.

Financial income, net for the six months ended June 30, 2018 aggregated $0.6 million compared to financial income, net of $0.2 million for the same period in 2017. The increase in financial income, net was mainly due to fair value revaluation of our long-term investment.

Can-Fite’s loss for the six months ended June 30, 2018 was U.S. $3.0 million compared with a loss of U.S. $3.5 million for the same period in 2017. The difference in loss for the first half of 2018 was primarily attributable to an increase in revenues and an increase in financial income, net.

As of June 30, 2018, Can-Fite had cash and cash equivalents of U.S. $5.8 million as compared to U.S. $3.5 million at December 31, 2017. The increase in cash during the six months ended June 30, 2018 is due to U.S. $4.4 million received from a registered direct offering in March 2018, net of issuance expenses, and the $2.2 million upfront payment received from Gebro.

The Company’s consolidated financial results for the six months ended June 30, 2018 are presented in accordance with International Financial Reporting Standards.

On August 31, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, reported that Daniel J. O’Connor, President and Chief Executive Officer of OncoSec, will present a corporate overview at the H.C. Wainwright 20th Annual Global Investment Conference on Thursday, September 6, 2018 at 11:15 a.m. ET in New York City (Press release, OncoSec Medical, AUG 31, 2018, View Source [SID1234529219]).

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A live audio webcast of the presentation will be available on the Investors section of OncoSec’s website at ir.oncosec.com, where it will be archived for approximately 30 days.

On August 31, 2018 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that the National Medical Products Administration of China (NMPA, formerly known as CFDA or CDA) has accepted the new drug application (NDA) for tislelizumab, an investigational anti-PD-1 antibody, as a potential treatment for patients with relapsed/refractory classical Hodgkin’s lymphoma (R/R cHL) (Press release, BeiGene, AUG 31, 2018, View Source [SID1234529218]).

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"The acceptance of our first NDA for tislelizumab represents an important milestone for BeiGene and for Chinese patients with Hodgkin’s lymphoma. Patients who relapse or don’t respond to standard treatment with chemotherapy or radiation often have poor prognoses. We are encouraged by the potential for tislelizumab to provide a new treatment option for these patients," said Jane Huang, M.D., Chief Medical Officer, Hematology, at BeiGene.

The NDA is supported by a clinical and non-clinical data package, including the results from a pivotal Phase 2 study of tislelizumab in Chinese patients with R/R cHL. A recent independent review of data from all 70 enrolled patients in an intent-to-treat analysis showed that with a minimum of 24 weeks of follow-up and a median follow-up time of 7.85 months at the data cutoff, overall response rate (ORR) was 85.7 percent, including 61.4 percent complete response (CR). Frequency and severity of adverse events were generally consistent with previously reported Phase 1 safety and tolerability data for tislelizumab, or, in the case of certain immune-related events such as hypothyroidism and fever, consistent with previous reports of other PD-1 antibodies for the treatment of cHL. Full results of the study are planned to be presented at an upcoming medical conference.

"We are excited by the response rates, including high complete response rates we have seen in our pivotal study in R/R cHL, and look forward to working closely with the NMPA to make tislelizumab available to patients in China as quickly as possible," said Wendy Yan, Global Head of Regulatory Affairs at BeiGene.

In addition to the pivotal Phase 2 clinical trial in R/R cHL, tislelizumab is also being studied in global Phase 3 trials in a number of malignancies, including non-small cell lung cancer, hepatocellular carcinoma, and esophageal squamous cell carcinoma; as well as two global Phase 2 trials in patients with previously treated hepatocellular carcinoma or with R/R mature T- and NK-cell lymphomas, and an additional pivotal Phase 2 trial in China in urothelial cancer.

About Classical Hodgkin’s Lymphoma
Hodgkin’s lymphoma is one of the two major types of lymphoma that begin in the lymph nodes and tissues of the lymphatic system. All other lymphomas are classified as non-Hodgkin’s lymphomas. Classical Hodgkin’s lymphoma, the most common form representing about 95 percent of the patients with Hodgkin’s lymphoma, is characterized by the presence of very large cells called Reed-Sternberg cells. There were approximately 2,100 diagnosed cases of Hodgkin’s lymphoma in China in 2012.i Although the cancer can occur in both children and adults, it is most commonly diagnosed in young adults between the ages of 15 and 35 and in older adults over age 50.

About Tislelizumab
Tislelizumab (BGB-A317) is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. Discovered by BeiGene scientists in Beijing, tislelizumab is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. Tislelizumab has demonstrated high affinity and specificity for PD-1. It is potentially differentiated from the currently approved PD-1 antibodies in an engineered Fc region, which is believed to minimize potentially negative interactions with other immune cells, based on preclinical data. Tislelizumab is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. BeiGene and Celgene Corporation have a global strategic collaboration for the development of tislelizumab in solid tumor cancers outside of Asia (except Japan).

On August 31, 2018 Selecta Biosciences, Inc. (Nasdaq: SELB), a clinical-stage biopharmaceutical company focused on unlocking the full potential of biologic therapies by mitigating unwanted immune responses, reported that Chief Scientific Officer Takashi Kei Kishimoto, Ph.D. will present on the poster entitled Ongoing Phase 2 Clinical Trial of SEL-212 Shows Sustained Reduction of Serum Uric Acid by Mitigating Formation of Anti-Uricase Antibodies at the 20thAsia Pacific League of Associations for Rheumatology Congress (APLAR), taking place 6-9 September 2018 at the Kaohsiung Exhibition Centre, Taiwan (Press release, Selecta Biosciences, AUG 31, 2018, View Source [SID1234529216]).

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