On January 22, 2020 Genmab A/S (Nasdaq: GMAB) reported that worldwide net trade sales of DARZALEX (daratumumab) as reported by Johnson & Johnson were USD 2,998 million in 2019 (Press release, Genmab, JAN 22, 2020, View Source [SID1234553395]). Net trade sales were USD 1,567 million in the U.S. and net trade sales in the rest of the world were USD 1,430 million. Genmab receives royalties on the worldwide net sales of DARZALEX as calculated on the basis of the license agreement terms under the exclusive worldwide license to Janssen Biotech, Inc. (Janssen) to develop, manufacture and commercialize DARZALEX. Worldwide net trade sales of DARZALEX in 2018 were USD 2,025 million, resulting in royalty income of DKK 1,708 million to Genmab.

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Genmab has also achieved a USD 150 million sales volume milestone payment triggered by sales of DARZALEX reaching USD 3 billion in the calendar year of 2019 as calculated on the basis of the license agreement terms. Under the license agreement, DARZALEX sales are calculated based on a hedged foreign exchange rate and as such are different than net trade sales reported by Johnson & Johnson. The difference was mainly due to the translation of sales denominated in currencies other than USD into USD under the license agreement. No further sales volume milestones are due under the license agreement.

"We are extremely pleased that DARZALEX continued its solid sales growth in 2019, as it is indicative of the strong benefit DARZALEX provides across its many indications in multiple myeloma," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "We are grateful to our partner for DARZALEX, Janssen, and their continued efforts to ensure that this treatment is made available to all the many patients who might benefit from it."

The milestone was included in the original financial guidance issued by Genmab on February 20, 2019, and in the improved financial guidance issued on November 6, 2019, as such there is no change to the company’s financial guidance for 2019.

About DARZALEX(daratumumab)
DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; 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.1 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX intravenous infusion is indicated for the treatment of adult patients in Europe: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; 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 therapy2. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S. In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma; 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 for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. 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).1,2,3,4,5,6

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 refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis, NKT-cell lymphoma and T-cell ALL. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

On January 22, 2020 Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) reported that received regulatory approval on December 9, 2019 from China’s National Medical Products Administration (NMPA) for LYNOAMP BC, an in vitro diagnostic reagent (Press release, Sysmex, JAN 22, 2020, View Source [SID1234553394]). Our system to test for breast cancer lymph node metastasis using the OSNA method has received Class III1 regulatory approval as the first product for lymph node metastasis testing using a molecular biological technique.

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The Japanese Breast Cancer Society’s Breast Cancer Clinical Practice Guideline has described a lymph node metastasis testing system for breast cancer using the OSNA method as an alternative to the H&E staining test2 for the pathological testing of sentinel lymph nodes, in addition the system is also recommended outside Japan by the Spanish Society of Senology and Mammary Pathology and the U.K. National Institute for Health and Clinical Excellence. The system has been introduced at more than 300 medical institutions in Japan and overseas, where it is playing an important role in helping doctors determine treatment methods.

GLOBOCAN 2018, issued by the International Agency for Research on Cancer (IARC) of the World Health Organization (WHO), projects that the number of breast cancer patients around the world will reach approximately 2.6 million by 2030. In China, where the number of breast cancer patients has been trending upward recently, the number of new patients numbered around 370,000 in 2018, making breast cancer the fifth-highest cause of death among women.

In treating breast cancer, the use of lymph node metastasis testing plays an important role in the selection of surgical methods and the determination of other treatment methods. With conventional testing methods, the pathologist prepares pathological samples from surgically removed lymph nodes, and then views those samples under a microscope either during or after the surgery to determine whether the cancer has metastasized. Problems with this approach are that it relies heavily on the quality of the prepared pathological samples, and accuracy may differ from pathologist to pathologist.

On December 9, 2019, Sysmex received regulatory approval from China’s NMPA for LYNOAMP BC, an in vitro diagnostic reagent, as a new product in the Class III category managed under the strictest safety and efficacy requirements. Accordingly, Sysmex is currently creating a framework for introducing into the Chinese market a breast cancer lymph node metastasis testing system using the OSNA method, comprising LYNOAMP BC and the RD-100i gene amplification detector.

Breast cancer lymph node metastasis testing systems using the OSNA method, a proprietary Sysmex technology, can determine within around 30 minutes whether lymph node metastasis has occurred. Accordingly, our technology can be used in lymph node metastasis testing for intraoperative determination of the resection area. This can prevent the need for subsequent surgery, reducing the burden on the patient and lowering the risk of recurrence. Furthermore, automation and simplification mean that testing is less dependent on operator skills and provides more objective testing results, reducing the burden on pathologists and standardizing breast cancer treatment.

Our system to test for breast cancer lymph node metastasis using the OSNA method has received regulatory approval in China for the first time for lymph node metastasis testing using a molecular biological technique. Going forward, we are targeting early-stage market introduction and uptake of this system throughout China in order for it to be recommended in China’s breast cancer treatment guidelines.

Though the creation and global dissemination of high-value testing and diagnostic technologies, Sysmex is contributing to advances in personalized medicine and the standardization of treatment in the field of cancer.
Details of Regulatory Registration in China of the RD-100i Gene Amplification Detector
Name: RD-100i Gene Amplification Detector (In Chinese: 基因扩增分析仪)
Classification: Class III
Registration renewal: April 15, 2019
Target use: This product is based on reverse transcription-loop-mediated isothermal amplification (RT-LAMP) technology. Used in combination with an appropriate reagent, this product is used for the qualitative detection of CK19 mRNA in human lymph node samples.
Registration number: 国械注进20193221975
Product photo:
RD-100i Gene Amplification Detector
Details of Regulatory Registration in China of the LYNOAMP BC
Name: LYNOAMP BC (In Chinese: 细胞角蛋白19核酸(CK19 mRNA)检测试剂盒(环介导等温核酸扩增法))
Classification: Class III
Registration: December 9, 2019
Target use: This product is used in the semi-quantitative detection of cytokeratin 19 mRNA (CK19 mRNA) in sentinel lymph nodes removed during breast cancer surgery.
Registration number: 国械注进20193400611
Product photo:
LYNOAMP BC
Terminology
1Products categorized as Class III in China:
China’s National Medical Products Administration (NMPA) classifies medical devices and pharmaceuticals from Class I to Class III, based on their risk level. Class III indicates a relatively high-risk level, and items with this classification must be managed stringently in accordance with special measures, and their safety and efficacy must be guaranteed.

2H&E staining test:
Hematoxylin and eosin (H&E) is one of the most fundamental and important staining methods for pathological tissue.

Information contained in the press release is current as of the date of the announcement,
but may be subject to change without prior notice.

On January 22, 2020 PDC*line Pharma, a clinical stage biotech company developing a new class of potent and scalable active immunotherapies for cancers, reported the completion of its Series B round of financing (Press release, PDC Line Pharma, JAN 22, 2020, View Source [SID1234553381]). The company has raised a total of €20 million ($22.2M).

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Two and a half years after its last round of fundraising in July 2017, PDC*line Pharma has attracted new investors, securing a further capital increase of €13.9M ($15.5M). In addition, the company will receive €6.1M ($6.8M) in loans and subsidies from the Walloon Region of Belgium, which has backed the company since it expanded its operations there in 2016.

PDC*line Pharma has attracted five new investors: Korean Investment Partners, the leading multi-billion dollar South-Korean fund, two further South-Korean funds, Shinhan-Cognitive Start-up Fund and UTC 2019 BIOVENTUREFUND, as well as two Belgian funds, SRIW (The Regional Investment Company of Wallonia) and Sambrinvest (the investment fund of Charleroi). They join the company’s historical investors: SFPI-FPIM, the Belgian Federal Holding and Investment Company, Noshaq Group (ex-Meusinvest), the Financière Spin-off Luxembourgeoise/INVESTSUD Group and a group of international business angels and well-known entrepreneurs.

"We are delighted by the trust our investors have placed in us and the opportunity to successfully complete this fund raising," said Eric Halioua, president & CEO of PDC*line Pharma. "The competitive advantage of our vaccinal platform in cancer immunotherapy and the significant achievements we have made over the last three years, including the signing of an important licensing deal with LG-Chem in Asia and the start of our phase I/II trials in France and Belgium in non-small-cell lung cancer (NSCLC), have been key factors in our investors’ decisions."

The objectives of the phase I/II study (PDC-LUNG-101) are to assess the safety, tolerability, immunogenicity and preliminary clinical activity of the drug candidate, PDC*lung01, associated or not with anti-PD-1 treatment in NSCLC. A total of 66 evaluable HLA-A*02:01 positive NSCLC patients are expected in three clinical centers in Belgium and six sites in France. PDC*lung01 comprises PDC*line professional antigen-presenting cells loaded with HLA-A2 restricted peptides derived from six shared tumor antigens.

According to François Fontaine, general advisor to PDC*line Pharma at SFPI-FPIM, "PDC*line Pharma’s cancer vaccine platform is both highly innovative and meets an important medical need. It also has a clear societal impact for the Liège region, for Belgium and beyond. We welcome the continued strong support of the Walloon region and the new funding by existing and new investors."

"In line with our strategy to support transformative technologies, we are thrilled to join PDC*line Pharma in advancing its Smission to treat cancer patients," said Sangwoo Lee, managing director at Korea Investment Partners. "PDC*line Pharma’s scientific expertise is matched by the management it has assembled to advance its clinical and research programs."

On January 21, 2020 HepaRegeniX GmbH, a preclinical stage company developing a novel therapy for the treatment of acute and chronic liver diseases reported the closing of its Series B financing round in excess of € 11 Mio. with contribution from all its existing investors namely Boehringer Ingelheim Venture Fund GmbH (BIVF), Novo Holdings A/S, the High-Tech Gruenderfonds, Coparion and Ascenion.

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The proceeds will be used to advance the first MKK4 inhibitor for treatment of acute and chronic liver diseases to the clinics later in 2020. MKK4 (Mitogen-Activated Protein (MAP) Kinase 4) is a key regulator of liver regeneration and suppression of MKK4 unlocks the regenerative capacity of hepatocytes even in severely diseased livers. Over the last 2,5 years, HepaRegeniX focused on discovery of new and proprietary MKK4 inhibitors which led to the identification of several preclinical drug candidates. Results from experimental, clinically relevant disease models further validated the concept that MKK4-inhibition improves the regeneration capacity of hepatocytes in affected organs and provided strong evidence for successful clinical development.

"This is an exciting phase for HepaRegeniX to soon advance our first compound into the clinic based on compelling preclinical data for our proprietary MKK4 inhibitor" commented Dr. Wolfgang Albrecht, Managing Director of HepaRegeniX. "In this regard, we are very proud to have been able to secure this Series B financing round from our current investor base within a very short time period".

Prof. Dr. Johannes Zanzinger from BIVF, concluded on behalf of all investors, "HepaRegeniX with its unique therapeutic concept around acute and chronic liver diseases represents a company with significant potential. This Series B round will substantially help to clinically validate the underlying concept and deliver novel and proprietary orally available small molecule kinase inhibitors with significant potential in the field of liver regeneration".

(Press release, HepaRegeniX, JAN 21, 2020, View Source [SID1234666460])

On January 21, 2020 Gene Techno Science (Kidswell Bio) reported a joint development agreement with MabGenesis to obtain and apply patent for new antibodies with the effect of killing cancer cells (Press release, Kidswell Bio, JAN 21, 2020, View Source [SID1234625473]).

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1. Purpose and background for concluding this agreement
This agreement aims to expand the new pipeline in the new biologic business, which is a future growth driver for our company. Recently, efficiency in cancer treatments has been improved with the emergence of antibody drugs and antibody drug conjugates in addition to conventional small molecule drugs. Furthermore, the realization of antibody drugs with new molecular mechanisms of action, such as Opdivo, has become a long-awaited solution for patients previously considered as untreatable. However, there are still many patients who cannot be cured with those drugs. In fact, R&D for rare and intractable cancers with small number of patients is inactive for financial reasons at present, and therefore development of new cancer treatment is essential.

MabGenesis is a bio venture company aiming to obtain a first-in-class, best-in-class monoclonal antibody using innovative and ingenious antibody isolation technology owned by Professor Kazuhiro Morishita, University of Miyazaki and Lecturer Gene Kurosawa, Fujita Health University. Focusing on this technology, GTS signed a joint research agreement with the aim of executing the development of cancer treatments with a new mechanism of action for rare and intractable cancers by acquiring monoclonal antibodies that bind specifically and firmly to specific antigens expressed on the surface of cancer cells.

2. Contents of this agreement Joint research agreement for acquisition of monoclonal antibodies to specific antigens expressed on the surface of cancer cells

3. Outline of counterparties to this agreement
1. Company Name MabGenesis Inc.
2. Name and title of
representatives
Chief Executive Officer Katsuhiro Shinjo
3. Head Office 1-4, Honcho, Nihonbashi, Chuo-ku, Tokyo
4. Established June 3rd, 2019
5. Main Business Research and development of pharmaceutical drugs
6. Capital 21,750 thousand Japanese Yen
4. Future outlook
The impact on the business results for the fiscal year ending March 2020 is expected
to be minimal.