On July 31, 2020 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported financial results for the second quarter ending June 30, 2020 and provided a corporate update (Press release, VBI Vaccines, JUL 31, 2020, View Source [SID1234562653]).

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Jeff Baxter, President and CEO, commented: "The second quarter of 2020 was again a time of unprecedented disruption, with the COVID-19 pandemic continuing to have severe global public health, societal, and economic consequence. We have implemented and maintained measures required to ensure the safety and wellbeing of all our employees, while also continuing to achieve milestones that we hope will enable VBI to contribute meaningfully to public health solutions. As a result of the commitment, dedication, and passion of the entire VBI team, the remainder of 2020 is expected to be a milestone-rich period across our pipeline. To support the ongoing advancement of VBI’s pipeline candidates, we strengthened our balance sheet over the last few months. With $86 million in cash, cash equivalents, and short term investments, we continue to be well-positioned to capitalize on the growth and value-driving opportunities ahead."

Recent Highlights and Upcoming Program Milestones

Financing

April 2020: $57.5 million gross proceeds raised in an underwritten public offering
May 2020: Up to $50 million debt financing facility secured with K2 HealthVentures (K2HV), a healthcare-focused specialty finance company
May 2020: Repaid $15.3 million of debt to Perceptive Credit Holdings L.P.
Sci-B-Vac: Tri-Antigenic Prophylactic HBV Vaccine

May and July 2020: Productive pre-BLA and pre-submission meetings held with the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), respectively
Q4 2020: Submission of applications for regulatory approvals in the U.S., Europe, and Canada expected to begin
VBI-1901: Glioblastoma (GBM) Cancer Vaccine Immunotherapeutic Candidate

June 2020: Data presented at the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting highlighting:
Observation of a confirmed partial response in a patient treated with VBI-1901 + GM-CSF, with recurrent GBM tumor reduction of greater than 50%
Evidenced by five out of the six tumor responses seen to-date, identification of a normal baseline CD4+/CD8+ T cell ratio as a promising, potentially predictive biomarker strategy associated with tumor responses
Q4 2020: Initial immunologic and tumor response data expected from the Phase 2a VBI-1901 + AS01B study arm
Results observed to-date support further clinical development – exploring potential registrational study, expected to initiate in 2021
VBI-2901: Trivalent Prophylactic Pan-Coronavirus Candidate

As part of the collaboration with the National Research Council of Canada (NRC), announced in March 2020, a series of three pre-clinical animal models began in Q2 to evaluate:
Trivalent vaccine constructs targeting SARS-CoV-2, SARS-CoV, and MERS-CoV vs. monovalent vaccine constructs targeting SARS-CoV-2
Multiple different adjuvants
Pre-fusion vs. post-fusion spike proteins
Q3 2020: Pre-clinical data expected to enable selection of the optimal clinical vaccine candidate(s)
Q4 2020: Clinical study materials expected to be available
VBI-2601 (BRII-179): HBV Immunotherapeutic Candidate

H2 2020: Initial human proof-of-concept data expected from ongoing Phase 1b/2a study
Formation of Commercial Advisory Board

May 2020: To support the Company’s commercial strategy, VBI formed a Commercial Advisory Board consisting of leading experts in public health policy, epidemiology, and vaccine development, with members Damian Braga (Chair), Eddy A. Bresnitz, M.D., M.S.C.E., Michael D. Decker, M.D., M.P.H., and John D. Grabenstein, Ph.D., R.Ph.

Second Quarter 2020 Financial Highlights

Cash Position: VBI ended the second quarter of 2020 with $86.1 million in cash, cash equivalents, and short term investments compared to $44.2 million as of December 31, 2019. Short term investments consist of guaranteed income certificates held with Schedule 1 Canadian banks for maturity terms greater than 3 months, but less than one year from the date of acquisition.
Net Cash Used in Operating Activities: Net cash used in operations for the six months ended June 30, 2020 was $15.5 million compared to the $26.3 million for the same period in 2019. The decrease is the result of the completion of the Sci-B-Vac Phase 3 clinical studies, the first of which (PROTECT) was completed in June 2019, the second of which (CONSTANT) was completed in January 2020.
Cash Used for Purchase of Property and Equipment: Cash used for the purchase of property and equipment was $0.3 million for the six months ended June 30, 2020 compared to $2.9 million for the same period in 2019. The decrease was due to the completion of the modernization and capacity increase of VBI’s manufacturing facility in Rehovot, Israel, which re-commenced operations in May 2019.
Revenue: Revenue in the second quarter of 2020 was $0.2 million compared to $0.6 million for the same period in 2019. The decrease was due to a decrease in product revenue of Sci-B-Vac on a named-patient basis during the three months ended June 30, 2020 compared to the three months ended June 30, 2019. The decrease was also related to a decrease in R&D services revenue for VBI-2601 following the initiation of the clinical study in November 2019 as part of the ongoing collaboration with the Brii Biosciences.
Cost of Revenues: Cost of revenues was $2.1 million for the second quarter of 2020 compared to $2.4 million for the same period in 2019. This slight decrease is due to lower costs related to R&D services revenue.
Research and Development (R&D): R&D expenses were $2.4 million for the second quarter of 2020, compared to $7.4 million for the same period in 2019. The decrease in R&D expenses is the result of the completion of the Sci-B-Vac Phase 3 studies and is offset by an increase in expenses due to the ongoing Phase 1/2a study of VBI-1901.
General and Administrative (G&A): G&A expenses were $3.9 million for the second quarter of 2020, compared to $3.2 million for the same period in 2019. The increase is a result of the increase in pre-commercialization activities for Sci-B-Vac.
Net Loss: Net loss and net loss per share for the second quarter of 2020 were $9.5 million and $0.04, respectively, compared to a net loss of $13.2 million and a net loss per share of $0.13 for the second quarter of 2019.

On July 31, 2020 Takeda Pharmaceutical Company Limited (TOKYO:4502/NYSE:TAK) ("Takeda") reported financial results for the first quarter of fiscal year 2020 (quarter ended June 30, 2020) (Press release, Takeda, JUL 31, 2020, View Source [SID1234562652]). Based on the first quarter performance, the company confirms management guidance, and raises reported operating profit and reported net profit for the full year. The company also announced recent updates to its R&D pipeline and highlighted its R&D momentum with seven potential New Drug Application filings planned for the next 12 months.

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Underlying revenue growth was 0.9% year on year. Takeda’s five key business areas, which represent 83% of revenue, delivered underlying revenue growth of 6%, and its 14 global brands, with reported revenue of JPY 308.0 billion in aggregate, posted 20% underlying revenue growth
Reported revenue was JPY 801.9 billion, with the impact of foreign currency and divestitures resulting in a year-on-year decline of 5.6%
Core operating profit1 was JPY 280.9 billion, with the core operating profit margin at 35.0% driven by cost synergies and OPEX efficiencies
Reported operating profit increased significantly, up 270% to JPY 167.3 billion, driven by lower purchase accounting and integration-related expenses; reported net profit increased to JPY 82.5 billion from JPY 7.0 billion a year earlier2
Reported operating cash flow increased by 21% to JPY 145.9 billion; free cash flow of JPY 146.3 billion represents a 64% increase over the prior year
Robust cash generation enabled further deleveraging to 3.7x net debt/adjusted EBITDA, demonstrating strong progress from 4.7x at the end of March 2019
Takeda increased its forecast for FY2020 reported operating profit to JPY 395 billion from JPY 355 billion, reported net profit to JPY 92 billion from JPY 60 billion, and for reported EPS to JPY 59 from JPY 39, to reflect a net gain from one-time items recognized in the first quarter
Takeda Chief Financial Officer Costa Saroukos commented:

"Takeda delivered solid first quarter results even during a period of great challenges for our employees, for patients, and for the communities we serve around the world. The performance of our global brands and key business areas demonstrates the quality of our product portfolio and resilient demand for medicines targeting severe chronic or life-threatening conditions. Among the Q1 highlights, ENTYVIO delivered exceptional underlying growth of 26%, TAKHZYRO is ramping up very well with underlying growth of 66%, and Immunoglobulin delivered strong underlying growth of 30%.

"Momentum is also building in our R&D pipeline, with seven potential Wave 1 New Drug Application filings targeted over the next 12 months, as well as further expansions of our global brands. In addition, we are making progress in various efforts to develop potential therapies for patients at risk from serious complications of COVID-19.

"Takeda has sustained the financial strength which underpins our success, with underlying revenue growth and strong underlying core operating profit growth, margins and cash flow. We continue to make steady progress toward our deleveraging and divestiture targets, and remain confident in Takeda’s growth momentum for the full year and in opportunities to accelerate growth in the medium term."

Pipeline Update: Momentum in Our Dynamic R&D Growth Engine

Takeda has built a world-class R&D engine leveraging our internal research capabilities, while also actively engaging with innovative ecosystems around the world to translate science into highly innovative medicines. The main drivers for targeted new product launches are 12 unique New Molecular Entities (NMEs) in Wave 1, which represent several potential best-in-class / first-in-class therapies targeted for launch by FY2024 with aggregate potential peak sales of more than $10 billion.

With seven potential Wave 1 NME filings in the next 12 months, as well as additional expansions of our global brands, the momentum of our R&D growth engine is increasing.

In Oncology, pevonedistat was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with higher-risk myelodysplastic syndromes (HR-MDS). Pevonedistat could be the first novel therapy in over a decade for HR-MDS and patients with acute myeloid leukemia for whom standard treatments are not appropriate.

We are excited about the transformative medium-term potential of a number of our major R&D programs, including:

In Oncology, TAK-007 for the treatment of hematologic malignancies on an outpatient basis, with encouraging Phase 1/2 data and cohort expansion ongoing for a pivotal study planned for next year and potential approval in FY2023
In Neuroscience, the first patient has been enrolled in a Phase 2 trial of TAK-994 for the treatment of narcolepsy type 1, with potential approval in FY2024
Progress on the extension of our global brands in Q1 included:

Approval of ALUNBRIG for first-line treatment for ALK+ advanced Non-Small Cell Lung Cancer (NSCLC) in the U.S.
Approvals for ADCETRIS in the EU for first-line systemic Anaplastic Large Cell Lymphoma (sALCL); and ADCETRIS in China for relapsed/refractory CD-30+ lymphomas
Wave 1 NME Filings targeted for the next 12 months include TAK-721, TAK-609, CoVIg-19, TAK-003, mobocertinib, pevonedistat and maribavir:

TAK-721 is on track to be the first FDA-approved agent to treat eosinophilic esophagitis
TAK-609 is in preparatory stages for a U.S. NDA submission for Hunter Syndrome with cognitive impairment
CoVIg-19 is expected to start a registration-enabling study in patients with COVID-19 in the coming weeks
TAK-003 is on track for a regulatory filing for Dengue vaccine in a number of endemic countries in Asia and Latin America
Mobocertinib (TAK-788) has the potential to set a new standard of care for a subset of Non-Small Cell Lung Cancer (NSCLC) patients with EGFR exon 20 insertions
Pevonedistat (TAK-924) has the potential to be the first novel HR-MDS therapy in over a decade; anticipated Phase 3 PANTHER trial in HR-MDS readout in second half of FY2020
Maribavir (TAK-620) has the potential to be the first approved treatment for patients with post-transplant Cytomegalovirus (CMV) infection in over a decade
The CoVIg-19 Plasma Alliance continued development of a potential non-branded investigational hyperimmune globulin (H-Ig) treatment for COVID-19. Manufacturing of the first batch of CoVIg-19 was initiated at Takeda’s Georgia U.S, manufacturing site in May, and is ready to be shipped to study sites.

In addition, Takeda is evaluating repositioning of other internal therapies (icatibant and lanadelumab) and investigational medicines (TAK-981 and TAK-671), while also researching novel approaches.

1 Underlying growth compares two periods (quarters or years) of financial results under a common basis and is used by management to assess the business. These financial results are calculated on a constant currency basis and excluding the impact of divestitures and other amounts that are unusual, non-recurring items or unrelated to our ongoing operations.

2 Core Operating Profit represents net profit adjusted to exclude income tax expenses, the share of profit or loss of investments accounted for using the equity method, finance expenses and income, other operating expenses and income, amortization and impairment losses on acquired intangible assets and other items unrelated to Takeda’s core operations, such as purchase accounting effects and transaction related costs.

3 Further information on certain of Takeda’s Non-IFRS measures is posted on Takeda’s investor relations website at View Source

Takeda delivered solid performance for the first quarter of FY2020:

Takeda started the fiscal year with underlying revenue growth of 0.9%, consistent with full year guidance of "low-single-digit growth" and with a goal of accelerating growth in the medium term. Reported revenue was impacted by foreign exchange effects and divestitures, declining 5.6% year on year
We delivered a year-on-year increase in reported operating profit to JPY 167.3 billion and an increase in reported net profit to JPY 82.5 billion compared to JPY 7.0 billion for the same period in the prior year3. This is attributable to the effect of purchase accounting expenses in the previous fiscal year and significantly lower costs related to the Shire acquisition compared to last year, as we have successfully completed most of the integration process
Core operating profit of JPY 280.9 billion declined 0.7% year on year, as OPEX improvement including cost synergies could not fully offset the negative impact of foreign exchange and divestiture effects. The core operating profit margin was 35.0%
Underlying core operating profit margin, which adjusts for the impact of foreign exchange and divestiture effects, grew strongly to 34.7%. We are on track to achieve our target of mid-30% within FY2021-2023
Operational efficiencies and cost savings supported margin performance and we are on track to achieve our targeted annual run rate of $2.3 billion in cost synergies by the end of FY2021
Takeda is deleveraging rapidly, with a net debt/adjusted EBITDA ratio of 3.7x, at the end of Q1, down from 3.8x in March 2020 and compared to 4.7x in March 2019; we are on course to meet our medium-term deleveraging goal of 2x within FY2021-FY2023
At the same time as investing in promising R&D programs and efficient pipeline growth and returning cash to shareholders through dividends, Takeda continues to maintain strong cash flow. Reported cash flow from operations of JPY 145.9 billion represents a 21% increase year on year, while free cash flow of JPY 146.3 billion increased 64% over the same period
Takeda continues to make progress in shedding non-core assets as part of its $10 billion divestiture program. Six deals worth up to $8 billion have been announced since April 2019, including three transactions worth up to $6 billion that have already closed
In addition, we plan to unlock more than $700 million of incremental cash in FY2020 through the sale of real estate and marketable securities
Takeda’s five key business areas (Gastroenterology, Rare Diseases, Plasma-Derived Therapies, Oncology, Neuroscience), with JPY 662.0 billion of reported revenue representing 83% of total Q1 revenues, delivered year-on-year underlying revenue growth of 6%. Our 14 global brands, with reported revenue of JPY 308.0 billion in aggregate, delivered a strong 20% increase in underlying revenue growth compared to last year’s fiscal first quarter performance.

Among the highlights:

Our Gastroenterology franchise delivered exceptional growth as ENTYVIO expands its share of patients and enters new markets around the world. In Rare Diseases, TAKHZYRO sales are ramping up as its efficacy profile positions it as a leading option to expand the hereditary angioedema prophylaxis market; and PDT Immunology delivered strong growth driven by GAMMAGARD liquid demand in the U.S. and subcutaneous IG worldwide
Reported revenue and underlying revenue growth rates for notable Q1 FY2020 contributors include:
ENTYVIO JPY 101.2 billion +26% (Gastroenterology);
TAKHZYRO JPY 23.2 billion +66% (Rare Diseases);
ALUNBRIG JPY 2.0 billion +26% (Oncology)
NINLARO JPY 22.9 billion +31% (Oncology)
Immunoglobulin JPY 85.1 billion + 30% (PDT Immunology)
Our PDT Immunology business area delivered reported revenue of JPY 105.3 billion, representing a 19% improvement in underlying revenue growth year on year
Neuroscience reported revenue was JPY 106.9 billion, an underlying revenue decline of 1% year on year as COVID-19-related stay-at-home restrictions significantly reduced patient visits and subsequent diagnoses for VYVANSE; TRINTELLIX achieved continued market share increases in the U.S. market

Takeda has strong growth momentum heading into FY2020 and potential for accelerated underlying growth and achieving an underlying core profit margin in the mid-30s over the medium term.

Core and underlying guidance for FY2020 remains unchanged. Takeda upgraded its reported operating profit, reported net profit, and reported EPS forecast for FY2020 due to the net positive effect of one-time items recognized during the first quarter of FY2020: an approx. JPY 60 billion increase due to the European Commission’s decision to release Takeda from the obligation to divest SHP647; and a negative approx. JPY 20 billion impact due to the remeasuring to the estimated fair value of the contingent consideration financial asset related to potential milestone receipts of Xiidra as a result of Novartis’ withdrawal of the Marketing Authorization Application in Europe.

Key assumptions in FY2020 forecast:

Company guidance reflects management’s expectations for continued business momentum across Takeda’s five key business areas, underlying revenue growth of our 14 global brands, and accelerated realization of cost synergies.

FY2020 guidance also reflects the following key assumptions, including (i) that there will not be an additional 505(b)2 competitor for subcutaneous VELCADE launched in the U.S. within FY2020; (ii) no impact of any potential further divestitures beyond what has already been disclosed by Takeda; and (iii) management’s current expectations regarding COVID-19.

To date, Takeda has not experienced a material effect on its financial results as a result of the global spread of the novel coronavirus infectious disease (COVID-19), despite the various effects on its operations as detailed in Takeda’s Quick Report for the quarter ended June 30, 2020, released today. Based on currently available information, Takeda believes that its financial results for FY2020 will not be materially affected by COVID-19 and, accordingly, Takeda’s FY2020 forecast reflects this belief. However, the situation surrounding COVID-19 remains highly fluid, and future COVID-19-related developments in FY2020, including new or additional COVID-19 outbreaks and additional or extended lockdowns, shelter-in-place orders or other government action in major markets, could result in further or more serious disruptions to Takeda’s business, such as slowdowns in demand for Takeda’s products, supply chain related issues or significant delays in its clinical trial programs. These events, if they occur, could result in additional impacts on Takeda’s business, results of operations or financial condition, as well as resulting in significant deviations from Takeda’s FY2020 forecast.

On July 31, 2020 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, reported it will release its unaudited financial results for the quarter ended June 30, 2020 on Thursday, August 6, 2020, before the US markets open (Press release, BioLineRx, JUL 31, 2020, View Source [SID1234562651]).

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The Company will host a conference call on Thursday, August 6, 2020 at 10:00 a.m. EDT featuring remarks by Philip Serlin, Chief Executive Officer. The conference call will be available via webcast and can be accessed through the Investor Relations page of BioLineRx’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.

To dial into the conference call, please dial +1-888-668-9141 from the U.S. or +972-3-918-0610 internationally. A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx’s website. A dial-in replay of the call will be available until August 8, 2020; please dial +1-888-782-4291 from the U.S. or +972-3-925-5921 internationally.

On July 31, 2020 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) and Incyte (Nasdaq:INCY) reported that the U.S. Food and Drug Administration (FDA) has approved Monjuvi(R) (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT) (Press release, MorphoSys, JUL 31, 2020, View Source [SID1234562647]).1 Monjuvi, a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, has been approved under accelerated approval by the U.S. FDA based on overall response rate (ORR). Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The FDA decision represents the first approval of a second-line treatment for adult patients who progressed during or after first-line therapy.

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DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide2, characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs. It is an aggressive disease with about one in three patients not responding to initial therapy or relapsing thereafter.3 In the United States each year approximately 10,000 patients are diagnosed with relapsed or refractory DLBCL who are not eligible for ASCT.4,5,6

"We are incredibly proud that the FDA has approved Monjuvi in combination with lenalidomide as the first treatment in second-line for patients with relapsed or refractory DLBCL, and we thank all the health care professionals, patients and families involved in our Monjuvi trials," said Jean-Paul Kress, M.D., Chief Executive Officer, MorphoSys. "This approval marks an important step in MorphoSys’ transformation into a fully integrated biopharmaceutical company. We remain committed to developing innovative treatments to improve the lives of patients with serious diseases."

"The FDA approval of Monjuvi in combination with lenalidomide helps address an urgent unmet medical need for patients with relapsed or refractory DLBCL in the United States," said Hervé Hoppenot, Chief Executive Officer, Incyte. "At Incyte we are committed to advancing patient care and are proud to bring this new and much-needed targeted therapeutic option to appropriate patients and the clinical community."

"The FDA approval of Monjuvi brings a new treatment option to patients in dire need across the United States," said Professor Gilles Salles, M.D., Chair of the Clinical Hematology Department at the University of Lyon, France, and lead investigator of the L-MIND study. "Today’s FDA decision offers new hope for patients with this aggressive form of DLBCL who progressed during or after first-line therapy."

The FDA approval was based on data from the MorphoSys-sponsored Phase 2 L-MIND study, an open label, multicenter, single arm trial of Monjuvi in combination with lenalidomide as a treatment for adult patients with relapsed or refractory DLBCL. Results from the study showed an overall response rate (ORR) of 55% (primary endpoint), including a complete response (CR) rate of 37% and a partial response rate (PR) of 18%. The median duration of response (mDOR) was 21.7 months (key secondary endpoint).1 Warnings and Precautions for Monjuvi included infusion-related reactions (6%), serious or severe myelosuppression (including neutropenia (50%), thrombocytopenia (18%), and anemia (7%)), infections (73%) and embryo-fetal toxicity. Neutropenia led to treatment discontinuation in 3.7% of patients. The most common adverse reactions (>= 20%) were neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection, and decreased appetite.

The FDA previously granted Fast Track and Breakthrough Therapy Designation for the combination of Monjuvi and lenalidomide in relapsed or refractory DLBCL. FDA Breakthrough Therapy designation is intended to expedite development and review of drug candidates. It is granted if preliminary clinical evidence indicates that the drug candidate may demonstrate substantial improvement over existing therapies in the treatment of a serious or life-threatening disease. The Biologics License Application (BLA) for Monjuvi was granted Priority Review and approved under the FDA’s Accelerated Approval program.

Monjuvi is expected to be commercially available in the United States shortly. MorphoSys and Incyte will co-commercialize Monjuvi in the United States. Incyte has exclusive commercialization rights outside the United States.

MorphoSys and Incyte are committed to supporting patients throughout their treatment journeys and are working together to help lower patient access barriers. As part of this commitment, the Companies have launched My Mission Support, a robust patient support program offering financial assistance, ongoing education and other resources to eligible patients who are prescribed Monjuvi in the United States. Program information will be available online at www.MyMissionSupport.com.

Conference Call Information
MorphoSys and Incyte will host an analyst and investor conference call and webcast on Monday, August 3, 2020 at 8:00 a.m. EDT / 2:00 p.m. CEST. The live webcast and replay will be available via www.morphosys.com and investor.incyte.com.

To access the conference call, please dial 877-407-3042 for callers in the United States or +1 201-389-0864 for callers outside the United States. When prompted, provide the conference identification number 13706810.

If you are unable to participate, a replay of the conference call will be available for 90 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is +1 201-612-7415. To access the replay, you will need the conference identification number 13706810.

About L-MIND
The L-MIND trial is a single arm, open-label Phase 2 study (NCT02399085) investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have had at least one, but no more than three prior lines of therapy, including an anti-CD20 targeting therapy (e.g., rituximab), who are not eligible for high-dose chemotherapy or refuse subsequent autologous stem cell transplant The study’s primary endpoint is overall response rate (ORR). Secondary outcome measures include duration of response (DoR), progression-free survival (PFS) and overall survival (OS). In May 2019, the study reached its primary completion.

For more information about L-MIND, visit View Source

About Monjuvi(R) (tafasitamab-cxix)
Monjuvi is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

Monjuvi is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize Monjuvi globally. Monjuvi will be co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

A marketing authorization application (MAA) seeking the approval of tafasitamab in combination with lenalidomide in the EU has been validated by the European Medicines Agency (EMA) and is currently under review for the treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low grade lymphoma, who are not candidates for ASCT.

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

Monjuvi is a registered trademark of MorphoSys AG.
XmAb(R) is a registered trademark of Xencor, Inc.

Important Safety Information
What are the possible side effects of MONJUVI?
MONJUVI may cause serious side effects, including:

– Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get chills, flushing, headache, or shortness of breath during an infusion of MONJUVI.

– Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4 F (38 C) or above, or any bruising or bleeding.

– Infections. Serious infections, including infections that can cause death, have happened in people during treatments with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4 F (38 C) or above, or develop any signs and symptoms of an infection.

The most common side effects of MONJUVI include:

– Feeling tired or weak

– Diarrhea

– Cough

– Fever

– Swelling of lower legs or hands

– Respiratory tract infection

– Decreased appetite

These are not all the possible side effects of MONJUVI.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before you receive MONJUVI, tell your healthcare provider about all your medical conditions, including if you:

– Have an active infection or have had one recently.

– Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.

– You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of MONJUVI.

– Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI.

– Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment for at least 3 months after your last dose of MONJUVI.

You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

On July 31, 2020 Genmab A/S (Nasdaq: GMAB) reported that the European Myeloma Network (EMN) in collaboration with Janssen Research & Development, LLC (Janssen) reported positive results from the Phase 3 APOLLO (MMY3013) study of the subcutaneous (SC) formulation of daratumumab in combination with pomalidomide and dexamethasone (Pd) versus Pd alone as treatment for patients with relapsed or refractory multiple myeloma who have previously been treated with lenalidomide (an immunomodulatory drug) and a proteasome inhibitor (PI) (Press release, Genmab, JUL 31, 2020, View Source [SID1234562644]). The study met the primary endpoint of improving progression-free survival (PFS). Overall, the safety profile of daratumumab SC in combination with Pd was consistent with the safety profile for each therapy separately.

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"We are pleased with these positive results for daratumumab, administered as a subcutaneous formulation, in combination with pomalidomide and dexamethasone. The corresponding intravenous regimen was previously approved by the U.S. FDA based on the Phase1 single-arm EQUULEUS study," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Janssen Biotech, Inc., which obtained an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab in 2012, intends to discuss the data with health authorities in preparation for regulatory submissions and plans to submit the data for presentation at an upcoming medical conference.

The APOLLO study was designed to confirm the results from the Phase 1 EQUULEUS (MMY1001) study, which investigated intravenous (IV) daratumumab plus Pd in the same indication. In June 2017, the U.S. Food and Drug Administration (U.S. FDA) approved the use of DARZALEX in combination with Pd for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a PI based on the results of the EQUULEUS study.

About the APOLLO (MMY3013) study
This Phase 3 (NCT03180736), randomized, open-label, multicenter study included 304 patients with multiple myeloma who have previously been treated with lenalidomide and a PI. Patients were randomized 1:1 to either receive daratumumab in combination with Pd or Pd alone. In the original design of the study, patients in the daratumumab plus Pd arm were treated with the IV formulation of daratumumab. As of Amendment 1, all new subjects in the experimental arm were dosed with the SC formulation of daratumumab and patients who had already begun treatment with IV daratumumab had the option to switch to the SC formulation. The primary endpoint of the study was PFS. The study was conducted in Europe under an agreement between Janssen, EMN and Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON).

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 Multiple myeloma is the third most common blood cancer in the U.S., after leukemia and lymphoma.2 Approximately 26,000 new patients were estimated diagnosed with multiple myeloma and approximately 13,650 people were expected to have died from the disease in the U.S. in 2018.3 Globally, it was estimated that 160,000 people were diagnosed and 106,000 died from the disease in 2018.4 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.5

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.6 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 for the treatment of adult patients in Europe via intravenous infusion or subcutaneous administration: 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 therapy7. Daratumumab is the first subcutaneous CD38-directed antibody approved in Europe for the treatment of multiple myeloma. 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 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 relapsed or refractory multiple myeloma. 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.

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, is approved in the United States for the treatment of adult patients with multiple myeloma: in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for ASCT; in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients 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.8 DARZALEX FASPRO is the first subcutaneous CD38-directed antibody approved in the U.S. for the treatment of multiple myeloma.

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).6,9,10,11,12

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 and T-cell acute lymphocytic leukemia (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.