On February 15, 2017 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) reported that it has added a second patent with US Patent Number 9,200,061 to its lawsuit against Janssen Biotech, and Genmab, A/S (Press release, MorphoSys, FEB 15, 2017, https://www.morphosys.com/media-investors/media-center/district-court-grants-morphosyss-request-to-add-second-patent-in [SID1234556345]). This patent claims methods of treating hematologic cancer associated with the undesired presence of CD38-positive cells by administering antibodies that bind to a specific region of the target molecule, CD38. In a hearing that took place on February 6, 2017 the District Court granted MorphoSys’s request to add the 9,200,061 patent to the case.

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On April 4, 2016 MorphoSys filed a lawsuit in the United States (U.S.) District Court of Delaware against Janssen Biotech, and Genmab, A/S for patent infringement of U.S. Patent Number 8,263,746.

By its complaint, MorphoSys seeks redress for infringement by Janssen’s and Genmab’s daratumumab, a CD38-directed monoclonal antibody indicated for the treatment of certain patients with multiple myeloma. Janssen Biotech obtained FDA approval on daratumumab and markets the product as Darzalex(R) in the U.S. and other countries. MorphoSys continues to develop MOR202, its own investigational human antibody to CD38, for the treatment of cancer, including multiple myeloma.

On February 14, 2017 Incyte Corporation (Nasdaq:INCY) and Agenus Inc. (Nasdaq:AGEN) reported that the companies have amended the License, Development and Commercialization Agreement that was originally entered into January 9, 2015 (Press release, Incyte, FEB 14, 2017, View Source [SID1234517737]). The amended agreement converts the ongoing GITR and OX40 antibody programs from co-funded development and profit-sharing arrangements to royalty-bearing programs, with Incyte now responsible for funding and conducting global development and commercialization. Should candidates from either of these two programs be approved, Agenus would now become eligible to receive 15 percent royalties on global net sales of each approved product.

The ongoing TIM-3 and LAG-3 antibody programs remain royalty-bearing programs, at tiered rates of 6 to 12 percent, with Incyte retaining exclusive world-wide clinical development and commercial responsibilities.

Pursuant to the amended agreement, Agenus will receive today accelerated milestone payments of $20 million from Incyte related to the clinical development of INCAGN1876 (anti-GITR agonist) and INCAGN1949 (anti-OX40 agonist). Across all programs in the collaboration, Agenus will now be eligible to receive up to a total of $510 million in future potential development, regulatory and commercial milestones.

The parties have also entered into a separate Stock Purchase agreement whereby Incyte will purchase 10 million shares of Agenus common stock today at $6 per share.

"The antibody discovery collaboration between Incyte and Agenus has progressed well and has already resulted in two programs in clinical trials. We look forward to further developing our GITR and OX40 antibody programs, and exploring immunotherapy combinations with these compounds and other agents in the near future," said Hervé Hoppenot, CEO of Incyte.

"We believe the amended agreement will help streamline the development of our collaboration portfolio, provide the opportunity to prioritize our other internal programs towards rapid commercialization and help foster the development of our portfolio of novel I-O programs," said Garo Armen, Ph.D., Chairman and CEO of Agenus. "The revised agreement will also strengthen Agenus’ balance sheet and reduce cash burn."

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On February 14, 2017 Genomic Health, Inc. (Nasdaq: GHDX) reported financial results and business progress for the quarter and year ended December 31, 2016 (Press release, Genomic Health, FEB 14, 2017, View Source [SID1234517742]).

Total revenue was $327.9 million in the full year 2016, compared with $287.5 million in 2015, an increase of 14 percent.

U.S. product revenue was $280.1 million in the full year 2016, compared with $246.0 million in 2015, an increase of 14 percent. Prostate test revenue in the U.S. was $10.8 million and contributed to approximately 3 percent of total product revenue growth in the year.

International revenue for the full year 2016 was $46.8 million compared with $41.5 million in 2015, an increase of 13 percent, and an increase of 15 percent on a constant currency basis.i

"In 2016, we delivered double-digit revenue and test growth for the year, and achieved profitability in the fourth quarter," said Kim Popovits, chairman of the board, chief executive officer and president of Genomic Health. "With substantial opportunity for growth in our global breast and U.S. prostate business and leverage of our unique commercial channel with the planned launch this year of Oncotype DX AR-V7 Nucleus Detect, we expect to continue to deliver long-term revenue growth with improved profitability."

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Operating loss was $15.4 million for the year ended December 31, 2016, compared with an operating loss of $34.0 million for the year ended December 31, 2015. Net loss was $13.9 million for the year ended December 31, 2016, compared with a net loss of $33.3 million for the year ended December 31, 2015.

Basic and diluted net loss per share was $0.42 for the year ended December 31, 2016, compared with a basic and diluted net loss per share of $1.03 for the year ended December 31, 2015.

More than 118,570 Oncotype test results were delivered for the year ended December 31, 2016, an increase of 11 percent, compared with more than 107,030 test results delivered in 2015. Oncotype DX breast cancer tests delivered in the U.S. grew 7 percent in the full year, compared to the prior year. Oncotype DX Genomic Prostate Score tests delivered in the U.S. grew 16 percent in the full year, including 29 percent in the fourth quarter, and represented approximately 8 percent of total test volume in 2016. International tests delivered grew 23 percent in the full year compared to the prior year and represented approximately 24 percent of total test volume in 2016.

Additional Fourth Quarter 2016 Financial Results

Total revenue was $82.7 million in the fourth quarter of 2016, compared with $75.1 million in the fourth quarter of 2015, an increase of 10 percent.

U.S. product revenue was $70.0 million in the fourth quarter of 2016, an increase of 9 percent, compared with $64.5 million in the same period in the prior year. Prostate test revenue in the U.S. of $3.6 million contributed to approximately 4 percent of the year-over-year growth.

International product revenue was $12.0 million in the fourth quarter of 2016, compared with $10.6 million a year ago, an increase of 13 percent, and an increase of 16 percent on a constant currency basis.i

In the fourth quarter of 2016, more than 30,020 Oncotype test results were delivered, an increase of 8 percent, compared with more than 27,730 test results delivered in the same period in 2015.

Operating income for the fourth quarter of 2016 was $1.5 million, compared with an operating loss of $3.1 million for the fourth quarter of 2015. Net income was $1.4 million for the fourth quarter of 2016 compared with a net loss of $2.7 million for the fourth quarter of 2015.

Basic and diluted net income per share was $0.04 for the fourth quarter of 2016 compared with basic and diluted net loss per share of $0.08 for the same period in 2015.

Cash and cash equivalents and short-term marketable securities at December 31, 2016 were $87.7 million excluding the fair value of the company’s investment in a marketable security of $9.3 million, compared with $76.8 million at December 31, 2015 excluding the fair value of the company’s investment in a marketable security of $18.1 million.

2017 Financial Guidance

"In 2017 at the mid-point of revenue guidance, we expect to deliver 11 percent revenue growth and positive net income for the full year, which requires operating leverage of more than 40 percent," said Brad Cole, chief operating officer and chief financial officer of Genomic Health. "We anticipate that expected reimbursement progress in the second half of the year will contribute to accelerated revenue growth."

The company is providing the following financial guidance for the full year ending December 31, 2017:

· Total product revenue of between $355 to $370 million, representing growth of between 9 and 13 percent compared to 2016; and

· Positive net income at mid-point of revenue guidance.

Recent Business Highlights

Oncotype DX Commercial Progress

· The American Joint Committee on Cancer (AJCC) incorporated the Oncotype DX Breast Recurrence Score in its recently published Eighth Edition AJCC Cancer Staging Manual. Representing a rigorous, multi-disciplinary assessment, the updated criteria identify Oncotype DX as the only multi-gene test with Level I evidence to be used by pathologists and clinicians for formal staging of breast cancer patients.

· Established additional coverage for the Oncotype DX Genomic Prostate Score, bringing the total number of U.S. covered lives to more than 65 million.

· Knappschaft, one of Germany’s largest public health insurance funds, began offering Oncotype DX to early-stage breast cancer patients through an exclusive agreement, bringing the total number of German private covered lives to nearly 9 million.

Presentations and Publications

· Received acceptance to present results from a large Oncotype DX Genomic Prostate Score validation study, conducted in collaboration with Kaiser Permanente Northern California, at the Genitourinary (GU) Cancers Symposium, the European Association of Urology (EAU) Congress and the American Urological Association (AUA) Annual Meeting. With these new data, Oncotype DX is the first and only genomic prostate test validated in all major short- and long-term endpoints, including adverse pathology, biochemical recurrence, metastasis and prostate cancer specific death.

· Investigators from Memorial Sloan Kettering Cancer Center (MSK) and Epic Sciences Inc. published findings in European Urology demonstrating that only nuclear localization of the AR-V7 protein in circulating tumor cells (CTCs) from metastatic castration-resistant prostate cancer (mCRPC) patient blood samples is predictive of therapeutic benefit. Genomic Health expects to begin offering the Oncotype DX AR-V7 Nucleus Detect test this year.

· Presented results from multiple studies demonstrating the unparalleled value of the Oncotype DX test in individualizing breast cancer treatment decisions for patients with various stages of the disease at the 2016 CTRC-AACR San Antonio Breast Cancer Symposium. Presentations included two overviews of prospective outcomes data and clinical evidence supporting use of the test in both node-positive and node-negative disease.

· The Journal of the National Cancer Institute published results of an NSABP-led study demonstrating the Oncotype DX Breast Recurrence Score is an independent predictor of locoregional recurrence risk in node-positive breast cancer patients treated with chemo-endocrine therapy.

· The Journal of the National Cancer Institute published results of an additional analysis from the second clinical validation study of the Oncotype DX DCIS Score demonstrating its ability to identify women with low risk of recurrence following surgery who can avoid radiation therapy.

· The European Journal of Surgical Oncology published a UK decision impact study of node-negative and node-positive breast cancer patients demonstrating the Oncotype DX Breast Recurrence Score significantly reduced the use of chemotherapy and can lead to significant cost savings for the National Health Service (NHS).

· Received acceptance to present four Oncotype DX studies at the upcoming Miami Breast Cancer Conference and 15 Oncotype DX studies at the upcoming St. Gallen Breast Cancer Conference in March.

On February 13, 2017 PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported the comparator arm for its upcoming clinical trial and provided additional clarification on its recent pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding its upcoming clinical trial in locally advanced, inoperable pancreatic cancer (LAPC) (Press release, PharmaCyte Biotech, FEB 13, 2017, View Source [SID1234517708]).

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In the company’s upcoming trial, the comparator arm that PharmaCyte’s pancreatic cancer therapy will be compared to is the combination of the cancer drug 5-fluorouracil (FU) and the compound leucovorin (LV). The necessary and quick decision was made by Dr. Manuel Hidalgo, the Principal Investigator for the upcoming clinical, Dr. Daniel Von Hoff with Translational Drug Development (TD2), the CRO for PharmaCyte’s clinical trial, and Dr. Matthias Löhr, the Chairman of PharmaCyte’s Medical and Scientific Advisory Board.

"After our pre-IND meeting I am more confident and enthusiastic than ever about PharmaCyte’s ability to validate its therapy for locally advanced, inoperable pancreatic cancer in a human clinical trial," stated PharmaCyte’s Chief Executive Officer, Kenneth L Waggoner.

He continued, "And I am quite gratified that the FDA sees enough potential in our product to consider our trial a pivotal one under the right circumstances. Now the mission for our entire team is to work diligently towards the submission of our IND to the FDA. We all feel that the suggested changes we received from the FDA should not take long to make and will certainly be well worth it in the long run. For example, we quickly gained agreement on the comparator arm for the trial and, in doing so, we’ve moved closer to filing our IND with the FDA."

PharmaCyte’s management, Dr. Manuel Hidalgo, TD2 and TD2’s consulting statistician are actively working to finalize the number of patients that will be included in the trial. This is the final element and will complete the adjustments necessary for a newly designed trial.

In PharmaCyte’s recent pre-IND meeting with the FDA, the FDA stated that it would be willing to change PharmaCyte’s clinical trial from an "exploratory" trial to a "pivotal" trial under certain conditions. A pivotal trial is a clinical trial intended to provide evidence for a drug marketing approval by the FDA.

This indeed is a landmark moment in PharmaCyte’s history. Generally, a pivotal trial must be a Phase 3 trial (which PharmaCyte’s upcoming trial could be labeled); in such a trial several hundred patients can be treated. However, the FDA indicated that: (i) if PharmaCyte’s therapy shows real promise; (ii) includes a sufficient number of patients; and (iii) includes primary endpoints of overall survival (OS) and safety rather than progression free survival (PFS) and safety, the trial may be considered a pivotal trial.

Mr. Waggoner said of this opportunity, "This is good news for PharmaCyte shareholders since the change from an "exploratory" trial to a "pivotal" trial can eliminate one or two lengthy and costly trials and potentially make PharmaCyte’s Cell-in-a-Box-based product, CypCaps, "market-ready" in a much shorter period of time than anticipated. It may also accelerate the overall development timeline if the results are very positive, thus making the therapy more attractive to potential investors or suitors."

To be a pivotal trial, the FDA wants at least 100 patients treated with CypCaps for purposes of determining the safety of PharmaCyte’s therapy. In the trial’s original design only 40 or so patients would have received CypCaps and been evaluated for safety.

Other highly positive news provided by Mr. Waggoner concerning the pre-IND meeting with the FDA included:

agreement with the FDA that PharmaCyte is on the "right track" in its development program;
agreement with the FDA on the cell line that will be used in the clinical trial;
agreement with the FDA on the patient population to be studied in the clinical trial;
agreement with the FDA on the secondary endpoints of the clinical trial, except that PFS will be added to the list of secondary endpoints if the trial becomes a pivotal trial;
agreement with the FDA on the number of patients needed to comprise an adequate safety database for a Biologics Licensing Application for CypCaps;
agreement that the FDA believes CypCaps is a drug/device combination product;
agreement with the FDA that it will assist PharmaCyte in its development program; and
agreement with the FDA that the next step for PharmaCyte is to submit an IND.
There is still a "hard stop" at the six-month mark after a certain number of patients have been enrolled in the trial to review the data generated to that point. The timing of this hard stop may change, however, to the point in time when 50% of the patients have been treated. Because the clinical trial is an "open-label" trial (the trial is not a "blinded" study), this interim analysis should give PharmaCyte an important indication of the successfulness of its CypCaps therapy for LAPC.

Mr. Waggoner commented on the significance of following the FDA’s guidance moving forward stating, "We have one shot at this, and we intend to get it right. We greatly appreciate the continued patience and support of our shareholders during this process."

On February 13, 2017 Novimmune and LegoChem Biosciences reported that they have entered into a research collaboration to evaluate an antibody drug conjugate candidate (Press release, LegoChem Biosciences, FEB 13, 2017, View Source;sc_seq=373 [SID1234617970]).

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Financial terms of the deal were not disclosed, but shares of LegoChem were down 3.8% at 27,950 South Korean won by late afternoon trading.

LegoChem has been successfully developing global partnerships through the potential of its proprietary ADC platform technology. In 2015, LegoChem out-licensed an anti-Her2-ADC molecule to Fosun Pharma. In October 2016 it signed a deal with Norway’s Nordic Nanovector (OSE: NANO) to develop novel CD37-targeting antibody-drug conjugates (ADCs) for the treatment of leukemias, and in January this year, signed a research licensing deal with Japan’s largest drugmaker Takeda Pharmaceutical (TYO: 4502), to evaluate next-generation ADC candidates.

"Our antibody expertise married with LCB’s proprietary ADC technology, supports our quest to provide better options to cancer patients," said Novimmune chairman and chief executive, Eduard Holdener.

ADCs are molecules composed of a tumor specific monoclonal antibody linked to a cytotoxic agent. Unlike chemotherapy, they are intended to target only cancer cells and spare healthy cells. Novimmune brings expertise in the field of targeted therapies with their anti-CD47/anti-CD19 and anti-CD47/anti-mesothelin bispecific antibodies that selectively bind to hematological and solid tumors, respectively.