On September 26, 2016 Janssen Research & Development, LLC reported that a supplemental New Drug Application (sNDA) for ibrutinib (IMBRUVICA) has been submitted to the U.S. Food and Drug Administration (FDA) for the treatment of patients with marginal zone lymphoma (MZL) who require systemic therapy (Press release, Johnson & Johnson, SEP 26, 2016, View Source [SID:SID1234515474]). The filing is based on data from the multi-center, open-label Phase 2 PCYC-1121 trial assessing the use of ibrutinib, a BTK inhibitor, in patients with MZL who have received at least one prior therapy. IMBRUVICA is jointly developed and commercialized by Janssen and Pharmacyclics LLC, an AbbVie company.

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"We are encouraged by the results of this study of ibrutinib in yet another type of B-cell malignancy," said Peter F. Lebowitz, M.D., Ph.D., Global Oncology Head, Janssen. "This FDA submission represents an 2 exciting and important step towards a potential new treatment option for MZL patients who currently have a great unmet need. Currently there are no therapies approved for this rare form of cancer."

The PCYC-1121 international trial enrolled 63 patients with MZL who had received at least one prior therapy, including splenic MZL (SMZL), nodal MZL (NMZL) and extranodal MZL (EMZL). Patients received ibrutinib 560mg orally, once daily until progression or unacceptable toxicity. The primary endpoint of the study was overall response rate as assessed by an Independent Review Committee. Key secondary endpoints included duration of response and overall response rate. The data have been submitted for publication in a peer-reviewed journal and presentation at an upcoming medical conference. More information about the study can be found on www.clinicaltrials.gov (NCT01980628).

IMBRUVICA is currently approved to treat patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) including patients with 17p deletion, patients with mantle cell lymphoma (MCL) who have received at least one prior therapy and patients with Waldenström’s macroglobulinemia (WM). Accelerated approval was granted for MCL based on overall response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials.

Janssen and Pharmacyclics are continuing an extensive clinical development program for IMBRUVICA, including Phase 3 study commitments in multiple patient populations.

About Marginal Zone Lymphoma (MZL)
MZL is a B-cell lymphoma arising from white blood cells (lymphocytes) at the margins, or edges of lymph nodes and various tissues, including the stomach, salivary glands, thyroid gland, eyes, lungs and spleen. 1 MZL accounts for approximately 12 percent of all cases of non-Hodgkin lymphoma in adults, and the median age of diagnosis is 65 years old. There are currently no approved treatments or established standards of care specifically indicated for patients with MZL.

About IMBRUVICA
IMBRUVICA was one of the first therapies to receive U.S. approval after having received the FDA’s Breakthrough Therapy Designation. IMBRUVICA works by blocking a specific protein called Bruton’s tyrosine kinase (BTK).2 The BTK protein transmits important signals that tell B cells to mature and produce antibodies and is needed by specific cancer cells to multiply and spread.3 IMBRUVICA targets and blocks BTK, inhibiting cancer cell survival and spread. For more information, visit www.IMBRUVICA.com.
Additional Information about IMBRUVICA
INDICATIONS 3 IMBRUVICA is indicated to treat people with:
Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL)
Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion Waldenström’s macroglobulinemia (WM)
Mantle cell lymphoma (MCL) who have received at least one prior therapy
o Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Hemorrhage – Fatal bleeding events have occurred in patients treated with IMBRUVICA . Grade 3 or higher bleeding events (intracranial hemorrhage [including subdural hematoma], gastrointestinal bleeding, hematuria, and post-procedural hemorrhage) have occurred in up to 6% of patients. Bleeding events of any grade, including bruising and petechiae, occurred in approximately half of patients treated with IMBRUVICA .

The mechanism for the bleeding events is not well understood. IMBRUVICA may increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies and patients should be monitored for signs of bleeding. Consider the benefit-risk of withholding IMBRUVICA for at least 3 to 7 days preand postsurgery depending upon the type of surgery and the risk of bleeding.

Infections – Fatal and nonfatal infections have occurred with IMBRUVICA therapy. Grade 3 or greater infections occurred in 14% to 29% of patients. Cases of progressive multifocal leukoencephalopathy (PML) have occurred in patients treated with IMBRUVICA . Evaluate patients for fever and infections and treat appropriately.

Cytopenias – Treatment-emergent Grade 3 or 4 cytopenias including neutropenia (range, 19% to 29%), thrombocytopenia (range, 5% to 17%), and anemia (range, 0% to 9%) based on laboratory measurements occurred in patients treated with single agent IMBRUVICA . Monitor complete blood counts monthly.

Atrial Fibrillation – Atrial fibrillation and atrial flutter (range, 6% to 9%) have occurred in patients treated with IMBRUVICA , particularly in patients with cardiac risk factors, hypertension, acute infections, and a previous history of atrial fibrillation. Periodically monitor patients clinically for atrial fibrillation. Patients who develop arrhythmic symptoms (eg, palpitations, lightheadedness) or new-onset dyspnea should have an 4 ECG performed. Atrial fibrillation should be managed appropriately and if it persists, consider the risks and benefits of IMBRUVICA treatment and follow dose modification guidelines.

Hypertension – Hypertension (range, 6% to 17%) has occurred in patients treated with IMBRUVICA with a median time to onset of 4.6 months (range, 0.03 to 22 months). Monitor patients for new-onset hypertension or hypertension that is not adequately controlled after starting IMBRUVICA . Adjust existing antihypertensive medications and/or initiate antihypertensive treatment as appropriate.

Second Primary Malignancies – Other malignancies (range, 5% to 16%) including non-skin carcinomas (range, 1% to 4%) have occurred in patients treated with IMBRUVICA . The most frequent second primary malignancy was non-melanoma skin cancer (range, 4% to 13%).

Tumor Lysis Syndrome – Tumor lysis syndrome has been infrequently reported with IMBRUVICA therapy. Assess the baseline risk (eg, high tumor burden) and take appropriate precautions. Monitor patients closely and treat as appropriate.

Embryo-Fetal Toxicity – Based on findings in animals, IMBRUVICA can cause fetal harm when administered to a pregnant woman. Advise women to avoid becoming pregnant while taking IMBRUVICA and for 1 month after cessation of therapy. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

ADVERSE REACTIONS The most common adverse reactions (≥20%) in patients with B-cell malignancies (MCL, CLL/SLL, and WM) were neutropenia* (64%), thrombocytopenia* (63%), diarrhea (43%), anemia* (41%), musculoskeletal pain (30%), rash (29%), nausea (29%), bruising (29%), fatigue (27%), hemorrhage (21%), and pyrexia (21%).

*Based on adverse reactions and/or laboratory measurements (noted as platelets, neutrophils, or hemoglobin decreased).

The most common Grade 3 or 4 non-hematologic adverse reactions (≥5%) in MCL patients were pneumonia (7%), abdominal pain (5%), atrial fibrillation (5%), diarrhea (5%), fatigue (5%), and skin infections (5%). Approximately 6% (CLL), 14% (MCL), and 11% (WM) of patients had a dose reduction due to adverse reactions.

5 Approximately 4%-10% (CLL), 9% (MCL), and 6% (WM) of patients discontinued due to adverse reactions. Most frequent adverse reactions leading to discontinuation were pneumonia, hemorrhage, atrial fibrillation, rash and neutropenia (1% each) in CLL patients and subdural hematoma (1.8%) in MCL patients.

DRUG INTERACTIONS

CYP3A Inhibitors – Avoid coadministration with strong and moderate CYP3A inhibitors. If a moderate CYP3A inhibitor must be used, reduce the IMBRUVICA dose. CYP3A Inducers – Avoid coadministration with strong CYP3A inducers.

SPECIFIC POPULATIONS

Hepatic Impairment – Avoid use in patients with moderate or severe baseline hepatic impairment. In patients with mild impairment, reduce IMBRUVICA dose.

Please see Full Prescribing Information: View Source A

On September 26, 2016 Rosetta Genomics Ltd. (NASDAQ:ROSG), a leading developer and provider of microRNA-based and other molecular diagnostics, reported financial results for the three and six months ended June 30, 2016 (Press release, Rosetta Genomics, SEP 26, 2016, View Source [SID:SID1234515420]).

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Recent developments include:

Gross billings for RosettaGX Reveal ("Reveal"), the Company’s first-of-its-kind microRNA classifier for indeterminate thyroid nodules, are tracking to be approximately $1.5 million for the first nine months of 2016;
Announced that Reveal is now available for use on ThinPrep samples;
Published data confirming the analytical validity of Reveal to classify indeterminate thyroid nodules in the peer-reviewed journal Cancer Cytopathology;
Entered into a services agreement with an unnamed global pharmaceutical company to provide Fluorescence in Situ Hybridization (FISH) testing services for a clinical study the pharmaceutical company is conducting in prostate cancer;
Launched OncoGxSelect, a next-generation sequencing (NGS)-based test that detects somatic mutations frequently found in cancers and provides actionable results to help guide decisions related to targeted cancer therapies; and
Received U.S. patent allowance for a microRNA-based ovarian cancer treatment.
Management Commentary

"Throughout the first half of 2016 we demonstrated our ability to increase revenues by expanding our molecular diagnostics test menu and advancing our commercial programs to enable precision medicine for patients and physicians," said Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics. "We are particularly pleased about our progress with the commercial launch and clinical adoption of our Reveal test for the classification of indeterminate thyroid nodules.

"We made two key advances that significantly enhance our commercial efforts with Reveal. First, compelling analytical data was published in a peer-reviewed journal that supports the robustness of the Reveal assay under many different laboratory conditions. In addition, we presented data at the recent American Thyroid Society annual meeting confirming that Reveal produces the same high-level performance on ThinPrep prepared slides as it does on a direct smear from a thyroid Fine Needle Aspirate ("FNA") biopsy. We believe offering the option of using Reveal with either ThinPrep or direct smears will expand our customer base and potentially increase our test volumes by more than 50% over the next several months.

"We are gaining traction with our strategy to use Reveal to access new accounts to promote our exceptional thyroid offering as well as our urologic cancer and solid tumor product lines. In the near term, this primary focus on Reveal may temporarily slow the growth of the solid tumor and urology business lines as our sales people will be mainly calling on pathologists and endocrinologists, rather than oncologists and urologists. Over the long term, we believe that by winning new accounts with our Reveal offering we will be able to expand use of our solid tumor and urologic oncology offerings by many of these new accounts, thus further accelerating revenue growth.

"The commercial launch of Reveal will continue to be a prime focus of our company. We believe Reveal’s excellent performance – combined with the assay’s ability to be used with either ThinPrep or FNA biopsy, as well as its unique ability to use the same smears from the original indeterminate diagnosis – gives Reveal a significant competitive advantage that we expect will allow us to gain meaningful market share in this $350 million market in the U.S. and recent trends in demand and gross billings for Reveal demonstrate this. For example, in the third quarter we expect approximately 300 Reveal orders with gross billings of approximately $900,000.

"With demand for Reveal reaching higher levels in the current quarter and with that demand expected to continue to increase substantially going forward, we are increasing capacity at our Philadelphia laboratory to process samples. In addition, the investments we made in enhancing billing and collections is bearing fruit as we continue to improve collections.. We are pleased with our progress to date, as evidenced by our cash collections during the first half of 2016.

"Throughout the balance of the year we will continue to build on recent progress to drive demand for Reveal and the rest of our products and improve billings, collections and reimbursement. We look forward to making advances that will enhance shareholder value," concluded Mr. Berlin.

Second Quarter Financial Results

Revenues for the second quarter of 2016 increased 23% to $2.4 million compared with revenues of $2.0 million for the second quarter of 2015, and decreased 7% compared with revenues of $2.6 million for the first quarter of 2016. On a pro-forma basis (as if the PersonalizeDx acquisition occurred on January 1, 2015 instead of the actual acquisition date of April 13, 2015), revenues increased 13% compared with revenues of $2.1 million for the second quarter of 2015.
Revenues from urologic cancer testing services in the second quarter of 2016 increased 43% to $1.4 million, compared with $971,000 for the second quarter of 2015, and represented approximately 58% of clinical testing revenues for the second quarter of 2016. On a pro-forma basis, revenues increased 26% compared with $1.1 million for the second quarter of 2015.
Revenues from solid tumor testing services in the second quarter of 2016 of $855,000 decreased 13% compared with $986,000 in the second quarter of 2015, primarily due to a refocused sales force emphasis on the Reveal introduction. Solid tumor testing services, represented 35% of total clinical testing revenues during the second quarter of 2016. On a pro-forma basis, revenues decreased 17% compared with $1.0 million in the second quarter of 2015.
Reveal revenues during the second quarter of 2016 were $166,000 compared with $17,000 in the first quarter of 2016. There were no Reveal revenues in the second quarter of 2015 as the assay was not launched commercially until the first quarter of 2016. On a non-GAAP basis, gross billings for Reveal during the second quarter of 2016 were $511,000 compared with gross billings of Reveal of $111,000 in the first quarter of 2016. Gross billings are the aggregate amounts invoiced to customers.
Cost of revenues for the second quarter of 2016 increased to $2.0 million from $1.9 million for the second quarter of 2015.
Research and development expenses for the second quarter of 2016 increased to $618,000 from $613,000 for the second quarter of 2015.
Sales, marketing and business development expenses for the second quarter of 2016 decreased to $1.7 million from $2.5 million in the prior-year period primarily due to higher headcount in 2015 and transitional expenses associated with the consolidation of the PersonalizeDx business into Rosetta.
General and administrative expenses for the second quarter of 2016 decreased to $1.5 million compared with $2.2 million for the same period in 2015 primarily due to acquisition-related expenses in 2015.
The operating loss for the second quarter of 2016 was $3.4 million, which included $229,000 of non-cash stock-based compensation expense, compared with an operating loss of $2.9 million for the second quarter of 2015, which included $268,000 of non-cash stock-based compensation expense as well as a gain of $2.4 million on bargain purchase related to the acquisition of PersonalizeDx.
The net loss for the second quarter of 2016 was $3.4 million, or $0.16 per ordinary share on 20.9 million weighted average shares outstanding, compared with a net loss for the second quarter of 2015 of $2.8 million, or $0.20 per ordinary share on 14.4 million weighted average shares outstanding.
On a non-GAAP basis, excluding $229,000 of non-cash stock-based compensation expense, the net loss for the second quarter of 2016 was $3.2 million, or $0.15 per ordinary share on 20.9 million weighted average shares outstanding. For the second quarter of 2015, excluding the $268,000 of non-cash stock-based compensation expense as well as the gain of $2.4 million on bargain purchase related to the acquisition of PersonalizeDx, the non-GAAP net loss was $4.9 million, or $0.34 per ordinary share on 14.4 million weighted average shares outstanding.
Six Month Financial Results

Revenues for the first six months of 2016 increased 120% to $5.0 million compared with revenues of $2.3 million for the first six months of 2015. On a pro forma basis, revenues for the six months of 2016 increased 20% compared with pro forma revenues of $4.2M for the first six months of 2015.
Cost of revenues for the six-month period ended June 30, 2016 was $3.6 million compared with $2.3 million for the same period of 2015.
Total operating expenses for the first six months of 2016 of $8.8 million compared with $6.7 million in the first six months of 2015, which included a gain of $2.4 million on bargain purchase related to the acquisition of PersonalizeDx.
The operating loss for the first half of 2016 was $7.4 million, which included $459,000 of non-cash stock-based compensation expense, compared with an operating loss of $6.7 million for the first half of 2015, which included $544,000 of non-cash stock-based compensation expense as well as a gain of $2.4 million on bargain purchase related to the acquisition of PersonalizeDx.
The net loss for the first six months of 2016 was $7.4 million, or $0.36 per ordinary share on 20.8 million weighted average shares outstanding, compared with a net loss for the first six months of 2015 of $6.7 million, or $0.49 per ordinary share on 13.6 million weighted average shares outstanding.
On a non-GAAP basis, excluding $459,000 of non-cash stock-based compensation expense, the net loss for the first half of 2016 was $7.0 million, or $0.34 per ordinary share on 20.8 million weighted average shares outstanding. For the first half of 2015, excluding the $544,000 of non-cash stock-based compensation expense as well as the gain of $2.4 million on bargain purchase related to the acquisition of PersonalizeDx, the non-GAAP net loss was $8.5 million, or $0.62 per ordinary share on 13.6 million weighted average shares outstanding.
Balance Sheet Highlights

As of June 30, 2016, Rosetta Genomics had cash, cash equivalents, restricted cash and short-term bank deposits of $8.7 million, compared with $13.6 million as of December 31, 2015. The Company used approximately $6.5 million in cash to fund operations during the first six months of 2016, and collected approximately $4.9 million in cash from its clinical testing services as well as $1.6 million from a licensing deal signed in December 2015. Based on the Company’s current operations and plans, which include a cost-reduction plan should it be unable to raise sufficient additional capital, if necessary, Rosetta Genomics expects its current cash position will fund operations into May 2017.

On September 26, 2016 Cambrex Corporation (NYSE: CBM), a leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), reported that it has agreed to acquire PharmaCore Inc., a privately-owned company specializing in developing, manufacturing and scaling up small molecule APIs for clinical phase projects, for approximately $25 million (Press release, Cambrex, SEP 26, 2016, View Source [SID:SID1234515425]). PharmaCore was founded in 1999 and occupies a 35,000 sq. ft. GMP site in High Point, North Carolina, USA.

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PharmaCore develops and produces complex APIs and intermediates requiring multi-step synthetic processes in batch sizes from milligrams to 100 kg to support clinical trials from Phase I to Phase III. The company is licensed with the US Drug Enforcement Administration (DEA) to manufacture Schedule II to Schedule V controlled substances. PharmaCore has more than 60 full time employees, focused on projects at laboratory and pilot plant scale, with nearly 40 lab-based Process and Analytical Chemists, the majority of whom hold PhDs.

The acquisition will enhance Cambrex’s portfolio of small molecule API services and complements its existing large scale, multi-purpose manufacturing facilities in the US and Europe. PharmaCore is currently generating $15 to $17 million per year in revenues and just over two million dollars per year in EBITDA. Cambrex expects the transaction, net of deal fees, to have a neutral impact on earnings per share in 2016 and to be accretive in 2017.

"We are excited to announce our acquisition of PharmaCore, which we believe underlines our commitment to continually enhancing our service offering to our global pharmaceutical and biotech customers. The acquisition will provide the capability and expertise to efficiently develop early clinical phase products and new technologies. We expect PharmaCore’s substantial customer base and robust project pipeline to broaden our potential late stage clinical development and commercial manufacturing opportunities," commented Steven Klosk, CEO of Cambrex.

He added, "Through the end of 2016, Cambrex will have invested over $200 million in capital projects within our existing facilities, including a recently completed $50 million production and warehousing expansion of our large scale US API facility in Charles City, Iowa, and a $9 million investment to expand large scale manufacturing capacity at our Karlskoga facility in Sweden, which we expect will be completed shortly."

Rob Maddox, President of PharmaCore added, "PharmaCore is proud of the reputation we have developed, both as a trusted CMO and a company with a strong track record of innovative chemistry. We are thrilled to be joining Cambrex’s global network and to have the opportunity to participate in Cambrex’s growth strategy."

PharmaCore’s NC facility has a 15,000 sq. ft. chemistry laboratory and a 13,000 sq. ft. pilot plant, with reactor capacity ranging from 20L to 2000L, with supporting GMP analytical services.

The completion of the transaction is subject to customary closing conditions, and is expected to occur within 30 days. PharmaCore was advised on this transaction by Wombat Capital Markets, LLC.

On September 26, 2016 Advaxis, Inc. (NASDAQ:ADXS), a clinical stage biotechnology company developing cancer immunotherapies, reported three poster presentations have been accepted by the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 31st Annual Meeting & Associated Programs taking place from Nov. 9-13 at Gaylord National Hotel & Convention Center in National Harbor, Md (Press release, Advaxis, SEP 26, 2016, View Source [SID:SID1234515427]). The poster presentations showcase the potential of Advaxis’ Lm Technology immunotherapies for monotherapy and combination therapy in difficult-to-treat cancers.

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The poster presentations featuring Advaxis immunotherapies at SITC (Free SITC Whitepaper) 2016 include:

"AIM2CERV: a randomized Phase 3 study of adjuvant AXAL immunotherapy following chemoradiation in patients who have high-risk locally advanced cervical cancer (HRLACC)"
"A Phase 1/2 study of durvalumab alone or in combination with AXAL in recurrent/persistent or metastatic cervical or human papillomavirus (HPV)+ squamous cell cancer of the head and neck (SCCHN): preliminary Phase 1 results"
"Combination of Listeria-based human papillomavirus (HPV) E7 cancer vaccine (AXAL) with CD137 agonist antibody provides an effective immunotherapy for HPV-positive tumors in a mouse model"

On September 26, 2016 Cellerant Therapeutics, Inc., a clinical-stage company developing innovative cell- and antibody-based immunotherapies for hematologic malignancies (blood cancers) and other blood-related disorders, reported that the National Cancer Institute has awarded the Company a $1.5 million Small Business Innovation Research (SBIR) Phase II contract to support preclinical development of CSC012-ADC, a novel antibody drug-conjugate to treat acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) (Press release, Cellerant Therapeutics, SEP 26, 2016, View Source [SID:SID1234515417]). CSC012-ADC targets the interleukin 1 receptor accessory protein (IL1RAP), which has been shown to be expressed on leukemic cancer stem cells, but not on normal hematopoietic stem cells. The award will fund preclinical studies and other activities over the next two years which, if successful, will position the Company to pursue an Investigational New Drug application for CSC012-ADC.

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"We are very pleased to receive this award to support the development of CSC012-ADC and address a high unmet medical need," said Ram Mandalam, Ph.D., President and Chief Executive Officer of Cellerant. "Our studies to date show IL1RAP to be a promising target for the treatment of AML and MDS, which are aggressive diseases with low survival rates, particularly among elderly patients. We believe our approach of targeting and killing the leukemic cancer stem cells with an IL1RAP antibody drug-conjugate has the potential to improve outcomes for AML and MDS patients."

This contract was awarded by the National Cancer Institute under the Small Business Research Innovation Research Program Contract Topic 326, "Development of Novel Therapeutic Agents that Target Cancer Stem Cells." IL1RAP has been shown to be expressed on leukemic cancer stem cells and on tumors from several solid cancers. The Company was previously awarded an SBIR Phase 1 contract to support research and development of IL1RAP antibodies.