On August 20, 2015 Navidea Biopharmaceuticals (NYSE MKT: NAVB), reported publication of the results from an investigator-initiated, comparative study of Lymphoseek (technetium Tc 99m tilmanocept) injection versus filtered Tc-99m Sulfur Colloid (fTcSC) measuring injection site pain in patients with breast cancer undergoing lymphoscintigraphy (Press release, Navidea Biopharmaceuticals, AUG 20, 2015, View Source;p=RssLanding&cat=news&id=2080893 [SID:1234507304]). The paper titled, "Comparison of Post-injection Site Pain Between Technetium Sulfur Colloid and Technetium Tilmanocept in Breast Cancer Patients Undergoing Sentinel Lymph Node Biopsy," was published online in the Annals of Surgical Oncology [DOI – 10.1245/s10434-015-4802-y] and indicated, with patient-reported data, a statistically significant reduction in the level of post-injection associated pain using Lymphoseek compared with use of an fTcSC tracer.

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"The publication of these investigator-initiated study findings affirms the value that surgeons place on minimizing pain and discomfort for their patients and continues to reinforce the clinical importance of Lymphoseek," said Michael Tomblyn, M.D., Navidea’s Chief Medical Officer. "We believe that these results will enhance the visibility and awareness of Lymphoseek with surgical oncologists and illustrate both the clinical utility and clear benefits for patients."

"As surgeons who perform sentinel lymph node (SLN) biopsy procedures in breast cancer patients, one of our key focuses is optimizing a patient’s overall experience," said Dr. Anne Wallace, M.D., professor of surgery, UC San Diego School of Medicine, director of the Comprehensive Breast Health Center at UC San Diego Moores Cancer Center and the study’s lead investigator. "We designed this study to understand if Lymphoseek injection is less painful and could improve the patient experience. The results demonstrated that Lymphoseek, in fact, minimizes patient discomfort while allowing for effective SLN mapping."

The publication included results of the randomized, double-blind clinical trial comparing post-injection site pain using fTcSC versus Lymphoseek in 52 [(27) fTcSC and (25) Lymphoseek] breast cancer patients undergoing lymphoscintigraphy. Pain was evaluated with a visual analogue scale and short form McGill Pain Questionnaire at 1, 2, 3, 4, 5, 15 and 30 minutes post-injection. Analysis of the data indicated baseline pain scores were similar between groups. At one minute post-injection, patients receiving fTcSC experienced a mean change in pain of 16.8mm (standard deviation (SD) 19.5) compared to 0.2mm (SD 7.3) in the Lymphoseek group (p =0.0002). Overall, patients receiving Lymphoseek experienced statistically significant less change in pain scores compared to patients receiving fTcSC at 1-3 minutes post-injection.

About Lymphoseek
Lymphoseek (technetium Tc 99m tilmanocept) injection is the first and only FDA-approved receptor-targeted lymphatic mapping agent. It is a novel, receptor-targeted, small-molecule radiopharmaceutical used in the evaluation of lymphatic basins that may have cancer involvement in patients. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymphoseek is approved by the U.S. Food and Drug Administration (FDA) for use in solid tumor cancers where lymphatic mapping is a component of surgical management and for guiding sentinel lymph node biopsy in patients with clinically node negative breast cancer, melanoma or squamous cell carcinoma of the oral cavity. Lymphoseek has also received European approval in imaging and intraoperative detection of sentinel lymph nodes in patients with melanoma, breast cancer or localized squamous cell carcinoma of the oral cavity.

Accurate diagnostic evaluation of cancer is critical, as it guides therapy decisions and determines patient prognosis and risk of recurrence. Overall in the U.S., solid tumor cancers may represent up to 1.2 million cases per year. The sentinel node label in the U.S. and Europe may address approximately 235,000 new cases of breast cancer, 76,000 new cases of melanoma and 45,000 new cases of head and neck/oral cancer in the U.S., and approximately 367,000 new cases of breast cancer, 83,000 new cases of melanoma and 55,000 new cases of head and neck/oral cancer diagnosed in Europe annually.

Lymphoseek Indication and Important Safety Information
Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:

Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.
Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.
Important Safety Information
In clinical trials with Lymphoseek, no serious hypersensitivity reactions were reported, however Lymphoseek may pose a risk of such reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).

Prior to the administration of Lymphoseek, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of Lymphoseek administration, and patients observed for signs or symptoms of hypersensitivity following injection.

Any radiation-emitting product may increase the risk for cancer. Adhere to dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to patients or health care workers.

In clinical trials, no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain (<1%).

FULL LYMPHOSEEK PRESCRIBING INFORMATION CAN BE FOUND AT: WWW.LYMPHOSEEK.COM.

(Filing, 10-K, Immunomedics, AUG 19, 2015, View Source [SID:1234507298])

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On August 19, 2015 SignalRx Pharmaceuticals Inc., focused on developing more effective oncology drugs through molecular design imparting selective multiple target inhibition, reported that the first pediatric cancer patient has been dosed with the "first-in-pediatric-class" PI-3 kinase (PI3K) inhibitor SF1126 (Press release, SignalRx, AUG 19, 2015, http://www.ireachcontent.com/news-releases/signalrx-pharmaceuticals-inc-announces-first-pediatric-cancer-patient-treated-with-the-pi-3-kinase-inhibitor-sf1126-522259401.html [SID1234527328]). This represents a breakthrough for our strategy to leverage the novel anticancer agent SF1126, successfully evaluated in adult Phase I clinical trials, into helping children with cancer in an area of great unmet need: pediatric cancer treatment.

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SF1126 is the first drug of its kind used to treat a child with cancer. The drug has been reported to have no dose limiting toxicity in adult cancer patient trials and was well tolerated with significant clinical benefit. The first pediatric patient to receive SF1126 was previously diagnosed with neuroblastoma and showed no side effects after their first treatment with SF1126. This agent holds a great potential to have a significant impact on the treatment of pediatric cancers in the future. We are excited to report this new pediatric cancer development in the clinic and the promise SF1126 brings to help kids with cancer.

The clinical evaluation of SF1126 in pediatric patients with neuroblastoma is being performed as part of the New Approaches to Neuroblastoma Therapy Consortium (NANT) Study, funded by the St. Balderick’s Foundation and the National Institutes of Health (NIH). SF1126 is a "first-in-pediatric class" targeted anticancer therapeutic agent being developed by SignalRx in collaboration with Donald L. Durden, MD PhD, at the UCSD/Moores Cancer Center and Rady Children’s Hospital.

SF1126 was designed to inhibit PI3K, a proven central nodal element in cancer cells. SF1126 has a unique inhibition profile that also includes the inhibition of the epigenetic reader bromodomain protein BRD4, a protein responsible for the transcription of the oncogene MYC. Since PI3K inhibition has also been shown to enhance degradation of MYC, our dual PI3K/BRD4 inhibitor SF1126 represents a unique approach in cancer treatment to block multiple synergistic pathways important to many cancers. "By benefit of this dual inhibition maximally blocking MYC, SF1126 may be most effective in patients whose cancers are highly dependent on cMYC or MYCN such as in certain neuroblastoma patients. SignalRx Pharmaceuticals is dedicated to bringing new dual targeted therapies, like SF1126, into pediatric oncology trials" said Dr. Durden.

On August 19, 2015 United Therapeutics Corporation (NASDAQ: UTHR) reported that it has entered into an agreement to sell its Rare Pediatric Disease Priority Review Voucher (PPRV) to a subsidiary of AbbVie Inc. (NYSE: ABBV) (Press release, United Therapeutics, AUG 19, 2015, View Source [SID:1234507296]). United Therapeutics received the PPRV when Unituxin was approved by the U.S. Food and Drug Administration (FDA) for the treatment of neuroblastoma, a rare pediatric disease.

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Upon closing of the transaction, United Therapeutics will receive $350 million in cash in exchange for the PPRV. The voucher was awarded by the FDA under a provision that encourages development of new drugs and biologics for the prevention and treatment of rare pediatric diseases.

"We are very pleased to monetize our PPRV, and hope that this transaction will encourage others to join us in focusing development efforts on rare pediatric diseases," said Roger Jeffs, Ph.D., United Therapeutics’ President and Co-CEO.

The transaction is subject to customary closing conditions and clearance under the Hart-Scott-Rodino Antitrust Improvements Act.

About the Rare Pediatric Disease Priority Review Voucher Program

The program is intended to encourage development of new drug and biological products for prevention and treatment of certain rare pediatric diseases. A PPRV may be issued to the sponsor of a rare pediatric disease product application and would entitle the holder to priority review of a single New Drug Application or Biologics License Application, which reduces the target review time and could lead to an expedited approval. The sponsor receives the PPRV upon approval of the rare pediatric disease product application and it can be sold without limitation.

On August 19, 2015 Immunomedics, Inc. (Nasdaq:IMMU) reported financial results for the fourth quarter and fiscal year ended June 30, 2015 (Filing, 8-K, Immunomedics, AUG 19, 2015, View Source [SID:1234507297]). The Company also highlighted recent key developments and planned activities for its clinical pipeline.

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Fourth Quarter Fiscal 2015 Results

Total revenues for the fourth quarter of fiscal year 2015, which ended on June 30, 2015, were $2.4 million as compared to total revenues of $1.2 million for the same quarter last fiscal year. The increase of $1.2 million in total revenues this quarter was primarily due to a $1.0 million license fee revenue earned upon reaching a clinical milestone in the Company’s Collaboration Agreement, as amended, with Bayer (formerly Algeta ASA). There was no license fee revenue recorded in the same quarter last fiscal year.

Total costs and expenses for the current quarter were $13.6 million, as compared to $13.1 million for the same period in 2014, representing an increase of $0.5 million, or 4%. This increase was driven primarily by $1.1 million higher research and development expenses from increased clinical trial cost for the Phase 3 PANCRIT-1 registration study of yttrium-90-labeled clivatuzumab tetraxetan for the therapy of patients with advanced pancreatic cancer, and increased product development and manufacturing expenses related to the expansion of clinical studies for the two antibody-drug conjugate (ADC) programs. The increase in research and development expenses was partially offset by $0.4 million decreased general and administrative costs mainly from reduced legal and professional fees.

Interest expense this quarter related to the 4.75% Convertible Senior Notes was $1.4 million, including the amortization of $0.2 million debt issuance costs. There was no interest expense for the same quarter last fiscal year.

Net loss attributable to our stockholders this quarter was $12.4 million, or $0.13 per basic share, compared with a net loss attributable to our stockholders of $11.8 million, or $0.13 per basic share for the same quarter in fiscal 2014. The increase in net loss this quarter was primarily due to the increase in research and development expenses and interest expense, partially offset by the decrease in legal and professional fees, as described above.

Fiscal Year 2015 Results

Total revenues for fiscal year 2015 were $5.7 million as compared to $9.0 million for fiscal year 2014, representing a decrease of $3.3 million or 37%. The decrease in total revenues this fiscal year primarily resulted from $4.6 million of license fee revenue earned from the Bayer Collaboration Agreement during fiscal 2014, which was partially offset by the Agreement’s $1.0 million clinical milestone payment in fiscal year 2015.

Total costs and expenses for the fiscal year ended June 30, 2015 were $51.9 million, as compared to $44.6 million for fiscal 2014, representing an increase of $7.3 million, or 16%. This increase was driven primarily by $8.0 million higher research and development expenses from the continuing efforts of the Phase 3 PANCRIT-1 clinical trial in pancreatic cancer and increased clinical trial expenses and manufacturing costs for the ADCs’ clinical studies, as well as a $0.9 million increase in legal and professional fees, principally from the arbitration proceedings with Takeda-Nycomed. The increase in cost and expenses this fiscal year was partially offset by the prior year’s $1.2 million of cost from the recognition of manufacturing costs related to the Bayer Agreement, which did not recur in the current year.

Interest expense this fiscal year for the Convertible Senior Notes due 2020 was $2.1 million, including the amortization of $0.3 million debt issuance costs. There was no interest expense last fiscal year.

Net loss attributable to our stockholders for the fiscal year ended June 30, 2015 was $48.0 million, or $0.51 per basic share, as compared to net loss attributable to our stockholders of $35.4 million, or $0.42 per basic share, in fiscal year 2014. The increase in net loss of $12.6 million this fiscal year was primarily due to increased research and development costs attributable to clinical trials, increased legal and professional fees, interest expense, and lower license fee revenue from Bayer.

As of June 30, 2015, cash, cash equivalents, and marketable securities totaled $99.6 million.

"We are pleased to have a strong balance sheet to support the development of our clinical pipeline," commented Peter P. Pfreundschuh, Vice President Finance and Chief Financial Officer. "To that end, cash requirements in fiscal year 2016 are expected to be in the range of $52 to $54 million, which include the production of sacituzumab govitecan for a Phase 3 registration trial in metastatic triple-negative breast cancer anticipated in calendar year 2016, the ongoing PANCRIT-1 trial, and interest on the convertible notes," Mr. Pfreundschuh added.

The Company’s key clinical developments and future planned activities:

Epratuzumab

In July 2015, UCB announced that the two Phase 3 EMBODY clinical trials for epratuzumab in systemic lupus erythematosus did not meet the primary clinical efficacy endpoints in either dose in both studies. Treatment response in patients who received epratuzumab in addition to standard therapy was not statistically significant when compared to those who received placebo in addition to standard therapy. UCB is in the process of analyzing the full set of data from both studies. A high level review of the safety data did not identify any new safety concerns.
Sacituzumab Govitecan (IMMU-132)

Interim Phase 2 results with sacituzumab govitecan in patients with advanced, metastatic lung cancers will be reported in an oral presentation on Monday, September 7, 2015 at the 16th World Conference on Lung Cancer to be held in Denver, CO.

At the 2015 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO meeting"), updated results from a Phase 2 study of sacituzumab govitecan in patients with metastatic triple-negative breast cancer were presented. Among the 49 patients evaluated for response, 31%, or 15 patients, showed a reduction in tumor size of 30% or more. They included 2 patients with complete response. For the 48 responding patients who received the optimal doses of 8 or 10 mg/kg, the interim median progression-free survival, ("PFS"), was 6.0 months. The median prior cancer therapies for this group of patients was 4 (range, 1-11). (For more information on the updated results, please refer to the Company’s press release at View Source).

Sacituzumab govitecan also produced promising anti-tumor activity with durable responses in patients with metastatic lung cancer. For the 25 patients who responded to the ADC with either a 30% or more tumor shrinkage or stable disease, all 11 patients with small-cell lung cancer and 12 of 14 patients with non-small-cell lung cancer, or 86%, had a time to progression that was longer than their last therapy. These patients had previously failed a median of 2.5 (range, 1-7) and 3 (range, 1-8) cancer treatments, respectively. (View Source).

Also reported at the same ASCO (Free ASCO Whitepaper) meeting were results in patients with heavily-pretreated, metastatic gastrointestinal cancers. Even in this late-stage setting, a majority of patients, 57%, responded to sacituzumab govitecan with partial responses and durable stable disease, including 2 esophageal cancer patients and 1 colorectal cancer patient with a partial response. (View Source).
Labetuzumab Govitecan (IMMU-130)

Interim results from a Phase 2 study of labetuzumab govitecan in patients previously treated with at least one prior irinotecan-containing regimen for their metastatic colorectal cancer were reported in an oral presentation at the 2015 ASCO (Free ASCO Whitepaper) meeting. For the 33 patients who received the ADC once a week at the 8 or 10 mg/kg dose levels, the interim median PFS was 4.4 months, with 22% of these patients still benefiting from their cancer not progressing. In 32 patients with at least one response assessment following treatments, the disease control rate of 78%, with 1 partial response and 24 patients reporting stable disease as their best response. (View Source).
Clivatuzumab Tetraxetan

Final results from a Phase 1b study of yttrium-90-labeled clivatuzumab tetraxetan with or without low-dose gemcitabine in patients with metastatic pancreatic cancer after two or more prior therapies have been published online in the European Journal of Cancer. (View Source(15)00645-0/fulltext).
Veltuzumab

The Office of Orphan Products Development of the U.S. Food and Drug Administration has granted orphan status for the use of veltuzumab for the treatment of immune thrombocytopenia.