March 2016 – Page 109 – 1stOncology™: Cancer Intelligence Service

Advaxis Study in Head and Neck Cancer Selected for Late-Breaking Poster at the American Association for Cancer Research Annual Meeting

On March 02, 2016 Advaxis, Inc. (NASDAQ:ADXS), a clinical stage biotechnology company developing cancer immunotherapies, reported that data from a Phase 2 study of its lead Lm immunotherapy candidate in HPV-associated head and neck cancer, axalimogene filolisbac (AXAL), has been selected as a late-breaker poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, Advaxis, MAR 2, 2016, View Source [SID:1234509327]). According to AACR (Free AACR Whitepaper)’s selection criteria, late-breaking abstracts demonstrate highly significant and timely findings in any area of cancer research that were not available at the time of the regular abstract deadline. Additionally, only abstracts deemed to be of high scientific priority are accepted for presentation.

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The Phase 2 study by Andrew G. Sikora, M.D., Associate Professor of Otolaryngology and co-director of the Head and Neck Cancer Program in the NCI Comprehensive-Designated Dan L. Duncan Cancer Center at Baylor College of Medicine, is evaluating the efficacy of axalimogene filolisbac as neoadjuvant treatment prior to robot-assisted surgery in patients with HPV-associated head and neck cancer. The poster will present data on the effect of axalimogene filolisbac in targeting and inducing a T-cell response in the tumor microenvironment. The study received a three-year $1.1 million grant from the U.S. Food and Drug Administration’s Office of Orphan Products Development, which funds research for the development of products for rare diseases.

"Our research into the potential of AXAL in targeting HPV-related cancers continues to make remarkable progress. We are pleased to have the opportunity to share these results with the cancer research community at AACR (Free AACR Whitepaper)," said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis.

This year’s meeting will focus on "Delivering Cures through Cancer Science," and will take place in New Orleans, Louisiana April 16-20 at the Ernest N. Morial Convention Center. Once confirmed, the time and date of the Advaxis poster presentation will be available on Advaxis.com.

HPV-Associated Head and Neck Cancers

More than 90 percent of head and neck squamous cell oropharyngeal cancers originate from the mucosal linings of the oral cavity, pharynx, or larynx. Currently, 60 to 80 percent of these cancers are caused by HPV. Head and neck cancers are treated by surgical removal of the cancer and lymph nodes, often followed by radiation and chemotherapy based on the extent of the disease. While patients may achieve good long-term survival, standard treatments can change their physical appearance and are associated with significant short and long-term toxicities which may interfere with salivary gland function, taste, smell, and the ability to swallow.

The incidence of HPV-associated head and neck cancers has been increasing at an epidemic rate, while head and neck cancers from other causes have been decreasing. According to the World Health Organization, approximately 15 to 20 percent of the 400,000 new cases of head and neck cancer are HPV-related. In the US, there are about 12,000 new cases of HPV-associated head and neck cancer per year and it affects men about 3 times more frequently than women. HPV-associated head and neck cancer is growing fastest in developed countries like the U.S.

About Axalimogene Filolisbac

Axalimogene filolisbac (ADXS-HPV) is Advaxis’ lead Lm Technology immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company’s Lm Technology. Axalimogene filolisbac has Orphan Drug Designation in the U.S. for the treatment of anal cancer.

10-K

In December 2006, we entered into a license agreement with Halozyme Therapeutics, Inc. (Halozyme), under which we granted Halozyme a worldwide, limited exclusive license to certain of our proprietary PEGylation technology to develop, manufacture and commercialize particular products that use our proprietary PEGylation materials linked only with certain qualifying hyaluronidase protein molecules including PEGPH20 (Filing, 10-K, Nektar Therapeutics, MAR 1, 2016, View Source [SID:1234513765]).

According to Halozyme, certain cancers, including pancreatic, breast, colon and prostate, have been shown to accumulate high levels of hyaluronan (HA). Halozyme’s FDA-approved, HYLENEX recombinant human hyaluronidase, rHuPH20, is administered subcutaneously and temporarily and reversibly degrades HA to facilitate the absorption and dispersion of other injected drugs or fluids and for subcutaneous fluid administration. However, rHuPH20 acts only locally at the injection site, is rapidly inactivated in the body, and does not survive in the blood. PEGPH20 is an investigational PEGylated form of rHuPH20, under development by Halozyme to increase the half-life of the compound in the blood and allow for intravenous administration.

Halozyme is currently evaluating PEGPH20 in a Phase 2 multicenter, randomized clinical trial evaluating PEGPH20 as a first-line therapy for patients with stage IV metastatic pancreatic cancer. Halozyme is also evaluating PEGPH20 in an on-going Phase 1b/2 multi-center, randomized clinical trial evaluating PEGPH20 as a second-line therapy for patients with locally advanced or metastatic non-small cell lung cancer. On October 2, 2014, the FDA granted Orphan Drug designation for PEGPH20 for the treatment of pancreatic cancer.

We are entitled to future development milestones and royalties on net sales subject to reduction in the absence of patent coverage. Our right to receive royalties in any particular country will expire upon the later of twelve years after first commercial sale of the product or expiration of patent rights in the particular country. We also manufacture and supply Halozyme with clinical and future commercial supply of our proprietary PEGylation materials used in the manufacture of PEGPH20.

Nuvo Research® Inc. Completes Reorganization into Two Publicly Traded Companies

On March 1, 2016 Nuvo Pharmaceuticals Inc. (TSX:NRI) (Nuvo Pharma or the Company), formerly known as Nuvo Research Inc. and Crescita Therapeutics Inc. (TSX:CTX) (Crescita), reported the completion of the reorganization of Nuvo Research Inc. into two separate publicly traded companies (the Reorganization) (Press release, Nuvo Research, MAR 1, 2016, View Source [SID:1234512698]). As a result of the Reorganization, the shareholders of what was formerly Nuvo Research Inc., now own 100% of Nuvo Pharma, a revenue and EBITDA generating commercial healthcare company, and 100% of Crescita, a drug development company. The Reorganization was approved by the shareholders of Nuvo Research Inc. at a special shareholders meeting on February 18, 2016 and by the Ontario Superior Court of Justice on February 24, 2016.

"This transaction gives both businesses greater flexibility to focus on, and pursue, their respective growth strategies," said John London, President and CEO of Nuvo Pharma. "Nuvo Pharma is a profitable business with significant revenue and EBITDA growth potential." "We are very excited about the launch of Crescita," added Dan Chicoine, Chairman and CEO of Crescita. "We have exciting technologies, a proven management team that has obtained FDA approval for four topical pharmaceutical products and a strong balance sheet to support our growth."

Under the Reorganization, existing Nuvo Research Inc. share certificates now represent common shares of Nuvo Pharma and the right to receive a share certificate representing an equal number of Crescita common shares. The distribution record date (the Record Date) for certificates representing Crescita common shares is Thursday March 3, 2016. However, the TSX has implemented due bill trading for the Nuvo Pharma common shares (TSX: NRI) until the close of trading on Friday March 4, 2016. Accordingly, shareholders who purchase Nuvo Pharma common shares through the facilities of the TSX prior to the close of trading on Friday March 4, 2016 will automatically receive one Crescita common share for each Nuvo Pharma common share purchased. Crescita common shares (TSX:CTX) are expected to commence trading on the TSX on Monday March 7, 2016. Nuvo Pharma and Crescita shareholders are encouraged to contact their brokers for additional information.

As part of the Reorganization, Nuvo has changed its name from "Nuvo Research Inc." to "Nuvo Pharmaceuticals Inc."

03/01/2016 Corcept Therapeutics Announces 2015 Financial Results

On March 1, 2016 Corcept Therapeutics Incorporated (NASDAQ: CORT), a pharmaceutical company engaged in the discovery, development and commercialization of drugs that treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, reported its financial results for the fourth quarter and full year ended December 31, 2015 (Press release, Corcept Therapeutics, MAR 1, 2016, http://www.corcept.com/news_events/view/pr_1456870143 [SID:1234509336]).

Corcept reported revenue of $15.0 million for the fourth quarter of 2015 and $50.3 million for the full year. GAAP net income for the fourth quarter of 2015 was $1.0 million or $0.01 per share, compared to a net loss of $3.9 million or $0.04 per share in the fourth quarter of 2014. For the full year, the company reported a GAAP net loss of $6.4 million or $0.06 per share for 2015, compared to a net loss of $31.4 million or $0.31 per share in 2014.

The company’s cash and cash equivalents were $40.4 million at year-end, an increase of $4.0 million from September 30, 2015.

The company reiterated its 2016 revenue guidance of $76-81 million.

"2015 was a pivotal year for Corcept," said Dr. Joseph K. Belanoff, Corcept’s Chief Executive Officer. "We made a GAAP profit in the fourth quarter, while conducting our Phase 1/2 trial of mifepristone to treat TNBC and advancing our lead selective cortisol modulator toward Phase 2 trials in Cushing’s syndrome and solid-tumor cancers. In 2016, we plan to expand our pipeline further by advancing additional selective modulators towards human use – funded by our cash on hand and revenue from the sale of Korlym."

Financial Discussion

Corcept’s GAAP net income in the fourth quarter of 2015 was $1.0 million, compared to a net loss of $3.9 million in the fourth quarter of 2014. The company’s net loss for the full year was $6.4 million, compared to a net loss $31.4 million in 2014. Excluding non-cash expenses related to stock-based compensation and accreted interest on the company’s capped royalty obligation (the "Royalty Financing"), Corcept generated $3.1 million of non-GAAP net income in the fourth quarter, compared to a non-GAAP net loss of $1.7 million in the fourth quarter of 2014. Non-GAAP net income for 2015 was $2.5 million, compared to a non-GAAP net loss of $22.5 million for 2014. A reconciliation of GAAP to non-GAAP net operating results is set forth below.

Operating expenses for the fourth quarter of 2015 were $13.3 million, compared to $12.1 million for the fourth quarter of 2014. The increase was primarily due to spending on the company’s expanded sales force and operational costs associated with increased sales volumes. For the full year, operating expenses declined to $53.7 million, from $54.2 million in 2014, as savings from discontinuation of the company’s Phase 3 trial of mifepristone to treat psychotic depression more than offset increased spending on its Phase 1/2 trial of TNBC, clinical development of CORT125134, pre-clinical development of other selective cortisol modulators and costs related to the company’s larger sales force and increased sales volumes.

Corcept’s cash and cash equivalents totaled $40.4 million as of December 31, 2015, compared to $24.2 million as of December 31, 2014. These cash balances reflect Corcept’s scheduled payments due under the Royalty Financing. Pursuant to the terms of the agreement, Corcept paid $2.8 million in the fourth quarter of 2015, with payments totaling $9.2 million for the full year. In 2014, Corcept paid $1.6 million in the fourth quarter and $4.9 million for the year. Corcept expects to make its final payment under the Royalty Financing in 2017.

About Cushing’s Syndrome

Endogenous Cushing’s syndrome is caused by prolonged exposure of the body’s tissues to high levels of the hormone cortisol and is generated by tumors that produce cortisol or ACTH. Cushing’s syndrome is an orphan indication that most commonly affects adults aged 20-50. An estimated 10-15 of every one million people are newly diagnosed with this syndrome each year, resulting in over 3,000 new patients annually in the United States. An estimated 20,000 patients in the United States have Cushing’s syndrome. Symptoms vary, but most people have one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Cushing’s syndrome can affect every organ system in the body and can be lethal if not treated effectively.

About Triple-Negative Breast Cancer (TNBC)

TNBC is a form of the disease in which the three receptors that fuel most breast cancer growth – estrogen, progesterone and the HER-2/neu gene – are not present. Because the tumor cells lack the necessary receptors, treatments that target estrogen, progesterone and HER-2 receptors are ineffective. In 2013, approximately 40,000 women were diagnosed with TNBC. It is estimated that more than 75 percent of these women’s tumor cells expressed the GR receptor to which cortisol binds. There is no FDA-approved treatment and neither a targeted treatment nor an approved standard chemotherapy regimen for relapsed TNBC patients exists.

About Korlym

Korlym modulates the effect of cortisol at GR, one of the two receptors to which cortisol binds, thereby inhibiting the effects of excess cortisol in patients with Cushing’s syndrome. Since 2012, Corcept has made Korlym available as a once-daily oral treatment of hyperglycemia secondary to endogenous Cushing’s syndrome in adult patients with glucose intolerance or diabetes mellitus type 2 who have failed surgery or are not candidates for surgery. Korlym was the first FDA-approved treatment for that illness and the FDA has designated it as an Orphan Drug for that indication.

About CORT125134

CORT125134 is the lead compound in Corcept’s portfolio of selective cortisol modulators. It is a non-steroidal competitive antagonist of GR that does not bind to the body’s other hormone receptors, including the progesterone receptor. It is the affinity of Korlym for the progesterone receptor that results in termination of pregnancy and can cause endometrial thickening and irregular vaginal bleeding in some women. CORT125134 will not have these effects. The compound is proprietary to Corcept and is protected by composition of matter and method of use patents extending to 2033.

Nektar Therapeutics Reports Fourth Quarter and Year-End 2015 Financial Results

On March 1, 2016 Nektar Therapeutics (Nasdaq: NKTR) reported its financial results for the fourth quarter and year ended December 31, 2015 (Press release, Nektar Therapeutics, MAR 1, 2016, View Source [SID:1234509335]).

Cash and investments in marketable securities at December 31, 2015 were $308.9 million as compared to $262.8 million at December 31, 2014. Cash and investments include the net proceeds from the $250 million private placement of 7.75% Senior Secured Notes due in 2020, which was closed on October 5, 2015. A portion of the proceeds from this secured debt financing was used to fully redeem the $125.0 million of 12% Senior Secured Notes due in 2017.

"Nektar begins 2016 with two new medicines launched by our partners in the past year and multiple late-stage drug candidates advancing in the clinic," said Howard W. Robin, President and Chief Executive Officer of Nektar. "MOVANTIK is performing very well with positive feedback from physicians and patients. ADYNOVATE was launched in the U.S. in December 2015 and Baxalta recently submitted BLA filings in the U.S. to expand use of ADYNOVATE to pediatric and surgical settings. The NKTR-181 Phase 3 efficacy study in patients with chronic low back pain is on track to provide top-line results in early 2017. Finally, NKTR-214, our immuno-oncology candidate, is advancing nicely in a first-in-human trial evaluating its safety and efficacy in patients with solid tumors. We remain on track to report initial top-line data from the dose-escalation stage of the NKTR-214 study in the second half of 2016."

Revenue for the year ended December 31, 2015 was $230.8 million as compared to $200.7 million in 2014. Revenue for the fourth quarter of 2015 was $39.4 million as compared to $19.6 million in the fourth quarter of 2014. Revenue for the year ended December 31, 2015 includes the recognition of $90.0 million of the $100.0 million milestone payment from AstraZeneca following the first commercial sale of MOVANTIK in the U.S., recognition of the $40.0 million milestone payment from AstraZeneca following the first commercial sale of MOVENTIG in the EU and recognition of the $10 million milestone payment from Baxalta for the approval and first commercial sale of ADYNOVATE in the U.S. In addition, product sales and royalty revenue increased by $17.6 million in 2015 as compared to the same period in 2014.

Revenue also included non-cash royalty revenue, related to our 2012 royalty monetization, of $7.3 million and $22.1 million in the fourth quarter and the full year of 2015, respectively, and $5.2 million and $21.9 million in the fourth quarter and the full year of 2014, respectively. This non-cash royalty revenue is substantially offset by non-cash interest expense, also incurred in connection with the 2012 royalty monetization. Non-cash interest expense was $5.2 million and $20.6 million in the fourth quarter and year ended December 31, 2015, respectively, as compared to $5.2 million and $20.9 million in the fourth quarter and year ended December 31, 2014, respectively. Total operating costs and expenses for the year ended December 31, 2015 were $260.2 million as compared to $217.2 million in 2014. Total operating costs and expenses increased primarily as a result of higher research and development (R&D) expense. Total operating costs and expenses in the fourth quarter of 2015 were $68.7 million as compared to $57.0 million in the fourth quarter of 2014.

For the year ended December 31, 2015, R&D expense was $182.8 million as compared to $147.7 million in 2014. R&D expense in the fourth quarter of 2015 was $47.1 million as compared to $38.5 million for the fourth quarter of 2014. R&D expense was higher in the fourth quarter of 2015 and the year ended December 31, 2015 as compared to the same periods in 2014 primarily due to the initiation of the Phase 3 efficacy trial of NKTR-181 in chronic low back pain and the long-term safety study for NKTR-181. R&D expense for the full year 2015 also increased as a result of initiation of the Phase 1/2 clinical program for NKTR-214.

General and administrative (G&A) expense for the year ended December 31, 2015 was $43.3 million as compared to $40.9 million in 2014. G&A expense for the quarter and year ended December 31, 2015 includes the expense and payment of a $3.0 million settlement of a commercial litigation matter. G&A expense was $13.2 million in the fourth quarter of 2015 as compared to $12.2 million in the fourth quarter of 2014.

Net loss for the year ended December 31, 2015 was $81.2 million or $0.61 loss per share as compared to a net loss of $53.9 million or $0.42 loss per share for the year ended December 31, 2014. Net loss for the fourth quarter of 2015 was $54.1 million or $0.40 loss per share as compared to a net loss of $45.7 million or $0.35 loss per share in the fourth quarter of 2014.

The company also announced upcoming presentations at the following scientific congresses during the first half of 2016:

ISICEM (International Symposium on Intensive Care and Emergency Medicine), Brussels, Belgium:

Abstract Title: "In vitro evaluation of Amikacin Inhale and other commercial nebulizers in mechanical ventilator", Challoner, P., et al.
Date: March 17, 2016
AACR Annual Meeting, New Orleans, LA:

Abstract 558: "Durable antitumor activity of the CD122-biased immunostimulatory cytokine NKTR-214 combined with immune checkpoint blockade", Langowski, J., et al.
Poster Session: Immune Modulating Agents 1
Date: April 17, 2016, 1:00 p.m. – 5:00 p.m. Central Time

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Month: March 2016

Advaxis Study in Head and Neck Cancer Selected for Late-Breaking Poster at the American Association for Cancer Research Annual Meeting

10-K

Nuvo Research® Inc. Completes Reorganization into Two Publicly Traded Companies

03/01/2016 Corcept Therapeutics Announces 2015 Financial Results

Nektar Therapeutics Reports Fourth Quarter and Year-End 2015 Financial Results