On May 9, 2017 NantCell and NantKwest Inc. (NASDAQ:NK), two pioneering, next generation, clinical-stage immunotherapy companies focused on harnessing the unique power of our immune system using natural killer (NK) cells to treat cancer, infectious diseases and inflammatory diseases, reported that the U.S. Food & Drug Administration (FDA) has authorized an Investigational New Drug (IND) Application for the NANT Cancer Vaccine for clinical trial enrollment for pancreatic cancer patients (ClinicalTrials.gov NCT03136406) (Press release, NantKwest, MAY 9, 2017, http://ir.nantkwest.com/phoenix.zhtml?c=254059&p=RssLanding&cat=news&id=2271181 [SID1234518925]).

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The NANT Cancer Vaccine is the first combination immunotherapy protocol to orchestrate the delivery of metronomic low-dose radiation and chemotherapy with molecularly-informed, tumor-associated antigen vaccines and natural killer cells, to activate the innate and adaptive immune system and to induce immunogenic cell death. By inducing immunogenic cell death and protecting as well as enhancing the innate and adaptive immune system, the NANT Cancer Vaccine seeks to attain long-term sustainable remission of multiple tumor types with lower toxicity and higher efficacy than current standards of care.

"Abraxane, a nanoparticle albumin-bound (Nab) paclitaxel, was the first protein-based drug to alter the survival of metastatic pancreatic cancer in over 20 years," noted Patrick Soon-Shiong, MD, Chairman and CEO of NantKwest. "But we were not content just with the approval of Abraxane as being sufficient to transform this disease. In January 2016, we announced our Cancer Breakthroughs 2020 journey towards developing effective personalized cancer treatments to further harness the human body’s innate immune system as a paradigm change to treating patients with cancer. Today’s FDA clearance is a further step in our 25-year quest to develop this cancer vaccine that seeks to induce immunogenic cell death and orchestrate the innate and adaptive immune system of the patient through the delivery of molecularly informed, biological platforms. To our knowledge this is the first clinical study whereby protein nanoparticles (Nab) delivering low dose metronomic chemotherapy is combined with molecularly informed (GPS Cancer) tumor associated antigens activating dendritic and T cells by adenoviral and yeast vectors, and orchestrated with both endogenous (IL-15) and exogenous (off the shelf) activation of NK cells. This NANT Cancer Vaccine will be studied in patients suffering from all types of cancers and at all stages of disease in the coming 12 months, a Cancer Breakthroughs 2020 goal," Dr. Soon-Shiong added.

"Cancer has historically been one of the most complex challenges that the medical community has tried to combat," said John Lee, MD, FACS, Senior Vice President of Clinical Development at NantKwest. "Receiving authorization from the FDA for the IND application for the NANT Cancer Vaccine is a testament to our novel immunotherapy approach. Today marks an important milestone for cancer care and reinforces the need for a paradigm shift in the way we approach this deadly disease. NantKwest and NantCell are actively working to initiate the clinical trial across investigational centers and we look forward to offering the NANT Cancer Vaccine regimen to pancreatic cancer patients."

"Cancer cells often go undetected by the immune system; recently, it was found that cancer cells place a brake on the immune system by checkpoint receptors. This discovery has brought forth a new revolution of immuno-oncology with the launch of multiple checkpoint inhibitors. We realize, however, that checkpoint inhibition alone is insufficient to fully activate the immune system to combat the cancerous tumor," stated Leonard S. Sender, M.D., Senior Vice President of Medical Affairs for Pediatric, Adolescent and Young Adult Oncology at NantKwest. "NANT Cancer Vaccine is a unique, multi-agent protocol aimed at orchestrating all the components of the immune system needed to combat cancer."

On May 9, 2017 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported financial results for the first quarter ended March 31, 2017 (Press release, Loxo Oncology, MAY 9, 2017, View Source [SID1234518923]). Loxo Oncology will not be conducting a conference call in conjunction with this earnings release.

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"We had a very productive first quarter. We fully enrolled our larotrectinib registrational program, announced a diagnostics collaboration with Roche, presented proof-of-concept clinical data in glioblastoma at the AACR (Free AACR Whitepaper) Annual Meeting, and announced the acceptance of two oral presentations at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting," said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. "For the upcoming quarter, we eagerly look forward to the larotrectinib presentations at ASCO (Free ASCO Whitepaper) and beginning the clinical development of LOXO-292, our highly selective RET kinase inhibitor."

Recent Highlights

Larotrectinib Oral Presentations Accepted at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting: On April 5, 2017, Loxo Oncology announced that larotrectinib (LOXO-101) interim clinical data for RECIST-evaluable TRK fusion patients, integrated across all three ongoing clinical trials, will be presented as a late-breaking oral presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting held June 2 – 6, 2017 in Chicago, Illinois. The presentation is entitled, "The efficacy of larotrectinib (LOXO-101), a selective tropomyosin receptor kinase (TRK) inhibitor, in adult and pediatric TRK fusion cancers." Loxo Oncology also announced that interim pediatric Phase 1 clinical trial data, included in the aforementioned data set, will also be presented in a separate oral presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting, entitled, "A pediatric phase 1 study of larotrectinib, a highly selective inhibitor of the tropomyosin receptor kinase (TRK) family." Loxo Oncology will be hosting a conference call in association with the ASCO (Free ASCO Whitepaper) Annual Meeting and details are included below.
Proof-of-Concept Clinical Data for Larotrectinib in TRK Fusion Glioblastoma Presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting: On April 5, 2017, investigators from Memorial Sloan Kettering Cancer Center presented a poster describing initial clinical data across the larotrectinib program for all patients with TRK fusion primary CNS cancers at the AACR (Free AACR Whitepaper) meeting in Washington D.C. The cases include three patients with glioblastoma: one patient treated under an expanded access protocol and two patients treated in the ongoing Phase 2 NAVIGATE trial. In the cases presented, larotrectinib showed preliminary evidence of anti-tumor activity.
Collaboration with Ventana Medical Systems, Inc., a member of the Roche Group for Larotrectinib Pan-TRK IHC Companion Diagnostic: Loxo Oncology announced a collaboration agreement with Ventana Medical Systems, Inc., a member of the Roche Group (Roche), to develop and commercialize a pan-TRK immunohistochemistry (IHC) test as a companion diagnostic to identify patients across tumor types suitable for treatment with larotrectinib. The parties plan to first globally commercialize an analytical assay and then develop a Class III assay for pre-market approval from the U.S. Food and Drug Administration.
ASCO Conference Call

In conjunction with the ASCO (Free ASCO Whitepaper) Annual Meeting, Loxo Oncology will host a conference call and live webcast with slide presentation and Q&A on Sunday, June 4, 2017 at 6 p.m. CT to discuss the larotrectinib oral presentations. To participate in the conference call, please dial (877) 930-8065 (domestic) or (253) 336-8041 (international) and refer to conference ID 14447513. A live webcast of the presentation will be available at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the company’s website for 90 days following the call.

First Quarter 2017 Financial Results

As of March 31, 2017, Loxo Oncology had aggregate cash, cash equivalents and investments of $244.3 million, compared to $141.8 million as of December 31, 2016. Based on the current operating plan, the company continues to believe existing capital resources will be sufficient to fund anticipated operations to mid-2019.

Research and development expenses were $20.2 million for the first quarter of 2017 compared to $8.4 million for the first quarter of 2016. This increase was primarily due to expanded larotrectinib development activities including clinical costs and costs related to the companion diagnostics agreement with Roche, as well as additional expenses related to LOXO-292 and the preclinical pipeline and increases in employment costs primarily due to increased headcount. Loxo Oncology also recognized research and development-related stock-based compensation expense of $2.4 million during the first quarter of 2017 compared to $0.3 million for the first quarter of 2016.

General and administrative expenses were $4.8 million for the first quarter of 2017 compared to $3.4 million for the first quarter of 2016. The increase was primarily due to increases in employment costs and professional fees. Loxo Oncology also recognized general and administrative-related stock-based compensation expense of $1.6 million during the first quarter 2017 compared to $1.0 million for the first quarter of 2016.

Net loss was $24.5 million and $11.6 million for the first quarters 2017 and 2016, respectively.

On May 9, 2017 Cascadian Therapeutics, Inc. (NASDAQ:CASC), a clinical-stage biopharmaceutical company, reported financial results for the first quarter ended March 31, 2017 (Press release, Cascadian Therapeutics, MAY 9, 2017, View Source [SID1234518921]).

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"In the first quarter, we continued to build a solid management team and the financial foundation that will help us execute our core objectives over the next several years," said Scott Myers, President and CEO of Cascadian Therapeutics. "We are focused on enrolling HER2CLIMB, our pivotal study of tucatinib in combination for late-stage HER2-positive metastatic breast cancer for patients with and without brain metastases. We are very pleased with the current pace of enrollment and are expanding HER2CLIMB globally."

First Quarter and Recent Highlights

In April 2017, the Company announced data highlights from presentations of preclinical data for the Company’s investigational orally bioavailable, potent and selective checkpoint kinase 1 (Chk1) inhibitor known as CASC-578 and data from the first public presentation on the Company’s preclinical antibody program targeting the immune checkpoint receptor TIGIT. These data were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2017.

In March 2017, the Company announced the appointment of Robert W. Azelby to the Company’s Board of Directors. Mr. Azelby is a biotechnology and pharmaceutical industry veteran. The Company also announced that Richard L. Jackson, Ph.D., retired from the Board.

In January 2017, the Company closed an $88 million net public offering of common and Series E preferred stock. The net proceeds, along with cash on hand, support the development of tucatinib, the registrational HER2CLIMB trial through top-line data, with funds to carry on operations for a period of time thereafter. On May 8, 2017, in connection with the registration rights agreement entered into for the Series E preferred stock issued in this financing, the Company filed a required resale S-3 registration statement to allow the holder of these preferred shares to sell shares of common stock issuable upon conversion of the preferred shares. The S-3 relates to these shares and does not provide for any future issuance of new common shares for financings.
First Quarter Financial Results

Cash, cash equivalents and investments totaled $136.1 million as of March 31, 2017, compared to $62.8 million at December 31, 2016, an increase of $73.3 million, or 116.7 percent. The increase was primarily due to the result of net proceeds of $88.0 million from the Company’s January 2017 financing offset by cash used to fund operations of $14.6 million.

Net loss attributable to common stockholders for the first three months ended March 31, 2017 was $12.4 million, or $0.30 per share, compared to a net loss attributable to common stockholders of $12.9 million, or $0.81 per share, for the same period in 2016. The $0.5 million decrease in net loss attributable to common stockholders for the quarter was primarily due to a decrease in general and administrative expense of $3.7 million related to the retirement and separation of the former chief executive officer in the first quarter of 2016. This decrease was offset by higher research and development expenses of $2.3 million due to greater activity related to the development of the Company’s product candidate and a non-cash deemed dividend of $1.0 million related to the beneficial conversion feature on the Series E convertible preferred stock.
2017 Financial Outlook

Cascadian Therapeutics expects operating expenses in 2017 to be slightly higher than in 2016, primarily due to an increase in activities related to the ongoing worldwide HER2CLIMB pivotal trial. Cash used in operations for 2017 is expected to be approximately $50.0 million to $54.0 million.

Cascadian Therapeutics believes the above financial guidance to be correct as of the date provided and is providing the guidance as a convenience to investors and assumes no obligation to update it.