On November 8, 2017 Cascadian Therapeutics, Inc. (NASDAQ:CASC), a clinical-stage biopharmaceutical company, reported financial results for the third quarter ended September 30, 2017, and provided an update on tucatinib, an investigational oral, small molecule kinase inhibitor that is highly selective for HER2 and the Company’s lead product in development for the treatment of HER2 overexpressing cancers (Press release, Cascadian Therapeutics, NOV 8, 2017, View Source [SID1234521791]).

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Scott Myers, President and CEO of Cascadian Therapeutics, stated, "We had a productive third quarter. Tucatinib was granted orphan drug designation for a second indication, HER2+ colorectal cancer and enrollment began for an investigator-sponsored study of tucatinib in combination with trastuzumab in HER2 amplified metastatic colorectal cancer. Results from a pooled analysis of tucatinib combination studies were presented at ESMO (Free ESMO Whitepaper) that provide further support for the development of tucatinib in HER2+ metastatic breast cancer with brain metastases. Finally, enrollment of the HER2CLIMB pivotal trial continues to be robust, and we expect to end the year within our cash guidance."

Mr. Myers added, "We look forward to sharing new follow up data from our tucatinib Phase 1b studies at the San Antonio Breast Cancer Symposium in early December."

Third Quarter and Recent Highlights

● Tucatinib was granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of HER2+ colorectal cancer. This is the second orphan designation for tucatinib, which also has orphan designation in breast cancer with brain metastases.

● Began enrollment in an investigator-initiated Phase 2 study of tucatinib in combination with trastuzumab for patients with HER2 amplified metastatic colorectal cancer. The study, known as MOUNTAINEER, is described on www.clinicaltrials.gov (NCT03043313).

● Presented at the European Society for Medical Oncology 2017 Congress in September results from a pooled analysis of Phase 1b combination studies supporting the potential utility of tucatinib for patients with HER2+ metastatic breast cancer with brain metastases, including untreated or progressive brain metastases after radiation therapy. Additional analyses of long-term patients in tucatinib studies will be presented at the 40th San Antonio Breast Cancer Symposium 2017 in early December. In addition, results of non-clinical studies were presented that support the MOUNTAINEER study, demonstrating tucatinib is active as a single agent in models of HER2+ colorectal cancer, as well as in other gastrointestinal cancers.

● Continued enrollment of HER2CLIMB pivotal trial, which is on track and enrolling in North America, Western Europe and Australia.

● Received positive regulatory feedback from the European Medicines Agency’s (EMA) Scientific Advice Working Group and Health Canada, validating the potential for the ongoing HER2CLIMB pivotal clinical trial and nonclinical programs to be sufficient for tucatinib registration, if data are supportive.

● Management is pursuing partnering opportunities for CASC-578, a Chk1 kinase inhibitor, and CASC-674, a TIGIT antibody program, and is closing internal laboratory operations to focus resources on tucatinib registration-enabling critical path activities.

Third Quarter Financial Results

● Cash, cash equivalents and investments totaled $113.0 million as of September 30, 2017, compared to $62.8 million at December 31, 2016. The increase was primarily due to net proceeds of $88.0 million from the Company’s January 2017 financing, less cash used in operations of $37.2 million.

● Net loss attributable to common stockholders for the three months ended September 30, 2017 was $14.1 million, or $0.28 per share, compared with a net loss attributable to common stockholders of $11.8 million, or $0.52 per share, for the comparable period in 2016. The $2.3 million increase in net loss attributable to common stockholders for the quarter was primarily due to an increase in research and development expenses of $3.6 million primarily due to greater activity related to the development of the Company’s product candidates, offset by a non-cash deemed dividend of $1.0 million related to the beneficial conversion feature on convertible preferred stock for the three months ended September 30, 2016.

● Net loss attributable to common stockholders for the nine months ended September 30, 2017 was $41.2 million, or $0.87 per share, compared to a net loss attributable to common stockholders of $49.8 million, or $2.74 per share, for the same period in 2016. The $8.6 million decrease in net loss attributable to common stockholders for the nine months ended September 30, 2017 was primarily due to the non-cash intangible asset impairment charge of $19.7 million offset by a $6.9 million tax benefit related to the reversal of the deferred tax liability, each of which was recorded in connection with the termination of the STC.UNM license agreement in 2016. In addition, the decrease was due to lower general and administrative expenses of $4.6 million primarily due to compensation-related expenses in connection with management changes in the first quarter of 2016 and lower non-cash expenses of $1.6 million from the deemed dividend related to the beneficial conversion feature on convertible preferred stock. The decrease in net loss attributable to common stockholders were partially offset by increases in research and development expenses of $11.0 million due to greater activity related to the development of the Company’s product candidates.

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 hereof and is providing the guidance as a convenience to investors and assumes no obligation to update it.

Conference Call Information

Cascadian Therapeutics management will host a conference call and live audio webcast to review its third quarter financial results and provide an update on business activities today at 4:30 p.m. ET / 1:30 p.m. PT. Participants can access the call at +1 (877) 280-7291 (domestic) or +1 (707) 287-9361 (international). To access the live audio webcast or the subsequent archived recording, visit the Events & Presentations page of the News & Events section of the Cascadian Therapeutics’ website at www.cascadianrx.com.

On November 8, 2017 FibroGen, Inc. (NASDAQ:FGEN), a science-based biopharmaceutical company, today reported financial results for the third quarter of 2017 and provided an update on the company’s recent developments (Press release, FibroGen, NOV 8, 2017, View Source;p=RssLanding&cat=news&id=2315520 [SID1234521792]).

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"We have achieved significant clinical and regulatory progress in FibroGen’s product development programs. With the reporting of positive data from our placebo-controlled Phase 2 study of pamrevlumab for the treatment of moderate-to-severe idiopathic pulmonary fibrosis, we are very excited about the potential for pamrevlumab to help IPF patients who currently have few options. These results position us well on the path towards Phase 3 clinical development in IPF, as we continue to advance pamrevlumab in additional indications, where there is critical need for new therapies," said Thomas B. Neff, FibroGen’s Chief Executive Officer. "With respect to roxadustat, the filing of our new drug application with the China Food and Drug Administration for the treatment of anemia associated with chronic kidney disease marks several important firsts for FibroGen, the HIF-PHI class of drugs, and towards the registration of a new chemical entity in China."

Recent Developments and Highlights
Pamrevlumab for Idiopathic Pulmonary Fibrosis (IPF)

Announced positive results from a randomized, placebo-controlled, double-blind Phase 2 study of pamrevlumab, a first-in-class fully human antibody targeting connective tissue growth factor (CTGF)
Presented Phase 2 findings in an oral presentation at the European Respiratory Society (ERS) International Congress in September 2017
Results also presented at the ERS meeting from a preclinical mouse radiation-induced lung fibrosis model showed that pamrevlumab monotherapy reduced fibrosis to a greater extent than either pirfenidone or nintedanib monotherapy, and that the results of combination therapy with either standard-of-care were not statistically significantly better than those for pamrevlumab alone
Clinical and preclinical data has been accepted for presentation in November 2017 at Pulmonary Fibrosis Foundation (PFF) Summit 2017 in Nashville, TN
Pamrevlumab for Pancreatic Cancer

We expect to define a registrational strategy in the first half of 2018
Roxadustat for Anemia in Chronic Kidney Disease (CKD)

New drug application (NDA) filing with the U.S. Food and Drug Administration targeted for 2018
Positive topline results reported from the first completed Japan roxadustat Phase 3 CKD trial, for the treatment of anemia in peritoneal dialysis patients in October 2017
In November 2017, the independent data safety monitoring board, which reviews the U.S. and European Phase 3 programs quarterly, recommended that all trials continue without modification to current protocols
Roxadustat for Anemia in Myelodysplastic Syndromes (MDS)

Phase 3 U.S. clinical trial anticipated to start in the fourth quarter of 2017
Roxadustat for Anemia in CKD in China

NDA accepted for review by the China Food and Drug Administration (CFDA) for anemia associated with CKD in dialysis-dependent and non-dialysis-dependent patients in October 2017
Twenty-six week data from the two Phase 3 trials showed correction of anemia and maintenance of hemoglobin levels, and comparable results with or without inflammation
Data from the fifty-two week safety extension study showed durability of effect
No safety signals were identified
Roxadustat for Anemia in MDS in China

Initiation of Phase 2/3 clinical study is planned for the fourth quarter of 2017/first quarter of 2018
Corporate and Financial Highlights

Appointed Gerald Lema to the company’s Board of Directors, adding extensive experience to FibroGen’s leadership in commercialization, finance, and strategy in the Asia Pacific region, as well as in Europe/Middle East and Africa, U.S., and Latin America
Earned $15.0 million milestone from partner AstraZeneca for the submission of the NDA for roxadustat in CKD to the CFDA in October 2017, which will be received and recognized as license and milestone revenue in the fourth quarter of 2017
Closed an equity financing in August 2017 that generated $356.2 million in net proceeds
Net loss per basic and diluted share for the quarter ended September 30, 2017 was $0.50, as compared to a net loss per based and diluted share of $0.38 a year ago
At September 30, 2017, FibroGen had $762.7 million of cash, restricted time deposits, cash equivalents, investments, and receivables
Conference Call Details
FibroGen will host a conference call and webcast today, November 8, 2017, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the company’s website, www.fibrogen.com. To participate in the conference call by telephone, please dial 1 (888) 771-4371 (U.S. and Canada) or 1 (847) 585-4405 (international), reference the FibroGen Third Quarter 2017 conference call, and use the confirmation number 45903141. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial (888) 843-7419 (domestic) or (630) 652-3042 (international), and use the passcode 45903141#.

On November 8, 2017 Genmab reported Financial Results for the First Nine Months of 2017 (Press release, Genmab, NOV 8, 2017, View Source [SID1234521793]).

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Interim Report for the First Nine Months Ended September 30, 2017

Highlights

USD 871 million in net sales of DARZALEX (daratumumab); resulting in royalty income of DKK 707 million

DARZALEX approved for relapsed or refractory multiple myeloma in Japan

Announced positive topline results in Phase III ALCYONE study of daratumumab in front line multiple myeloma

Seattle Genetics exercised its option to co-develop tisotumab vedotin with Genmab

"This past quarter we continued to focus on progressing our innovative antibody pipeline. DARZALEX received its first approval in Japan, for the treatment of relapsed or refractory multiple myeloma. We also reported exciting data from the Phase III ALCYONE study of daratumumab in front line multiple myeloma. Finally, we were pleased to announce that Seattle Genetics exercised its option to co-develop tisotumab vedotin and we very much look forward to our collaboration to rapidly bring this product into the next stages of clinical evaluation," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Nine Months of 2017
Revenue was DKK 1,348 million in the first nine months of 2017 compared to DKK 889 million in the first nine months of 2016. The increase of DKK 459 million, or 52%, was mainly driven by higher DARZALEX royalties and milestones.
Operating expenses were DKK 707 million in the first nine months of 2017 compared to DKK 544 million in the first nine months of 2016. The increase of DKK 163 million, or 30%, was due to the additional investment in our pipeline of products, including the advancement of tisotumab vedotin, HexaBody-DR5/DR5, DuoBody-CD3xCD20, and other products in our pipeline.
Operating income was DKK 641 million in the first nine months of 2017 compared to DKK 345 million in the first nine months of 2016. The increase of DKK 296 million, or 86%, was driven by higher revenue, which was partly offset by increased operating expenses in 2017.

On September 30, 2017, Genmab had a cash position of DKK 5,184 million compared to DKK 3,922 million at December 31, 2016. This represented a net increase of DKK 1,262 million, which was mainly driven by positive working capital adjustments of DKK 575 million related to milestones achieved in the fourth quarter of 2016 that were received in 2017, our operating income of DKK 641 million, and proceeds from the exercise of warrants of DKK 208 million.

Outlook
Genmab is maintaining its 2017 financial guidance published on February 22, 2017 and reiterated on September 27, 2017.

Conference Call
Genmab will hold a conference call in English to discuss the results for the first nine months of 2017 today, Wednesday, November 8, at 6.00 pm CET, 5.00 pm GMT or 12.00 pm EDT. The dial in numbers are:
+1 646 254 3360 (US participants) and ask for the Genmab conference call
+44 20 3427 1910 (international participants) and ask for the Genmab conference call

A live and archived webcast of the call and relevant slides will be available at www.genmab.com.

On November 8, 2017 Genomic Health, Inc. (NASDAQ: GHDX) reported financial results and business progress for the quarter ended September 30, 2017 (Press release, Genomic Health, NOV 8, 2017, View Source [SID1234521794]).

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Total revenue was $83.8 million in the third quarter of 2017, compared with $82.3 million in the third quarter of 2016, an increase of 2 percent. Revenue was negatively impacted by approximately $3 million due to the hurricane disruption in certain regions of the United States.
U.S. product revenue was $70.9 million in the third quarter of 2017, compared with $70.0 million in the third quarter of 2016. U.S. invasive breast revenue from Oncotype DX Breast Recurrence Score tests was $63.1 million in the third quarter of 2017, compared with $64.6 million in the third quarter of 2016. U.S. prostate revenue from Oncotype DX Genomic Prostate Score (GPS) tests was $5.5 million in the third quarter of 2017, compared with $2.3 million in the third quarter of 2016.

International product revenue was $12.9 million in the third quarter of 2017, compared with $12.1 million in the third quarter of 2016, an increase of 7 percent.

"In the third quarter, we generated solid results including a 2 percent increase in revenue and a 5 percent increase in test volume, despite disruption in U.S. regions affected by hurricanes. We also reported a net loss of $2.2 million, and on a non-GAAP basis delivered a $1.1 million profit in the third quarter. Importantly, we expect to deliver full-year profit, excluding transaction costs from our collaboration with Biocartis," said Kim Popovits, chairman of the board, chief executive officer and president of Genomic Health. "We look forward to significant revenue drivers in 2018 including a new higher Medicare rate under PAMA and anticipated TAILORx results, while we expand our business model to increase worldwide access through the development of an in vitro diagnostic, or IVD, version of the Oncotype DX breast cancer test."

More than 31,580 Oncotype test results were delivered in the third quarter of 2017, an increase of 5 percent, compared with more than 29,990 test results delivered in the same period in 2016. U.S. test volume was negatively impacted by approximately 3 percent due to the hurricane disruption in certain regions of the country. Oncotype DX Breast Recurrence Score tests delivered in the U.S. were consistent with the third quarter of the prior year. Oncotype DX Genomic Prostate Score tests delivered in the U.S. grew 39 percent compared with the third quarter of the prior year. International tests delivered grew 14 percent compared with the same period of the prior year and represented approximately 26 percent of total test volume in the third quarter of 2017.
Operating loss for the third quarter of 2017 improved to $2.6 million, compared with $3.0 million for the third quarter of 2016. Net loss was $2.2 million, or $0.06 per share, for the third quarter of 2017, compared with a net loss of $2.8 million, or $0.08 per share, for the third quarter of 2016. Basic and diluted net loss per share was $0.06 for the third quarter of 2017, compared with basic and diluted net loss per share of $0.08 for the third quarter of 2016.
Total revenue for the nine months ended September 30, 2017 was $253.3 million compared with $245.1 million for the nine months ended September 30, 2016, an increase of 3 percent. On a constant currency basis, revenue increased 4 percent compared with the same period in the prior year.i
International product revenue was $39.4 million for the nine months ended September 30, 2017, compared with $34.8 million for the nine months ended September 30, 2016, an increase of 13 percent, and an increase of 16 percent on a constant currency basis.i
Operating loss improved to $8.6 million for the nine months ended September 30, 2017, compared with an operating loss of $16.9 million for the nine months ended September 30, 2016. Net loss was $5.7 million, or $0.17 per share, for the nine months ended September 30, 2017, compared with a net loss of $15.3 million, or $0.46 per share, for the nine months ended September 30, 2016.
Cash and cash equivalents and short-term marketable securities at September 30, 2017 were $119.0 million, compared with $97.0 million at December 31, 2016 which included the fair value of the company’s investment in a marketable security of $9.3 million at December 31, 2016.
The non-GAAP financial measures used adjust for specified items that can be highly variable or difficult to predict. A reconciliation of the non-GAAP financial measures to the most directly comparable GAAP financial measures is included in the tables accompanying this release.

2017 Financial Outlook

·
The company expects to deliver full-year profit, excluding the $3.2 million cost of the Biocartis transaction.
·
The company expects to meet the low end of its full year revenue guidance, which is $345 million, excluding the estimated hurricane impact on revenue of approximately $3 million in the third quarter.

Recent Business Highlights

·
Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses molecular diagnostic technologies, issued a positive final Local Coverage Determination (LCD) that became effective on October 9, 2017 to expand Medicare coverage of the Oncotype DX Genomic Prostate Score test to qualified patients with favorable intermediate-risk prostate cancer throughout the U.S.
·
Established additional private coverage for the Oncotype DX Genomic Prostate Score test, bringing the total number of U.S. covered lives to more than 66 million.
·
Established new private coverage for the Oncotype DX Breast Recurrence Score test in Germany, bringing the total number of German private covered lives to 15 million.

·
Announced an exclusive agreement with Biocartis Group NV to develop an IVD version of the Oncotype DX Breast Recurrence Score test on Biocartis’ Idylla platform that can be performed locally by laboratory partners and in hospitals around the world to broaden future global patient access.
·
European Urology published results from a large, community-based, multi-center clinical validation study conducted at Kaiser Permanente. The results confirmed that the Oncotype DX GPS test is a strong independent predictor of prostate cancer-specific death and metastases at 10 years in men with localized prostate cancer.
·
Presented results from four studies that provide additional evidence of the unmatched value of the Oncotype DX Breast Recurrence Score test in accurately predicting outcomes in early-stage breast cancer patients at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress.
·
Nature Partner Journals Breast Cancer, a peer-reviewed journal published by Nature, published two articles highlighting results from a large prospectively designed registry conducted by Clalit Health Services, the largest Health Maintenance Organization in Israel. The results reinforce the ability of the Oncotype DX Breast Recurrence Score test to predict clinical outcomes in both node-negative and node-positive patients.
·
Received acceptance to present nine studies at the 2017 San Antonio Breast Cancer Symposium (SABCS) in December.
Conference Call Details
To access the live conference call today, November 8, at 4:30 p.m. Eastern Time via phone, please dial (877) 303-7208 from the United States and Canada, or +1 (224) 357-2389 internationally. The conference call ID is 5697809. Please dial in approximately ten minutes prior to the start of the call. To access the live and subsequently archived webcast of the conference call, go to the Investor Relations section of the company’s web site at View Source Please connect to the web site at least 15 minutes prior to the presentation to allow for any software download that may be necessary.

On November 8, 2017 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported financial results for the quarter ended September 30, 2017 (Press release, Inovio, NOV 8, 2017, View Source [SID1234521796]).

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Total revenue was $2.6 million for the three months ended September 30, 2017, compared to $12.5 million for the same period in 2016. Total operating expenses were $31.8 million for the current year quarter compared to $32.7 million for the prior year quarter.

The net loss attributable to common stockholders for the quarter ended September 30, 2017 was $34.1 million, or $0.39 per basic share, compared to $20.8 million, or $0.28 per share, for the quarter ended September 30, 2016. The increase in net loss for the quarter resulted primarily from lower revenue recognized from our DARPA Ebola grant and a higher non-cash accounting expense related to the change in fair value of our investment in an affiliated entity.

Revenue

The decrease in revenue was primarily due to lower revenues recognized due to the nearing of successful completion of our DARPA Ebola grant.

Operating Expenses

Research and development expenses for the third quarter of 2017 were $25.5 million compared to $27.0 million for the third quarter of 2016. The decrease in R&D expenses was primarily the result of lower expenses incurred related to our DARPA Ebola grant. General and administrative expenses were $6.3 million for the third quarter of 2017 versus $5.8 million for the third quarter of 2016. The increase in G&A expenses was primarily related to an increase in employee headcount.

Capital Resources

As of September 30, 2017, cash and cash equivalents and short-term investments were $141.9 million compared with $104.8 million as of December 31, 2016. At quarter end the company had 90.3 million shares of common stock outstanding and 99.7 million shares of common stock outstanding on a fully diluted basis.

Inovio’s balance sheet and statement of operations are provided below. The Form 10-Q providing the complete 2017 third quarter financial report can be found at: View Source

Corporate Update

Cancer Immunotherapies

VGX-3100: Cervical Pre-Cancer (Phase 3)

In June, Inovio commenced its phase 3 clinical program to evaluate the efficacy of Inovio’s DNA-based immunotherapy, VGX-3100, to treat cervical dysplasia caused by human papillomavirus (HPV). In a little over three months since trial initiation, Inovio has opened nearly 35 sites, recruiting and dosing patients. The company is on track to open at least 50 sites by the end of the year.

VGX-3100: Vulvar Pre-Cancer (Phase 2)

In April, Inovio commenced a randomized, open-label phase 2 trial to evaluate the efficacy of VGX-3100 in women with high-grade HPV-related vulvar high-grade intraepithelial lesions (HSIL), a disease with a high unmet medical need. The primary endpoint of the study is histologic clearance of high-grade lesions and virologic clearance of the HPV virus in vulvar tissue samples. The study will also evaluate safety and tolerability. There are 10 sites in the U.S. open and recruiting patients.

MEDI0457: HPV-Related Head & Neck Cancer (Phase 1/2)

In May, Inovio announced that MedImmune, AstraZeneca’s global biologics research and development arm, commenced a new clinical trial investigating the combination of MEDI0457 (formerly INO-3112, in-licensed from Inovio), an immunotherapy designed to generate antigen-specific killer T cell responses targeting HPV-associated tumors, and durvalumab (IMFINZI), MedImmune’s PD-L1 checkpoint inhibitor. The combination trial will enroll patients with metastatic HPV-associated squamous cell carcinoma of the head and neck (SCCHN) with persistent or recurrent disease after chemotherapy treatment. This study marks a significant moment for Inovio as it transitions into a late-stage biotechnology company. MedImmune is investigating elevating the response rate of checkpoint inhibitors by using durvalumab in combination with a DNA plasmid vaccine originally licensed from Inovio, which has shown the ability to generate killer T cells.

INO-5401: Metastatic bladder cancer phase 1/2 trial initiated in combination with Genentech’s TECENTRIQ

In October, Inovio initiated a phase 1b/2 immuno-oncology trial to evaluate Genentech/Roche’s atezolizumab (TECENTRIQ) in combination with Inovio’s INO-5401, a T cell activating immunotherapy encoding multiple antigens, and INO-9012, an immune activator encoding IL-12. The multi-center, open-label efficacy trial will be managed by Inovio, and Genentech will supply atezolizumab. The trial is evaluating the safety, immune response and clinical efficacy of the combination therapy in approximately 80 patients with advanced bladder cancer, specifically advanced unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer. The majority of the patients to be enrolled in the trial will have previously received and failed to demonstrate meaningful response to an anti-PD-1 or PD-L1 checkpoint inhibitor alone. Thus, the study will evaluate the potential benefit of a checkpoint inhibitor combined with a DNA-based immunotherapeutic and T cell activator within a bladder cancer patient population with very limited treatment options and poor outcomes.

INO-5401: Glioblastoma phase 1/2 trial initiated in combination with Regeneron’s PD-1 inhibitor

In November, Inovio initiated a phase 1b/2a immuno-oncology trial in patients with newly diagnosed glioblastoma (GBM) designed to evaluate Regeneron’s PD-1 inhibitor, REGN2810, in combination with Inovio’s INO-5401 and INO-9012. The open-label trial of 50 patients will be conducted at approximately 30 U.S. sites, and will evaluate safety, tolerability, immune responses as well as progression-free survival and overall survival. GBM is the most aggressive brain cancer and its prognosis is extremely poor, despite a limited number of new therapies approved over the last 10 years. The median overall survival for patients receiving standard of care therapy is approximately 15 months, and the average five-year survival rate is less than three percent.

INO-5150: Prostate cancer immunotherapy slowed PSA rise in patients with recurrent prostate cancer

An interim data analysis from an ongoing open-label phase 1b study showed that Inovio’s INO-5150 cancer immunotherapy product generated antigen-specific CD8+ killer T cell responses measured in peripheral blood from subjects with biochemically recurrent prostate cancer. In the study, INO-5150 treatment as a monotherapy generated prostate specific antigen (PSA) and prostate specific membrane antigen (PSMA) specific T cell responses in peripheral blood in 60% of the subjects. Moreover, patients with specific CD8+ T cell responses experienced dampening in the rise of PSA and significant increases in PSA Doubling Times (PSADT). PSA is a prostate cancer-associated biomarker, and positive changes in PSA levels could signal INO-5150’s potential positive impact on the treatment of prostate cancer.

dMAb shrunk prostate tumors and protected against antibiotic-resistant bacterial infection in published preclinical studies

Two peer-reviewed scientific papers highlighted the potential impact of dMAb constructs on prostate tumors and in preventing infection from a pneumonia-causing bacteria in preclinical studies. A journal article detailed how Inovio’s dMAb construct against PSMA produced monoclonal antibodies that shrank prostate tumors in a preclinical animal model. This research publication is significant because it is the first to report on the use of Inovio dMAb technology to develop novel monoclonal antibody-based therapies against cancer targets. In another first, Inovio also published results of studies in which its dMAb constructs targeting antibiotic-resistant bacteria protected mice when challenged with a lethal dose of drug-resistant pseudomonas, a pneumonia-causing bacteria.

Infectious Disease Vaccines

Positive Zika vaccine clinical data published in New England Journal of Medicine

In October, Inovio reported positive safety and immune response results from a first-in-man, multi-center phase 1 trial of a vaccine against the Zika virus. The phase 1 trial of Inovio’s DNA-based Zika vaccine (GLS-5700) induced high levels of binding antibodies in 100% of participants. Robust neutralizing antibody and T cell immune response were also observed in vaccinated subjects. These positive results were published in the New England Journal of Medicine in the article, titled "Safety and Immunogenicity of an Anti-Zika Virus DNA Vaccine," authored by Inovio researchers and collaborators. A second phase 1 study, now fully enrolled with 160 participants in Puerto Rico, is designed with a placebo control to explore a potential trend towards clinical efficacy. Inovio is the first company to generate positive human data that clearly supports advancement of DNA technology and its Zika vaccine candidate.

Fully-funded phase 1/2 MERS trial initiated in South Korea

Following approval by the Korean Ministry of Food and Drug Safety, in September, Inovio and its development partner, GeneOne Life Science, initiated a study to evaluate GLS-5300, Inovio’s vaccine against the MERS virus (Middle East Respiratory Syndrome), in a phase 1/2a trial. The International Vaccine Institute (IVI) is fully funding this trial utilizing a $34 million grant from the Samsung Foundation provided to IVI in 2015 to support the development of a MERS vaccine. This phase 1/2a trial represents the second clinical trial of GLS-5300, which remains the first and only MERS vaccine being tested in humans. In the first phase 1 MERS study conducted in the United States, high levels of binding antibodies were measured in 92% of evaluated subjects. Significant antigen-specific cytotoxic T-lymphocyte (CTL) responses were also observed.

Lassa fever vaccine advances

Demonstrating its commitment to global public health, in October, Inovio announced positive results of a preclinical study in which a DNA vaccine provided protection against the Lassa fever virus, which infects about 300,000 people annually. In the study, partnered with U.S. Army scientists and fully funded by a grant from the NIH, Inovio’s DNA vaccine provided 100% protection for non-human primates challenged with a lethal dose of the Lassa fever virus. Inovio’s DNA-based platform is especially well-suited to rapidly respond to viral outbreaks and newly emerging pathogens due to its safety profile, ease and speed of development and manufacturing, as well as the ability to be shipped and stored without a cold-chain environment.