On November 8, 2018 Dova Pharmaceuticals, Inc. (NASDAQ: DOVA), a pharmaceutical company focused on acquiring, developing, and commercializing drug candidates for diseases where there is a high unmet need, reported its operating and financial results for the third quarter ended September 30, 2018 (Press release, Dova Pharmaceuticals, NOV 8, 2018, View Source [SID1234531030]).

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"We continued to make steady progress in the third quarter with both our launch efforts for DOPTELET for patients with thrombocytopenia associated with chronic liver disease as well as the potential expansion of DOPTELET for additional indications," said Alex C. Sapir, President and Chief Executive Officer of Dova. "We were also delighted to have finalized an agreement with Salix Pharmaceuticals, one of the world’s premier gastrointestinal pharmaceutical companies, in order to expand our reach to target gastroenterologists. We continue to hear very positive feedback from the market on how DOPTELET is performing in patients and because of that experience, we are consistently adding more new prescribers. In addition, we are also excited that FDA accepted the avatrombopag supplemental New Drug Application (sNDA) for review for the treatment of chronic ITP, which provides additional long-term growth potential for DOPTELET."

DOPTELET Launch Highlights
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From launch through September 30, 2018, a total of 335 health care professionals have prescribed DOPTELET to their patients with an increasing number using DOPTELET for multiple patients within their practice.

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During the third quarter, for prescriptions that completed the adjudication process with payers, Dova has seen 81% of those prescriptions approved by the payer with an average approval time of 7.9 days.

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Dova has made significant progress in its outreach efforts having reached 67% of target prescribers an average of 2.8 times from launch through September 30, 2018.

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Inventory held by specialty pharmacies increased by approximately 65% from July 1, 2018 to September 30, 2018 as certain specialty pharmacies increased their inventory levels and stocking locations based on increased patient shipments.

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In September, Dova entered into an exclusive co-promotion agreement with Salix Pharmaceuticals to co-promote DOPTELET in the United States. Salix is deploying approximately 100 sales specialists who will promote DOPTELET to gastroenterology healthcare professionals. Dova will continue its commercial efforts targeting primarily hepatologists and interventional radiologists and certain other specialties.

Other Important Highlights for the Quarter
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The U.S. FDA accepted for review Dova’s sNDA for DOPTELET for the treatment of thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to a previous treatment. The sNDA for ITP is supported by safety and efficacy data from two Phase 2 clinical trials and one randomized, placebo-controlled Phase 3 clinical trial that met its primary and secondary efficacy endpoints with high statistical significance. The Prescription Drug User Fee Act (PDUFA) goal date for an FDA decision is June 30, 2019.

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Following the submission in April of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for DOPTELET for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure, the Company expects a target decision date for approval in Europe in the second or third quarter of 2019.

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Enrollment remains ongoing for the Company’s Phase 3 clinical trial for the treatment of patients with chemotherapy-induced thrombocytopenia (CIT), the pre-surgery study treating thrombocytopenia, and the CLD registry study.

Third Quarter and Financial Results

Dova reported a net loss of $19.5 million for the third quarter of 2018, compared to a net loss of $9.7 million for the same period in 2017.

For the third quarter of 2018, Dova reported net product sales from DOPTELET of $2.9 million. The Company recognizes revenue when products are delivered to its specialty pharmacy partners.

Cost of product sales for the third quarter were $0.4 million, which consisted of the cost of inventory, royalty payments due to Astellas and certain distribution and overhead costs.

Research and development expenses were $4.8 million in the third quarter of 2018, compared to $5.4 million for the same period in 2017. The decrease was primarily driven by the $1.0 million

milestone payment that Dova became obligated to pay Astellas upon submission of the NDA and the completion of the clinical trials in 2017 of DOPTELET, partially offset by the initiation of clinical trials to evaluate DOPTELET for the treatment of a broader population of surgical patients as well as for CIT.

Selling, general and administrative expenses were $17.0 million in the third quarter of 2018, compared to $4.2 million for the same period in 2017. The increase was primarily driven by increased headcount and sales and marketing activities to support the commercial launch of DOPTELET, increased corporate infrastructure, and additional costs associated with operating as a public entity.

As of September 30, 2018, Dova had $122.0 million in cash and equivalents compared to $94.8 million as of December 31, 2017.

Company to Host Conference Call

Dova will host a conference call today, November 8, 2018 at 4:30 p.m. ET to discuss third quarter 2018 financial results and recent operational highlights. A question-and-answer session will follow Dova’s remarks.

To participate on the live call, please dial 866-550-8145 (domestic) or +1-430-775-1344 (international) and provide the conference ID 2574148 five to 10 minutes before the start of the call.

A live audio webcast of the call will also be available via the "Investor Relations" page of the Dova website, www.dova.com. Please log on through Dova’s website approximately 10 minutes before the scheduled start time. A replay of the webcast will be archived on Dova’s website for 90 days following the call.

Indication and Important Safety Information

INDICATION

DOPTELET (avatrombopag) is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

DOPTELET is a thrombopoietin (TPO) receptor agonist and TPO receptor agonists have been associated with thrombotic and thromboembolic complications in patients with chronic liver disease. Portal vein thrombosis has been reported in patients with chronic liver disease treated with TPO receptor agonists. In the ADAPT-1 and ADAPT-2 clinical trials, there was 1 treatment-emergent

event of portal vein thrombosis in a patient (n=1/430) with chronic liver disease and thrombocytopenia treated with DOPTELET.

Consider the potential increased thrombotic risk when administering DOPTELET to patients with known risk factors for thromboembolism, including genetic prothrombotic conditions (Factor V Leiden, Prothrombin 20210A, Antithrombin deficiency or Protein C or S deficiency).

DOPTELET should not be administered to patients with chronic liver disease in an attempt to normalize platelet counts.

CONTRAINDICATIONS:

None

ADVERSE REACTIONS:

Most common adverse reactions (≥ 3%) were: pyrexia, abdominal pain, nausea, headache, fatigue, and edema peripheral.

Please see full Prescribing Information for DOPTELET (avatrombopag) www.doptelet.com

On November 8, 2018 Inovio Pharmaceuticals, Inc. (NASDAQ:INO), a late-stage biotechnology company focused on the development and commercialization of DNA immunotherapies targeted against cancers and infectious diseases, reported financial results for the third quarter ended September 30, 2018 (Press release, Inovio, NOV 8, 2018, View Source [SID1234531047]). Inovio’s management will host a live conference call and webcast at 4:30 p.m. Eastern Time today to discuss financial results and provide a general business update.

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Inovio Highlights

VGX-3100 – HPV-related Precancers
Phase 3 trial enrollment remains ongoing and on track for REVEAL 1, with REVEAL 2 expected to begin in early 2019. To date, REVEAL 1 has opened sites across 19 countries, actively recruiting patients. Recruitment for Phase 2 studies in vulvar dysplasia and anal dysplasia is also underway. In August, Inovio entered into a partnership with the AIDS Malignancy Consortium to evaluate VGX-3100 in a multi-site Phase 2 study in HIV-positive adult men and women. Interim efficacy data from all these Phase 2 studies are expected in 2019.
MEDI0457 (formerly INO-3112, licensed to MedImmune)
The October issue of Clinical Cancer Research detailed results of a patient with head and neck cancer treated with MEDI0457 who achieved a sustained complete response (full remission) following subsequent treatment with a PD-1 checkpoint inhibitor. In the Inovio-sponsored study of 22 patients with head and neck squamous cell carcinoma, 91% of patients (20/22) showed T cell activity in the blood or tissue. MEDI0457 is currently in a Phase 2 study to evaluate the anti-tumor activity of MEDI0457 in combination with durvalumab in patients with recurrent/metastatic HPV 16- or 18- associated head and neck cancer. MedImmune is also expected to begin another Phase 2 study in the fourth quarter to evaluate the anti-tumor activity of MEDI0457 in combination with durvalumab in patients with recurrent/metastatic HPV 16- or 18- associated cancers (other than head and neck). The commencement of this study will trigger a milestone payment to Inovio under the terms of the parties’ collaboration agreement.
INO-5150 – Prostate cancer
Presented prostate cancer data from Inovio’s Phase 1 study at the ESMO (Free ESMO Whitepaper) 2018 conference in which a slowing of Prostate-Specific Antigen Doubling Time (PSADT) was observed in men with prostate cancer, with 86% of patients remaining progression-free at week 72.
INO-5401 – Cancer Combination Trials
Enrollment is going as planned and is on target to report interim Phase 2 data for both glioblastoma (GBM) and bladder cancer in 2019. In both trials INO-5401 is combined with a checkpoint inhibitor – for GBM with Regeneron (PD-1); for bladder cancer with Genentech (PD-L1).
PENNVAX-GP – HIV
In August, first patient was dosed with PENNVAX-GP in a randomized clinical trial that will evaluate its ability to drive remission of HIV infection. Enrollment remains on track. The trial is part of a previously reported multi-year $6.95 million grant from the NIH’s National Institute of Allergy and Infectious Diseases to develop a single or combination therapy using Inovio’s PENNVAX-GP with the goal of attaining long-term HIV remission. Inovio anticipates interim results in 2019.
INO-4700 (GLS-5300) – MERS
First patient was dosed with vaccine to prevent infection from the deadly MERS virus (Middle East Respiratory Syndrome) in a Phase 1/2a study to evaluate INO-4700 (or GLS-5300). The trial is ongoing in South Korea, sponsored by Inovio’s Korean development partner GeneOne Life Science (KSE: 011000) with full funding from the International Vaccine Institute. Inovio anticipates interim results in 2019.
DNA-Encoded Monoclonal Antibody (dMAb)
In October, Inovio received the first two U.S. patents for its DNA-encoded monoclonal antibody technology (dMAb) from the USPTO and was awarded a $2.2 million grant from the Bill & Melinda Gates Foundation to advance its dMAb platform and new clinical delivery devices. In addition, Inovio announced an important milestone in the field of dMAb immunotherapies where Inovio was the first to report evidence on the use of dMAb technology to develop novel monoclonal antibody-based therapies targeting checkpoint inhibitors.
Cash Position
As of September 30, 2018, cash and cash equivalents and short-term investments were $85.5 million compared to $95.6 million as of June 30, 2018.
Dr. J. Joseph Kim, Inovio’s President & CEO said, "Utilizing ample resources, Inovio is making significant advancements on many fronts. The Phase 3 REVEAL 1 study for our lead VGX-3100 program is on track to fully enroll in 2019 and our three separate immuno-oncology, checkpoint combination Phase 2 trials, being executed with top partners and collaborators, MedImmune, Genentech, and Regeneron, are also advancing well. In fact, we saw a potential preview of what could come from the ongoing cancer efficacy studies in a new publication in Clinical Cancer Research which showcased the first complete responder from our Phase 1 MEDI0457 head & neck cancer trial. Also progressing well are our externally funded vaccine programs including the CEPI-funded Lassa vaccine program as well as IVI-funded MERS and GeneOne-funded Zika vaccine trials. Overall, these clinical trial advancements ensure that we will have multiple, meaningful data catalysts in the coming months."

Third Quarter 2018 Financial Results

Total revenue was $2.0 million for the three months ended September 30, 2018, compared to $2.6 million for the same period in 2017. Total operating expenses were $28.6 million compared to $31.8 million for the same period in 2017.

As a result of the adoption of Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers, beginning on January 1, 2018, all contributions received from current grant agreements have been recorded as a contra-expense as opposed to revenue on the consolidated statement of operations. For the three months ended September 30, 2018, $2.6 million was recorded as contra-research and development expense, which amount would have been classified as grant revenue in the prior year. Had this change in presentation not occurred, total revenue would have been $4.6 million for the three months ended September 30, 2018, compared to $2.6 million for the same period in 2017. Total operating expenses would have been $31.2 million compared to $31.8 million for the same period in 2017.

Inovio’s net loss for the quarter ended September 30, 2018 was $25.0 million, or $0.27 per basic and diluted share, compared to $34.1 million, or $0.39 per basic and $0.40 per diluted share, for the quarter ended September 30, 2017.

Revenue

The increase in comparable revenue and grant agreement recognition for the third quarter of 2018 compared to 2017 was primarily due to increases from Inovio’s MedImmune collaboration and its CEPI grant of $1.5 million and $1.2 million, respectively. These increases were offset by a decrease in grant funding recognized from Inovio’s DARPA Ebola grant of $1.2 million, among other variances.

Operating Expenses

Research and development (R&D) expenses for the three months ended September 30, 2018 were $21.9 million compared to $25.5 million for the same period in 2017. The decrease in R&D expenses was primarily due to the $2.6 million contra-research and development expense recorded from grant agreements as discussed above, as well as a decrease of $2.4 million in expenses related to Inovio’s DARPA Ebola grant. These decreases were slightly offset by an increase of $1.4 million for drug manufacturing related to Inovio’s collaboration with MedImmune and an increase of $746,000 related to employee headcount to support clinical trials and partnerships, among other variances.

General and administrative (G&A) expenses were $6.8 million for the three months ended September 30, 2018 versus $6.3 million for the same period in 2017.

Capital Resources

As of September 30, 2018, cash and cash equivalents and short-term investments were $85.5 million compared to $95.6 million as of June 30, 2018. As of September 30, 2018, the Company had 94.5 million common shares outstanding and 105.1 million common shares outstanding on a fully diluted basis, after giving effect to outstanding options, restricted stock units and convertible preferred stock.

During the nine months ended September 30, 2018 the Company sold 2,967,480 shares of common stock under its current and prior ATM common stock sales agreements for aggregate net proceeds of $14.9 million.

During the nine months ended September 30, 2018, stock options and warrants to purchase an aggregate of 713,944 shares of common stock were exercised for aggregate net proceeds of $2.3 million.

Inovio’s balance sheet and statement of operations are provided below. Form 10-Q for the quarter ended September 30, 2018 providing the complete 2018 third quarter financial report can be found at: View Source

Conference Call / Webcast Information

Inovio’s management will host a live conference call and webcast at 4:30 p.m. Eastern Time today to discuss Inovio’s financial results and provide a general business update.

The live webcast and a replay may be accessed by visiting the Company’s website at View Source Telephone replay will be available approximately two hours after the call at 877-481-4010 (domestic) or 919-882-2331 (international) using replay ID 39603.

On November 8, 2018 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, reported financial results and business highlights for the third quarter ended September 30, 2018 (Press release, Tocagen, NOV 8, 2018, View Source;p=RssLanding&cat=news&id=2376312 [SID1234531164]).

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"We conclude the eventful third quarter of 2018 having met important milestones, including early completion of enrollment and the first interim analysis of our ongoing Phase 3 Toca 5 trial. We’ve also further improved our balance sheet to advance our lead program and execute against our goals," said Marty Duvall, chief executive officer of Tocagen. "With the planned second interim and final analyses for Toca 5 anticipated in 2019, we are preparing for a potential rolling BLA submission and planning for commercial launch."

Third Quarter 2018 and Recent Highlights

First interim analysis of Toca 5 Phase 3 trial: In August 2018, Tocagen announced the Toca 5 pivotal Phase 3 trial evaluating Toca 511 (vocimagene amiretrorepvec) & Toca FC (extended-release flucytosine) in patients with recurrent high grade glioma (rHGG) will continue without modification following a pre-planned first interim analysis of data. An Independent Data Monitoring Committee completed its analysis at 50% of events occurring in the trial and recommended the trial continue without modification. Tocagen estimates the second interim analysis, at 75% of events in the trial, will occur in the first half of 2019 and that the final analysis will occur by the end of 2019.
Completed Toca 5 enrollment: In September 2018, Tocagen completed the planned enrollment of 380 patients in the ongoing Toca 5 Phase 3 trial approximately three months ahead of schedule.
Received milestone payment from ApolloBio: Completing the Toca 5 enrollment triggered a milestone payment of $2 million from ApolloBio, Tocagen’s licensee of Toca 511 & Toca FC within the greater China region.
Initiated commercial organization buildout: In September 2018, Mohamed Ladha joined Tocagen as vice president, head of commercial. Mr. Ladha will build, oversee and execute the global commercial strategies for Tocagen’s oncology products upon regulatory approval in the United States and other key markets.
Presented Toca 6 data: Tocagen presented new clinical data on Toca 511 & Toca FC in advanced solid tumors at the International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) in late September. Data showed favorable safety, vector deposition in "hot" and "cold" tumors and immune changes consistent with preclinical and clinical observations. Based on these data, Tocagen is now planning future safety and efficacy trials in select tumor types.
Publication of Toca 511 & Toca FC data: In October 2018, two peer-reviewed clinical data manuscripts appeared in print related to Toca 511 & Toca FC in rHGG. Data published by Timothy F. Cloughesy and co-authors in Neuro-Oncology demonstrated multiyear durable responses observed in rHGG patients treated in a Toca 511 & Toca FC Phase 1 trial. Data published by Daniel J. Hogan and co-authors in Clinical Cancer Research demonstrated Toca 511 & Toca FC treatment was not associated with concerning integration sites and clonal expansion. These manuscripts first published online May 12, 2018 and June 26, 2018, respectively.
Third Quarter 2018 Financial Results

License Revenue: License revenue was $18.0 million for the quarter ended September 30, 2018, compared to less than $0.1 million for the quarter ended September 30, 2017. The 2018 revenue was associated with a $16.0 million upfront payment recognized under Tocagen’s license agreement with ApolloBio and a $2.0 million development milestone earned upon completion of enrollment in the Toca 5 clinical study.

Research and Development (R&D) Expenses: R&D expenses were $12.3 million for the quarter ended September 30, 2018, compared to $7.6 million for the quarter ended September 30, 2017. The increase in R&D expenses in 2018 was primarily driven by higher costs to support the expanded Toca 5 Phase 3 clinical study and manufacturing activities related to Toca 511.

General and Administrative (G&A) Expenses: G&A expenses were $4.3 million for the quarter ended September 30, 2018, compared to $2.2 million for the quarter ended September 30, 2017. The increase in G&A expenses was primarily due to foreign non-income tax expense of approximately $1 million paid under Tocagen’s license agreement with ApolloBio and an increase in non-cash stock-based compensation expense.

Net Loss: Net loss was $0.4 million, or $0.02 per common share (basic and diluted), for the quarter ended September 30, 2018, compared to a net loss of $10.0 million, or $0.50 per common share (basic and diluted), for the quarter ended September 30, 2017. The reduction in net loss in 2018 was due to $18.0 million in revenue recognized under Tocagen’s license agreement with ApolloBio. Tocagen recognized $1.5 million in income taxes for the quarter ended September 30, 2018 related to the license agreement with ApolloBio. The 2018 calculation is based on 20.0 million average common shares outstanding for the third quarter of 2018, compared to 19.8 million average shares outstanding for the third quarter of 2017.

2018 Nine-Month Results

License Revenue: License revenue was $18.0 million for the nine months ended September 30, 2018, compared to less than $0.1 million for the nine months ended September 30, 2017. The 2018 revenue was associated with a $16.0 million upfront payment recognized under Tocagen’s license agreement with ApolloBio and a $2.0 million development milestone earned upon completion of enrollment in the Toca 5 clinical study.

R&D Expenses: R&D expenses were $35.5 million for the nine months ended September 30, 2018 compared to $20.8 million for the nine months ended September 30, 2017. Similar to the third quarter results, the R&D expenses primarily reflect increased costs to support the expanded Toca 5 Phase 3 clinical study, manufacturing activities related to Toca 511 & Toca FC and personnel and related costs due to increased headcount.

G&A Expenses: G&A expenses were $9.3 million for the nine months ended September 30, 2018 compared to $6.2 million for the nine months ended September 30, 2017. Similar to the third quarter results, the G&A expenses primarily reflect the foreign non-income tax expense paid under Tocagen’s license agreement with ApolloBio and an increase in non-cash stock-based compensation expense.

Net Loss: Net loss for the nine months ended September 30, 2018 was $29.4 million, or $1.47 per common share (basic and diluted), compared to a net loss of $28.1 million, or $2.19 per common share (basic and diluted), for the nine months ended September 30, 2017. This calculation is based on 19.9 million average common shares outstanding for the nine months ended September 30, 2018, compared to 12.8 million average shares outstanding for the same period in 2017.

Cash Position and Guidance
Cash, cash equivalents and marketable securities were $79.8 million at September 30, 2018 compared to $88.7 million at December 31, 2017. Tocagen refined its annual cash burn guidance and estimates the total cash used in 2018 to fund operations and capital expenditures will be approximately $50 million, resulting in a year-end cash balance of approximately $70 million, up from approximately $40 million implied in guidance provided in January 2018.

About Toca 511 & Toca FC
Tocagen’s lead product candidate is a two-part cancer-selective immunotherapy comprising an investigational biologic, Toca 511, and an investigational small molecule, Toca FC. Toca 511 is a retroviral replicating vector (RRV) that selectively infects cancer cells and delivers a gene for the enzyme, cytosine deaminase (CD). Through this targeted delivery, only infected cancer cells carry the CD gene and produce CD. Toca FC is an orally administered prodrug, 5-fluorocytosine (5-FC), which is converted into an anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD. 5-FU kills cancer cells and immune-suppressive myeloid cells resulting in anti-cancer immune activation and subsequent tumor killing.

On November 8, 2018 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported financial results for the third quarter ended September 30, 2018 and provided an update on clinical and corporate developments (Press release, Deciphera Pharmaceuticals, NOV 8, 2018, View Source [SID1234530953]).

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"Recent clinical and corporate achievements support Deciphera’s transition to a late-stage, pre-commercial company," said Michael D. Taylor, Ph.D., President and Chief Executive Officer of Deciphera. "Data presented at ESMO (Free ESMO Whitepaper) have bolstered our confidence in DCC-2618’s potential to transform the current treatment paradigm for GIST patients. As we approach the completion of enrollment for our pivotal Phase 3 INVICTUS study in the coming weeks, we look forward to the data readout from that study expected next year. In addition, we remain on track to initiate our Phase 3 INTRIGUE study later this year. We are building our commercial capabilities for DCC-2618 in the United States and are continuing to invest in our clinical-stage pipeline, with the recent initiation of our Phase 1b/2 clinical study of our investigational agent rebastinib in combination with paclitaxel."

Clinical Programs

DCC-2618
At the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress in October 2018, Deciphera presented updated preliminary Phase 1 clinical study results of DCC-2618 in patients with gastrointestinal stromal tumors (GIST). Highlights from the presentation included:
Preliminary median progression free survival (mPFS) in second- and third-line GIST patients of 42 weeks and 40 weeks, respectively, that the Company believes demonstrates the potential for improved and durable clinical outcomes in patients with less advanced disease.
Updated objective response rates (ORR) and disease control rates (DCR) in second- and third-line GIST patients continue to exceed previously published results of registrational trials for currently approved therapies.
In fourth-line and fourth-line-plus GIST patients, for whom there are currently no approved therapies, the Company believes that the observed mPFS of 24 weeks demonstrates the potential for durable clinical outcomes in patients with advanced disease. Published studies have reported a mPFS of 4 to 6 weeks for similarly heavily pre-treated patients who did not receive an active therapy.
Deciphera expanded the ongoing Phase 1 study to include additional cohorts for patients with: various solid tumors, including melanoma; non-small cell lung cancer; germ cell cancer; penile cancer; soft tissue sarcoma; GIST or other solid tumor patients with renal impairment.
Deciphera will present preclinical data on the effects of the combination of DCC-2618 and MAPK pathway inhibitors on cell death and apoptosis in cellular assays of GIST and mastocytosis in a poster session at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium on November 13, 2018.
Data in GIST patients from the ongoing Phase 1 study that were presented at the ESMO (Free ESMO Whitepaper) 2018 Congress in October 2018 will also be presented at the Annual Meeting of the Connective Tissue Oncology Society (CTOS) on November 15, 2018.
Deciphera previously announced that, following discussions with regulatory authorities in the United States and Europe, it is planning to initiate later this year a randomized, multicenter, open-label, pivotal Phase 3 INTRIGUE study evaluating DCC-2618 compared to sunitinib in second-line GIST patients.
Rebastinib
Deciphera initiated a Phase 1b/2 clinical study of rebastinib, the Company’s small molecule kinase switch control inhibitor of TIE2. In this two-part clinical study, rebastinib will be evaluated for the treatment of patients with advanced or metastatic solid tumors in combination with paclitaxel.
DCC-3014
Deciphera continues to enroll patients in the Phase 1 dose escalation study of DCC-3014, a selective small molecule kinase switch control inhibitor of CSF1R and expects to provide an update on this study later this year.
Corporate Updates

In September 2018, Deciphera appointed Daniel C. Martin as Chief Commercial Officer. Mr. Martin has more than 20 years of commercial experience within the biopharmaceutical industry with extensive background in oncology, including immuno-oncology.
In November 2018, Oliver Rosen, M.D., informed Deciphera that effective November 30, 2018, he would leave his position as the Company’s Chief Medical Officer to pursue another opportunity at an early-stage, private biotechnology company. The Company has commenced a search for his replacement.
"On behalf of the management team and board of directors, I want to thank Oliver for his many contributions to Deciphera over the past four and a half years," said Dr. Taylor. "During his tenure, Oliver was instrumental in developing DCC-2618 from a promising preclinical asset into a robust late-stage clinical program with a pivotal Phase 3 study expected to read out in 2019, a second Phase 3 study that is planned to initiate soon and a series of expansion studies in multiple indications. We wish Oliver all the best in his future endeavors."

"It has been a privilege to be a part of Deciphera’s successful growth since 2014 led by the rapid development of DCC-2618," said Dr. Rosen. "I am proud of the progress the Company has made in translating the promise of its kinase switch control platform into an exciting pipeline of clinical-stage drug candidates designed to provide cancer patients with novel therapies that address unmet medical needs."

Third Quarter 2018 Financial Results

Cash Position: As of September 30, 2018, cash and cash equivalents were $320.9 million, compared to cash and cash equivalents of $196.8 million as of December 31, 2017. This increase was primarily related to proceeds obtained through the Company’s June 2018 underwritten public offering, offset by cash used in operating activities. We expect our current cash and cash equivalents will enable us to fund our operating and capital expenditures and debt service payments into the second half of 2020.
R&D Expenses: Research and development expenses for the third quarter of 2018 were $20.6 million, compared to $9.8 million for the same period in 2017. The increase was primarily due to an increase in spending on the DCC-2618 program of $6.1 million as a result of clinical trial costs related to the pivotal Phase 3 INVICTUS study that began enrollment in January 2018. Clinical trial costs also increased due to start-up activities related to a second Phase 3 INTRIGUE study in second-line GIST, which is expected to be initiated by the end of 2018. In addition, chemistry, manufacturing and controls development and manufacturing costs for the DCC-2618 program increased as a result of process development activities to support anticipated drug requirements for commercialization and the manufacture of registration lots to support the submission of a new drug application. Expenses related to the rebastinib program increased $1.5 million, primarily due to start-up activities related to the Phase 1b/2 study of rebastinib in combination with paclitaxel, which initiated in October 2018. Personnel-related costs increased $2.7 million due to increased headcount in our research and development functions. Personnel-related costs for the third quarters of 2018 and 2017 included non-cash share-based compensation expense of $1.1 million and $0.5 million, respectively.
G&A Expenses: General and administrative expenses for the third quarter of 2018 were $5.3 million, compared to $2.4 million for the same period in 2017. The increase was primarily due to an increase in non-cash share-based compensation expense related to additional employee stock options and a higher value of our common stock and to an increase in legal and professional fees as a result of various advisory fees related to ongoing operations as a public company. Facility-related and other costs increased due to director and officer insurance costs and higher rent expense related to our new lease. Non-cash share-based compensation was $1.5 million and $0.6 million for the third quarters of 2018 and 2017, respectively.
Net Loss: For the third quarter of 2018, Deciphera reported a net loss of $24.4 million, or $0.65 per share, compared with a net loss of $12.0 million, or $1.04 per share, for the same period in 2017.

On November 8, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, reported the appointment of Robert Ward to its Board of Directors. Mr. Ward is currently Chairman and Chief Executive Officer of Eloxx Pharmaceuticals (Press release, OncoSec Medical, NOV 8, 2018, View Source [SID1234530999]).

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"It is with great pleasure that we welcome Bob to our Board. His considerable industry experience leading pharmaceutical companies in bringing new therapies to market and deep insight into successful commercialization strategies will be extremely valuable to OncoSec as we continue to advance our TAVO platform," said Avtar Dhillon, Chairman of OncoSec.

Mr. Ward brings to OncoSec over 30 years of experience as a global biopharmaceutical industry leader with experience across the full spectrum of drug development and commercialization. Mr. Ward currently serves as Chairman and Chief Executive Officer of Eloxx Pharmaceuticals. Prior to joining Eloxx, Mr. Ward was President and Chief Executive Officer of Radius Health, Inc., where he helped the company successfully complete its initial public offering and lead the development, approval and launch of the company’s TYMLOS injection. Prior to joining Radius, Mr. Ward was Vice President for Strategy and External Alliances for the New Opportunities iMed of Astra Zeneca. He has held a series of progressive management and executive roles with established companies such as NPS Pharmaceuticals, Schering-Plough (Merck), Pharmacia (Pfizer), Bristol-Myers Squibb and Genentech. Mr. Ward currently serves as a Director of the Massachusetts High Technology Council and had served as a Director of Akari Therapeutics from October 2016 to August 2018.

Mr. Ward received a B.A. in Biology and a B.S. in Physiological Psychology, both from the University of California, Santa Barbara, an M.S. in Management from the New Jersey Institute of Technology and an M.A. in Immunology from the John Hopkins University School of Medicine.