1stOncology™: Cancer Intelligence Service – Page 13228 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Inovio Pharmaceuticals Reports 2018 Fourth Quarter and Year-End Financial Results

On March 12, 2019 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 fourth quarter and year ended December 31, 2018 (Press release, Inovio, MAR 12, 2019, View Source [SID1234534260]). 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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

Inovio Pharmaceuticals. (PRNewsFoto/Inovio Pharmaceuticals, Inc.)
Inovio Highlights

MEDI0457 (formerly INO-3112, licensed to AstraZeneca)
Between October 2018 and January 2019, Inovio announced two patients with human papilloma virus (HPV)-related head and neck cancer that were treated with INO-3112 (now called MEDI0457) in a Phase 1 trial achieved a sustained complete response (full remission) following subsequent treatment with a PD-1 checkpoint inhibitor. Both patients who achieved full cancer remission were treated with four doses of synthetic DNA vaccine as part of a Phase 1 monotherapy trial of 22 patients with HPV-related head and neck squamous cell carcinoma in which 91% of patients (20/22) showed T cell activity in the blood or tissue. The administration of synthetic DNA vaccine in the trial generated robust HPV16/18 specific CD8+ T cell responses in peripheral blood and increased CD8+ T cell infiltration in resected tumor tissue samples. Complete response in 2 out of 4 (50%) progressors is encouraging, as to Inovio’s knowledge, the best complete response rate by PD-1 inhibitors as a monotherapy in metastatic head and neck cancer is approximately 4% (8/192 with KEYTRUDA alone and 6/240 with OPDIVO alone).

Additionally, in December 2018, Inovio announced a second Phase 2 study in collaboration with AstraZeneca and the MD Anderson Cancer Center to evaluate MEDI0457 in combination with durvalumab targeting a broad array of cancers associated with HPV. The treatment of the first patient with cervical cancer in this trial resulted in a milestone payment from AstraZeneca to Inovio.
VGX-3100 – HPV-related Pre-cancers
VGX-3100, which is a sibling product candidate to MEDI0457, continues to be evaluated in the double-blind global Phase 3 study for the treatment of cervical dysplasia (CIN). The enrollment for primary study, REVEAL 1, is nearing completion; while the confirmatory study, REVEAL 2, is now open and recruiting. The company maintains the target objective on a BLA submission for VGX-3100 in 2021. In addition to VGX-3100 for the treatment of CIN, the company anticipates interim efficacy later this year from our 2 separate Phase 2 studies that are evaluating the efficacy of VGX-3100 in patients with precancerous lesions of the vulva, or vulvar dysplasia, as well as for anal dysplasia.
INO-5401 – Cancer Combination Trials
Inovio’s Phase 1/2 immuno-oncology trial evaluating INO-5401 plus INO-9012, in combination with Regeneron Pharmaceuticals’ cemiplimab (REGN2810) in patients with newly diagnosed glioblastoma currently has 20 sites open within the United States with the enrollment of 52 patients nearly completed. In Inovio’s other Phase 1/2a study of INO-5401 plus INO-9012, in combination with Genentech/Roche’s atezolizumab, for the treatment of advanced or metastatic bladder cancer, the company recently opened sites in Europe to further accelerate enrollment along with its 13 active sites in the United States. The company expects interim efficacy results from both programs in 2019.
Infectious Diseases
Inovio and its partner GeneOne Life Science, with a full funding from the International Vaccine Institute, are conducting a Phase 1/2a MERS vaccine study in South Korea, with data report expected in 2019. Inovio also plans to initiate a Phase 2 MERS vaccine field trial in the Middle East with full CEPI funding in 2H 2019.
Inovio received IND approval for another CEPI funded vaccine for combatting Lassa fever, which will advance into the first human trial in the second quarter.
All patient samples have been collected for Inovio’s Zika vaccine trial in Puerto Rico. Inovio’s partner GeneOne is analyzing all samples blindly and will report safety, immune responses and infection rate data from this study in 2019.
Inovio expects to have clinical data from several Phase 1 vaccine programs published multiple publications in 2019: Ebola vaccine; MERS vaccine; HIV; and ZIka vaccine study in Puerto Rico.
DNA-Encoded Monoclonal Antibody (dMAb)
In February 2019, the company dosed the first subject in the first-ever human study of Inovio’s DNA-encoded monoclonal antibody (dMAb) technology evaluating the dMAb’s (INO-A002) ability to prevent or treat Zika virus infection. This study is being fully funded by The Bill and Melinda Gates Foundation. While the trial’s focus is on evaluating the dMAb for Zika infection, the clinical results are intended to help advance Inovio’s dMAb programs in infectious diseases and cancer.
Geneos Therapeutics, Inc.
In February 2019, Inovio’s subsidiary Geneos, secured a Series A financing round with potential proceeds of up $10.5 million. This funding has launched Geneos’ operations as a standalone entity to develop the next generation of neoantigen-targeting cancer immunotherapies. Geneos has an exclusive license to Inovio’s DNA-based immunotherapy platform for personalized cancer immunotherapy; Inovio will continue to develop and potentially commercialize all global population-based (non-personalized) cancer immunotherapies and infectious disease vaccines based on its proprietary SynCon design.
Cash Position
As of December 31, 2018, cash and cash equivalents and short-term investments were $81.2 million compared to $85.5 million as of September 30, 2018. In February and March 2019, the Company completed a private placement of $78.5 million aggregate principal amount of 6.50% convertible senior notes due 2024, or the Notes. The Notes were sold in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. Net proceeds from the offering were approximately $75.8 million, after deducting the initial purchasers’ discount and estimated offering expenses payable by the Company.
Dr. J. Joseph Kim, Inovio’s President & CEO said, "Our Phase 3 program for VGX-3100 is advancing with REVEAL 1 nearing complete enrollment and the opening of sites for REVEAL 2. Moreover, Inovio continues to generate impressive efficacy data for HPV-related head and neck cancers, further validating our objective to be the global leader in treating HPV-related diseases. The announcement of the second patient achieving full cancer remission in January provides additional corroboration for Inovio’s overall cancer combination strategy using a T cell activator combined with a checkpoint inhibitor against an array of cancers with big pharma partners providing various checkpoint inhibitors. With interim efficacy data expected later this year from our INO-5401 programs, we believe Inovio is well-positioned to continue to build upon its synthetic DNA immunotherapy approach, while continuing to leverage our current partnerships and seeking to form new ones."

Fourth Quarter 2018 Financial Results

Total revenue was $2.5 million and $30.5 million for the quarter and year ended December 31, 2018, respectively, compared to $8.8 million and $42.2 million for the same periods in 2017. Total operating expenses were $32.0 million and $124.6 million for the quarter and year ended December 31, 2018, respectively, compared to $31.7 million and $125.9 million for the same periods in 2017, respectively.

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 quarter and year ended December 31, 2018, $2.8 million and $9.5 million, respectively, was recorded as contra-research and development expense, which would have been classified as grant revenue in the prior year. Had this change in presentation not occurred, total revenue would have been $5.3 million and $40.0 million for the quarter and year ended December 31, 2018, respectively, compared to $8.8 million and $42.2 million for the same periods in 2017. Total operating expenses would have been $34.8 million and $134.1 million for the quarter and year ended December 31, 2018, respectively, compared to $31.7 million and $125.9 million for the same periods in 2017.

Inovio’s net loss for the quarter and year ended December 31, 2018 was $33.0 million, or $0.34 per basic and diluted share, and $97.0 million, or $1.05 per basic and diluted share, respectively, as compared to $21.5 million, or $0.24 per basic and diluted share, and $88.2 million, or $1.08 per basic and $1.09 per diluted share, for the same periods in 2017.

Revenue

The year over year decrease in comparable revenue and grant agreement recognition was primarily due to $15.4 million in lower revenues recognized under Inovio’s collaborative research and development agreement with AstraZeneca, as previously deferred revenue was recognized in June 2017 upon AstraZeneca’s selection of the first cancer research collaboration product candidate. There was also a decrease in grant funding recognized from Inovio’s DARPA Ebola grant of $8.8 million as well as no revenue recognized in 2018 from Roche compared to $6.1 million for 2017 due to the termination of the agreement in 2017. These decreases were partially offset by the recognition of the gross up-front payment from ApolloBio of $23.0 million during the year (approximately $19.4 million after payment of required taxes), as well as an increase in grant funding from the CEPI grant of $4.3 million, among other variances.

Operating Expenses

Research and development (R&D) expenses for the quarter and year ended December 31, 2018 were $26.4 million and $95.3 million, respectively, compared to $24.6 million and $98.6 million for the same periods in 2017. The year over year decrease in R&D expenses was primarily due to the $9.5 million contra-research and development expense recorded from grant agreements as discussed above, as well as a decrease in expenses related to Inovio’s DARPA Ebola grant. These decreases were offset by an increase in expenses for drug manufacturing related to Inovio’s collaboration with AstraZeneca, employee headcount to support clinical trials and partnerships, and expenses related to clinical trials, among other variances.

General and administrative expenses were $5.6 million and $29.3 million, respectively, for the quarter and year ended December 31, 2018 versus $8.0 million and $28.3 million, respectively, for the same periods in 2017.

Capital Resources

As of December 31, 2018, cash and cash equivalents and short-term investments were $81.2 million compared to $85.5 million as of September 30, 2018. As of December 31, 2018, the Company had 97.2 million common shares outstanding and 107.7 million common shares outstanding on a fully diluted basis, after giving effect to outstanding options, restricted stock units and convertible preferred stock.

During the year ended December 31, 2018, the Company sold 5,669,025 shares of common stock under its current and prior "at-the-market" (ATM) common stock sales agreements for aggregate net proceeds of $29.2 million.

During the year ended December 31, 2018, stock options and warrants to purchase an aggregate of 756,853 shares of common stock were exercised for aggregate net proceeds of $2.4 million.

In February and March 2019, the Company completed a private placement of $78.5 million aggregate principal amount of 6.50% convertible senior notes due 2024, or the Notes. The Notes were sold in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. Net proceeds from the offering were approximately $75.8 million, after deducting the initial purchasers’ discount and estimated offering expenses payable by the Company.

CTI BioPharma to Present at Oppenheimer’s 29th Annual Healthcare Conference on Tuesday, Mar. 19

On March 12, 2019 CTI BioPharma Corp. (CTI BioPharma) (NASDAQ: CTIC) reported that management will provide a corporate overview at Oppenheimer’s 29th Annual Healthcare Conference at 4:30 p.m. EDT at the Westin New York Grand Central (Press release, CTI BioPharma, MAR 12, 2019, View Source;p=RssLanding&cat=news&id=2390949 [SID1234534257]).

Presentation details:

Event:

Oppenheimer’s 29th Annual Healthcare Conference

Date:

Tuesday, Mar. 19

Time:

4:30 p.m. EDT

The presentation will be webcast live and available for replay from the Investors section of CTI BioPharma’s website at www.ctibiopharma.com.

Lilly’s CYRAMZA® (ramucirumab) Phase 3 RELAY Trial Met Primary Endpoint, Significantly Improving Progression-Free Survival in First-Line Treatment of Patients with Metastatic EGFR-Mutated Non-Small Cell Lung Cancer

On March 12, 2019 Eli Lilly and Company (NYSE: LLY) reported that its Phase 3 RELAY study of CYRAMZA (ramucirumab) met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant improvement in the time patients lived without their cancer growing or spreading after starting treatment (Press release, Eli Lilly, MAR 12, 2019, View Source [SID1234534255]). The Phase 3 global, randomized, double-blind trial is evaluating CYRAMZA in combination with erlotinib, compared to placebo in combination with erlotinib, as a first-line treatment in patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have activating EGFR mutations.

The safety profile observed in the RELAY study was consistent with what has been previously observed for CYRAMZA in Phase 3 clinical trials and the established safety profile of erlotinib. The most common (>5% incidence) Grade ≥3 adverse events occurring at a higher rate (≥5% difference) on the CYRAMZA-plus-erlotinib arm compared to the placebo-plus-erlotinib arm were hypertension, dermatitis acneiform (an acne-like rash), and diarrhea. Detailed efficacy and safety results will be submitted for presentation at a medical meeting in 2019.

"Despite recent treatment advances in metastatic EGFR-mutated non-small cell lung cancer, prognosis remains poor and there is an ongoing need for additional first-line treatment options to help patients with this deadly disease," said Maura Dickler, M.D., vice president of late phase development, Lilly Oncology.

There is no cure for people with metastatic lung cancer. The disease is associated with low survival rates and disease progression following acquired resistance remains a challenge. Most patients receive several lines of treatment and the therapeutic regimen prescribed for first-line treatment can impact a person’s options for later lines of treatment. Tyrosine kinase inhibitors (TKIs) are the current standard treatment option for EGFR-mutated NSCLC. Erlotinib, the TKI included in the RELAY trial regimen, is a globally recognized standard of care for this type of lung cancer.

"We are excited about these results, which show CYRAMZA plus erlotinib significantly delayed disease progression in this patient population. The RELAY trial is another example of Lilly’s deep commitment to providing new treatment options to patients with lung cancer," said Dr. Dickler. "We would like to thank the patients, investigators and clinical trial sites that are participating in the RELAY study, and we look forward to working with regulatory authorities globally on our submissions."

Lilly intends to initiate global regulatory submissions in mid-2019.

RELAY is the second positive Phase 3 study of CYRAMZA in metastatic NSCLC. In the positive Phase 3 REVEL study, CYRAMZA plus docetaxel was compared to placebo plus docetaxel in people with metastatic NSCLC whose cancer had progressed on or after prior platinum-based chemotherapy for locally advanced or metastatic disease. The primary endpoint of overall survival was met, as well as key secondary endpoints of PFS and response rate. The REVEL results supported CYRAMZA’s current indication in second-line NSCLC.

Results of previously completed Phase 3 studies of CYRAMZA have also supported approvals in second-line gastric and colorectal cancer. Based on the REACH-2 results, Lilly has made regulatory submissions in the U.S., EU and Japan for the use of CYRAMZA in second-line treatment of patients with hepatocellular carcinoma.

About the RELAY Trial
RELAY is a global randomized, double-blind, placebo-controlled Phase 3 study of CYRAMZA in combination with erlotinib, compared to placebo in combination with erlotinib, as a first-line treatment in previously untreated patients with metastatic NSCLC whose tumors have EGFR (epidermal growth factor receptor) exon 19 deletions or exon 21 (L858R) substitution mutations. Initiated in 2015, the study randomized 449 patients across North America, Europe and Asia. The primary endpoint of the RELAY trial is progression-free survival; key secondary endpoints include safety, response rate, overall survival, and patient-reported outcomes.

About Lung Cancer and EGFR Mutations
Lung cancer is the leading cause of cancer death in the U.S. and most other countries, killing nearly 1.7 million people worldwide each year.1 In the U.S., lung cancer is responsible for approximately 25 percent of all cancer deaths, more than those from breast, colon and prostate cancers combined.2 Non-small cell lung cancer (NSCLC) is much more common than other types of lung cancer and accounts for about 80 to 85 percent of all lung cancer cases.3 Stage IV NSCLC is a very difficult-to-treat cancer and the prognosis is poor for metastatic NSCLC.4

EGFR is a protein that helps cells grow and divide. When the EGFR gene is mutated it can cause the protein to be overactive, resulting in the formation of cancer cells. EGFR mutations may occur in 10 to 35 percent of NSCLC tumors globally.5 Activating EGFR mutations are found in about 10 to 20 percent of Caucasian patients with lung adenocarcinomas and in up to 40 to 60 percent of Asian patients.6,7,8 Regardless of ethnicity, these mutations are commonly found in females, non-smokers and those with adenocarcinoma histology.9,10 The most common EGFR mutations are activating exon 19 deletion and exon 21 (L858R) substitution mutations, which are present in over 90 percent of EGFR-mutated tumors.7,8

About CYRAMZA (ramucirumab)
In the U.S., CYRAMZA (ramucirumab) is approved for use as a single agent or in combination with paclitaxel as a treatment for people with advanced or metastatic gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy. It is also approved in combination with docetaxel as a treatment for people with metastatic non-small cell lung cancer (NSCLC) whose cancer has progressed on or after platinum-based chemotherapy. Additionally, it is approved with FOLFIRI as a treatment for people with metastatic colorectal cancer (mCRC) whose cancer has progressed on or after therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.

CYRAMZA is being investigated in a broad global development program that has enrolled more than 14,000 patients across more than 100 trials worldwide. These include several studies investigating CYRAMZA in combination with other anti-cancer therapies for the treatment of multiple tumor types.

Ramucirumab is an antiangiogenic therapy. It is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that specifically binds and blocks activation of VEGF Receptor 2 by blocking the binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D. Ramucirumab inhibited angiogenesis in an in vivo animal model.

About Angiogenesis and VEGF Protein
Angiogenesis is the process of making new blood vessels. In a person with cancer, angiogenesis creates new blood vessels that give a tumor its own blood supply, allowing it to grow and spread.

Some tumors create proteins called VEGF. These proteins attach to the VEGF receptors of blood vessel cells causing new blood vessels to form around the tumors, enabling growth. Blocking the VEGF protein from linking to the blood vessels helps to inhibit tumor growth by slowing angiogenesis and the blood supply that feeds tumors. Of the three known VEGF receptors, VEGF Receptor 2 is linked most closely to VEGF-induced tumor angiogenesis.

INDICATIONS
Gastric Cancer
CYRAMZA, as a single agent or in combination with paclitaxel, is indicated for the treatment of patients with advanced or metastatic, gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.

Non-Small Cell Lung Cancer
CYRAMZA, in combination with docetaxel, is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. Patients with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving CYRAMZA.

Colorectal Cancer
CYRAMZA, in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil), is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.

Altimmune Announces Closing of $14 Million Registered Direct Offering

On March 12, 2019 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, reported the closing of the previously announced registered direct offering of common units and pre-funded units receiving gross proceeds of $14 million (Press release, Altimmune, MAR 12, 2019, View Source [SID1234534252]).

On March 8, 2019, the Company disclosed approximately $34.4 million in cash, cash equivalents and restricted cash as of December 31, 2018. Altimmune intends to use the cash on hand together with the net proceeds of approximately $12.7 million from this offering for the continued advancement and development activities for its product pipeline, strategic growth opportunities (including potential acquisitions and/or licensing transactions), and general working capital purposes.

Roth Capital Partners acted as sole placement agent for the offering.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

The securities described above were offered by Altimmune pursuant to a registration statement on Form S-3 (File No. 333-217034) that was declared effective by the Securities and Exchange Commission (SEC) on April 6, 2017. A final prospectus supplement and an accompanying prospectus relating to the offering were filed with the SEC on March 11, 2019 and are available on the SEC’s web site at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained by contacting Roth Capital Partners, LLC, Attention: Equity Capital Markets, 888 San Clemente Drive, Suite 400, Newport Beach, California 92660, by telephone at (800) 678-9147 or e-mail at [email protected].

Company Presentation, March 2019

On March 12, 2019 Y-mAbs Therapeutics presented Corporate presentation (Presentation, Y-mAbs Therapeutics, MAR 12, 2019, View Source [SID1234534247]).