1stOncology™: Cancer Intelligence Service – Page 13122 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Coordination Pharmaceuticals Announces Enrollment of the First Patient in Phase 1 Study of CPI-200 in Patients With Advanced Tumors

On August 8, 2019 Coordination Pharmaceuticals Inc. (CPI), a privately-held oncology drug development company reported that the first patient has been dosed in a Phase 1 study of CPI-200 in patients with advanced tumors (Press release, Coordination Pharmaceuticals, AUG 8, 2019, View Source [SID1234538464]). CPI-200 is a novel nanoscale coordination polymer (NCP) containing two new molecular entities (NMEs) with synergistic antitumor activities. In addition, CPI is also conducting Phase 1 studies of CPI-100 and RiMO-301 on patients with advanced tumors. CPI-100 is another NCP containing two synergistic NMEs to activate tumor microenvironments for combination therapy with an immune checkpoint inhibitor while RiMO-301 elicits unprecedented radiotherapy-radiodynamic therapy (RT-RDT) to enhance the efficacy of X-ray radiotherapy.

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!

"Initiation of this study represents a significant milestone for CPI as CPI-200 is the company’s third candidate to enter clinical studies in the past year," said Wenbin Lin, Ph.D., founder and chairman of RiMO and also the James Franck Professor of Chemistry, Radiation & Cellular Oncology, and the Ludwig Center for Metastasis Research at the University of Chicago. "We believe our two innovative technology platforms have the potential to change treatment paradigms for multiple cancer types and significantly benefit patients."

Dr. Lin and coworkers have pioneered the development of the NCP and RiMO technology platforms, publishing extensively on these novel nanotherapeutics. "We expect that this study will generate important insights about the safety and pharmacokinetics of CPI-200 and the synergistic actions of the two NMEs on patients’ tumors which no longer respond to standard therapies," said Everett Vokes, M.D., University of Chicago Medicine.

About the Studies

The Phase 1 study is a prospective, open-label, single-arm, non-randomized study of CPI-200 in patients with advanced tumors. The primary objectives in the study include determining maximum tolerated dose (MTD), pharmacokinetics and preliminary anti-tumor activity of CPI-200. For additional clinical trial details, please refer to View Source;rank=1.

For CPI-100 Phase I study: View Source;rank=1

For RiMO-301 Phase I study: View Source;rank=1

. CPI-200 is a novel nanoscale coordination polymer (NCP) containing two new molecular entities (NMEs) with synergistic antitumor activities. In addition, CPI is also conducting Phase 1 studies of CPI-100 and RiMO-301 on patients with advanced tumors. CPI-100 is another NCP containing two synergistic NMEs to activate tumor microenvironments for combination therapy with an immune checkpoint inhibitor while RiMO-301 elicits unprecedented radiotherapy-radiodynamic therapy (RT-RDT) to enhance the efficacy of X-ray radiotherapy.

About the Studies

For CPI-100 Phase I study: View Source;rank=1

For RiMO-301 Phase I study: View Source;rank=1

Clovis Oncology Announces Pricing of $250 Million of Convertible Senior Notes

On August 8, 2019 Clovis Oncology, Inc. (NASDAQ: CLVS) reported the pricing of $250 million aggregate principal amount of its 4.50% convertible senior notes due 2024 (the "notes") in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Clovis Oncology, AUG 8, 2019, View Source [SID1234538463]). Clovis Oncology has also granted to the initial purchasers a 13-day option to purchase up to $37.5 million aggregate principal amount of additional notes on the same terms and conditions.

The notes will bear interest at a rate of 4.50% per annum, payable semi-annually in arrears on February 1st and August 1st of each year. The notes will mature on August 1, 2024 unless earlier converted or repurchased. The holders of the notes may convert their notes at their option at any time prior to the close of business on the business day immediately preceding the maturity date at an initial conversion rate of 137.2213 shares of Clovis Oncology’s common stock per $1,000 principal amount of notes, which is equivalent to an initial conversion price of approximately $7.29 per share of common stock. The initial conversion price of the notes represents a premium of approximately 25% to the last reported sale price, $5.83 per share, of Clovis Oncology’s common stock on August 8, 2019.

Clovis Oncology will not have the right to redeem the notes prior to their maturity. Holders of the notes may require Clovis Oncology to repurchase for cash all or part of their notes upon certain fundamental changes at a repurchase price equal to 100% of the principal amount of the notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. In addition, following certain corporate events that occur prior to the maturity date, Clovis Oncology will, in certain circumstances, increase the conversion rate for a holder who elects to convert its notes in connection with such corporate event.

The offering of the notes is expected to close on August 13, 2019, subject to customary closing conditions. Concurrently with the offering, in separate transactions, Clovis Oncology entered into privately negotiated transactions with a limited number of holders to repurchase, for settlement on or about August 13, 2019, approximately $190.3 million aggregate principal amount of its outstanding 2.50% Convertible Senior Notes due 2021 (the "2021 Notes"), for an aggregate repurchase price of approximately $171.8 million, including accrued interest. Clovis Oncology intends to use the net proceeds from the offering for these repurchases of the 2021 Notes. Any repurchase of the 2021 Notes could affect the market price of Clovis Oncology’s common stock. Clovis Oncology intends to use the remaining net proceeds from this offering for general corporate purposes, including sales and marketing expenses associated with Rubraca (rucaparib), funding of Clovis Oncology’s development programs, payment of milestones pursuant to Clovis Oncology’s license agreements, general and administrative expenses, acquisition or licensing of additional product candidates or businesses, repurchase or repayment of other debt obligations and working capital.

The offer and sale of the notes and the shares of common stock issuable upon conversion of the notes have not been registered under the Securities Act or any state securities laws and, unless so registered, the notes and any such shares may not be offered or sold in the United States except pursuant to an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws. This press release does not constitute an offer to sell or the solicitation of an offer to buy the notes or any other securities, nor will there be any sale of notes or any other 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.

IMV Inc. Announces Second Quarter 2019 Financial Results and Provides Company Update

On August 8, 2019 IMV Inc. (TSX: IMV; NASDAQ: IMV), a clinical stage immunotherapy company, reported its financial and operational results for the second quarter ended June 30, 2019 (Press release, IMV, AUG 8, 2019, View Source [SID1234538462]).

"At IMV, we are leveraging DPX, our no-release delivery technology that enables us to program immune cells in vivo. We continue to believe this mechanism offers potential to produce a new class of immunotherapies that elicit a more rapid, robust and sustained immune response," said Frederic Ors, IMV’s Chief Executive Officer. "In the second quarter, we reported important updates from two Phase 2 studies of our lead program, DPX-Survivac, our T cell-activating immunotherapy harnessing the power of this approach to target survivin, which is present in more than 20 solid and hematological tumor types. These results continue to validate our DPX platform and this novel target, with encouraging signs of anti-tumor activity contributing to the body of data we have accumulated to demonstrate DPX-Survivac’s potential in hard-to-treat cancers, both as a monotherapy and in combination with other agents. We look forward to providing additional data from this program by year-end, including top-line results from our Phase 2 study evaluating DPX-Survivac as a monotherapy in ovarian cancer and additional results from our Phase 2 r/r DLBCL and basket trial, evaluating DPX-Survivac in combination with Keytruda in multiple solid tumor indications."

DPX-Survivac Clinical Program Updates:

Phase 1b/2 DeCidE1 Clinical Study in Advanced Recurrent Ovarian Cancer

In June 2019, IMV presented new data at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting from DeCidE1, its ongoing Phase 1b/2 study evaluating the safety and efficacy of DPX-Survivac and intermittent low-dose cyclophosphamide (CPA), with and without epacadostat, in advanced recurrent ovarian cancer. These results expand on data previously reported from this study, which exhibited a durable response. Highlights of the new data from evaluable patients in the Phase 2 monotherapy arm of the trial include:

Five out of seven patients showed signs of treatment benefits, including reduction of target lesions in two patients;
Three out of four patients with low tumor burden showed stable disease, including two with tumour regression at first CT scan;
Of the five patients evaluable for T cell responses, all showed survivin-specific T cell activation in the blood; and
Treatments were well-tolerated supporting our views of the favourable safety profile of our approach.
Additionally, longer-term follow-up data from the Phase 1b portion of the study continued to demonstrate the prolonged duration of clinical benefits, surpassing two years of progression-free survival from previous treatments, including platinum-based chemotherapy.

We have enrolled 16 additional patients in the expanded monotherapy arm of the DeCidE1 trial. IMV expects to provide the top-line clinical results from this study before the end of 2019.

Phase 2 SPiReL Study of DPX-Survivac in Combination with KEYTRUDA in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

In June 2019, IMV reported updated data from SpiRel, its ongoing investigator-sponsored Phase 2 clinical trial assessing DPX-Survivac in combination with intermittent low dose cyclophosphamide and Merck’s checkpoint inhibitor Keytruda, linking antitumor activity with T cell responses that correlate with expression of survivin.

At the first "on treatment" interim assessment, five of the first six patients demonstrated clinical benefit, including four patients with tumor regressions. Two patients reached a complete radiological response, one exhibited a partial response and two reached stable disease while on the study. In addition, the study continued to demonstrate an acceptable safety profile for the two therapies in combination.

Based on these data, IMV agreed with the principal investigator to increase the number of sites recruiting patients from 5 to 9. As of August 8, 2019, investigators had enrolled 12 patients across four different clinical sites in Canada. Additional patients are being screened and IMV expects to give another update on this trial before the end of 2019 and report top-line clinical data from this study in the first half of 2020.

Phase 2 Basket Trial of DPX-Survivac in Combination with KEYTRUDA in Multiple Solid Tumor Indications

Fifteen patients have been enrolled to date, while screening and enrollment of patients is ongoing across nine clinical sites in the U.S. and Canada for five cohorts of patients with bladder, liver (hepatocellular carcinoma), ovarian, or non-small cell lung (NSCLC) cancers, as well as tumors shown to be positive for the microsatellite instability high (MSI-H) biomarker.

Patients have been treated in every cohort and IMV expects to report preliminary clinical results on several of the solid tumor indications included in this basket trial before the end of 2019.

Operational Highlights:

Modification of $5M loan agreement with the province of Nova Scotia. Previously, the entire loan was payable on August 9, 2020. Per this modification, the Corporation will now repay the loan over 60 months starting in January 2021. All the other terms remain the same. This revised repayment schedule will allow IMV to focus its cash resources towards developing its clinical programs.

Upcoming Milestones:

Milestones

Key dates

Preliminary clinical results from basket trial in 5 indications

H2 2019

Top-line monotherapy clinical results in ovarian cancer

H2 2019

Clinical results update in the DLBCL combination trial (investigator-sponsored)

H2 2019

Top-line clinical results in the DLBCL combination trial (investigator-sponsored)

H1 2020

Top-line clinical results from basket trial

H1 2020

Overview of Q2 2019 Financial Results

(In Canadian dollars)

At June 30, 2019, the Corporation had cash and cash equivalents of $26.9M and working capital of $28.3M, compared with $14.9M and $12.2M, respectively at December 31, 2018. Management believes that the Corporation’s cash resources of $26.9M and its additional potential cash resources of $3.1M will be sufficient to fund operations up to Q4-2020. For the six-month period ended June 30, 2019, IMV’s cash burn rate (defined as net loss and comprehensive loss adjusted for charges to operations not involving cash as described in the statement of cash flows) was $10.4 million. Based on the current business plan, the Corporation forecasts the quarterly cash burn rate to be between $5 million and $6 million for the remaining of 2019.

The net loss and comprehensive loss of $5.0M ($0.10 per share) for the three-month period ended June 30, 2019, was $0.2M lower than the net loss and comprehensive loss for three-month period ended June 30, 2018. This relates mainly to a $0.4M decrease in general and administrative expenses and a $0.9M increase in government assistance partly compensated by a $1.2M increase in research and development (R&D) expenses, in the three-month period ended June 30, 2019.

For the six-month period ended June 30, 2019, the net loss and comprehensive loss of $11.0M was $2.7M higher than the net loss and comprehensive loss for six-month period ended June 30, 2018. This relates mainly to a $3.3M increase in R&D expenses and a $0.2M increase in general and administrative expenses partly compensated by $1.0M increase in government assistance in the six-month period ended June 30, 2019. As of August 8, 2019, the number of issued and outstanding common shares was 50,612,125 and a total of 1,997,232 stock options, warrants, and deferred share units were outstanding at that date.

The Corporation’s unaudited interim condensed consolidated results of operations, financial condition and cash flows for the three and six-months ended June 30, 2019 and the related management’s discussion and analysis (MD&A) are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.

Conference Call and Webcast Information

IMV will host a conference call and webcast tomorrow at 8:00 am ET to discuss these results and provide an update on the company.

Financial analysts are invited to join the conference call by dialing (844) 461-9932 (U.S. and Canada) or (636) 812-6632 (international) using the conference ID: 7148568.

Other interested parties will be able to access the live audio webcast at this link: View Source The webcast will be recorded and available on the IMV website for 30 days following the call.

About IMV

IMV Inc. is a clinical stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and other serious diseases. IMV is pioneering a new class of immunotherapies based on the Corporation’s proprietary drug delivery platform. This patented technology leverages a novel mechanism of action that enables the programming of immune cells in vivo, which are aimed at generating powerful new synthetic therapeutic capabilities. IMV’s lead candidate, DPX-Survivac, is a T cell-activating immunotherapy that combines the utility of the platform with a target: survivin. IMV is currently assessing DPX-Survivac as a monotherapy in advanced ovarian cancer, as well as a combination therapy in multiple clinical studies with Merck. Connect at www.imv-inc.com

NantHealth Reports 2019 Second-Quarter Financial Results

On August 8, 2019 NantHealth, Inc. (NASDAQ-GS: NH), a next-generation, evidence-based, personalized healthcare company, reported financial results for its second quarter ended June 30, 2019 (Press release, NantHealth, AUG 8, 2019, View Source [SID1234538461]).

"Our 2019 second quarter represents the fourth consecutive quarter of total revenue growth," said Bob Petrou, Chief Financial Officer of NantHealth. "We generated strong topline growth and substantial gross margin improvement, which was largely driven by continued positive momentum in our Software and SaaS business, and the continuation of cost management throughout the company."

Software and Services Highlights:

Clinical Decision Support (Eviti):
In Q2, at America’s Health Insurance Plans (AHIP) Institute & Expo 2019, showcased Eviti Connect, the company’s evidence-based treatment intelligence and web-based oncology decision support platform
In Q2, as previously announced, signed and launched a three-year partnership with CareSource, a leading nonprofit multi-state health plan, expanding Eviti Connect’s total covered lives to over 25 million
In Q2, released v7.8 with Smart Regimen Search, an enhancement that expedites treatment plan entry via intelligent regimen driven drug matches
Payer Engagement (NaviNet):
In Q2, at America’s Health Insurance Plans (AHIP) Institute & Expo 2019, showcased NaviNet Open, the company’s secure, multi-payer platform that lets payers and providers exchange vital administrative and clinical information
In Q2, released a number of enhancements to the NaviNet Open Authorization application, which enable the company’s health plans to offer more configuration options. These include reducing the need for manual intervention via phone and fax processes and saving providers time managing their authorization requests, speeding up delivery of care
In Q2, launched the NaviNet API Gateway, which allows the company’s partners to interact directly with its API’s in a standard method, reducing the reliance on custom integration methods and enabling payer flexibility for their provider networks
Connected Care (DeviceConX):
In Q2, at the 2019 HIMSS and Health 2.0 European Conference, participated in the first-ever U.S. Pavilion where the company showcased DeviceConX, HBox and VitalsConX to Europe’s eHealth decision makers
In May, at Vitalis, the largest e-health event in Scandinavia, presented the company’s latest connected care solutions and sponsored the Intelligent Hospital Pavilion (IHP), where the company demonstrated its latest DeviceConX 5.15 medical device integration solution
In August, entered into a memorandum of understanding with ASCO (Free ASCO Whitepaper)M to provide the company’s Denmark client increased visibility of their device parameters. The combined capabilities provide clinicians with increased visibility of intelligent alert notifications, driving more informed decisions at the point of care, closing digital information gaps and allowing for the best possible decisions throughout the hospital ecosystem
Sequencing and Molecular Analysis – Highlights:

In Q2, total GPS orders were 136, comprised of 86 GPS Cancer and 50 Liquid GPS
In Q2, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) 2019 Annual Meeting, scientific teams from NantHealth and NantOmics presented:
With collaborators from Virginia Commonwealth University (VCU), "Tumor mutation burden and PD-L1 expression in SDH/FH mutated solid tumors," which support, for the first time, a potential therapeutic role for inhibition of PD-1/PD-L1 pathway in these tumors
With collaborators from the University of California, San Diego (UCSD), "Evidence for selective silencing of MHC-binding neoepitopes to avoid immune surveillance," which can inform the development of effective immunotherapy and cancer vaccine strategies
In Q2, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2019 Annual Meeting, scientific teams from NantHealth and NantOmics presented:
With collaborators from Duke University and the Sarcoma Center of Southern California, "Enhanced expression of human cyclin G1 (CCNG1) gene in metastatic cancer, a novel biomarker in development for CCNG1 inhibitor therapy," which may position CCNG1 as a companion diagnostic for the Delta Rex-G drug
A study entitled "The genomic and transcriptomic landscape of left versus right sided breast cancer in 410 cases," which sheds new light on ESR1 signaling in right sided breast cancers
Business and Financial Highlights

For the 2019 second quarter, total net revenue was $25.7 million, compared with $22.0 million in the 2018 second quarter. Gross profit was $15.9 million, or 62% of total net revenue, compared with $11.5 million, or 52% of total net revenue, for the prior year period. Selling, general and administrative expenses declined to $15.2 million, from $18.4 million in 2018 second quarter. Research and development expenses decreased to $4.6 million from $5.9 million.

Financial results for the second quarter of 2019 included non-cash charges for loss from related party equity method investment of $2.2 million. Net loss from continuing operations, net of tax, was $14.7 million, or $0.13 per share, compared with $21.8 million, or $0.20 per share, for the 2018 second quarter. Net loss (including discontinued operations) was $14.7 million, or $0.13 per share, compared with $23.4 million, or $0.21 per share, for 2018 second quarter.

On a non-GAAP basis, net loss from continuing operations, which excludes the losses from our related party equity investment of $2.2 million, an intangible asset impairment charge of $4.0 million, and a gain from change in the fair value of the Bookings Commitment liability of $1.0 million, among other things, was $4.4 million, or $0.04 per share, down from $11.1 million, or $0.10 per share, for the second quarter of last year.

Gossamer Bio Announces Second Quarter 2019 Financial Results

On August 8, 2019 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported its financial results for the quarter ended June 30, 2019 and provided a corporate update (Press release, Gossamer Bio, AUG 8, 2019, View Source [SID1234538460]).

"Over the last several months, we have made significant progress advancing our diversified development portfolio, with five clinical trials now active," said Sheila Gujrathi, M.D., Co-Founder and Chief Executive Officer of Gossamer. "We are poised for a steady cadence of data readouts throughout 2020. Supported by a strong balance sheet and our experienced and growing team, we are well positioned to advance toward our goal of becoming an industry leader in immunology, inflammation and oncology."

Pipeline Updates

GB001: Oral DP2 Antagonist for Asthma and Allergic Disease

Enrollment in the Phase 2b LEDA study in moderate-to-severe eosinophilic asthma is on track, with an interim analysis expected in the first half of 2020. Full results from the LEDA study are expected in the second half of 2020.
Patient enrollment in the TITAN Phase 2 proof-of-concept study in chronic rhinosinusitis, with and without nasal polyps, commenced in the second quarter. Topline data from the TITAN study are expected in the second half of 2020.
GB002: Inhaled PDGFR Inhibitor for Pulmonary Arterial Hypertension (PAH)

During the second quarter, the European Medicines Agency granted orphan medicinal product designation to GB002 for the treatment of PAH.
Sites have been initiated for a Phase 1b translational study in patients with PAH, with patient enrollment expected to begin in the third quarter. Results from the Phase 1b study are expected in the first half of 2020.
GB004: Oral HIF-1α Stabilizer for Inflammatory Bowel Disease

Patient enrollment in a Phase 1b study of active mild-to-moderate ulcerative colitis (UC) began during the second quarter, and the Company expects topline results from the study in the first half of 2020.
GB1275: Oral CD11b Modulator for Oncology Indications

Patient screening in a Phase 1/2 study in selected solid tumors is now underway, with patient enrollment expected to begin in the third quarter of 2019. Following monotherapy dose escalation, we will explore combinations with anti-PD-1 therapy and chemotherapy. Initial data from the Phase 1/2 study is expected in the second half of 2020.
Preclinical data supporting GB1275 were published in the July 3, 2019 edition of Science Translational Medicine by researchers at the Washington University School of Medicine in St. Louis and Rush University.
Financial Results for Quarter Ended June 30, 2019

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of June 30, 2019, were $464.0 million. The Company expects current cash, cash equivalents and marketable securities, and access to its debt facility will be sufficient to fund its operating and capital expenditures into the second half of 2021.
Research and Development (R&D) Expenses: For the quarter ended June 30, 2019, R&D expenses were $35.7 million, including $2.5 million of stock-based compensation, compared to R&D expenses of $7.9 million for the quarter ended June 30, 2018. The increase was primarily due to costs related to the research and development of GB001, GB002, GB004 and GB1275.
In-Process Research and Development (IPR&D) Expenses: For the quarter ended June 30, 2019, IPR&D expenses were $1.0 million, compared to $20.5 million for the quarter ended June 30, 2018, which included $20.0 million associated with the in-license of GB004.
General and Administrative (G&A) Expenses: For the quarter ended June 30, 2019, G&A expenses were $9.7 million, which included $2.7 million of stock-based compensation. This compared to G&A expenses of $4.6 million for the quarter ended June 30, 2018, which included $1.3 million of stock-based compensation. The increase was primarily attributable to personnel-related expenses, professional and legal fees, and stock-based compensation.
Net Loss: For the quarter ended June 30, 2019, net loss was $44.5 million, or a loss of $0.74 per share.
Conference Call and Webcast

Gossamer’s management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Thursday, Aug. 8, 2019, to discuss its second quarter 2019 financial results and provide a corporate update.

The live audio webcast may be accessed through the Events/Presentations page in the Investors section of the Company’s website at www.gossamerbio.com. Alternatively, the conference call may be accessed through the following:

Conference ID: 1393207
Domestic Dial-in Number: (866) 221-1654
International Dial-in Number: (470) 495-9466
Live Webcast: View Source

A replay of the audio webcast will be available for 30 days on the Investors section of the Company’s website, www.gossamerbio.com.