KIYATEC Assay Hits the Mark in Study to Predict Patient Response to First Line Ovarian Cancer Drugs

On August 1, 2019 KIYATEC, Inc. reported that results from its prospective, multi-center pilot study, to investigate their assay’s predictive accuracy and correlation to outcome among newly diagnosed ovarian cancer patients, have been published in Scientific Reports. Study findings represent both a preliminary clinical validation for the company’s ovarian cancer assay and a significant developmental milestone for the assay’s technology platform, known as Ex Vivo 3D Cell Culture (EV3D) (Press release, KIYATEC, AUG 1, 2019, View Source [SID1234538040]).

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"For ovarian cancer patients and their physicians, this study represents an important step in demonstrating our ability to deliver a robust predictive assay with the potential to positively support therapeutic decision-making and improve patient outcomes," said Matthew Gevaert, CEO of KIYATEC. "Our mission is to optimize and leverage our EV3D cell culture technology to develop response-predictive clinical assays across a range of solid tumor types and make a difference in the future of cancer care."

In the study, primary tissue from 92 newly diagnosed ovarian cancer patients were prospectively collected and tested for response to National Comprehensive Cancer Network (NCCN)-recommended frontline chemotherapy drugs at KIYATEC’s central laboratory. Assay results were successfully generated for 83 (90%) patient samples. All 92 patients received standard of care chemotherapy (80% adjuvant, 20% neoadjuvant) independent of the KIYATEC drug response prediction test result.

A total of 44 patients (of the 83 patients tested) met minimum follow-up time of 6 months post-chemotherapy for inclusion in this publication. The KIYATEC assay successfully predicted responders (i.e. platinum sensitive) and non-responders (i.e. platinum resistant) with an accuracy of 89% (39/44, p<0.0001).

Investigators also assessed assay accuracy and correlation to outcome among the 35 of 44 (80%) patients who received adjuvant chemotherapy. In this cohort, the KIYATEC assay correctly predicted responders and non-responders with 89% accuracy (31/35, p=0.0004). From date of surgical debulk, progression free survival (PFS) among test subjects predicted to respond to the first line chemotherapy they received was over 20 months v. 9 months for patients predicted not to respond (p=0.01).

"At present, clinicians have no way of knowing, prior to treatment, which of our newly diagnosed or relapsed ovarian cancer patients will respond or not to approved drug therapies," said Larry Maxwell, MD, Chairman of Obstetrics and Gynecology and co-director of Inova’s Women’s Health Integrated Research Center (WHIRC), and an author of the study. "To predict a complex future result with very high accuracy is a meaningful achievement, especially given that sometimes these outcomes take months to define. Similar test performance in larger, follow-on studies would establish this as a go-to tool in cancer drug selection that should help improve patient outcomes in ovarian cancer."

Based on these promising findings, KIYATEC has opened a prospective, pivotal clinical study, 3D-PREDICT (NCT03561207), in 500 patients to further validate EV3D-enabled clinical assays for newly diagnosed and recurrent ovarian cancer (8-drug panel) and glioblastoma (12-drug panel). The study is currently open to enrollment.

IDEXX Laboratories Announces Second Quarter Results

On August 1, 2019 IDEXX Laboratories, Inc. (NASDAQ: IDXX), a global leader in veterinary diagnostics, veterinary practice software and water microbiology testing, reported revenues of $620 million for the second quarter of 2019, an increase of 7% compared to the prior year period on a reported basis, and 9% on an organic basis (Press release, IDEXX Laboratories, AUG 1, 2019, View Source [SID1234538056]).

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Second quarter results were driven by CAG Diagnostics recurring revenue growth of 9% reported and 11% organic, net of an estimated 0.5% growth headwind related to Brexit order timing and equivalent day effects. Global results reflected 10% reported and 13% organic growth in IDEXX VetLab consumables, continued strong double-digit gains in U.S. reference laboratory diagnostic and consulting services revenues, and 8% reported and 9% organic revenue growth in rapid assay products revenues. High IDEXX VetLab consumables revenue growth was supported by a 21% year-over-year increase in Catalyst chemistry analyzer installed base, benefiting from 761 placements at new and competitive accounts in international markets, a 39% year-over-year increase, and 486 Catalyst placements in North America, an 8% year-over-year increase. Overall organic revenue growth results in the second quarter were moderated by comparisons to very strong prior year period instrument placement levels, and flat organic growth in livestock, poultry and dairy ("LPD") revenue, including declines in swine diagnostic testing related to the African swine fever epidemic in China.

Earnings per diluted share ("EPS") was $1.43 for the second quarter, representing reported EPS growth of 16% and comparable constant currency EPS growth of 19%. These results reflected continued strong CAG Diagnostics recurring revenue gains, which supported a higher than projected 140 basis point improvement in operating margins on a reported basis and 120 basis points on a constant currency basis.

The Company is refining its full year 2019 revenue growth outlook to 7.5% – 9% on a reported basis and 9.5% – 10.5% on an organic basis. This reflects adjustments to our reported revenue growth outlook related to updated projections for foreign exchange rate impacts, and a 0.5% reduction to the high end of previous organic growth guidance, incorporating second quarter results. The Company is refining its full year reported revenue growth guidance for CAG Diagnostics recurring revenues to 9% – 10.5% and reinforcing its organic revenue growth guidance of 11% – 12%, consistent with strong year-to-date trends. The Company is raising its 2019 EPS guidance range by $0.05 per share at mid-point to $4.82 – $4.92, reflecting $0.04 per share in benefit from a lower projected effective tax rate from higher share-based compensation tax benefits and $0.02 per share in operational improvement from raised expectations for full year operating margin improvement of 100 – 125 basis points on a constant currency basis and lower interest expense projections. These benefits are partially offset by a $0.01 per share negative impact related to updated foreign exchange rate assumptions. Our updated EPS guidance is for 13% – 15% in reported EPS growth, or 17% – 20% on a comparable constant currency basis, aligned with our long-term performance goals.

"IDEXX business momentum remained strong in the second quarter driven by high organic growth in CAG Diagnostics recurring revenues. The solid performance we continue to deliver is the result of a deep and talented global team, an unrelenting commitment to innovation, a unique multi-modal strategy and our durable recurring revenue business model. We’re well positioned to build on this foundation through the expansion of key initiatives like IDEXX Preventive Care, which is building momentum as a driver of increased diagnostic testing, supporting faster growth for engaged IDEXX customers," said Jay Mazelsky, the Company’s Interim President and Chief Executive Officer.

Second Quarter Performance Highlights

Companion Animal Group

The Companion Animal Group generated 8% reported and 10% organic revenue growth for the quarter, supported by CAG Diagnostics recurring revenue growth of 9% reported and 11% organic.

IDEXX VetLab consumables generated 10% reported and 13% organic revenue growth, net of a combined 1% negative growth impact related to Brexit related stocking orders which benefited the first quarter and reversed in the second quarter, and equivalent day impacts from international holiday timing. IDEXX VetLab consumables growth was supported by ongoing expansion of our global premium instrument installed base, as well as continued strong customer retention, increases in testing utilization and moderate price gains.
Reference laboratory diagnostic and consulting services generated 8% reported and 10% organic revenue growth. These results were driven by continued strong double-digit organic growth in the U.S., reflecting volume gains with existing customers, moderate net price realization and benefits from net customer additions. Global organic revenue growth rates were moderated by consistent mid single-digit revenue gains in international markets.
Rapid assay products generated 8% reported and 9% organic revenue growth, driven by continued volume gains in SNAP 4Dx Plus Tests, supported by planned promotional programs, increasing customer retention rates and moderate net price gains.
Veterinary software, services and diagnostic imaging systems revenue growth increased 9% on a reported basis and 7% on an organic basis, driven by growth in subscription-based service revenues, including continued expansion of our practice management platforms.

Water

Water achieved revenue growth of 6% on a reported basis and 10% on an organic basis in the second quarter, supported by continued strong growth in international markets and mid single-digit gains in the U.S.

Livestock, Poultry and Dairy ("LPD")

LPD revenue declined 5% on a reported basis and was flat on an organic basis for the second quarter, supported by growth in herd health screening and solid increases in pregnancy and poultry testing. These gains were offset by significant declines in swine diagnostic testing related to African swine fever outbreaks in China, and moderate declines in European disease eradication programs.

Gross Profit and Operating Profit

Gross profits increased 8% year-over-year, and gross margin was 57.7%, an increase of 50 basis points compared to prior year period results on a reported basis and 30 basis points on a constant currency basis. Gross margin improvement was driven by mix benefits from strong growth in IDEXX VetLab consumable and rapid assay revenues and lower relative IDEXX VetLab instrument revenue growth, and continued moderate CAG Diagnostics recurring revenue net price gains. Gains in these areas were partially offset by increased investments in reference laboratory capacity and systems, and expanded field software support resources.

Operating margin was 26.5% in the quarter, 140 basis points higher than the prior year period results on a reported basis and 120 basis points on a constant currency basis, supported by gross margin gains and operating expense leverage on high revenue growth. Operating expenses increased 4% on a reported basis and 6% on a constant currency basis, driven by increases in our CAG segment’s sales and marketing costs and research and development spending, with overall expense increases moderated by low constant currency growth in general and administrative costs.

2019 Financial Outlook

The following guidance for 2019 reflects the assumptions that for the remainder of 2019, the value of foreign currencies will remain at the following rates in U.S. dollars:

the euro at $1.11;
the British pound at $1.23;
the Canadian dollar at $0.75; and
the Australian dollar at $0.68;
and relative to the U.S. dollar:

the Japanese yen at ¥110.00;
the Chinese renminbi at RMB 6.97; and
the Brazilian real at R$3.85.
Outlook for 2019

We are refining our 2019 revenue outlook to $2,380 million – $2,410 million, reflecting expectations for reported revenue growth of 7.5% – 9% and organic revenue growth of 9.5% – 10.5%. At mid-point, the updated revenue outlook is $10 million below our previous guidance, including $5 million of impact related to updated foreign exchange estimates and $5 million in operational refinements related to our second quarter results, resulting in a 0.5% reduction to the high end of our earlier organic revenue growth guidance. Our outlook reflects expectations for CAG Diagnostics recurring reported revenue growth of 9% – 10.5% and consistent expectations for organic revenue growth of 11% – 12%. At the foreign exchange rate assumptions in 2019 noted above, we estimate that the effect of the stronger U.S. dollar will reduce full year 2019 reported revenue growth by approximately 1.5% to 2%.

We are updating our 2019 EPS outlook to $4.82 – $4.92 per share, reflecting an increase of $0.05 per share at mid-point, reflecting $0.04 per share of improvement related to updated estimates for share-based compensation tax benefits and $0.02 per share of benefit from improved expectations for full year operating performance supported by higher projected operating margin gains of 100 – 125 basis points on a constant currency basis and lower projected interest expense. For the full year, we now expect a foreign exchange headwind of $0.04 per share, a $0.01 higher impact compared to previously projected impact, net of projected hedge gains of approximately $11.5 million in 2019. The updated outlook represents EPS growth of 13% – 15% on a reported basis, and 17% – 20% on a comparable constant currency growth basis.

The Company continues to project free cash flow at approximately 60% – 65% of net income in 2019, including an estimated $70 million of capital spending related to the completion of our Westbrook, Maine headquarters expansion and the relocation and expansion of our core laboratory in Germany. For 2019, the Company projects capital spending of approximately $160 million – $175 million.

We now expect an effective tax rate of approximately 19.5% – 20%, incorporating expectations for a benefit from share-based compensation accounting of $12 million – $14 million or approximately 250 basis points. We are now projecting a reduction in weighted average shares outstanding of approximately 1%, and interest expense, net of interest income, of approximately $34 million reflecting current and projected borrowings.

Conference Call and Webcast Information

IDEXX Laboratories, Inc. will be hosting a conference call today at 8:30 a.m. (Eastern) to discuss its second quarter 2019 results and management’s outlook. To participate in the conference call, dial 1-800-230-1093 or 1-612-288-0337 and reference confirmation code 470018. Replay of the conference call will be available through Thursday, August 8, 2019 by dialing 1-800-475-6701 or 1-320-365-3844 and referencing replay code 470018. Individuals can access a live webcast of the conference call through a link on the IDEXX website, www.idexx.com/investors. An archived edition of the webcast will be available after 1:00 p.m. (Eastern) on that day via the same link and will remain available for one year.

Intrexon to Announce Second Quarter and First Half 2019 Financial Results on August 8th

On August 1, 2019 Intrexon Corporation (NASDAQ: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, reported it will release second quarter and first half 2019 financial results after the market closes on Thursday, August 8th, 2019 (Press release, Intrexon, AUG 1, 2019, View Source [SID1234537985]). The Company will host a conference call that day at 5:30 PM ET to discuss the results and provide a general business update.

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The conference call may be accessed by dialing 1-888-317-6003 (Domestic US), 1-866-284-3684 (Canada), and 1‑412-317-6061 (International) and providing the number 4443860 to join the Intrexon Corporation Call. Participants may also access the live webcast through Intrexon’s website in the Investors section at View Source

Corvus Pharmaceuticals Provides Business Update and Reports Second Quarter 2019 Financial Results

On August 1, 2019 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies, reported financial results for the second quarter ended June 30, 2019 (Press release, Corvus Pharmaceuticals, AUG 1, 2019, View Source [SID1234538009]).

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"Corvus continues to be a leader in the field of drug development targeting the adenosine pathway, with complementary lead programs – ciforadenant and CPI-006 – that have shown promising activity in a range of solid tumors. We also have a third program in the clinic, CPI-818, which is an ITK inhibitor for the treatment of patients with advanced T-cell lymphomas. Together, I believe these three programs position Corvus as a leader in the development of second-generation immuno-oncology agents," said Richard A. Miller, M.D., president and chief executive officer of Corvus. "At ASCO (Free ASCO Whitepaper) this year, initial clinical data on CPI-006 was presented in an oral session and subsequently selected for the Highlight of the Day session. The data demonstrated activity as a monotherapy and in combination with ciforadenant and that CPI-006 represents a potential novel immuno-oncology approach via activation of immune cells and the inhibition of adenosine production. We plan to continue presenting new data on our programs at the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting and other meetings over the remainder of the year."

Recent Achievements
Ciforadenant (CPI-444): A2A Receptor Antagonist of Adenosine

Continued enrollment of patients with renal cell cancer (RCC) in an amended Phase 1b/2 clinical trial evaluating ciforadenant in combination with Genentech’s Tecentriq (atezolizumab), an anti-PD-L1 antibody. The RCC patients in the trial have failed treatments with anti-PD-(L)1 antibodies and tyrosine kinase inhibitors. This trial is also evaluating the use of a novel gene expression biomarker known as the Adenosine Signature, that may have the potential to predict patients most likely to respond to therapy.
Amending our ongoing Phase 1b/2 study to include an arm evaluating ciforadenant in combination with Tecentriq in patients with prostate cancer. This arm will also evaluate the use of the Adenosine Signature.
Continued follow-up in a Phase 1b/2 trial of ciforadenant and Tecentriq being conducted by Genentech as part of their MORPHEUS platform. The study is evaluating this combination in patients who have failed no more than two prior regimens.
CPI-006: Immunomodulatory Anti-CD73 Antibody

Continued enrollment of up to 350 patients with advanced cancer in a Phase 1/1b clinical trial evaluating CPI-006 as a single agent and in combination with either ciforadenant or pembrolizumab. The trial is currently enrolling patients in the dose escalation phase for CPI-006 administered as a monotherapy and in combination with ciforadenant.
Initial clinical data covering 20 patients with advanced, refractory cancer from the Phase 1/1b trial was delivered in an oral presentation at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2019. The initial data showed a trend toward longer disease control with higher doses of CPI-006, and enhanced disease control with CPI-006 in combination with ciforadenant compared with monotherapy. Additional highlights from the presentation:
Clinical and laboratory results demonstrated potential for a new immuno-oncology approach with CPI-006 via activation of immune cells and the inhibition of adenosine production.
Dose-dependent disease control when administered as a monotherapy and in combination with ciforadenant.
CPI-006 was well tolerated at all dose levels, with no dose-limiting toxicities. Grade 1 infusion reactions were detected (N=3 patients) and mitigated with premedication with acetaminophen and antihistamine. Grade 3 or 4 toxicities included a grade 3 anemia (N=1).
CPI-818: A small molecule ITK inhibitor

Continued enrolling patients with T-cell lymphomas, including peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphoma (CTCL) and others, in a Phase 1/1b study with CPI-818, an ITK inhibitor.
Anticipated Events in 2H 2019

Updated clinical and immunologic data from the Phase 1/1b clinical trial of CPI-006 monotherapy and combination with ciforadenant is expected to be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting in November 2019.
Presentation on identification and role of biomarkers in adenosine pathway therapies is expected to be presented at SITC (Free SITC Whitepaper).
Preclinical and early clinical data regarding CPI-818 is expected to be presented in late 2019 or early 2020.
Financial Results

At June 30, 2019, Corvus had cash, cash equivalents and marketable securities totaling $96.8 million, as compared to cash, cash equivalents and marketable securities of $114.6 million at December 31, 2018. Corvus expects full-year 2019 net cash used in operating activities to be between $38 and $42 million and estimates ending 2019 with cash, cash equivalents and marketable securities of between $73 and $77 million.

Research and development expenses for the three months ended June 30, 2019 totaled $10.6 million, as compared to $9.7 million for the same period in 2018. The increase of $0.9 million was primarily due to an increase in CPI-006 program costs.

The net loss for the three months ended June 30, 2019 was $13.0 million, compared to a net loss of $11.6 million for the same period in 2018. Total stock compensation expense for the three months ended June 30, 2019 was $1.9 million, as compared to $1.7 million for the same period in 2018.

Conference Call Details
Corvus will host a conference call and webcast today, Thursday, August 1, 2019, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the second quarter 2019 financial results. The conference call can be accessed by dialing 1-888-599-8686 (toll-free domestic) or 1-720-543-0302 (international) and using the conference ID 2091306. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days following the call.

Modra Pharmaceuticals Announces First Patients Treated in Phase IIb Metastatic Prostate Cancer Trial

On August 1, 2019 Modra Pharmaceuticals B.V. ("Modra") reported the start of patient treatment in its Phase IIb clinical study evaluating the efficacy and tolerability of its lead candidate, ModraDoc006/r, in metastatic Castration-Resistant Prostate Cancer (mCRPC) (Press release, Modra Pharmaceuticals, AUG 1, 2019, View Source [SID1234538041]). ModraDoc006/r is a proprietary oral therapeutic based on the standard intravenous taxane chemotherapy, docetaxel. In evaluation to-date, ModraDoc006/r has shown potential to reduce important toxicities, such as neutropenia and neuropathy, with the possibility of enhancing the efficacy of treatment, in addition to providing the benefits of oral ‘at-home’ administration. The trial will be conducted at approximately 40 clinical centers in the United States and Europe, with initial data readout expected during the first half of 2021. The compound is also being tested in a Phase II clinical study in breast cancer, which began earlier this year.

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"Prostate cancer is one of the most commonly diagnosed malignancies in men in the Western world, with docetaxel typically administered as the first line of chemotherapy treatment in the metastatic setting. Improving outcomes for these patients by reducing key toxicities and enhancing efficacy associated with the use of chemotherapy would meet a significant need. Our objective is therefore to demonstrate clinical benefit over current standard of care while also making a positive impact on patients’ lives," commented Colin Freund, CEO of Modra.

"Based on our existing pre-clinical and clinical data, we believe ModraDoc006/r has the potential to favorably impact treatment outcomes and raise the quality of life for prostate cancer patients," explained Dr. Edwin de Wit, Chief Development Officer of Modra. "This comparative Phase IIb trial will enable us to evaluate the benefits of oral ModraDoc006/r versus standard of care intravenous docetaxel."

The Phase IIb study, randomized 1:1 Modra006/r versus intravenous docetaxel, will evaluate 100 mCRPC patients eligible for first line systemic chemotherapy. The primary endpoint is objective response rate as assessed by response evaluation criteria in solid tumors (RECIST 1.1). The secondary endpoints include efficacy, safety and health-related quality of life assessments.

"Intravenously administered chemotherapy is widely used, but nevertheless always involves a significant time investment for patients in regard to travel to and from the clinic and receiving the treatment itself, as well as the considerable burden of dealing with its side effects. To that end, ModraDoc006/r has the potential to become an exciting new oral option for prostate cancer which retains or improves on the therapeutic characteristics of docetaxel and easily incorporates chemotherapy within the lives of cancer patients," added Ulka Vaishampayan, MD, Principal Investigator of the study and Professor of Oncology at Karmanos Cancer Institute, Detroit.

About metastatic Castration-Resistant Prostate Cancer (mCRPC)

mCRPC is an advanced form of prostate cancer and the fourth most common cause of cancer death overall. mCRPC is resistant to surgical treatment or androgen deprivation therapy, an antihormone therapy used to prevent the growth of prostate cancer cells.

About ModraDoc006/r

ModraDoc006/r is a proprietary boosted taxane chemotherapy based on docetaxel, an intravenously administered therapy that is very broadly used in a variety of tumor types. ModraDoc006 – an oral docetaxel tablet – is given in combination with ritonavir (r), which acts as a booster to increase the systemic bioavailability of ModraDoc006. ModraDoc006/r is designed to combine the convenience and practicality of taking chemotherapy treatment at home with the potential for an improved safety profile and enhanced efficacy, as compared to standard IV docetaxel.