On September 17, 2019 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that the U.S. Food and Drug Administration (FDA) has approved ERLEADA (apalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC) (Press release, Johnson & Johnson, SEP 17, 2019, View Source [SID1234539591]).1 Today’s approval follows FDA Priority Review Designation of the supplemental New Drug Application (sNDA) that was submitted in April 2019 and reviewed through the FDA Real-Time Oncology Review program. The new indication for ERLEADA will make this androgen receptor inhibitor available for the approximately 40,000 people in the U.S. diagnosed with mCSPC annually.2

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Approval is based on results from the Phase 3 TITAN study, which achieved statistical significance in the dual primary endpoints of overall survival (OS) and radiographic progression-free survival (rPFS) at the first pre-planned interim analysis.3 The trial recruited patients regardless of extent of disease, including both high- and low- volume disease, or prior docetaxel treatment history.1,3 Results were presented in an oral session at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and simultaneously published in The New England Journal of Medicine.

"Prostate cancer is more difficult to treat once it spreads, and for patients with castration-sensitive disease, it is clear that androgen deprivation therapy (ADT) alone, is often not enough," said Dr. Kim Chi, Medical Oncologist at BC Cancer – Vancouver and principal investigator of the TITAN study. "Results from the TITAN study showed that, regardless of the extent of disease, patients with metastatic castration-sensitive prostate cancer have the potential to benefit from treatment with apalutamide in addition to ADT."

In the TITAN study, ERLEADA plus ADT significantly extended OS compared to placebo plus ADT with a 33 percent reduction in the risk of death (HR=0.67; 95 percent CI, 0.51-0.89; P=0.0053).1 ERLEADA plus ADT also significantly improved rPFS compared to placebo plus ADT with a 52 percent lower risk of radiographic progression or death (HR=0.48; 95 percent CI, 0.39-0.60; P<0.0001).1 As reported in the published results from the TITAN study, the two-year OS rates, after a median follow-up of 22.7 months, were 84 percent for ERLEADA plus ADT compared to 78 percent for placebo plus ADT.3

"ERLEADA has the potential to change how patients with prostate cancer are treated, regardless of the extent of the disease or prior docetaxel treatment history, by delaying disease progression and prolonging survival," said Margaret Yu, M.D., Vice President, Prostate Cancer Disease Area Leader, Janssen Research & Development, LLC. "This milestone highlights Janssen’s commitment to improve the standard of care for patients with prostate cancer as we continue to develop innovative treatments across the disease continuum."

The most common adverse reactions (≥10 percent) that occurred more frequently in ERLEADA treated patients (≥2 percent over placebo) from the randomized placebo-controlled clinical trials (TITAN and SPARTAN) were fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea, and fracture.1

For the full U.S. Prescribing Information, please visit www.ERLEADA.com.

About the TITAN Study1
TITAN (NCT02489318) is a Phase 3, randomized, placebo-controlled, double-blind study in patients with mCSPC. The study included 1,052 patients in 23 countries across 260 sites in North America, Latin America, South America, Europe, and Asia Pacific. Patients with mCSPC were randomized 1:1 and received either ERLEADA (240 mg) plus ADT (n=524), or placebo plus ADT (n=527). The recruitment period for the study spanned from December 2015 to July 2017.1 The study included patients with mCSPC with both low- and high-volume disease, and those who were newly diagnosed, or those who had received prior definitive local therapy or prior treatment with up to six cycles of docetaxel for mCSPC.3

An Independent Data-Monitoring Committee was commissioned by the sponsor to monitor safety and efficacy.3 Dual primary endpoints of the study were OS and rPFS.1 Secondary endpoints included time to cytotoxic chemotherapy, time to pain progression, time to chronic opioid use, and time to skeletal-related event.3 Exploratory endpoints included time to PSA progression, PFS2 and time to symptomatic progression.3 For additional study information, visit ClinicalTrials.gov.

About Metastatic Castration-Sensitive Prostate Cancer
Metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC), refers to prostate cancer that still responds to ADT and has spread to other parts of the body.4

About ERLEADA
ERLEADA (apalutamide) is an androgen receptor (AR) inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and for the treatment of patients with mCSPC. ERLEADA received FDA approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019.1 ERLEADA is taken orally, once daily, with or without food.1 The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Prostate Cancer include apalutamide (ERLEADA) as a treatment option for patients with non-metastatic (M0) CRPC with a Category 1 recommendation for those with a PSA doubling time ≤10 months.*5 The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) include apalutamide (ERLEADA) with androgen deprivation** as a Category 1 treatment option for patients with metastatic (M1) castration-naive prostate cancer.†5 The American Urological Association (AUA) Guidelines for Castration-Resistant Prostate Cancer (CRPC) recommend clinicians offer apalutamide (ERLEADA) with continued androgen deprivation therapy (ADT) as one of the treatment options for patients with nmCRPC at high risk for developing metastatic disease. (Standard; Evidence Level Grade A)***.6 ERLEADA is being studied in five Phase 3 clinical trials.

* Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Prostate Cancer V.4.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed September 16, 2019. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application, and disclaims any responsibility for their application or use in any way.

** Orchiectomy, LHRH agonist, or LHRH antagonist

† The term "castration-naive" is used to define patients who are not on ADT at the time of progression. The NCCN Prostate Cancer Panel uses the term "castration-naive" even when patients have had neoadjuvant, concurrent, or adjuvant ADT as part of radiation therapy provided they have recovered testicular function.

***Standard: Directive statement that an action should (benefits outweigh risks/burdens) or should not (risks/burdens outweigh benefits) be taken based on Grade A or B evidence.

***Evidence Level: A designation indicating the certainty of the results as high, moderate, or low (A, B, or C, respectively) based on AUA nomenclature and methodology.

ERLEADA IMPORTANT SAFETY INFORMATION1
WARNINGS AND PRECAUTIONS

Ischemic cardiovascular events — In a randomized study (SPARTAN) of patients with nmCRPC, ischemic cardiovascular events occurred in 4% of patients treated with ERLEADA and 3% of patients treated with placebo. In a randomized study (TITAN) in patients with mCSPC, ischemic cardiovascular events occurred in 4% of patients treated with ERLEADA and 2% of patients treated with placebo. Across the SPARTAN and TITAN studies, 6 patients (0.5%) treated with ERLEADA and 2 patients (0.2%) treated with placebo died from an ischemic cardiovascular event. Patients with current evidence of unstable angina, myocardial infarction, or congestive heart failure within six months of randomization were excluded from the SPARTAN and TITAN studies.

Ischemic cardiovascular events, including events leading to death, occurred in patients receiving ERLEADA. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Consider discontinuation of ERLEADA for Grade 3 and 4 events.

Fractures — In a randomized study (SPARTAN) of patients with nmCRPC, fractures occurred in 12% of patients treated with ERLEADA and in 7% of patients treated with placebo. In a randomized study (TITAN) of patients with mCSPC, fractures occurred in 9% of patients treated with ERLEADA and in 6% of patients treated with placebo. Evaluate patients for fracture risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone targeted agents.

Falls — In a randomized study (SPARTAN), falls occurred in 16% of patients treated with ERLEADA compared to 9% of patients treated with placebo. Falls were not associated with loss of consciousness or seizure. Falls occurred in patients receiving ERLEADA with increased frequency in the elderly. Evaluate patients for fall risk.

Seizure — In two randomized studies (SPARTAN and TITAN), five patients (0.4%) treated with ERLEADA and one patient treated with placebo (0.1%) experienced a seizure. Permanently discontinue ERLEADA in patients who develop a seizure during treatment. It is unknown whether anti-epileptic medications will prevent seizures with ERLEADA. Advise patients of the risk of developing a seizure while receiving ERLEADA and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others.

Embryo-Fetal Toxicity — The safety and efficacy of ERLEADA have not been established in females. Based on its mechanism of action, ERLEADA can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of ERLEADA [see Use in Specific Populations (8.1, 8.3)].

ADVERSE REACTIONS

Adverse Reactions — The most common adverse reactions (≥10%) that occurred more frequently in the ERLEADA-treated patients (≥ 2% over placebo) from the randomized placebo-controlled clinical trials (TITAN and SPARTAN) were fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea and fracture.

Laboratory Abnormalities — All Grades (Grade 3-4)

Hematology — In TITAN study, white blood cell decreased ERLEADA 27% (0.4%), placebo 19% (0.6%). In SPARTAN study anemia ERLEADA 70% (0.4%), placebo 64% (0.5%); leukopenia ERLEADA 47% (0.3%), placebo 29% (0%); lymphopenia ERLEADA 41% (2%), placebo 21% (2%)
Chemistry — In TITAN study, hypertriglyceridemia ERLEADA 17% (3%), placebo 12% (2%). In SPARTAN study hypercholesterolemia ERLEADA 76% (0.1%), placebo 46% (0%); hyperglycemia ERLEADA 70% (2%), placebo 59% (1%); hypertriglyceridemia ERLEADA 67% (2%), placebo 49% (0.8%); hyperkalemia ERLEADA 32% (2%), placebo 22% (0.5%).
Rash — In two randomized studies, rash was most commonly described as macular or maculo-papular. Adverse reactions of rash were 26% with ERLEADA versus 8% with placebo. Grade 3 rashes (defined as covering >30% body surface area [BSA]) were reported with ERLEADA treatment (6%) versus placebo (0.5%).

The onset of rash occurred at a median of 83 days. Rash resolved in 78% of patients within a median of 78 days from onset of rash. Rash was commonly managed with oral antihistamines, topical corticosteroids, and 19% of patients received systemic corticosteroids. Dose reduction or dose interruption occurred in 14% and 28% of patients, respectively. Of the patients who had dose interruption, 59% experienced recurrence of rash upon reintroduction of ERLEADA.

Hypothyroidism — In two randomized studies hypothyroidism, was reported for 8% of patients treated with ERLEADA and 2% of patients treated with placebo based on assessments of thyroid-stimulating hormone (TSH) every 4 months. Elevated TSH occurred in 25% of patients treated with ERLEADA and 7% of patients treated with placebo. The median onset was at the first scheduled assessment. There were no Grade 3 or 4 adverse reactions. Thyroid replacement therapy, when clinically indicated, should be initiated or dose-adjusted.

DRUG INTERACTIONS

Effect of Other Drugs on ERLEADA — Co-administration of a strong CYP2C8 or CYP3A4 inhibitor is predicted to increase the steady-state exposure of the active moieties. No initial dose adjustment is necessary; however, reduce the ERLEADA dose based on tolerability [see Dosage and Administration (2.2)].

Effect of ERLEADA on Other Drugs — ERLEADA is a strong inducer of CYP3A4 and CYP2C19, and a weak inducer of CYP2C9 in humans. Concomitant use of ERLEADA with medications that are primarily metabolized by CYP3A4, CYP2C19, or CYP2C9 can result in lower exposure to these medications. Substitution for these medications is recommended when possible or evaluate for loss of activity if medication is continued. Concomitant administration of ERLEADA with medications that are substrates of UDP-glucuronosyl transferase (UGT) can result in decreased exposure. Use caution if substrates of UGT must be co-administered with ERLEADA and evaluate for loss of activity.

P-gp, BCRP or OATP1B1 substrates — Apalutamide is a weak inducer of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), and organic anion transporting polypeptide 1B1 (OATP1B1) clinically. Concomitant use of ERLEADA with medications that are substrates of P-gp, BCRP, or OATP1B1 can result in lower exposure of these medications. Use caution if substrates of P-gp, BCRP or OATP1B1 must be co-administered with ERLEADA and evaluate for loss of activity if medication is continued.

Please see the full Prescribing Information for ERLEADA.

On September 16, 2019 Oncoheroes Biosciences Inc ("Oncoheroes") and Boehringer Ingelheim International GmbH ("Boehringer Ingelheim") reported that have signed a worldwide, exclusive licensing agreement for volasertib, an investigational anti-cancer compound that was originally discovered and developed by Boehringer Ingelheim (Press release, Oncoheroes Biosciences, SEP 16, 2019, View Source [SID1234568288]). Under the terms of this agreement Boehringer Ingelheim assigns to Oncoheroes the intellectual property of volasertib, with exclusive rights to research, develop, sell and sublicense the compound. Oncoheroes is committed to further develop and commercialize volasertib for pediatric cancer indications.

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Volasertib is an inhibitor of Polo-like-kinase 1 (PLK1), an enzyme known to be involved in cancer progression in a number of diseases. The compound was being developed by Boehringer for the treatment of a specific form of leukemia but clinical development activities were halted after a large Phase III study with adult patients failed to meet its primary endpoints. Meanwhile, independent academic groups had generated strong data in support of further developing the drug for rhabdomyosarcoma and a few other pediatric cancer indications. By signing this licensing agreement, Oncoheroes and Boehringer Ingelheim make it possible to continue the clinical development of volasertib to the benefit of younger cancer patients.

Oncoheroes is a Boston-based biotech company exclusively focused on the development of innovative medicines to treat cancer in children and adolescents. The company was co-founded by Ricardo Garcia and Cesare Spadoni, two parents touched by childhood cancer and determined to change the outlook for these young patients.

"This is probably the first example of an investigational compound being specifically repurposed to investigate it as a treatment for a form of childhood cancer. We are committed to identify more such opportunities and also develop our own innovative treatments for children and adolescents with cancer", jointly stated Ricardo Garcia and Dr Cesare Spadoni, Oncoheroes’ Chief Executive Officer and Chief Operating Officer, respectively.

The financial details of this deal are not disclosed. Oncoheroes has already established links with international pediatric oncology networks and is actively working to start clinical development activities as soon as possible.

On September 16, 2019 Blue Earth Diagnostics, a Bracco company focused on molecular imaging diagnostics, reported results from an investigational clinical trial ("FALCON") evaluating the impact of 18F-fluciclovine PET/CT imaging on the clinical management of men with biochemically recurrent prostate cancer eligible for salvage therapy (Press release, Blue Earth Diagnostics, SEP 16, 2019, View Source [SID1234539543]). The FALCON trial is a UK-based, prospective, multi-center, open-label study (NCT02578940). Its primary endpoint examined the percentage of men who had their management plan changed after an 18F-fluciclovine PET/CT scan.

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Axumin (fluciclovine F 18) injection is approved for use in positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood levels of prostate specific antigen (PSA) following prior treatment. (For additional product information please see the end of this news release.)

Investigators in the FALCON trial recorded intended patient management plans prior to 18F-fluciclovine PET/CT imaging and then recorded how the plans were altered following review of the scan results. Results of the trial indicated that 64% (66/104) of patients had their clinical management plan changed when results of 18F-fluciclovine PET/CT imaging were added to the standard-of-care diagnostic work-up. Of those changes, 65% (43/66) were classified as "major," denoting a change in treatment modality (e.g. salvage radiotherapy to androgen deprivation therapy (ADT)).

Results from the study were summarized in an oral presentation, "Impact of positron emission tomography (PET) with 18F-fluciclovine PET/CT on management of patients with recurrence of prostate cancer: results from the FALCON trial," by David Bottomley, MBBS, St. James Institute of Oncology, Leeds UK, at the 2019 American Society for Radiology Oncology (ASTRO) Annual Meeting, September 15 – 18, 2019.

"We are very pleased to share results from the FALCON study with the radiation oncology community at ASTRO and look forward to publishing the results in an upcoming peer-reviewed journal," said Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics. "As part of our mission to develop and commercialize innovative PET imaging agents for cancer, Blue Earth Diagnostics conducted the FALCON and LOCATE studies to evaluate the utility of a 18F-fluciclovine PET/CT scan in providing physicians with actionable information for the management of men with recurrent prostate cancer. Each of these two independent, prospective studies arrived at similar conclusions – that 18F-fluciclovine PET/CT located recurrent disease in the majority of men in the study, which frequently resulted in major changes to their management plans for biochemical recurrence."

"The FALCON study evaluated men with biochemically recurrent prostate cancer who were being considered for curative-intent salvage therapy, and compared their treatment plans before and after 18F-fluciclovine PET/CT imaging to assess whether or not it impacted their management," said David Bottomley, MD, St. James Institute of Oncology, Leeds UK. "Results indicated that management plans were revised for the majority of patients, with 65% of revisions involving a major change in treatment modality. These results indicate that decisions based on 18F-fluciclovine PET/CT findings may facilitate more personalized management in men with biochemically recurrent prostate cancer. Investigation of the long-term clinical outcomes of these changes in management is warranted."

The primary endpoint of the FALCON trial examined the percentage of men who had their management plan changed following an 18F-fluciclovine scan. Previously planned therapeutic management was revised after an 18F-fluciclovine PET/CT scan in 64% (66/104) of patients. Of the patients with revised treatment plans, major revisions (e.g., salvage radiotherapy to hormone deprivation or watchful waiting) were made for 65% (43/66) of patients. Salvage treatment was revised to watchful waiting for 24% (16/66) patients and to systemic therapy for 24% (16/66) patients, and 17% (11/66) experienced alternative changes to their treatment modality. Of the patients with revised treatment plans, 35% (23/66) had their intended radiotherapy/brachytherapy plans modified. The safety profile of 18F-fluciclovine in the FALCON trial is consistent with that described in the approved U.S. Prescribing Information.

"Between 30 – 40% of patients with prostate cancer will develop local or distant recurrences within 10 years of radical prostatectomy or radiation therapy, underscoring the need for accurate information on the extent and location of recurrent disease," said Gerald L. Andriole, MD, the Robert K. Royce Distinguished Professor and Chief of Urologic Surgery at Washington University School of Medicine and lead author on behalf of the LOCATE study group. "Results of the FALCON study are consistent with those of the U.S., multi-center LOCATE study of 213 patients, which demonstrated that 59% of men with recurrent prostate cancer following prior treatment had a change in their management plan after 18F-fluciclovine PET/CT imaging."

About the FALCON Trial

The FALCON trial, "Fluciclovine (18F) PET/CT in biochemicAL reCurrence Of prostate caNcer (FALCON)," was an open-label, multi-center study in the UK designed to assess the clinical utility of 18F-fluciclovine PET imaging in the management of patients with prostate cancer with biochemical recurrence after initial treatment. The primary endpoint was to evaluate the clinical impact of 18F-fluciclovine in affecting treatment decisions and was assessed by comparing records of the patient’s treatment plan after an 18F-fluciclovine PET scan with the treatment plan prior to the scan. Secondary endpoints included evaluation of the optimal PSA threshold for detection, salvage treatment outcome assessment based on 18F-fluciclovine involvement and safety.

The FALCON trial was jointly funded by Innovate UK and Blue Earth Diagnostics and was conducted at six leading institutions in the UK: Oxford University Hospitals NHS Foundation Trust, University College London, Kings College London, The Royal Marsden NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust, Mount Vernon Cancer Centre and Greater Glasgow Health Board. Additional information about the FALCON trial is available at: www.clinicaltrials.gov (NCT02578940).

This press release is intended to provide information about Blue Earth Diagnostics’ business in the United States and Europe. Please be aware that the approval status and product label for Axumin varies by country worldwide. For EU Axumin product information refer to: View Source;mid=WC0b01ac058001d124.

U.S. INDICATION AND IMPORTANT SAFETY INFORMATION ABOUT AXUMIN
INDICATION
Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full Axumin prescribing information is available at www.axumin.com.

About Axumin (fluciclovine F 18)

Axumin (fluciclovine F 18) injection is a novel product indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men. Recurrence of prostate cancer is suspected by an increase in prostate specific antigen (PSA) levels following prior treatment. PET imaging with Axumin may identify the location and extent of such recurrence. Axumin was developed to enable visualization of the increased amino acid transport that occurs in many cancers, including prostate cancer. It consists of a synthetic amino acid that is preferentially taken up by prostate cancer cells compared with surrounding normal tissues and is labeled with the radioisotope F 18 for PET imaging. Fluciclovine F 18 was invented at Emory University in Atlanta, Ga., with much of the fundamental clinical development work carried out by physicians at Emory University’s Department of Radiology and Imaging Sciences. Axumin was approved by the U.S. Food and Drug Administration in May 2016, following Priority Review, and is the first product commercialized by Blue Earth Diagnostics, which licensed the product from GE Healthcare. The molecule is being investigated by Blue Earth Diagnostics for other potential cancer indications including neuro-oncology.

On September 16, 2019 Champions Oncology, Inc. (Nasdaq: CSBR), engaged in an end-to-end range of research and development technology solutions and services to improve the development and use of oncology drugs, reported its financial results for the first fiscal quarter ended July 31, 2019 (Press release, Champions Oncology, SEP 16, 2019, View Source [SID1234539577]).

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First Quarter and Recent Business Highlights:

Quarterly revenue of $6.7 million, an increase of 8.2% year-over-year

Record quarterly bookings

Launched clinical flow services

Ronnie Morris, CEO of Champions, commented, "While our first quarter financial results were slightly weaker than expected, the cause was mainly due to the timing of study completions and revenue recognition."

Morris added, "We began aggressively selling our recently launched flow cytometry services during the quarter, expanding sales efforts beyond our core PDX offerings. We have multiple opportunities in the pipeline and look forward to finalizing deals in the coming months. With the combination of continued strength in our core bookings and new product launches, we remain confident in the long term prospects for the Company."

David Miller, CFO of Champions added, "As expected, our revenue declined from the fourth quarter but grew 8% year over year. We anticipate this growth rate will be the low point for the year. The overall health of our business remains strong with continued growth from our core products. With the launch of our clinical flow cytometry services, we expect meaningful contribution to our financial results over the long term."

First Fiscal Quarter Financial Results

For the first quarter of fiscal 2020, revenue increased 8.2% to $6.7 million compared to $6.2 million for the first quarter of fiscal 2019. The increase in revenue is due to increased sales, both in number and size of studies, and growth of the platform. Total costs and operating expenses for the first quarter of fiscal 2020 were $7.4 million compared to $5.7 million for the first quarter of fiscal 2018, an increase of $1.6 million or 28.0%.

Exhibit 99.1

For the first quarter of fiscal 2020, Champions reported a loss from operations of $614,000, including $131,000 in stock-based compensation and $182,000 in depreciation expenses, an increase in the loss of $1.1 million compared to the income from operations of $481,000, inclusive of $83,000 in stock-based compensation and $118,000 depreciation expenses, in the first quarter of fiscal 2018. Excluding stock-based compensation and depreciation, Champions reported loss from operations of $301,000 for the first quarter of fiscal 2020 compared to an income from operations, excluding stock-based compensation and depreciation, of $682,000 in the first quarter of fiscal 2018 a decrease of $983,000.

Cost of oncology solutions was $3.8 million for the three months ended July 31, 2019, an increase of $669,000, or 21.7% compared to $3.1 million for the three months ended July 31, 2018. For the three months ended July 31, 2019, gross margin was 44.3% compared to 50.5% for the three months ended July 31, 2018. The increase in cost of oncology services for the three month period was mainly due to an increase in salaries, mice costs, and lab supplies resulting from the increase in study volume. Gross margin varies based on timing differences between expense and revenue recognition and was impacted by the increase in cost ahead of the revenue related to the studies performed.

Research and development expense was $1.3 million for the three months ended July 31, 2019, an increase of $215,000, or 19.8%, compared to $1.1 million for the three months ended July 31, 2018. The increase is due to lab costs and salaries related to new product development costs. Sales and marketing expense for the three months ended July 31, 2019 was $870,000, an increase of $352,000, or 68.0%, compared to $518,000 for the three months ended July 31, 2018. The increase was mainly due to the expansion of the sales force and commission accrual. General and administrative expense was $1.4 million for the three months ended July 31, 2019 compared to $1.1 million for the three months ended July 31, 2018, an increase of $371,000 or 35.2%. The increase for the three month period is mainly due to the increase in salary expense and audit fees.

Net cash used was $1.0 million for the three months ended July 31, 2019 compared to cash generated of $160,000 for the same period last year. Included in the $1.0 million spend for the quarter was an investment of $750,000 in new lab equipment.

The Company ended the quarter with $2.2 million of cash and reiterated its position that it does not intend to raise capital to fund operations.

Conference Call Information:

The Company will host a conference call today at 4:30 p.m. EDT (1:30 p.m. PDT) to discuss its first quarter financial results. To participate in the call, please call 844-602-0380 (domestic) or 862-298-0970 (international) 10 minutes ahead of the call and give the verbal reference "Champions Oncology."

Full details of the Company’s financial results will be available Monday, September 16, 2019 in the Company’s Form 10-Q at www.championsoncology.com.

* Non-GAAP Financial Information

See the attached Reconciliation of GAAP net (loss) income to Non-GAAP net (loss) income for an explanation of the amounts excluded to arrive at Non-GAAP net (loss) income and related Non-GAAP (loss) earnings per share amounts for the nine months ended July 31, 2019 and 2018. Non-GAAP financial measures provide investors and management with supplemental measures of operating performance and

Exhibit 99.1

trends that facilitate comparisons between periods before and after certain items that would not otherwise be apparent on a GAAP basis. Certain unusual or non-recurring items that management does not believe affect the Company’s basic operations do not meet the GAAP definition of unusual or non-recurring items. Non-GAAP net (loss) income and Non-GAAP (loss) earnings per share are not, and should not be viewed as a substitute for similar GAAP items. Champions’ defines Non-GAAP dilutive (loss) earnings per share amounts as Non-GAAP net (loss) earnings divided by the weighted average number of diluted shares outstanding. Champions’ definition of Non-GAAP net (loss) earnings and Non-GAAP diluted (loss) earnings per share may differ from similarly named measures used by other companies.

On September 16, 2019 Context Therapeutics, a clinical-stage biopharmaceutical company dedicated to advancing medicines for hormone driven cancers, reported a clinical collaboration with SOLTI, a leading collaborative and academic group in Spain dedicated to clinical and translational research in breast cancer (Press release, Context Therapeutics, SEP 16, 2019, View Source [SID1234539544]). This clinical collaboration, being supported by Context and sponsored by SOLTI, is a window of opportunity study (WOO) in the neoadjuvant setting for breast cancer.

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During the study, patients participating in the ONAWA (ONApristone Window Assessment) trial will receive oral doses of the progesterone receptor antagonist, Apristor (onapristone ER). Patients will be biopsied on day one, followed immediately by treatment and a final biopsy after three weeks, on the day of their full lumpectomy or mastectomy. Data generated from this study is intended to confirm the Recommended Phase 2 Dose (RP2D) of Apristor and to provide comprehensive biomarker data to further validate that the antitumor activity of Apristor is driven through downregulation of progesterone receptor and associated signaling pathways. This data will support Context’s ongoing and planned Phase 2 studies in breast, ovarian, and endometrial cancers.

"We are thrilled to enter into this collaboration with SOLTI and facilitate this window of opportunity study. We expect that this study will provide additional biomarker data to support our planned Phase 2 studies in progesterone receptor positive (PR+) female cancers," said Martin Lehr, CEO of Context Therapeutics.

The study, conducted within SOLTI’s network, has two Principal Investigators, both members of SOLTI Governing Board: Dr. Meritxell Bellet, Senior Consultant at Breast Cancer Unit at Vall d’Hebron University Hospital and Dr. Cristina Saura, Head of Breast Cancer Unit at Vall d’Hebron University Hospital. "The majority of breast cancer patients have an hormone-dependent disease. The hormones estrogen and progesterone drive breast cancer progression in those patients, but antiestrogens are the only antihormonal therapy available to clinicians. As such, antiestrogen resistance is now a major clinical challenge," said Dr. Bellet. "We believe that a progesterone receptor antagonist has the potential to address antiestrogen resistance and/or potentiate antiestrogen activity, which we believe will lead to better outcomes for patients. This window of opportunity provides us with the first clinical opportunity to delve deep into how progesterone receptor antagonists modulate the breast cancer tumor and its microenvironment."

About Hormone Driven Breast Cancer
Hormone receptor positive (HR+) breast cancer is the most common form of breast cancer and accounts for more than 70% of all breast cancers. HR+ cancer is usually treated with antiestrogen therapies first that help stop tumor growth. For many patients, antiestrogen therapy becomes ineffective over time and the cancer becomes resistant to antiestrogen therapy. In this recurrent setting, progesterone receptor has emerged as a prominent resistance mechanism. It is estimated that there are over 750,000 patients with recurrent disease worldwide.

About Window of Opportunity Trials
Window of opportunity (WoO) trials take advantage of natural scheduling delays that occur between initial consultation and surgery. This allows learning about anticancer activity of the intervention in a patient who has not been exposed to previous therapies. Such studies can better define biological effects of the therapy and outline the target patient population for the following studies. In turn, development and identification of promising drugs could speed up. WoO trials are usually short, in the order of 2–6 weeks of treatment, making it difficult to achieve clinical endpoints such as objective response. The endpoint of WoO trial is usually biomarker modulation. The collection of before and after treatment tumor biopsies allows determination of extent of target inhibition, cell proliferation and apoptosis, and identification of other biomarkers.

About Apristor
Apristor (onapristone extended release) is a potent and specific antagonist of the progesterone receptor that is orally administered. Currently, there are no approved therapies that selectively target PR+ cancers. Preliminary preclinical and clinical data suggest that Apristor has anticancer activity by inhibiting the binding of progesterone receptor to chromatin, downregulating cancer stem cell mobilization, and blocking immune evasion. Apristor is an investigational drug that has not been approved for marketing by any regulatory authority.