On November 11, 2019 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer, and other indications, reported its financial results for the third quarter of 2019 ended September 30, 2019, and provided an update on the Company’s recent and future developments (Press release, Pieris Pharmaceuticals, NOV 11, 2019, View Source [SID1234550862]).

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"The recent presentations of clinical data for our two lead programs, PRS-060 and PRS-343, represent critical inflection points in the history of Pieris," said Stephen S. Yoder, President and Chief Executive Officer of Pieris. "In October, we presented positive data from our ongoing phase 1b study of PRS-060, an inhaled IL-4 receptor alpha antagonist for moderate-to-severe asthma, and we continue to be excited about the program as we plan with AstraZeneca to move into phase 2 next year. Over the weekend, we presented promising data from our phase 1 dose-escalation study of PRS-343, a 4-1BB/HER2 bispecific for HER2-positive solid tumors, demonstrating single-agent activity that we believe is linked to 4-1BB engagement, and we look forward to initiating an indication-specific expansion study for this drug candidate next year. Our recently-announced financing, supported not only by key existing shareholders but also by fundamental focused new investors, will enable more near-term data-driven clinical development investment and is intended to provide a funding mechanism to facilitate Pieris’ ability to opt-into co-development of PRS-060 with AstraZeneca if phase 2a data are positive."

PRS-060: Pieris presented data from the phase 1b placebo-controlled multiple ascending dose study of PRS-060/AZD1402, an inhaled IL-4 receptor alpha antagonist for moderate-to-severe asthma, at the 2019 European Respiratory Society International Congress on October 1st. In that analysis, PRS-060/AZD1402 was found to be safe and well tolerated at all doses, led to a statistically significant reduction in fractional exhaled nitric oxide (FeNO) relative to placebo, and showed dose-dependent systemic target engagement in patients with mild asthma and elevated levels of FeNO (≥ 35 ppb). Following the presentation of these encouraging data, AstraZeneca and Pieris have been preparing to move into a phase 2a study in moderate-to-severe asthmatics next year. Upon completion of that study, which will be sponsored and funded by AstraZeneca, Pieris will have options to co-develop and co-commercialize the drug candidate in the United States.
PRS-343: Pieris presented data from its phase 1 dose-escalation monotherapy study of PRS-343, a 4-1BB/HER2 bispecific for HER2-positive solid tumors, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting on November 9th. PRS-343 was safe and well tolerated at all doses and schedules tested, demonstrated anti-tumor activity in a heavily pre-treated patient population across multiple tumor types, and showed a potent increase in CD8+ T cell numbers in the tumor microenvironment of responders, indicative of 4-1BB agonism on T cells. Pieris continues to enroll patients in that study at higher dose cohorts and plans to initiate an indication-specific expansion trial next year. The Company also continues to enroll the dose-escalation phase 1 study of PRS-343 in combination with atezolizumab, with the objective of interrogating the synergy between 4-1BB agonism and PD(L)-1 blockade, and will report emerging data from that study at the Pieris R&D day on November 19th.
Immuno-oncology Pipeline: Pieris plans to file an IND application for PRS-344, a 4-1BB/PD-L1 bispecific that the Company is developing as part of its collaboration with Servier, in the first half of next year. Pieris holds exclusive commercialization rights for PRS-344 in the United States and will receive royalties on ex-U.S. sales for this program.
R&D Day: Pieris will host an R&D day in New York on Tuesday, November 19th from 12:00-3:30 PM EST. The event will be accessible via a live webcast through this link beginning at 12:30 PM EST.
Private Placement: The Company completed a $32 million private placement led by BVF Partners L.P., with significant additional participation from EcoR1 Capital, Aquilo Capital Management, Surveyor Capital (a Citadel company), and Samsara BioCapital. The placement consisted of 9,014,960 units at a price of $3.55 per unit, with each unit consisting of (i) one share of common stock or 0.001 non-voting Series C convertible preferred stock and (ii) one warrant to purchase one share of common stock at an exercise price of $7.10 per share. Each share of non-voting Series C convertible preferred stock is convertible into 1,000 shares of Pieris common stock, provided that conversion will be prohibited if, as a result, the holder and its affiliates would own more than 9.99% of the total number of shares of Pieris common stock then outstanding. The warrants are intended to facilitate Pieris’ exercise of its co-development option for PRS-060/AZ1402 following the conclusion of a positive phase 2a study. If top-line results of that study disclose achievement of the primary efficacy endpoint and the stock reaches a pre-specified price, then the warrants will expire 60 days following such disclosure and may only be exercised for cash. Otherwise, the warrants will be exercisable for a period of five years from the date of issuance.
Third Quarter Financial Update:

Cash Position – Cash, cash equivalents, and investments totaled $86.2 million as of September 30, 2019, compared to cash equivalents, and investments totaling $128.1 million as of December 31, 2018. This amount excludes the $32 million in gross proceeds from the November 2019 financing. Included in the Company’s cash spend during the third quarter of 2019 was a one-time $2.3 million payment to the Technical University of Munich for sub-license royalties due on upfront and milestone payments related to collaboration agreements signed in 2017 and 2018.

R&D Expense – R&D expenses were $13.2 million for the quarter ended September 30, 2019, compared to $11.4 million for the quarter ended September 30, 2018. The Company’s increase in R&D expenses reflects higher (albeit reimbursable) manufacturing efforts related to PRS-060/AZD1402 as part of phase 2a readiness activities for the program, as well as higher personnel and allocated facility costs due to growth in the Company’s R&D organization to support higher levels of pre-clinical and clinical activities.

G&A Expense – G&A expenses were $4.8 million for the quarter ended September 30, 2019, compared to $4.7 million for the quarter ended September 30, 2018. There was no significant change in the composition of G&A expenses on a quarter over quarter basis.

Net Loss – Net loss was $2.6 million or $(0.05) per share for the quarter ended September 30, 2019, compared to a net loss of $6.6 million or $(0.11) per share for the quarter ended September 30, 2018.

Conference Call:

Pieris management will host a conference call beginning at 8:00 AM EST on Monday, November 11, 2019 to provide a corporate update. Individuals can join the call by dialing +1-877-407-8920 (US & Canada) or +1-412-902-1010 (International). An archived replay of the call will be available by dialing +1-877-660-6853 (US & Canada) or +1-201-612-7415 (International) and providing the Conference ID #: 13661472.

On November 11, 2019 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported its financial results for the third quarter and nine months ended September 30, 2019 (Press release, Castle Biosciences, NOV 11, 2019, View Source [SID1234550878]).

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"We are pleased with our strong third quarter performance, driven by solid growth in our DecisionDx-Melanoma test report volume, which is a result of our investment in evidence development and scaling our commercial team in the first quarter of 2019," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "Based upon our results, we have decided to execute our commercial expansion plans in December 2019.

"We recently presented the clinical validation study data for our DecisionDx-SCC test for use in patients diagnosed with high risk cutaneous squamous cell carcinoma, which we expect to launch in the second half of 2020. Additionally, we continue to progress our third skin cancer product for use in patients with a suspicious pigmented lesion, which is also on track for anticipated commercial availability in the second half of 2020. We believe these two late stage pipeline products will increase our estimated total addressable U.S. market by more than $1.4 billion, for an estimated total addressable U.S. market of $2.0 billion for current and pipeline products."

Third Quarter Ended September 30, 2019, Financial Highlights

Revenues were $14.8 million, an increase of $11.1 million from Q3 2018.
Delivered 4,126 DecisionDx-Melanoma test reports in the 2019 third quarter, compared to 3,136 reports during the third quarter of 2018, representing growth of 32%.
Delivered 356 DecisionDx-UM test reports in the 2019 third quarter, compared to 324 reports during the third quarter of 2018, representing growth of 10%.
Gross margin was $13.1 million, or 88%.
Operating cash flows were $0.8 million in Q3 2019, compared to $(1.9) million in Q3 2018.
Nine Months Ended September 30, 2019, Financial Highlights

Revenues were $34.2 million, an increase of $22.9 million over the same period in 2018.
Delivered 12,141 DecisionDx-Melanoma and DecisionDx-UM proprietary test reports, an increase of 24% over the same period in 2018, with DecisionDx-Melanoma increasing 26%.
Gross margin was $28.9 million, or 85%.
Operating cash flows were $2.5 million, compared to $(9.1) million for the same period in 2018.
Cash and Cash Equivalents

As of September 30, 2019, the Company’s cash and cash equivalents was $94.5 million, and the outstanding principal balance on our bank term loan was $26.7 million.

Supplemental Revenue Information

Affecting the year-over-year comparability of our revenues were (a) the issuance of the Medicare Local Coverage Determination (LCD) for our DecisionDx-Melanoma test, effective December 3, 2018 and (b) confirmation of the Medicare Contractor rate for DecisionDx-Melanoma. As a result of timing of these two elements, all 2018 Medicare claims covered under the LCD were recognized as revenue in the fourth quarter of 2018. Medicare revenues for DecisionDx-Melanoma associated with test reports delivered in the three and nine months ended September 30, 2018, but not recorded until the fourth quarter of 2018, were $2.2 million and $5.2 million, respectively. Also, included in revenues for the quarter ended September 30, 2019, and 2018, were positive (negative) revenue adjustments related to tests delivered in prior periods of $3.2 million and $(1.2) million, respectively. For the nine months ended September 30, 2019, and 2018, these amounts totaled $2.4 million and $0.6 million, respectively.

Third Quarter Business and Clinical Evidence Updates

The Company expanded the number of outside sales territories from 14 to 23 in the first quarter of 2019, with commensurate increases in other commercial and medical affairs support roles. Subsequently, new ordering clinicians for DecisionDx-Melanoma grew 26% in the third quarter, compared to the same period in 2018. For comparison purposes, third quarter growth in new ordering clinicians in 2018 was 5%, compared to the same period in 2017. As a result, the Company has decided to execute its commercial expansion plans in December 2019, which is expected to include the addition of nine new outside sales territories and commensurate increases in commercial and medical affairs support roles.
A multicenter study establishing an evidence-based population to guide appropriate use of the DecisionDx-Melanoma test in patients with thinner (1.0 mm or less) melanoma tumors was published in the peer-reviewed journal SKIN: The Journal of Cutaneous Medicine. The results established a minimum Breslow thickness of 0.3 mm as an appropriate population to use DecisionDx-Melanoma to guide decisions on treatment plan decisions for follow-up and surveillance for cutaneous melanoma patients. An earlier publication (February 2019) established appropriate use criteria for the treatment plan decision to guide sentinel lymph node biopsy (SNLB) surgical procedures in patients diagnosed with a melanoma ≤2.0mm thick. Together, these two appropriate use criteria cover more than 90% of all melanoma patients currently tested.
The Company closed the initial public offering of 4,600,000 shares of its common stock, which included 600,000 shares sold pursuant to the exercise in full by the underwriters of their option to purchase additional shares, at a price to the public of $16.00 per share. Including the option exercise, the gross proceeds to the Company from the offering, before deducting the underwriting discounts and commissions and offering expenses, were $73.6 million.
The Company was added as a member of the U.S. small-cap Russell 2000 Index. Membership in the Russell 2000 Index, which remains in place for one year, is based on membership in the broad-market Russell 3000 Index. The stock also was automatically added to the appropriate growth and value indexes.
Recent Developments

An expert panel consensus statement that includes appropriate use criteria for DecisionDx-Melanoma in patients with cutaneous melanoma was published in the peer-reviewed journal SKIN: The Journal of Cutaneous Medicine. Using a modified Delphi technique, the panel established an evidence-based appropriate use framework to integrate the DecisionDx-Melanoma test into the management of patients with cutaneous melanoma. The appropriate use recommendations cover more than 90% of all patients currently tested.
One of the two appropriate uses of the DecisionDx-Melanoma test is the ability to guide or rule out a SLNB surgical procedure in patients with a melanoma ≤2.0mm thick. The Company published data from a prospective, multi-center, consecutively tested population of 1,421 patients in February 2019, that demonstrated that a Class 1A test result identified a group of patients with melanomas ≤2.0mm thick, in which the likelihood of a positive sentinel lymph node (SLN) was ≤5%; the National Comprehensive Cancer Network (NCCN) threshold for offering a SLNB surgical procedure. Within this ≤2.0mm group, an important question is performance of DecisionDx-Melanoma in "thin" melanomas, which are defined as a melanoma ≤1.0mm deep.

In October, the Company presented data on a new prospective, multi-center, consecutively tested cohort of 1,166 patients at the International Congress on Cancer Metastasis. The study combined patients with melanoma with those of the study published in February 2019, for a total number of patients with melanomas ≤1.0mm thick of 1,058. Within this group, the SLN positivity rate for patients with a Class 1A test result of any age was 3.2%, for patients ≥65 years of age, the rate was 0.9% and for those ≥65 years of age who underwent a SLNB procedure, the SLN positivity rate was 1.0%. These data support the use of a DecisionDx-Melanoma Class 1A test result in patients with a melanoma ≤1.0mm deep to identify patients who are at low risk for a positive SLN and can avoid a SLNB surgical procedure. SLNB surgery has an average reimbursed cost of $20,000 to $24,000; therefore, this could represent a significant potential healthcare savings, in addition to enabling patients to avoid a surgical procedure with an 11% complication rate.
Nomograms are a clinical tool that enable clinicians to combine independent risk factors to estimate an individual cancer patient’s likelihood of recurrence or metastasis. In October, the Cutaneous Oncology Research Consortium (CORC) presented a nomogram that was developed from data on a prospectively tested cohort of 1,124 patients, 685 of which had ≥1 year of recurrence-free follow-up or a recurrence event (median follow-up =3.0 years) and were included in development of the nomogram. The nomogram demonstrated that the combination of DecisionDx-Melanoma test results with Breslow’s thickness and ulceration, commonly referred to as T-stage, improved prediction of patients’ risk of melanoma recurrence compared to clinicopathologic features alone. This nomogram was independently validated using the Company’s archival study of 901 patients.
DecisionDx-SCC, the Company’s late stage pipeline product expected to be commercially available in the second half of 2020, is designed to predict a low risk of metastasis in patients with cutaneous squamous cell carcinoma (SCC), who are identified as high risk by traditional clinicopathologic staging criteria. Results of the clinical validation study (n=321) for DecisionDx-SCC were recently presented at the American Society for Dermatologic Surgery (ASDS) Annual Meeting. The development goal for DecisionDx-SCC was to enable a clinician to de-escalate treatment plans in patients with one or more high risk clinical or pathologic features who are at low biological risk of metastasis. Importantly, 93% of patients in the validation cohort had one or more high risk features. The validation data showed that approximately 60% of high-risk patients were identified as low risk with a Negative Predictive Value (NPV) of 91.1%. Conversely, the highest risk of the remaining patients had a Positive Predictive Value (PPV) of 60%, compared to 35.3% for the Brigham and Women’s criteria, 20.9% for the American Joint Committee on Cancer and 16.7% for NCCN risk criteria.
Data from a multicenter, prospective study demonstrating that DecisionDx-UM test results significantly impacted treatment plan recommendations for patients with uveal melanoma was presented at the American Academy of Ophthalmology 2019 Annual Meeting. The CLEAR II study (Clinical Application of DecisionDx-UM Gene Expression Assay Results) was designed to prospectively evaluate metastatic surveillance regimens for patients with uveal melanoma, who were tested with the DecisionDx-UM gene expression profile (GEP) test as part of their diagnostic work-up. The study met the primary endpoints demonstrating a clinically and statistically relevant reduction in treatment plans for patients with a low risk Class 1 test result, compared to a Class 2 test result, with 95% of Class 2 patients being referred to medical oncology.
The Company received notification that the American Medical Association (AMA)’s Current Procedural Terminology (CPT) Editorial Panel accepted its application for a Category I Multianalyte Assays with Algorithmic Analyses (MAAA) CPT code for its DecisionDx-Melanoma test. The CPT Editorial Panel is an independent group of expert volunteers representing various sectors of the health care industry. Their role is to ensure that code changes undergo evidence-based review and meet specific criteria. The code will be effective on January 1, 2021.
Conference Call and Webcast Details

Castle Biosciences will hold a conference call on Monday, November 11, 2019, at 4:30 p.m. Eastern time to discuss its third quarter 2019 results and provide a corporate update.

A live webcast of the conference call can be accessed here: View Source or via the webcast link on the Investor Relations page of the Company’s website (www.castlebiosciences.com). Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until December 2, 2019.

To access the live conference call via phone, please dial 877-282-2581 from the United States and Canada, or +1 470-495-9479 internationally, at least 10 minutes prior to the start of the call, using the conference ID 4476877.

There will be a brief Question & Answer session following management commentary.

On November 11, 2019 Replimune Group Inc. (Nasdaq: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported financial results for its second fiscal quarter, ended September 30, 2019, and provided a corporate update (Press release, Replimune, NOV 11, 2019, View Source [SID1234550863]).

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"It has been a very productive and exciting period for Replimune," said Robert Coffin, Ph.D., President and CEO of Replimune. "The highlight was the SITC (Free SITC Whitepaper) 2019 presentation of RP1 clinical data which confirmed the expected mechanism of action, initial safety profile, and evidence of anti-tumor efficacy providing strong support for our ongoing and expanded programs in CSCC and melanoma. Based directly on this data, the decision was taken to conduct a new clinical trial in solid organ transplant patients with CSCC and in melanoma patients who are refractory to prior treatment with anti-PD1 directed therapy. We were also very pleased to have initiated the first clinical trial of our second clinical product candidate, RP2. Overall we are thrilled with Replimune’s progress in the quarter and excited for the future as we continue to execute upon our mission to make our oncolytic immuno-gene therapies a cornerstone of cancer treatment."

Recent Business Highlights and Upcoming Events

RP1 – Presented initial data from the Phase 1/2 clinical trial of RP1 alone and in combination with Opdivo at SITC (Free SITC Whitepaper) 2019. The data presented demonstrated that RP1 used alone and in combination with Opdivo is well tolerated and showed clear anti-tumor efficacy in target tumor types that provides strong support for Replimune’s ongoing and planned development programs in melanoma and CSCC. This clinical trial is being conducted under a clinical trial collaboration and agreement with Bristol Myers Squibb (BMS) for the supply of Opdivo.

RP1 – Initiated the registration-directed Phase 2 clinical trial of RP1 in combination with Libtayo in CSCC. This multi-center, randomized, controlled clinical trial is intended to enroll approximately 240 patients with CSCC. The clinical trial’s primary objective is to compare the response rate following treatment with RP1 in combination with Libtayo to the response rate achieved with Libtayo alone. Libtayo is an FDA-approved anti-PD-1 therapy developed by Regeneron and Sanofi for the treatment of patients with metastatic or locally-advanced CSCC who are not candidates for curative surgery or radiation. This clinical trial is being conducted under the Company’s collaboration agreement with Regeneron, whereby the Company and Regeneron will split equally development and supply costs. Recruitment into this clinical trial is expected to take approximately 18 to 24 months.

RP1 – Recruitment ongoing in the Phase 2 part of the Phase 1/2 trial of RP1 in combination with Opdivo. The Phase 2 part of the clinical trial is currently enrolling 30-patient cohorts of patients with melanoma, non-melanoma skin cancers, metastatic bladder cancer and microsatellite instability high (MSI-H) tumors.

RP1 – New clinical trial planned of RP1 as monotherapy in organ transplant recipients with CSCC. CSCC represents a significant unmet medical need in organ transplant recipients where it is the most prevalent tumor type in a population at higher risk for malignancy in general, and where anti-PD-1 therapy provides a significant risk of rejection of the transplanted organ. The U.S. Food and Drug Administration (FDA) has accepted the protocol for this clinical trial under the Company’s previously accepted Investigational New Drug Application for RP1. The clinical trial is intended to enroll approximately 30 patients and assess the safety and efficacy of RP1 in liver and kidney transplant recipients with recurrent CSCC. Replimune expects to initiate the clinical trial in the first quarter of 2020.

RP1 – Additional clinical trial intended of RP1 in combination with an anti-PD-1 therapy in anti-PD-1 refractory melanoma patients. Based on the clinical efficacy data to date with RP1 in melanoma, the Company has decided to conduct a new clinical trial of RP1 in combination with an anti-PD-1 therapy in anti-PD-1 refectory melanoma patients. Discussions are underway to determine the particular anti-PD-1 therapy to be used. The trial is expected to begin enrollment in 2020.

RP2 – Initiation of the Phase 1 clinical trial of RP2 alone and in combination with Opdivo. RP2 is based on RP1 but additionally expresses a genetically encoded anti-CTLA-4 antibody-like molecule. The addition of anti-CTLA-4 is intended to block the inhibition of the initiation of immune responses otherwise caused by CTLA-4. The clinical trial is designed to assess the safety, tolerability and to determine the optimal dose of RP2 alone and in combination with Opdivo and is being conducted under a clinical trial collaboration and agreement with BMS for the supply of Opdivo.

RP3 – The Phase 1 clinical trial of RP3 alone and in combination with an anti-PD1 therapy remains on track to initiate in 2020. RP3 is a further armed oncolytic immuno-gene therapy which expresses two immune co-stimulatory activating ligands (CD40L and 4-1BBL) in addition to the GALV-GP R- fusogenic protein and anti-CTLA-4.

Build-out of Replimune’s manufacturing facility to support late-stage development and commercialization remains on schedule. The 63,000-square-foot facility in Framingham, MA is intended to provide multi-product manufacturing capabilities for Replimune’s Immulytic product candidates. The capacity of this facility will be sufficient to support full commercialization of the Company’s product candidates. An occupancy certificate for the facility has been obtained and technology transfer is underway.
Financial Highlights

Replimune reported a net loss of $11.1 million for the quarter ended September 30, 2019 compared with $6.5 million for the same period in the prior year.

Research and development expenses for the quarter ended September 30, 2019 were $8.2 million compared with $5.0 million for the same period in the prior year. The increase in research and development expenses was primarily driven by additional costs related to Replimune’s preclinical and clinical development activities for its pipeline.

General and administrative expenses for the quarter ended September 30, 2019 were $4.1 million compared with $2.1 million for the same period in the prior year. The increase in general and administrative expenses was primarily due to an increase in employee headcount, professional fees and facility costs.

Replimune ended the quarter with $109.9 million in cash, cash equivalents, and short-term investments, compared with $134.8 million as of March 31, 2019.

Based on its current operating plan, Replimune expects that its current cash, cash equivalents, and short-term investments will enable it to fund its operating expenses and capital expenditure requirements into the second half of calendar year 2021.

On November 11, 2019 IBM (NYSE: IBM), American Cancer Society (ACS), the National Comprehensive Cancer Network (NCCN) and the Clinton Health Access Initiative (CHAI), reported a new alliance to help improve access to high-quality cancer care and treatment in Sub-Saharan Africa called Allied Against Cancer (Press release, IBM – Initiate Systems, NOV 11, 2019, View Source [SID1234550879]). The Alliance will support a network of African oncology experts and technical assistance partners to help improve the quality of cancer care, including collaborating closely with the African Cancer Coalition to establish priorities and execute these initiatives locally.

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There are more than 800,000 new cancer cases each year in Sub-Saharan Africa and incidence is projected to double by 2040. And as these countries address the growing cancer epidemic, data and emerging technologies can play a significant role in cancer treatment control and care. The need for more affordable cancer treatment and strong systems for their delivery are crucial to help improve patients’ survival.

To address gaps in access to cancer medicines, ACS and CHAI teamed up in 2016 to bring lower prices for 16 common chemotherapy drugs to a half-dozen countries in Sub-Saharan Africa. And top American oncologists have supported the African Cancer Coalition — comprising of 110 African oncologists representing 34 hospitals from 13 countries in Sub-Saharan Africa—to adapt cancer-treatment guidelines for use in African hospitals. The African Cancer Coalition, working with experts from NCCN, adapted the 46 NCCN Guidelines and NCCN Framework for Resource Stratification of NCCN Guidelines (NCCN Framework) to create the NCCN Harmonized Guidelines for Sub-Saharan Africa specifically to be used by oncologists across Sub-Saharan Africa. These guidelines have been endorsed by leading cancer centers or health ministries in six countries to date.

IBM then developed an online tool called Cancer Guidelines Navigator to provide African oncology professionals with interactive access to the NCCN Harmonized Guidelines for Sub-Saharan Africa at no charge. Oncologists based in Sub Saharan Africa can input a clinical description for a cancer patient1 — such as tumor type, stage, biomarker status, and prior treatments — into the online tool. The Cancer Guidelines Navigator then points the user to relevant treatment options input from the NCCN Harmonized Guidelines. At this time, the tool includes NCCN Harmonized Guidelines for cervical cancer, prostate cancer, breast cancer, diffuse large B-cell lymphoma, and Kaposi sarcoma.

IBM also helped to transform the ACS ChemoSafe Facility Assessment Tool – from an Excel-based document to an interactive, easy to use mobile application- to scale the program’s goal of improving the safety and quality for chemotherapy handling in cancer centers. This tool, which is accessible at no cost on iOS or Android mobile phones or tablets, allows healthcare workers to review the safety of hazardous drugs at each location where they may be handled in their healthcare facility, including the pharmacy receiving, treatment areas, housekeeping, and waste area. Upon completion of the assessment, the tool provides recommendations to help improve the handling of hazardous drugs at potential points of exposure, based on international and national standards. This information may be used by hospitals to create policies and budgets supporting quality improvement.

"Allied Against Cancer brings together a group of top-notch experts to tackle the growing burden of cancer in Africa, and the American Cancer Society is proud to be a founding member of the alliance," said Gary Reedy, Chief Executive Officer, American Cancer Society.

"With the increasing burden of cancer in this part of the world, we must strive to improve patients’ access to timely and affordable care. Technology and data can help create efficient healthcare systems so that national and regional medical networks can increase support their local communities," said Dr. Solomon Assefa, Vice President, Africa & Emerging Market Solutions and Director, IBM Research – Africa.

"These evidence and expert consensus-based treatment recommendations combine the practical with the aspirational, to elevate the quality of cancer care at a time when the people of Sub-Saharan Africa need it most," said Robert W. Carlson, MD, Chief Executive Officer, NCCN.

"This new alliance will help ensure that lifesaving medications and tools are available where and when they are needed so that health professionals can better diagnose, treat, and care for patients suffering with cancer throughout Sub-Saharan Africa," said CHAI CEO Ira C. Magaziner.

"To address the growing burden of cancer in Africa and worldwide, African oncologists need quick and easy access to current treatment options as well as quality, affordable treatment for their patients. This alliance provides an opportunity to strengthen the ties within the global oncology community in ways that can deliver better outcomes for our patients," said Professor Isaac Adewole, Co-chair of the African Cancer Coalition.

On November 11, 2019 USA News Group – As the global oncology drug market is projected to grow at a rate of 7.6% CAGR to hit $176.5 billion by 2025, there’s a growing interest within the big pharma sector to tap into the power of viruses to fight cancer (Press release, Oncolytics Biotech, NOV 11, 2019, View Source [SID1234550880]). It’s estimated that the therapeutic cancer vaccine market alone will reach more than $15 billion by 2025. Dubbed ‘oncolytic viruses’ these treatments utilize all types of viruses to encourage the patient’s immune system to respond and attack cancer cells with heightened efficacy. It’s been seen that a variety of majors including Amgen Inc. (NASDAQ:AMGN), Merck & Co. (NYSE: MRK), AbbVie Inc. (NYSE:ABBV), and Bristol-Myers Squibb (NYSE:BMY) are looking at a variety of oncolytic virus developers, such as Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC).

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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

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Innovators like development stage Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) are drawing interest from major partners for developing their own immuno-oncology virus. The companuy’s proprietary reovirus, marketed as pelareorep, is currently being studied for potential combination with Opdivo from Bristol-Myers Squibb Company and Keytruda from Merck & Co., Inc.

In 2018, both Opdivo and Keytruda are multi-billion dollar products—Opdivo sales were $6.7 billion, while Keytruda sales were $7.2 billion. Pelareorep is also being studied for potential combinations with Merck/Pfizer’s paclitaxel and Bavencio (which sold $75.5 million in 2018), and Roche’s Tecentriq (which had sales of $766 million in 2018).

Now with the Opdivo and Keytruda developments, it’s worth noting that Bristol-Myers Squibb and Merck are no strangers to the oncolytic virus scene. Both companies have made significant investments in the oncolytics virus sector in recent years.

MAJORS MAKING 9-DIGIT ONCOLYTIC VIRUS INVESTMENTS

In 2015, Amgen Inc. became the first company to win approval for such a treatment, when the FDA approved the therapy T-VEC (or Imlygic) to treat metastatic melanoma that cannot be surgically removed. The approval was based on the results of a multicenter phase 3 clinical trial of patients with metastatic melanoma lesions in the skin and lymph nodes.

Bristol-Myers Squibb followed up this approval, by entering a partnership in 2016 with PsiOxus involving its lead asset Adenovirus, which was in phase 1. The transaction involved a $50 million payment up front, with up to $886 million in milestone payments and royalties at stake. The first milestone payment was earned the following year when it achieved approval for its Clinical Trial Application.

Merck has also been active, including the acquisition of Viralytics for its lead asset Coxsackievirus which was in phase 1b at the time of acquisition, and another immunotherapy partnership with Vyriad (and lab partner Pfizer), involving its lead drug candidate Voyager-V1.

Merck acquired the virus-based cancer drug firm Viralytics for $394 million in 2018, at a premium price of 160% to the average stock price over the previous month. Viralytics’s leading experimental product at the time of acquisition was Cavatak, which uses a proprietary formulation of a common cold virus, and was in the process of being studied in multiple Phase I and Phase II clinical trials.

In 2017, AbbVie Inc. partnered with another Canadian drug developer Turnstone Biologics. The deal gives AbbVie the exclusive right to license up to three of Turnstone Biologics’ immunotherapy treatments for commercial purposes. Terms of the deal, however, are not publicly available.

PELAREOREP’S ONGOING PROGRESS

Pelareorep from Oncolytics Biotech Inc. (ONCY – ONC.TO) selectively infects tumor cells, leading to the creation of inflamed tumors. The body’s ability to target the inflamed tumors is heightened, leading to the creation of tumor reactive T cells. In turn, pelareorep expands existing T cell clones priming the immune system for checkpoint blockade. To date, the drug has synergized with all checkpoint inhibitor combinations tested.

So far, based on the final advice from the FDA following their EOP2 meeting, the company’s been granted Special Protocol Assessment (SPA). It’s been recommended that identification of biomarker should be done before Phase III. Confirmation of a single phase 3 study is required for approval.

Through a partnership with Northwestern Medicine’s Feinberg School of Medicine, and Merck & Co., Oncolytics is studying pelareorep’s potential with Merck’s Keytruda in targeting metastatic pancreatic cancer. The phase 2 study incorporates up to 30 patients.

In another partnership involving Keytruda, Oncolytics is pairing with Merck and Keck Medicine of USC to study a combination efficacy involving multiple myeloma. The phase 2 study involves 22 patients, and will incorporate existing safety data in combination with Keytruda.

For a combination with Opdivo, Oncolytics is also targeting multiple myeloma, by collaborating with Bristol-Myers Squibb and Emory University, in a phase 1 study. The study involves 40 to 50 patients, and so far at the top dose, there has been a 100% response rate.

"Having worked with pelareorep in multiple myeloma and understanding its ability to act as a potentiator of checkpoint blockade, I’m very excited to work with the Oncolytics team on this study," said Dr. Craig Hofmeister, Associate Professor, Department of Hematology and Medical Oncology Emory University School of Medicine. "Pelareorep has proven its ability to create an inflamed phenotype and its potential for upregulation of PD-1 on tumor-infiltrating lymphocytes. My hope is this study leads not only to an effective combination dosing schedule but provides quantitative data describing the expression of PD-1, along with correlative studies that reveal the roles of both immune-mediated and direct cytotoxic myeloma cell killing."

To date, pelareorep has been involved with 1,100 patients treated, of which over 900 were administered intravenously. To date, no maximum tolerated dose (MTD) has been reached.

In terms of manufacturing the product, Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) has established cost-effective contract manufacturing. The final formulation was produced at 100 liter-scale under cGMP—which is more than 50,000 standard doses per production run.

Oncolytics has established a commercial scale manufacturing agreement with SAFC (part of Merck Millipore Sigma). When stored frozen, the liquid formulation is stable for at least five years (with stability testing ongoing).

Pelareorep has been given biosafety level 2 classification, thus requiring no specialized handling requirements. Cost of Goods (COGS) are in line with those of other products made via vaccine manufacturing process.

Oncolytics has 398 patents issued worldwide, including 48 US and 21 Canadian, with over 21 more pending applications worldwide. The reovirus issued patent claims cover compositions of matter comprising reovirus (through 2028 and extendable to 2033), and all pharmaceutical uses of it.

THE ONCOLYTIC VIRUS SCENE AHEAD

Merck & Co. (NYSE:MRK) made a big splash in the oncolytic virus scene when it bought the Australian biotech firm Viralytics for $394 million. The massive price paid signaled that Viralytics was an asset that Merck just had to own.

This was similar to the size of payment that Amgen Inc. (NASDAQ:AMGN) made, when it paid $424 million for Biovex in 2011. Given that Amgen’s T-VEC was the first oncolytic virus to receive FDA approval, it’s realistic to believe that they’re not done solidifying their position in the space. T-VEC is a genetically engineered oncolytic herpes virus, that’s injected into skin tumors, resulting in shrinkage or complete remission of tumors.

AbbVie Inc. (NYSE:ABBV) tipped its hand towards an interest in oncolytics viruses, when it secured an option on three oncolytic viral immunotherapies from Turnstone Biologics. The deal gives AbbVie the chance to add Turnstone’s lead MAGEA3 candidate to its pipeline once data from the two ongoing phase 1/2 trials are available.

While Bristol-Myers Squibb (NYSE:BMY) continues to work with Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) for a combination with Opdivo, the major invested heavily in a partnership with PsiOxus for roughly $900 million. Together, they are developing an oncolytic adenovirus, which has already earned a $15 million milestone payment for PsiOxus.