On November 9, 2020 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported its third quarter 2020 financial results and provided an update on the Company, including its third quarter progress with eganelisib (IPI-549), the Company’s first-in-class, oral immuno-oncology product candidate targeting immune-suppressive tumor-associated myeloid cells through selective phosphoinositide-3-kinase-gamma (PI3K-gamma) inhibition (Press release, Infinity Pharmaceuticals, NOV 9, 2020, View Source [SID1234570368]).

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"We are approaching an important inflection point at Infinity, with expected data readouts across our clinical programs in the next few months that demonstrate the benefit of eganelisib across multiple indications, patient populations and treatment settings." said Adelene Perkins, Chief Executive Officer and Chair of Infinity Pharmaceuticals. "We are pleased that the IDMC supports the further exploration of eganelisib in second-line metastatic urothelial cancer. We will continue to follow the forty-nine patients previously enrolled through the remainder of the year and use these data to determine the best path forward, which may include the re-opening of enrollment of MARIO-275 or the initiation of a new study that leverages our clinical and translational insights from the patients enrolled to date."

Ms. Perkins continued, "In addition, encouraging data from the MARIO-3 TNBC cohort suggest that eganelisib has the potential to be an important component of a new treatment regimen in the front-line setting, and we look forward to presenting these data at SABCS next month. This week we also shared data from the melanoma and SCCHN cohorts of MARIO-1 at SITC (Free SITC Whitepaper)."

Key Q3 2020 Updates:

Clinical and Regulatory:

MARIO-275 is the Company’s ongoing controlled, randomized Phase 2 study evaluating eganelisib in combination with Opdivo in platinum-refractory, I/O naïve patients with advanced urothelial cancer (aUC), in collaboration with Bristol Myers Squibb.
The MARIO-275 Independent Data Monitoring Committee (IDMC) determined that the risk/benefit for patients warrants resumption of enrollment after the successful implementation of a dose reduction from 40mg QD to 30mg QD to reduce the reversible liver enzyme elevations, which were reported after the first scheduled MARIO-275 IDMC meeting.
Infinity is continuing to evaluate the forty-nine patients previously enrolled across safety and time-to-event measures including progression free survival and overall survival and will determine next steps by year end. This may include the re-opening of enrollment of MARIO-275 or the initiation of a new study which leverages our findings from the patients enrolled to date.
MARIO-3 is the Company’s ongoing Phase 2 study in collaboration with Roche/Genentech to evaluate eganelisib in a novel triple combination in the front-line setting with Tecentriq and Abraxane in triple negative breast cancer (TNBC) and with Tecentriq and Avastin in renal cell cancer (RCC).
Encouraging data from the TNBC cohort of MARIO-3 will be presented at the San Antonio Breast Cancer Symposium (SABCS) Annual Meeting, December 8-11, 2020.
Fast Track Designation: Infinity received Fast Track Designation for eganelisib in combination with a checkpoint inhibitor and chemotherapy for first-line treatment of advanced TNBC.
Enrollment has been completed in the RCC cohort. In TNBC, we have implemented a number of enrollment initiatives and expect to provide an update on enrollment expectations at SABCS.
MARIO-1-is the Company’s ongoing Phase 1/1b study evaluating eganelisib as a monotherapy and in combination with Opdivo in patients with solid tumors in collaboration with Bristol Myers Squibb.
Presented data from the MARIO-1 melanoma and squamous cell carcinoma of the head and neck (SCCHN) cohorts, which were designed to isolate the clinical benefit of eganelisib by examining clinical activity in patients not expected to respond to checkpoint inhibitor monotherapy due progression on an immediate prior checkpoint inhibitor, at SITC (Free SITC Whitepaper). Both presentations demonstrate that eganelisib had a manageable safety and tolerability profile, provide further validation of the eganelisib mechanism of action of immune modulation, and support the Company’s strategy of moving eganelisib into earlier treatment settings.
Arcus Collaboration: A Phase 1b collaboration study being conducted by Arcus Biosciences is evaluating a checkpoint-inhibitor free, novel triple-combination regimen of eganelisib + etrumadenant (AB928, dual adenosine receptor antagonist) + Doxil in up to approximately 40 advanced TNBC patients.
Data from the study will be presented at SABCS in December 2020.
Third Quarter 2020 Financial Results:

At September 30, 2020, Infinity had total cash, cash equivalents and available-for-sale securities of $41.3 million, compared to $42.7 million at June 30, 2020.
Research and development expense for the third quarter of 2020 was $6.1 million, compared to $7.1 million for the same period in 2019. The decrease is primarily related to a combination drug purchase during the third quarter of 2019.
General and administrative expense was $2.9 million for the third quarter of 2020, compared to $3.6 million for the same period in 2019. The decrease is primarily related to a reduction in professional services and consulting.
Net loss for the third quarter of 2020 was $9.5 million, or a basic and diluted loss per common share of $0.16, compared to a net loss of $11.4 million, or a basic and diluted loss per common share of $0.20 for the same period in 2019.
2020 Financial Outlook:

Net Loss: Infinity expects net loss for 2020 to range from $35 million to $45 million.

Cash and Investments: Infinity expects to end 2020 with a year-end cash, cash equivalents and available-for-sale securities balance ranging from $25 million to $35 million.

Cash Runway: Based on its current operational plans, Infinity expects that its existing cash, cash equivalents and available-for-sale securities, will be adequate to satisfy the Company’s capital needs through 2021. Infinity’s financial guidance does not include potential additional funding or business development activities, a potential $5 million milestone payment from BVF based on PellePharm’s ongoing Phase 3 clinical trial of patidegib topical gel in Gorlin Syndrome, or any milestones from, or the sale of the Company’s equity interest in, PellePharm.

Conference Call Information

Infinity will host a conference call today, November 9, 2020, at 4:30 p.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors/Media" section of Infinity’s website at www.infi.com. To participate in the conference call, please dial (877) 316-5293 (domestic) and (631) 291-4526 (international) five minutes prior to start time. The conference ID number is 1575996. An archived version of the webcast will be available on Infinity’s website for 30 days.

On November 9, 2020 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported financial results for the third quarter ended September 30, 2020 and provided a corporate update (Press release, Cellectar Biosciences, NOV 9, 2020, View Source [SID1234570367]).

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Third Quarter and Recent Corporate Highlights

·Held FDA Type B guidance meeting to define the registrational pathway for our priority adult hematology oncology indications and planned initiation of the pivotal study for our lead indication in the fourth quarter

·Announced CLR 131 achieved a 40% overall response rate (ORR) in Triple Class Refractory Multiple Myeloma (MM) patients with an administered total body dose (TBD) of 60mCi or greater from the Phase 2 CLOVER-1 study

·Interim results from the Phase 2 COVER-1 study at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Virtual Meeting: Advances in Malignant Lymphoma demonstrated a 100% ORR and a 75% major response rate (MRR) in LPL/WM. Mean duration of response exceeding 17 months (8.4 – 31.7 months); duration of response continues to increase for all patients

·Strengthened the management team with the appointment of Dr. John Friend, chief medical officer

"We continue to make good progress towards the fourth quarter initiation of the CLR 131 pivotal study in our lead heme-oncology indication. Our recent FDA guidance meeting was most encouraging and we look forward to providing greater details in the near-term," said James Caruso, president and CEO of Cellectar. "Additional data from our Phase 2 CLOVER-1 study remain strong, with patients in WM achieving a 100% ORR and a 75% MRR in patients failing a BTKi and a 40% ORR in the challenging to treat triple class refractory MM patient population."

Third Quarter 2020 Financial Highlights

·Cash and Cash Equivalents: As of September 30, 2020, the company had cash and cash equivalents of $18.8 million compared to $10.6 million at December 31, 2019. Cash used in operating activities was approximately $10.1 million during the nine months ended September 30, 2020 as compared to $9.0 million during the nine months ended September 30, 2019.

·Research and Development Expense: R&D expense for the three months ended September 30, 2020 was $2.7 million, compared to $2.7 million for the three months ended September 30, 2019. The cumulative R&D spending for the first nine months of 2020 was $7.8 million as compared to $6.8 million for the first nine months of 2019. The increase in R&D expense year-to-date in 2020 was primarily a result of higher general research and development costs resulting from increased personnel related costs and clinical study costs. Manufacturing and related costs decreased because of a reduction in materials production processes and related costs.

·General and Administrative Expense: G&A expense for the three months ended September 30, 2020 was $1.2 million compared to $1.3 million for the three months ended September 30, 2019. The cumulative G&A spending for the first nine months of 2020 were of $3.7 million as compared to $4.0 million for the first nine months of 2019. The decrease in G&A expense year-to-date in 2020 was primarily a result of lower stock-based compensation expense.

·Net Loss: The net loss attributable to common stockholders for the three months ended September 30, 2020 was ($3.9) million, or ($0.15) per share, compared to ($3.9) million, or ($0.42) per share, in 2019. Net loss attributable to common stockholders for the nine months ended September 30, 2020 was ($11.5) million, or ($0.69) per share, compared to ($10.7) million, or ($1.51) per share, in 2019.

On November 9, 2020 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported its financial results for the third quarter ended September 30, 2020 and provided revised full-year 2020 financial expense guidance (Press release, Neurocrine Biosciences, NOV 9, 2020, View Source [SID1234570366]).

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"Our focus remains on helping as many patients with tardive dyskinesia as possible and we are adapting to the challenges posed by the pandemic, including the slow recovery of in-person visits with psychiatrists. We are encouraged by recent trends and remain confident in the intermediate and long-term opportunity of INGREZZA to help many more patients with tardive dyskinesia," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "We are pleased to expand our reach with neurologists with the addition of ONGENTYS to our movement disorder portfolio and continue to advance our development programs focused on neurological, endocrine and psychiatric disorders."

Net Product Sales Highlights:
•INGREZZA net product sales for the third quarter of 2020 were $254 million, representing a year-over-year increase of 28%. Inventory adjusted net sales for the third quarter of 2020 were approximately $248 million.
•New prescriptions increased slightly in the third quarter of 2020 vs. the second quarter of 2020.
•Refill and persistency rates for existing INGREZZA patients in the third quarter 2020 moderated slightly vs. the second quarter of 2020 and remained at the higher end of historical averages.
•ONGENTYS launched in the United States in late September 2020 and net product sales for the third quarter of 2020 were approximately $0.1 million.
Financial Highlights:
•Third quarter 2020 GAAP net loss and loss per share were approximately $58 million and $0.62, respectively, compared with net income and diluted earnings per share of approximately $54 million and $0.56, respectively, in the third quarter of 2019, primarily driven by higher In-Process Research and Development (IPR&D) costs and operating expenses, offset by higher INGREZZA sales.
•Third quarter 2020 non-GAAP net income and diluted earnings per share were approximately $96 million and $0.97, respectively, compared with approximately $87 million and $0.90, respectively, in the third quarter of 2019 driven by higher INGREZZA sales.
•Research and Development (R&D) expense increased in the third quarter of 2020 versus the third quarter of 2019, primarily due to increased investment across our expanded pipeline programs and higher headcount costs.
•Selling, General and Administrative (SG&A) expense increased in the third quarter of 2020 versus the third quarter of 2019, primarily due to increased investment in marketing initiatives and higher headcount costs.
•At September 30, 2020, the Company had cash, cash equivalents and debt securities available-for-sale of $1.1 billion.
A reconciliation of GAAP to non-GAAP quarterly financial results can be found in Table 3 at the end of this earnings release.
Recent Events
•In September 2020, the Company launched ONGENTYS (opicapone), the first and only once-daily COMT inhibitor, as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing "off" episodes – periods of time when motor symptoms such as tremor, slowed movement and difficulty walking occur. ONGENTYS also increases "on" time without troublesome dyskinesia, the time when the motor symptoms of a patient with Parkinson’s disease are better controlled.
•In October 2020, the U.S. Food and Drug Administration (FDA) provided feedback on an Investigational New Drug (IND) application submitted by Neurocrine Biosciences in support of a Phase II clinical trial of NBI-921352 in pediatric SCN8A developmental and epileptic encephalopathy syndrome patients. As part of its review of the IND, the FDA is requesting additional non-clinical data to support dose justification in this pediatric study. Together with Xenon, the Company will engage with the FDA to address the feedback received with the goal of initiating a Phase II clinical trial in 2021. In parallel, the Company is advancing clinical plans to develop NBI-921352 for the treatment of adult focal epilepsy.
•In November 2020, the Company announced the initiation of a Phase II study of NBI-827104 (formerly ACT-709478) in CSWS, a rare pediatric epilepsy. NBI-827104 was licensed from Idorsia and is a potent, selective, orally-active and brain penetrating T-type calcium channel blocker.
•In November 2020, the Data Safety Monitoring Board (DSMB) for the RESTORE-1 Phase II clinical trial reviewed patient imaging data from the ongoing trial. The DSMB requested additional data and recommended the Company pause dosing of subjects in RESTORE-1 until the DSMB can review these additional data, which is expected by year-end. The DSMB informed the Company and Voyager Therapeutics that they could continue screening patients for potential enrollment into the trial. However, as previously announced, trial sites participating in RESTORE-1 are not currently screening and enrolling patients as a result of the COVID-19 pandemic. In response to the DSMB’s recommendation, the Company and Voyager Therapeutics have decided to delay the planned resumption this quarter of patient screening in the RESTORE-1 trial until the DSMB is able to complete its evaluation. The Company is preparing an expedited safety report that will be submitted to the FDA within the 15-day reporting window.
Conference Call and Webcast Today at 4:30 PM Eastern Time
Neurocrine Biosciences will hold a live conference call and webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). Participants can access the live conference call by dialing 877-830-2596 (US) or 785-424-1744 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine Biosciences’ website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

On November 9, 2020 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported its financial results for the third quarter ended September 30, 2020 and provided revised full-year 2020 financial expense guidance (Press release, Neurocrine Biosciences, NOV 9, 2020, View Source [SID1234570365]).

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Discover why more than 1,500 members use 1stOncology™ to excel in:

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

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"Our focus remains on helping as many patients with tardive dyskinesia as possible and we are adapting to the challenges posed by the pandemic, including the slow recovery of in-person visits with psychiatrists. We are encouraged by recent trends and remain confident in the intermediate and long-term opportunity of INGREZZA to help many more patients with tardive dyskinesia," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "We are pleased to expand our reach with neurologists with the addition of ONGENTYS to our movement disorder portfolio and continue to advance our development programs focused on neurological, endocrine and psychiatric disorders."

Net Product Sales Highlights:

INGREZZA net product sales for the third quarter of 2020 were $254 million, representing a year-over-year increase of 28%. Inventory adjusted net sales for the third quarter of 2020 were approximately $248 million.
New prescriptions increased slightly in the third quarter of 2020 vs. the second quarter of 2020.
Refill and persistency rates for existing INGREZZA patients in the third quarter 2020 moderated slightly vs. the second quarter of 2020 and remained at the higher end of historical averages.
ONGENTYS launched in the United States in late September 2020 and net product sales for the third quarter of 2020 were approximately $0.1 million.
Financial Highlights:

Third quarter 2020 GAAP net loss and loss per share were approximately $58 million and $0.62, respectively, compared with net income and diluted earnings per share of approximately $54 million and $0.56, respectively, in the third quarter of 2019, primarily driven by higher In-Process Research and Development (IPR&D) costs and operating expenses, offset by higher INGREZZA sales.
Third quarter 2020 non-GAAP net income and diluted earnings per share were approximately $96 million and $0.97, respectively, compared with approximately $87 million and $0.90, respectively, in the third quarter of 2019 driven by higher INGREZZA sales.
Research and Development (R&D) expense increased in the third quarter of 2020 versus the third quarter of 2019, primarily due to increased investment across our expanded pipeline programs and higher headcount costs.
Selling, General and Administrative (SG&A) expense increased in the third quarter of 2020 versus the third quarter of 2019, primarily due to increased investment in marketing initiatives and higher headcount costs.
At September 30, 2020, the Company had cash, cash equivalents and debt securities available-for-sale of $1.1 billion.
A reconciliation of GAAP to non-GAAP quarterly financial results can be found in Table 3 at the end of this earnings release.

Recent Events

In September 2020, the Company launched ONGENTYS (opicapone), the first and only once-daily COMT inhibitor, as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing "off" episodes – periods of time when motor symptoms such as tremor, slowed movement and difficulty walking occur. ONGENTYS also increases "on" time without troublesome dyskinesia, the time when the motor symptoms of a patient with Parkinson’s disease are better controlled.
In October 2020, the U.S. Food and Drug Administration (FDA) provided feedback on an Investigational New Drug (IND) application submitted by Neurocrine Biosciences in support of a Phase II clinical trial of NBI-921352 in pediatric SCN8A developmental and epileptic encephalopathy syndrome patients. As part of its review of the IND, the FDA is requesting additional non-clinical data to support dose justification in this pediatric study. Together with Xenon, the Company will engage with the FDA to address the feedback received with the goal of initiating a Phase II clinical trial in 2021. In parallel, the Company is advancing clinical plans to develop NBI-921352 for the treatment of adult focal epilepsy.
In November 2020, the Company announced the initiation of a Phase II study of NBI-827104 (formerly ACT-709478) in CSWS, a rare pediatric epilepsy. NBI-827104 was licensed from Idorsia and is a potent, selective, orally-active and brain penetrating T-type calcium channel blocker.
In November 2020, the Data Safety Monitoring Board (DSMB) for the RESTORE-1 Phase II clinical trial reviewed patient imaging data from the ongoing trial. The DSMB requested additional data and recommended the Company pause dosing of subjects in RESTORE-1 until the DSMB can review these additional data, which is expected by year-end. The DSMB informed the Company and Voyager Therapeutics that they could continue screening patients for potential enrollment into the trial. However, as previously announced, trial sites participating in RESTORE-1 are not currently screening and enrolling patients as a result of the COVID-19 pandemic. In response to the DSMB’s recommendation, the Company and Voyager Therapeutics have decided to delay the planned resumption this quarter of patient screening in the RESTORE-1 trial until the DSMB is able to complete its evaluation. The Company is preparing an expedited safety report that will be submitted to the FDA within the 15-day reporting window.
Conference Call and Webcast Today at 4:30 PM Eastern Time

Neurocrine Biosciences will hold a live conference call and webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). Participants can access the live conference call by dialing 877-830-2596 (US) or 785-424-1744 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine Biosciences’ website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

On November 9, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) and SOLTI-Innovative Breast Cancer Research reported the publication of an electronic poster with clinical data from the AWARE-1 window-of-opportunity breast cancer study at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting (Press release, Oncolytics Biotech, NOV 9, 2020, View Source [SID1234570364]).

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The AWARE-1 study, a collaboration between Oncolytics Biotech and SOLTI, combines the appropriate intervention for each patient’s breast cancer sub-type, plus pelareorep, with or without atezolizumab (Tecentriq), followed by surgery in early-stage breast cancer patients. Data presented in the electronic poster were from the ten HR+/HER2- breast cancer patients that make up the study’s first cohort. These data demonstrate the ability of pelareorep to promote a pro-inflammatory tumor microenvironment (TME) and provide a basis for the findings of a prior successful phase 2 trial (IND-213) that showed a near doubling of overall survival with pelareorep treatment in HR+/HER2- breast cancer patients (link to PR, link to poster).

"AWARE-1’s elegant paired-biopsy design allows us to assess the impact of pelareorep on each patient’s tumor immune environment, and the results to date have been very promising," said Dr. Aleix Prat, M.D., PhD., Translational Investigator of the Study, SOLTI President and Head of the Medical Oncology Department at Hospital Clinic in Barcelona. "These data continue to support pelareorep’s ability to train the immune system to target cancer and highlight its potential to address a critical unmet need by increasing the number of patients responding to checkpoint inhibitor therapies. Data presented at SITC (Free SITC Whitepaper) showing pelareorep-induced generation and expansion of anti-tumor and anti-viral T cell clones are also noteworthy, as they suggest the induction of a durable anti-cancer immune memory effect. These data, together with previously reported AWARE-1 results, provide strong support for the observed survival benefit in a prior randomized phase 2 study evaluating pelareorep in metastatic breast cancer patients."

Key data and conclusions from the electronic poster include:

•Tumor-cell specific pelareorep replication was observed in all cohort-1 patients following systemic pelareorep administration

•70% of cohort 1 patients saw an increase in CelTIL, the study’s primary endpoint and a measure of tumor-associated cellularity and tumor-infiltrating lymphocytes that is associated with favorable clinical outcomes

•On average, there was a 14-fold increase in intratumoral CD8+ T cells from baseline (pre-pelareorep administration) to surgery (21-days post-administration), with increases observed in all cohort-1 patients

•Pelareorep administration led to the generation and expansion of new T cell clones in the tumor and periphery, which included both anti-tumor and anti-viral clones

Thomas Heineman, M.D., Ph.D., Global Head of Clinical Development and Operations at Oncolytics, commented, "These newly announced AWARE-1 results add to the promising clinical dataset supporting pelareorep’s immunotherapeutic mechanism of action and to the proposed registration pathway in our lead metastatic breast cancer program. The observed 70% CelTIL response rate in cohort-1 patients is highly encouraging, as CelTIL is associated with favorable patient outcomes, and this response rate was achieved despite the absence of checkpoint blockade therapy. Further, previously announced data have shown that CelTIL scores correlate with high peripheral T cell clonality, underscoring T cell clonality’s potential as a predictive biomarker that may facilitate the design of future registrational trials and improve their chances of success. We look forward to presenting additional AWARE-1 data later this year and to the continued progress of the trial, which will be key as we move our lead breast cancer program towards a registrational study."

The electronic poster, titled, "Changes in T cell clonality in AWARE-1 study, a window-of-opportunity study with atezolizumab and the oncolytic virus pelareorep in early breast cancer" is being presented at SITC (Free SITC Whitepaper) by Dr. Prat. As of the SITC (Free SITC Whitepaper) data cut-off, AWARE-1 has enrolled 23 out of 38 patients, including all patients in the study’s first two cohorts.

Details on the AWARE-1 electronic poster, which are available on the SITC (Free SITC Whitepaper) 2020 website and on the Posters & Publications page of Oncolytics’ website (LINK), are shown below.

Poster Number: 806
Title: Changes in T cell clonality in AWARE-1 study, a window-of-opportunity study with atezolizumab and the oncolytic virus pelareorep in early breast cancer
Presentation Date and Time: Thursday, November 12 from 4:50-5:20 p.m. EST and Saturday, November 14 from 1:00-1:30 p.m. EST
Presenter: Dr. Aleix Prat

About AWARE-1
AWARE-1 is an open label window-of-opportunity study in early-stage breast cancer enrolling 38 patients into five cohorts:
•Cohort 1 (n=10), HR+ / HER2- (pelareorep + letrozole)

•Cohort 2 (n=10), HR+ / HER2- (pelareorep + letrozole + atezolizumab)

•Cohort 3 (n=6), TNBC (pelareorep + atezolizumab)

•Cohort 4 (n=6), HR+ / HER2+ (pelareorep + trastuzumab + atezolizumab)

•Cohort 5 (n=6), HR- / HER2+ (pelareorep + trastuzumab + atezolizumab)

The study combines pelareorep with the standard of care according to breast cancer subtype and atezolizumab. Patients are biopsied on day one followed immediately by treatment, then again on day three, and a final biopsy after three weeks, on the day of their mastectomy. Data generated from this study is intended to confirm that the virus is acting as a novel immunotherapy and to provide comprehensive biomarker data by breast cancer subtype. The primary endpoint of the study is overall CelTIL (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study include CelTIL by breast cancer subtype, safety and tumor, and blood-based biomarkers.
For more information about the AWARE-1 study, refer to View Source

About Breast Cancer
Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. Incidence rates vary widely across the world, from 27 per 100,000 in Middle Africa and Eastern Asia to 85 per 100,000 in Northern America. It is the fifth most common cause of death from cancer in women globally, with an estimated 522,000 deaths.

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

About SOLTI
SOLTI is a leading cooperative group in the field of clinical cancer research. With its academic and translational core, the group is committed to designing and executing clinical trials based on the molecular biology of tumors. Its focus is on breast cancer, but it also explores other kinds of tumors. The main goal of SOLTI is to promote through disruptive means the development of innovative research that will improve the well-being and future outcomes of cancer patients. Since its creation in 1995, SOLTI’s purpose has been to bring about a paradigm shift in clinical and translational cancer research from within academia. With 77 clinical trials under their belt and more than 30 ongoing investigations, SOLTI counts on the work of more than 400 researchers from a network comprising more than 100 hospitals in Spain and Portugal, all coordinated by the team of 50 workers from the head office. SOLTI is a member of the Spanish Society of Medical Oncology (SEOM).
To find out more about SOLTI, visit www.gruposolti.org / Twitter: @SOLTI / LinkedIn / Youtube