On November 15, 2021 Nuvo Pharmaceuticals Inc. (TSX:MRV; OTCQX:MRVFF) d/b/a Miravo Healthcare (Miravo or the Company), a Canadian-focused healthcare company with global reach and a diversified portfolio of commercial products, reported its financial and operational results for the three and nine months ended September 30, 2021 (Press release, Nuvo Pharmaceuticals, NOV 15, 2021, View Source [SID1234595625]). For further details on the results, please refer to Miravo’s Management, Discussion and Analysis (MD&A) and Condensed Consolidated Interim Financial Statements for the three and nine months ended September 30, which are available on the Company’s website (www.miravohealthcare.com) and on SEDAR (www.sedar.com). All figures are in Canadian dollars, unless otherwise noted.

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Key Developments

Three months ended September 30, 2021 include the following:

Adjusted total revenue(1) was $17.1 million, an increase of 3% compared to $16.7 million for the three months ended September 30, 2020.
Adjusted EBITDA(1) was $7.0 million, an increase of 7% compared to $6.6 million for the three months ended September 30, 2020.
Revenue related to Blexten, Cambia and Suvexx was $8.1 million, an increase of 24% compared to revenue of $6.5 million for the three months ended September 30, 2020. Total Canadian prescriptions of Blexten and Cambia increased by 16% and 5% respectively compared to the three months ended September 30, 2020.
The Company repaid $3.7 million (US$2.9 million) of the Amortization Loan to Deerfield Management Company, L.P. (Deerfield).
As at September 30, 2021, cash and cash equivalents were $28.4 million.
Nine months ended September 30, 2021 include the following:

Adjusted total revenue(1) was $51.6 million, a decrease of 4% compared to $53.6 million for the nine months ended September 30, 2020.
Adjusted EBITDA(1) was $18.8 million, a decrease of 15% compared to $22.2 million for the nine months ended September 30, 2020.
Revenue related to Blexten, Cambia and Suvexx was $23.5 million, an increase of 26% compared to revenue of $18.7 million for the nine months ended September 30, 2020. Canadian prescriptions of Blexten and Cambia increased by 22% and 10% respectively compared to the nine months ended September 30, 2020.
The Company repaid $10.3 million (US$8.3 million) of the Amortization Loan to Deerfield.
(1) Non-International Financial Reporting Standards (IFRS) financial measure defined by the Company below.

Business Update

In October 2021, Resultz was commercially launched in the U.S. market by The Mentholatum Company, Resultz is marketed in the U.S. under the brand name Mentholatum Kids Headlice Removal Kit. The Company’s Irish subsidiary, Nuvo Pharmaceuticals (Ireland) DAC (Miravo Ireland) receives revenue from the supply of finished product to The Mentholatum Company.
In September 2021, Miravo Ireland’s distribution partner for Suvexx in South Korea, SK Chemicals Co., Ltd. (SK Chemicals), filed the Suvexx marketing authorization application with the Ministry of Food and Drug Safety (the MFDS) in South Korea. In July 2021, Miravo Ireland entered into an exclusive license and supply agreement with SK Chemicals for the exclusive right to commercialize Suvexx in the Republic of South Korea. Miravo Ireland will receive up to €1.1 million in upfront consideration, regulatory and sales-based milestone payments, as well as royalties on net sales of Suvexx in South Korea and revenue pursuant to the supply of product.
In August 2021, Miravo announced Health Canada issued a Notice of Compliance (NOC) in relation to the Company’s Supplement to New Drug Submission for the pediatric use of Blexten. The pediatric use expands the label for use in children as young as 4 years old and includes the two new dosage formats; a 2.5mg/mL oral solution and a 10mg Quick Melt tablet. Upon commercial launch, which is anticipated for Q1 2022, the pediatric formats will be available to patients with a prescription from their healthcare provider.
"We are encouraged by the strength of our key promoted brands, Blexten, Cambia and Suvexx, which continued their year-over-year gains in prescription and revenue growth despite the fact that many prescribers have not yet resumed seeing patients in-person at pre-COVID-19 pandemic levels. We anticipate that the gradual return of in-person, patient-physician visits, over the coming quarters, will provide enhanced opportunities for patient education and new prescription growth," said Jesse Ledger, Miravo’s President & CEO. "We continued to execute on our plans to expand and diversify our revenue base during the quarter, with the Health Canada approval of the pediatric form of Blexten, as well as the submission of a marketing authorization application for Suvexx in South Korea by our partner SK Chemicals."

Third Quarter 2021 Financial Results
Adjusted total revenue was $17.1 million and $51.6 million for the three and nine months ended September 30, 2021 compared to $16.7 million and $53.6 million for the three and nine months ended September 30, 2020. The $0.4 million increase in adjusted total revenue in the current quarter was primarily attributable to an increase of $1.8 million in the Commercial Business segment and an increase of $0.4 million of revenue from the Licensing and Royalty Business segment, offset by a decrease of $1.8 million of revenue in the Production and Service Business segment.

Revenue attributable to the Commercial Business segment increased during the three months ended September 30, 2021 due to a $1.8 million increase in sales of the Company’s promoted products (Blexten, Cambia, Suvexx and Neovisc). In the current quarter, revenue from the Company’s mature products was consistent with the three months ended September 30, 2020.

The Production and Service Business segment revenue decreased during the three months ended September 30, 2021, primarily due to a decrease in Pennsaid 2% product sales, slightly offset by an increase in sales of Pennsaid.

The increase in revenue attributable to the License and Royalty business segment during the three months ended September 30, 2021 was primarily attributable to a $0.5 million increase in royalty earned on European net sales of Vimovo, a $0.2 million increase in royalty earned from net sales of Yosprala and a $0.2 million increase from the recognition of milestones in the SK Chemicals contract. The increase in license revenue in the current three-month period was slightly offset by an unfavourable foreign exchange movement where a stronger Canadian dollar against the U.S. dollar reduced the contribution from U.S. denominated royalty streams, as well as a $0.6 million decrease in royalty earned on U.S. net sales of Vimovo due to a competitor launching a generic version of Vimovo in March 2020. The Company earned a $0.2 million and $1.0 million royalty on U.S. net sales of Vimovo during the three and nine months ended September 30, 2021 compared to $0.8 million and $4.4 million during the three and nine months ended September 30, 2020.

Adjusted EBITDA was $7.0 million and $18.8 million for the three and nine months ended September 30, 2021 compared to $6.6 million and $22.2 million for the three and nine months ended September 30, 2020. During the three months ended September 30, 2021, an increase in gross profit from the Company’s Commercial Business and License and Royalty Business segments was offset by a decrease in gross profit contribution from the Production and Service Business segment, an increase in sales and marketing expenses and an increase in general and administrative expenses. During the three months ended September 30, 2021, the Company recorded $nil in government assistance resulting from the Canada Emergency Wage Subsidy (CEWS). The Company recognized $1.1 million in government assistance resulting from CEWS in the comparative three-month period.

Non-IFRS Financial Measures

The Company discloses non-IFRS measures (such as adjusted total revenue, adjusted EBITDA, adjusted EBITDA per share and cash value of loans) that do not have standardized meanings prescribed by IFRS. The Company believes that shareholders, investment analysts and other readers find such measures helpful in understanding the Company’s financial performance. Non-IFRS financial measures do not have any standardized meaning prescribed by IFRS and may not have been calculated in the same way as similarly named financial measures presented by other companies. These measures should be considered as supplemental in nature and not as a substitute for related financial information prepared in accordance with IFRS. Please see below and refer to the MD&A for a reconciliation of these measures to standardized IFRS measures.

Adjusted Total Revenue

The Company defines adjusted total revenue as total revenue, plus amounts billed to customers for existing contract assets, less revenue recognized upon recognition of a contract asset. Management believes adjusted total revenue is a useful supplemental measure to determine the Company’s ability to generate cash from its customer contracts used to fund its operations.

Adjusted EBITDA
EBITDA refers to net income (loss) determined in accordance with IFRS, before depreciation and amortization, net interest expense (income) and income tax expense (recovery). The Company defines adjusted EBITDA as EBITDA, plus amounts billed to customers for existing contract assets, inventory step-up expenses, stock-based compensation expense, Other Expenses (Income), less revenue recognized upon recognition of a contract asset and other income. Management believes adjusted EBITDA is a useful supplemental measure to determine the Company’s ability to generate cash available for working capital, capital expenditures, debt repayments, interest expense and income taxes.

(1) Income tax expense for the three and nine months ended September 30, 2021 includes $0.7 million and $2.1 million for deferred income tax due to the utilization of loss carryforwards that were previously recognized. The Company did not recognize deferred income tax expense in the comparative three and nine-month periods.

(2) The Company’s derivative liabilities are measured at fair value through profit or loss at each reporting date. As a result of the increase in the share price in the current quarter and an increase in the volatility of the Company’s shares, amongst other inputs, the value of the Company’s derivative liabilities increased and the Company recognized losses of $2.9 million and $14.4 million on the change in fair value of derivative liabilities for the three and nine months ended September 30, 2021.

(3) During the three and nine months ended September 30, 2021, the Company recorded impairment of $14.7 million and $14.7 million of goodwill and certain intangible assets in the Commercial Business and Licensing and Royalty segments. During the three months ended September 30, 2021, the Company reviewed carrying values of certain intangible assets as it had changed its commercial expectations for certain products in response to COVID-19 trends. Additional details regarding the Company’s methodology and assumptions are disclosed in Note 4, Intangible Assets and Note 5, Goodwill to the unaudited Condensed Consolidated Interim Financial Statements for the three and nine months ended September 30, 2021.

With respect to the above noted impairment, the Company will continue to carefully monitor the situation as it pertains to COVID-19. With the ongoing prevalence of the COVID-19 pandemic, the length and severity of impacts on the Company’s business and industry in which it operates remain subject to uncertainty, and accordingly, may materially and adversely affect our commercial expectations and the assumptions used in our consideration of the impairment of goodwill and intangible assets. See "Impairment" and "Risk Factors" in the MD&A.

Management to Host Conference Call/Webcast
Management will host a conference call to discuss the results today (Monday, November 15, 2021) at 11:00 a.m. ET. To participate in the conference call, please dial (289) 536-4777 or 1 (888) 550-2239 / Conference ID: 6216508. Please call in 15 minutes prior to the call to secure a line. You will be put on hold until the conference call begins.

A live audio webcast and replay webcast of the conference call will be available through View Source

Please connect at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to hear the webcast.

On November 15, 2021 Novocure (NASDAQ: NVCR) reported that Dr. David Tran, Chief of the Division of Neuro-Oncology at the McKnight Brain Institute at the University of Florida, has released updated data from the phase 2 pilot 2-THE-TOP trial testing the safety and efficacy of Tumor Treating Fields (TTFields) together with pembrolizumab and temozolomide for the treatment of adult patients with newly diagnosed glioblastoma (GBM) (Press release, NovoCure, NOV 15, 2021, View Source [SID1234595639]). In patients with greater than 9 months of follow-up, median progression-free survival, the primary endpoint, was at least 11.2 months. 24% of patients achieved partial to complete response. Dr. Tran will present these data at the Society for Neuro-Oncology (SNO) 2021 Annual Meeting in Boston on November 19, 2021.

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"These data show that Tumor Treating Fields have the potential to activate the pathways needed to create an effective, anti-cancer environment in the tumor," said Dr. Ely Benaim, Novocure’s Chief Medical Officer. "The results published today suggest a potential paradigm shift in how we approach treatment of patients with newly diagnosed glioblastoma."

"We are very encouraged by the results of the 2-THE-TOP study, especially in light of the poor prognostic factors of the patient population," said William Doyle, Novocure’s Executive Chairman. "Dr. Tran’s research is an important continuation of our exploration of synergies between TTFields and immunotherapy agents. We would like to thank Dr. Tran and the patients enrolled in the 2-THE-TOP trial for their ingenuity and courage."

Twenty-five patients with a median age of 61 years were enrolled in the 2-THE-TOP study, with a median follow-up of 14.7 months. Eight (32%) had biopsy only and partial resection, respectively. Eighteen (72%) had unmethylated MGMT and 3 (12%) had an IDH mutation. Twelve (48%) were progression-free, and 15 (60%) were still alive. Of the 19 patients with follow-up greater than 9 months, the median progression-free survival was at least 11.2 months compared to 6.7 months from the historical control study, EF-14, in which patients received TTFields and adjuvant temozolomide. Six (24%) patients with measurable tumors achieved partial or complete response. 193,760 peripheral blood mononuclear cells were sequenced in 12 patients before pembrolizumab and detected robust post-TTFields T cell activation in 11 of 12 patients via the T1IFN trajectory with a strong correlation with the TCRαβ clonal expansion Simpson index (Spearman coefficient r=-0.8, P=0.014). The study defined a T cell-based gene signature of TTFields effects on TCRαβ clonal expansion. The most common adverse events were thrombosis (4 patients, 16%), seizure (3 patients, 12%), and metabolic disturbances (2 patients, 8%).

The 2-THE-TOP trial is a phase 2 pilot trial designed for the treatment of patients with newly diagnosed GBM. Patients enrolled in the trial underwent maximal tumor resection followed by standard chemoradiation. Following the completion of chemoradiation, patients began a course of monthly cycles of adjuvant temozolomide. Treatment with TTFields started at approximately the same time as the first cycle of adjuvant temozolomide. Pembrolizumab was introduced in the second cycle of treatment and subsequent cycles of pembrolizumab were administered every three weeks until first disease progression or unacceptable toxicities or 2 years, whichever comes first.

About EF-14

The EF-14 trial was a randomized, phase 3 pivotal trial which compared, post radiation, TTFields plus temozolomide versus temozolomide alone for the treatment of newly diagnosed GBM. Median progression-free survival, the primary endpoint, was 6.7 months for TTFields plus temozolomide versus 4.0 months for temozolomide alone. Median overall survival was 20.9 months for TTFields plus temozolomide versus 16.0 months for temozolomide alone.

About Tumor Treating Fields

Tumor Treating Fields, or TTFields, are electric fields that disrupt cancer cell division. Fundamental scientific research extends across more than two decades and, in all preclinical research to date, TTFields have demonstrated a consistent anti-mitotic effect. TTFields therapy is intended principally for use together with other standard-of-care cancer treatments. There is a growing body of evidence that supports TTFields’ broad applicability with certain other cancer therapies, including radiation therapy, certain chemotherapies and certain immunotherapies. In clinical research and commercial experience to date, TTFields therapy has exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect. The TTFields global development program includes a network of preclinical collaborators and a broad range of clinical trials across all phases, including four phase 3 pivotal trials in a variety of tumor types. To date, more than 20,000 patients have been treated with TTFields therapy.

On November 15, 2021 Recludix Pharma, a leader in platform approaches to discover inhibitors of challenging cancer and inflammatory disease targets, reported its launch with a proprietary platform technology, three SH2 domain inhibitor programs, and a new chief executive officer, Nancy Whiting, Pharm.D. Series A investors include NEA, Westlake Village BioPartners, and Access Biotechnology (Press release, Recludix Pharma, NOV 15, 2021, View Source [SID1234595578]).

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Recludix has built a proprietary platform to discover potent and selective inhibitors of challenging protein targets. The platform comprises custom generated DNA-encoded libraries, massively parallel determination of structure activity relationships, and a proprietary screening tool to ensure compound selectivity.

"Recludix has created highly differentiated technology and capabilities to harness the potential of targeting SH2 domains with potent and selective therapies," said Carol Gallagher, Pharm.D., venture partner at NEA. "We were especially attracted by the founders and the new terrain the company is exploring to create a pipeline of oral medicines that address previously undruggable, high-potential targets to treat patients with cancer and inflammatory diseases."

By integrating new chemical approaches and technologies, including custom DNA-encoded libraries and assays, Recludix is developing precision small molecule medicines against critical targets of interest, with the initial focus of its three lead programs of STAT3, STAT6, and an undisclosed non-STAT target. Abnormal STAT activation is found in numerous cancer types, including multiple leukemias, lymphomas and solid tumors, as well as inflammatory diseases, such as rheumatoid arthritis, asthma, atopic dermatitis, inflammatory bowel disease and others.

"The important role of the STAT family in disease signaling is well-characterized, but these proteins have remained elusive as targets for drug discovery until now. We believe Recludix’s platform will be a key differentiating factor leading to the successful development of treatments for these important targets," said Nancy Whiting, Pharm.D., chief executive officer of Recludix. "Our lead programs are targeting STAT3 and STAT6 through the novel mechanism of inhibition of their SH2 domains. With our proprietary technology, we believe we will be uniquely able to selectively and potently inhibit these important targets, resulting in more effective and better tolerated agents compared to the existing, less selective JAK/STAT targeting approaches."

Dr. Whiting is the newly appointed chief executive officer of Recludix and has an established track record in all phases of drug development. She is a 15-year veteran of Seagen, formerly Seattle Genetics. Most recently, Dr. Whiting was the executive vice president of corporate strategy. She previously served as executive vice president of late-stage development, senior vice president of clinical development and medical affairs, and head of experimental medicine. During her tenure at Seagen, Dr. Whiting played a central role in the development of ADCETRIS for lymphoma, PADCEV for bladder cancer, TUKYSA for breast cancer, TIVDAK for cervical cancer, and several other pipeline compounds. She completed her undergraduate training at the University of British Columbia and received her Pharm.D. from the University of Washington. Dr. Whiting serves on the Board of Directors of Caribou Biosciences.

Nicholas Lydon, Ph.D., FRS, is Recludix’s co-founder and chairman of the board of directors. Dr. Lydon is also a scientific founder of Blueprint Medicines and has served as a member of their board of directors since April 2011. Dr. Lydon has also served as a scientific advisor and member of the board of AnaptysBio (which he co-founded) and Ambit Biosciences. Dr. Lydon has extensive leadership experience in the discovery and development of small molecule therapies and protein kinase inhibitors, including as the vice president of small molecule drug discovery at Amgen, a founder of Kinetix Pharmaceuticals (acquired by Amgen), and at Ciba-Geigy AG (now Novartis AG). Dr. Lydon played a pivotal role in the discovery and development of GLEEVEC and was awarded the Lasker-DeBakey Clinical Medical Research Award, the Kettering Price from the General Motors Cancer Research Foundation and the Japan Prize for his role in its development. Dr. Lydon received a B.S. in biochemistry and zoology from the University of Leeds, England, and received a Ph.D. in biochemistry from the Medical Sciences Institute, University of Dundee, Scotland.

Additional members of Recludix’s senior leadership team include:

Patrick Zarrinkar, Ph.D., co-founder of Recludix, president and chief scientific officer, who has over 20 years of experience in drug discovery and technology development. His experience includes co-leading the development of the KINOMEscan kinase profiling platform, as well as part of Pfizer’s drug discovery and as part of the founding scientific team at Blueprint Medicines.
Daniel Treiber, Ph.D., co-founder of Recludix and vice president of discovery technology, has invented and developed multiple disruptive and commercially successful platforms addressing unmet needs in the areas of protein family-wide screening and profiling (KINOMEscan, BROMOscan, BCL2scan, E3scan), cellular target engagement (InCELL Pulse), and safety pharmacology (SAFETYscan47).
Brian Hodous, Ph.D., co-founder of Recludix and vice president of chemistry, has nearly 20 years of experience in drug discovery and preclinical development, including at Blueprint Medicines. Over his career, he contributed to the discovery of multiple clinical molecules and one approved drug, including: AYVAKIT (avapritinib) for PDGFRa mutant GIST and advanced systemic mastocytosis; fisogatinib for hepatocellular carcinoma; IPN60130 for fibrodysplasia ossificans progressiva, evobrutinib for multiple sclerosis, and AMG-900 for cancer.
Thomas W. Davis, Ph.D., vice president of biology, has over 20 years of experience in small molecule drug development, primarily in oncology and inflammation. He has worked on the COX2-selective inhibitor celecoxib, kinase inhibitor sunitinib, PTC299 (for various liquid cancers), PTC596 (for pediatric brain cancer), and the mutant p53 reactivator PMV586 (for patients harboring the Y220C p53 mutation).
Catherine Bovenizer, CPA, is the vice president of finance and business operations. She was previously the CFO of Renova Therapeutics and held finance leadership roles at Apricus Biosciences and Ambit Bioscience through its initial public offering and sale to Daiichi Sankyo.

On November 15, 2021 Aadi Bioscience, Inc. ("Aadi") (Nasdaq: AADI), a clinical-stage biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported two oral presentations that were made related to its lead candidate, FYARRO (ABI-009 or nab-sirolimus) at the Connective Tissue Oncology Society (CTOS) 2021 Annual Meeting, held virtually from November 10-13, 2021 (Press release, Aadi Bioscience, NOV 15, 2021, View Source [SID1234595594]). CTOS is a multi-disciplinary group of specialized physicians, medical professionals and scientists from around the world who connect and share their knowledge, experiences and research for the advancement of treatment of sarcomas. Both studies, sponsored by Aadi, provided data in patients with advanced malignant PEComa, which is the clinical indication currently under review by the Food and Drug Administration (FDA) with a November 26, 2021 target Prescription Drug User Fee Act (PDUFA) date.

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Abstract (ID: 1080984), lead-authored by Mark A. Dickson, M.D., medical oncologist at Memorial Sloan Kettering Cancer Center is entitled, "nab-Sirolimus in Patients with Malignant PEComa Previously Treated With mTOR Inhibitors: Emerging Experience from an Expanded Access Program". Sixteen patients with Advanced Malignant Perivascular Epithelioid Cell Tumors (PEComa) were treated in an Expanded Access Program (NCT03817515) with nab-sirolimus, dosed intravenously at 100 mg/m2 given on day one and day eight of a 21-day cycle. The investigators concluded that nab-sirolimus showed encouraging clinical benefit including partial responses (PR) in 25% of patients previously progressing on other mTOR inhibitors and, in some cases, other targeted therapies. Disease control rate (DCR) as defined by complete or partial response + stable disease for ≥3 months, was 63%. In this study, the safety profile of nab-sirolimus was acceptable and allowed ongoing treatment for almost one year or more in several patients. In addition, consistent with results of the AMPECT trial, TSC1 or TSC2 alterations were associated with a higher response rate of 44% of patients, despite prior progression on other mTOR inhibitors and/or multiple lines of prior therapy. These results provide further rationale for investigation of nab-sirolimus in a tumor-agnostic study in patients with pathogenic inactivating TSC1 or TSC2 alterations.

A second abstract (ID: 1080747), lead-authored by Andrew J. Wagner, M.D., Ph.D., a senior oncologist at Dana-Farber Cancer Institute, is entitled, "Final Analysis from AMPECT, an Open-Label Phase 2 Registration Trial of nab-Sirolimus for Patients with Advanced Malignant Perivascular Epithelioid Cell Tumors (PEComa)". This abstract provided a final analysis of the AMPECT study with a data cut of June 30, 2021, updating the recent publication in the Journal of Clinical Oncology which was based on a data cut of November 23, 2020. nab-Sirolimus demonstrated rapid and durable responses in mTOR-naïve patients with locally advanced unresectable or metastatic PEComa. Specifically, of 31 treated and evaluable patients, the independently assessed confirmed overall response rate (ORR) was 39% (12/31, 95% confidence interval: 22, 58); of which 7% (2/31) of patients had a complete response (CR) and 32% (10/31) had a PR. Disease control was achieved in 71% of patients. The patient responses demonstrated long-term durability with a duration of response (DOR) of 92% at 6 months and 66% at 36 months amongst the 12 patients with a response. At the final analysis, the median DOR has not been reached, 50% of patients had a DOR of over 36 months (range 5.6, 55.5+ months). By the final analysis, two patients converted from a PR to CR after 11 months and 34 months of treatment, respectively. Finally, nab-sirolimus demonstrated an acceptable safety profile with no grade 4 or 5 treatment-related adverse events (TRAE) and no unexpected adverse events or new safety signals. Some of the most common TRAEs were stomatitis, rash, fatigue, anemia, nausea, diarrhea and hyperglycemia.

Dr. Dickson commented, "I am encouraged by the activity of nab-sirolimus not only in the AMPECT study, but in advanced PEComa patients previously progressing on other mTOR inhibitors, as well as in other solid tumor histologies with TSC1 or TSC2 inactivating alterations that has been previously presented. There is a strong rationale for conducting a broader investigation of nab-sirolimus in a tumor-agnostic setting."

About Malignant PEComa

Perivascular epithelioid-cell tumors (PEComa), defined by the World Health Organization as ‘mesenchymal tumors composed of distinctive cells that show a focal association with blood-vessel walls and usually express both melanocytic and smooth muscle markers,’ are a rare subset of soft-tissue sarcomas, with an undefined cell of origin. While there is no formal epidemiology for malignant PEComa, it is estimated that there are about 100-300 new patients per year in the United States. Malignant PEComas may arise in almost any body site (typically the uterus, retroperitoneum, lung, kidney, liver, genitourinary, and gastrointestinal tract with a female predominance) and can have an aggressive clinical course including distant metastases and ultimate death. The estimated survival based on retrospective reports is 12-16 months. Cytotoxic chemotherapies typically used for sarcoma show minimal benefit and there are currently no drugs approved for this disease. Malignant PEComas have been shown to frequently harbor mutations in the TSC1 and/or TSC2 genes that result in the activation of mTOR pathway making it a rational therapeutic target for this disease.

On November 15, 2021 Zenith Capital Corp. ("Zenith" or the "Company") reported that Zenith Epigenetics Ltd. ("Zenith Epigenetics"), a wholly-owned subsidiary of Zenith Capital, has entered into a licensing agreement with Newsoara Biopharma Co., Ltd. ("Newsoara") for Zenith Epigenetics’ lead compound, ZEN-3694, in Asia excluding Middle East and North Africa ("MENA"), India, and ten Eurasian countries (the "Territories") (Press release, Zenith Epigenetics, NOV 15, 2021, View Source [SID1234595610]). Under the terms of the agreement, Newsoara will have the rights to develop, market, and distribute ZEN-3694 for all indications in the Territories. Zenith will receive an upfront payment of US$3.5 million, sales-based milestones and single digit royalties.

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Concurrent with the execution of the license agreement, Newsoara has entered into a subscription agreement to subscribe for 1.5 million units at a price of US$1.00 per unit, and Newsoara also agreed to subscribe for an additional 10 million units of Zenith by way of completing ZEN-3694 development programs with a budget of $10 million over the next 15 months. Each unit ("Unit") shall be comprised of one common share and one-half of a common share purchase warrant. Each whole warrant shall be exercisable into one common share at US$1.00 for a period of two years from the date of the subscription agreement.

"We are very pleased to further expand our partnership with Newsoara to introduce the therapeutic potential of ZEN-3694 to additional Asian markets," stated Donald McCaffrey, President and CEO of Zenith. "ZEN-3694 is a leading and differentiated BET inhibitor now having shown clinical proof of concept in two solid tumor indications with significant unmet need, metastatic castration-resistant prostate cancer and metastatic triple negative breast cancer. This additional financing will support advancing these programs towards registration enabling studies for these indications in collaboration with our partner Newsoara."