On December 7, 2020 Theralase Technologies Inc. ("Theralase" or the "Company") (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company focused on the research and development of light activated Photo Dynamic Compounds ("PDC") and their associated drug formulations used to safely and effectively destroy various cancers, bacteria and viruses reported that the University of British Columbia ("UBC") Review Ethics Board ("REB") has approved the commencement of a Pivotal Phase II Non-Muscle Invasive Bladder Cancer ("NMIBC") Clinical Study to enroll and treat patients who present with Carcinoma In-Situ ("CIS") and who are considered Bacillus Calmette Guerin("BCG")-Unresponsive or are intolerant to BCG Therapy ("Study II") (Press release, Theralase, DEC 7, 2020, View Source [SID1234572397]).

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The University of British Columbia is a global center for teaching, learning and research, consistently ranked among the top 20 public universities in the world and recently recognized as North America’s most international university.

To date 14 patients have been treated in Study II. With the addition of UBC, the Company now has 5 sites open for patient enrollment and treatment in Canada. The Company is in advanced discussions to launch a number of U.S. based clinical study sites in 4Q2020, subject to the United States economy recovering from the COVID-19 pandemic. The U.S. based Trial Management Organization plans to launch 4 to 5 clinical study sites in 4Q2020 and commence Study II patient enrollment and treatment as early as 1Q2021.

Dr. Peter Black, MD, FRCSC, a Urologic Oncologist at Vancouver General Hospital, a Research Scientist at the Vancouver Prostate Centre, and a Professor in the Department of Urologic Sciences at the University of British Columbia stated "I think this is a great opportunity for patients to gain access to a promising new technology and treatment that is easy to deliver and very patient-friendly. We are delighted to be able to offer it to patients in British Columbia."

Shawn Shirazi PhD, Chief Executive Officer, Theralase, stated, "We are extremely pleased that the UBC, REB provided approval to proceed with Study II. We are excited that our recent FDA Fast Track Designation status for Study II could lead to the expedited development of this drug-device combination for NMIBC patients. The TLD-1433 technology represents a paradigm shift in medical technology and an advanced approach to treat NMIBC."

About Study II

Study II utilizes the Therapeutic Dose (0.70 mg/cm2) of TLD-1433 and is focused on the enrollment and treatment of approximately 100 BCG-Unresponsive NMIBC CIS patients in up to 20 clinical study sites located in Canada and the US.

Study II has a:

Primary endpoint of efficacy (defined by Complete Response ("CR") at any point in time
Secondary endpoint of duration of CR at 360 days post-initial CR (approximately 450 days post initial Study treatment, assuming CR is achieved at the 90 day assessment)
Tertiary endpoint of safety measured by incidence and severity of Adverse Events ("AEs") grade 4 or higher that do not resolve within 450 days post-initial treatment
The FDA, in its 2018 guidance to industry has stated that, "For single-arm trials of patients with BCG-unresponsive disease, the FDA defines a CR as at least one of the following:

Negative cystoscopy and negative (including atypical) urine cytology
Positive cystoscopy with biopsy-proven benign or low-grade NMIBC and negative cytology
For intravesical therapies without systemic toxicity, the FDA includes, in the definition of a CR, negative cystoscopy with malignant urine cytology, if cancer is found in the upper tract or prostatic urethra and random bladder biopsies are negative.
Intravesical instillation does not deliver the investigational drug to the upper tract or prostatic urethra; therefore, the development of disease in these areas cannot be attributed to a lack of activity of the investigational drug. Thus, sponsors can consider patients with new malignant lesions of the upper tract or prostatic urethra, who have received intravesical therapy to have achieved a CR in the primary analysis; however, sponsors should record these lesions and conduct sensitivity analyses in which these patients are not considered to have achieved a CR."1

On December 7, 2020 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a pharmaceutical company focused on the development of targeted therapies for difficult-to-treat hematological diseases reported updated efficacy and safety data from the ongoing phase 2 ANCHOR combination study, following an oral presentation at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) virtual annual meeting (Press release, Oncopeptides, DEC 7, 2020, View Source [SID1234572395]). The data showed that a triplet regimen with melflufen (INN melphalan flufenamide) plus dexamethasone in combination with daratumumab or bortezomib in heavily pretreated patients with relapsed refractory multiple myeloma, demonstrated encouraging activity, was well tolerated and had a similar safety profile as when used as a doublet regimen with only melflufen plus dexamethasone. The severe treatment related adverse events reported were primarily hematologic and were clinically manageable with dose reduction.

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The primary objective of the phase 2 ANCHOR study is overall response rate, and a secondary objective is progression free survival. The data represents an analysis of both treatment arms, with a cut-off date of October 19, 2020. The overall response rate for melflufen plus dexamethasone was 73% in combination with daratumumab and 62% in combination with bortezomib. The median progression free survival was 12.9 months when combined with daratumumab. The recommended dose of melflufen for future studies with daratumumab shall be 30 mg. Since the bortezomib arm of ANCHOR still is recruiting, progression free survival has not been reported and the recommended phase 2 dose is yet to be determined. The recruitment is expected to be completed in 2021.

"The ANCHOR data are very promising: both combinations are well tolerated and demonstrated encouraging activity. The data support further development of melflufen in triplet regimens", says Klaas Bakker, MD, PhD, Chief Medical Officer, Oncopeptides AB. "This provides a clear rational for our larger randomized phase 3 LIGHTHOUSE study, which compares melflufen and dexamethasone with subcutaneous daratumumab vs. subcutaneous daratumumab alone. We are preparing study start in close dialogue with relevant authorities and expect to enroll the first patient during the first quarter of 2021".

ANCHOR is a phase 1/2 open label multicenter study evaluating the safety and efficacy of melflufen plus dexamethasone in combination with either daratumumab or bortezomib in patients with relapsed refractory multiple myeloma, who have undergone 1-4 prior lines of therapy. The patients are refractory to an immunomodulatory drug and/or a proteasome inhibitor. They have not received any prior anti-CD38 monoclonal antibody therapy.

On December 7, 2020 JW Therapeutics (stock code: 2126.HK), a leading clinical stage cell therapy company, reported data from the pivotal study (RELIANCE Trial) of relmacabtagene autoleucel ("relma-cel") under IND pathway at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, taking place virtually December 5th – 8th, 2020 (Press release, JW Therapeutics, DEC 7, 2020, View Source [SID1234572394]).

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The RELIANCE Trial was the first study of a CAR-T therapy manufactured in China for the treatment of patients with relapsed or refractory ("r/r") B-cell lymphoma in China. Compared with other anti-CD19 CAR-T therapies approved in the US and EU, relma-cel shows similar efficacy and pharmacokinetic profiles while providing the potential for an improved toxicity profile in heavily-pre-treated patients with r/r LBCL of poor risk features.

Dr. James Li, Co-Founder, Chairman and CEO of JW Therapeutics commented: "The presentation reinforced relma-cel’s significant competitive advantage in the CAR-T market in China, highlighting its competitive efficacy and safety profiles. We are confident that these data will provide strong support to relma-cel’s ongoing New Drug Application (NDA) in China and we look forward to bringing this innovative CAR-T therapy to patients as soon as possible."

Reference

Summary of Pivotal Study Data of Relma-cel

In JWCAR029 pivotal study (RELIANCE Trial), 69 patients were screened, and 59 with r/r large B cell lymphoma were enrolled and treated with relma-cel, with median age of 56.0 years (18-75). The median doses administered in low and high dose groups were 99.7×106 (range, 80.1-101.3) and 150.0×106 (range, 120.0-156.4) CAR+ T cells, respectively.

As of June 17, 2020 data cut-off, Best Overall Response Rate was 75.9% (95% CI, 62.8- 86.1) with Best Complete Response Rate of 51.7% (95% CI, 38.2-65.1) in 58 evaluable patients. With a median follow-up of 8.9 months, median OS were not reached, and 6 month DOR, PFS and OS were 60.0%, 54.2% and 90.8%, respectively.

Of 59 treated patients, 28 patients (47.5%) experienced CRS of any grade. Grade 3 and 4 CRS was observed in 2 patients (3.4%) and 1 patient (1.7%), respectively. The median onset of CRS was at 4.5 days (range 1 to 5) after infusion with a median duration of 7.0 days (range 1 to 18). Neurologic events occurred in 12 patients, with only 3 (5.1%) having severe grade events (all Grade 3). Median onset of NT was at 8.5 days after infusion, with a median duration of 12.5 days (range 1 to 49). CRS and NT were generally manageable and all cases resolved except one patient who died at day 8 of sepsis and ongoing grade 4 CRS.

The RELIANCE Trial provided the first demonstration of licensure-quality CAR-T manufacturing and clinical trial data generation in r/r patients originating in China. These results with relma-cel demonstrate similar preliminary response rates while providing the potential for an improved toxicity profile in heavily-pre-treated patients with r/r LBCL having poor risk features relative to other CD19-specific CAR-Ts approved in the US and EU.

About Relmacabtagene autoleucel ("relma-cel")

Relmacabtagene autoleucel ("relma-cel"), JW Therapeutics’ lead product, is an anti-CD19 CAR-T therapy for third-line treatment for relapsed or refractory ("r/r") B-cell lymphoma. The New Drug Application (NDA) for relma-cel as a third-line treatment for diffuse large B-cell lymphoma ("DLBCL") was accepted for review by China’s National Medical Products Administration ("NMPA") in June 2020 and was granted priority review status in September 2020. Moreover, the NMPA also granted Breakthrough Therapy Designation for relma-cel as a treatment for follicular lymphoma. Relma-cel is expected to be the first CAR-T therapy to be approved as a Category 1 biologics product in China.

On December 7, 2020 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of fully human antibody therapeutics, reported that the company will present the updated interim data from the ongoing phase Ib trial of olinvacimab and pembrolizumab combination therapy in metastatic triple-negative breast cancer (mTNBC) patients at the 2020 San Antonio Breast Cancer Symposium (SABCS 2020) taking place virtually over December 8-11, 2020 (Press release, PharmAbcine, DEC 7, 2020, View Source [SID1234572393]).

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Positive data from the ongoing safety and tolerability study will highlight safety and certain efficacy data including ORR (Overall Response Rate) & DCR (Disease Control Rate) from 11 patients diagnosed with mTNBC.

"We are excited to present highly encouraging data from our ongoing trial in the biggest breast cancer symposium. These data offer important insights into future development of the combo therapy," said Dr. Jin-San Yoo, CEO of PharmAbcine.

Following is the detail of the company’s virtual poster presentation at 2020 SABCS.

Title: Phase Ib trial of olinvacimab and pembrolizumab in patients with metastatic triple-negative breast cancer
Presenter: Arlene Chan, M.D.
Poster #PS10-18
Date/time: Wednesday, December 9, 2020; 8:00 a.m. CT

About San Antonio Breast Cancer Symposium

San Antonio Breast Cancer Symposium (SABCS) is the world’s largest breast cancer conference held every year. Nearly 10,000 researchers and medical experts participate in this event every year. The core mission of this event is to provide the latest research data in breast oncology to all participants around the globe. For the safety and security of all members in the COVID-19 global pandemic, the SABCS executive committee has decided to hold this year’s event virtually.

About metastatic triple-negative breast cancer

mTNBC is a highly malignant type of cancer that shows a high recurrence rate within the first five years after the diagnosis. mTNBC accounts for 10-20% of all breast cancers and shows a 5-year survival rate of circa 11%. Unlike some other breast cancers, mTNBC does not express estrogen or progesterone receptors or human epidermal growth factor receptor 2 (HER2), and it does not respond to existing cancer drugs designed to target these markers. mTNBC is very difficult to treat, and there are very few FDA approved treatment options for these patients.

On December 7, 2020 Viracta Therapeutics, Inc. (Viracta or the Company), a precision oncology company targeting virus-associated malignancies, reported recent clinical and regulatory developments regarding its lead program for the treatment of relapsed/refractory (R/R) EBV+ lymphomas (Press release, Viracta Therapeutics, DEC 7, 2020, View Source [SID1234572391]).

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At the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, Dr. Pierluigi Porcu of Sidney Kimmel Cancer Center, Thomas Jefferson University, presented updated data from Viracta’s ongoing clinical trial evaluating its all-oral combination regimen of nanatinostat and valganciclovir for the treatment of patients with R/R EBV+ lymphoma that had failed one or more prior therapies and lacked treatment options.

As of the data cutoff (October 27, 2020), 46 patients were enrolled (B-cell non-Hodgkin lymphoma (B-NHL; n=10), T/NK-cell non-Hodgkin lymphoma (T/NK-NHL; n=15), immunodeficiency-associated lymphoproliferative disorder (IA-LPD; n=13) and Hodgkin lymphoma (HL: n=8). The number of median prior therapies was 2; 80% were refractory to their last prior therapy and 80% had exhausted all prior therapies.

Key results include:

Complete responses were observed across multiple EBV+ lymphoma subtypes (diffuse large B-cell lymphoma (DLBCL), T/NK-NHL and IA-LPD); preliminary efficacy in Phase 2 is consistent with Phase 1b results
Highly active in T/NK-NHL (n=10) with an overall response rate (ORR) of 80% (8/10) and complete response rate (CR) of 40% (4/10)
Encouraging activity in DLBCL (n=6) with an ORR of 66% (4/6) and a CR of 33% (2/6); both CR’s were in patients refractory to first-line R-CHOP
Generally well-tolerated; most common Grade 3/4 toxicities were reversible cytopenias with limited extra-hematologic toxicity
Three patients (2 T/NK-NHL, 1 Hodgkin lymphoma) previously ineligible for immunotherapy approaches were withdrawn from the trial to undergo stem cell transplantation and CAR-T cell therapy respectively
Median duration of response of 10.4 months
In November 2020, Viracta held an End of Phase 2 Meeting with the United States Food and Drug Administration (FDA) to address various nonclinical and clinical topics. Based on the outcome of this meeting, the Company intends to initiate a global registration trial in R/R EBV+ lymphomas in 1H 2021. This trial is designed to support multiple potential marketing approvals across the various subtypes of EBV+ lymphoma. An End of Phase 2 Meeting with the United States FDA to address chemistry, manufacturing and controls is planned for December 2020, and preliminary comments from the Agency indicate alignment in key areas.

Lisa Rojkjaer, M.D., Chief Medical Officer of Viracta commented, "EBV+ lymphoma is an area of high unmet medical need, with adverse survival outcomes reported with standard of care regimens and no approved therapies. The encouraging efficacy and safety profile observed thus far in these highly refractory patients underscores the potential of this oral combination regimen of nanatinostat with valganciclovir for the treatment of patients with recurrent disease. We look forward to advancing our clinical development program in EBV+ lymphoma into its next stages."

Ivor Royston, M.D., President and Chief Executive Officer of Viracta added, "Alignment with the FDA on our registrational trial design and manufacturing plans provide clarity about our development pathway to potential marketing approval for our combination product candidate. We believe the FDA’s support for our registrational trial design is a reflection of the Agency’s recognition of the unmet medical need of patients with EBV+ lymphoma and the promising potential of our inducible synthetic lethality approach. In addition, with our recently announced merger agreement with Sunesis Pharmaceuticals and significant financings, we are well capitalized with significant momentum to advance this and our EBV+ solid tumor program forward in 2021."

Details of ASH (Free ASH Whitepaper) Presentation

Abstract number: 624
Title: Oral Nanatinostat (Nstat) and Valganciclovir (VGCV) in Patients with Recurrent Epstein-Barr Virus (EBV)-Positive Lymphomas: Initial Phase 2 Results
Presenter: Pierluigi Porcu, MD, Sydney Kimmel Cancer Center, Thomas Jefferson University
Session: Hodgkin lymphoma and T/NK cell lymphoma—Clinical studies
A copy of the presentation can be accessed by visiting the "News/Media" section of the Viracta website: View Source

Viracta’s Planned Merger with Sunesis Pharmaceuticals

On November 30, 2020, Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) and Viracta announced the parties entered into a definitive merger agreement (the Merger Agreement) pursuant to which Viracta will combine with Sunesis in an all-stock transaction (the Merger). The merged company will focus on the advancement and expansion of Viracta’s clinical stage, precision oncology pipeline targeting virus-associated malignancies, including Viracta’s lead program for the treatment of EBV+ R/R lymphomas. Upon completion of the Merger, the combined company will operate under the name Viracta Therapeutics, Inc. and intends to be listed on the Nasdaq Global Market under the ticker symbol "VIRX".

Under the terms of the Merger Agreement, pending stockholder approval of the transaction, Viracta will merge with a wholly owned subsidiary of Sunesis, and stockholders of Viracta will receive shares of newly issued Sunesis common stock. Viracta stockholders are expected to own approximately 86% and Sunesis stockholders will own approximately 14% of the combined company on a fully diluted basis using the treasury stock method. The percentage of the combined company that Sunesis stockholders will own as of the close of the Merger may be subject to adjustment based on Sunesis’ net cash.

The Merger Agreement has been unanimously approved by the Board of Directors of each company. The transaction is expected to close in the first quarter of 2021, subject to approvals by stockholders of each company and other customary closing conditions.

A more complete description of the terms of and conditions of the merger can be found in Sunesis’ Form 8-K filed on November 30, 2020 with the Securities and Exchange Commission (SEC) and in the Merger Agreement, which is filed as an exhibit to that Form 8-K.

About Nanatinostat

Nanatinostat (VRx-3996) is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which is key to inducing latent viral genes which are epigenetically silenced in EBV-associated malignancies. The nanatinostat and valganciclovir combination is being investigated in EBV+ lymphomas in an ongoing Phase 2 clinical trial [NCT03397706].

Viracta has received Fast Track designation from the FDA for the nanatinostat and valganciclovir combination in R/R EBV+ lymphomas, as well as orphan drug designations for the treatment of post-transplant lymphoproliferative disorder, plasmablastic lymphoma, and T-cell lymphomas.