On November 10, 2021 Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, reported that management will participate in the upcoming Virtual Jefferies London Healthcare Conference set to take place November 16 – 19, 2021 (Press release, Wugen, NOV 10, 2021, View Source [SID1234595059]). The presentation will be available to registered conference attendees for on-demand viewing on Thursday, November 18 at 8:00 a.m. GMT (3:00 a.m. ET).

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On November 10, 2021 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, reported financial results for the third quarter of 2021 and provided an update on recent corporate activities (Press release, Viracta Therapeutics, NOV 10, 2021, View Source [SID1234595058]).

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"Over the past months we achieved key milestones that have furthered the development of Nana-val and positioned us to broaden our addressable patient population," said Ivor Royston, M.D., President and Chief Executive Officer of Viracta. "We expanded our clinical trial pipeline with the initiation of our EBV-positive solid tumor trial and reacquired all rights to Nana-val in China, a strategically important territory given the high prevalence of EBV-associated cancers in Asia. Looking ahead, we expect continued progress in our solid tumor trial, as well as continued global expansion of our pivotal NAVAL-1 trial in EBV-positive lymphoma. In addition, we are excited about our multiple ASH (Free ASH Whitepaper) presentations that will feature final results from our Phase 1b/2 EBV-positive lymphoma trial and preclinical findings on vecabrutinib, our reversible inhibitor of Bruton’s tyrosine kinase (BTK) and interleukin-2-inducible kinase (ITK), which we are exploring for potential use in combination with CAR T-cell therapy."

Dan Chevallard, Chief Operating Officer and Chief Financial Officer of Viracta, added, "Viracta remains in a strong financial position as we move toward the end of year. We ended the third quarter with approximately $111.0 million in cash and have reiterated our plan to end the year with over $100.0 million in cash. Importantly, we have now secured access to significant additional and undrawn non-dilutive and available capital through our recently expanded credit facility. We believe our financial strength positions us well to deliver on our development and strategic objectives into 2024."

Third Quarter 2021 and Recent Highlights

Clinical

Continued the global expansion of pivotal NAVAL-1 trial; multiple U.S. and international sites now open for enrollment. NAVAL-1 (Nanatinostat in Combination with Valganciclovir) is a global, multicenter, open-label Phase 2 basket trial. The trial, which will include patients with multiple subtypes of R/R EBV+ lymphoma, is designed to evaluate the anti-tumor activity of Nana-val and is designed to enroll approximately 140 patients. The primary endpoint of the trial is objective tumor response rate as assessed by an independent review committee. If successful, the Company believes this trial could potentially support multiple new drug application (NDA) filings across various EBV+ lymphoma subtypes. The study employs a Simon two-stage design where a limited number of patients are enrolled into each cohort in Stage 1 and, if a pre-specified activity threshold is reached, additional patients will be enrolled in Stage 2. During Stage 2, the Company anticipates discussing the preliminary results with the U.S. Food and Drug Administration (FDA) and may amend the protocol to include additional patients as necessary to enable registration. The Company anticipates providing an update on the initial cohort(s) that have expanded into Stage 2 in the second half of 2022.

Initiated a Phase 1b/2 trial of Nana-val in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) and other EBV+ solid tumors. This Phase 1b/2 open-label multicenter trial is evaluating Nana-val alone and in combination with pembrolizumab in patients with advanced EBV+ solid tumors. The Phase 1b dose escalation part will evaluate safety and determine the recommended Phase 2 dose (RP2D) of Nana-val in patients with EBV+ RM-NPC. In Phase 2, up to 60 patients with EBV+ RM-NPC will be randomized to receive Nana-val at the RP2D with or without pembrolizumab to evaluate safety and preliminary efficacy. Additionally, patients with other EBV+ solid tumors will be enrolled to receive Nana-val at the RP2D in a Phase 1b dose expansion cohort. The Company anticipates providing preliminary clinical data from the trial in 2022.

Announced an upcoming oral presentation at the 2021 ASH (Free ASH Whitepaper) Annual Meeting featuring final results from VT3996-201, the Phase 1b/2 trial of Nana-val in R/R EBV+ lymphoma. Data indicate that Nana-val was well tolerated and shows promising efficacy in patients with R/R EBV+ lymphoma. The presentation’s corresponding abstract is currently available on the ASH (Free ASH Whitepaper) website.
Preclinical

Announced upcoming oral and poster presentations at the 2021 ASH (Free ASH Whitepaper) Annual Meeting featuring preclinical data on vecabrutinib, a reversible inhibitor of BTK and ITK. Data to be featured in the oral presentation demonstrate that using vecabrutinib is a novel strategy to modulate CD19-targeted chimeric antigen receptor (CAR) T-cell functions by increasing their efficacy, and decreasing their toxicity, while maintaining their proliferative potential. The poster presentation will feature data showing that vecabrutinib treatment demonstrated efficacy and beneficially regulated B cell and T cell immune subsets in a preclinical murine model of sclerodermatous chronic graft-versus-host disease. The presentations’ corresponding abstracts are currently available on the ASH (Free ASH Whitepaper) website.
Corporate

Reacquired the exclusive development and commercialization rights for Nana-val in China. Following the reacquisition of the exclusive rights to develop and commercialize Nana-val in the People’s Republic of China from Shenzhen Salubris Pharmaceuticals Co., Ltd., Viracta now controls global rights to its all-oral combination therapy.

Secured expanded $50 million credit facility from Silicon Valley Bank (SVB) and Oxford Finance. The credit facility replaces Viracta’s prior $15 million loan and security agreement with SVB and provides the Company with the option to obtain additional non-dilutive funding at a single-digit cost of capital. Through this expanded credit facility, the Company’s existing $5 million debt balance was refinanced. The remaining $45.0 million is available and the Company is under no obligation to draw funds in the future.

Appointed Flavia Borellini, Ph.D., and Jane F. Barlow, M.D., MPH, MBA, as independent members to its Board of Directors. Dr. Borellini has more than 25 years of executive management experience in the pharmaceutical and biotechnology industry, with a particular focus on the development of targeted oncology drugs. As the former Chief Executive Officer of Acerta Pharma, she oversaw the development and approval of the BTK inhibitor Calquence (acalabrutinib). Dr. Barlow is currently the Chief Executive Officer of Jane Barlow & Associates, LLC and has over 25 years of leadership experience in driving cost-effective medical, diagnostic and pharmaceutical strategies.

Expanded Scientific Advisory Board with the addition of Dr. Shannon Kenney. Dr. Kenney is the Wattawa Bascom Professor in Cancer Research at the University of Wisconsin-Madison School of Medicine and Public Health, in the Departments of Oncology and Medicine. She obtained her B.A. and MD degrees from Yale University and was a postdoctoral research fellow at the NIAID and the Lineberger Comprehensive Cancer Center. Dr. Kenney’s research is focused on understanding the molecular regulation and pathogenesis of EBV in both epithelial cells and B cells, including viral gene regulation, host-pathogen interactions, and virally-induced transformation.
Anticipated 2021 Milestones and Key Upcoming Events

Final results from the Phase 1b/2 trial of Nana-val in R/R EBV+ lymphoma (VT3996-201) will be presented in an oral presentation at the 2021 ASH (Free ASH Whitepaper) Annual Meeting in December 2021

Results from preclinical studies of vecabrutinib will be presented in both an oral and poster presentations at the 2021 ASH (Free ASH Whitepaper) Annual Meeting in December 2021
Third Quarter 2021 Financial Results

Cash position – Cash and cash equivalents totaled approximately $111.0 million as of September 30, 2021. Viracta expects to end 2021 with greater than $100.0 million in cash and cash equivalents, which it anticipates will be sufficient to fund its operations into 2024, excluding any additional borrowings under the $50.0 million credit facility.

Research and development expenses – Research and development expenses were $7.1 million and $16.6 million for the three and nine-months ending September 30, 2021, respectively, compared to $3.1 million and $9.9 million for the same periods in 2020. The increase was primarily due to costs associated with the initiation of the NAVAL-1 and solid tumor trials as well as an increase in headcount and non-cash share-based compensation.

Purchased and acquired in-process research and development – Purchased and acquired in-process research and development expenses of $4.0 million and $88.5 million were recorded for the three and nine-months ending September 30, 2021. The expenses were related to the $4.0 million payment associated with the termination of the collaboration and license agreement with Shenzhen Salubris Pharmaceutical Co. Ltd. and non-cash and non-recurring costs of $84.5 million related to the write-off of in-process research and development acquired in the merger with Sunesis Pharmaceuticals.

General and administrative expenses – General and administrative expenses were $3.7 million and $11.4 million for the three and nine-months ending September 30, 2021, respectively, compared to $0.9 million and $2.8 million for the same periods in 2020. The increase was largely due to incremental costs associated with being a publicly traded company, including legal fees, audit fees, consulting expenses, filing fees and increased directors and officer’s insurance costs, in addition to an increase in non-cash share-based compensation.

Gain on Royalty Purchase Agreement – Gain on Royalty Purchase Agreement for the nine-months ending September 30, 2021, was associated with upfront proceeds of $13.5 million received in connection with the multi-license milestone and royalty monetization transaction with XOMA Corporation in March 2021.

Adjusted loss from operations – Adjusted loss from operations for the nine-months ended September 30, 2021, excluding the non-recurring operating expenses associated with the write-off of in-process research and development acquired in the merger and the termination agreement with Salubris Pharmaceutical Co. Ltd. (a non-GAAP measure) was $14.5 million, compared to a loss from operations of $103.0 million. There is not a comparative adjustment to loss from operations for the same period in 2020.

Net loss – Net loss was $14.9 million, or $0.40 per share (basic and diluted) for the quarter ended September 30, 2021, compared to a net loss of $4.1 million, or $14.22 per share for the same period in 2020. Net loss was $103.3 million, or $3.44 per share (basic and diluted) for the nine months ended September 30, 2021, compared to a net loss of $12.7 million, or $46.27 per share (basic and diluted) for the same period in 2020.

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 viral genes that are epigenetically silenced in EBV-associated malignancies. Nana-val (nanatinostat and valganciclovir) is being investigated in multiple subtypes of relapsed/refractory EBV+ lymphoma and in advanced EBV+ solid tumors in three clinical trials, one of which is a registration-enabling global, multicenter, open-label Phase 2 basket trial in relapsed/refractory EBV+ lymphoma (NAVAL-1).

About Vecabrutinib

Vecabrutinib is a selective, reversible, non-covalent inhibitor of Bruton’s tyrosine kinase (BTK) and interleukin-2-inducible kinase (ITK). Vecabrutinib is being studied as a potential enhancer of efficacy and safety of CAR T-cell therapy.

On November 10, 2021 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, reported that Dr. Elizabeth Evans, PhD, Chief Operating Officer and SVP, Discovery and Translational Medicine, reported that it will present Poster #434, Phase 1/2 study to evaluate pepinemab in combination with pembrolizumab in advanced, recurrent or metastatic head and neck cancer (KEYNOTE B84), at the Society for Immunology of Cancer’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting being held from November 12th – 14th in Washington D.C (Press release, Vaccinex, NOV 10, 2021, View Source [SID1234595057]). Please see Presentation details below:

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SITC Conference Information

Date: November 12-14, 2021
Session Title: Clinical Trials in Progress, Poster Session
Poster #: Title Poster #434: Phase 1/2 study to evaluate pepinemab in combination with pembrolizumab in advanced, recurrent or metastatic head and neck cancer (KEYNOTE B84)
Add to calendar: View Source
Program Link: View Source
Access: The Poster will be presented in-person 12:30 -2 and 7 – 8:30 p.m. ET on Saturday, November 13, and on the SITC (Free SITC Whitepaper) 2021 virtual meeting platform from 7 a.m. ET on Friday, November 12, 2021, until the virtual meeting platform is closed on January 9, 2022. The Poster will also be available on Vaccinex’s website starting on November 12, 2021, at: View Source
For more information about the SITC (Free SITC Whitepaper) Annual Meeting please refer to the conference website. The in-person program in Washington D.C. will be streamed live on the digital platform.

On November 10, 2021 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or the "Company"), an Australian-based clinical stage radiopharmaceutical company developing next-generation products to address the growing need in oncology, reported that it has completed recruitment for the initial dosimetry phase of its US-based SECuRE clinical trial (NCT04868604)1 investigating SAR-bisPSMA Targeted Copper Theranostics (TCT) in patients with metastatic castrate-resistant prostate cancer (mCRPC) (Press release, Clarity Pharmaceuticals, NOV 10, 2021, View Source [SID1234595055]).

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The SECuRE trial is a Phase I/IIa theranostic trial for identification and treatment of prostate specific membrane antigen (PSMA)-expressing mCRPC using TCT. 64Cu SAR-bisPSMA is used to visualise PSMA expressing lesions and select candidates for subsequent 67Cu SAR-bisPSMA therapy. The initial dosimetry phase utilised 64Cu SAR-bisPSMA to determine biodistribution and dosimetry of the products in humans. The SECuRE trial is a multi-centre, single arm, dose escalation study with a cohort expansion planned for up to 44 patients in the US. The aim of this trial is to determine the safety and efficacy of 67Cu SAR-bisPSMA as a therapy.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are very pleased to have quickly and successfully completed the recruitment for the initial dosimetry phase of the SECuRE trial in mCRPC using our optimised next-generation PSMA agent, SAR-bisPSMA, and look forward to progressing through the safety review shortly. We are excited to move quickly to the therapy phase with 67Cu SAR-bisPSMA at all seven clinical sites selected for this trial in the US.

"The PET imaging data acquired in the SECuRE trial to date looks very promising and the images confirm our excellent preclinical results of high tumour targeting and retention whilst seeing washout in other tissues. We are excited with the comparison to the standard of care bone scan (the recommended modality for bone imaging in clinical trials according to the Prostate Cancer Clinical Trials Working Group 3), indicating that 64Cu SAR-bisPSMA is able to visualise bone involvement. This further supports the emerging evidence of increased sensitivity and specificity of PSMA PET tracers for detecting micrometastatic disease compared to conventional imaging. With the recently updated US National Comprehensive Cancer Network Guidelines now allowing FDA-approved PSMA PET agents to be used as an alternative to conventional imaging, we are really looking forward to progressing this product quickly through clinical trials with the added value of manufacturing, logistics and patient benefits that 64Cu provides.

"Our TCT platform uniquely uses the same chemical entity for both diagnosis and therapy, leading to high accuracy and high precision, and highlights the benefits of generating 64Cu imaging data from 1h to 72h after administration to help determine the suitability of treatment with 67Cu. We strongly believe SAR-bisPSMA will be an important pillar in the next generation of radiopharmaceuticals, with blockbuster potential both diagnostically and therapeutically. The central manufacture, logistical and treatment advantages of TCT associated with using the isotope pairing of 64Cu and 67Cu in large patient populations such as prostate cancer will provide significant benefits to both patients and clinicians in comparison to current products in the market."

Dr Luke Nordquist, CEO, Urologic Medical Oncologist at the Urology Cancer Center and GU Research Network in Omaha, Nebraska, who treated patients in the initial dosimetry phase of the trial, commented, "I am very impressed with the data from the initial dosimetry phase and we look forward to progressing the SECuRE trial into the therapy phase and further validating the benefits of the 64Cu SAR-bisPSMA and 67Cu SAR-bisPSMA products for both clinicians and patients. Current standard of care SPECT imaging agents don’t have the resolution of the new PET agents, however the new PET agents rely on radionuclides with very short half-lives such as 18F and 68Ga, which limits their availability and utilisation. Having access to centrally manufactured PET imaging products with a more suitable half-life, such as 64Cu, will significantly improve patient care and address the current backlog of patients waiting for critical imaging scans. Importantly, the potential for improved prostate cancer diagnosis and treatment will have significant benefits for prostate cancer patients."

Dr Taylor said: "The future of radiopharmaceuticals is here, where patient care is not dictated by the limited half-life of the isotope, and instead focuses on what is important for the patient, clinician and treating staff – safety, efficacy, access and flexibility. The further expansion of radiopharmaceuticals into more indications, with greater utilisation from a broad spectrum of clinicians, will be dependent upon centralised, large volume and simple supply logistics of isotopes and ready-to-use radiopharmaceuticals whilst focusing on long-term environmental impacts of the supply chain. Clarity’s ability to centrally manufacture and broadly distribute large volumes of copper-based products, without long lived radioactive waste products or dependance on nuclear reactors, will be a significant factor in addressing large markets in a sustainable manner. To that end, we are very excited to be quickly advancing our TCT platform and numerous TCT products through clinical trials to generate compelling clinical data and move closer to achieving our ultimate goal of developing better treatments for children and adults with cancer."

This announcement has been authorised for release by the Executive Chairman.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide2. In 2021, the National Cancer Institute estimated 248,530 new cases of prostate cancer in the US and around 34,130 deaths from the disease3. Annually, there are around ~34,000 men in the US who are diagnosed with mCRCP4, ~90% of whom have tumours which express PSMA5.

References
gov Identifier: NCT04868604 View Source
Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries View Source
American Cancer Society, Cancer Statistics Center, View Source!/cancer-site/Prostate
American Cancer Society, Cancer Statistics Center, View Source!/cancer-site/Prostate
A. Silver, I. Pellicer, W. R. Fair, W. D. Heston and C. Cordon-Cardo 1997. "Prostate-specific membrane antigen expression in normal and malignant human tissues." Clinical Cancer Research. vol. 3, 81-85, January 1997

On November 10, 2021 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics, reported financial results for the third quarter ended September 30, 2021 (Press release, Repare Therapeutics, NOV 10, 2021, View Source [SID1234595054]).

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"We are pleased with the progress we’ve made this quarter in our Phase 1 part of the RP-3500 program, including the comprehensive safety data and emerging evidence of activity from the TRESR study which was part of the featured oral presentation at the AACR (Free AACR Whitepaper)-NCI-EORTC conference this year," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "The findings continue to suggest RP-3500 may have broad clinical efficacy in tumors with diverse genetic alterations and provides further clinical proof of concept and validation of our SNIPRx platform. We look forward to providing updates in the future on the potential of RP-3500, both as a monotherapy and in combination with PARP inhibitors."

Third Quarter 2021 Review and Operational Updates:

Announced initial monotherapy clinical data from Phase 1/2 TRESR study of RP-3500 in patients with solid tumors at the AACR (Free AACR Whitepaper)-NCI-EORTC conference
Early data showed RP-3500 appears safe and well tolerated. The most common treatment emergent adverse events in any of the 101 patients treated, expectedly, was grade 1-2 anemia, with only 21.8% of all patients experiencing Grade 3 anemia (no Grade 4). There were no discontinuations related to RP-3500 emergent adverse events and dose interruptions, and reductions or red blood cell transfusions were infrequent on the recommended 3 days on/4 days off weekly regimen.
Recommended Phase 2 dose and schedule for further monotherapy RP-3500 evaluation was determined to be 160mg, taken weekly for 3 days on and 4 days off. This schedule assures repeated weekly exposure to RP-3500 at an efficacious dose. The Grade 3 anemia rate at this schedule overall was only 14.5%.
Antitumor activity, defined as RECIST based objective responses, was observed in patients with tumors harboring SNIPRX predicted genomic alternations at doses >100mg (ATM, CDK12, BRCA1, BRCA2, RAD51C), across multiple tumor types and included patients after PARP inhibitor failure. Meaningful clinical benefit was observed in 49% of 69 patients with available scans. Those include 12 patients with tumor responses per established international efficacy criteria, 14 patients with ongoing stable disease for at least 16 weeks and an additional 8 patients with stable disease who only had two radiological evaluations, but had demonstrated significant decreases in tumor markers or initial tumor shrinkage of less than 30%. Promising deep molecular responses in circulating tumor DNA (ctDNA) for tumors with STEP2 genomic alterations were observed in a subset of patients available for serial ctDNA analysis.
Final readouts from patients enrolled in the monotherapy arm of the TRESR trial, as well as initial data from the combination arm testing RP-3500 together with PARP inhibitors, are expected in 2022.

Raised Gross Proceeds of $101.2 Million in Upsized Follow-on Public Offering
In November 2021, the Company announced the closing of an upsized unwritten follow-on public offering yielding aggregate gross proceeds of approximately $101.2 million, or net proceeds of approximately $93.9 million, after deducting underwriting commissions and estimated offering expenses of $1.2 million payable by us. All of the shares in the offering were offered by Repare Therapeutics.
Appointed Thomas Civik to Board of Directors as new Chairman
In September 2021, the Company appointed Thomas Civik to its Board of Directors as its Chairman. He replaced Jerel Davis, Ph.D., who remains a Board member.
Mr. Civik was most recently President and CEO of Five Prime Therapeutics until its $1.9 billion acquisition by Amgen in April 2021. He has over 25 years of leadership and commercial experience at various companies including Foundation Medicine and Genentech.
Achieved $0.9 million (¥100 million) research trigger pursuant to the terms of its research services, license and collaboration agreement with Ono Pharmaceutical Co., Ltd
On October 13, 2021, upon the occurrence of a specified research trigger, the Company became eligible to receive a portion, amounting to ¥100 million ($0.9 million), of the research service payments provided for in its research services, license and collaboration agreement with Ono Pharmaceutical Co., Ltd., or Ono, ("Ono Agreement") for the research of potential product candidates targeting Polθ. Furthermore, on October 29, the Company and Ono entered into an amendment to the Ono Agreement whereby the Research Term, as defined in the Ono Agreement, was extended by one year.
Third Quarter 2021 Financial Results:

Cash and cash equivalents, restricted cash and marketable securities: Cash and cash equivalents, restricted cash and marketable securities as of September 30, 2021 were $268.2 million, exclusive of the proceeds from the follow-on public offering.
Research and development expenses, net of tax credits (Net R&D): Net R&D expenses were $25.4 million and $62.1 million for the three- and nine-month periods ended September 30, 2021, respectively, as compared to $10.1 million and $27.7 million for the three- and nine-month periods ended September 30, 2020, respectively. The increase in R&D expenses for the three and nine-month periods were primarily due to increases in development costs related to the Company’s RP-3500 and RP-6306 programs, as well as increases in personnel related expenses, including share-based compensation.
General and administrative (G&A) expenses: G&A expenses were $6.6 million and $18.6 million for the three and nine-month periods ended September 30, 2021, respectively, as compared to $4.0 million and $9.6 million for the three and nine-month periods ended September 30, 2020, respectively. The increase in G&A expenses for the three and six-month periods were due to personnel related costs, including share-based compensation, and D&O insurance which increased as a result of the Company’s IPO in June 2020.
Net loss: Net loss was $30.9 million, or $0.83 per share and $78.6 million, or $2.12 per share, in the three and nine-month periods ended September 30, 2021, respectively, and $13.8 million, or $0.37 per share and $38.2 million, or $2.63 per share in the three and nine-month periods ended September 30, 2020, respectively.
About Repare Therapeutics’ SNIPRx Platform

Repare’s SNIPRx platform is a genome-wide CRISPR-based screening approach that utilizes proprietary isogenic cell lines to identify novel and known synthetic lethal gene pairs and the corresponding patients who are most likely to benefit from the Company’s therapies based on the genetic profile of their tumors. Repare’s platform enables the development of precision therapeutics in patients whose tumors contain one or more genomic alterations identified by SNIPRx screening, in order to selectively target those tumors in patients most likely to achieve clinical benefit from resulting product candidates.