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Sirnaomics Doses First Patient in Phase 2b Study of STP705 for Treatment of Squamous Cell Skin Cancer

On June 30, 2021 Sirnaomics, Inc., a biopharmaceutical company engaged in the discovery and development of RNAi therapeutics against cancer and fibrotic diseases, reported dose administration for the first patient in a Phase 2b study of the company’s drug candidate, STP705, for the treatment of squamous cell skin cancer in situ (isSCC) (Press release, Sirnaomics, JUN 30, 2021, View Source [SID1234584510]). STP705 is a siRNA (small interfering RNA) therapeutic that takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX-2 gene expression.

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The randomized, double-blind, placebo-controlled Phase 2b study is evaluating the safety and efficacy of intralesional injection of STP705 in up to 100 adult patients with isSCC. This portion of the trial will further evaluate the two most efficacious dosing regimens of 30 ug and 60 ug. The primary endpoint of this trial is the proportion of participants with histological clearance of treated isSCC lesion at the end of treatment. Histological clearance will be defined as the absence of detectable evidence of isSCC tumor cell nests as determined by central pathology review.

"For many patients with isSCC, surgery is still considered the only viable treatment option, so with our first patient dosed in this Phase 2b study, we’ll be able to observe the efficacy of STP705, which has to the potential to be a non-surgical, non-invasive alternative," said Michael Molyneaux M.D., Chief Medical Officer. "Our interim readout later this year will guide our clinical development for this indication."

"After a high rate of patients achieved histological clearance in the Phase 2a study of STP705 for isSCC, we’re looking forward to seeing the results of our Phase 2b study as we begin patient dosing," said Patrick Lu, Ph.D., founder, President and CEO of Sirnaomics. "The anticipated clinical readout in the second half of 2021 will provide more insights into the potential of STP705 for the treatment of non-melanoma skin cancer and the impact of RNAi therapeutics in oncology."

Additional information about this clinical trial is available at clinicaltrials.gov using the identifier: NCT04844983.

About Non-melanoma Skin Cancer and Squamous Cell Carcinoma In Situ
Skin cancer is the most common type of all cancers diagnosed each year in the United States. It is estimated that nearly half of cancers diagnosed every year will be skin cancers. Over the past decade, the incidence of skin cancers has increased dramatically. According to the JAMA Dermatology paper (Rogers, et. al. JAMA Dermatol. 2015151(10):1081-1086), an estimated 3.3 million people in the US suffer from non-melanoma skin cancer (NMSC) along with 5.43 million people that are currently living with cancer lesions.

Squamous cell carcinoma in situ, also called Bowen disease, is the earliest form of squamous cell skin cancer (SCC). Along with basal cell carcinoma, SCC is one of two major subtypes of NMSC. The key driver for development of SCC is ultraviolet rays from the sun. It is believed that development of SCC is linked closely to genomic perturbations, genetic mutations, and altered expression of key molecules (e.g., overexpression of TGF-β1 and COX-2) that impacts squamous cell lineage commitment and terminal differentiation.

Surgery is the currently the most common treatment option for the treatment of NMSC. The various forms of surgical modalities carry significant cutaneous adverse events, risk of scar, infection and bleeding. Surgery can also have a significant recurrence rate. As a result, there is a high unmet need for an FDA approved local injection therapy that is safe and effective.

About STP705
Sirnaomics’ product candidate, STP705, is a siRNA (small interfering RNA) therapeutic that takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX-2 gene expression. The product candidate has received multiple IND approvals from both the US FDA and Chinese NMPA, including treatments of cholangiocarcinoma, nonmelanoma skin cancer and hypertrophic scar. STP705 has also received Orphan Drug Designation for treatment of cholangiocarcinoma and primary sclerosing cholangitis. A Phase 2a study of STP705 for treatment of squamous cell skin cancer (isSCC) in adult patients demonstrated positive efficacy and safety results, with 76% of all patients (19/25) achieving complete histologically clearance and the two optimal dosing ranges achieving 90% histological clearance of tumor cell in the lesion. No significant or serious adverse events, including no significant cutaneous skin reactions, were reported in the study, and the company was able to define a clear therapeutic window in advance of later stage studies.

SELLAS Reports Promising Updated Clinical Data and Initial Immune Response Profiles from Ongoing Phase 1/2 Study of Galinpepimut-S (GPS) Combined with Keytruda for Treating WT1+ Advanced Ovarian Cancer

On June 30, 2021 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on developing novel cancer immunotherapies for a broad range of indications, reported promising updated clinical data and initial immunobiological data from its Phase 1/2 clinical trial with its lead asset, galinpepimut-S (GPS), the Company’s Wilms Tumor-1 (WT1)-targeting peptide immunotherapeutic, in combination with the checkpoint inhibitor pembrolizumab (Keytruda) (Press release, Sellas Life Sciences, JUN 30, 2021, View Source [SID1234584509]).

Conducted under a Clinical Trial Collaboration and Supply Agreement with Merck & Co., Inc., Kenilworth, N.J. USA (known as MSD outside of the United States and Canada), the study is investigating the combination of GPS and pembrolizumab in treating patients diagnosed with second- or third-line WT1(+) relapsed or refractory platinum-resistant, advanced metastatic ovarian cancer. The WT1 antigen is one of the most widely expressed cancer antigens in multiple malignancies and has been ranked by the National Cancer Institute as the top priority among cancer antigens for immunotherapy.

The study details are as follows:

Eleven patients (median age: 63 years) who received at least three GPS doses, the last of which was combined with pembrolizumab, were evaluated for clinical responses and three of those patients were also evaluated for immune responses.
66.7 percent of evaluable patients were refractory to or had failed their second-line therapies, and 33.3 percent failed third-line therapy or later.
All enrolled patients (100 percent) were resistant to the standard of care platinum-based therapy. Expected overall survival for patients receiving standard of care platinum-based therapy is nine to 12 months.
Median overall survival among the patients in this trial is not yet known as all patients are still alive at the time of the analysis, which period of time exceeds nine months.
Disease Control Rate
An ad hoc analysis of clinical outcomes in the cohort of 11 patients shows a disease control rate (DCR), the sum of overall response rate and rate of stable disease, of 63.6 percent, with a median follow-up of 15.4 weeks. In December 2020, the Company reported initial data showing a DCR of 87.5 percent in eight patients, with a median follow-up of 9.4 weeks. In this very difficult treatment-resistant patient population, at the time of the follow-up analysis, median progression-free survival (PFS) was 11.8 weeks. The landmark PFS rate by log-rank analysis at six months (26 weeks) was 33 percent.

Analysis of the updated data, using a validated immunohistochemistry assay during the eligibility screening period, shows that the rate of WT1 ovarian tumor positivity in this patient population remained high at approximately 63.6 percent. As of the time of this analysis, all patients are alive, and five patients (45.5 percent) are continuing to receive investigational therapy. Enrollment for this study is ongoing, with a target of approximately 20 total evaluable patients.

The safety profile of the GPS-pembrolizumab combination was similar to that seen with pembrolizumab alone, with the addition of only low-grade, temporary local reactions at the GPS injection site, consistent with previously performed clinical studies with GPS.

Immunobiological Data
CD8+ and CD4+ T-lymphocytes were isolated from peripheral blood mononuclear cells from three patients from whom samples had been collected both at baseline and at the time of the sixth GPS dose (i.e., 18 weeks after starting investigational therapy). The T-cells were assayed ex-vivo for immune responses against the pool of the four peptides that comprise GPS using the validated assay intracellular cytokine staining with fluorescence-activated single cell sorting (ICS-FACS) (Scorpion Biological Services, San Antonio, Texas), with appropriate positive and negative controls.

A total of five cytokine "channels" were used for the analysis (i.e., interferon-g, TNF-a, interleukin-2, CD107a and MIP-1b). The peptide re-challenge incubation period was seven days. At the 18-week time point versus pre-vaccination baseline, the assay demonstrated a relative increase in WT1-specific T-lymphocyte frequencies in peripheral blood averaging +242 percent (range: +104 to +385 percent across five cytokines) for CD8+ and +80.5 percent (range: +1 to +174 percent) for CD4+. There was also evidence of polyfunctional T-cell activation (increases in secretion of >2 cytokines) in two out of three patients (66 percent).

"Considering the overall poor prognosis in this particular clinical setting and based on the observed median PFS, overall survival and DCR in this study, combining GPS with the PD1 inhibitor pembrolizumab appears to be clinically promising as compared to bevacizumab-free salvage chemotherapy regimens and without the toxicity burden associated with the latter," said Angelos Stergiou, M.D., Sc.D. h.c., President and CEO, SELLAS. "Patients treated with GPS plus pembrolizumab also appear to maintain a considerable degree of stable disease, as evidenced by the median DCR of 63.6 percent – all evaluable patients are alive. Continuing to review the clinical data will help us determine the fundamental value of the combination approach to fighting this disease. The initial trends are promising, and further maturity of the data and studying additional patients will allow us to draw more definitive conclusions regarding the clinical benefit. We expect to perform another set of similar ad hoc clinical and immunobiological analyses over the next six months as the study progresses."

"Based on this early data, it is encouraging to see the induction of WT1-specific T-cell immune responses with the administration of GPS in combination with pembrolizumab with a validated complex ex-vivo immune response assay on peripheral blood from patients with platinum-refractory metastatic ovarian cancer who had undergone numerous prior therapies," added Jeffrey S. Weber, M.D., Ph.D.; Deputy Director of the Perlmutter Cancer Center at New York University (NYU)-Langone Health; Co-Director of its Melanoma Research Program Center; and Chair of SELLAS’ Scientific Advisory Board. "Expansion of these results with data from additional patients, as well as at time points longer than 18 weeks (when such patient samples become available for testing), will be key in getting a more comprehensive picture of the combination immunotherapy’s biological effect."

About Ovarian Cancer
Ovarian cancer is one of the most common gynecologic malignancies and the fifth most frequent cause of cancer death in women in the United States. Over 22,000 cases are diagnosed annually, and there are an estimated 15,500 deaths per year. The majority of patients have widespread disease at presentation. The five-year survival for the advanced-stage disease remains less than 30 percent. Combining GPS with the checkpoint inhibitor pembrolizumab, which beneficially and profoundly alters the tumor microenvironment (TME), is hypothesized to increase the proportion of patients who develop an immune response against their cancer and potentially improve their clinical outcome over pembrolizumab monotherapy, without the burden of additional toxicities in macroscopically measurable malignancies.

Merck to Hold Second-Quarter 2021 Sales and Earnings Conference Call on July 29

On June 30, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that it will hold its second-quarter 2021 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. EDT on Thursday, July 29 (Press release, Merck & Co, JUN 30, 2021, View Source [SID1234584508]). During the call, company executives will provide an overview of Merck’s performance for the quarter.

Investors, journalists and the general public may access a live audio webcast of the call on Merck’s website at View Source A replay of the webcast, along with the sales and earnings news release and supplemental financial disclosures and slides highlighting the results, will be available at www.merck.com.

Institutional investors and analysts can participate in the call by dialing (833) 353-0277 or (469) 886-1947 and using ID code number 5951886. Members of the media are invited to monitor the call by dialing (833) 353-0277 or (469) 886-1947 and using ID code number 5951886. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call.

Genomic Testing Cooperative Announces Collaboration with Elevation Oncology to Expand Comprehensive Genomic Testing for NRG1 Fusions Across Solid Tumors in Support of the Phase 2 CRESTONE Study

On June 30, 2021 Genomic Testing Cooperative, a first-in-class diagnostic company based on a cooperative business model (Co-Op) using the most recent advances in NGS technology, reported a collaboration with Elevation Oncology to enhance identification of patients with any solid tumor harboring an NRG1 fusion who may be eligible for enrollment in the Phase 2 CRESTONE study (Press release, Genomic Testing Cooperative, JUN 30, 2021, View Source [SID1234584507]).

GTC’s business is based on a cooperation model and has partnerships with multiple Co-Op members, all offering identical menus as GTC. This identification of patients with tumors harboring an NRG1 fusion is extended to all Co-Op members laboratories including Anthology Diagnostics in Edison, NJ and Key Genomics Laboratory at the John Theurer Cancer Center. Patients identified at these sites may be eligible for referral into the CRESTONE study.

"Our goal is to provide comprehensive actionable molecular profiling so patients and their treating physicians can personalize therapy and select the proper treatment that has the potential of improving outcome," stated Dr. Maher Albitar, GTC Chief Executive Officer and Chief Medical Officer "The Co-Op model allows us to enable all members of the Co-Op to update their offering and make testing for NRG1 fusion available to their patients."

"We believe that comprehensive biomarker testing of DNA and RNA is critical to give each patient their best chance of getting matched with a precision medicine," said Shawn Leland, PharmD, RPh, Founder and Chief Executive Officer of Elevation Oncology. "We are pleased to add Genomic Testing Cooperative to our growing community of collaborators, who share our vision of profiling every patient’s tumor to identify genomic driver alterations that may be actionable."

The Solid Tumor Profile Plus offered by GTC combines the analysis of DNA with RNA to provide comprehensive evaluation of cancer that includes detection of single nucleotide variation, copy number variation, expression and fusion. This includes testing of abnormalities in 434 DNA genes and 1408 RNA genes.

Under the terms of the agreement, GTC will help Elevation Oncology identify patients with advanced solid tumors that harbor an NRG1 fusion for participation in Elevation Oncology’s CRESTONE trial. Eligible patients will be referred to active clinical trial sites in Elevation Oncology’s Phase 2 CRESTONE trial of seribantumab in adult patients with recurrent, locally advanced or metastatic solid tumors that harbor an NRG1 fusion.

Patients and physicians can learn more about the CRESTONE study at www.nrg1fusion.com or on www.ClinicalTrials.gov under the NCT number NCT04383210.

FairJourney Biologics Introduces “THE ANTIBODY SERIES” Conference

On June 30, 2021 FairJourney Biologics S.A. (FJB), leaders in the discovery and optimization of antibodies, reported the launch of "THE ANTIBODY SERIES" – a 1-day conference bringing together top experts in the antibody field to explore the latest innovation within antibody drug discovery (Press release, FairJourney Biologics, JUN 30, 2021, View Source [SID1234584506]). The conference is being launched in Porto, Portugal, celebrating FairJourney Biologics’ inauguration of their new purpose built, state-of-the-art facilities. Online registration to the event has been made available free for a limited period here: Online Registration.

THE ANTIBODY SERIES takes place on September 9th 2021 (8:45 am BST) and will play host to a panel of influential and international speakers ranging from Biotechs, Universities and Nobel Prize Laureate including:

Sir Gregory Winter, Winner of the 2018 Chemistry Nobel Prize
Hans Clevers (Principle Investigator at Hubrecht Institute)
Ton Logtenberg (University Medical Center Utrecht)
John McCafferty (CSO of IONTAS)
Maria Pajuelo (CSO of FJB)
Daniela Teixeira (COO FJB)
Teresa Barata (Head of Protein Production and Characterization at Flow Eighteen38)
Allan Jensen (VP of Lundbeck)
Mihri Tuna (CSO of Adaptate)
Tatiana Novobrantseva (CSO of Verseau)
Tim Van Hauwermeiren (CEO argenx)
Hans De Haard (CSO argenx)
THE ANTIBODY SERIES will be broadcast live from Porto to enable audiences globally the chance to participate and watch the conference, with the in-person event attended by notable invitees across Industry and Academia.

António Parada, CEO of FairJourney Biologics commented: "We believe our customers and clients will benefit greatly from the decades of experience, innovation and insight each speaker brings to this new event. Having such a diverse panel of speakers, from leading industry to academia, including Nobel Laureate at our first event is truly encouraging and we look forward to sharing this special event with our community and growing the platform."