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Sirnaomics, Inc. to Present at TIDES USA 2021

On September 22, 2021 Sirnaomics, Inc., a biopharmaceutical company engaged in the discovery and development of RNAi therapeutics against cancer and fibrotic diseases, reported that it will be presenting positive results from a Phase 2a clinical study of the company’s lead drug candidate, STP705, for treatment of squamous cell skin cancer in situ (Nonmelanoma Skin Cancer) at the 2021 TIDES USA event (Press release, Sirnaomics, SEP 22, 2021, View Source [SID1234590112]). The hybrid conference is taking place in person at the Boston Convention and Exhibition Center, and digitally on-demand, September 20-30.

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Title: Novel Dual Targeting siRNA Therapeutic Offers Innovative Solution for Derm-Oncology Treatment
Presenter: Michael Molyneaux, MD, MBA, Chief Medical Officer at Sirnaomics, Inc.
Presentation Overview: Clinical trial results showing STP705, used to target TGF-β1 and COX-2 siRNAs for the treatment of nonmelanoma skin cancer, has demonstrated rates of histological clearance that rival surgical excision combined with improved cosmetic appearance.
Time/Date: 11:45am ET, Thursday, September 23, 2021. The session will be available to watch on demand for attendees starting on September 28 for a 30-day period.
Location: Room 205A, Boston Convention and Exhibition Center
Tides 2021
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 for the treatment treatments of cholangiocarcinoma and other solid liver tumors, nonmelanoma skin cancer and hypertrophic scar, and Keloid scarring. STP705 has also received Orphan Drug Designation for treatment of cholangiocarcinoma, primary sclerosing cholangitis, and hepatocellular carcinoma. 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.

Cue Biopharma Granted U.S. Patents on Lead Clinical Program Novel Drug Product Candidate CUE-101

On September 21 2021 Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells directly within the body, reported the issuance of two new United States Patents Nos. 11,117,945 and 11,104,712 from the United States Patent and Trademark Office (Press release, Cue Biopharma, SEP 21, 2021, View Source [SID1234608271]).

U.S. Patent No. 11,117,945 covers Cue Biopharma’s first clinical drug candidate, CUE-101, and its use in treating HPV16-associated cancers such as head and neck, cervical, and genitoanal cancers. CUE-101 is currently in a Phase 1b clinical trial in which second line and beyond patients are receiving CUE-101 as a monotherapy for HPV16+ recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). To date, CUE-101 has demonstrated monotherapy clinical activity by selective activation of targeted CD8+ T cells specific for HPV+ cancer cells with a 40% clinical benefit in the first 10 evaluable patients at the recommended Phase 2 dose of 4mg/kg. CUE-101 is also in a dose escalation study in combination with pembrolizumab in front-line patients with HPV16+ recurrent/metastatic HNSCC. A Phase 2 exploratory clinical trial in which CUE-101 will be administered in the neoadjuvant phase before standard of care (SOC) therapy in treatment-naïve, HLA-A*0201 positive patients with locally advanced, HPV-positive oropharyngeal squamous-cell carcinoma, is expected to begin enrolling patients this fall.

The second U.S. Patent, No. 11,104,712, covers the use of CUE-101 in combination with KEYTRUDA (pembrolizumab) for treating HPV16-associated cancers such as head and neck, cervical, and genitoanal cancers. The combination of CUE-101 and pembrolizumab is being evaluated by Cue Biopharma in collaboration with Merck Sharp & Dohme Corp.

"The issuance of these patents represents an important development as we continue to build-up our IP portfolio and bolster patent protection for the novel protein engineering platforms we have enabled, particularly as we begin demonstrating clinical activity in what we believe will be a disruptive and transformational breakthrough in immunotherapy for addressing cancer and other debilitating and life-threatening diseases," said Daniel Passeri, chief executive officer of Cue Biopharma. "Furthermore, obtaining these patents early in the clinical development of CUE-101 enhances our ability to receive a Patent Term Extension from the United States Patent and Trademark Office if CUE-101 is approved by the FDA. We continue to make a substantial investment in protecting our intellectual property, and we look forward to the issuance of additional patents that cover our important platforms and pipeline products."

Cue Biopharma’s IP portfolio includes approximately 300 pending applications and issued patents that are either owned by Cue Biopharma or exclusively licensed from the Albert Einstein College of Medicine.

Zenith Epigenetics and Newsoara Announce Initiation of a Randomized Phase 2b Metastatic Castration-Resistant Prostate Cancer (mCRPC) Study

On September 21, 2021 Zenith Epigenetics Ltd. ("Zenith" or the "Company") and Newsoara BioPharma Co., Ltd. ("Newsoara") reported the initiation of a multi-national, randomized Phase 2b clinical trial testing the combination of ZEN-3694, a leading BET bromodomain inhibitor (BETi), with Astellas Pharma Inc. ("Astellas") and Pfizer’s androgen receptor signaling inhibitor (ARSI), enzalutamide, in patients with mCRPC who had a poor response to prior abiraterone treatment (Press release, Zenith Epigenetics, SEP 21, 2021, View Source [SID1234590199]). The study will evaluate the efficacy of ZEN-3694 + enzalutamide vs. single agent enzalutamide as measured by its primary endpoint, radiographic free progression.

Abiraterone, also an ARSI, is frequently prescribed as a first line therapy for patients with metastatic prostate cancer. A significant fraction of these patients, whose tumors have low androgen receptor (AR) signaling activity, have a sub optimal response to abiraterone and their subsequent treatment options are limited to cytotoxic therapies. The rationale for this study design is supported by a recent publication in Clinical Cancer Research whose authors uncovered a potential mechanism explaining the role of BETi in sensitizing tumors with low AR signaling to ARSI by blocking a treatment-emergent neuroendocrine differentiation program. This mechanistic study built on a previous clinical trial conducted by Zenith where results suggested that ZEN-3694 + enzalutamide was most active in mCRPC patient tumors who had the lowest AR activity. Furthermore, patients in that trial that had a poor response to prior abiraterone therapy had the most durable response with ZEN-3694 + enzalutamide.

"We are delighted to initiate this study in collaboration with our partners Newsoara and Astellas to continue the development of ZEN-3694 in mCRPC patients," said Donald McCaffrey, President and Chief Executive Officer of Zenith. "We are pursuing a novel approach of treating mCRPC patients whose tumors are resistant to ARSI. Other therapies, either approved or in development, are either cytotoxic or mainly target AR signaling which resistant tumors are no longer dependent on," Mr. McCaffrey further commented.

Dr. Benny Li, Chief Executive Officer of Newsoara added, "with promising data from the completed Phase 1b/2a trial, the initiation of the multi-national, randomized Phase 2b clinical study in patients with mCRPC is a significant milestone for us to pursue a novel treatment through our partnership with Zenith."

About Prostate Cancer

Prostate cancer is the second-most commonly diagnosed cancer among men and the fifth most common cause of male cancer death worldwide. Adenocarcinoma of the prostate is dependent on androgen for tumor progression and depleting or blocking androgen action has been a mainstay for over six decades. Although tumors are often initially sensitive to medical or surgical therapies that decrease levels of testosterone and to ARSIs that block AR signaling, disease progression ultimately occurs leading to mCRPC. The treatment of prostate cancer patients has evolved rapidly over the past ten years with second generation ARSIs. Despite these advances, many patients with mCRPC fail or develop resistance to existing treatments, leading to continued disease progression and limited survival rates.

Kiniksa Pharmaceuticals to Present at 2021 Cantor Fitzgerald Virtual Global Healthcare Conference

On September 21, 2021 Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) reported that it will present at the 2021 Cantor Fitzgerald Virtual Global Healthcare Conference on Tuesday, September 28, 2021 at 10:40 a.m. Eastern Time (Press release, Kiniksa Pharmaceuticals, SEP 21, 2021, View Source [SID1234590166]).

A live webcast of Kiniksa’s presentation will be accessible through the Investors & Media section of the company’s website at www.kiniksa.com. A replay of the webcast will also be available on Kiniksa’s website within approximately 48 hours after the event.

SHINE’s new name highlights technology competencies and multiple phase opportunities

On September 22, 2021 SHINE Medical Technologies LLC reported that the company has changed its name to SHINE Technologies LLC (Press release, Shine Medical Technologies, SEP 22, 2021, View Source [SID1234590122]).

SHINE’s new name highlights the company’s core technological competencies, skilled team and focus as a next-generation nuclear technology company. SHINE is pursuing a four-phase strategy for the development of nuclear fusion technology to achieve its ultimate goal: producing fusion energy. SHINE’s technology is currently being applied to advanced industrial inspection services and medical isotope production, phases I and II of the company’s four-phase approach, respectively.

"Our long-term goal is to create and deploy systems that produce clean fusion energy, and we are continuing to grow towards that goal by commercializing more near-term applications of fusion," said Greg Piefer, SHINE’s founder and CEO. "In addition, our merger with Phoenix earlier this year strengthened our position by enabling us to integrate a key technological capability that supports our near- and long-term plans."

Phoenix commercialized phase I, advanced industrial inspection services, over a decade ago by utilizing its fusion-based technology for nondestructive testing. These applications take neutron images or perform other assay measurements of modern materials in detail, ensuring that the quality and safety needs of clients in the aerospace, defense and energy industries are met.

SHINE’s phase II involves the application of fusion to the production of medical isotopes. The company expects to produce diagnostic isotopes for heart disease and other applications and is producing therapeutic isotopes for certain cancers. SHINE anticipates producing these isotopes at commercial scale at facilities on its campus in Janesville, Wis.

"The goal of each phase of our approach is to create social and economic value while building additional capacity and capability, and deepening our scientific understanding of fusion technology as we progress to clean energy production," Piefer said.

SHINE’s next step will be to explore the use of its technology to recycle nuclear waste in phase III. Carbon-free nuclear power currently faces a major political obstacle because it produces radioactive waste, some of which can last for millions of years. If successful, SHINE’s phase III is expected to help mitigate this problem by recycling a portion of this waste and using fusion to shorten the half-life on long-lived waste forms. Importantly, SHINE’s work in this phase could help fission power become a more sustainable form of carbon-free energy.

The goal of phase IV is to generate clean, abundant and affordable fusion energy. SHINE believes its achievement of this goal will be built on the strength of its skilled team, including their experience with challenging nuclear technology projects, the breadth of the company’s unique technological capabilities, and the experience expected to be gained from operating many powerful fusion systems in the field during phase III.

"We are excited that our new name more clearly reflects our core technological competencies, strong team and long-term ambitions," Piefer said. "SHINE was founded on differentiated technology, and a unique, lean and phased approach to developing nuclear technology. It’s great to be telling the world more about the company we’ve built, with an updated brand that reflects it."