On November 14, 2023 EMulate Therapeutics, Inc. (EMTx) reported the acceptance of their abstract for presentation and publication in the 28th Annual Meeting and Education Day of the Society for Neuro-Oncology (SNO), November 2023, in Vancouver, British Columbia (Press release, EMulate Therapeutics, NOV 14, 2023, View Source [SID1234637680]). The accepted abstract will be published in SNO’s official journal, Neuro-Oncology, which is now available at View Source

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The abstract describes the poster material developed by EMTx for the SNO meeting and can be downloaded from EMTx’s website for viewing here. The title of the abstract and poster are: "Low/Ultra-low Radio Frequency Magnetic Field Therapies for the Treatment of CNS Tumors: rGBM and DIPG – Past and Current Results Using the EMulate Therapeutics, Inc. Technology."

"EMTx continues to move forward with research in support of the humanitarian device exemption (HDE) application to FDA," said Chris Rivera, CEO of EMTx. "The data we are presenting in our SNO poster demonstrates mechanisms of action and increased survival time in a DMG/DIPG animal model of the EMTx technology using the A1A signal. These data are in addition to safety and benefit data demonstrated in our compassionate use study for the DMG/DIPG indication."

"We believe that the results and publication of our recurrent glioblastoma clinical trials may provide support in our HDE application for DMG/DIPG," stated Dr. Xavier Figueroa, Pre-clinical Director for EMTx. "While there is no guarantee that our HDE application will be approved, the needs of this underserved pediatric population and the demonstrated safety profile of our therapeutic device give us reason to feel confident that the FDA will grant us HDE approval."

Diffuse intrinsic pontine glioma (DIPG, a subset of diffuse midline glioma) primarily affects children, mostly diagnosed between 5 and 7 years of age. DIPG makes up 10-15% of all brain tumors in children, with about 150-300 new diagnoses per year in the United States. Unfortunately, median survival for children diagnosed with this disease is only 9-10 months.

Glioblastoma multiforme (GBM) is the most common type of malignant (cancerous) brain tumor in adults. More than 13,000 Americans are diagnosed with GBM every year. GBM accounts for almost half of all cancerous brain tumors. GBM commonly affects people aged 45 to 70. Most people live on average 12 to 18 months after diagnosis. Only about 7% of people are still alive in five years.

EMTx is dedicated to changing the treatment and prolonging survival in both DIPG and GBM.

On November 14, 2023 Agilent Technologies Inc. (NYSE: A) reported that it has received FDA approval for the use of PD-L1 IHC 22C3 pharmDx as a diagnostic tool to aid in identifying patients with Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma who may be eligible for treatment with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy (Press release, Agilent, NOV 14, 2023, View Source [SID1234637677]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

PD-L1 IHC 22C3 pharmDx is the only FDA-approved companion diagnostic that can identify gastric or GEJ adenocarcinoma patients suitable for treatment with KEYTRUDA in combination with chemotherapy and trastuzumab plus fluoropyrimidine. This marks the sixth cancer type for which PD-L1 IHC 22C3 pharmDx has gained FDA approval.

Lou Welebob, vice president and general manager of Agilent’s Pathology Division, stated, "PD-L1 expression is a critical biomarker for response to anti-PD-1 therapies such as KEYTRUDA. This endorsement underscores Agilent’s leadership in the development of companion diagnostics for groundbreaking anti-PD-1 therapies."

In addition to gastric or GEJ adenocarcinoma, PD-L1 IHC 22C3 pharmDx also helps physicians identify patients with non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), cervical cancer, head and neck squamous cell carcinoma (HNSCC), and triple-negative breast cancer (TNBC) who may benefit from treatment with KEYTRUDA.

KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2‑positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

Gastric cancer is a leading cause of cancer-related mortality worldwide1. The incidence of GEJ adenocarcinoma is on the rise and is considered one of the fastest growing cancers in the country 1,2.

KEYTRUDA is a humanized monoclonal antibody that enhances the immune system’s ability to detect and fight tumor cells. It works by blocking the PD-1 pathway, activating T lymphocytes that may affect both tumor cells and healthy cells. KEYTRUDA and other targeted immunotherapies are revolutionizing cancer treatment across a growing list of cancer types.

PD-L1 IHC 22C3 pharmDx was developed by Agilent in partnership with Merck (known as MSD outside the United States and Canada) as a companion diagnostic for KEYTRUDA.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

On November 14, 2023 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported that it has entered into an agreement with Merck, known as MSD outside the United States and Canada, under which Merck will utilize Natera’s real-world database (RWD) to advance oncology research (Press release, Merck & Co, NOV 14, 2023, View Source [SID1234637676]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Natera’s oncology RWD contains de-identified clinical and genomic data from more than 100,000 early- and late-stage patients with cancer who have been tested with Signatera, the company’s personalized and tumor-informed molecular residual disease (MRD) test. Longitudinal monitoring data is available for the majority of patients, providing an objective measure of molecular response to treatment and connected to a multi-modal database that includes clinical outcomes, genomic profiling, and imaging. Pharmaceutical companies can use Natera’s RWD to strategically advance drug development programs across early-stage and metastatic settings.

"With Signatera being ordered now on a regular basis by over a third of all oncologists in the U.S., Natera is in a unique position to structure and share its real-world experience to inform drug discovery and clinical research," said John Fesko, Natera’s president & chief business officer.

About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer (stage IIb and higher) and muscle invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 50 peer-reviewed papers.

On November 14, 2023 TriSalus Life Sciences Inc., (Nasdaq: TLSI), a publicly traded oncology company integrating its novel delivery technology with immunotherapy to transform treatment for patients with liver and pancreatic tumors, reported its financial results for the third quarter ended September 30, 2023, and provided a business update (Press release, TriSalus Life Sciences, NOV 14, 2023, View Source [SID1234637675]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Today marks an important milestone for TriSalus as we host our first quarterly earnings call as a public company. I am proud of our team’s considerable progress in the commercialization of the TriNav Infusion System, our Pressure Enabled Drug Delivery (PEDD) method, which achieved $5.2 million in revenues in the quarter, up over 30% from the third quarter of 2022," said Mary Szela, Chief Executive Officer of TriSalus. "We remain focused on integrating the TriNav system with immunotherapy to transform treatment for patients with liver and pancreatic tumors by solving two main barriers to tumor treatment in the tumor microenvironment (TME): mechanical barriers that limit drug delivery and biological barriers to driving immunosuppression."

"Data from our three Phase 1/1b trials indicates that our innovative immunotherapy approach for liver and pancreas tumors has been well tolerated, with evidence of SD-101 being delivered into difficult to reach tumors, potentially overcoming limitations posed by intravenous or direct needle injection approaches. The mechanical and biologic TME barriers that TriSalus is targeting are commonly present in solid tumors, creating a significant opportunity to impact a large patient population across cancer types," commented Steven Katz, MD, FACS, Chief Medical Officer of TriSalus.

Third Quarter 2023 and Subsequent Highlights

PERIO-01 Phase 1 Data Selected for Late Breaking Podium Presentation at the 2023 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting

In November, TriSalus announced that SITC (Free SITC Whitepaper) had selected the PERIO-01 Phase 1 data for a late breaking podium presentation and participation in the press conference of its 2023 annual meeting. The data demonstrated that delivery of SD-101 by TriNav plus systemic immune checkpoint inhibitor (ICI) in uveal melanoma with liver metastases (UMLM) patients results in clinical activity with median progression free survival (PFS) of 11.7 months, myeloid derived suppressor cell (MDSC) re-programming, and evidence of peripheral and intra-tumoral immune activation.

PERIO-03 Phase 1 Initial Safety and Feasibility Data Selected for Poster Presentation at SITC (Free SITC Whitepaper) Annual Meeting

In November, the company presented data on its PERIO-03 Phase 1 clinical trial on pressure enabled intra-pancreatic delivery of SD-101 with checkpoint blockade for locally advanced pancreatic adenocarcinoma. The data demonstrated that TriNav pancreatic retrograde venous infusions (PRVI) of SD-101 were well tolerated in the initial three patients and infusions were associated with potentially favorable immune changes in the periphery and tumors. These findings support continuing with single-agent dose escalation and subsequent combination with systemic ICI.

The PERIO-03 Phase 1 study with single-agent SD-101 is expected to be completed at the end of 2023 with subsequent initiation of the Phase 1b PERIO-03 dose expansion beginning early 2024. In the expansion study, intravenous anti-PD-1 therapy will be added to SD-101 delivered by PEDD. The trial will target patients with unresectable, locally advanced pancreatic adenocarcinoma who failed or progressed on at least one line of standard therapy.

Jodi Devlin appointed as President, Commercial Operations

In September, TriSalus announced that Jodi Devlin was appointed as President, Commercial Operations. Ms. Devlin joined TriSalus with more than two decades of experience in building brands in a wide range of therapeutic areas, with expertise in developing and executing strategies across sales, marketing, medical affairs, market access, and policy for biotech and pharmaceutical products.

Financial Results

Revenue, all of which is from the sale of TriNav, was $5.2 million and $12.8 million, respectively, in the three and nine months ended September 30, 2023. These amounts represent growth vs. prior year of 32% in the third quarter and 39% for nine months year to date, primarily due to continued market share increases.

Gross margins were 89% in the third quarter ended September 30, 2023, and 84% for nine months year to date versus 82% and 84%, respectively, in the third quarter and year to date in 2022. The seven percent improvement in the third quarter of 2023 is due to increased factory volumes and improved operations efficiency.

Operating losses are $18.5 million and $40.0 million, respectively, for the third quarter and nine months ended September 30, 2023. These amounts include non-recurring professional service fee costs of $4.8 million in the quarter and $7.7 million year to date, primarily related to the completion of our deSPAC process in August 2023. These amounts compare to prior year losses of $8.1 million and $24.7 million, respectively. The Company increased investments in 2023 in R&D to support clinical program progress and in sales and marketing, primarily to expand its sales force to continue to increase market penetration.

Net losses attributable to common stockholders are $1.7 million and $27.0 million, respectively, for the third quarter and nine months ended September 30, 2023. These amounts compare to prior year losses of $8.1 million and $24.6 million, respectively. Net losses include the impact of a non-cash related gain on revaluation of contingent earnout liabilities of $19.9 million in the third quarter and nine-month period of 2023. In addition, net losses include the impact of non-cash related gains/(losses) associated with revaluation of tranche and warrant liabilities of ($2.8) million and $0.7 million, respectively, for the third quarter and nine-month period ending September 30, 2023. The nine-month period ending September 30, 2023 also includes a non-cash related loss on equity issuance of $4.2 million.

Basic and diluted loss per share for the three and nine months ended September 30, 2023, was $0.13 and $5.68, respectively, compared to a basic and diluted loss per share of $25.95 and $82.17 for the three and nine months ended September 30, 2022, respectively.

Conference Call

The event will be webcast live on the investor relations section of TriSalus’ website at View Source Following the conclusion of the event, a webcast replay will be available on the website for approximately 90 days. Interested parties participating by phone will need to register using this online form. After registering for the webcast, dial-in details will be provided in an auto-generated e-mail containing a link to the conference phone number along with a personal pin.

On November 14, 2023 CG Oncology, Inc. reported that interim Phase 3 monotherapy data from the BOND-003 study will be presented as a late-breaking abstract at the upcoming 24th Annual Meeting of the Society of Urologic Oncology (SUO), held November 28-December 1, 2023, at the Omni Shoreham Hotel in Washington, DC (Press release, CG Oncology, NOV 14, 2023, View Source [SID1234637674]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

BOND-003 (NCT04452591) is a single-arm, open-label, Phase 3 clinical trial evaluating cretostimogene grenadenorepvec as monotherapy in patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG). The study enrolled 116 patients with BCG-unresponsive NMIBC across North America and the Asia-Pacific region. The primary endpoint of the study is complete response (CR) at any time, with duration of response measured as a secondary endpoint.

Details of the oral presentation are as follows:

First results from BOND-003, a Phase 3 study of intravesical Cretostimogene grenadenorepvec monotherapy for patients with high-risk Bacillus Calmette-Guerin (BCG)-unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)

Abstract Number: 3396
Session: Urothelial Cancer Session I
Presenter: Mark D. Tyson, M.D., Urologic Oncologist at Mayo Clinic, Scottsdale, AZ
Date & Time: Thursday, November 30, 2023, from 11:59am-12:04pm Eastern Standard Time

About Cretostimogene Grenadenorepvec

Cretostimogene grenadenorepvec is an investigational, intravesically delivered oncolytic immunotherapy being evaluated in BOND-003, a Phase 3 clinical trial for the treatment of BCG-unresponsive Non-Muscle Invasive Bladder Cancer. Cretostimogene grenadenorepvec is also being evaluated in a Phase 2 clinical trial (CORE-001) in combination with pembrolizumab in the same indication. In addition, cretostimogene grenadenorepvec is being evaluated in an investigator-sponsored clinical trial in combination with nivolumab for the treatment of muscle invasive bladder cancer.

About Bladder Cancer

More than 82,000 people are estimated to be diagnosed with bladder cancer in 2023. NMIBC is the most common form of bladder cancer, representing approximately 75% of newly diagnosed cases. Bladder cancer is the sixth most common form of cancer in the United States, and men account for three quarters of newly diagnosed cases.