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ERYTECH Completes Enrollment in TRYbeCA-1 Phase 3 Trial in Second-Line Pancreatic Cancer

On December 14, 2020 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported the completion of enrollment in the TRYbeCA-1 Phase 3 trial in second-line pancreatic cancer (Press release, ERYtech Pharma, DEC 14, 2020, View Source [SID1234572850]).

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TRYbeCA-1, the pivotal Phase 3 clinical trial evaluating ERYTECH’s lead product candidate, eryaspase, in second-line metastatic pancreatic cancer, has completed patient enrollment. A total of 510 patients participated in the trial, slightly above the target enrollment of 482 patients.

The trial recently accrued the required number of events for the planned interim superiority analysis, to be performed by an Independent Data Monitoring Committee. The results from the interim superiority analysis are expected to be reported in the first quarter of 2021. Since the interim analysis does not include an evaluation for futility, there will be two possible outcomes: the trial will either: (1) continue toward a final analysis, expected in the fourth quarter of 2021, or (2) be concluded early if compelling improvement in overall survival is demonstrated, in which case the Company expects to file for regulatory approval in the United States and in Europe in the second half of 2021.

Earlier this year, the U.S. Food and Drug Administration granted eryaspase Fast Track Designation as a potential second-line treatment for patients with metastatic pancreatic cancer. Eryaspase also benefits from Orphan Drug status in pancreatic cancer in both the United States and Europe.

"We are extremely pleased that the TRYbeCA-1 trial enrollement has continued to progress on schedule despite the challenges caused by the COVID-19 global pandemic," said Dr. Iman El Hariry, Chief Medical Officer of ERYTECH. "This achievement is only possible because of the hard work of the study investigators, hospital staff at the trial sites, patients and their families. We look forward to the outcome of the planned interim analysis for superiority early next year."

"Patients with advanced pancreatic cancer need new treatment options, particularly in the second line setting after failure of gemcitabine-nab-paclitaxel or FOLFIRINOX combinations," added Dr Jean-Philippe Metges, medical oncologist at the University Hospital in Brest (France) and the national coordinator of the TRYbeCA-1 trial for France. "TRYbeCA-1 is one of the largest clinical trials currently open in second-line metastatic pancreatic cancer. If successful, this will lead to a treatment paradigm shift in this disease."

About TRYbeCA-1

TRYbeCA-1 is a randomized controlled Phase 3 clinical trial evaluating ERYTECH’s lead product candidate, eryaspase, in second-line metastatic pancreatic cancer. Target enrollment was 482 patients. Five-hundred and ten patient were enrolled in the trial in close to 90 clinical sites in the United States and 11 countries in Europe and randomized 1-to-1 to receive eryaspase in combination with standard chemotherapy (gemcitabine/nab paclitaxel or an irinotecan-based regimen) or chemotherapy alone. The primary endpoint of TRYbeCA1 is overall survival (OS). The trial was designed to detect an OS hazard ratio (HR) of 0.725 with close to 90% power at a single-sided alpha level of 2.5%. An interim superiority analysis, to be performed by an independent data monitoring committee (IDMC), is foreseen on two-thirds of total OS events. Demonstration of improved OS with a single-sided p-value below 0.006 will be considered compelling evidence of survival benefit at this interim analysis and can form the basis for the IDMC to recommend early conclusion of the trial for superiority.

About Pancreatic Cancer

Pancreatic cancer is a disease in which malignant (cancer) cells are found in the tissues of the pancreas. Every year, there are approximately 185,000 new cases of pancreatic cancer diagnosed in Europe and the United States. Advanced pancreatic cancer is a particularly aggressive cancer, with a five-year survival rate below 10%. It is currently the fourth leading cause of cancer death in the United States and is projected to rise to the second leading cause by 2030. Limited therapeutic options are currently available for this indication, thereby reinforcing the need to develop new therapeutic strategies and rational drug combinations with the aim of improving overall patient outcomes and quality of life. Approximately 50% of patients are eligible for second-line treatment.

Teon Therapeutics Announces Approval for Collaboration with Cancer Research UK

On December 14, 2020 Teon Therapeutics, a private biopharmaceutical company developing a focused portfolio of small molecules that modulate metabolic signaling pathways in the tumor microenvironment, reported that Cancer Research UK, the world’s leading cancer charity dedicated to saving lives, has formally approved Teon’s TT-702 program to enter into a clinical collaboration (Press release, Teon Therapeutics, DEC 14, 2020, View Source [SID1234572841]). TT-702, a first-in-class A2BR-specific antagonist being pursued in prostate cancer and other tumor types, expects to initiate a Phase 1b/2a clinical study in early 2021. In a collaboration, Cancer Research UK would sponsor and oversee the clinical trial, which will be run through the Centre for Drug Development. Future considerations would be contingent upon achievement of TT-702 development milestones by Teon.

"We are excited for the opportunity to collaborate with Cancer Research UK," said Ken Horne, President and Chief Operating Officer of Teon Therapeutics. "They have helped develop 10 marketed cancer drugs, including Zytiga (abiraterone), Lynparza (olaparib), and Balversa (erdafitinib), so it is a tremendous honor to be approved to partner with Cancer Research UK under its Clinical Development Partnership initiative, which has seen 27 early clinical development collaborations established to date. We look forward to announcing more details around our collaboration in early 2021."

Hummingbird Bioscience Announces Collaboration with Tempus to Harness AI-driven Precision Medicine to Accelerate Clinical Development of HMBD-001 In HER3 Driven Cancers

On December 14, 2020 Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing revolutionary therapies for hard-to-drug targets, reported a collaboration with Tempus, a leader in artificial intelligence and precision medicine, to drive the development of Hummingbird’s lead clinical program, HMBD-001, as it advances into clinical trials in HER3-driven cancers, including those that harbor neuregulin 1 (NRG1) fusions (Press release, Hummingbird Bioscience, DEC 14, 2020, View Source [SID1234572840]). As part of the collaboration, Hummingbird will be leveraging Tempus’ AI-enabled platform and proprietary data, as well as joining its TIME Trial Network, for rapid identification, site activation and efficient enrollment of cancer patients who have NRG1 fusions and meet eligibility criteria for HMBD-001 clinical trials.

NRG1 fusions are a rare genetic mutation that are increasingly recognized as a driver of multiple tumor malignancies, and an actionable target for HER3 targeted therapy. NRG1 fusions cause the overproduction of NRG1 ligands, resulting in increased HER3 activation and tumor growth. Up to 1% of all solid tumors harbor NRG1 fusions, therefore, it is important to identify this patient population and develop therapies that can treat them.[1]

HMBD-001 is a uniquely differentiated anti-HER3 neutralizing antibody that was developed using Hummingbird’s proprietary Rational Antibody Discovery platform. HMBD-001 has been immune-engineered to bind with high affinity to the HER3 dimerization interface and block HER3 growth signals to the cancer. Most importantly, HMBD-001 uniquely blocks HER3 in both open and closed conformations, and in the presence or absence of high concentrations of NRG1.[2] Pre-clinical studies have shown that these differentiated properties of HMBD-001 lead to robust and sustained tumor growth inhibition in multiple HER3 cancer models, including those with NRG1-fusions.

"We are excited to collaborate with Tempus to leverage their just-in-time clinical trial program and apply Hummingbird’s deep knowledge of disease driving protein mechanisms in order to identify patients with actionable genetic abnormalities," said Dr Piers Ingram, Co-founder and CEO of Hummingbird.

"We look forward to Hummingbird joining our TIME Trial Network, providing patients across the country access to its HMBD-001 clinical trial," said Amy Franzen, Vice President of Operations, Therapies, Tempus. "This collaboration is an opportunity to identify those patients who could benefit from this investigational therapy, and if they are eligible, rapidly open the trial just for them."

About NRG1 fusions

A subset of patients with cancer have recently been identified who possess abnormal NRG1 gene fusions, that is the hybridization of their NRG1 gene with any one of a number of genes to produce NRG1 proteins that overexpress the HER3-binding domains.[3] This results in increased HER3 binding and dimerization, which consequently leads to increased tumor growth. Less than 1% of all solid tumors harbor NRG1 fusions, and there are currently no approved therapies to treat this patient population.[1] Moreover, studies suggest that NRG1 fusions are mutually exclusive with other known molecular drivers of cancer, such as ALK, ROS, and RET gene fusions, meaning that NRG1 fusions are likely to be a distinct orphan indication in a discrete patient population.[1]

About HMBD-001

HMBD-001 represents a unique, highly-specific, anti-HER3 neutralizing antibody with a novel mechanism of action that offers significant potential for broad clinical benefit. Previous attempts to block the HER3 receptor, a key player in the signaling pathway that promotes cell division and tumor growth in cancer, have not proven to be efficacious. HER3 is activated by the binding of NRG1, which stabilizes a transient open conformation to allow it to form heterodimers with HER2/EGFR. In the presence of abundant HER2/EGFR, heterodimers can form without NRG1.

Pre-clinical models have shown that HMBD-001 is able to effectively and uniquely bind to a difficult-to-target region on HER3, blocking the heterodimerization of HER3 with HER2/EGFR independent of NRG1 binding. This potently inhibits the activation of the signaling pathway – and consequently, stops tumor growth. Cancer Research UK has partnered with Hummingbird Bioscience to advance this novel antibody drug into clinical trials for the treatment of HER3-driven cancer.

IDEAYA Biosciences Announces Addition to NASDAQ Biotechnology Index

On December 14, 2020 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics, reported that it has been selected for addition to the NASDAQ Biotechnology Index (Press release, Ideaya Biosciences, DEC 14, 2020, View Source [SID1234572839]). The addition to the NASDAQ Biotechnology Index will become effective prior to market open on Monday, December 21, 2020.

The NASDAQ Biotechnology Index is designed to track the performance of a set of securities listed on the NASDAQ Stock Market (NASDAQ) that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark (ICB). The NASDAQ Biotechnology Index is re-ranked annually and all securities in the index are listed on the NASDAQ Global Market or the NASDAQ Global Select Market, and meet minimum market value and share volume requirements among other criteria.

The NASDAQ Biotechnology Index is the basis for the iShares NASDAQ Biotechnology IndexSM Fund. In addition, options based on the iShares NASDAQ Biotechnology Index Fund trade on various exchanges. For more information about the NASDAQ Biotechnology Index visit www.nasdaq.com.

Immunic, Inc. Added to NASDAQ Biotechnology Index

On December 14, 2020 Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, reported that it has been selected for addition to the NASDAQ Biotechnology Index (Nasdaq: NBI), effective prior to market open on Monday, December 21, 2020 (Press release, Immunic, DEC 14, 2020, View Source [SID1234572838]).

The NASDAQ Biotechnology Index is designed to track the performance of a set of securities listed on The Nasdaq Stock Market (NASDAQ) that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark. The NASDAQ Biotechnology Index is re-ranked annually. All securities in the index are listed on the NASDAQ Global Market or the NASDAQ Global Select Market and meet minimum market value and share volume requirements, among other criteria.

The NASDAQ Biotechnology Index forms the basis for a number of Exchange Traded Funds (ETFs), including the iShares NASDAQ Biotechnology ETF (Nasdaq: IBB). More information about the Index can be found at View Source