On January 13, 2021 Strata Oncology, Inc., a precision oncology company advancing molecular indications for cancer therapies, reported plans to begin enrolling the Sentinel Trial in the first half of 2021 (Press release, Strata Oncology, JAN 13, 2021, View Source [SID1234573985]). Sentinel is a prospective, observational study designed to enroll approximately 100,000 patients diagnosed with stage 1-3 solid tumors and indicated for surgery or definitive therapy. The study will evaluate the ability of Strata’s investigational liquid biopsy assay to detect disease recurrence and to monitor treatment effectiveness in patients across solid tumors.

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"The Sentinel Trial will support the validation of our personalized recurrence monitoring assay for patients with solid tumors in a diverse population," said Dan Rhodes, PhD, co-founder and Chief Executive Officer, Strata Oncology. "The study will also evaluate the utility of our approach for guiding treatment decisions in patients with early-stage solid tumors. To date, most advances in precision oncology have been in late-stage cancer. The clinical and molecular information generated in this study has the potential to advance precision cancer care to the early-stage."

The Sentinel Trial will pair simultaneous DNA and RNA tissue-based molecular profiling with liquid biopsy-based recurrence monitoring. Study participants will receive the StrataNGS comprehensive genomic profiling test upfront to identify a personalized mutation profile and a treatment selection profile. Results will inform custom design of a personalized liquid biopsy test to detect tumor-specific genomic alterations with high clinical sensitivity and specificity.

Strata Oncology recently made StrataNGSTM broadly available in the U.S. based on its experience processing more than 40,000 tissue specimens from patients with advanced cancer through the Strata Trial. Recent data showed that the StrataNGS test’s performance on small tumor tissue samples may provide treatment selection results for 50% more patients than other leading tumor profiling tests.

About StrataNGS

StrataNGS is a comprehensive genomic profiling (CGP) test that features the lowest tumor tissue requirements in the industry (>2mm2 surface area). The 429-gene assay is performed on co-isolated RNA and DNA. Single-/multi-nucleotide variants (SNVs), short insertions and deletions (indels), copy number alterations (CNAs; amplifications and deep deletions), microsatellite instability (MSI) status, gene fusions, and tumor mutation burden (TMB) are assessed simultaneously.

On January 13, 2021 Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, reported that has been granted approval for a pivotal seamless Phase 1/2 clinical trial for GC007g, an allogeneic donor-derived anti-CD19 chimeric antigen receptor (CAR)-T cell therapy, for the treatment of B-cell acute lymphoblastic leukemia (B-ALL), by China’s National Medical Products Administration (NMPA) on December 24, 2020. The seamless Phase 1/2 pivotal clinical trial of GC007g will enable Gracell to potentially substantially accelerate the clinical development of GC007g in China (Press release, Gracell Biotechnologies, JAN 13, 2021, View Source;an-allogeneic-car-t-cell-therapy-for-the-treatment-of-relapsed-or-refractory-b-all-301206086.html [SID1234573984]).

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GC007g is an allogeneic CAR-T therapy under development for the treatment of a subset of B-ALL patients who relapsed after receiving an allogeneic transplant. The allogeneic therapy is derived from human leukocyte antigen (HLA)-matched donor T cells. This allogeneic approach has the potential to resolve the T cell fitness issue associated with autologous CAR-T cell therapies. The donor-derived CAR-T cell therapy, GC007g, is designed for relaspsed/refractory B-ALL patients who may not be eligible for autologous CAR-T therapy due to poor cell fitness, infections, and other conditions.

"The approval of the pivotal study for GC007g is an exciting milestone for the program, and more importanty, the approval of the new study design by the Chinese regulatory agency expedites the process of delivering a potential new treatment option to eligible patients in need," Dr. Martina Sersch, M.D., Chief Medical Officer of Gracell, commented. "As we continue to explore the potential of GC007g, Gracell remains focused on developing innovative cell therapies for patients with high unmet medical needs."

About GC007g

GC007g is an investigational CD19-targeted CAR-T cell therapy, where HLA-matched donors’ T cells were employed to be redirected to eradicate CD19 positive leukemia cells.

About B-ALL

B-ALL, a major form of acute lymphoblastic leukemia (ALL), is one of the most common forms of cancer in children between the ages of two and five and adults over the age of 50.[1] In 2015, ALL affected around 837,000 people globally and resulted in 110,000 deaths worldwide.[2] It is also the most common cause of cancer and death from cancer among children.

On January 13, 2021 Adastra Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of first-in-class therapeutics for the treatment of cancer, reported the completion of the Phase 1b clinical trial conducted by the NCI with its lead clinical candidate zotiraciclib (ZTR/TG02), a potent oral cyclin-dependent kinase 9 (CDK9) inhibitor (Press release, Adastra Pharmaceuticals, JAN 13, 2021, View Source [SID1234573983]). The trial investigated the safety and efficacy of ZTR, in combination with temozolomide (TMZ), in patients with recurrent high-grade gliomas.

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The Phase 1b trial exceeded or met the prespecified trial endpoint of progression-free survival (PFS) and provided a recommended dosing of ZTR. In the subset of patients who had isocitrate dehydrogenase (IDH) mutated tumors, the combined treatment with ZTR and temozolomide conferred a profound benefit of mPFS over historical control. The study additionally found ZTR to be well tolerated. The trial was sponsored and conducted by the NCI, and NCI expects to publish and report its findings and present them at an upcoming medical conference in 2021.

"Because preclinical data demonstrated the ability of ZTR to inhibit CDK9, enhance apoptosis and cause mitochondrial dysfunction and ultimately ATP depletion in glioma cells, we were optimistic about this first-in-human glioma trial," said Jing Wu, M.D., Ph.D., NCI’s Principal Investigator of the 17-C-0009 trial. "The data from the Phase 1b trial support our initial expectations and reinforce our energies to continue to investigate ZTR as a treatment for patients with gliomas."

"We are very grateful to our NCI colleagues, the patients, and their families for their participation in this trial. Recurrent high-grade gliomas are aggressive malignant brain tumors and remain difficult cancers to treat. Currently, available agents used for the treatment of gliomas offer little or no proven benefit; new therapeutic options are needed," said Scott Megaffin, Chief Executive Officer of Adastra. "We are exceptionally encouraged by the potential of zotiraciclib as a new treatment alternative for patients with recurrent high-grade gliomas. On the basis of these findings, Adastra is in active preparation of a registration-enabling clinical study of ZTR in patients with recurrent high-grade gliomas, in addition to work now underway to expand the application of ZTR to additional solid tumors and hematologic malignancies."

The majority of glioblastoma multiforme (GBM) cases are recurrent, and the mortality rate for patients with recurrent gliomas is nearly 100%, representing a significant unmet medical need. Furthermore, currently approved treatment options for recurrent, high-grade gliomas have limited effectiveness, creating the need for medicines like ZTR, which possesses a unique mechanism of action. ZTR is a potent oral CDK9 inhibitor with the ability to readily cross the blood-brain barrier and deplete short-lived proteins like Mcl-1 and Myc, known antiapoptotic oncogenes.

On January 13, 2021 Philogen S.p.A., a clinical-stage biotechnology company focused on antibody-based therapeutics, reported that 50% of the expected events for the primary outcome analysis of the PIVOTAL study were reached in December 2020 (Press release, Philogen, JAN 13, 2021, View Source [SID1234573982]). In this phase III clinical trial, the effect of Nidlegy is evaluated in melanoma patients with locally advanced, fully resectable metastatic cancer, and at the time of the second interim analysis, had already recruited 149 out of the anticipated 214 patients (one additional patient was enrolled recently). As a consequence, the second interim data analysis foreseen by the clinical protocol was carried out and submitted to the Data and Safety Monitoring Board of the study for their consideration. On Dec. 22, 2020, the DSMB met to review the data and issued to the company a recommendation to continue with the study and patient accrual as detailed by the clinical protocol.

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PIVOTAL is a phase III, international, multi-center, randomized, comparator-controlled, parallel-group study evaluating the efficacy and safety of intratumoral injections of Nidlegy as a neoadjuvant, followed by standard-of-care treatment (surgery + approved adjuvants), as opposed to standard-of-care treatment alone, in melanoma patients with locally advanced, fully resectable cutaneous, sub-cutaneous, or nodal metastases, accessible to intratumoral injection. A first interim analysis at 25% of the expected events and 82 enrolled patients had already been carried out in March 2019.

The primary endpoint of the trial comprises the assessment of Recurrence-Free Survival at one year after randomization. Secondary endpoints include Overall Survival, Local Recurrence-Free Survival and Distant Metastasis-Free Survival, as well as Safety.

The study is expected to include 214 patients across more than 20 centers (currently 18 centers) in four different EU countries (France, Germany, Italy, Poland).

Dario Neri, Chief Executive Officer of Philogen, commented, "We are extremely pleased to record the PIVOTAL study DSMB’s recommendation to carry on with the study as originally planned. This reinforces the confidence in our strategy to bring Nidlegy to the market as a new therapeutic opportunity for melanoma patients."

On January 13, 2021 Inhibrx, Inc. (Inhibrx), a clinical-stage biotechnology company with a broad pipeline of biotherapeutics in development, reported the U.S. Food and Drug Administration (FDA) granted Fast Track designation to INBRX-109 for the treatment of patients with unresectable or metastatic conventional chondrosarcoma (Press release, Inhibrx, JAN 13, 2021, View Source [SID1234573981]). INBRX-109 is a precisely engineered tetravalent single domain antibody (sdAb)-based therapeutic candidate that agonizes death receptor 5 (DR5) to induce tumor selective programmed cell death.

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Fast Track designation is granted by the FDA upon the request of the sponsor to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening diseases. Depending upon the stage of the product’s development, the sponsor must also provide FDA with nonclinical or clinical data to demonstrate the drug’s potential to address unmet medical needs for such a disease or condition. Investigational drug products with Fast Track designation may benefit from early and frequent communication with the FDA, and are eligible for rolling submission and FDA review of its future marketing application. The designation was granted to INBRX-109 based on preliminary data from the chondrosarcoma expansion cohort of the Phase 1 clinical trial of INBRX-109.

"There are currently no approved agents for the treatment of unresectable or metastatic conventional chondrosarcoma, and we are excited about the potential of this treatment to meaningfully improve the outcome for patients," said Mark Lappe, CEO of Inhibrx. "We look forward to working closely with the FDA throughout the clinical development of INBRX-109."

A potential registration-enabling Phase 2 study of INBRX-109 has been discussed with the FDA and will be designed as a randomized, blinded, placebo-controlled study in unresectable or metastatic conventional chondrosarcoma with progression-free survival as the primary endpoint. Inhibrx expects to start dosing patients in this potentially registration-enabling study in the second or third quarter of this year.

About the Inhibrx sdAb Platform

Inhibrx utilizes diverse methods of protein engineering in the construction of therapeutic candidates that can address the specific requirements of complex target and disease biology. A key tool for this effort is the Inhibrx proprietary sdAb platform, which enables the development of therapeutic candidates with attributes superior to other monoclonal antibody and fusion protein approaches. This platform allows the combination of multiple binding units in a single molecule, enabling the creation of therapeutic candidates with defined valency or multiple specificities, potentially capable of enhanced cell signaling or conditional activation. An additional benefit of this platform, these optimized, multi-functional entities can be manufactured using the established processes that are commonly used to produce therapeutic proteins.

Initially, Inhibrx is pursuing targets with early clinical validation, such as DR5, where other therapeutics have demonstrated liabilities. In addition, Inhibrx is developing a portfolio of sdAb based therapeutic candidates in a variety of indications for both known and novel targets.