Wave of FDA Fast Track Designations Sparks Renewed Interest in Biotech Sector That's Heating Up

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VANCOUVER, British Colombia, Dec. 1, 2022 /PRNewswire/ -- USA News Group  -  A series of new Fast Track designations have been handed out by the United States Food and Drug Administration (FDA) this week, causing a flurry of activity in the markets for the worthy recipients. The most recent to gain such a designation is pelareorep from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) in combination with atezolizumab, an anti-PD-L1 checkpoint inhibitor from Roche Holding AG (OTCQX: RHHBY) for the treatment of advanced/metastatic pancreatic ductal adenocarcinoma (PDAC). Among the small handful of other companies that recently received this distinction for their platforms have been Aravive, Inc. (NASDAQ: ARAV), Caribou Biosciences, Inc. (NASDAQ: CRBU), and Kintara Therapeutics, Inc. (NASDAQ: KTRA).

The Fast Track process is designed to facilitate the development and expedite the review of investigational drugs to treat serious conditions and fill an unmet medical need. Drugs that receive Fast Track designation may be eligible for more frequent communications and meetings with the FDA to discuss the drug's development plan. Drugs with Fast Track designation may also qualify for accelerated and priority review of new drug applications if relevant criteria are met.

"Receiving this Fast Track designation is an important accomplishment that speaks to the impressive response rate and the durability of the response in our PDAC study, and it also reflects the pressing need to improve upon the standard of care in this indication," stated Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "We expect the opportunity for more frequent communication about our data with FDA provided by this designation will be invaluable as we work to align with the Agency on the best design for a registrational PDAC study. With our core programs in breast and pancreatic cancer both nearing pivotal trials, and eligible for the Fast Track program's numerous benefits, we believe we are at a crucial point in Oncolytics' evolution and are excited for what's ahead."

The approval for pelareorep came swiftly on the heels of the release of interim clinical data in a cohort of first-line advanced/metastatic PDAC patients treated with the combination of pelareorep, atezolizumab, gemcitabine, and nab-paclitaxel in Oncolytics' phase 1/2 GOBLET study. Within that study's cohort was a 69% objective response rate (ORR), including a complete response, which the National Cancer Institute defines as "the disappearance of all signs of cancer in response to treatment" (aka "remission").

For reference, this ORR is nearly triple the average ORR of ~25% reported in historical control trials evaluating gemcitabine in combination with nab-paclitaxel in pancreatic cancer.

"The robust efficacy signal in GOBLET markedly exceeded expectations based on historical results and is especially encouraging as most responding patients had their tumor regressions confirmed by subsequent evaluations," said Thomas C. Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics Biotech. "We were particularly excited to see a partial response deepen into a confirmed complete response as of the latest data cut, since this further indicates potentially durable anti-cancer effects from the combination therapy."

This represents the second FDA Fast Track designation in Oncolytics' history, with the first being for pelareorep in Metastatic Breast Cancer back in May 2017.

Though not in the United States, the day prior saw Roche Holding AG (OTC: RHHBY) subsidiary Roche Korea's lymphoma treatment Lunsumio gain the distinction of the first drug designated as the subject of the South Korean government's Global Innovative products on Fast Track (GIFT).

South Korea's Ministry of Food and Drug Safety said that it picked Lunsumio Inj. as the first product of the government's new program, as it was designated as a drug with no existing competitors as a treatment for recurrent and refractory follicular lymphoma.

The news of both the pelareorep combination and Lunsumio win in Korea comes as an optimistic spot for Roche, having just rescinded its indication for Tecentriq® (the trade name for atezolizumab) for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC, bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.

"While we are disappointed with this withdrawal, we understand the need to uphold the principles of the FDA's Accelerated Approval Program, which brings innovative medicines to patients sooner," said Levi Garraway, M.D., Ph.D., Chief Medical Officer and head of Global Product Development. "We remain confident in the benefit Tecentriq offers to people diagnosed with some of the most difficult-to-treat forms of cancer."

Late clinical-stage oncology company Aravive, Inc. (NASDAQ: ARAV) also announced that Fast Track Designation was granted by the FDA, for its lead program, batiraxcept, for treatment of patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have progressed after 1 or 2 prior lines of systemic therapy that include both immune-oncology (IO)-based and vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI)-based therapies (either in combination or sequentially).

The designation comes after Aravive demonstrated new data that delivered a 57% ORR and median Progression-Free Survival (PFS) of 11.4 months. 

"Response rates to single agent targeted kinase inhibitors are approximately 30% with a PFS of approximately 7 months," said lead investigator for the trial, Kathryn Beckermann, M.D., Ph.D., Assistant Professor, Division of Hematology and Oncology, Vanderbilt University Medical Center. "The early data seen with batiraxcept including biomarker development, response rate, and progression-free survival are promising."

Leading clinical-stage CRISPR genome-editing biopharmaceutical company Caribou Biosciences, Inc. (NASDAQ: CRBU) also announced the FDA granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track Designations to CB-010, an allogeneic anti-CD19 CAR-T cell therapy for relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL).

"RMAT and Fast Track designations for CB-010 are important recognitions of the significant unmet patient need for an off-the-shelf cell therapy in the treatment of aggressive B-NHL," said Caribou President and CEO, Rachel Haurwitz, Ph.D. "Through genome editing with our precision CRISPR chRDNA genome-editing technology, CB-010 has been designed with a PD-1 knockout strategy to improve the persistence of antitumor activity by limiting premature CAR-T cell exhaustion. In our ANTLER Phase 1 trial, 3 of 6 patients treated with CB-010 at dose level 1 maintained a durable complete response at 6 months. We are encouraged that CB-010 has demonstrated early potential as an off-the-shelf cell therapy that may meaningfully rival autologous cell therapies."

The FDA also granted Fast Track Designation to REM-001 Therapy from Kintara Therapeutics, Inc. (NASDAQ: KTRA), for the treatment of patients with cutaneous metastatic breast cancer (CMBC), after being studied in four Phase 2/3 clinical trials in patients with CMBC who had previously received chemotherapy and/or failed radiation therapy.

With clinical efficacy to-date of 80% complete responses of CMBC evaluable lesions, and with an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is focused on securing the funding necessary to restart a 15-patient study in CMBC patients in advance of a Phase 3 study.

"This designation from the FDA emphasizes the important unmet medical need for safe and effective therapeutic options to address CMBC," said Dennis Brown, Ph.D., Chief Scientific Officer of Kintara. "We have extensive data in hand to support the advancement of this clinical program and look forward to the continued investigation of our drug candidate in the next study as planned."

For more information please visit: https://usanewsgroup.com/2020/02/24/why-biotechnology-companies-are-so-important/

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