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Wave of FDA Fast Track Designations Highlight Biotech Momentum Carrying into 2023

FN Media Group Presents USA News Group News Commentary


Vancouver, BC – September 13, 2023 – USA News Group  –  Sufferers of many different ailments saw reason to grow their hope in 2022 when the US Food and Drug Administration (FDA) granted several approvals and new Fast Track designations towards the end of 2022 and into January of 2023. In particular, the FDA’s Fast Track Designation (FTD) is designed to facilitate the development and to expedite the review of investigational drugs to treat serious conditions and fill an unmet medical need. It’s these drugs that receive Fast Track designation that become eligible for more frequent communications and meetings with the FDA for the purpose of discussing the drug’s development plan. Drugs with FTD may also qualify for accelerated approval and priority review if relevant criteria are met. Some recent examples with FTDs include Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Avidity Biosciences, Inc. (NASDAQ:RNA), Fulcrum Therapeutics, Inc. (NASDAQ:FULC), BriaCell Therapeutics Corp. (NASDAQ:BCTX) (TSX:BCT), and a once-Fast Track designated and now approved drug from Gilead Sciences, Inc. (NASDAQ:GILD).


Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) closed out 2022 on a high note, having received notice of FTD for its flagship asset, pelareorep, a first-in-class intravenously delivered immunotherapeutic agent for the treatment of solid tumors and hematological malignancies.


“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.”


Coming swiftly on the heels of the release of interim clinical data in a cohort of first-line advanced/metastatic pancreatic ductal adenocarcinoma (PDAC) patients from the company’s phase 1/2 GOBLET study treated with the combination of pelareorep, the chemotherapies gemcitabine and nab-paclitaxel, and Roche Holdings AG’s (RHHBY) anti-PD-L1 checkpoint inhibitor, atezolizumab, Oncolytics announced that pelareorep received FTD for the treatment of advanced/metastatic PDAC.


The GOBLET study’s pancreatic cohort delivered an impressive 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 contextual reference, these ORR results were nearly triple the average ORR of ~25% reported in historical control trials evaluating gemcitabine in combination with nab-paclitaxel in pancreatic cancer.


“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,” said Thomas C. Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics Biotech.


Also in December, the FDA gave another FTD to Fulcrum Therapeutics, Inc. (NASDAQ:FULC) for FTX-6058, which is the company’s candidate for the genetic blood disorder sickle cell disease (SCD). After the drug moved into a Phase Ib trial and reported improved biomarkers of hemolysis on 6 mg doses, Fulcrum began enrolling patients in a study using a 12 mg dose, with a new release of data planned for the fourth quarter of 2023.


“We are entering 2023 with a tremendous amount of momentum and expect it to be a productive year for our two clinical programs: FTX-6058 for SCD, and losmapimod for FSHD,” said Robert J. Gould, Ph.D., Fulcrum’s interim President and CEO. “FTX-6058 is a potential best-in-class oral HbF inducer candidate that could address critical gaps in the SCD treatment landscape.”


Avidity Biosciences, Inc. (NASDAQ:RNA) just received its own FTD for AOC 1020 for the treatment of facioscapulohumeral muscular dystrophy (FSHD). FSHD is a serious, rare, hereditary muscle-weakening condition marked by life-long, progressive loss of muscle function that causes significant pain, fatigue, and disability.


“The FDA Fast Track designation for AOC 1020 reinforces the importance of finding an effective treatment to help people living with FSHD, a devastating and debilitating muscular dystrophy disorder with no treatment options,” said Steve Hughes, M.D., Chief Medical Officer at Avidity. “AOC 1020 is designed to directly target the disease-causing gene, DUX4, to address the underlying cause of FSHD. We look forward to working collaboratively with the FDA to bring the first RNA therapy directly targeting DUX4 to patients as quickly as possible.”


AOC 1020 is being studied in the Phase 1/2 FORTITUDE™ clinical trial in adults with FSHD and is the company’s second muscle-targeting small interfering RNA (siRNA) AOC in clinical development. The FORTITUDE™ trial is a randomized, placebo-controlled, double-blind, Phase 1/2 clinical trial designed to evaluate AOC 1020 in approximately 70 adult participants with FSHD. Avidity plans to share data from a preliminary assessment of AOC 1020 in approximately half of study participants from the FORTITUDE trial in the first half of 2024.


After a positive End of Phase II meeting with the FDA, BriaCell Therapeutics Corp. (NASDAQ:BCTX) (TSX:BCT) announced it had come to an agreement and positive feedback from the FDA regarding the company’s lead clinical candidate, Bria-IMT™ in combination with a checkpoint inhibitor (under Fast Track designation), in advanced metastatic breast cancer.


As per the announcement, BriaCell and the FDA have agreed on the primary end point, the essential elements of the study design, and the type of patients to be enrolled in BriaCell’s upcoming pivotal clinical study. This pivotal registration study will be enrolling advanced metastatic breast cancer patients for whom no approved treatment options exist.


“The importance of this milestone speaks for itself and is yet another major step towards our goal to become one of the leading immuno-oncology companies,” said Dr. William V. Williams, BriaCell’s President and CEO. “Jumping directly into a pivotal study shortly after receiving Fast Track status has greatly advanced our lead clinical program timetable with the ultimate goal of commercializing our novel immunotherapy approach for women with no approved treatment options.”


For an example of what can happen next after the FDA has already given a FTD and lived up to the “fast track” moniker, look no further to the FDA’s late-December approval of Sunlenca (lenacapavir) from Gilead Sciences, Inc. (NASDAQ:GILD) for adult patients living with HIV, whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations.


Sunlenca is the first of a new class of drugs called capsid inhibitors to be FDA-approved for treating HIV-1. Sunlenca works by blocking the HIV-1 virus’ protein shell (the capsid), thereby interfering with multiple essential steps of the viral lifecycle. Sunlenca’s starting dose is given as oral tablets and subcutaneous injections, followed by maintenance injections every six months; Sunlenca is given in combination with other antiretroviral(s).


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