PYC Therapeutics Highlights Advancement of Ocular and CNS Development Programs And Continued U.S. Expansion in Second Quarter 2021 Update

SAN DIEGO and PERTH, Australia, July 28, 2021 /PRNewswire/ -- PYC Therapeutics (ASX: PYC), a biotechnology company combining two complementary platform technologies (selective drug delivery and precision drug design) to develop a new generation of RNA therapeutics to change the lives of patients with inherited diseases, today announced a second quarter update highlighting the progress of its development pipeline, growth of its U.S. operations and upcoming milestones.

The Company made significant progress during the second quarter across lead eye programs but also for the first time expanding application of the Company's RNA therapeutic technology beyond the eye. For VP-001 for the treatment of retinitis pigmentosa type 11, the commencement of larger animal studies was a critical step towards Investigational New Drug (IND) filing which is on-track for mid-2022. For VP-002, comprehensive preclinical data released during the quarter demonstrated this program's potential to generate the first disease-modifying treatment for autosomal dominant optic atrophy, addressing a significant unmet patient need and a multi-billion dollar market opportunity. Beyond the eye, PYC reported preclinical results early in the quarter showing the promising potential of the Company's PPMO technology platform to address diseases of the central nervous system, opening up a very large and underserved market opportunity.

During the quarter, PYC also continued to expand its presence in the United States naming a new U.S. headquarters in the thriving biotech hub of San Diego, recruiting top-tier drug development talent and deepening engagement with potential investors and business development partners. Presence in the U.S. is critical for the Company to accelerate program development and maximize the impact of upcoming value catalysts.

Recent Achievements

Inherited Ocular Diseases: 

• Commenced key rabbit studies for lead candidate VP-001 for the treatment of retinitis pigmentosa 11. Data from larger animal studies are expected in the second half of 2021, and will enable PYC to move toward regulatory engagement for the VP-001 program and initiate the final step of preclinical development with formal Good Laboratory Practice (GLP) toxicity studies. The Company remains on track to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in mid-2022 before entering clinical trials.
• Announced comprehensive preclinical results demonstrating potential for VP-002 to become the first disease-modifying therapy for for the treatment of autosomal dominant optic atrophy (ADOA). The majority of ADOA cases are caused by loss of function mutations in the OPA1 gene. PYC's preclinical studies have found that the Company's PPMO technology used in VP-002 significantly increased levels of OPA1 protein, corrected major functional deficits that underly ADOA, and demonstrated an ability to reach the target cells in the retina, a key barrier facing other potential treatments for the condition. These data support continued development of the program toward clinical trials, and the Company expects to file an IND with the U.S. FDA in the first half of 2023.
• Advanced our ocular pipeline discovery efforts. PYC is cultivating a rich pipeline of novel development candidates to address additional ocular diseases. The Company expects to unveil additional development candidates for the treatment of high unmet need ocular indications during 2021.

Central Nervous System (CNS) Diseases:

• Demonstrated superior ability of PPMO technology to deliver high levels of RNA therapeutic throughout the brain. In April, PYC announced preclinical results demonstrating its PPMO technology has significant potential to provide therapies for patients with neurodegenerative diseases. This is an important expansion of the application of PYC's technology beyond the eye, and demonstrates the broad potential of the platform to change the lives of patients with inherited diseases. Building on these data, the Company expects to nominate a candidate targeting a high unmet need neurodegenerative condition in 2021.

Corporate Initiatives: 

• Established new U.S. headquarters in San Diego. PYC announced residency at Johnson & Johnson Innovation, JLABS at San Diego (JLABS @ SAN DIEGO). PYC has appointed several key team members based at the new U.S. headquarters, who will build out capabilities related to preclinical and clinical development such as chemistry, manufacturing and controls and toxicology, along with business development, regulatory and other corporate activities. This cross-functional team will support the development of VP-001 and VP-002 as these programs move toward clinical trials and complement the continued work done at the drug discovery and scientific research hub in Perth.
• Continued to engage key U.S. stakeholders including prospective investors and potential business development partners. PYC's growing U.S.-based team has deepened engagement with prominent healthcare industry investors along with a wide range of potential business development partners. The Company's U.S. management team has attended multiple investor and pharma conferences this year, and has been invited to attend multiple additional conferences before the end of the year in order to establish PYC as a global leader in RNA therapeutics in the largest life science market in the world.
• Holds strong cash position to support program discovery and development and continued U.S. expansion. PYC ended June 2021 with $38 million in cash and cash equivalents. Based on its current operating plans, and considering the Australian R&D tax rebate, this provides the Company with a multi-year cash runway enabling a very strong foundation for execution of both Corporate and Program objectives.

About PYC Therapeutics

PYC Therapeutics (ASX: PYC) is a development-stage biotechnology company pioneering a new generation of RNA therapeutics that utilize PYC's proprietary library of naturally derived cell penetrating peptides to overcome the major challenges of current genetic medicines. PYC believes its PPMO (Peptide conjugated Phosphorodiamidate Morpholino Oligomer) technology enables a safer and more effective RNA therapeutic to address the underlying drivers of a range of genetic diseases for which no treatment solutions exist today. The Company is leveraging its leading-edge science to develop a pipeline of novel therapies including three preclinical stage programs focused on inherited eye diseases and preclinical discovery efforts focused on neurodegenerative diseases. PYC's discovery and laboratory operations are located in Australia, and the Company's preclinical, clinical, regulatory and corporate operations are based in San Diego, California.  For more information, visit pyctx.com, or follow us on LinkedIn and Twitter.

Forward looking statements

Any forward-looking statements in this ASX announcement have been prepared on the basis of a number of assumptions which may prove incorrect and the current intentions, plans, expectations and beliefs about future events are subject to risks, uncertainties and other factors, many of which are outside the Company's control. Important factors that could cause actual results to differ materially from assumptions or expectations expressed or implied in this ASX announcement include known and unknown risks. Because actual results could differ materially to assumptions made and the Company's current intentions, plans, expectations and beliefs about the future, you are urged to view all forward-looking statements contained in this ASX announcement with caution. The Company undertakes no obligation to publicly update any forward-looking statement whether as a result of new information, future events or otherwise.

CONTACTS:
INVESTORS
Deborah Elson/Matthew DeYoung
Argot Partners
[email protected]  
[email protected]   

MEDIA
Leo Vartorella
Argot Partners
[email protected]  

SOURCE PYC Therapeutics

Related Links

http://pyctx.com

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