PYC Therapeutics Ltd.

PYC has developed a new drug candidate for the >5 million people worldwide[1] with Polycystic Kidney Disease (PKD) This drug candidate has demonstrated efficacy in human models derived from the kidneys of patients with end-stage renal failure due to PKD [2] PKD is a life-changing disease affecting 1 in every 1,000 people[3] Half of the patient population with PKD will require a kidney transplant by the age of 60 due to the absence of impactful treatment options in this disease[4] PKD represents an addressable market of >US$10 billion p.a. and is an area of major commercial interest for the drug development industry[5] Pre-clinical models suggest that addressing the underlying cause of PKD (the way that PYC's drug candidate works) could arrest the course of the disease in humans, enabling damaged kidneys to regenerate and restore function[6] PYC plans to accelerate this drug candidate into human trials in ~12 months – pursuing a potential high-velocity path through clinical trials to market[7] Investor Webinar Friday 17 November PYC will host an investor call at 9am AWST/12pm AEDST on Friday 17 November to discuss these results – investors can register for the call here: PERTH, Australia and SAN FRANCISCO, Nov. 13, 2023 /PRNewswire/ -- PYC Therapeutics today announces the results of a study conducted in human 3-dimensional models derived from patients with end-stage renal failure due to Autosomal Dominant Polycystic Kidney Disease (PKD). The results demonstrate that an investigational drug candidate designed by PYC (known as PYC-003) to address this disease at its root cause is effective. These 3D patient-derived cyst models represent the 'gold-standard' pre-clinical assay for evaluating drug candidates in this indication[8]. Continue Reading Figure 1 Figure 2 Figure 3 Figure 4

PYC is a clinical-stage biotechnology company developing a pipeline of first-in-class precision medicines for patients who have genetic diseases and no treatment options available The Company is currently evaluating the safety/tolerability and efficacy of an investigational drug candidate with disease-modifying potential in patients with a blinding eye disease of childhood called Retinitis Pigmentosa type 11 (RP11) for which there are no existing treatments PYC's drug candidate for the treatment of RP11 has today been designated a Fast Track development program by the US Food and Drug Administration (FDA) The purpose of the Fast Track designation is described by the FDA as being 'to get important new drugs to the patient earlier'[1] This drug candidate is now eligible for Accelerated Approval and Priority Review along with a range of other benefits[2] PERTH, Australia and SAN FRANCISCO, Aug. 11, 2023 /PRNewswire/ -- PYC Therapeutics Limited (ASX:PYC) today announces that the VP-001 program, the first investigational drug candidate designed to address Retinitis Pigmentosa type 11 ( RP11) to progress to human trials, has received Fast Track designation from the US Food and Drug Administration ( FDA). The Fast Track process is "designed to facilitate the development, and the review of drugs to treat serious conditions and fill an unmet medical need" with Fast Track status "often leading to earlier drug approval and access by patients"[3]. Benefits of the Fast Track designation include: Increased frequency of meetings with the FDA to discuss the drug's development plan; Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met; and The potential for a Rolling Review in support of a New Drug Application[4]. PYC will utilise the Fast Track designation to work with the FDA on advancing this important drug program towards patients on an accelerated timeline. PYC's CEO Dr Rohan Hockings commented: "We welcome the opportunity to work with the FDA to progress this important drug candidate towards becoming the first treatment option available for patients with RP11 with disease-modifying potential" About VP-001 – the first potential treatment for Retinitis Pigmentosa Type 11 RP11 is a blinding eye disease that begins in childhood and ultimately leads to legal blindness in middle age. The disease affects ~1 in every 100,000 people and is caused by insufficient expression of the PRPF31 gene in the retina. There are currently no treatment options available for patients with RP11 nor are there any in clinical development. VP-001 is a precision therapy that aims to restore the expression of the PRPF31 gene back to levels required for the normal function of the retina. VP-001 utilises PYC's proprietary drug delivery technology to overcome the major challenge for RNA drugs by ensuring that sufficient drug reaches its target inside the cells affected by RP11. About PYC Therapeutics PYC Therapeutics (ASX: PYC) is a clinical-stage biotechnology company creating a new generation of RNA therapies to change the lives of patients with genetic diseases. The Company utilises its proprietary drug delivery platform to enhance the potency of precision medicines within the rapidly growing and commercially proven RNA therapeutic class. PYC's drug development programs target monogenic diseases – the indications with the highest likelihood of success in clinical development[5]. The Company was the first to progress a drug candidate for a blinding eye disease of childhood into human trials and is now progressing multiple 'fast-follower' programs into the clinic. For more information, visit pyctx.com, or follow us on LinkedIn and Twitter. SOURCE PYC Therapeutics

ALBANY, N.Y., April 13, 2023 /PRNewswire/ -- YDS Pharmatech, a computational drug discovery company specializing in induced proximity, today announced the appointment of Dr. Robert Sullivan as Head of Medicinal Chemistry. With over 20 years of experience in the field, Dr. Sullivan possesses expertise in small molecules, PROTACs, peptides, and oligonucleotides. Dr. Sullivan previously served as Head of Preclinical Development at BioTheryX, where he played a pivotal role in creating the Cereblon binding library and directed research that led to more than 20 issued patents. These patents encompass a broad range of small molecules (molecular glues) and PROTACs. Before BioTheryX, Dr. Sullivan held the position of Executive Director of Drug Development at NovoMedix, where he contributed to the drug discovery efforts for antifibrotic and breast cancer development candidates entering IND-enabling studies. Over the course of his distinguished career, Dr. Sullivan has held leadership positions at PYC Therapeutics, Protagonist, Amylin Pharmaceuticals, Kemia, Neurocrine, and Signal Pharmaceuticals. As one of the pioneering scientists in high throughput parallel synthesis technologies and combinatorial chemistry, he has co-authored over 20 peer-reviewed publications. Dr. Sullivan earned his B.S. in Chemistry from the University of California, Santa Barbara, and a Ph.D. in Chemistry from the University of California, Irvine. "We are thrilled to welcome Dr. Robert Sullivan to the YDS Pharmatech team," said Dr. Xing Che, CEO of YDS Pharmatech. "His extensive experience in targeted protein degrader discovery is invaluable to us. Dr. Sullivan's expertise will enhance YDS's ability to bridge the gap between computational scientists, biologists, and chemists, fostering more efficient integrated research. As a result, our computational platform for rationalizing drug discovery of protein degraders will see accelerated development. "I am truly excited to join such a dynamic organization like YDS Pharmatech. YDS's unique platform of combining AI and biophysics simulations to help drive drug discovery and development are second to none," said Robert Sullivan, Ph.D., Head of Medicinal Chemistry. "I look forward to working with the YDS team and it's partners to create drugs that address unmet medical needs." Dr. Sullivan's appointment as Head of Medicinal Chemistry bolsters YDS Pharmatech's dedication to remaining at the cutting edge of combining AI and biophysics simulations for induced proximity drug discovery. This state-of-the-art approach ensures that YDS Pharmatech stays at the forefront of innovation, while providing valuable support to partner companies collaborating with YDS to create groundbreaking medicines that address unmet medical needs. About YDS Pharmatech YDS Pharmatech, Inc. is a computational drug discovery company dedicated to developing cutting-edge computational platforms for multispecific drugs. Utilizing AI-accelerated enhanced sampling molecular dynamics simulations, the company examines ternary complex interactions, thermodynamics, and kinetics to advance induced proximity studies and transform degrader discovery from serendipitous to rational design. YDS Pharmatech currently specializes in PROTACs and molecular glue protein degraders. Their interdisciplinary team of scientists is committed to accelerating their collaborators' efforts in pioneering innovative treatments for a diverse range of diseases.