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Apeiron Enrolls First Patient in Phase 1a/b Study of PRMT5 Inhibitor GTA182 for MTAP-Deleted Solid Tumors

- Potentially best-in-class MTA-cooperative PRMT5 inhibitor -

- First patient in for Phase 1a/b study to evaluate GTA182 clinically in patients having tumors with MTAP deletion -

SAN FRANCISCO, CA and SHANGHAI, China, Nov. 19th, 2024 — Apeiron Therapeutics (Apeiron), a precision oncology company leveraging state-of-the-art structural biology and AI-guided molecular modeling for drug discovery, today announced the enrollment of the first patient in its Phase 1a/b study to evaluate GTA182 for advanced solid tumors with MTAP deletions. The trial is designed to evaluate the safety, efficacy, and pharmacokinetics of GTA182 across multiple ascending doses, as a monotherapy and in combination with standard of care therapy, in adults with advanced MTAP null solid tumors.

“The initiation of the GTA182 Phase 1a/b clinical trial represents a significant milestone in our company’s growth and marks our second drug candidate to enter clinical studies,” said Mingxi Li, Ph.D., Chief Executive Officer of Apeiron.

“GTA182 was designed to overcome the safety and efficacy limitations of existing second-generation PRMT5 inhibitors, with the goal of delivering a transformative therapy for patients with few treatment options,” added Fred Aswad, J.D., Ph.D., Senior Vice President of Apeiron Therapeutics.

The first-in-human Phase 1a/b clinical trial of GTA182 is an open-label, multicenter study involving dose escalation and dose expansion. The study will enroll patients with MTAP-null solid tumors, with the primary objectives being to characterize the safety and tolerability of GTA182 and determine its optimal therapeutic dose. For more details about our trial, please visit: https://www.cde.org.cn.

About GTA182

GTA182 is a proprietary small molecule discovered through Apeiron’s AI-guided drug discovery platform. In preclinical studies, Apeiron’s preclinical studies demonstrated that GTA182 is a potent and selective PRMT5 inhibitor, exhibiting greater than 100-fold selectivity for MTAP-deleted tumor cell lines. Importantly, GTA182 is brain-penetrant and has shown tumor growth inhibition and regression in in vivo preclinical models, including glioblastoma (GBM) and various non-CNS cancer models with MTAP deletions.

About Apeiron Therapeutics

Apeiron is redefining medical discovery through the integration of artificial intelligence, streamlining the drug development process from target selection to clinical trials. With strategic locations in the San Francisco Bay Area and Shanghai, Apeiron combines world-class talent and cutting-edge technologies from across the globe. We are committed to pushing the frontiers of biomedical innovation to create breakthrough therapies that address the most pressing unmet medical needs.

Investor and Media Contact

media@apeiron-bio.com

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Fred Aswad Fred Aswad

Apeiron Receives IND Clearance from NMPA for next generation PRMT5 Inhibitor GTA182 to Treat MTAP Null Tumors

- Potentially best-in-class MTA-cooperative PRMT5 inhibitor

- Demonstrates substantially expanded therapeutic window in pre-clinical models of glioblastoma and non-CNS tumor models with MTAP deletion

- Apeiron plans to file an Investigational New Drug (IND) application with the US FDA for GTA182 in 2025

SAN FRANCISCO, CA and SHANGHAI, China, Oct. 14th, 2024 — Apeiron Therapeutics (Apeiron), a precision oncology company leveraging cutting-edge technology and artificial intelligence (AI) for cancer drug discovery, today announced that the China National Medical Products Administration (NMPA) has cleared Apeiron’s Investigational New Drug (IND) application for GTA182, its potentially best-in-class MTA-cooperative PRMT5 inhibitor, for the treatment of MTAP-null solid tumors.

MTAP (Methylthioadenosine Phosphorylase) is co-deleted with the tumor suppressor gene CDKN2A in 10-15% of cancer patients across a broad spectrum of tumor types. GTA182 is a next-generation MTA-cooperative, brain-penetrant inhibitor of protein arginine methyltransferase 5 (PRMT5) with a substantially expanded therapeutic window, as demonstrated in preclinical studies.

“NMPA’s clearance of the GTA182 IND is an important milestone for Apeiron,” said Fred Aswad, Ph.D., Co-Founder and Senior Vice President of Apeiron. “GTA182 represents a significant advance in targeting MTAP-null tumors. Our preclinical data shows compelling tumor growth inhibition and regression in multiple models, including glioblastoma, one of the most challenging cancers to treat. We are excited to advance this therapy into clinical trials and look forward to filing a US IND with the FDA in 2025 to expand our global development efforts.”

The first-in-human Phase 1a/b clinical trial of GTA182 is an open-label, multicenter study involving dose escalation and dose expansion. The study will enroll patients with MTAP-null solid tumors, with the primary objectives being to characterize the safety and tolerability of GTA182 and determine its optimal therapeutic dose.

About GTA182

GTA182 is a proprietary small molecule discovered through Apeiron’s AI-guided drug discovery platform. In preclinical studies, Apeiron demonstrated that GTA182 is a potent and selective PRMT5 inhibitor, exhibiting greater than 100-fold selectivity for MTAP-deleted tumor cell lines. Importantly, GTA182 is brain-penetrant and has shown tumor growth inhibition and regression in in vivo preclinical models, including glioblastoma (GBM) and various non-CNS cancer models with MTAP deletions.

About Apeiron Therapeutics

Apeiron is redefining medical discovery through the integration of artificial intelligence, streamlining the drug development process from target selection to clinical trials. With strategic locations in the San Francisco Bay Area and Shanghai, Apeiron combines world-class talent and cutting-edge technologies from across the globe. We are committed to pushing the frontiers of biomedical innovation to create breakthrough therapies that address the most pressing unmet medical needs.

Investor and Media Contact

media@apeiron-bio.com

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Fred Aswad Fred Aswad

Apeiron to Expand Investment in Synthetic Lethality Pipeline After New Phase in Collaboration with Exscientia

July 18, 2024 – San Francisco, USA, and Shanghai, China – Apeiron Therapeutics (Apeiron) announced today that it has reached an agreement with Exscientia plc (NASDAQ: EXAI), granting Exscientia full control over GTAEXS617 ('617) and all related intellectual property. This asset is currently in the ELUCIDATE Phase 1/2 clinical trial stage.

Under the terms of the agreement, Apeiron will receive an upfront payment of $30 million in cash and equity, in addition to receiving single digit royalties if Exscientia or a third party commercializes '617, which could be worth over $100 million in the upcoming years.

The ELUCIDATE trial's monotherapy dose escalation phase aims to evaluate the safety, pharmacokinetics, and pharmacodynamics of '617 in patients with advanced solid tumors. Recruitment for the trial is progressing well. Data from the monotherapy dose escalation phase is expected in the second half of 2024 and transition to a combination dose escalation phase in late 2024 or early 2025.

Dr. Mingxi Li, CEO of Apeiron, commented, "Our collaboration with Exscientia has entered a new phase, with Exscientia taking full control of '617 while we remain a supportive shareholder. We are confident in the potential of '617 and believe Exscientia has the resources and capabilities to develop this transformative asset. This transaction enables us to concentrate our efforts on the remainder of our synthetic lethality pipeline and deepen our commitment to providing innovative therapies to cancer patients worldwide. This includes GTA182, a potentially best-in-class next-generation PRMT5 inhibitor, which will soon enter clinical trials.”

About ELUCIDATE

The ELUCIDATE trial is a multicentre, open-label, two-stage clinical trial to evaluate safety, pharmacokinetics, pharmacodynamics and efficacy of ‘617 administered orally as monotherapy and in combination with standard of care therapies. The company is enrolling patients with solid tumours including head and neck cancer, colorectal cancer, pancreatic cancer, non-small cell lung cancer (NSCLC), breast cancer and ovarian cancer, who have advanced, recurrent or metastatic disease and have failed standard of care.

Both the monotherapy and combination therapy dose escalation portion of the trial will enrol patients across multiple dose levels to determine the optimal biological dose (OBD). The dose expansion phase of the trial will commence upon identification of the OBD. The primary efficacy endpoint of the expansion phase is objective response rate (ORR).

CDK7 inhibition combines many potential benefits such as transcription inhibition, reduction of aberrant kinome activation, cell cycle inhibition and modulation of estrogen receptor activity. This makes it an attractive target to overcome common resistance pathways associated with CDK4/6 inhibition, which only targets the cell cycle. Exscientia believes ‘617 has the potential to overcome significant safety and efficacy limitations of existing approved treatments due to the underlying biology of CDK7 and our laser focus on maximising therapeutic index through an AI-designed molecule that enables tight control of both extent and duration of target inhibition.

About Apeiron Therapeutics

Apeiron is redefining medical discovery, using artificial intelligence to streamline the drug development process—from target selection to clinical trials. With strategic locations in the San Francisco Bay Area and Shanghai, and significant partnerships in Europe, Apeiron integrates talent and cutting-edge technologies spanning multiple regions. We believe that by pushing the frontiers of biomedical innovation and engaging talent globally we can create breakthrough medicines for the highest unmet medical needs.

About Exscientia

Exscientia is a technology-driven drug design and development company, committed to creating more effective medicines for patients, faster. Exscientia combines precision design with integrated experimentation, aiming to invent and develop the best possible drugs in the most efficient manner. Operating at the interfaces of human ingenuity, artificial intelligence (AI), automation and physical engineering, we pioneered the use of AI in drug discovery as the first company to progress AI-designed small molecules into a clinical setting. We have developed an internal pipeline focused on oncology, while our partnered pipeline extends to many other therapeutic areas. By leading this new approach to drug creation, we believe we can change the underlying economics of drug discovery and rapidly advance the best scientific ideas into medicines for patients.

For more information about GT Apeiron, please visit www.apeiron-bio.com.

For investor and media inquiries, please contact media@apeiron-bio.com.

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Fred Aswad Fred Aswad

GT Apeiron Announces Development Candidate Nomination of Brain Penetrant PRMT5 Inhibitor, GTA182, for the Potential Treatment of MTAP-Deleted Solid Cancers

- Potentially best-in-class MTA-cooperative PRMT5 inhibitor -

- Demonstrates efficacy in pre-clinical models of glioblastoma and non-CNS tumor models with MTAP deletion -

- Apeiron plans to file Investigational New Drug (IND) application for GT182 in mid-2024 -

SAN FRANCISCO & SHANGHAI, October 17, 2023 -- GT Apeiron Therapeutics (‘Apeiron’), a biopharmaceutical company harnessing the power of artificial intelligence to develop targeted precision therapies for unmet medical needs, today announced the development candidate nomination of GTA182, a brain penetrant protein arginine methyltransferase 5 (PRMT5) inhibitor that exhibits methylthioadenosine (MTA) cooperativity resulting in high selectivity for MTAP-deleted cancer cells while sparing MTAP-expressing non-cancer cells. This selectivity is expected to provide a more effective and safer treatment option for patients with MTAP-deleted cancers.

“GTA182’s high selectivity for MTAP deleted cancers and its ability to cross the blood brain barrier make it a best-in-class candidate for advancement into clinical development for the potential treatment of CNS tumors as well as non-CNS indications,” said Fred Aswad, J.D., Ph.D., Senior Vice President of Biology and Translational Science. “Approximately 10% of solid tumors harbor MTAP deletions, including glioblastoma, lung, pancreatic, and bladder cancers all of which have limited treatment options and represent a significant unmet need for patients.”

In preclinical studies, Apeiron has demonstrated that GTA182 is a potent and selective PRMT5 inhibitor exhibiting greater than 100-fold selectivity for MTAP deleted tumor cell lines. GTA182 is brain penetrant and has demonstrated tumor growth inhibition and tumor regression in in vivo pre-clinical models of glioblastoma (GBM) as well as non-CNS murine cancer models with MTAP deletions.

Apeiron plans to file an Investigational New Drug (IND) application in mid-2024.

"The nomination of our wholly–owned GTA182 program as a candidate for clinical development represents another significant milestone for Apeiron and our commitment to developing innovative therapies for cancer patients with unmet medical needs," said Mingxi Li, Ph.D., Chief Executive Officer of Apeiron.

About GT Apeiron

GT Apeiron is redefining medical discovery, using artificial intelligence to streamline the drug development process—from target selection to clinical trials. With strategic locations in the San Francisco Bay Area and Shanghai, and significant partnerships in Europe, Apeiron integrates talent and cutting-edge technologies spanning multiple regions. We believe that by pushing the frontiers of biomedical innovation and engaging talent globally we can create breakthrough medicines for the highest unmet medical needs.

For additional information about GTA182, visit www.apeiron-bio.com/gta182

For additional information about Apeiron, visit www.apeiron-bio.com

Investor and Media Contact

media@apeiron-bio.com

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Fred Aswad Fred Aswad

GT Apeiron Announces Enrollment of First Patient in Phase 1/2 “ELUCIDATE” Clinical Trial of CDK7 Inhibitor, GTAEXS617, in Advanced Solid Tumors

- Preclinical data from AI-optimized  GTAEXS617 support  potential for improved therapeutic index compared to other CDK7 inhibitors under development

- Parallel translational initiative to evaluate preclinically identified non-invasive PD biomarkers with potential to predict GTAEXS617 treatment responders

SAN FRANCISCO & SHANGHAI, July 10, 2023 -- GT Apeiron, a biopharmaceutical company harnessing the power of artificial intelligence (AI) to develop targeted precision therapies for unmet medical needs, today announced the enrollment of the first patient in the Phase 1/2 “ELUCIDATE” study which is designed to evaluate GTAEXS617 for the treatment of advanced solid tumors. Developed in collaboration with its strategic partner, Exscientia plc (Nasdaq: EXAI), GTAEXS617 is a highly selective, small molecule, non-covalent inhibitor of cyclin-dependent kinase 7 (CDK7).  The ELUCIDATE trial is designed to evaluate the safety, efficacy, and pharmacokinetics of GTAEXS617 across multiple ascending doses, as a monotherapy and in combination with standard of care therapy, in adults with advanced solid tumors.

"The initiation of the ELUCIDATE study represents a significant milestone in our company’s development  and is the first drug candidate from our partnership with Exscientia to enter clinical studies," said Mingxi Li, Ph.D., chief executive officer of GT Apeiron. "GTAEXS617 is a product of our collaboration that uses AI-driven precision design to create a potentially best-in-class therapy and provide a new therapeutic option for patients with these difficult to treat cancers."

GTAEXS617 provides a differentiated approach to treating a range of advanced solid tumors, including head and neck cancer, colorectal cancer, pancreatic cancer, non-small cell lung cancer (NSCLC), HR+/HER2- breast carcinoma, and ovarian cancer. As a highly selective, noncovalent inhibitor of CDK7, GTAEXS617 combines the ability to disrupt the cell cycle and inhibit transcription in tumor cells, offering a promising alternative to CDK4/6 inhibitors, which only target the cell cycle and lead to the emergence of resistance pathways. In addition, orally available GTAEXS617 has the potential to overcome significant safety and efficacy limitations of treatments currently in development due to its differentiated reversibility and potentially reduced gastrointestinal toxicity.

In parallel to ELUCIDATE, GT Apeiron and Exscientia are undertaking a comprehensive translational initiative to study the potential enrichment for patients most likely to respond to GTAEXS617. This precision medicine-based approach involves the integration of data from clinical endpoints, peripheral and tumor multi-omics data, and correlation of those data with previously collected ex vivo results to potentially predict GTAEXS617 treatment response, thus increasing the probability of treatment success.

Fred Aswad, J.D., Ph.D., senior vice president, shared, "In collaboration with Exscientia we have used the power of AI to enable the efficient discovery and development of GTAEXS617. Our preclinical data in models of multiple solid tumor types demonstrate potent anti-tumor activity of this novel CDK7 inhibitor and support its clinical development.  We are excited to advance GTAEXS617 into clinical testing and take this next step towards making a potentially transformative impact on the treatment of solid tumors."

 About the Phase 1/2 ELUCIDATE trial

The ELUCIDATE trial is a multicenter, open-label, two-stage clinical trial designed to evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of GTAEXS617 administered orally as monotherapy and in combination with standard of care therapies. The trial is enrolling patients with solid tumors who have advanced, recurrent, or metastatic disease and have failed standard of care. Both the monotherapy and combination therapy dose escalation portion of the trial will enroll patients in up to seven dose levels to define the recommended Phase 2 dose (RP2D). The dose expansion phase of the trial will commence upon identification of the RP2D. The primary efficacy endpoint of the expansion phase is objective response rate (ORR).

 About GT Apeiron

GT Apeiron is redefining medical discovery, using artificial intelligence to streamline the drug development process—from target selection to clinical trials. With strategic locations in Shanghai and the San Francisco Bay Area, and significant partnerships in Europe, Apeiron integrates talent and cutting-edge technologies spanning multiple regions. We believe that by pushing the frontiers of biomedical innovation and engaging talent globally we can create breakthrough medicines for the highest unmet medical needs. For additional information visit www.apeiron-bio.com

 About Exscientia

Exscientia is an AI-driven precision medicine company committed to discovering, designing, and developing the best possible drugs in the fastest and most effective manner. Exscientia developed the first-ever functional precision oncology platform to successfully guide treatment selection and improve patient outcomes in a prospective interventional clinical study, as well as to progress AI-designed small molecules into the clinical setting. The company’s internal pipeline is focused on leveraging its precision medicine platform in oncology, while its partnered pipeline broadens its approach to other therapeutic areas. By pioneering a new approach to medicine creation, Exscientia believes the best ideas of science can rapidly become the best medicines for patients.

 Investor and Media Contact

media@apeiron-bio.com

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Fred Aswad Fred Aswad

Apeiron will present the latest research on KIF18A at AACR 2023

Apeiron team will attend AACR 2023 in Orlando, FL on April 18th 2023.

Dr. James D. Joseph, Executive Director of biology will present our latest research on targeting the mitotic kinesin, KIF18A, in chromosomally unstable cancers. Dr. Fred Aswad, SVP of biology and Dr. Minghua Wang, Director of AIDD will be available to meet with you there as well.

Stay tuned for Apeiron poster:

Abstract Title: Targeting the mitotic kinesin, KIF18A, in chromosomally unstable cancers

Session category: Experimental and Molecular Therapeutics

Session title: Novel Targets and Pathways

Published abstract number: 4965

Session date & time: April 18, 2023, 1:30 PM - 5:00 PM

https://www.abstractsonline.com/pp8/#!/10828/presentation/6687

About KIF18A

- Background:

Chromosome instability (CIN), characterized by frequent and ongoing loss or gain of chromosome number, is commonly observed in tumor cells. Although long recognized as a vulnerability of cancer cells, potential CIN-selective therapeutic targets have only recently been discovered. Genetic studies from multiple groups have identified the mitotic kinesin, KIF18A, as selectively essential for the proliferation of CIN and aneuploid cells. By targeting KIF18A genetically and with novel small molecule inhibitors here we present data supporting KIF18A as therapeutic target in CIN tumors.

- Methods and Materials: 

To explore the therapeutic potential of KIF18A, we evaluated the effects of KIF18A genetic depletion and small molecule inhibition in both CIN-positive and CIN-negative cell lines. Biochemical, cell proliferation and phenotypic assays were used to characterize the potency and cellular activity of reference and novel KIF18A small molecule inhibitors. Anti-tumor activity of KIF18A inhibitors was assessed in CIN-positive cell line xenograft models.

- Results: 

In triple negative breast and colorectal CIN positive cancer cell lines siRNA mediated KIF18A knockdown and small molecule inhibition of the KIF18A ATPase activity both lead to a reduction in proliferation associated with an increase in mitotic index and multi-polar spindles. Consistent with KIF18A knockdown, KIF18A inhibition results in increased spindle length and chromosome alignment defects. Importantly, these effects are not observed with KIF18A knockdown or KIF18A inhibition in non-transformed, near diploid cells. In vivo, treatment of CIN-positive xenograft tumors with potent, novel KIF18A inhibitors results in robust anti-tumor activity with minimal impact on body weight.

- Conclusions: 

Collectively our data support KIF18A as a therapeutic target and provide rationale for the continued development of potent selective small molecule KIF18A inhibitors for the treatment of CIN positive cancers.

About AACR:  

The AACR Annual Meeting 2023 (American Association for Cancer Research) being held in Orlando, Florida from April 14-19, 2023, is the focal point of the cancer research community.

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Fred Aswad Fred Aswad

Exscientia Presents Novel Patient Stratification and Biomarker Data for GTAEXS-617 at the 34th EORTC-NCI-AACR Annual Symposium

Combines precision oncology platform with single-cell sequencing and transcriptomics with aim to select patients most likely to benefit from GTAEXS-617 therapy

Confirmed and identified CDK7-specific pharmacodynamic biomarkers in cancer and immune cells

Phase 1/2 clinical trial to validate correlation of signature and response expected to commence in 1H 2023 following planned CTA submission in 4Q 2022

Exscientia plc (Nasdaq: EXAI) today highlighted new data aimed at enriching for patients that are more likely to respond to its precision-designed CDK7 inhibitor, GTAEXS-617 (‘617). The research confirmed a CDK7-specific pharmacodynamic (PD) biomarker, while revealing potential novel PD markers, and identified an initial novel patient selection gene expression signature that will, in part, be evaluated in its planned Phase 1/2 study. The data are being presented at the 34th EORTC-NCI-AACR (ENA 2022) Symposium on Molecular Targets and Cancer Therapeutics, being held October 26-28, 2022, in Barcelona, Spain.

In this study, researchers leveraged Exscientia's translational oncology platform, combining AI-based primary cancer tissue profiling with transcriptomics, to understand how cells from diverse patient populations respond to therapy with ‘617. Results demonstrated differential sensitivity in some patient samples, enabling Exscientia to correlate response with individual patient genomic and phenomic profiles. These correlations can then be used to identify which patients are most likely to respond to ‘617 therapy and can be incorporated into upcoming clinical trials.

In addition, the data showed that ‘617 induced less cell death on immune cells than select CDK4/6 and other investigational CDK7 inhibitors, potentially indicating a differentiated clinical safety profile. '617 is currently in IND-enabling studies as a potential treatment for transcriptionally addicted cancers.

“We’re excited to highlight new data supporting the power of our translational platform to rapidly assess the activity of new targeted therapies that could lead to improved clinical outcomes for patients,” said Gregory Vladimer, VP of Translational Research at Exscientia. “By leveraging our functional precision medicine platform coupled with single cell transcriptomics and AI modeling in primary disease tissue, we believe we are uniquely positioned to enrich studies for patient groups more likely to respond, or not respond, to a therapy, therefore meaningfully improving cancer treatment outcomes for patients."

Poster Presentation Details:

Title: Defining activity and patient selection of a novel CDK7 inhibitor, GTAEXS-617, through AI-supported primary cancer tissue profiling

Poster Session Title: Preclinical Models

Abstract Number: #124

Date/Time: Wednesday, October 26 / 12:00 PM – 8:00 PM CET

GTAEXS-617 is a novel CDK7 inhibitor that has been designed by Exscientia in collaboration with GT Apeiron for high potency, selectivity, bioavailability and safety. CDK7 inhibition combines cell cycle disruption with transcription inhibition, making it an attractive target to overcome common resistance pathways in CDK4/6 inhibition.

Exscientia anticipates submitting a Clinical Trial Application (CTA) by the end of 2022 and initiating a Phase 1/2 clinical trial in multiple solid tumour indications, including ovarian cancer, in the first half of 2023.

About Exscientia

Exscientia is an AI-driven pharmatech company committed to discovering, designing and developing the best possible drugs in the fastest and most effective manner. Exscientia developed the first-ever functional precision oncology platform to successfully guide treatment selection and improve patient outcomes in a prospective interventional clinical study, as well as to progress AI-designed small molecules into the clinical setting. Our internal pipeline is focused on leveraging our precision medicine platform in oncology, while our partnered pipeline broadens our approach to other therapeutic areas. By pioneering a new approach to medicine creation, we believe the best ideas of science can rapidly become the best medicines for patients.

Exscientia is headquartered in Oxford (England, U.K.), with offices in Vienna (Austria), Dundee (Scotland, U.K.), Boston (Mass., U.S.), Miami (Fla., U.S.), Cambridge (England, U.K.), and Osaka (Japan).

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Fred Aswad Fred Aswad

Apeiron Closes $17.5 Million Series A and Launches Strategic Partnerships

GT Apeiron Therapeutics (‘Apeiron’) announced it has completed a $17.5 million Series A financing. Panacea Venture led the investment round with participation from Viva BioInnovator and existing investors. This is the company’s second round of financing in the last year following a Pre-A+ round in May 2021. The investment will enable the company to advance its lead CDK7 program to enter clinical trials, as well as several earlier stage programs. In conjunction with the financing, James Huang, Founding Managing Partner at Panacea Venture joined the Apeiron Board of Directors.

Apeiron, in collaboration with Exscientia (NASDAQ: EXAI), is developing a pipeline of novel CDK therapies. Its leading asset, GTAEXS617, an orally bioavailable, highly potent and selective small-molecule inhibitor of CDK7, is currently in IND-enabling studies and pre-clinical data will be presented at this year’s AACR.

Apeiron also announced a strategic partnership with Viva Biotech (HK: 01873) under which Viva Biotech provides world-leading structure-based drug discovery expertise to enhance Apeiron’s AI-empowered innovative drug discovery and development platform.

“We are excited to welcome a group of visionary investors, embracing our journey and mission to deliver breakthrough therapies to cancer patients globally,” said Dr. Mingxi Li, Co-Founder and CEO of Apeiron, “Over the past two years, our team has built a unique pipeline of precision oncology therapies, focusing on CDKs and synthetic lethality. We will continue strengthen our integrated drug discovery platform with AI and structural biology.”

About GT Apeiron Therapeutics

Apeiron is strategically based in Shanghai and in the San Francisco Bay Area, with significant collaborations in the UK enabling us to tap into technologies and talent from all three continents. Our team and partners bring together deep expertise in oncology and drug discovery to enable efficient and scalable discovery and development of novel drugs.

About Panacea Venture

Panacea Venture is a healthcare focused venture capital firm, with offices in Shanghai, Hong Kong, and Silicon Valley. Founded in 2017, Panacea Venture focuses on investing in and incubating early-stage life science companies with breakthrough technologies and discoveries that can potentially address unmet medical needs and enhance the quality of life on a global scale. Our investment team members are located across China, U.S., and Europe, with an extensive coverage of all the major global life sciences hubs.

About Viva Biotech Holdings

Since its establishment in 2008, Viva Biotech (01873.HK) has always been adhering to the mission of "Becoming the cradle of global innovative biotech companies from around the world" and provided one-stop services for drug R&D and production to global biopharmaceutical innovators. Leveraging the technical advantages in the field of Structure-based Drug Discovery (SBDD), we provide leading CRO drug discovery services and CMC / CDMO services throughout the whole drug production process to global biopharmaceutical clients. At the same time, we focus on finding and investing in high potential biotech start-ups, solve unmet clinical medical needs in the form of EFS (service for equity), and continue to build an open cooperation platform and win-win ecosystem for biotech innovation.

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Fred Aswad Fred Aswad

Apeiron is making its debut at AACR

Dr. Fred Aswad, SVP of Biology at Apeiron will present preclinical data on GTAEXS617, a novel, orally bioavailable, selective small-molecule inhibitor of CDK7 discovered using AI-driven drug discovery. GTAEXS617 is currently in IND-enabling studies. Preclinical data demonstrates that GTAEXS617 has favorable drug like properties and exhibits potent anti-tumour activity in HGSOC and TNBC xenograft tumour-bearing mice, resulting in complete tumour regression. Furthermore, by leveraging Exscientia's precision oncology platform, Apeiron and Exscientia are examining the impact of GTAEXS617 on primary patient cancer samples to identify predictive biomarkers that may enable patient and indication enrichment in early clinical development.

The AACR Conference (American Association for Cancer Research) being held in New Orleans from April 8-13, 2022, is the focal point of the cancer research community.

Stay tuned for Apeiron session:

Title: AI-driven discovery and profiling of GTAEXS-617, a selective and highly potent inhibitor of CDK7

Session Title: Emerging New Anticancer Agents

Abstract Number: #3930

Date/Time: Wednesday, April 13 / 9:00 AM - 12:30 PM CT

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Fred Aswad Fred Aswad

Exscientia and GT Apeiron Therapeutics Enter Oncology Joint Venture

Combines Exscientia’s leading AI-driven drug identification and design capabilities with GT Apeiron’s expertise in cyclin-dependent kinase (CDK) targets for oncology

Expands existing CDK7 drug discovery partnership with additional CDK targeting drugs

  

Oxford & Shanghai – July 21st, 2021 Exscientia, an AI-driven pharmatech company with a mission to revolutionise how drugs are discovered, and GT Apeiron Therapeutics (Apeiron), a Shanghai based company focused on novel oncology drugs, announced today a strategic research and development collaboration agreement. The collaboration will leverage the patient-centric AI-first capabilities of Exscientia to accelerate the discovery of multiple small molecule therapeutic drug candidates designed to selectively treat aberrant cell cycle driven cancers and build a pipeline of CDK novel therapies. All pipeline products will be equally owned and Exscientia holds an equity stake in Apeiron.

This expanded collaboration follows the successful design of multiple selective CDK7 compounds. The potent, highly selective, non-covalent CDK7 compounds have demonstrated consistent tumour responses in xenograft models as well as exceptional pharmacokinetics. In addition, using live primary tissue samples from ovarian cancer patients, the CDK7 inhibitors showed both enhanced tumour cell cytotoxicity as well as selectivity over immune cells in the same microenvironment.

“Based on what they have already achieved, Exscientia is clearly the leader in AI-driven drug discovery, and we have witnessed this first-hand in our collaboration so far.”, stated Dr. Mingxi Li, President of GT Apeiron Therapeutics.  “We have been incredibly impressed by the combined power of the AI design and use of patient data to optimize and select molecules that are more likely to give positive effects in the clinic. This joint venture is a significant step in building GT Apeiron’s valuable and robust pipeline of CDK inhibitor drugs and substantially accelerates our early-stage output and progression towards being a clinical stage biotech company.”

“We are driven to bring drugs to market that make a difference for patients”, says Andrew Hopkins, chief executive officer of Exscientia. Apeiron bring a focus and an expertise on the biological basis of multiple cancers and helps us to create better drugs for better outcomes in the clinic and beyond. This collaboration has already proven to be capable of delivering potential drug candidates with promising patient-relevant data, and we look forward to extending that into a portfolio of multiple clinical assets.”

About GT Apeiron Therapeutics

GT Apeiron Therapeutics is strategically based in Shanghai and in the San Francisco Bay Area, with significant collaborations in the UK enabling us to tap into technologies and talent from all three continents. Our team and partners bring together deep expertise in oncology and drug discovery to enable efficient and scalable discovery and development of novel drugs.

About Exscientia

Exscientia is an AI-driven pharmatech company committed to discovering and designing the best possible medicines in the fastest and most effective manner. Exscientia is the first company to progress AI-designed small molecules into the clinical setting and repeatedly demonstrate the ability of AI to transform how drugs are created. Exscientia’s AI platform has now designed three drugs that are in Phase 1 human clinical trials.

Drug design is precision engineering at the molecular scale. Exscientia has built dedicated AI systems that efficiently learn from the widest range of data and consistently reapply enhanced knowledge through iterations of design. Because Exscientia’s AI platform learns more effectively and rapidly than human-led efforts alone, candidate molecules satisfying complex therapeutic requirements are created with revolutionary efficiency.  Exscientia believes that designing better drugs, faster, will allow the best ideas of science to rapidly become the best medicines for patients.

Exscientia has offices in Oxford, Miami, Osaka and Dundee.  For more information visit on www.exscientia.ai

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Fred Aswad Fred Aswad

GT Apeiron Therapeutics Strengthens Advisory Board

Keith Lenden and Dr. Honggang Bi has been appointed as new members of the Advisory Board at GT Apeiron Therapeutics, an AI empowered drug discovery start-up developing oncology therapeutics. Mr. Lenden and Dr. Bi add further expertise in drug discovery innovation, translational medicine, and clinical development; and deep knowledge and perspectives from both USA and Asia-Pacific region, to the Company's Advisory Board.

Mr. Keith Lenden is a seasoned entrepreneur and leader in the biotechnology and pharmaceutical industries with a proven track record in company formation, executive and project leadership, corporate development and product and market strategy. Mr. Lenden is a Venture Partner at ARCH Venture Partners and a co-founder of Autobahn Therapeutics, Boundless Bio, Receptos (acquired by Celgene), and Abide Therapeutics (acquired by H. Lundbeck A/S).

Dr. Honggang Bi is currently Senior Vice President, Drug Development Head APAC, and General Manager China at Covance by Labcorp, a proven global leader and expert in preclinical development, clinical trial testing and clinical trial management. Dr. Bi brings more than 28 years of industry experience as he held R&D leadership roles at companies such as SmithKline Beecham, Parke-Davis, Pfizer, and Frontage, prior to joining Covance.

The Advisory Board will help support the advancement of Company's differentiated portfolio, including next generation selective CDK inhibitors for oncology.

About GT Apeiron Therapeutics

GT Apeiron Therapeutics is a Shanghai-headquartered biotechnology platform utilizing artificial intelligence and state-of-the-art technologies for drug discovery.

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Apeiron Therapeutics opens US headquarter

Apeiron Therapeutics opens US headquarter in the San Francisco Bay Area. The Bay Area office will enable Apeiron to tap into the deep expertise and talent pool at the intersection of biotechnology and artificial intelligence in the Bay Area and in the broader US. Fred Aswad, Ph.D., J.D., and Vice President of Biology will lead the US efforts.

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Apeiron founded and announces its partnership with Exscientia

Apeiron Therapeutics was launched in 2019 by GT Healthcare Capital Partners. It is a Shanghai-headquartered biotechnology platform utilizing state-of-the-art technologies for drug discovery.

Apeiron Therapeutics is pleased to announce its partnership with Exscientia to accelerate the drug discovery process on several targets in oncology. Details of the deal are not disclosed at this time.

About Healthcare Capital Partners

GT Healthcare Capital Partners is an Asia-based private equity firm that specializes in life science investments around the globe that aim to benefit patients. GT Healthcare aims to provide capital and scale expertise to healthcare businesses in Asia / Greater China.

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