Phase I, Open-Label, Multicentre, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of A Single Intravenous PPMX-T003 in Polycythemia Vera

This is PhaseI Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of PPMX-T003 in Polycythemia Vera

Start Date24 Aug 2022

Sponsor / Collaborator

Perseus Proteomics, Inc.

100 Clinical Results associated with Perseus Proteomics, Inc.

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Literatures (Medical) associated with Perseus Proteomics, Inc.

01 Aug 2024·Leukemia

Amino acid influx via LAT1 regulates iron demand and sensitivity to PPMX-T003 of aggressive natural killer cell leukemia

Article

Author: Nakamura, Naoya ; Hirao, Atsushi ; Nakagawa, So ; Matsuura, Tadashi ; Onizuka, Makoto ; Carreras, Joaquim ; Yamauchi, Takuji ; Hasegawa, Ami ; Ando, Kiyoshi ; Kameda, Kazuaki ; Watanabe, Natsumi ; Yanagiya, Ryo ; Handa, Hiroshi ; Mashima, Tetsuo ; Miyatake, Yuji ; Ueno, Masaya ; Kanamori, Akane ; Kamakura, Takeshi ; Kotani, Ai ; Maeda, Takahiro ; Ishizawa, Kenichi ; Okabe, Sachiko ; Ishii, Keisuke ; Nakayama, Shunya ; Shimizu, Takanobu

AbstractAggressive natural killer cell leukemia (ANKL) is a rare hematological malignancy with a fulminant clinical course. Our previous study revealed that ANKL cells proliferate predominantly in the liver sinusoids and strongly depend on transferrin supplementation. In addition, we demonstrated that liver-resident ANKL cells are sensitive to PPMX-T003, an anti-human transferrin receptor 1 inhibitory antibody, whereas spleen-resident ANKL cells are resistant to transferrin receptor 1 inhibition. However, the microenvironmental factors that regulate the iron dependency of ANKL cells remain unclear. In this study, we first revealed that the anti-neoplastic effect of PPMX-T003 was characterized by DNA double-strand breaks in a DNA replication-dependent manner, similar to conventional cytotoxic agents. We also found that the influx of extracellular amino acids via LAT1 stimulated sensitivity to PPMX-T003. Taken together, we discovered that the amount of extracellular amino acid influx through LAT1 was the key environmental factor determining the iron dependency of ANKL cells via adjustment of their mTOR/Myc activity, which provides a good explanation for the different sensitivity to PPMX-T003 between liver- and spleen-resident ANKL cells, as the liver sinusoid contains abundant amino acids absorbed from the gut.

02 Nov 2023·Blood

Interim Phase I Safety Study of Anti-Transferrin Receptor Antibody(PPMX-T003) in Patients with Polycythemia Vera

Author: Takakuwa, Teruhito ; Matsuura, Tadashi ; Ito, Tomoki ; Hino, Masayuki ; Nakamae, Hirohisa

Background:Transferrin Receptor (TfR) 1 is thought to be anti-cancer target by controlling ion supply for decades. Anti-TfR1 fully human monoclonal antibody (PPMX-T003) has an uniqe epitope on the ligand-binding domain of TfR1. This antibody can efficiently inhibit iron influx into cells rather than preceding reported similar antibodies (US20220332838). This antibody can inhibit growth of erythroblast as well as various cancer cell lines at subnanomolar level, both cells are highly expressed TfR. Antibody administrated on normal cell expressing TfR at low levels has little effect except for RBC formation. Prior to apply cancer therapy, the safety was evaluated at low dose in healty volunteers (Ogama et al., 2023). In this study, we aimed to determine safety profiles at higher dose in patients with polycythemia vera (PV) by inhibiting elevation of erythropoiesis, followed by P1a study. Except for an antibody drug conjugate (CX-2029), this is the first-in-class trial of an unmodified human antibody other than the murine P1a trial conducted in the 1990s.Methods:This is a multicenter, open-label intra-patient dose escalation study (NCT05074550). Adults patients are eligible who were diagnosed with PV and had periodical phlebotomy (PLB) between 4 to 9 weeks. Patients were excluded if they had cytoreductive therapy. The primary objective is to evaluate the safety and the pharmacokinetics after single dose of administration. The secondary objective is pharmacodynamics, such as RBC count, hemoglobin, hematocrit. Dose escalation is an intra-patient dose escalation design, due to disease progression being individually different in each patient. Starting dose (0.25mg/kg) was determined as previous P1a trial in healty volunteers (n=40) observed decreased hemoglobin level out of normal value. A single dose of PPMX-T003 is intravenously infused for 1 hour, one day after a scheduled PLB. Dose is increased (0.25, 0.4, 0.64, 1mg/kg) when the next PLB treatment scheduled within 4 to 9 weeks, depending on the participants' adverse event (AE) profiles. The primary endpoint is the incidence and severity of treatment-related AEs, Key secondary end point meets next PLB does not required for more than 12 weeks.Results:As the data cutoff at the end of June 2023, all three cases did not require PLB for more than 12 weeks as reached endpoint. Two cases did not require PLB immediately after the first single dose of 0.25mg/kg. Both cases were observed no AE. Another patient was required periodical PLB within 4 to 9 weeks interval at two consecutive doses of 0.25-0.4mg/kg, then escalated up to the third dose of 0.64mg/kg till reached end point with mild AE, which was significant fatigue and mild fever, up to 37.6℃ within 24 hours after the highest dose of infusion, approximately 6.5 mg/dL CRP elevation after 3days after infusion, lymphopenia 2days after infusion recovered after 7 days. Those AEs are considered to be standard Infusion Related Reactions observed in other antibody therapeutics. Hematocrit and hemoglobin were controlled below 50% and 15.5g/dL, respectively, while RBC count are rather elevated up to 7 million/mL and MCV was down to 73 fL. Pharmacokinetics revealed half-life of the antibody was up to 12hrs, which is shorter than other antibody therapeutics. Enrollment is on going.Conclusions:AEs are mild as observed within the level of previous healthy volunteer's trial. Efficacy observed in all erythroid parameters including hematocrit, hemoglobin and other parameter shown symptoms seen in iron deficiency anemia. This antibody can specifically suppress erythrocyte differentiation by inhibiting iron influx in the target erythroid lineage, which cells are highly expressed TfR1, without any significant AE on other normal organs with low expression level of TfR. PPMX-T003 affects on erythrocyte differentiation in bone marrow may expect to reduce PLB treatment clinically. This preliminary result could be given helpful safety prospect recently initiated P1/2 trial in patients with aggressive NK leukemia (NCT05863234), supported by a grant from the Japan Agency for Medical Research and Development (23nk0101231j0002).References:Ogama, Y. et al., Phase 1 Clinical Trial of PPMX-T003, a Novel Human Monoclonal Antibody Specific for Transferrin Receptor 1, to Evaluate Its Safety, Pharmacokinetics, and Pharmacodynamics. Clin Pharmacol Drug Dev. 2023;12(6):579

27 Jul 2023·Blood

The hepatic niche leads to aggressive natural killer cell leukemia proliferation through the transferrin-transferrin receptor 1 axis.

Article

Author: Ishida, Fumihiro ; Takahashi, Naoto ; Ishihara, Rei ; Nakazawa, Hideyuki ; Carreras, Joaquim ; Harigae, Hideo ; Nakamura, Naoya ; Miyatake, Yuji ; Fukuhara, Noriko ; Iida, Shinsuke ; Yanagiya, Ryo ; Fujioka, Yuki ; Ando, Kiyoshi ; Murakami, Yuki ; Nakagawa, So ; Imadome, Ken-Ichi ; Higuchi, Hiroshi ; Kanda, Yoshinobu ; Matsuura, Tadashi ; Tagawa, Hiroyuki ; Murayama, Hiromichi ; Hashimoto, Shinichi ; Iwabuchi, Sadahiro ; Ishida, Takashi ; Ishizawa, Kenichi ; Wada, Hidenori ; Ito, Asahi ; Kameda, Kazuaki ; Kotani, Ai

Aggressive natural killer cell leukemia (ANKL) is a rare lymphoid neoplasm frequently associated with Epstein-Barr virus, with a disastrously poor prognosis. Owing to the lack of samples from patients with ANKL and relevant murine models, comprehensive investigation of its pathogenesis including the tumor microenvironment (TME) has been hindered. Here we established 3 xenograft mice derived from patients with ANKL (PDXs), which enabled extensive analysis of tumor cells and their TME. ANKL cells primarily engrafted and proliferated in the hepatic sinusoid. Hepatic ANKL cells were characterized by an enriched Myc-pathway and proliferated faster than those in other organs. Interactome analyses and in vivo CRISPR-Cas9 analyses revealed transferrin (Tf)-transferrin receptor 1 (TfR1) axis as a potential molecular interaction between the liver and ANKL. ANKL cells were rather vulnerable to iron deprivation. PPMX-T003, a humanized anti-TfR1 monoclonal antibody, showed remarkable therapeutic efficacy in a preclinical setting using ANKL-PDXs. These findings indicate that the liver, a noncanonical hematopoietic organ in adults, serves as a principal niche for ANKL and the inhibition of the Tf-TfR1 axis is a promising therapeutic strategy for ANKL.

News (Medical) associated with Perseus Proteomics, Inc.

12 Dec 2023

·www.fiercepharma.com

ASH: J&J, Sanofi square off in newly diagnosed multiple myeloma, with one med showing 'unprecedented' efficacy

Sanofi's Sarclisa aims to compete with Johnson & Johnson's Darzalex in newly diagnosed multiple myeloma. Another data face-off between the two anti-CD38 multiple myeloma drugs—Johnson & Johnson’s Darzalex and Sanofi’s Sarclisa—took place at the 65th American Society of Hematology meeting. Both regimens showed strong efficacy data in newly diagnosed patients, but only one result is considered practice-changing right now. For J&J, a combination of the subcutaneous Darzalex Faspro and the traditional VRd regimen slashed the risk of progression or death by a whopping 58% compared with VRd alone in first-line multiple myeloma patients who were eligible for stem cell transplant, according to data from the phase 3 Perseus trial. VRd consists of Takeda’s Velcade, Bristol Myers Squibb’s Revlimid and the steroid dexamethasone. After a median follow-up of 47.5 months, an estimated 84.3% of patients in the Darzalex arm were alive without disease worsening at the four-year mark, versus 67.7% in the control arm. Such a magnitude of progression-free survival (PFS) benefit is “unprecedented,” Pieter Sonneveld, M.D., Ph.D., from the Erasmus MC Cancer Institute in the Netherlands, who led the Perseus study, said during a press briefing. For doctors who were still holding out after a previous positive phase 2 readout, Perseus offers very important confirmatory data and “changes their practice,” Surbhi Sidana, M.D., from Stanford University, who moderated the press event, added. Sidana was referring to the phase 2 Griffin trial. Back at ASH 2021, that study linked Darzalex-VRd to a similar 54% PFS benefit over VRd alone after a median follow-up of 38.6 months, although the trial was only powered to show statistical significance on tumor clearance. As Sidana noted, many academic myeloma doctors have already adopted the Darzalex-VRd regimen in practice following the Griffin readout. An analysis on overall survival is “a long way” away, Sonneveld said when asked if doctors should wait until that readout. An analysis of median PFS itself is estimated to be as far away as 8 to 10 years, he noted. “If we wait for overall survival data, we deny an effective treatment to a lot of patients,” he said. But one question remains for the Darzalex combo. Though not likely to affect Darzalex’s approvability, it could significantly impact how long doctors end up using the J&J drug, and hence sales. After giving the full combo for six cycles during treatment induction and consolidation, the regimen calls for Darzalex and Revlimid during the maintenance phase for at least two years, or 26 more cycles. It allows patients to discontinue Darzalex only after that time and if the patient has been in a state of deep myeloma cell clearance in the bone marrow, known as minimal residual disease negativity, for at least a year. As Sidana pointed out, the phase 3 Cassiopeia trial previously showed that continuing Darzalex treatment during the maintenance phase was no better than simple observation at fending off disease progression in first-line patients who already achieved a partial response or better after consolidation. Compared with Perseus, Cassiopeia used thalidomide instead of Velcade. Both agents are immunomodulators, and thalidomide is viewed as inferior to Velcade. If Cassiopeia’s finding is translatable to Perseus, many patients simply wouldn’t need the long Darzalex maintenance treatment. “I think you cannot compare those two trials,” Sonneveld said. “Moreover, I think that we show in Perseus trial that [Darzalex] from the start keeps improving the depth of response. MRD negativity keeps improving.” Sarclisa’s rivaling readout Before Tuesday’s Darzalex presentation, investigators also shared positive results for a phase 3 trial of Sanofi’s Sarclisa in newly diagnosed, transplant-eligible multiple myeloma at an ASH plenary session. A combination of Sarclisa, Amgen’s Kyprolis, Revlimid and dexamethasone (KRd) helped significant more patients achieve MRD negativity, compared with KRd alone. Both Velcade and Kyprolis are proteasome inhibitors. Kyprolis is newer, and a phase 3 head-to-head trial called Endeavor previously showed that Kd was better than Vd at extending the lives of patients with relapsed or refractory multiple myeloma. In the phase 3 IsKia trial, 77% of patients who got Sarclisa-KRd reached MRD negativity after consolidation when measured at a sensitivity of 10-5, versus 67% for KRd alone. The Sarclisa group had a 67% higher chance of achieving that status. When measured at an even higher sensitivity of 10-6, the respective rates were 67% versus 48%, respectively. Sarclisa’s advantage showed after induction therapy and was maintained through to consolidation. Investigators are now following patients to see whether that MRD negativity can sustain past one year, with those data expected next year. The Sarclisa-KRd combo’s MRD efficacy looked not so different from the Darzalex-VRd regimen, even though KRd alone appeared superior to VRd. In Perseus, 75.2% of patients on the Darzalex combo achieved MRD negativity rate at any time as measured by 10-5 sensitivity, versus 47.5% for VRd. At a higher sensitivity, the rates were 65.1% and 32.2%, respectively. MRD as a surrogate endpoint The Sanofi data are encouraging. But as Francesca Gay, M.D., Ph.D., from the University of Torino, pointed out during her IsKia presentation, MRD is not yet considered an optimal endpoint that’s accepted by regulators. Researchers are working to build a more robust link between MRD negativity and a PFS benefit. As therapies become increasingly effective, it would take longer trials for newer multiple myeloma agents to prove themselves on the PFS endpoint in first-line myeloma, Peter Voorhees, M.D., from Atrium Health, noted during his introduction of the IsKia data at ASH. Voorhees raised a hypothetical phase 3 trial that pits a bispecific antibody against VRd’s combo with either Darzalex or Sarclisa in first-line transplant-eligible patients. To be statistically powered to show a PFS benefit, the trial would need to enroll more than 1,700 patients, would take nearly four and a half years to accrue and nine-and-a-half years to reach the final PFS analysis. “Clearly, we need a surrogate endpoint for longitudinal outcomes that reads out earlier than progression-free survival if we’re going to continue to make progress for this group of patients,” Voorhees said. MRD has emerged as a powerful tool for measuring response in multiple myeloma and could potentially become a surrogate endpoint, he said, pointing to past pooled analyses associating MRD negativity to better PFS. During his Perseus presentation, Sonneveld also said that MRD negativity “really represents a deep state of responsiveness.” Toward that end, the International Independent Team for Endpoint Approval of Myeloma MRD (I2TEAMM) initiative is collecting data from clinical trials to validate MRD as a surrogate endpoint to ultimately make it an endpoint for drug approval.

Clinical ResultPhase 3Phase 2ASH

19 Oct 2023

·www.prnewswire.com

Monoclonal Antibodies: A Transformative Force in Biopharmaceuticals, Driving Growth in Antibody Discovery Services and Platforms

DUBLIN, Oct. 19, 2023 /PRNewswire/ -- The "Antibody Discovery Market: Focus on Services and Platforms - Distribution by Type of Service Offered, Antibody Discovery Method, Type of Antibody Generated, Nature of Antibody Generated, Therapeutic Areas and Key Geographies: Industry Trends and Global Forecasts, 2023-2035" report has been added to ResearchAndMarkets.com's offering. The global antibody discovery services and platforms market is poised for significant growth, with a projected value of over $1.6 billion in 2023 and a forecasted Compound Annual Growth Rate (CAGR) of 12.0% during the coming years. The market is driven by pharmaceutical companies' increasing reliance on outsourcing antibody discovery processes and the growing demand for targeted therapies. Streamlining Drug Development with Outsourcing The traditional drug development process is lengthy, spanning 10-15 years and involving investments of over $2 billion. Despite these efforts and investments, more than 90% of drug candidates fail in clinical trials. To streamline drug development, reduce timelines, and mitigate financial risks associated with failed trials, pharmaceutical companies are increasingly outsourcing their discovery-stage operations to specialized contract research organizations (CROs). Outsourcing allows companies to optimize resource utilization, save costs, and tap into a global network of scientific talent, ultimately enhancing the efficiency and success rate of bringing novel antibody-based therapeutics to market. Evolution of Monoclonal Antibodies Since the approval of the first monoclonal antibody-based therapy, Orthoclone OKT3, in 1986, monoclonal antibodies have become a versatile class of biopharmaceuticals. These antibodies have seen significant advancements in engineering, format diversification, and discovery methods. Over 160 monoclonal antibodies have been approved worldwide for the treatment of diseases such as cancer, chronic inflammatory diseases, infectious diseases, and cardiovascular diseases. Recent approvals include ELREXFIOT, TALVEYT, Rystiggo, COLUMVI, and EPKINLYT. Due to the complexities associated with discovering such antibodies, many firms are licensing and utilizing specialized antibody discovery platforms and technologies, driving the growth of the antibody discovery services and platforms market. Market Drivers: Biotech Advancements and Increasing Demand Key drivers of the global antibody discovery services and platforms market include recent advancements in biotechnology, a growing demand for targeted therapies, rising prevalence of chronic diseases, increased R&D expenditure in the pharmaceutical industry, and a growing trend of outsourcing antibody discovery. Collaborations between academic institutions and antibody discovery companies further contribute to market growth. Market Size and Segments The global market size for antibody discovery services and platforms is projected to grow at an annualized CAGR of 11.0% during the forecast period. The hit generation segment holds the largest market share, driven by its significance in R&D expenditure. In terms of the antibody discovery method, the hybridoma method is dominant, thanks to its capability to create immortalized cell lines for continuous antibody manufacturing. Regional Analysis: North America Leads North America currently captures nearly 40% of the market, driven by a rising interest in advanced antibody discovery platforms and increased outsourcing in the pharmaceutical industry. North America is anticipated to grow at a CAGR of 12% during the forecast period. Key Players and Recent Developments Key players in the antibody discovery services and platforms market include Ablexis, Antibody Solutions, ChemPartner, GenScript, Genmab, Harbour BioMed, ImmunoPrecise, Mabsilico, and more. Recent developments in the field include the launch of transgenic mouse-based antibody discovery platforms and initiatives to support the discovery of bispecific antibody formats. Recent Developments: In June 2023, AbTherx announced the launch of its transgenic mouse-based antibody discovery platform, AtlasT Mice. In June 2023, Sanyou Biopharmaceuticals, a China-based company, launched its Sanyou Super Trillion Common Light Chain Antibody Discovery Platform, which supports the discovery of bispecific antibody formats. In January 2023, IASO Biotherapeutics raised USD 75 million in a venture series C round, highlighting the increasing funding activity in the antibody drug discovery service and platform domain. In March 2023, Twist Bioscience announced the launch of its antibody discovery services under the Twist Biopharma Solutions subsidiary after acquiring Abveris, an antibody discovery CRO, in 2022. Key Topics Covered: 1. PREFACE 2. RESEARCH METHODOLOGY 3. ECONOMIC AND OTHER PROJECT SPECIFIC CONSIDERATIONS 4. EXECUTIVE SUMMARY 5. INTRODUCTION 6. ANTIBODY DISCOVERY: PROCESS AND METHODS 7. ANTIBODY DISCOVERY SERVICE PROVIDERS: MARKET LANDSCAPE 8. COMPANY COMPETITIVENESS ANALYSIS 9. COMPANY PROFILES: ANTIBODY DISCOVERY SERVICE PROVIDERS 10. ANTIBODY DISCOVERY TECHNOLOGIES: MARKET LANDSCAPE 11. TECHNOLOGY COMPETITIVENESS ANALYSIS 12. COMPANY PROFILES: ANTIBODY DISCOVERY PLATFORM PROVIDERS 13. PARTNERSHIPS AND COLLABORATIONS 14. FUNDING AND INVESTMENT ANALYSIS 15. MARKET IMPACT ANALYSIS: DRIVERS, RESTRAINTS, OPPORTUNITIES AND CHALLENGES 16. GLOBAL ANTIBODY DISCOVERY SERVICES MARKET 17. ANTIBODY DISCOVERY SERVICES MARKET, BY TYPE OF SERVICE OFFERED 18. ANTIBODY DISCOVERY SERVICES MARKET, BY TYPE OF ANTIBODY DISCOVERY METHOD 19. ANTIBODY DISCOVERY SERVICES MARKET, BY NATURE OF ANTIBODY DISCOVERED 20. ANTIBODY DISCOVERY SERVICES MARKET, BY TYPE OF THERAPEUTIC AREAS 21. ANTIBODY DISCOVERY SERVICES MARKET, BY KEY GEOGRAPHIES 22. GLOBAL ANTIBODY DISCOVERY TECHNOLOGIES MARKET 23. ANTIBODY DISCOVERY TECHNOLOGIES MARKET, BY TYPE OF ANTIBODY DISCOVERED 24. ANTIBODY DISCOVERY TECHNOLOGIES MARKET, BY KEY GEOGRAPHIES 25. LICENSING DEAL STRUCTURE 26. SWOT ANALYSIS: ANTIBODY HUMANIZATION SERVICE PROVIDERS 27. CASE IN POINT: DRUG DISCOVERY PROCESSES OF TOP SELLING ANTIBODIES 28. FUTURE GROWTH OPPORTUNITIES IN ANTIBODY DISCOVERY 29. CONCLUSION 30. EXECUTIVE INSIGHTS 31. APPENDIX 1: TABULATED DATA 32. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATION Companies Mentioned 2BScientific 3SBio AAT Bioquest Ab Initio Biotherapeutics Ab Studio ABBA Therapeutics AbBioSci Abbiotec AbbVie Abcalis Abcam AbCellera Abcentra (formerly CardioVax) Abcepta AbCheck Abclonal Abcore ABDYS Abeome Abexxa Biologics ABGENEX AbGenics Life Sciences Abilita Bio ABL Bio Ablexis Ablynx Abnova Abpro AbSano Absci Absea Biotechnology Absolute Antibody Abterra Biosciences AbTherx AbTis Abveris (Acquired by Twist Bioscience) AbVision Abwiz Bio Abzena Abzyme Therapeutics AC Immune Acceleron Pharma Accurus Biosciences AceMab Achaogen Aclys Bio ACROBiosystems ACYTE Biotech Adagene Adaptate Biotherapeutics ADC Therapeutics Adcentrx Therapeutics Adimab AdipoGen Life Sciences Administration for Strategic Preparedness and Response (ASPR) Aduro Biotech AffinityImmuno AFSBio Aganitha Agency for Science, Technology and Research Agenus Agro-Bio AIMM Therapeutics Aimmune Therapeutics Akeagen Akeso Akeso Biopharma Alacrita Alamar Biosciences Aldevron Alector Alexion AlivaMab Discovery Services Alligator Bioscience Allogene Therapeutics Alloy Therapeutics Almirall AlpalifeBio ALSA Ventures Alvaxa Biosciences (Acquired by Sensei Biotherapeutics) ALX Oncology Alytas Therapeutics Amerigo Scientific Amgen AMSBIO Analytics Engine AnaptysBio Angios Annoron Biotechnology Antengene Antibodies Incorporated Antibodies-online Antibody Analytics Antibody Design Labs Antibody Production Services (A division of Life Science Group) Antibody Solutions Antiverse AP Biosciences Apexigen APITBIO Applied Biological Materials Applied StemCell AprilBio Aptevo Therapeutics Aragen Life Sciences Aravive Arctoris Arcus Biosciences argenx Aridis Pharmaceuticals aRNAy Sciences Aro Biotherapeutics Aronora Arsanis Artizan Biosciences Arvinas ARVYS Proteins AskGene Pharma Astellas AstraZeneca aTen Therapeutics Atlantis Bioscience Atlas Venture Atreca ATUM Aureka Aurigene Pharmaceutical Services Autolus Therapeutics Automated Lab Solutions AvantGen Aviva Systems Biology AxioMx Axxora Bayer BBI Group BBI Solutions Beckman Coulter BeiGene BenevolentAI Berkeley Lights Betta Pharmaceuticals Bhami's Research Laboratories Bhat Bio-tech India Big Cypress Acquisition BigHat Biosciences Bill & Melinda Gates Foundation Bill & Melinda Gates Medical Research Institute Bio Bench BioArctic BioAtla BioBench Solutions Biochem Pharma BioClue (Acquired by ImmunoPrecise Antibodies) Bio-Connect Biocure Technology Biocytogen BioD BioDuro-Sundia Biogen BioHub International Trade Bioinborn Scientific Biointron BioInvent BioKey (Acquired by ImmunoPrecise Antibodies) Biologics International Biomolecular Discovery Services BioNTech Bioqube Ventures Bio-Rad Laboratories Biosion BioStrand (Acquired by ImmunoPrecise Antibodies) Biosynth Biotalys Bio-Techne Biotecnol BIOTEM BioTeZ Biotheus BioTickle BioVision BioXpress Therapeutics Bird Rock Bio Blue Sky BioServices (Acquired by LakePharma) BlueBird Bio Bluejay Therapeutics Boan Biotech Boehringer Ingelheim Bolt Biotherapeutics Boster Biological Technology Bristol Myers Squibb Broteio Pharma CALIXAR Cambridge Research Biochemicals CANbridge Pharmaceuticals Cancer Research UK Cantargia Capra Science Capralogics Caris Life Sciences Carterra CASI Pharmaceuticals Catalent Biologics Cayman Chemical CD ComputaBio CDI Laboratories Celexion Celgene Cell Signaling Technology Celltrion Celros Biotech Celsius Therapeutics Centre for Applied Medical Research Centers for Disease Control and Prevention Charles River ChemBio Discovery Solutions ChemPartner Cherry Biolabs Chia Tai Tianqing Pharmaceutical Chiome Bioscience Chipscreen Biosciences ChromoTek Chugai Pharmabody Research Chugai Pharmaceutical Cidara Therapeutics Cilag Citryll City of Hope Cizzle Biotechnology Clayton Biotechnologies Click Chemistry Tools Clinica Universidad de Navarra CliniSciences Columbia University Irving Medical Center Compass Therapeutics Context Therapeutics Coronavirus Immunotherapy Consortium Corvidia Therapeutics Cosmo Bio CP Qingdao Creative Bioarray Creative Biolabs Creative Biostructure Creative Diagnostics Crescendo Biologics Crystal Bioscience CSL Behring Cstone Pharmaceuticals CureVac Curia CUSABIO Cyclogenix Cygnus Technologies DAAN Biotherapeutics Daiichi Sankyo Dako Dana-Farber Cancer Institute Danaher DaTaMabs DBA Italia Deerfield Discovery and Development Denali Therapeutics DetaiBio Diagnostic BioSystems Diatheva Digital Proteomics Dingkang Biology discoveric bio Distributed Bio DJS Antibodies Dragonfly Therapeutics E2DG Eisai Elabscience Eli Lilly and Company Elpis Biopharmaceuticals Emergent BioSolutions Empirico e-nnovation Life Sciences ENPICOM Enthera Entos Pharmaceuticals Envigo EpimAb Biotherapeutics EQRx Erasmus MC Ethris Eureka Therapeutics Eurofins Discovery Everest Medicines Evitria Evotec EVQLV Exelixis ExeVir Bio Exiris exonbio Exscientia Faculta (Acquired by Prosci) FairJourney Biologics Faron Pharmaceuticals Ferring Pharmaceuticals FibroGen Five Prime Therapeutics Fluoroprobes Forty Seven Foundery Innovations Fred Hutchinson Cancer Center Frederick National Laboratory for Cancer Research French Institute of Health and Medical Research Frugi Biotechnology Funakoshi Fusion Antibodies Fusion Pharmaceuticals G&P Biosciences G.CLIPS BIOTECH Gator Bio Genagon Therapeutics Gene Techno Science GeneBeyond Genedata GeneFrontier GENEWIZ (Acquired by Azenta Life Sciences) GeneX India Bioscience Genmab Genome Institute of Singapore Genor Biopharma GenoSafe Genovac GenScript Genuv Gen-Y Biologics GigaGen Gilead Sciences Gladstone Institutes Glenmark Pharmaceuticals Glythera Gmax Biopharm Government of British Columbia Government of Canada Green Mountain Antibodies Grenoble Hospital GSK Gustave Roussy GV20 Therapeutics HaemaLogiX Hangzhou Qiantang River Electric Harbour Antibodies Harbour BioMed Harpoon Therapeutics HD Biosciences Helix BioPharma Jiangsu Hengrui Pharmaceuticals Henlix Biotech Heptares Therapeutics HI-Bio HiFiBiO Therapeutics Himalaya Therapeutics H-Immune Therapeutics (Acquired by HiFiBiO Therapeutics) HJB Holzel Diagnostika Handels Horizon Discovery Hualan Genetic Engineering Hubrecht Institute Humanigen Hummingbird Bioscience I&L Biosystems i2 Pharmaceuticals IAMA France IASO Biotherapeutics Ibex Biosciences iBio Icagen Icosagen IGEM Therapeutics IgGenix IGM Biosciences I-Mab Biopharma iMetabolic Biopharma Immatics Biotechnologies Immorna Immune Biosolutions Immune Pharmaceuticals Immunitas Therapeutics immunitoAI Immunochem ImmunoChina Pharmaceuticals ImmunoGenes Immunome Immunomic Therapeutics ImmunoPrecise Antibodies ImmunoQure Immusmol Immutep In-Cell-Art Incyte Indivumed InflaRx Inhibrx Innate Pharma InnoBation Bio Innovagen Innovative Targeting Solutions Innovent Inotiv InstaDeep Institute for Research in Biomedicine Intarcia Therapeutics (Acquired by i2o Therapeutics) Integral Molecular Integrated DNA Technologies International Livestock Research Institute Invenra Invetx IONTAS IRBM Isogenica Italian National Institute of Health ITBMed iTeos Therapeutics Janssen Jazz Pharmaceuticals Johnson & Johnson Innovation Jotbody Jounce Therapeutics Juno Therapeutics Junshi Biosciences Just Biotherapeutics JW Pharmaceuticals Kadmon Kairos Therapeutics KAKEN PHARMACEUTICAL Kanwhish Biotechnology KareBay Biochem Karolinska University Hospital Kemp Proteins KGbio Kite Pharma KMD Bioscience Kodiak Sciences KYinno Kymab Kyoritsuseiyaku Kyowa Kirin La Jolla Institute for Immunology LabGenius Labtoo LakePharma LamKap Bio LAMPIRE Biological Labs Lanier Biotherapeutics Lava Therapeutics Leadgene Biomedical Leading Biology Leads Biolabs LegoChem Biosciences Leica Microsystems LEO Pharma LG Chem LifeArc LifeTein Ligand Pharmaceuticals Light Chain Bioscience Lineage Cell Therapeutics Lonza Loxo Oncology Lunaphore Lundbeck Luye Pharma MAB Discovery MabGenesis Mablytics Mabpharm MAbSilico mAbsolve MabSpace Biosciences Mabtech MabVax Mabworks MacroGenics Magenta Therapeutics Maine Biotechnology Services Maravai LifeSciences Masaachusetts General Hospital Mass Biologics Maverick Therapeutics Beijing Mede Taikang Biotechnology MedAbome MedGenome Medicilon MedImmune Medix Biochemica MEDx MEMO Therapeutics Memorial Sloan Kettering Cancer Center Merck Merus Mila MI-mAbs Mithra Pharmaceuticals Mitsubishi Tanabe Pharma Corporation Moderna ModeX Therapeutics ModiQuest Molcure Molecular Devices Molecular Templates MolMed Mologic Moradec MorphoSys Mount Sinai MSD MSM Protein Technologies Mycenax Biotech Myrio Therapeutics Mythic Therapeutics Nanjing Chia-Tai Tianqing Pharmaceutical Company Nanocarry Therapeutics NanoCellect Biomedical NanoString Technologies National Cancer Institute National Research Council of Canada's Human Health Therapeutics Research Centre National, Heart, Lung, and Blood Institute NaturalAntibody Nautilus Systems NB Health Laboratory NBE Therapeutics Nelum NeoBiotechnologies NeoClone Neon Therapeutics neoX Biotech Neurimmune Nexum Nidus MB Technologies Nidus 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AcquisitionImmunotherapy

23 Aug 2021

·www.globenewswire.com

Perseus Mining Updates Yaouré Life of Mine Plan

PERTH, Western Australia, Aug. 24, 2021 (GLOBE NEWSWIRE) -- Perseus Mining Limited (ASX/TSX: PRU) has updated its Life of Mine Plan (“LOMP”) for the Yaouré Gold Mine in Côte d’Ivoire, West Africa (“Yaouré”). HIGHLIGHTS 1. OVERVIEW OF YAOURÉ Yaouré is located in a rural area in central Côte d’Ivoire, West Africa, on the southern edge of Lake Kossou, 35 km north-west of the capital city of Yamoussoukro and 25 km east-north-east of the city of Bouaflé. The Kossou hydroelectric power station is located 6 km east of the mine site while the villages of Angovia and Allahou-Bazi are adjacent to the mine site. The main sources of ore to be processed at Yaouré during the remaining 8.0 years of mine life, as currently defined, are two adjacent open pits (CMA and Yaouré) while additional ore will be mined from the smaller Govisou and Angovia 2 pits and two small pit-lets known as Y2N and Y3. Ore feed will continue to be supplemented with oxide material drawn from decommissioned heap leach pads located close to the run-of-mine pad. Ore will be transported from these various sources to the adjacent processing plant and waste will be taken to a single, large waste dump located between the pits and the adjacent villages. Tailings from the process plant will be stored in a single, HDPE lined, tailings storage facility located to the south of the process plant. A significant majority of Yaouré’s workforce live in five local communities located near the mine site. An on-site camp has been constructed to accommodate those members of the workforce who are not local residents. Figure 1: Yaouré Gold Project Layout is available at 2. MINERAL RESOURCES AND ORE RESERVES SUMMARYFor a comprehensive description of Yaouré’s Mineral Resources and Ore Reserves, refer to Perseus’s ASX release, Perseus Mining Updates Mineral Resources and Ore Reserves, dated 24 August 2021. Tables 1 to 3 below summarise the currently estimated Mineral Resources and Ore Reserves at Yaouré. Table 1: Mineral Resources – 30 June 2021 1,2,4 Table 2: Inferred Mineral Resources – 30 June 2021 7, 8 Table 3: Proved and Probable Ore Reserves as at 30 June 2021 5,7 3. LIFE OF MINE PLAN Based on detailed mining and processing schedules recently prepared as part of the life of mine planning process, the key forecast operating parameters for Yaouré are summarised in Table 4. To illustrate the changes to the LOMP since the original Definitive Feasibility Study (“DFS”) was published in November 2017, equivalent data from this study is also tabulated below, however, it should be noted that the updated LOMP is net of depletion of Ore Reserves, that has occurred during FY2021 whereas the DFS incorporates data from the commencement of the planned mining operation. Mining cost estimates in the updated LOMP are based on contracted prices provided by the Spanish mining contractor, EPSA (“EPSA”), who have been carrying out mining activities on site since mining operations started in the September 2020 quarter. EPSA are contracted to perform the full mining, drilling and grade control service required at Yaouré. Explosive costs are based on the contracted prices provided by a subsidiary of the EPC Groupe, one of the world’s leaders in explosives manufacture, storage and distribution. Gold recovery rates and processing costs are based on actual costs incurred and gold recoveries achieved, since processing of ore commenced in the December 2020 quarter, combined with forward projections based on a comprehensive metallurgical test work program for areas with no experiential data. Processing operating costs include costs associated with all consumables including maintenance, electricity, fuel, labour and other processing overheads. G&A and other costs are based on actuals and budget projections of current and future state. G&A operating costs include all labour costs, Abidjan regional office costs, HR administration costs as well as all costs associated with the management of the environment, OH&S, security, government and community relations, general administration including insurances and other contracts. Sustaining capital costs include stage lifting of the TSF, closure costs, progressive clearing, contractor demobilisation, and plant modifications. The total sum estimated for Sustaining Capital is US$51.3M million which over the current life of mine equates to US$36/oz of gold produced. Sustaining capital does not include any capital costs estimated for the delineation of additional Mineral Reserves and Ore Reserves or the establishment of new open pit or underground mining operations. Any such developments will be regarded as development capital and disclosed accordingly. Table 4: Overview Key Parameters 4. MINING AND PROCESSING SCHEDULES Based on the estimated Ore Reserves summarised in Table 3, the mining production profile for Yaouré is forecast as shown in Figure 2 below. No Inferred Mineral Resources have been included as mill feed in the updated LOMP. Ore and waste will be mined from the CMA pit, Yaouré pit, Govisou pit, Angovia 2 pit and the small Y-pits, complimented with the remaining stocks of previously heap leach ore stacked as part of previous decommissioned mining operations. The CMA and Yaouré pits currently provide the bulk of the ore feed sources throughout the life of mine, as currently envisaged. Mining is currently expected to be complete within 6 years of operation from 1 July 2022, with only rehandling of stockpiled ore thereafter. Studies are currently in progress to assess the viability of mining additional open pit and underground mineralisation at several sites within the immediate mining area. It is expected that the studies will result in the progressive addition of further Mineral Resources and Ore Reserves to the LOMP. Figure 2: Yaouré Gold Mine - Scheduled monthly ex-pit material movement by cutback is available at During the first 6 months of gold production at Yaouré, heap leach ore was fed to the mill while the pre-strip in the CMA pit was undertaken. Since March 2021, ore has been fed to the mill from both the CMA pit and historical heap leach pads. A total of 91koz has been depleted by mining and processing ore sourced from these areas in FY2021. In FY2022, the main ore source will continue to be stages 1 and 2 of the CMA pit with additional ore being sourced from the newly added smaller pits on the mining lease. The following 3 years of mill feed is expected to be sourced from the completion of the CMA stages and the two stages of the Yaouré pit. The mining strategy is aimed at maximising the NPV of Yaouré and optimising the mining sequence. The mill feed profile has been scheduled accordingly (refer to Figure 3). The result of this strategy delivers solid cash flows with consistent gold production and low risk profile throughout the forecast mine life. The processing rate averages 3.8 million tonnes per year over an 8-year mine life, an increase of 0.5 million tonnes per year relative to the DFS estimated of mill throughput rate. The improvement in the milling rate at Yaouré is principally the result of strategically timing the blending of oxide material from the heap leach pads with the hard fresh ore to be mined form the CMA and Yaouré pits. The average gold production estimated for the next 3 years of the mine from 1 July 2022, is estimated at approximately 260,000 ounces at an average head grade of 2.3g/t and an average metallurgical recovery of 90.2%. A total of 1.43 million ounces of gold are forecast to be recovered over the currently estimated 8-year life of the Yaouré operation. Figure 3: Yaouré Gold Mine – Annual Tonnes and Grade to Mill is available at This announcement was authorised for release by the Technical Committee of the Board Competent Person Statement: All production targets referred to in this report are underpinned by estimated Ore Reserves which have been prepared by competent persons in accordance with the requirements of the JORC Code. The information in this report that relates to Open Pit and Heap Leach Mineral Resources and Ore Reserves at Yaouré was first reported by the Company in a market announcement released on 28 August 2019 and updated for mining depletion as at 30 June 2021 in a market announcement released on 24 August 2021. The information in this report that relates to Underground Mineral Resources at Yaouré was first reported by the Company in a market announcement released on 5 November 2018 and adjusted to exclude material lying within the US$1,800/oz pit shell that constrains the Open Pit Mineral Resources in a market announcement released on 28 August 2019. The information in this report that relates to the Yaouré near mine satellite deposit Mineral Resource and Ore Reserve estimates was first reported by the Company in a market announcement released on 24 August 2021. The Company confirms that all material assumptions underpinning those estimates and the production targets, or the forecast financial information derived therefrom, in that market release continue to apply and have not materially changed. The Company further confirms that material assumptions underpinning the estimates of Ore Reserves described in “Technical Report — Yaouré Gold Project, Côte d’Ivoire” dated 18 December 2017 continue to apply. Caution Regarding Forward Looking Information: This report contains forward-looking information which is based on the assumptions, estimates, analysis and opinions of management made in light of its experience and its perception of trends, current conditions and expected developments, as well as other factors that management of the Company believes to be relevant and reasonable in the circumstances at the date that such statements are made, but which may prove to be incorrect. Assumptions have been made by the Company regarding, among other things: the price of gold, continuing commercial production at the Yaouré Gold Mine, the Edikan Gold Mine and the Sissingué Gold Mine without any major disruption due to the COVID-19 pandemic or otherwise, , the receipt of required governmental approvals, the accuracy of capital and operating cost estimates, the ability of the Company to operate in a safe, efficient and effective manner and the ability of the Company to obtain financing as and when required and on reasonable terms. Readers are cautioned that the foregoing list is not exhaustive of all factors and assumptions which may have been used by the Company. Although management believes that the assumptions made by the Company and the expectations represented by such information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate. Forward-looking information involves known and unknown risks, uncertainties, and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any anticipated future results, performance or achievements expressed or implied by such forward-looking information. Such factors include, among others, the actual market price of gold, the actual results of current exploration, the actual results of future exploration, changes in project parameters as plans continue to be evaluated, as well as those factors disclosed in the Company's publicly filed documents. The Company believes that the assumptions and expectations reflected in the forward-looking information are reasonable. Assumptions have been made regarding, among other things, the Company’s ability to carry on its exploration and development activities, the timely receipt of required approvals, the price of gold, the ability of the Company to operate in a safe, efficient and effective manner and the ability of the Company to obtain financing as and when required and on reasonable terms. Readers should not place undue reliance on forward-looking information. Perseus does not undertake to update any forward-looking information, except in accordance with applicable securities laws.

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