Janux Therapeutics, Inc. · NASDAQ:JANX
Janux Therapeutics — Investor Presentation (March 2024)
36 slides from Janux Therapeutics's investor presentation, March 2024
Slide 1: Tumor Activated Cancer Therapeutics
Tumor Activated Cancer Therapeutics Restoring anti-tumor immune responses to treat cancer patients March 2024
Slide 2: Forward-looking statements and disclaimers
Forward-looking statements and disclaimers This presentation includes certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking sta
Slide 3: Janux – multiple near-term high value opportunities in CD3 TCE targets
Janux – multiple near-term high value opportunities in CD3 TCE targets Clinical Pipeline • PSMAxCD3-TRACTr to treat mCRPC illustrating a potential best-in-class profile • Promising efficacy with favorable safety profile and no CRS > Grade 2 observed • Deepening PSA and RECIST responses with increase
Slide 4: Multiple programs in Janux drug development pipeline
Multiple programs in Janux drug development pipeline Clinically validated targets Stage of Development Initial Program Target(s) Discovery IND-Enabling Phase 1 Phase 2 Phase 3 Indication(s) Wholly owned TRACTr Programs PSMA-TRACTr PSMAxCD3 mCRPC JANX007 EGFR-TRACTr CRC, SCCHN, EGFRxCD3 JANX008 NSCLC
Slide 5: T-cell engagers – a strategy for creating potent anti-tumor immune responses
T-cell engagers – a strategy for creating potent anti-tumor immune responses Solid tumor treatments have been hindered by safety and PK challenges Limitations of conventional TCEs Conventional TCEs are not tumor specific and Healthy bind to all tissues expressing target Tissue • Healthy tissue activ
Slide 6: Janux Tumor Activated T-Cell Engager (TRACTr) platform design principles
Janux Tumor Activated T-Cell Engager (TRACTr) platform design principles Each program is designed as a potent T-cell engager with reduced toxicity Healthy Tissue Tumor Tissue Tumor Tissue Activation • Tumor proteases cleave linkers • Releases both masks and the half-life extender • Fully active TCE
Slide 7: JANX007 interim clinical PK data consistent with TRACTr design principles
JANX007 interim clinical PK data has been consistent with TRACTr design principles TRACTr activation without TCE accumulation observed PK of TRACTr Components in a mCRPC Subject 0.1 mg 0.3 mg 0.45 mg • TRACTr plasma levels consistent with ≥ once-weekly dosing Plasma concentration (nM) 10 PSMA TRACTr
Slide 8: Janux clinical update summary
Janux clinical update summary Proof of Principle • PSMA and EGFR-TRACTr clinical programs showcase an early display of efficacy combined with a differentiated favorable safety profile in heavily pre-treated, late state cancer patients • Clinical data provides compelling proof-of principle for the TR
Slide 9: PSMA-TRACTr Program
PSMA-TRACTr Program JANX007
Slide 10: JANX007 phase 1 trial design in mCRPC
JANX007 phase 1 trial design in mCRPC Eligibility Criteria QW • Male ≥18 years of age at the time of signing informed consent • Histologically or cytologically C8 TBD confirmed adenocarcinoma of the prostate C7 0.3/1/3 mg Q2W or Q3W • Documented progression after treatment with least 1 anti- C6 0.2/
Slide 11: Summary of preliminary data from ongoing Phase 1a trial of JANX007
Summary of preliminary data from ongoing Phase 1a trial of JANX007 Continued deepening of PSA reductions with increased dose levels while maintaining low-grade CRS and TRAE profiles Efficacy Safety • Subjects with first step dose ≥ 0.2mg (n=6) • CRS PSA30 PSA50 PSA90 • No CRS > Grade 2 for any cohor
Slide 12: JANX007 subject characteristics
JANX007 subject characteristics Heavily pre-treated subjects with a median of 4+ lines of therapy Characteristic All subjects, n = 23 Median age, years (range) 69 (46-75) Race White, n (%) 17 (74) Asian, n (%) 1 (4) Black, n (%) 4 (17) Number of prior lines of therapy, median (range) 4 (2 – 6) Prior
Slide 13: PSA responses deepening with increased doses while maintaining low grade CRS
PSA responses deepening with increased doses while maintaining low grade CRS CRS observed only in subjects with PSA reductions Best Overall % Change in PSA Values From Baseline 40 * • Early evidence of antitumor activity Flat Dose Cohorts QW 20 • PSA declines observed in the majority 0.1 mg 0 * of s
Slide 14: JANX007 PSA reduction and CRS addresses limitations of prior PSMA-TCEs
JANX007 combination of PSA reduction and CRS addresses safety and efficacy limitations of prior PSMA-TCEs G3 P90 Competitive PSA drops G1/2 • High response rate Percentage of Subjects P90 P50 • Majority of subjects experienced PSA declines G1/2 G3 G1/2 • Greater percentage of subjects achieving ≥50%
Slide 15: Improved PSA responses observed at higher doses of JANX007
Improved PSA responses observed at higher doses of JANX007 Subjects receiving initial step dose of 0.1 mg Subjects receiving initial step dose of ≥ 0.2 mg 100 100 0.2 mg 0.6 mg 2 mg 0.1 0.3 0.45 mg or or or % PSA change from baseline 75 mg mg or 1mg 75 0.3 mg 1 mg 3 mg % PSA change from baseline 50
Slide 16: Prior therapies and time on JANX007 treatment for all subjects
Prior therapies and time on JANX007 treatment for all subjects PRIOR THERAPIES: Tn PARP RL Received Tx Tn: taxane; RL: 177Lu-TRT Flat Dose Cohorts QW 0.1 mg 0.3 mg Step Dose Cohorts QW 0.05/0.1/0.3 mg 0.1/0.3/0.45 mg 0.1/0.3/1 mg 0.2/0.6/2 mg 0.3/1/3 mg QW Step Dose Cohorts Q2W target 0.1/0.3/1 mg 0
Slide 17: Significant tumor burden reductions demonstrated by PSMA-PET
Significant tumor burden reductions demonstrated by PSMA-PET Subject 013 (cohort 4, 0.1/0.3/0.45mg) Past medical history Baseline 9 Weeks • Subject: 75-year-old • Diagnosis: Nov 2020 with Gleason score 9, stage IVB • Prior therapies: heavily treated with 6 prior lines of therapy JANX007 treatment hi
Slide 18: Treatment related adverse events in ≥2 subjects
Treatment related adverse events in ≥2 subjects Majority low-grade AEs occurring in cycle 1 of treatment All Subjects (n=23) All Subjects (n=23) Preferred Term Preferred Term Grade 1 Grade 2 Grade ≥3 All Grades Grade 1 Grade 2 Grade ≥3 All Grades Cytokine release syndrome 8 (35) 13 (57) 0 21 (91) My
Slide 19: Emerging clinical data highlights the competitive potential for JANX007
Emerging clinical data highlights the competitive potential for JANX007 AMG509 (n=44) ARX517 (n=23) Characteristic JANX007 (n=18) JANX007 (n=6) STEAP1xCD3 PSMA-ADC Selected cohorts 1st dose ≥ 0.1mg 1st step dose ≥ 0.2mg Target dose ≥ 0.75mg Dose ≥ 2mpk ≥ 30% PSA 78% 100% 77% 61% ≥ 50% PSA 56% 83% 59
Slide 20: JANX007 positioning in mCRPC
JANX007 positioning in mCRPC Target • PSMA is a clinically validated (Pluvicto®) and highly expressed target that is expressed in >80%† of mCRPC patients JANX007 potential development strategies • Single-agent efficacy and safety data in heavily pre-treated, late-stage mCRPC patients • Supports sing
Slide 21: Substantial market potential for a best-in-class TCE in mCRPC
There is substantial market potential for a best-in-class TCE in mCRPC Metastatic Castration Resistant Prostate Cancer (~70k) 1L 2L+ 3L+ (42k) (27k) (18k) Enza, abi, chemo Abi, chemo, enza, Pluvicto®, Xofigo®, PARP Chemo, Pluvicto®, pembro, Xofigo®, abi, enza JANX007 Potential Market Opportunity ~$2
Slide 22: EGFR-TRACTr Program
EGFR-TRACTr Program JANX008
Slide 23: EGFR-TRACTr is being evaluated in multiple large patient settings
EGFR-TRACTr is being evaluated in multiple large patient settings EGFR Overexpression in Phase 1 Indications US Yearly New Cases of EGFR Overexpressed Cancers NSCLC 50% - 90% Phase 1a indications CRC ~80% Overexpressed EGFR incidence RCC 73% - 94% Expansion HNC 90% - 95% indications US Globocan, 202
Slide 24: JANX008 Phase 1 trial design in NSCLC, SCCHN, CRC, and RCC
JANX008 Phase 1 trial design in NSCLC, SCCHN, CRC, and RCC Eligibility Criteria • Subjects ≥18 years of age at the time of signing informed consent • Histologically or cytologically QW documented locally advanced or metastatic NSCLC, SCCHN, CRC, or RCC • Progressed or was intolerant to all C6 TBD av
Slide 25: Summary of preliminary data from ongoing Phase 1a trial of JANX008
Summary of preliminary data from ongoing Phase 1a trial of JANX008 Encouraging signs of efficacy coupled with differentiated, low-grade CRS and TRAE profiles demonstrated in early cohorts Efficacy Safety • Confirmed RECIST partial response with 100% target • CRS lesion reduction in a subject with NS
Slide 26: JANX008 subject characteristics
JANX008 subject characteristics All subjects NSCLC CRC RCC SCCHN Characteristic n = 11 n=4 n=4 n=2 n=1 Median age, years (range) 65 (37 – 81) 67.5 (62 – 71) 53 (37 – 72) 61.5 (42 – 81) 65 (65) Male, n (%) 8 (73) 3 (75) 2 (50) 2 (100) 1 (100) White/Black/Asian, % 100/0/0 100/0/0 100/0/0 100/0/0 100/0
Slide 27: Time on treatment for all subjects
Time on treatment for all subjects 21001 CRC 21002 CRC Flat Dose Cohorts QW 21003 SCCHN SD 0.05 mg 21005 NSCLC 0.15 mg 100% decease size of TL and elimination of hepatic metastasis 1 mg 21008 NSCLC Confirmed PR Step Dose Cohorts QW 0.5/1.25 mg 21009 NSCLC SD 21010 CRC SD - On treatment 21011 RCC NE
Slide 28: Confirmed PR observed in a heavily pretreated subject with NSCLC
Confirmed PR observed in a heavily pretreated subject with NSCLC, ongoing at 18 weeks Subject 21008 (0.15 mg QW) Past medical history JANX008 treatment summary • Subject: 62-year-old male • Cycle 1 Day 1: 11 Oct 2023 • Diagnosis: Feb 2021 with NSCLC, adeno, Stage IIIB • Active on therapy • Mutations
Slide 29: Early anti-tumor activity observed in a subject with RCC
Early anti-tumor activity observed in a subject with RCC Subject 21011 (0.5/1.25 mg QW) Past medical history • Subject: 42-year-old male • Diagnosis: Jan 2023 with RCC, clear cell, stage IV • Mutations: MSI-L/MSS, pMMR • Prior therapies: three prior lines of therapy JANX008 treatment summary • Cycle
Slide 30: Encouraging anti-tumor activity observed in early cohorts
Encouraging anti-tumor activity observed in early cohorts 40 28% 24% Best % Change from baseline in sum of 18% 20 17% 4% RCC NSCLC 0% 011 008 0 NSCLC CRC SCCHN CRC NSCLC CRC Flat Dose Cohorts QW 005 001 003 002 009 010 0.05 mg -20 -12%* Early evidence of anti-tumor activity diameters 0.15 mg in anti
Slide 31: Treatment related adverse events
Treatment related adverse events All Subjects (n=11) All Subjects (n=11) TRAE Preferred Term TRAE Preferred Term Grade 1 Grade 2 Grade ≥3 All Grades Grade 1 Grade 2 Grade ≥3 All Grades Arthralgia 3 (27) 0 0 3 (27) Lymphocyte count decreased 0 1 (9) 0 1 (9) Anemia 0 1 (9) 1 (9) 2 (18) Oedema peripher
Slide 32: Combination of efficacy and safety enables opportunity in multiple large indications
Combination of efficacy and safety enables opportunity to treat multiple large patient indications EGFR Overexpression JANX008 Potential Market Opportunity Additional NSCLC $4B+ Opportunities 50% - 90% • Breast • Bladder • Ovarian $4B+ CRC • Liver ~80% • Pancreas $2B+ RCC 73% - 94% $2B+ SCCHN 90% -
Slide 33: Corporate Summary
Corporate Summary y Janux
Slide 34: Plug-and-play platform designed to enable rapid generation of tumor activated therapeutics
Plug-and-play platform designed to enable rapid generation of potential tumor activated therapeutics TRACTr & TRACIr Pipeline Research Programs Tumor Binding Domains Cleavable Mask Linker Multiple Tumor BD PSMA EGFR Targets T Cell BD T Cell Binding Domains Cleavable Mask Linker Albumin BD Multiple C
Slide 35: Janux scientific and business leadership team
Janux scientific and business leadership team Byron Robinson, Ph.D., J.D. Tommy DiRaimondo, Ph.D. Chief Strategy Officer Chief Scientific Officer Zach McIver, D.O., Ph.D. David Campbell, Ph.D. Tighe Reardon, CPA Vice President President and Chief Executive Officer Acting Chief Financial Officer Clin
Slide 36: David Campbell, Ph.D.
JanuxRx.com David Campbell, Ph.D. President and CEO 10955 Vista Sorrento Parkway San Diego, CA 92130 [email protected]
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