0001640455FALSE00016404552022-09-012022-09-01

 
 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 
________________________________
FORM 8-K
_____________________________________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of The Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported): August 30, 2022
 
________________________________________________________________________________________________________
JOUNCE THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
________________________________________________________________________________________________________
 
Delaware 001-37998 45-4870634
(State or Other Jurisdiction
of Incorporation)
 (Commission
File Number)
 (IRS Employer
Identification No.)
 
 
780 Memorial Drive 02139
Cambridge,Massachusetts
(Address of Principal Executive Offices) (Zip Code)
 
Registrant’s telephone number, including area code: (857) 259-3840

Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
 
    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, $0.001 par value per shareJNCEThe Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  



Item 7.01. Regulation FD Disclosure.
Jounce Therapeutics, Inc., a Delaware corporation (the “Company” or “Jounce”), prepared the corporate presentation attached as Exhibit 99.1 to this Current Report on Form 8-K (the "Corporate Presentation"). Information from this Corporate Presentation may be used by the management of the Company in future meetings regarding the Company. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.1.
The information in Item 7.01 in this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing. 
Item 8.01.  Other Events.
On August 30, 2022, the Company issued a press release providing an update on the Company's Phase 2 SELECT trial of vopratelimab in combination with pimivalimab versus pimivalimab alone in immunotherapy naïve, TISvopra biomarker-selected, second line non-small cell lung cancer patients. A copy of this press release is filed as Exhibit 99.2 to this Form 8-K and incorporated herein by reference. The information contained on websites referenced in this press release is not incorporated herein.
Cautionary Note Regarding Forward-Looking Statements
This Form 8-K contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Form 8-K, including without limitation, Jounce’s expectations regarding the timing, expansion, progress, results of and release of data for clinical trials of Jounce’s product candidates, including vopratelimab and pimivalimab, are forward-looking statements. The words “trend,” “expect,” “will,” “intend,” “plan” or similar terms, variations of such terms or the negative of those terms are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including, without limitation, Jounce’s ability to successfully demonstrate the efficacy and safety of its product candidates; risks that the COVID-19 pandemic may disrupt Jounce’s business and/or the global healthcare system more severely than anticipated, which may have the effect of delaying completion of Jounce’s ongoing clinical trials, or delaying timelines or data disclosures and regulatory submissions for its product candidates; risks that the invasion of Ukraine and political unrest in the surrounding region may disrupt clinical trial activities, which may adversely affect the completion of Jounce’s ongoing clinical trials, or delay timelines or data disclosures; the clinical results for its product candidates, which may not support further development and marketing approval; the potential advantages of Jounce’s product candidates; Jounce’s ability to successfully manage its clinical trials; the development plans of its product candidates and any companion or complementary diagnostics; management of Jounce’s supply chain for the delivery of drug product and materials for use in clinical trials and research and development activities; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials of Jounce’s product candidates; abstract submissions and acceptance, or lack thereof, related to Jounce’s clinical programs; Jounce’s ability to obtain, maintain and protect its intellectual property; Jounce’s ability to manage operating expenses and capital expenditures; and those risks more fully discussed in the section entitled “Risk Factors” in Jounce’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission as well as discussions of potential risks, uncertainties, and other important factors in Jounce’s subsequent filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and Jounce undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Item 9.01.  Financial Statements and Exhibits.
(d) Exhibits
Exhibit No.    Description
 
104Cover Page Interactive Data File (embedded within the Inline XBRL document)




SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 JOUNCE THERAPEUTICS, INC.
   
Date: August 30, 2022By:/s/ Kim C. Drapkin
  Kim C. Drapkin
  Treasurer and Chief Financial Officer


Jounce Therapeutics Corporate Presentation A NEXT GEN IMMUNOTHERAPY COMPANY AUGUST 2022 Exhib i t 99.1


 
Legal Disclaimer 2 Various statements concerning our future expectations, plans and prospects, including without limitation, our expectations regarding financial guidance, operating expenses and capital expenditures, the timing, initiation, progress, results of and release of data for clinical trials of our product candidates, including JTX-8064, vopratelimab and pimivalimab, identification, selection and enrollment of patients for our clinical trials, the timing, progress and results of discovery programs, preclinical studies and clinical trials for our product candidates and any future product candidates, the potential benefits of any of these product candidates and the timing or likelihood of regulatory filings, and our cash position may constitute forward- looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws and are subject to substantial risks, uncertainties and assumptions. . You should not place reliance on these forward-looking statements, which often include words such as “anticipate,” “expect,” “goal,” ”trend,” “may,” “plan,” “predictive” or similar terms, variations of such terms or the negative of those terms. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee such outcomes. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, risks that the COVID-19 pandemic and/or the conflict in Ukraine may disrupt our business and/or the global healthcare system more severely than we have anticipated, which may have the effect of further delaying our ability to enroll and complete our ongoing clinical trials, delaying our timelines for conducting analyses of our clinical trial data, preparing regulatory submissions or disclosing data, or delaying or interrupting the work of our third-party partners, our ability to successfully demonstrate the efficacy and safety of our product candidates and future product candidates, the preclinical and clinical results for our product candidates, which may not support further development and marketing approval, the potential advantages of our product candidates, the development plans of our product candidates, the management of our supply chain for the delivery of drug product and materials for use in our clinical trials and research and development activities, the use of our product candidates in combination with other therapies and our ability to obtain such therapies, actions of regulatory agencies, which may affect the initiation, timing and progress of preclinical studies and clinical trials of our product candidates and our anticipated milestones, our ability to obtain, maintain and protect our intellectual property, our ability to enforce our patents against infringers and defend our patent portfolio against challenges from third parties, the market opportunity for our product candidates, competition from others developing products for similar uses, our ability to manage operating expenses, our ability to establish or maintain collaborations, our dependence on third parties for development, manufacture and commercialization of product candidates and unexpected expenditures, as well as those risks more fully discussed in the section entitled “Risk Factors” in Jounce’s most recent Annual Report on Form 10-K or Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and we undertake no obligation to update or revise publicly any forward- looking statements, whether as a result of new information, future events or otherwise.


 
Proven Management Team • Founded by IO pioneers: Nobel Coley Lasker Prize • Cash runway into Q1 2024 The Jounce Difference 3 * Out licensed to Gilead Sciences, Inc. (clinical trial sponsor) The right immunotherapy for the right patients Productive Translational Science Platform • Various immune cell types • Pharmacodynamic & predictive biomarkers • Multiple value generating deals Internally Developed Candidates in Clinical Trials • JTX-8064 (LILRB2) • Vopratelimab (ICOS) • Pimivalimab (PD-1i) • GS-1811 (CCR8)* Next Clinical Candidate in IND enabling studies • JTX-1484 (LILRB4) 4 Platform Pipeline Milestones Corporate Profile Clinical Data Expected from Both Lead Programs by Year End • INNATE Study: JTX-8064 & Pimivalimab • SELECT Study: Vopratelimab & Pimivalimab


 
The Challenge and Promise of IO Therapy Lessons Learned Define New Opportunities 4 *PD-(L)1i = PD-1 inhibitor or PD-L1 inhibitor • Tumor with PD-(L)1i* approval • Minority of pts benefit • Tumor with PD-(L)1i approval • Majority pts do not respond • Tumor with no PD-(L)1i approval • Little to no benefit in that tumor Human Solid Tumors & Immunotherapy Response Different Immune Cell Types Can Mediate Activation and Suppression Multiple barriers to realizing a full immune response to the tumor Primary or Acquired PD-(L)1i resistance inhibits even broader use of IO CD8 T cells CD4 T cells T reg cells Myeloid NK cells Pimivalimab Vopratelimab JTX-8064 GS-1811 JTX-1484 Anti-LILRB1


 
New Immune Cell Targets Are Needed For Next Gen IO Extend benefit to more patients and realize IO market potential 5 2022 IO Market $44B* 2026 IO market $74B & growing* Next Gen IO T cell-focused • Durable benefit in minority of patients • Many tumor types unresponsive • Majority of combos are chemo Multi-immune cell-focused • New IO mechanisms (myeloid cell CPI**) • Extend IO benefit to: • PD-(L)1 treatment resistance • T cell CPI unresponsive tumor types • Employ biomarkers to reach new patients * GlobalData PD-(L)1 and CTLA-4 sales forecast **CPI = checkpoint inhibitor


 
Human Tumor Samples The Core of Our Approach: Translational Science Platform 6 *PD= Pharmacodynamic Translational Drug Discovery • Sustainable engine • Multiple immune cell types • Goal of new IND every 12 – 18 months Reverse Translational Analysis • Patients with clinical outcomes • PD* and predictive biomarkers • Patients more likely to respond


 
DISCOVERY PROGRAMS LILRB1 (ILT2) Myeloid & Lymphoid Bi-Specifics (Not Disclosed) Diverse Immune Cell Types Other Targets (Not Disclosed) PD-(L)1i Resistance Mechanisms Jounce Immunotherapy Pipeline 7 * Formerly JTX-1811 now out-licensed to Gilead Sciences, Inc. Program Target Biology Discovery Preclinical IND Enabling Clinical Phase 1 Phase 2 Phase 3 DEVELOPMENT PROGRAMS Vopratelimab ICOS CD4 Focused Pimivalimab PD-1 CD8 Focused JTX-8064 LILRB2 (ILT4) Macrophage Focused GS-1811* CCR8 T-Reg Focused JTX-1484 LILRB4 (ILT3) Myeloid Focused SELECT (PD-(L)1i naïve patients) SELECT & INNATE INNATE (PD-(L)1i experienced & naïve patients)


 
Lead Macrophage Program: JTX-8064 8


 
JTX-8064: Potential Macrophage Checkpoint Inhibitor LILRB2 / ILT4 Target • LILRB2 is expressed on immunosuppressive macrophages • Immunosuppressive macrophages are a negative prognostic factor for many cancer types • Inhibition of LILRB2 reprograms macrophages to an immune active state and activates T cells • Supportive clinical data on the target* 9 *Siu et al. ESMO Sep. 2020; Siu et al. Clinical Cancer Research, Jan. 2022 (Merck’s LILRB2 / ILT4 Program) JTX-8064 Program Highlights • Novel, highly selective & potent IgG4 antibody to LILRB2 • Potential to reverse PD-(L)1i resistance • INNATE Trial: • Monotherapy and combo dose escalation complete • Phase 2 POC expansion cohorts initiated • Ovarian and Renal Cell Carcinoma combo cohorts advanced to Simon’s 2nd stage • Ovarian combo cohort completed stage 2 enrollment • NSCLC (2/3L) cohort did not meet stage 2 expansion criteria • Well tolerated to date Preliminary Clinical Data by Year End


 
LILRB2 (ILT4) May Inhibit Response to PD-(L)1i Therapy 10 • CD163 is a general marker for immunosuppressive macrophages • Similar associations between OS and CD163 have been reported for most tumor types in INNATE High LILRB2 / IFNγ Signature Ratio Correlates With Poor Response to PD- (L)1i Treatment2 1 Analysis of TCGA data; Each dot represents one tumor sample. Spearman correlation coefficient: 0.77 2 Data adapted from Mariathasan et al. Nature 2018; Responder = complete or partial response. Expression data from pre-treatment biopsies; Additional details presented by McGrath et al at AACR 2021; *** p<0.0001 P = 0.0006 n=66 High Levels of Immunosuppressive Macrophages (CD163+) are a Negative Prognostic Marker in Many Cancer Types Correlation between LILRB2 and CD1631 Clear Cell Renal Cell Carcinoma ***


 
JTX-8064 Inhibits A Unique Macrophage Checkpoint LILRB2 (ILT4) Proposed mechanism of action 11 Potential to Reverse PD-(L)1i Resistance JTX-8064 Immunosuppressive Macrophage (M2-like) Immune Activated Macrophage (M1-like) • Cytokine Production • Antigen Presentation • T-cell Activation


 
JTX-8064 Reprograms Macrophages to Enhance T Cell Responses 12 1. Cohen et al., Abstract 5007, AACR 2019; 2. McGrath et al., Abstract 1727, AACR 2021. JTX-8064 reprogrammed macrophages are more effective at stimulating T cells in co-culture2 Reprogramming of macrophages from M2 to an M1 state through inhibition of LILRB21 JTX-8064 precursors polarize macrophages to an M1 state1 Control IgG JTX-8064 T cells only T cells + macrophagesT cells only T cells + macrophages Control IgG JTX-8064 IF N γ (p g/ m l) N um be r o f C D8 + T Ce lls 4-fold decrease 4-fold increaseSame P < 0.05 (with FDR correction) normalized to isotype control T-Cell Activation T-Cell Proliferation Downregulated Upregulated


 
Translational Informatics Defined Initial Tumor Types Higher Lower • Relative evaluation and ranking across all TCGA indications • Focus on 3 key RNA measures (LILRB2, Jounce TAM signature, IFNγ signature) • Figure sorted by LILRB2 13 TUMOR TYPE Testicular Cancer Mesothelioma Renal Cancer (clear cell) Soft Tissue Sarcoma NSCLC (nonsquamous) Gastric Cancer NSCLC (squamous) Pancreatic Cancer HNSCC Renal Cancer (papillary) Ovarian Cancer Liver Cancer Melanoma / Skin Cancer Colon Cancer Breast Cancer Top ranked tumor typesPrimary tumors ranked by median biomarker levels (TCGA) • Strong biologic rationale • High unmet medical need • Negative prognostic factors may be positive predictive markers


 
Mono (n=22) & Combo (n=9) Dose Escalation Completed  JTX-8064: INNATE Study Designed to Rapidly Demonstrate POC Preliminary Clinical Data by Year End 2022 • Full receptor occupancy at 300mg • 700mg RP2D* • No DLTs** (up to 1200mg) 14 Combo expansions • Ovarian (3/4L) • HNSCC (1L) • Sarcoma (2-4L) • HNSCC (2/3L) • ccRCC (2/3L) • NSCLC (2/3L)†† • cSCC (2/3L) PD-(L)1 Resistant Patients Mono expansion • Ovarian (3/4L) IO Naïve Patients • Ovarian (3/4L IO naïve) • ccRCC (2/3L PD-(L)1 resistant) Simon’s 2-Stage Expansion Cohorts Stage 1 (n = 14 mono; 10 combo) Stage 2 (Total n = up to 47 mono; 29 combo) † * RP2D = recommended Phase 2 Dose; ** DLT = Dose Limiting Toxicities; † Combined total of Stage 1 and 2 †† Did not meet criteria for stage 2 expansion


 
JTX-8064: INNATE Three Categories of Patients Mechanistic potential to improve effectiveness of T cell-directed therapies 15 3/4L Ovarian Cancer (Mono & Combo) No Approved PD-(L)1i (IO Naïve Patients) 1L Head and Neck Squamous Cell Carcinoma Approved PD-1i (IO Naïve Patients) 2/3L clear cell Renal Cell Carcinoma 2-4L Triple Negative Breast Cancer* 2/3L Head and Neck Squamous Cell Carcinoma 2/3L Cutaneous Squamous Cell Carcinoma 2/3L Non-Small Cell Lung Cancer* PD-(L)1i Resistant (progressed on or after PD-(L)1i Tx) 2-4L Sarcoma (UPS and LPS) Clinical Response to T Cell Checkpoint Inhibitors Unmet Medical Needs & Potential for New Mechanisms *Closed to enrollment


 
High Unmet Need in INNATE Indications * Clinical trial patients who received PD-(L)1i treatment beyond RECIST progression (PD-(L)1i as last prior therapy) References: 1 Gandara et al. Journal of Thoracic Oncology 2018; Kazandjian et al. Seminars in Oncology 2017; 2 Haddad et al. Cancer 2019; 3 Escudier et al. European Urology 2017, McDermott et al. Journal of Clinical Oncology 2016 reported an ORR of 21% from a Phase 1a trial; 4 Burgess et al. J Clin Oncol 37, 2019 (supplemental abstract 11015), Chen et al. J Clin Oncol 38: 2020 (supplemental abstract 11511); 5 Keytruda® prescribing information; 6 Matulonis et al. J Clin Oncol 38: 2020 (supplemental abstract 6005) 16 PD-(L)1i resistant patients* Tumor Type ORR for PD-(L)1i (Ph 2 & Ph 3 trials) NSCLC 7% 1 HNSCC 5% 2 RCC 13% 3 cSCC No data PD-(L)1i naïve patients Tumor Type ORR for PD-(L)1i (Ph 2 & Ph 3 trials) UPS 8-23% 4 LPS 7-10% 4 HNSCC (PD-L1+) 19% 5 Ovarian 9% 6 • Low response rates for PD-(L)1i as monotherapies • Opportunity for novel combos with the potential to overcome PD-(L)1i resistance


 
JTX-8064: Anticipated INNATE Study Data in 2022 Mono and Pimivalimab Combo Dose Escalation and Expansion 17 Preliminary Clinical Data by Year End  At least 80 Phase 2 patients  Complete mono and combo dose escalation data  Preliminary mono and combo expansion cohort data  Data from stage 1 of Simon’s 2 stage design from most cohorts  Additional combo patients from Simon’s 2nd stage  Preliminary biomarker data  Pharmacodynamic  Predictive 7 Indication Specific Phase 2 Combo Expansion Cohorts Ovarian Cancer Monotherapy Expansion Cohort Mono Dose Escalation Completed (n=22) Combo Dose Escalation Completed (n=9)


 
Vopratelimab 18


 
Vopratelimab Biological Activity Distinct from CD8 Focused PD-(L)1i • Vopra is an IgG1 agonist antibody selective for ICOS (inducible co-stimulatory of T cells) • Activates CD4 T cells that have been primed by antigen presentation Clinical Learnings to Date • Well tolerated at all doses tested alone and in combination with PD-1i across multiple trials • Highly durable clinical benefit and acceptable safety profile observed alone and in combination with PD-1i* or CTLA-4i • Pulsatile lower dose of 0.03 mg/kg + pimi shows encouraging trends by multiple measures • TISvopra may select for patient benefit independent of PD-L1 for PD-1i containing regimens 19 *Yap, T, ASCO 2018, 3000; Harvey, C., AACR 2019, 4053; Hanson, A., SITC 2018, P52


 
SELECT: Randomized Phase 2 Predictive Biomarker Study Clinical Study of Two Wholly Owned Antibodies with New Predictive Biomarker Phase 2 SELECT Randomized POC Study • Novel predictive biomarker approach – (TISvopra) RNA signature • IO naïve 2L NSCLC in 69 patients selected with TISvopra • Designed to demonstrate statistical superiority of vopra + pimi versus pimi • Evaluated 2 vopra doses: 0.1 mg/kg and 0.03 mg/kg 20 Study Design Study Hypothesis Vopra + Pimi Pimi vs PD-(L)1 Pimi Vopra + Pimi Unselected TISvopra Selected Cl in ic al B en ef it I L L U S T R A T I V E


 
SELECT Trial Top Line Results (ICR*; FAS) • Vopra continues to remain well tolerated and had no new safety signals • Expected differentiated pulsatile dosing was achieved 21 • Mean percent change from baseline in tumor size in all measurable lesions, averaged over 9 and 18 weeks • Continuous variable measure chosen to minimize study size and potential predictor of overall survival • Not a binary measure, susceptible to outliers General Primary Endpoint JTX-4014 (pimi) monotherapy (N=36) Pooled pimi + vopra combination doses** (N=33) pimi + vopra 0.1 mg/kg (N=18) pimi + vopra 0.03 mg/kg (N=15) Average over Week 9 & 18 *** Mean % change (95% CI) 7.33 (-12.46, 27.12) 0.23 (-20.10, 20.56) 8.35 (-19.94, 36.65) -7.89 (-37.15, 21.37) Difference vs. pimi monotherapy for Average of Week 9 & 18, Absolute % (95% CI) -7.10 (-35.42, 21.22) 1.02 (-33.46, 35.51) -15.22 (-50.51, 20.06) P-value 0.6174 0.9528 0.3908 Data-cut date: 07 July 2022 ; *ICR = Independent Central Review; ** vopra 0.1 mg/kg + pimi and vopra 0.03 mg/kg + pimi; *** Means, 95% CIs, difference between means, 95% CIs of difference, and p-values are based on a mixed-model repeated measures (MMRM) analysis


 
22 *ICR = Independent Central Review; **Disease Control Rate or DCR = CR + PR + SD of at least 9 weeks; Data cut date: 07 July 2022 JTX-4014 (pimi) (N=36) pimi + vopra 0.1 mg/kg (N=18) pimi + vopra 0.03 mg/kg (N=15) Overall response rate n (%) (95% CI) 9 (25.0) (12.12, 42.20) 3 (16.7) (3.58, 41.42) 6 (40.0) (16.34, 67.71) p-value compared to pimi mono therapy 0.4892 0.2879 DCR n (%)** (95% CI) 22 (61.1) (43.46, 76.86) 11 (61.1) (35.75, 82.70) 13 (86.7) (59.54, 98.34) Landmark 6 month Progression Free Survival (PFS), % (95% CI) 33 (16,50) 29 (10,52) 80 (50,93) Secondary Endpoints • Secondary endpoints included ORR, PFS (OS not mature) • More traditional and familiar endpoints SELECT Trial Summary RECIST v1.1 Response & PFS (ICR*; FAS) Data cut date: 07 July 2022; subject to change; landmark PFS data is only mature for the 0.03 mg/kg cohort.


 
SELECT Summary and Vopra Next Steps 23 • SELECT results do not support moving into registration studies as had been our previous goal and we expect to re-evaluate vopra in the context of our broader pipeline in the coming months • SELECT: Trends in improved mean tumor change over 9 and 18 weeks, overall response rate (ORR), and progression free survival (PFS) were observed in the low dose vopra arm in combination with pimivalimab compared to pimivalimab alone • Target engagement achieved the predicted pulsatile patterns, with vopra 0.03 mg/kg dose providing a shorter duration of receptor occupancy compared to the vopra 0.1 mg/kg dose • Mechanistic data in primary human immune cells in vitro supports shorter duration of target engagement achieved with the lower dose of vopra • There was no association between baseline PD-L1 score and ORR, suggesting that TISvopra may be used to select patients for potential benefit from PD-1i containing therapy independently of PD-L1 score


 
Pimivalimab PD-1 inhibitor 24


 
Pimivalimab (Pimi): PD-1 Inhibitor in 2 POC Combo Studies Well-Characterized PD-1 Antibody, Fully Human IgG4 Phase 2 SELECT Monotherapy Results • 9/36 (25.0%) overall response rate • Well tolerated Phase 1 Study Results* • 3/18 (16.7%) confirmed responses • No deaths or dose limiting toxicities Opportunities for Pimi • Biomarker selected IO naïve patients (SELECT) • PD-(L)1i naïve & experienced patients (INNATE) 25 *Papadopoulos, K., Cancer Immunology, Immunotherapy 2020


 
Discovery 26


 
Jounce’s Translational Science Platform Deconstructing the Tumor Microenvironment to Identify Novel Therapeutics 27 T cell Identify targets uniquely tied to cell types of interest Profile human tumors for target expression on cell types of interest More IO Responsive Less IO Responsive Targets for less IO responsive tumors: Any tumor resident cell type TAM T reg NK cell Stroma Design therapeutics in bispecific or mono specific format Create Cell Type Signatures Correlate Signature(s) to Expression from 1000s of Human Tumors


 
JTX-1484 (Anti-LILRB4) Development Program New addition to our differentiated cell type strategy 28 • Expressed on immuno-suppressive myeloid cells in the TME, including MDSCs, tolerogenic DCs and M2-like macrophages • Potent and specific blocker of human LILRB4 with favorable PK, pre-clinical safety and manufacturability profile • Blocking LILRB4 in the TME may lead to reduced immune suppression and enhancement of T cell functionality Different Immune Cell Types Can Mediate Activation and Suppression Multiple barriers to realizing a full immune response to the tumor JTX-1484 (Anti-LILRB4) CD8 T cells CD4 T cells T reg cells Myeloid NK cells Pimivalimab Vopratelimab JTX-8064 GS-1811 JTX-1484 Anti-LILRB1


 
JTX-1484 (Anti-LILRB4): New Development Program Proposed mechanism of action 29


 
Milestones & Financials 30


 
Vopratelimab (SELECT): Top-line results reported • Plan to submit full data clinical abstract to ESMO-IO in December 2022 • Safety and preliminary efficacy data • Performance of biomarker JTX-1484 (LILRB4): • Continue to advance towards a 2023 IND Discovery: • Continue to advance multiple new targets through discovery pipeline with a goal of an IND every 12-18 months Upcoming Milestones JTX-8064 (INNATE): • Clinical data by year end: • All mono and combo dose escalation • > 80 Phase 2 patients • Multiple expansion cohorts • Preliminary biomarker data • Pharmacodynamic • Predictive 31 


 
Financial Strength and Flexibility NASDAQ: JNCE Strong Balance Sheet • Cash runway into Q1 2024 • Excludes any potential milestone payments • $162.3M in cash, cash equivalents and investments, as of June 30, 2022 Cash Guidance • 2022 gross cash burn $115M - $130M Common Stock Outstanding • 51.7M shares as of June 30, 2022 32


 
The Jounce Difference 33 Opportunity Compelling Pipeline Upcoming Catalysts Financial Strength Clinical data expected by year end from both lead programs Next generation IO with discovery across a variety of different immune cell types leading to an extensive pipeline Multiple large market opportunities driven by a productive and sustainable translational drug discovery engine Continued value creation, Cash runway into Q1 2024 (excludes any potential milestones)


 
Jounce Therapeutics JOUNCETX.COM 34


 

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Exhibit 99.2
Jounce Therapeutics Reports Results from Phase 2 Randomized SELECT Trial Testing 2 Different Doses of Vopratelimab in TISvopra Biomarker-Selected Patients

- SELECT trial of vopratelimab in combination with pimivalimab versus pimivalimab alone did not meet its primary endpoint of mean tumor change averaged over 9 and 18 weeks -

- Encouraging trends in improved mean tumor change over 9 and 18 weeks, and secondary endpoints of overall response rate (ORR) and progression free survival (PFS) were observed in the low dose vopratelimab arm in combination with pimivalimab compared to pimivalimab alone -

- Pimivalimab monotherapy continues to demonstrate safety and clinical activity -

CAMBRIDGE, Mass., August 30, 2022 - Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, today reported top line data from the randomized Phase 2 SELECT trial evaluating vopratelimab (vopra), Jounce’s inducible costimulator (ICOS) agonist, in combination with pimivalimab (pimi) versus pimivalimab alone in immunotherapy naïve, TISvopra biomarker-selected, second line non-small cell lung cancer (NSCLC) patients. The trial tested two pulsatile and differentiated doses of vopra in the combination groups against pimi monotherapy, using as the primary endpoint the mean percent change from baseline in tumor size in all measurable lesions, averaged over 9 and 18 weeks as assessed by central independent radiology review. As the study was powered to detect a 20% absolute difference of the pooled combo doses compared to pimi monotherapy, and the actual difference was 7%, SELECT did not meet its primary endpoint. In the combination dose cohort with the lowest dose of vopra (0.03mg/kg), interesting trends were observed in both the primary endpoint, with an absolute mean change of 15%, and in the prespecified secondary endpoints of overall response rate (ORR), which was 40% compared to 25% in pimi alone, and landmark six month progression free survival (PFS) of 80% compared to 33% with pimi alone. Consistent with these clinical outcomes, recent mechanistic data in primary human immune cells in vitro supports shorter duration pulsatile dosing of ICOS agonism, with general implications for T cell agonist dosing. Data from SELECT is summarized as follows:

JTX-4014 (pimi) (N=36)Pooled pimi + vopra doses (N=33) pimi + vopra 0.1 mg/kg (N=18) pimi + vopra 0.03 mg/kg (N=15)
Primary Endpoint, mean % change from baseline1 (95% CI)
 7.33 (-12.46, 27.12)0.23 (-20.10, 20.56) 8.35 (-19.94, 36.65) -7.89 (-37.15, 21.37)
Difference in primary endpoint between combo and pimi monotherapy, absolute %1 (95% CI)
 NA -7.10 (-35.42, 21.22) 1.02 (-33.46, 35.51) -15.22 (-50.51,20.06)
Complete Response (CR), n (%)1 (2.8)1 (3.0)01 (6.7)
Partial Response (PR), n (%)8 (22.2)8 (24.2)3 (16.7)5 (33.3)
Stable Disease (SD), n (%)13 (36.1)15 (45.5)8 (44.4)7 (46.7)
Progressive Disease (PD), n (%)10 (27.8)6 (18.2)5 (27.8)1 (6.7)
Not Reported / Not Evaluable / Early Termination, n (%)4 (11.1)3 (9.1)2 (11.1)1 (6.7)
Overall Response Rate (ORR), n (%)9 (25.0)9 (27.3)3 (16.7)6 (40.0)
Disease Control Rate (DCR), n (%)2
22 (61.1)24 (72.7)11 (61.1)13 (86.7)
Landmark 6 month Progression Free Survival3 (PFS), % (95% CI)
33 (16,50)54 (35, 69)29 (10, 52)80 (50, 93)
Data cutoff: July 7, 2022, central radiology review
 1 Means, 95% CIs, difference between means, 95% CIs of difference are based on a mixed-model repeated measures (MMRM) analysis; 2 best overall response of CR, PR, or SD (duration of at least 9 weeks); 3 landmark PFS data is mature only for the 0.03 mg/kg cohort; CI: confidence interval;


jounceheadera.gif


Safety and Biomarkers
Vopra continued to be well tolerated, and the frequency and types of adverse events in the combination cohorts were comparable to those in the pimi monotherapy cohort. Most adverse events were mild to moderate, and there were few treatment related serious adverse events.

Target engagement achieved the expected pulsatile patterns, with the 0.03 mg/kg dose providing a shorter duration of receptor occupancy compared to the 0.1 mg/kg dose. There was no association found between baseline PD-L1 score and overall response rate, suggesting that TISvopra may be used to select patients for potential benefit from PD-1 containing therapy independently of PD-L1 score. The distribution of PD-L1 scores within the TISvopra positive patients was similar to what would be expected for an unselected patient population.

“The team did an outstanding job executing on a complex biomarker selected trial impacted by both the pandemic and the war in Ukraine. Although we are intrigued by the preliminary efficacy trends, particularly the landmark PFS and ORR in the lower vopra dose combination arm, the SELECT results do not support moving into registration studies as had been our previous goal. We will re-evaluate the vopra program in the context of our broader pipeline in the coming months,” said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. “We continue to be pleased with pimi’s activity, which supports its continued use in our ongoing and future combination trials. We plan to submit a clinical abstract to present the entire SELECT study, including more mature data, at the ESMO Immuno-Oncology Congress in December 2022. We remain focused on our mission of delivering meaningful and long-lasting benefit to cancer patients through the discovery and pursuit of therapies that target new mechanisms of immune suppression across different types of immune cells, and bringing the right immunotherapies to the right patients.”

About Pimivalimab

Pimivalimab (formerly JTX-4014) is a well-characterized fully human IgG4 monoclonal antibody designed to block binding to PD-L1 and PD-L2. Pimivalimab demonstrated a 17% durable overall response rate in a Phase 1 trial of 18 heavily pre-treated PD-(L)1 inhibitor naïve patients, which excluded all tumor types for which PD-(L)1 inhibitors were approved. In this Phase 1 trial, pimivalimab was shown to have an acceptable safety profile. Pimivalimab is currently being assessed in the INNATE Phase 1 trial (NCT04669899) in combination with JTX-8064, a LILRB2 (ILT4) inhibitor. Pimivalimab is also being assessed in the SELECT Phase 2 clinical trial (NCT04549025) in combination with vopratelimab.

About Vopratelimab

Vopratelimab is a clinical-stage monoclonal antibody that binds to and activates ICOS, the Inducible T cell CO-Stimulator, a protein on the surface of certain T cells commonly found in many solid tumors. Vopratelimab is being assessed in the SELECT Phase 2 clinical trial (NCT04549025) in combination with Jounce’s internal investigational PD-1 inhibitor, pimivalimab (formerly JTX-4014), compared to pimivalimab alone. The SELECT trial completed enrollment of 69 immunotherapy naïve NSCLC patients who have been pre-selected with the TISvopra predictive biomarker, an 18 gene RNA tumor inflammation signature which predicted the emergence of ICOS hi CD4 T cells and clinical benefit in the ICONIC trial of vopratelimab alone


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and in combination with a PD-1 inhibitor. SELECT is powered to demonstrate the statistical superiority of the combination of vopratelimab plus pimivalimab compared to pimivalimab.

About Jounce Therapeutics

Jounce Therapeutics, Inc. is a clinical-stage immunotherapy company dedicated to transforming the treatment of cancer by developing therapies that enable the immune system to attack tumors and provide long-lasting benefits to patients through a biomarker-driven approach. Jounce currently has multiple development stage programs ongoing while simultaneously advancing additional early-stage assets from its robust discovery engine based on its Translational Science Platform. Jounce’s highest priority program, JTX-8064, is a LILRB2 (ILT4) receptor antagonist shown to reprogram immune-suppressive tumor associated macrophages to an anti-tumor state in preclinical studies. JTX-8064 is being investigated alone and in combination with pimivalimab (formerly JTX-4014), Jounce’s internal PD-1 inhibitor, in one monotherapy and seven indication-specific combination therapy cohorts in the Phase 1/2 INNATE trial and is currently enrolling patients with advanced solid tumors in the Phase 2 portion of the study. Jounce’s most advanced product candidate, vopratelimab, is a monoclonal antibody that binds to and activates ICOS, and is currently being studied in the SELECT Phase 2 trial. Pimivalimab is a PD-1 inhibitor intended for combination use in the INNATE and SELECT trials and with Jounce’s broader pipeline. Additionally, Jounce exclusively licensed worldwide rights to GS-1811 (formerly JTX-1811), a monoclonal antibody targeting CCR8 and designed to selectively deplete T regulatory cells in the tumor microenvironment, to Gilead Sciences, Inc. For more information, please visit www.jouncetx.com.

Cautionary Note Regarding Forward-Looking Statements

Various statements in this release concerning Jounce’s future expectations, plans and prospects, including without limitation, Jounce’s expectations regarding the timing, initiation or expansion, progress, results of and release of data from clinical trials of Jounce’s product candidates, including vopratelimab and pimivalimab and the timing of presentation of clinical data may constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws and are subject to substantial risks, uncertainties and assumptions. You should not place reliance on these forward-looking statements, which often include words such as “trend,” “expect,” “will,” “intend,” “plan,” or similar terms, variations of such terms or the negative of those terms. Although Jounce believes that the expectations reflected in the forward-looking statements are reasonable, Jounce cannot guarantee such outcomes. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Jounce’s ability to successfully demonstrate the efficacy and safety of its product candidates and future product candidates; risks that the COVID-19 pandemic may disrupt Jounce’s business and/or the global healthcare system more severely than anticipated, which may have the effect of delaying enrollment and completion of Jounce’s ongoing clinical trials, or delaying timelines or data disclosures and regulatory submissions for its product candidates; risks that the invasion of Ukraine and political unrest in the surrounding region may disrupt clinical trial activities, which may adversely affect the completion of Jounce’s ongoing clinical trials, or delay timelines or data disclosures; the preclinical and clinical results for its product candidates, which may not support further development and marketing approval; the potential advantages of Jounce’s product candidates; Jounce’s ability to successfully manage its


jounceheadera.gif
clinical trials; the development plans of its product candidates and any companion or complementary diagnostics; management of Jounce’s supply chain for the delivery of drug product and materials for use in clinical trials and research and development activities; actions of regulatory agencies, which may affect the initiation, timing and progress of preclinical studies and clinical trials of Jounce’s product candidates; abstract submissions and acceptance, or lack thereof, related to Jounce’s clinical programs; Jounce’s ability to obtain, maintain and protect its intellectual property; Jounce’s ability to manage operating expenses and capital expenditures; and those risks more fully discussed in the section entitled “Risk Factors” in Jounce’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission as well as discussions of potential risks, uncertainties, and other important factors in Jounce’s subsequent filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and Jounce undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor and Media Contact:
Eric Laub
Jounce Therapeutics, Inc.
+1-857-259-3853
elaub@jouncetx.com

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