Vincerx Pharma Inc · OTC:VINC
Vincerx Pharma — LifeSci Acquisition — SPAC Merger (September 2020)
35 slides from Vincerx Pharma's SPAC merger presentation, Sep 29, 2020
Slide 1: Corporate Overview September 2020
CORPORATE OVERVIEW SEPTEMBER 2020 EXHIBIT 99.2
Slide 2: Important Notices
Important Notices This presentation is provided for informational purposes only and has been prepared to assist interested parties in making their own evaluation with respect to the proposed business combination between Vincera Pharma, Inc. (“Vincera” or the “Company”) and LifeSci Acquisition Corp.
Slide 3: Forward-looking Statements
Forward-looking Statements This presentation includes certain statements that are not historical facts but are forward-looking statements for within the meaning of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompan
Slide 4: Our Vision
OUR VISION We aspire to conquer cancer by addressing the unmet medical needs of our patients with paradigm-shifting therapeutics
Slide 5: Vincera Pharma Highlights
Cohesive, accomplished management team Highly engaged scientific advisory board and chair Proven track record of successful drug development & approvals, company creation, fundraising and value creation MANAGEMENT TEAM Vincera Pharma Highlights Clinical small molecule: Best-in-class PTEFb [CDK9] inh
Slide 6: Vincera Founders
Vincera Founders AHMED HAMDY, MD CEO Cofounder of Acerta Pharma Former CMO of Pharmacyclics, leading developer of Imbruvica® Proven track record for assembling experienced teams that deliver from INDs to NDAs RAQUEL IZUMI, PhD COO Cofounder of Acerta Pharma Former Sr Director of Clinical Development
Slide 7: Management Team Experience
Management Team Experience Proven Track Record $7B acquisition by AstraZeneca in 2016 for acalabrutinib in Phase 3 $975M partnership with Janssen in 2011 [$150 upfront, $825M in milestones] $21B acquisition of Pharmacyclics by AbbVie in 2015 Approved in CLL 2019 Accelerated approval in MCL 2017 AZ a
Slide 8: Vincera Pipeline
DISCOVERY PRECLINICAL PHASE 1 PROGRAM Vincera Pipeline* PTEFb Bioconjugation ADC = antibody-drug conjugate; AML = acute myeloid leukemia; MDS = myelodysplastic syndromes; NHL = nonHodgkin lymphoma; PoC = proof of concept; PTEFb = positive transcription elongation factor b; SMDC= small molecule drug
Slide 9: PTEFb Program
PTEFb PROGRAM VIP152 IV (Phase 1) VIP217 Oral (Discovery)
Slide 10: PTEFb (CDK9) Program Summary
MODE OF ACTION Best-in-class selective PTEFb inhibitor, rapid depletion of short-lived mRNAs of known oncogenes eg, MYC and MCL1 CLINICAL STATUS1,2 Trial in solid and heme cancers, early signs of efficacy in DH-DLBCL and disease control in solid tumors Safety and PK findings support further developm
Slide 11: PTEFb: A Novel Target for Oncology
PTEFb [CDK9] Positive transcription elongation factor beta is a key regulator of transcription through phosphorylation of RNA polymerase II A key target to address transcriptional addiction in cancer Inhibition causes rapid depletion of short-lived mRNA transcripts of known oncogenes eg, MCL1 and MY
Slide 12: CDK9 inhibitor clinical comparison
VIP152 Vincera Dinaciclib Merck Alvocidib (Flavopiridol) Tolero Patients Double hit DLBCL [MYC driven] r/r CLL [MCL1 driven] r/r CLL [MCL1 driven] Untreated AML r/r AML, MCL1 dependent Treatment VIP152 monotherapy Dinaciclib monotherapy vs ofatumumab Alvocidib monotherapy Alvocidib + cytarabine + mi
Slide 13: VIP152 is the Most Selective CDK9 Inhibitor in the Clinic
VIP152 is the Most Selective CDK9 Inhibitor in the Clinic Programs VIP152 Vincera AZD4573 AZ Dinaciclib Merck CYC065 Cyclacel Alvocidib (Flavopiridol) Tolero Voruciclib MEI Pharma Selectivity CDK9 CDK1/9 CDK1/2/5/9 CDK2/3/5/9 Pan CDK Pan CDK Development Stage P1 P1 P3 mono P2 combo P1 P2 P1 mono and
Slide 14: VIP152 Highly Selective and Potent CDK9 Inhibitor
VIP152 Highly Selective and Potent CDK9 Inhibitor Activity against all non-CDK kinases with <50x higher KDs Assay VIP152 Kinase Kd [nM] @ DiscoverRx IC50 [nM] @ Millipore Kinase Activity [nM] IC50 CDK9 [nM] low ATP 3 CDK9 1.3 13** CDK9 1.3 IC50 CDK9 [nM] high ATP 4 CDK1 n.a. 192 GSK3a 7.4 High poten
Slide 15: MoA – VIP152 Inhibits Transcription of MYC and MCL1
MoA – VIP152 Inhibits the Transcription of MYC and MCL1 Normalized band intensity MYC Protein Durable reduction of MYC protein levels In vivo MoA in JJN3 multiple myeloma xenografts in mice upon a singe dose of 15 mg/kg VIP152 IV Reduction of MYC & MCL1 mRNA levels Norm. expression MYC mRNA MCL1 mRN
Slide 16: VIP152 (IV) Clinical Trial Design & Status
Expansion cohort (ongoing; N=6) VIP152 (IV) - Clinical Trial Design & Status Two Phase 1 clinical trials Once weekly IV; 30-min infusion 21-day cycles No biomarker selection patient population (ie, all-comer advanced cancer) At recommended Phase 2 dose of 30 mg Double-hit DLBCL MTD FIRST-IN-HUMAN ST
Slide 17: VIP152 Pharmacodynamic Activity in Patient Samples
VIP152 Pharmacodynamic Activity in Patient Samples PD biomarker assessment: mRNA expression in whole blood, cycle 1, day 1 Inhibition of MYC, MCL1 and cell proliferation (PCNA) Time (h) Fold change (2-∆∆Ct) MYC PCNA MCL1 5 mg 10 mg 15 mg 22.5 mg 30 mg 0 0.5 1 2 4 6 8 24 48 0.0 0.5 1.0 1.5 2.0 0 0.5
Slide 18: Manageable Safety Profile
No patients withdrew due to toxicity Manageable Safety Profile Neutropenia manageable; Long-term CRs highlight tolerability profile Adverse Events (>15%) Grade 1 Grade 2 Grade 3 Grade 4 All (n=31) Nausea 17 (55) 9 (29) 0 (0) 0 (0) 26 (84) Vomiting 15 (48) 5 (16) 0 (0) 0 (0) 20 (65) Anemia 6 (19) 5 (
Slide 19: Early Signs of Monotherapy Efficacy with VIP152
Early Signs of Monotherapy Efficacy in Phase 1 with VIP152 2 CRs (29% CR rate)* 1 on treatment for 3.6 years 1 on treatment for 2.3 years Disease control observed in heavily pretreated solid tumor patients (1 pancreatic cancer and 1 salivary gland cancer pt) Expansion cohort ongoing in DH-DLBCL 1/6
Slide 20: Complete Metabolic Response in Treatment-refractory Double-hit DLBCL
Complete Metabolic Response Observed in Patient with Treatment-refractory Double-hit DLBCL Treatment summary GCB molecular subtype BCL2 and MYC rearrangement positive BCL2, BCL6, CD10, CD20 IHC positive; MYC IHC >80% positive Foundation Medicine FoundationOne®Heme panel sequencing: IGH-BCL2 fusion,
Slide 21: Survival outcomes in DLBCL with MYC and BCL2 breaks
Tumati et al Int J Radiation Oncol Biol Phys 2018;100:1126-32 Petrich et al Blood 2014;124:2354-61 Pfreundschuh et al Lancet Oncol 2011;12:1013-22 Overall survival (OS) and progression-free survival (PFS) after treatment with rituximab, cyclophosphamide, vincristine, doxorubicin, and prednisone in p
Slide 22: Potential Indications
Potential Indications MYC and MCL1 overexpression is a hallmark of multiple aggressive, resistant tumors representing a wide-ranging unmet medical need B-cell Lymphoma MYC dependent (DH-DLBCL, Transformed FL, RS, blastoid MCL) Broad sensitivity to VIP152 across NHL cell panel & clinical activity in
Slide 23: VIP152: Clinical Development Plan
VIP152: Clinical Development Plan Multiple Accelerated Approval Opportunities Phase Design Population Countries 1b Myc driven heme tumors DH-DLBCL, Transformed FL, RS, blastoid MCL US 1b Myc driven solid tumors Ovarian, TNBC, CRPC [incl NE] US 1b Double refractory/relapse (BTK & VEN) R/R CLL US
Slide 24: Summary: PTEFb Portfolio
Summary: PTEFb Portfolio* PTEFb INHIBITORS WITH BROAD CLINICAL POTENTIAL BEST-IN-CLASS PHARMACOLOGY AND PHARMACODYNAMIC PROFILE FAVORABLE ROBUST PRECLINICAL IN VIVO AND IN VITRO DATA CLEAR DEVELOPMENT PATHS IN HIGH UNMET MEDICAL NEEDS EARLY SIGNS OF SINGLE-AGENT CLINICAL EFFICACY SIGNIFICANT COMMERC
Slide 25: Bioconjugation Platform
BIOCONJUGATION PLATFORM VIP236 (SMDC) VIP943 (CD123) VIP924 (CXCR5)
Slide 26: Vincera's Proprietary Bioconjugate Platforms
Vincera’s Proprietary Bioconjugate Platforms – Shaping the Future* Turning 10 years of Bayer discovery know-how into break-through treatment modalities NEXT GEN ADC PLATFORM IL3RA ADC: Preclinical CXCR5 ADC: Preclinical SMALL MOLECULE DRUG CONJUGATE Preclinical IND in ~1 year DISCOVERY PROGRAMS Disc
Slide 27: Small Molecule Drug Conjugate (SMDC) VIP236
SMALL MOLECULE DRUG CONJUGATE (SMDC) VIP236
Slide 28: Key Features of VIP236 SMDC
MoA Small molecule ligand delivers a novel NCE payload into tumor stroma Targets cell surface antigen highly expressed on cancer cells DEVELOPMENT STATUS Candidate identified ~12-15 months to IND TOXICOLOGY (PRELIMINARY) Pending, well tolerated in xenograft models compared with SOC DRUG SUBSTANCE Re
Slide 29: SMDC Dual Targeting Rationale
SMDC Dual Targeting Rationale Tumor Stroma Activated Conjugate Linker enables tumor specific release of active payload Extracellular cleavage in tumor stroma Non-cleavable isomer is inactive Targeting moiety Ligand binds cancer selective markers Stable non-peptidic ligand Proven tumor homing Payload
Slide 30: Next Gen ADC Platform VIP943 VIP924
NEXT GEN ADC PLATFORM VIP943 VIP924
Slide 31: Vincera's Next Generation ADC Technology Solutions
Vincera’s Next Generation ADC Technology Solutions* KSPi payload with Cell Trapper™ is hydrophilic and does not cause aggregation Safety: No side effects associated with aggregation Efficacy: Allows for DAR of 6 without affecting PK CMC: Less risk for reduced shelf live & particle formation Highly l
Slide 32: Key Features of VIP943, an IL3RA-KSPi ADC
MoA ADC delivers highly potent KSP inhibitor to IL3RA+ (CD123+) tumors AML: >90% of patients express CD123 on blasts and leukemic stem cells High levels associated with aggressive disease and poor prognosis (p53 mutated, secondary AML & high risk MDS) TOXICOLOGY (PRELIMINARY)1 Non-GLP single and rep
Slide 33: Key Features of VIP924, a CXCR5-KSPi ADC
MoA ADC delivers KSP inhibitor to CXCR5 positive tumors High CXCR5 RNA and protein expression in different Non-Hodgkin lymphoma subtypes DEVELOPMENT STATUS ~24-36 months to IND; CMC synergies with IL3RA ADC TOXICOLOGY (PRELIMINARY) Pending, same toxophore-linker chemistry as IL3RA ADC DRUG SUBSTANCE
Slide 34: Expected Upcoming Milestones
Expected Upcoming Milestones VIP152 Q1 2021 – Begin Phase 1b study for Myc driven hematologic malignancies Q1 2021 – Begin Phase 1b study for Myc driven solid tumors Q1 2021 – Begin Phase 1b study for R/R D CLL Late 2021 – Initial clinical data from Phase 1b studies VIP236 H1 2022 – Begin FIH study
Slide 35: Vincera Summary
Vincera Summary A strong management team with a proven track record of successes Publicly traded company (PCYC): Co-development w JNJ, $1B; Sale to Abbvie, $21B Private company (Acerta) founded company on preclinical asset and took it to approval and sale of company: M&A $7B, AZN >20 years of experi