Pioneering Today
with a different kind of medicine
Transforming Tomorrow
for patients who need us
January 2024 |
NASDAQ |
L I S T E D
ARVN
© 2024 Arvinas. All rights reserved.
Safe harbor and forward-looking statements
This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding our expectation of brining the first PROTACT® protein degrader to market in partnership with Pfizer; the timing for our first neuroscience PROTAC® degrader to enter the clinic; the timing of presenting Phase 3 clinical trial topline data for vepdegestrant and our plans related to commercial launch of vepdegestrant; the plans for and anticipated timings related to our planned clinical trials and/or data read outs from such trials, including second-line Phase 3 clinical trials of vepdegestrant in combination with palbociclib and potentially other CDK4/6 inhibitors, a first-line Phase 3 clinical trial of vepdegestrant in combination with a CDK4 inhibitor, our Phase 3 clinical trial for ARV-766 as a monotherapy, and our Phase 1 dose escalation trials of ARV-393 (BCL6) and ARV-102 (LRRK2); the potential for vepdegestrant as an oral best-in-classtargeted therapy and to become a backbone estrogen receptor therapy in the metastatic breast cancer space; the potential therapeutic benefits and market opportunity of our product candidates, including vepdegestrant, ARV-766, ARV-393and ARV-102; the opportunity for ARV-766 in both post- and pre-novel hormonal agent settings to potentially treat metastatic castrate-sensitive prostate cancer and metastatic castrate-resistant prostate cancer; the potential for androgen receptor (AR)-targeting PROTAC degraders to address the unmet need of patients with prostate cancer across multiple stages of disease and surpass the benefits of other AR inhibitors; the timing to receive progression free survival data for the ARV-766 dose expansion
trial; whether our BCL6 PROTAC® degrader will be a first-in-class potential therapy for Diffuse Large B-Cell Lymphoma and additional opportunities for BCL6; whether PROTAC-induced LRRK2 degradation could be a disease-modifying modality for Parkinson's Disease and Progressive Supranuclear Palsy; whether a KRAS-targeting PROTAC will provide an advance in treatment for multiple cancers; and our plans and anticipated timing of clinical starts for KRAS, G12D and other programs; our plans to reach patients with additional indications
for vepdegestrant, extend our pipeline and reach profitability.
The words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of various risks and uncertainties, including but not limited to: whether we and Pfizer will be able to successfully conduct clinical development for vepdegestrant (ARV-471) and receive results from our clinical trials on our expected timelines, or at all; whether we will be able to successfully conduct and complete development for our other product candidates, including whether we initiate and complete clinical trials for our product candidates and receive results from our clinical trials on our expected timelines, or at all; our ability to protect our intellectual property portfolio; whether our cash and cash equivalent resources will be sufficient to fund our foreseeable and unforeseeable operating expenses and capital expenditure requirements; and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, discussed in the "Risk Factors" section of our quarterly and annual reports on file with the U.S. Securities and Exchange Commission. The forward-looking statements contained in this presentation reflect our current views as of the date of this presentation with respect to future events, and we assume no obligation to update any forward-looking statements, except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this presentation.
The Arvinas name and logo are our trademarks. We also own the service mark and the registered U.S. trademark for PROTAC®. The trademarks, trade names and service marks appearing in this presentation are the property of their respective owners. We have omitted the ® and ™ designations, as applicable, for the trademarks named in this presentation.
This presentation also contains estimates and other statistical data made by independent parties and by us relating to market size and other data about our industry. This data
involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such data and estimates. In addition, projections, assumptions and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk. This presentation is intended for the investor community only. It is not intended to promote the products referenced herein or otherwise influence healthcare prescribing decisions. Cross-trial comparisons are not based on head-to-head studies and no direct comparisons can be made.
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Arvinas: Advancing a new therapeutic modality to patients
PIONEER IN THE
FIELD
- Most advanced protein degradation platform
-
Expecting to bring the first PROTAC® protein degrader to market (in partnership
with ) - First neuroscience PROTAC® degrader anticipated in the clinic in 2024
NEW MECHANISIM
- PROTAC® protein degraders eliminate vs. inhibit disease- causing proteins
- Combines the power of genetic knockdown technology with the benefits of small-molecule therapeutics
DEEP PIPELINE
- Clear efficacy signals in patients with difficult-to-treat breast and prostate cancers
-
- 2 ongoing Phase 3 trials
- 10+ ongoing Phase 1 & 2 trials
- Pipeline of programs across oncology, neuroscience, hematology, and immuno- oncology
3
PROTAC® protein degraders combine the benefits of small molecules and gene-based knockdown technologies
E3 ligase |
Complex Formation: |
1 |
|
Recognizing disease |
|
causing protein of interest |
Target Protein
2 Protein Tagging:
Tagging of target
protein for degradation
Ubiquitin
Iterative
activity
3 |
|
Protein |
|
Destruction: |
|
PROTAC® |
Target protein is |
degraded by the |
|
High specificity without |
proteasome |
the requirement for |
Proteasome |
strong binding |
Arvinas' proteolysis-targeting chimera (PROTAC®) degraders can:
- Eliminate (rather than inhibit) disease-causing proteins
- Disrupt scaffolding functions of target proteins
- Bind and degrade classically "undruggable" proteins
- Act iteratively (catalytically)
- Be delivered orally and achieve broad tissue distribution, including across the blood-brain- barrier
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A History of Pioneering
To transform the treatments of tomorrow
Arvinas creates |
First Phase 2 trial |
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first PROTAC® |
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Proof of |
initiated with |
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degraders to cross |
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concept |
vepdegestrant |
Anticipating |
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blood-brain barrier |
First PROTAC® |
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Arvinas founded |
is achieved for |
first Phase 3 |
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to turn protein |
AR and ER |
degrader Phase |
trial topline data |
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degraders into |
PROTAC® |
3 trial initiated |
(vepdegestrant; |
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patient therapies |
degraders |
(vepdegestrant) |
2H 2024) |
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2013 |
2018 |
2020 |
2022 |
2024 |
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2001 |
2016 |
2019 |
2023 |
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2021 |
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Arvinas' founder |
Arvinas creates |
First PROTAC® |
Partnered with Pfizer to |
IND cleared |
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Craig Crews |
first oral PROTAC® |
degrader |
co-develop and |
for BCL6 PROTAC® |
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publishes first |
protein degraders |
clinical trials |
co-commercialize |
(ARV-393) |
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paper describing |
for clinical trial |
initiated |
vepdegestrant |
CTA authorized |
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First Phase 2 |
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PROTAC® |
evaluation |
for LRRK2 PROTAC® |
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degraders |
trial initiated with |
(ARV-102) |
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AR PROTAC® |
(1st neuroscience |
degrader |
candidate) |
The agents mentioned above are currently under investigation; their safety and effectiveness have not yet been established
IND, investigation new drug application; CTA, clinical trial authorization
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Our broad pipeline includes the first pivotal trials for PROTAC® degraders
Program |
Therapeutic Area / Indication |
Preclinical |
Phase 1/1b |
Phase 2 |
Phase 3 |
|
VERITAC-2: vepdegestrant monotherapy 2L pivotal trial |
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Vepdegestrant |
Vepdegestrant plus palbociclib and potentially other CDK4/6 inhibitors in 2La |
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VERITAC-3: vepdegestrant + palbociclib as 1L combination therapy (study lead-in) |
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(ARV-471) |
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Vepdegestrant plus CDK4 inhibitor (PF-07220060) in 1La |
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Global co-development/ |
Oncology: |
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co-commercialization |
VERITAC: vepdegestrant monotherapy dose expansion (2L+) |
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ER+/HER2- Breast |
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partners with |
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Cancer |
TACTIVE-N: vepdegestrant in neoadjuvant setting (to inform potential adjuvant plan |
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TACTIVE-U: vepdegestrant in combination with ribociclib, abemaciclib and other |
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targeted therapies |
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TACTIVE-E: vepdegestrant + everolimus |
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Oncology: |
ARV-766 monotherapy (mCRPC) |
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ARV-766 |
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ARV-766 monotherapy dose expansion (2L+) |
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Prostate Cancer |
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ARV-766 Phase 1/2 combination with abiraterone (pre-NHA setting)
ARV-393 (BCL6) |
Hematology |
Phase 1 dose escalation |
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ARV-102 (LRRK2) |
Neuroscience |
Phase 1 dose escalation |
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20+ pre-clinical |
Oncology and |
20+ programs, including |
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KRAS-G12D/V,AR-V7, Myc, |
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programs |
Neuroscience |
HPK1, Tau, α-Synuclein, |
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and mHTT |
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a Pending Health authority feedback on potential pivotal trial |
Planned |
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NHA, novel hormonal agent |
Pivotal Trial |
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These agents are currently under investigation; their safety and effectiveness for these investigational uses have not yet been established. |
6 |
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Arvinas' strategy positions us for the next stage of growth
Focused on Near-term
Patient Impact
- Planning for multiple launches with vepdegestrant
- Strengthened by a best-in-class pipeline and research engine
Data-driven Approach to
Resource Allocation
- Choose and invest in highest value drivers
- Use BD to enhance the value of our pipeline
- Invest for commercial success
Strong Capitalization
- Backed by a cash runway into 2027
- Capital to support us through the first years of our planned commercial launch
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CLINICAL PROGRAMS
Vepdegestrant
Vepdegestrant (ARV-471):First-in-class estrogen receptor (ER)-degrading PROTAC® in advanced breast cancer
1 in 8 U.S. women will develop breast cancer in her lifetimea
~80% of all newly
diagnosed cases of breast
cancer are ER-positive
(ER+)b
Vepdegestrant is
currently being
evaluated in two
Phase 3 trials in
metastatic breast cancer
Vepdegestrant has the potential to become an oral, best- in-class targeted therapy
Vepdegestrant degrades wild-typeand ESR1-mutant estrogen receptors (ER) to directly inhibit signaling pathways
More than 600 patients and healthy volunteers have been treated with vepdegestrant across 12 clinical trials
Consistent and compelling data in heavily pre-treatedpatients
Vepdegestrant could be a backbone ER therapy in the
~$17B ER+/HER2- metastatic breast cancer spacec
Vepdegestrant is an investigational compound. Its safety and efficacy has not been established |
|
a ACS: https://www.cancer.org/cancer/breast-cancer/about/how-common-is-breast-cancer.html; accessed 01/06/24; b https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4549764/,accessed 01/06/2024 |
|
c Clarivate/Decision Resources Group - Breast Cancer Disease Landscape & Forecast (Nov 2023). 2032 Projection. |
9 |
ER, estrogen receptor; HER2, human epidermal growth factor 2; ESR1, estrogen receptor 1 gene |
Our Phase 3 VERITAC-2 monotherapy trial in the 2L+ setting is on track for topline data in 2H24
Two ongoing monotherapy trials:
- VERITAC-2:Phase 3 trial
- VERITAC: Phase 2 trial (enrollment complete, N=71)
-
- At RP3D (200mg), vepdegestrant showed favorable safety profile, with <6% Grade 3+ TRAEs, no dose reductions, and low rate of discontinuations
VERITAC Phase 2 subset analysis:
- In the 8 patients in VERITAC who would meet the eligibility criteria for the Phase 3 VERITAC-2 trial (no prior fulvestrant, no prior chemotherapy for locally advanced/metastatic disease)a:
-
- CBR: 62.5% (5 of 8 patients)
- mPFS: 19 months (4 of 8 events)
- ORR: 29% (7 evaluable patients, 2 confirmed responses)
Study design for Phase 3 VERITAC-2
(Enrolling, NCT05654623)
a Data cutoff, June 6, 2023;.Post-hoc analysis |
10 |
RP3D, recommended phase 3 dose; TRAE, treatment related adverse events; CBR, clinical benefit rate; mPFS, media progression-free survival; ORR, objective response rate; |
ESR1, estrogen receptor 1; CDK, cyclin-dependent kinase
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Arvinas Inc. published this content on 08 January 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 08 January 2024 03:23:14 UTC.