Jasper Therapeutics
Corporate Presentation
April 2024
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Forward-Looking Statements
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Industry and Market Data
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Trademarks
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Briquilimab is an investigative | |
drug and is not approved | |
for any indication | 2 |
Briquilimab: Franchise Potential in Mast Cell Diseases
c- | Kit inhibition | • Mast cells are key drivers in immunological and dermatological diseases with high unmet need | |
• | Mast cell depletion has unique potential to deliver safe and durable disease control | ||
clinically validated | |||
MOA in mast cell | • | c-Kit inhibition is the only therapeutic mechanism shown to significantly deplete mast cells | |
diseases | • | c-Kit inhibition has demonstrated clinical proof of concept in multiple mast cell mediated diseases | |
Briquilimab | • Briquilimab is a potent c-Kit inhibitor proven to drive mast cell depletion | ||
• | Briquilimab could allow for less frequent dosing | ||
a | potent c-Kit | ||
• | Optimal biologic dosing and PK profile could minimize unwanted adverse effects | ||
inhibitor | |||
Robust pipeline | • CSU: Enrolling patients in Phase 1b/2a BEACON study (initial data expected 3Q 2024) | ||
• | CIndU: Enrolling patients in Phase 1b/2a SPOTLIGHT study (initial data expected 2H 2024) | ||
multiple company- | |||
• | Clinical study in an additional mast cell driven indication expected to commence 2H 2024 | ||
led clinical | |||
programs | • | LR-MDS: Phase 1 trial in the US ongoing (initial data expected mid-year 2024) | |
NON-CONFIDENTIAL
Briquilimab is an investigative | |
drug and is not approved | |
for any indication | 3 |
Expanded portfolio presents exciting new opportunities in mast cell diseases
Indication | Sponsor | Phase 1 | Phase 2 | Phase 3 | Program Milestones |
Briquilimab | |||||
Mast Cell Diseases (Subcutaneous) | |||||
BEACON | • Phase 1b/2a study being conducted in the US and EU | ||||
Chronic Spontaneous Urticaria | • Actively enrolling patients | ||||
• Initial clinical data expected in 3Q 2024 | |||||
SPOTLIGHT | • Phase 1b/2a study being conducted in the EU | ||||
Chronic Inducible Urticaria | • Actively enrolling patients | ||||
• Initial clinical data expected in 2H 2024 |
Stem Cell Diseases (Intravenous)
Low-to-Intermediate Risk MDS
SCID
Fanconi Anemia
Sickle Cell Disease
Chronic Granulomatous Disease
GATA2 MDS
- Enrolling patients
- Initial clinical data expected mid-year 2024
- Enrolling patients
- Discussing potential BLA filing with the FDA
- First 6 patients achieved full chimerism & count recovery
- Expansion to Phase 2a (enrolling)
- First 3 patients with full chimerism & Hb increase (enrolling)
- Enrolling patients
- Study start up
Investigator Sponsored Studies
Jasper maintains full worldwide rights to develop and commercialize briquilimab in all indications
Briquilimab is an investigative | |
drug and is not approved | |
for any indication | 4 |
Mast cells are key drivers of the inflammatory response in a number of allergic and dermatologic diseases
- Mast cells are the most potent drivers of inflammatory response in skin, lungs and gut
- Activated mast cells release pro-inflammatory compounds that drive diseases such as Chronic Spontaneous Urticaria, Chronic Inducible Urticaria, Asthma and many others
- Current approved therapies targeting mast cell driven diseases have limited efficacy and limited durability of response
Briquilimab is an investigative | ||
drug and is not approved | ||
Theoharides et al. N Engl J Med. (2015) | for any indication | 5 |
Depletion of mast cells by anti-c-Kit monoclonal antibody blockade is a novel approach to treat urticarias and other mast cell mediated diseases
- SCF signaling through c-Kit prevents mast cells apoptosis via the Bim-mediated pathway1
- Blockade of c-Kit signaling on mast cells leads to organized cell death and phagocytic clearance2
- Partial c-Kit inhibition blunts mast cell activation
- Aglycosylated c-Kit antibodies avoid indiscriminate ADCC driven killing of other c-Kit expressing cells3
- Unwanted effects on other c-Kit expressing cells can be minimized by the recovery of c-Kit signaling once the mast cells are depleted
- Moller C et al. Blood (2005)
- Hundley TR et al. Blood (2004)
3. Arnold JN et al. Annu Rev Immunol (2007)
Briquilimab-Mediated
Mast Cell Apoptosis
Briquilimab is an investigative | |
drug and is not approved | |
for any indication | 6 |
Briquilimab blocks c-Kit signaling leading to durable mast cell depletion
Mast cell survival assay1
- Briquilimab is an aglycosylated IgG1 anti c-Kit antibody with high affinity to c-Kit (Kd <5pm)
- Briquilimab blocks c-Kit signaling by blocking the SCF ligand binding site on the receptor and triggering apoptosis
- Mast cell depletion occurs within hours to days
Briquilimab is an investigative | ||
drug and is not approved | ||
1 Jasper internal data | for any indication | 7 |
Briquilimab delivered with a single subcutaneous injection significantly depletes skin mast cells in humans
- A single subcutaneous dose at / above ~80mg potently depletes mast cells in the skin of healthy volunteers
- Skin mast cell depletion highly correlated to serum briquilimab exposure after subcutaneous administration
- Significant depletion by day 7, with durable response lasting at least 29 days
- Once depleted with an anti-c-Kit antibody, skin mast cells take at least 3 months to recover, potentially leading to durable disease control2
Skin mast cell depletion 4 weeks after single dose (≥42 mg)1
Briquilimab Healthy Volunteer Phase 1 Subcutaneous Study
Dose (mg) | ||||
10 mg 40 mg | 80 mg 120 mg | 180 mg | 240 mg | Briquilimab CSU Phase |
1b/2a study doses | ||||
40 mg | 120 mg | Briquilimab CIndU Phase | ||
1b/2a study doses |
1 | Jasper internal data (Phase 1a, healthy volunteer study); Dose is adjusted to body weight (mg/kg) on graph. Skin biopsies were used to count mast cells. | Briquilimab is an investigative | |
drug and is not approved | |||
2 | Maurer et al, GA²LEN Global Urticaria Forum - Berlin, December 6, 2022 | for any indication | 8 |
Briquilimab's favorable pharmacokinetic properties may enable optimal biologic dosing
- Briquilimab is designed to minimize unwanted c-Kit-related effects
- Subcutaneous dosing leads to predictable PK profile
- Low frequency of ADAs and do not appear to affect PK
- Drug elimination profile is favorable for minimizing off target effects
- Clearance to allow for return of c-Kit signaling once the mast cells are depleted
- No modifications to extend FcRn recycling
Pharmacokinetics (≥10 mg)1
Briquilimab Healthy Volunteer Phase 1 Subcutaneous Study
Briquilimab is an investigative | ||
drug and is not approved | ||
1 Jasper internal data (Phase 1a, healthy volunteer study) | for any indication | 9 |
Briquilimab safety profile to-date supports development in a wide variety of mast cell diseases
- c-Kitis expressed on mast cells, hemopoietic stem cells, melanocytes, taste buds, spermatogonia and Cajal (GI) cells, which all may be impacted by anti-c-Kit agents
- Briquilimab's favorable elimination kinetics may allow for an improved safety profile on these other cell types
Relevant Preclinical & Clinical Experience
- NHP Chronic Toxicology Study
- Paleness in skin & fur, depletion of colonic mast cells, decrease in reticulocytes and RBC mass, impact on spermatogenesis
- All effects, except for paleness in skin/fur, reversible at highest dose of 300mg/kg weekly for 26 weeks
- Healthy Volunteer Subcutaneous Studies (n=77 briquilimab-treated)
- TEAEs in the HV studies, in the highest frequency of reporting, were Headache, Nausea, Upper Respiratory Tract Infection, Back Pain and Dizziness
- All were mild or moderate in severity and all resolved with no medical intervention
- One Grade 3 allergic reaction reported
Briquilimab is an investigative | |
drug and is not approved | |
for any indication | 10 |
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Jasper Therapeutics Inc. published this content on 16 April 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 16 April 2024 11:28:02 UTC.