UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO
RULE 13a-16 OR 15d-16 OF
THE SECURITIES EXCHANGE ACT OF 1934
For the Month of June, 2024
Commission File Number: 001-39173
I-MAB
(Translation of registrant’s name into English)
2440 Research Blvd, Suite 400
Rockville, MD 20850
(Address of principal executive office)
Indicate by check mark whether the registrant
files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F
x Form 40-F ¨
EXHIBIT INDEX
SIGNATURE
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.
Date: June 6, 2024
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I-MAB |
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|
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By: |
/s/ Joseph Skelton |
|
Name: |
Joseph Skelton |
|
Title: |
Chief Financial Officer |
Exhibit 99.1
| Transforming Potential into Reality
I-Mab Biopharma
June 5, 2024 |
| 2
Legal Disclaimer. This presentation has been prepared by I-Mab (the “Company”) solely for informational purposes. Certain of the information included herein was obtained from various sources, including certain third
parties, and has not been independently verified by the Company. By viewing or accessing the information contained in this presentation, you hereby acknowledge and agree that no representations, warranties, or
undertakings, express or implied, are made by the Company or any of its directors, shareholders, employees, agents, affiliates, advisors, or representatives as to, and no reliance should be placed on the truth, accuracy,
fairness, completeness, or reasonableness of the information or opinions presented or contained in, and omission from, this presentation. Neither the Company nor any of its directors, employees, agents, affiliates,
advisors, or representatives shall be responsible or liable whatsoever (in negligence or otherwise) for any loss, howsoever arising from any information presented or contained in this presentation or otherwise arising in
connection with the presentation, except to the extent required by applicable law. The information presented or contained in this presentation speaks only as of the date hereof and is subject to change without notice.
No Offer or Solicitation. This presentation does not constitute an offer to buy or sell or a solicitation of an offer to buy or sell any securities or instrument of the Company or to participate in any investment activity or
trading strategy, nor may it or any part of it form the basis of or to be relied on in connection with any contract or commitment whatsoever. NOTHING HEREIN CONSTITUTES AN OFFER TO SELL OR THE
SOLICITATION OF AN OFFER TO BUY ANY SECURITIES OR INSTRUMENT IN ANY STATE OR JURISDICTION.
This presentation does not purport to and does not contain all relevant information relating to the Company or its securities, particularly with respect to the risks and special considerations involved with an investment in the
securities of the Company. Nothing contained in this presentation shall be relied upon as a promise or representation as to the past or future performance of the Company. Past performance does not guarantee or predict
future performance. You acknowledge that any assessment of the Company that may be made by you will be independent of this presentation and that you will be solely responsible for your own assessment of the market
and the market position of the Company, and that you will conduct your own analysis and be solely responsible for forming your own view of the potential future performance of the business of the Company.
Forward Looking Statements. This presentation contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These
forward-looking statements can be identified by terminology such as “future”, “promising”, “may”, “plans”, “potential”, “will”, “could position”, “promise”, “advance”, “target”, “design”, “strategy”, “pipeline”, and “project”, and
similar terms or the negative thereof. Statements that are not historical facts, including statements about I-Mab's beliefs and expectations, are forward-looking statements. The forward-looking statements in this
presentation include, without limitation, statements regarding the following: the Company’s pipeline and capital strategy; the potential benefits, advantages, promise, attributes, and target usage of uliledlimab; the
Company’s plans for a U.S. IND submission for uliledlimab and the anticipated timing or outcome thereof; the potential differentiations of givastomig from other Claudin 18.2 targeted competitors; the ability to position
givastomig as a best-in-class Claudin 18.2 therapy; the anticipated timing of updated monotherapy dose expansion data; the potential of ragistomig, including to enable broader use; the projected advancement of the I-Mab
portfolio and anticipated key milestones in 2024 and related timing; the Company’s belief as to its positioning for meaningful value creation; and the market opportunity and I-Mab’s potential next steps (including, without
limitation, the potential expansion, differentiation, or commercialization) for uliledlimab, givastomig and ragistomig. These forward-looking statements involve inherent risks and uncertainties that could cause actual results to
differ materially from those expressed or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, the following: I-Mab’s ability to demonstrate the safety and efficacy of its
drug candidates; the clinical results for its drug candidates, which may or may not support further development or new drug application/biologics license application approval; the content and timing of decisions made by the
relevant regulatory authorities regarding regulatory approval of I-Mab’s drug candidates; I-Mab’s ability to achieve commercial success for its drug candidates, if approved; I-Mab’s ability to obtain and maintain protection of
intellectual property for its technology and drugs; I-Mab’s reliance on third parties to conduct drug development, manufacturing and other services; I-Mab’s limited operating history and I-Mab’s ability to obtain additional
funding for operations and to complete the development and commercialization of its drug candidates; and discussions of potential risks, uncertainties, and other important factors in I-Mab’s most recent annual report on
Form 20-F and I-Mab’s subsequent filings with the U.S. Securities and Exchange Commission (the “SEC”). I-Mab may also make written or oral forward-looking statements in its periodic reports to the SEC, in its annual
report to shareholders, in press releases and other written materials, and in oral statements made by its officers, directors, or employees to third parties. All forward-looking statements are based on information currently
available to I-Mab. I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.
Disclaimer |
| I-Mab is Well-positioned for Meaningful Value Creation
A global biotech with an innovative portfolio and a healthy balance sheet
3
Uliledlimab
(CD73)
Givastomig
(CLDN18.2 x 4-1BB)
Ragistomig
(PD-L1 x 4-1BB)
Advancing an
Innovative Pipeline
NASDAQ-listed
US-based Leadership Team
Headquartered in Rockville,
MD
Emerging U.S.
Entity
Transaction closed Apr-24
Aggregate consideration of
up to US$80M, contingent
on certain future regulatory
and sales-based
milestones
Divestiture of
China Operations
Disciplined
Capital Strategy
Cash balance of $321.8M1
as of December 31, 2023
Reduced cash burn
following divestiture to
align resources to most
promising programs
1. Cash position refers to cash, cash equivalents, and short-term investments
Notes: CLDN18.2 = Claudin 18.2 |
| 1. Co-developed with ABL Bio (also known as ABL503)
2. Global Data Epidemiology Data, Guidehouse legacy research
Notes: CPI = checkpoint inhibitors; NSCLC = non-small cell lung cancer; PD-(L)1 refers to inhibitors of PD-L1 or PD-1; Ab = antibody; GC = gastric cancers; GEJ = gastroesophageal junction; EAC = esophageal cancer
Advancing a Differentiated and Commercially Attractive Pipeline
4
Asset Phase 1 Phase 2 Phase 3 Market Opportunity Status/Potential Next Steps
Uliledlimab
CD73 Ab
Newly diagnosed stage 4
NSCLC: 300k+ patients2
H2 2024: First patient dosed in chemo +
CPI combination for treatment-naïve
NSCLC
Givastomig1
CLDN18.2 X 4-1BB
Bispecific Ab
1L GC, GEJ, EAC: Target
population of 100k+2
H1 2024: New combo cohort initiated
enrollment
H2 2024: Phase 1 dose expansion
monotherapy data
Ragistomig/TJ-L14B1
PD-L1 X 4-1BB Bispecific Ab
Refractory/relapsed cancers:
PD-(L)1 progression impacts
most patients with metastatic
disease2
H1 2024: Phase 1 monotherapy data
presented at ASCO 2024 |
| Uliledlimab (targeting CD73)
Initial development focused on newly diagnosed NSCLC with potential to expand across multiple indications in
combination with immune checkpoint inhibitors
Anti-CD73
CD73 Biology Key Advantages
CD73 is the only enzyme that converts AMP
into immunosuppressive adenosine
Uliledlimab completely inhibits CD73 activity
and the production of adenosine
Blocking CD73 activity leads to complete
inhibition of the adenosine pathway
Uliledlimab targets CD73 non-competitively
without the “hook effect”
5 |
| CD73 is the Rate-Limiting Enzyme in the Adenosine Immunosuppression
Pathway
All AMP pathways converge at CD73 to generate adenosine
6
Advantages of targeting CD73 for cancer therapy:
blocking CD73 activity leads to complete inhibition of the adenosine
pathway.
Known potential escape pathways (ATP, cyclic AMP, and nicotinamide
adenine dinucleotide through separate biochemical pathways) exist
when targeting upstream CD39 or downstream adenosine receptors.
NAD+
ATP CD39
CD203a
ADP
CD38
ADPR
CD39 AMP
CD203a
AMP
ADO
A1AR
A2aAR
A2bAR
A3AR
Canonical
Alternative
Multiple Pathways Multiple Receptors
CD73
Rate-limiting
Converging
Source: I-MAB information on file |
| CD73 enzyme activity inhibition
Complete CD73 inhibition without the
“hook effect”
Uliledlimab: A Differentiated CD73 Antibody
7
Open conformation (inactive) Closed conformation (active)
Oleclumab1
Intra-dimer binding mode
Inter-dimer binding mode
Open conformation (inactive) Closed conformation (active)
Unique intra-dimer binding through
a C-terminus epitope
Uliledlimab
inhibits CD73 by
binding to the
C-terminus and
preventing CD73
dimerization
Oleclumab
inhibits CD73 by
binding to the
N-terminus and
preventing CD73
dimerization
Uliledlimab
CD73 enzyme activity inhibition
Uliledlimab concentration
Oleclumab concentration
Uliledlimab
CD73 dimer
Oleclumab
CD73 dimer
Binding site
Binding site
1. Oleclumab (MEDI9447) was internally produced based upon the published sequence
Source: I-MAB information on file |
| Complete inhibition by intra-dimer binding mode Partial inhibition by inter-dimer binding mode
Uliledlimab Can Completely Inhibit CD73 Function in vitro Whereas Competitor
Antibody Does Not
Astra Zeneca is evaluating oleclumab in a Phase 3 study in patients with Stage III NSCLC
Oleclumab (MEDI9447) was internally produced based upon the published sequence
8
10-6 10-4 10-2 100 102
0
20
40
60
80
100
IgG
Oleclumab
Antibody conc.(µg/ml)
% of enzyme activity
10-6 10-4 10-2 100 102
0
20
40
60
80
100
IgG
Uliledlimab
Antibody conc.(µg/ml)
% of enzyme activity |
| Inhibition of CD73 Activity & Tumor Growth is Dose-Dependent for Uliledlimab
9
Inhibition of CD73 activity and tumor growth in vivo is
limited by oleclumab’s hook effect biology
Inhibition of CD73 activity and tumor growth in vivo by
uliledlimab is dose-dependent
0
20
40
60
80
Tumor inhibition
TGI (%)
10 mg/kg
30 mg/kg
100 mg/kg
0
20
40
60
80
100
CD73 inhibition
CD73 activity inhibition in tumor (%)
10 mg/kg
30 mg/kg
100 mg/kg
0
20
40
60
80
Tumor inhibition
TGI (%)
10 mg/kg
30 mg/kg
100 mg/kg
0
20
40
60
80
100
CD73 inhibition
CD73 activity inhibition in tumor (%)
10 mg/kg
30 mg/kg
100 mg/kg
Dose-dependency not observed for oleclumab
Source: Data on file (IMAB), based on in vivo study on a PDX mouse model of NSCLC (LU5212, Crown Bioscience) in which CD73 inhibition in tumor was evaluated using an enzyme-histochemistry assay
Oleclumab (MEDI9447) was internally produced based upon the published sequence |
| Initial safety profile of combination comparable
to CPI monotherapy studies
Initial Anti-Tumor Data Supports Proof of Mechanism and Promising Safety
Notes: ORR = objective response rate; MTD = maximally tolerated dose; Q3W = every three weeks; AE = adverse events; CPI = checkpoint inhibitors; TRAEs = treatment-related adverse events; ASCO23 = the
American Society of Clinical Oncology 2023 Annual Meeting; toripalimab (used in this study) = Approved/China and the US (Shanghai Junshi Biosciences/Coherus Biosciences)
*Patient disposition for Slides 11-13 based on ASCO23 Poster from a cohort of 70 enrolled patients with unresectable/metastatic disease, including 67 efficacy evaluable and 64 patients who received at least one post
baseline tumor assessment per iRECIST. Overall study (up to n=190) enrolled 5 cohorts (3 NSCLC sub-types, 1 ovarian, 1 all comers): data in this deck are from the treatment naïve, Stage 4 NSCLC patients
Well tolerated up to the highest doses tested
(30mg/kg Q3W), without MTD
Most TRAEs/AEs were Grade 1 or 2
ORR% (n) PD-L1 All PD-L1>1%
CD73High 53% (10/19) 63% (10/16)
CD73Low 18% (8/45) 20% (5/25)
Pembro(KN-042)
PD-L1+ Only NA 27% (174/637)
10
Phase 2 ORR Data from front-line NSCLC Cohort*
Correlation of response with CD73 expression and PD-L1 levels
suggest benefit driven by combination therapy
Safety observations for uliledlimab, administered to >200
patients in combination studies with CPIs |
| Most Tumors
Decrease in
Size
Notes: Response definitions per iRECIST criteria. PR = partial response, SD = stable disease, PD = progressive disease, BOR = best overall response 11
Source: ASCO23 Poster
Promising Early Phase 2 Data in Treatment Naïve NSCLC Patients |
| Most Responses are Durable
12
18 of 21 patients with an objective response remain
on treatment with a median follow-up of 10.8 months
Notes: Response definitions per iRECIST criteria. PR = partial response, SD = stable disease, PD = progressive disease, iUPD = unconfirmed progressive disease, NE not evaluable. IHC = immunohistochemistry
Source: ASCO23 Poster |
| Emerging Data Indicate that Chemotherapy May Extend the Benefit of
Uliledlimab to Patients Regardless of Baseline CD73 Expression
13
I-Mab plans to dose the first patient with
uliledlimab in combination with
chemotherapy and checkpoint inhibitor in
newly diagnosed patients with advanced
NSCLC in H2 2024
Expanding Therapeutic Reach Supporting Evidence Strategic Clinical Design
Combination of chemotherapy with a
checkpoint inhibitor is a standard treatment
approach across multiple advanced stage
malignancies
Chemotherapy co-administration may
increase the immunogenicity of cancer cells
1. Keynote-189 and Keynote-407 studies both
established that co-administration with
chemotherapy extends the benefit of
pembrolizumab to patients with <1% PD-L1
at baseline
2. Literature reports indicate that
chemotherapy upregulates CD73
expression in cancer cells1
1. https://doi.org/10.1073/pnas.1718197115 |
| Favorable Safety Profile as
Monotherapy and in
Combination with CPIs
Encouraging Phase 2 NSCLC
Responses Support Use in
Combination Studies
Developing Uliledlimab as an Immunotherapy Combination of Choice
14
A 63% ORR observed in NSCLC patients with both high CD73 expression and PD-L1 TPS>1%
suggests that when tumors are vulnerable to PD-L1 inhibition, uliledlimab appears to augment
clinical responses
Chemotherapy co-administration may broaden the patient population that benefits from uliledlimab
treatment
First patient dosed with uliledlimab in combination with chemotherapy and checkpoint inhibitors in
newly diagnosed patients with stage 4 NSCLC is planned for H2 2024
The lack of a “hook effect” could enable broad efficacy with optimized dosing
Phase 2 data suggest uliledlimab is safe and well tolerated up to the highest doses tested (45 mg/kg)
New Study Planned H2 2024
Notes: TPS = tumor proportional score; CPI = checkpoint inhibitor; NSCLC = non-small cell lung cancer; ORR = overall response rate; IND = investigational new drug |
| Molecular Design Key Differentiation
Binding activity demonstrated across
various levels of CLDN18.2 expression
Exhibits CLDN18.2 binding even on low
expressing tumor cells
Higher-affinity binding to CLDN18.2
compared to reference antibody
Zolbetuximab
Localized T cell activation in TME to avoid
4-1BB-mediated liver toxicity and systemic
immune response
Givastomig (targeting Claudin 18.2 and 4-1BB)
Ongoing triplet combination studies with nivolumab and chemotherapy across a wide range of Claudin 18.2 levels
15
Unique bispecific integrates Claudin 18.2 as a tumor engager and 4-1BB as a conditional T cell activator
4-1BB scFv
CLDN18.2
Notes: scFv = single chain Fragment-variable region; TME = tumor microenvironment |
| Early Phase 1 Responses in Heavily Pretreated Patients Provides Compelling
Support for Further Studies1
16
5 mg/Kg 8 mg/Kg 12 mg/Kg 15 mg/Kg
> Treatment Ongoing Numbers: CLDN18.2 % PD SD PR
Patient Overview:
• 20 efficacy evaluable patients with CLDN18.2+ GC/GEJ/EAC
• Three median lines of prior treatment (range 1-10)
• Dosed at 5-15 mg/kg (defined as the predicted efficacious dosing
range, based on preclinical studies)
• Cohort is a subset of the Phase 1a (NCT04900818)
Responses:
• Three partial response (PR) observed; two of those had received prior
anti-PD-(L)1 therapy
• Stable disease (SD) observed in four patients. Of those, one had a PR
on the first scan and subsequently withdrew from the study (counted
as SD per RECIST1.1)
• An additional PR (not on the chart) was observed in a patient with
head and neck squamous cell carcinoma receiving 12mg/kg who
remained on study 280 days at time of the ESMO 2023 presentation
1. Source: ESMO 2023
Notes: GC = gastric cancers; GEJ = gastroesophageal junction; EAC = esophageal cancer
Duration of Treatment in Gastric Cancer Patients
>
>
>
>
100
80
80
95
1
50
95
100
30
55
7
20
50
98
25
90
55
99
95
11
Stomach
Stomach
Stomach
Stomach
Stomach
Gastroesophageal junction
Stomach
Stomach
Gastroesophageal junction
Stomach
Stomach
Stomach
Stomach
Esophagus
Stomach
Stomach
Stomach
Esophagus
Stomach
Esophagus
0 25 50 75 100 125 150 175 200 225 250 275 300
Study Days (C1D1 to End of Treatment date) |
| Safety: Treatment Related AEs1
Preferred Term (all numbers are n(%)) Grade 1 Grade 2 Grade 3 Grade 4 Grade 5 All Grades
Nausea 10 (18.2) 3 (5.5) 0 0 0 13 (23.6)
Vomiting 7 (12.7) 2 (3.6) 0 0 0 9 (16.4)
Fatigue 7 (12.7) 1 (1.8) 0 0 0 8 (14.5)
Anemia 1 (1.8) 4 (7.3) 1 (1.8) 0 0 6 (10.9)
Abdominal pain 2 (3.6) 1 (1.8) 0 0 0 3 (5.5)
Alanine aminotransferase increased 2 (3.6) 0 1 (1.8) 0 0 3 (5.5)
Diarrhea 3 (5.5) 0 0 0 0 3 (5.5)
Headache 1 (1.8) 2 (3.6) 0 0 0 3 (5.5)
Lymphocyte count decreased 1 (1.8) 1 (1.8) 1 (1.8) 0 0 3 (5.5)
Pruritus 2 (3.6) 0 1 (1.8) 0 0 3 (5.5)
Pyrexia 3 (5.5) 0 0 0 0 3 (5.5)
White blood cell count decreased 0 2 (3.6) 1 (1.8) 0 0 3 (5.5)
Treatment-related adverse events (TRAEs) occurred in >5% (n=55)
17
• No DLT was reported up to
15mg/kg, and MTD was not
reached
• Most commonly reported TRAEs
(>10% of subjects): Grade 1 or 2
nausea (23.6%), vomiting (16.4%),
fatigue (14.5%), anemia (10.9%)
• 10 subjects (18.2%) experienced at
least one Grade 3 TRAE. No Grade
3 TRAEs occurred in more than one
subject
• Onset of gastrointestinal TRAEs:
generally, after 14 days of
treatment, recovery within one
week; none led to drug withdrawal
1. Source: ESMO 2023
Notes: DLT = dose-limiting toxicity, MTD = maximum tolerated dose |
| Notes: Zolbetuximab (Astellas) is currently under review with the FDA; mAb = monoclonal antibody; ORR = overall response rate; DCR = disease control rate; CR = complete response; PR = partial response; SD =
stable disease; GC = gastric cancers; GEJ = gastroesophageal junction; EAC = esophageal cancer. Note that the comparisons in the table above are not based on data from head-to-head trials and are not direct
comparisons. Differences in trial designs, patient groups, trial endpoints, study sizes and other factors may impact the comparisons
Givastomig Yields Better Monotherapy Responses in Patients with High and
Low CLDN Expression Compared to Phase 1/2 Zolbetuximab Studies
18
Drug Givastomig (bi-specific) Zolbetuximab (mAb)
Phase Phase 1 Phase 1 Phase 2
CLDN18.2 – Expression of the
Study Group
IHC ≥1+ in ≥1% cells IHC ≥1+ in ≥1% cells IHC ≥ 2+ in ≥ 50% cells
Diagnosis Previously treated GC/GEJ/EAC Previously treated GC/GEJ Previously treated GC/GEJ/EAC
Efficacy Evaluable 20 15 43
ORR 15% (3/20) 0 9% (4/43)
DCR (CR+PR+SD) 35% (7/20) 1 SD 23% (10/43)
Source Givastomig poster #1039P ESMO 2023 U Sahin et al. European Journal of
Cancer 100 (2018) 17e26
O Tureci et al. Annals of Oncology
30: 1487–1495, 2019 |
| Potential Differentiations of Givastomig from Other Claudin 18.2 Targeted
Competitors
Givastomig Zolbetuximab ADCs
MoA of
Monotherapy
CLDN18.2 dependent T cell activation in
tumor
4-1BB agonism to increase T cell expansion
in tumor and reinvigorate exhausted T cells
Bi-specific antibody designed to have
conditional 4-1BB activation
Direct killing of CLDN18.2 tumor cells by
ADCC may also release the tumor antigen
CLDN18.2 targeted chemotherapy and
direct killing by ADCC
Lysis of tumor cells by toxin can release the
tumor antigen to mediate immune response
Efficacy ~20% monotherapy ORR in previously
treated CLDN18.2 + GC/GEJ/EC
~10% monotherapy ORR in previously
treated CLDN18.2 + GC/GEJ/EC2
33% monotherapy ORR in previously
treated CLDN18.2 + GC/GEJ3
Safety No Grade 3 neutropenia
No Grade 3 vomiting 22% Grade 3 vomiting2 20% Grade 3+ Neutropenia
10% Grade 3 vomiting4
Claudin 18.2
Targetable
Expression
Broad expression due to Giva-mediated
bystander tumor-killing1
Limited to targeting higher CLDN-expressing tumors
Likely limited to targeting high CLDN-expressing tumors
19 1. Givastomig-mediated T cell activation by CLDN18.2-positive tumor cells leads to the killing of nearby CLDN18.2-negative tumor cells
2. ADC efficacy;
3. ASCO Plenary Series 2023 (Note: Examples reported are from representative molecules within ADC class as not all ADCs will have these specific numbers;
4. Annals of Oncology |
| Unique Design To Enable
Wide Use Plus Favorable
Initial Safety Profile
Encouraging Responses in
Previously Treated Patients,
including Those with Low
CLDN18.2
Dose Expansion Data and New
Chemotherapy/Nivolumab
Combo Planned for 2024
Unique Bispecific Design Properties and Monotherapy Data in Gastric
Cancers Could Position Givastomig as Best-in-Class Claudin 18.2 Therapy
Notes: Gastric cancers = gastric, gastroesophageal junction and esophageal cancer 20
Objective responses seen in patients with gastric and esophageal cancer who had received
multiple lines of prior treatment, including PD-(L)1, and had low CLDN18.2 levels
CLDN18.2 assay for patient selection is in development with a partner
New dose expansion in combination with nivolumab and chemotherapy cohort study
began in H1 2024 in treatment naïve patients with gastric cancers
Updated monotherapy dose expansion data in CLDN18.2+ patients with gastric cancers
whose disease has progressed after previous treatment to be presented in 2H 2024
Bispecific design results in CLDN18.2 conditional 4-1BB and T cell activation, potentially
inducing long-lasting immune memory response. Conditional localized activation of 4-1BB and T
cells enable superior anti-tumor activity even in tumors with low levels of CLDN18.2 expression
Phase 1 dose escalation reached highest planned dose without encountering DLT or liver
toxicity signals |
| Molecular Design Key Differentiation
Designed to treat PD-(L)1
expressing cancers
Targeting PD-L1+ tumor cells and
blocking PD-L1/PD-1 interaction
PD-L1-dependent conditional 4-1BB
activation via tumor site
4-1BB conditional activation with
localized immune activation in TME
Ragistomig (ABL503/TJ-L14B, targeting PD-L1 and 4-1BB)
Unique bispecific integrates PD-L1 as a tumor engager and 4-1BB as a conditional T cell activator
21
4-1BB scFv
PD-L1 IgG
Promising, early Phase 1 dose efficacy data presented at ASCO 2024
Notes: scFv = single chain Fragment-variable region; TME = tumor microenvironment |
| Unique Bispecific Design Properties and Monotherapy Data in R/R Patients
22
Objective responses seen in patients with progressive, locally advanced, or metastatic solid
tumors that are relapsed or refractory following prior lines of treatment:
• One Complete Response (CR), six Partial Responses (PR), three Stable Disease (SD)1
• Objective Response Rate (ORR) of 26.9%, Clinical Benefit Ratio (CBR) of 69.2% at
3 mg/kg and 5 mg/kg dosing groups (combined, n=26)
The CR was observed in a heavily pretreated ovarian cancer patient dosed at 3 mg/kg
(seven lines of prior therapy)
Data support further development as a monotherapy and in combination with other agents
Bispecific design to stimulate 4-1BB activation in the presence of PD-L1 expressing
tumor cells to minimize off-tumor toxicity
Maximally tolerated dose 7mg/kg Q2W
Dose expansion is ongoing with preliminary efficacy signals
Unique Design To Enable
Broader Use Plus Favorable
Initial Safety Profile
Preliminary Phase 1
Efficacy Signals Observed
Top-line Phase 1 Clinical
Data at ASCO 2024
1. Data cut-off as of April 19, 2024
Notes: MTD = maximum tolerated dose; CR = complete response; PR = partial response; uPR = unconfirmed partial response; R/R = relapsed/refractory. Study design per clinicaltrials.gov |
| I-Mab Portfolio Projected to Substantially Advance
Key milestones in 2024
23
Timing Program Milestone
H1 2024 givastomig New triple combination dose expansion cohort began enrollment
Givastomig/nivolumab/chemotherapy regimen (patients with gastric, GEJ, and esophageal cancers)
H1 2024 ragistomig
Phase 1 monotherapy data presented at ASCO 2024
Dataset included 1 CR, 6 PR, and 3 SD, resulting in a 26.9% ORR and 69.2% CBR at 3 mg/kg and 5 mg/kg
dosing groups (combined, n=26)
H2 2024 givastomig Presentation of updated Phase 1 dose expansion data
monotherapy (CLDN18.2+ patients with gastric, GEJ, and esophageal cancers)
H2 2024 uliledlimab US first patient dosed:
First patient dosed in chemo + CPI combination for treatment-naïve NSCLC
Notes: CPI = checkpoint inhibitor; CLDN = Claudin; NSCLC = non-small cell lung cancer; GEJ = gastroesophageal junction |
| I-Mab is Well-positioned for Meaningful Value Creation
A global biotech with an innovative portfolio and a healthy balance sheet
24
Uliledlimab
(CD73)
Givastomig
(CLDN18.2 x 4-1BB)
Ragistomig
(PD-L1 x 4-1BB)
Advancing an
Innovative Pipeline
NASDAQ-listed
US-based Leadership Team
Headquartered in Rockville,
MD
Emerging U.S.
Entity
Transaction closed Apr-24
Aggregate consideration of
up to US$80M, contingent
on certain future regulatory
and sales-based
milestones
Divestiture of
China Operations
Disciplined
Capital Strategy
Cash balance of $321.8M1
as of December 31, 2023
Reduced cash burn
following divestiture to
align resources to most
promising programs
1. Cash position refers to cash, cash equivalents, and short-term investments
Notes: CLDN18.2 = Claudin 18.2 |
| Stay connected
I-Mab Biopharma
IR Contact
Tyler Ehler
Sr. Director, Investor Relations
ir@imabbio.com |
Exhibit 99.2
I-Mab
Appoints Phillip Dennis, MD, PhD, as Chief Medical Officer
ROCKVILLE,
MD, June 6, 2024 – I-Mab (NASDAQ: IMAB) (the “Company”), a U.S.-based, global biotech company, exclusively
focused on the development and potential commercialization of highly differentiated immunotherapies for the treatment of cancer, today
announced the appointment of Dr. Phillip Dennis as Chief Medical Officer. Dr. Dennis, who will join I-Mab effective June 17,
2024, will lead the Company’s global clinical development efforts and serve as a member of I-Mab’s Executive Leadership Team.
“I am pleased
to welcome Dr. Phillip Dennis as our Chief Medical Officer. Dr. Dennis brings over two decades of experience in oncology
drug development, including his role as a cross-functional leader of the international team that developed a novel PD-L1 inhibitor
and his contributions to the development of other assets for lung and other cancers.” said Raj Kannan, CEO of I-Mab. “I
look forward to partnering with Phillip in further advancing our clinical development pipeline and unlocking the potential of I-Mab
for patients and shareholders.”
"I am pleased to
join I-Mab at this critical juncture in the Company’s growth," said Dr. Dennis. " I am excited about the opportunity
for uliledlimab, givastomig, and ragistomig, based on data from monotherapy and combination therapy in advanced solid tumors, including
lung and gastric cancers, presented at major medical meetings to date. I look forward to working with my accomplished colleagues to support
the accelerated development of I-Mab’s clinical pipeline."
Before
joining I-Mab, Dr. Dennis was Vice President of Lung Cancer Strategy and the Global Project Head for a novel, first-in-class ADC
at Sanofi (NASDAQ: SNY). Prior to Sanofi, Dr. Dennis was Vice President of Lung Cancer Strategy and Global Clinical Lead at AstraZeneca
(NASDAQ: AZN). In these roles, Dr. Dennis served as the disease strategy head for lung cancer and led the cross-functional
development of key assets, including IMFINZI®. Prior to his pharmaceutical career, Dr. Dennis was a widely published
professor of Oncology, Medicine, and Pharmacology at Johns Hopkins University. Dr. Dennis received his MS, MD, and PhD degrees from
the New York University School of Medicine as part of the Medical Scientist Training Program. Dr. Dennis completed his residency
in Internal Medicine and fellowship in Medical Oncology at Johns Hopkins. Dr. Dennis also spent 14 years as a translational researcher
at the US National Cancer Institute, achieving tenure as a Senior Investigator. He is an elected member of the American Society for Clinical
Investigation and has won several awards, including an NIH Merit Award.
About I-Mab
I-Mab
(NASDAQ: IMAB) is a U.S.-based, global biotech company, exclusively focused on the development and potential commercialization
of highly differentiated immunotherapies for the treatment of cancer.
I-Mab
has established operations in the U.S. in Rockville, Maryland, and in San Diego, California. For more information, please visit https://www.i-mabbiopharma.com and
follow us on LinkedIn and X.
IMFINZI® is a
registered trademark of AstraZeneca.
I-Mab Forward Looking Statements
This press release
contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as
"will", "expects", "believes", "designed to", "anticipates", "future",
"intends", "plan", “promise”, "potential", "estimate", "confident",
“explore”, “optimistic about”, “look forward to”, and similar terms or the negative thereof.
Statements that are not historical facts, including statements about I-Mab's beliefs and expectations, are forward-looking
statements. The forward-looking statements in this press release include, without limitation, statements regarding: the anticipated
terms, objectives, and potential for its clinical pipeline, including uliledlimab, givastomig, and ragistomig. These forward-looking
statements involve inherent risks and uncertainties that could cause actual results to differ materially from those expressed or
implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, the following:
I-Mab’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates,
which may not support further development or New Drug Application/Biologics License Application approval; the content and timing of
decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab’s drug candidates; I-Mab’s
ability to achieve commercial success for its drug candidates, if approved; I-Mab’s ability to obtain and maintain protection
of intellectual property for its technology and drugs; I-Mab’s reliance on third parties to conduct drug development,
manufacturing and other services; I-Mab’s limited operating history and I-Mab’s ability to obtain additional funding for
operations and to complete the development and commercialization of its drug candidates; and discussions of potential risks,
uncertainties, and other important factors in I-Mab’s most recent annual report on Form 20-F and I-Mab’s subsequent
filings with the U.S. Securities and Exchange Commission (the "SEC”). I-Mab may also make written or oral forward-looking
statements in its periodic reports to the SEC, in its annual report to shareholders, in press releases and other written materials,
and in oral statements made by its officers, directors, or employees to third parties. All forward-looking statements are based on
information currently available to I-Mab. I-Mab undertakes no obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events or otherwise, except as may be required by law.
I-Mab Contacts
Investors & Media |
Tyler Ehler |
Senior Director, Investor Relations |
IR@imabbio.com |
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