AI Terminal

MODULE: AI_ANALYST
Interactive Q&A, Risk Assessment, Summarization
MODULE: DATA_EXTRACT
Excel Export, XBRL Parsing, Table Digitization
MODULE: PEER_COMP
Sector Benchmarking, Sentiment Analysis
SYSTEM ACCESS LOCKED
Authenticate / Register Log In

Purple Biotech Ltd.

Foreign Filer Report Jun 6, 2022

7004_rns_2022-06-06_bb731d7c-09d3-46a6-9a03-4385d36f191e.pdf

Foreign Filer Report

Open in Viewer

Opens in native device viewer

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 2022

Commission File Number: 001-37643

PURPLE BIOTECH LTD. (Translation of registrant's name into English)

4 Oppenheimer Street, Science Park, Rehovot 7670104, Israel

(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

Form 20-F ☒ Form 40-F ☐

Indicate by check mark if the Registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐

Indicate by check mark if the Registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐

Purple Biotech Ltd. (the "Company" or the "Registrant") is announcing that it has made available an updated Company Presentation on its website. A copy of the updated Company Presentation is attached hereto as Exhibit 99.1 and may be viewed at the Company's website at www.purple-biotech.com.

Exhibit

99.1 Company Presentation – June 2022

Incorporation by Reference

This Form 6-K, including all exhibits attached hereto, is hereby incorporated by reference into each of the Registrant's Registration Statement on Form S-8 filed with the Securities and Exchange Commission on May 20, 2016 (Registration file number 333-211478), the Registrant's Registration Statement on Form S-8 filed with the Securities and Exchange Commission on June 6, 2017 (Registration file number 333-218538), the Registrant's Registration Statement on Form F-3, as amended, originally filed with the Securities and Exchange Commission on July 16, 2018 (Registration file number 333-226195), the Registrant's Registration Statement on Form S-8 filed with the Securities and Exchange Commission on March 28, 2019 (Registration file number 333-230584), the Registrant's Registration Statement on Form F-3 filed with the Securities and Exchange Commission on September 16, 2019 (Registration file number 333-233795), the Registrant's Registration Statement on Form F-3 filed with the Securities and Exchange Commission on December 2, 2019 (Registration file number 333-235327), the Registrant's Registration Statement on Form F-3 filed with the Securities and Exchange Commission on May 13, 2020 (Registration file number 333- 238229), the Registrant's Registration Statement on Form S-8 filed with the Securities and Exchange Commission on May 18, 2020 (Registration file number 333-238481), each of the Registrant's Registration Statements on Form F-3 filed with the Securities and Exchange Commission on July 10, 2020 (Registration file numbers 333-239807 and 333-233793) and the Registrant's Registration Statement on Form S-8 filed with the Securities and Exchange Commission on April 4, 2022 (Registration file number 333-264107), to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.

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, thereunto duly authorized.

June 6, 2022 PURPLE BIOTECH LTD.

By: /s/ Isaac Israel

Isaac Israel Chief Executive Officer

Forward-looking Statements and Safe Harbor

Certain statements in this presentation that and not statements of historical lact are forward-looking statements within the meaning of the safe farlor provisions of the Phate Securities Litigation Referm Act of 1955. Such re not imited to, statements that are not statements of historical fact, and the be be illed by words such as "believ", "ntend", "nay", "should", "might", "see", "targe", "will", "projec", "toreast", "continue" or their negatives of variations of these words or other comparable words. You should not person on hese forward-looking statements, which are not guarantees of future performance. Forward-looking statements reflect our curent views, expectations with respect o future events, and are subject to a number of assumptions, involve inown and unhown risk, may of which are beyond our control, as well as uncertaining and our actual results, performance or achievements to be significantly different from any future esults, performance on achievenents expressed or implied by the enterents. Important factors that could cause or contribute to such offerences include, anong others, risks relating to: the plans, strategies and objectives of nanagement for NT219 and CM24; the process by virith early stage therapeutic andidates such as N7219 and CM24 could potentially lead to an approved drighty significant risks, particularly with respect to a joint development collaboration; the fact that drug development and commercialization invives a lengthy and expense; our ability to successfully develop and commercialize our pharmaceutial product; the expense, length, proges and results of any clinical trials; the linical trials; the impat of any changes in regulation and legislation that could affect the pharmacutical industry the difficulty in receiving the recessary in order to commercialize our products; the difficulty of preticing actions of the U.S. Food and Dug Administration or any other applicable regulator of pharmaced and charges in the heath policies and regims in the countries in which we operate; the uneratiny surrounding the actual market reception to or celeared for marketing in a particular market, the introduction of competing podents attained by competitors; dependence on the effectivenes of our protections for inrovative probility to obtain, maintain and defend issued patents; the commencenent of any patent interference or infingenent action against our ablity to prevall, obtain a favorable decision or recover damages in any such action; and the expoure to litigation, including patent litigation, and other factors that are discussed in our in our Annual Report on Form 20-F for the year ended December 3, 2021 and in our other filings with the U.S. Securities and Exchange our castionary discussion of risk and uncertaintes under "Risk Factor" in our Registation Statements and Annal Reports. These are lactors that we believe our actual results. Other factors besides those we have listed could also adversely affect us, Any forward-looking statement in this presentation it is made. We distain any intention or obligation to publicy update or revise any forward-ooking statenert, on other information contained hew information, future events or otherwise, except as required by applicable law. You are advised, lowever, to consult any additional disclosures we make in our reports to the SEC, which are available on the SEC's website, http://www.sec.gov.

Business Highlights

We are a clinical-stage company committed to the development of first-in-class, effective therapies by harnessing the power of the tumor microenvironment (TME) to overcome drug resistance and improve treatment outcomes for cancer patients

  • · Two first-in-class drug candidates
  • · Multiple Phase II studies ongoing and planned
  • · Lean & global operation
  • · BD activity to grow our pipeline with innovative assets
  • · Extended cash runway to end of 2024

Strong balance sheet and cash position Purple Biotech (NASDAQ/TASE: PPBT)

ADSs outstanding: 17.8M

\$42.2M cash as of March 31st, 2022

Multiple data read-outs expected in the next 12 months

Harnessing the Power of the TME

  • · Hammering cancer cells is not sufficient (i.e, chemotherapy, radiotherapy)
  • · Tumors rely on a favorable environment to strive and escape the Immune surveillance
  • · Multiple resistance mechanisms prevent long-term survival
  • · Concept fully validated with the rise of Immuno-oncology treatments
  • · The current focus is largely on lymphoid cells while the "myeloid" component is largely overlooked

We focus on MOAs that impact both tumor cells and infiltrating cells

A Pipeline Dedicated to Advancing Oncology Therapies

Program Indication Phase I Phase 2 Phase 3 Value Drivers
Solid tumors (monotherapy) Completed V RP2D in combination: 20 mg/kg
Solid tumors (combination with nivolumab") cetuximab V Initiation of phase II in 2L PDAC
CM24
(CEACAM-1)
Pancreatic Cancer (combination with nivolumab Follow up OS data from P1
and 5-fluorouracil and liposomal irinotecan or
nab-paclitaxel")
Analysis part 1 of P2 (Simon 2-stages)
Combination with SOC, undisclosed indication Investigation in a second indication
Solid tumors (monotherapy) RP2D monotherapy & combination
NIP 19
(IRS1/2 & STAT3) cetuximab)
R/M SCCHN & CRC (dose escalation + P2 with Initiation of P2 combination with
Combination with SOC, undisclosed indication Investigation in a second indication

Advancing First-in-Class Oncology Therapies

CM24: an α-CEACAM1* mAb

*Carcinoembryonic Antigen Cell Adhesion Molecule

CM24: a New Multi-Functional Immune Checkpoint Inhibitor

CEACAM1 Plays a Key Role in Cancer Biology

01 | ADHESION

Horst, 2011 Oncogene "CEACAM1 creates a pro-angiogenic tumor microenvironment that supports tumor vessel maturation"

Ferri, 2020

@ immunology "Neutrophil extracellular trapassociated CEACAM1 as a putative therapeutic target to prevent metastatic progression of colon carcinoma"

02| IMMUNE CELLS/ IMMUNE EXCLUSION

"Immune-checkpoint molecules on requlatory T-cells as a potential therapeutic target in head and neck squamous cell cancers"

"[Blockade] enhances natural killer cell cytotoxicity against tumor cells through blockade of the inhibitory CEACAM1 / CEACAM5 immune checkpoint pathway"

03 | IMMUNO-ONCOLOGY

Blumberg, 2015

nature

"CEACAM1 regulates TIM-3-mediated tolerance and exhaustion"

Shively, 2013

"CEACAM1 regulates Fas-mediated apoptosis in Jurkat T-cells via its interaction with B-catenin"

18

CM24 MOA | Immuno-Oncology & Adhesion

Market d. Jannunol 2020, 2006; Inmunol Imnunother 2010; Orenberg et of, Mol Concer The 2012; 2009; U., 203; Hung, 2015; Hong, 2015; Achayo N, et al. J. Inmundheropy Car URPLE 8:01.22, 2020, Roys 8, et al. Neutrophil Extracellated CEACAM zo Perent Metsotic Progetto of Color Corone of Colon Corcinona. Inmuni. 2020 Gersel, O color Corconomi. Innuno.

CM24 Reduces Tumor Burden & Synergetic with α-PD-1

CEACAM1 is Highly Over-Expressed in PDAC

adenocarcinoma and normal tissues

| 11

Phase 1 Dose Escalation Interim Results CM24 is Safe and Well Tolerated in Combination with Nivolumab

Study design

  • · As of March 8th, 2022, a total of 13 patients were enrolled and 11 patients were evaluable for DLT determination (8 PDAC, 2 CRC and 1 PTC).
  • · 9 patients had received 2 prior regimens for metastatic disease, 2 patients had one previous line.

Safety

  • . No DLTs were observed across all dose levels; no Grade 4 AEs or treatment-related deaths have been reported.
  • · Grade 3 AEs were noted in 6/13 patients (46%).
Total Grade
AE Term 1 2 3 4/5
Diarrhea 5 4 1
Abdominal pain 4 1 3
Fever 4 2 2
Headache 4 3 1
Fatigue 4 4
Nausea 3 1 2
Creatinine increased 3 2 1
Hypokalemia 2 2
Dyspnea 2 1 1
Constipation 2 2
Cough 2 2
Abdominal pain aggravated 1 1
Alkaline phosphatase increase 1 1
Atrial flutter 1 1
C-Diff Collitis 1 1
GI bleed 1 1
Leukocytosis 1 1
Small bowel obstruction 1 1

CM24 Phase 1 Dose Escalation Interim Results (cont.) Sustained Clinical Benefit Even After Treatment Cessation

For the 11 evaluable patients as of March 8th, 2022, best overall response included 1 confirmed PR (PDAC patient) 3 SD (2 PDAC and 1 PTC) for a disease control rate of 36%

  • · 9/11 of the evaluable patients are in study follow-up
  • · Pharmacokinetic analysis of CM24 shows exposure is doseproportional across the 3 doses in this study with a complete receptor occupancy of peripheral CEACAM1 receptors on T cells and neutrophils at CM24 doses of 15 or 20mg/kg
  • Median overall survival has not yet been reached .

The Phase 2 portions of the study have been initiated at the conclusion of this dose-escalation part.

Confirmed Partial Response in a 3L PDAC Patient

Patient Profile

  • . 65 y/o female, pancreatic cancer
  • · 2 prior lines of treatments: FOLFIRINOX and gemcitabine/nab-paclitaxel
  • . Post Whipple Procedure
  • . Patient had a germline NF1 VUS, with MSI-S and PDL-1 IHC 2+ and 5% staining
  • · Confirmed Partial Response: after initial treatment, the patient had a Partial Response of 40%, with a definite reduction of the para-tracheal adenopathy and liver lesions and 58% reduction in CA19-9 levels
  • . Under treatment for 6 months, still under monitoring.

SCREENING FIRST VISIT - PREDOSE 2 MONTH VISIT -

PREDOSE

Large Market Opportunity in Pancreatic Cancer

· Pancreatic Cancer accounts for ~60K new cases/year in the US; with a 5-year relative survival rate of 10%3

  • I/O approaches have been limited to patients with high microsatellite instability (MSI-H) or high tumor mutational burden (TMB-H)
  • · 5-year overall survival rate with chemotherapy in 2L is 3%1
  • · CEACAM1 expression correlates with poor prognosis in Pancreatic cancer2
  • · Preclinical data support significant synergy

Combining nivolumab with CM24 in a clinical collaboration with Bristol Myers Squibb

(Illi Bristol Myers Squibb"

1 American Cancer Society, Cancer Facts & Figures 2019, and the ACS website,
https://seer.cancer.gov/statfacts/html/poncreas.html 2 Colinescu et al, Journal of Immunology Research 2018: 7169081; Carcinoembryonic antigen-related cell adhesion molecules (CEACAM) 1, 5 and 6 as biomarkers in pancreatic cancer, DOI: 10.1371/journal.pone.0113023

| 15

Advancing First-in-Class Oncology Therapies

NT219: A Small Molecule Dual Inhibitor of IRS 1/2 and STAT3

NT219 - A Novel Approach to Overcome Resistance to EGFRi and Beyond

NT219 - Dual Inhibitor of IRS1/2 & STAT3

IRS1/2

  • · Scaffold proteins, mediating mitogenic, metastatic, angiogenic and anti-apoptotic signals from IGF1R, IR, IL4R and other oncogenes, overexpressed in multiple tumors
  • Regulates major survival pathways such as the PI3K/AKT, MEK/ERK and WNT/β-catenin
  • · Activated as a feedback response to anticancer therapies
  • · IRS plays an important role in promoting a tumor-protective microenvironment, by mediating upregulation of TAMs and CAFs

NT219

STATS

  • · Well-established transcription factor associated with the tumorigenic phenotype
  • · STAT3 is broadly hyperactivated in many cancers, promoting proliferation, survival, angiogenesis and metastasis
  • · STAT3 pathway is required for TGFBinduced EMT and cancer cell migration and invasion
  • · STAT3 is a critical player in tumor immune evasion, suppressing immune stimulators and enhancing immunosuppressive factors

भारत के द्वादर को 2012 - 12:42 AM #12 - 2017 - 12:42 PM #1 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 1

Novel MOA: IRS Degradation By NT219 Blocking IGF1R-AKT Pathway1

Novel MOA: Signal Transducer and Activator of Transcription 3 (STAT3) Inhibition

  • · Point of convergence for numerous oncogenic signaling pathways
  • · Central in regulating the anti-tumor immune response
  • · Broadly hyperactivated both in cancer and non-cancerous cells within the tumor ecosystem and plays important roles in inhibiting the expression of crucial immune activation regulators and promoting the production of immunosuppressive factors
  • · Targeting the STAT3 signaling pathway has emerged as a promising therapeutic strategy for numerous cancers

NT219 demonstrates a durable and dose-dependent suppression of STAT3 tyrosine phosphorylation, affecting both the tumor cells and the tumor microenvironment.

NT219 Efficacy as Monotherapy

α-PD1 Cetuximab (Erbitux®) NT219 20mg/kg NT219 60mg/kg

Drugs

1 NSG mice were injected SC with SCC-9 cells. PBMCs were injected to the mousel and treatments initeded when
tumors were established. (NT219) and IP (c-PDI and cetuximob) tw 2020 Multidisciplinary Head and Neck Concers Symposium Poster presentation

NT219 Restores Tumor Volume (mm3) 2.000 Sensitivity to 1,500 EGFRi in PDX 1,000 500 Models 0 NT219 Osimertinib Osimertinib+NT219 Control Osimertinib 5 mg/kg, NT219 65 mg/kg, mean tumor volume at the end point, 3 mice/group; NSCLC Exon 19 deletion EGFR and T790M, biopsy of bone marrow metastasis, patient ** previously progressed on Tumor Volume (mm3) 2,000 afatinib and osimertinib 1,500 R/M SCCHN 1,000 metastasis, patient 500 previously progressed on chemoradiation, several 0 Cetuximab+NT219 chemotherapies, and Control NT219 Cetuximab pembrolizumab Treatments on days 0, 3 and 10, cetuximab - 1mg/mouse, 3 mice/group; PBMCs (1.4M cells/mouse) were injected on day 6 ** p<0.01, * p<0.02 based on one-way ANOVA with post hoc Tukey's HSD test

NT219 Phase 1 Dose Escalation Monotherapy Interim Results

Study design

  • · As of data cutoff date of May 12th, 2022, a total of 14 patients were enrolled and 12 patients were evaluable for DLT determination (4 CRC, 3 pancreatic cancer, 2 breast cancer, 1 GEJ, 1 esophageal and 1 appendiceal cancer)
  • · Median number of prior treatment regimens for metastatic disease was 4 (2-11).

Safety

  • No DLTs were observed across all dose levels. .
  • · Nine Grade 3 adverse events (AEs) were observed, two of which possibly related to NT219
Grade
AE Term Total 1 2 3 4/5
Fatigue 6 6
Constipation 4 4
ALP Increased 3 2 1
ALT increased 3 1 2
Anemia 3 1 2
AST increased 3 1 1 1
Diarrhea 3 2 1
Headache 3 3
Nausea 3 2 1
Andominal pain 2 1 1
Belching 2 2
Cough 2 2
Dizziness 2 2
Dyspnea 2 2
Edema limbs 2 2
Fever 2 2
Hot flashes 2 2
Hyperhidrosis 2 2
Urinary tract infection 2 2
Abdominopelvic Ascites 1 1
Closed displaced fracture of right
femoral neck 1 1
Intractable right hip pain 1 1
Malignant hypercalcemia 1 1
Toxic Encephalopathy 1 1
Worsening back pain 1 1
Abdominopelvic Ascites 1 1

| 26

NT219 Phase 1 Dose Escalation Monotherapy Interim Results: Encouraging Initial Efficacy Signals:

  • · For the 12 evaluable patients, best overall response included one confirmed PR (GEJ patient, > 5.5 months duration of response following end of treatment), and 3 SD with one patient awaiting follow up MRI/CT scans
  • · As of the cutoff date (May 12th , 2022), 10/12 patients are either on treatment or in follow up (range 1.1 to 18 months).

| 27

Confirmed PR as Single Agent in a GEJ Cancer Patient

  • · In a patient with refractory GE junction disease (mutated KRAS, TP53), NT219 administration (3mg/kg as a single agent) was associated with a confirmed partial response (PR):
    • · Complete remission at the largest target lesion (right)
    • · Complete resolution of all non-target lesions (two lymph nodes) has also been demonstrated
    • · The patient remained on treatment for nearly 6 months and is still on study for follow-up.

GEJ tumor at baseline screening

CT imaging of the GEJ tumor after 5 months of treatment with NT219

First Market Opportunity

Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)

Targeting the unmet medical need

  • · 1L Standard of care has shifted from chemotherapy towards immuno-oncology + chemotherapy
  • · < 20% of R/M SCCHN patients respond to Pembrolizumab
  • · SCCHN is the 6th most common cancer type ; 175k new cases/year are expected by 2024
  • · Market size forecasted to >\$5b in 2030

NT219 Monotherapy and Combination Phase 1/2 Study Design (NCT04474470)

Study title

A phase 1/2 study with open-label, dose escalation phase followed by single-arm expansion to assess the safety, tolerability, PK, PD and efficacy of NT219, alone in adults with recurrent or metastatic solid tumors and in combination with Erbitux® (cetuximab) in head and neck cancer

Endpoints

Primary endpoints: Safety, pharmacokinetics and to determine the MTD Secondary endpoints: Obtain preliminary efficacy data

Business Highlights

We are a clinical-stage company committed to the development of first-in-class, effective therapies by harnessing the power of the tumor microenvironment (TME) to overcome drug resistance and improve treatment outcomes for cancer patients

  • · Two first-in-class drug candidates
  • · Multiple Phase II studies ongoing and planned
  • · Lean & global operation
  • · BD activity to grow our pipeline with innovative assets
  • · Extended cash runway to end of 2024

Strong balance sheet and cash position Purple Biotech (NASDAQ/TASE: PPBT)

ADSs outstanding: 17.8M

\$42.2M cash as of March 31st, 2022

Multiple data read-outs expected in the next 12 months

EURPLE

THANK YOU

We are committed to provide cancer patients with first-in-class therapies to OVERCOME tumor drug resistance, ENHANCE treatment response and SLOW tumor progression

Contact Us: [email protected]

Appendix A | CM24

PK/PD Modeling Provides Dosage & Schedule Guidance

  • · CM24 completed Phase 1 monotherapy open-label, dose-escalation study to assess safety and tolerability
  • · Heavily pre-treated 24 evaluable patients with a median of 4 prior regimens
  • · Overall, treatment was well tolerated, no DLTs
  • · 33% SD (RECIST 1.0), mostly at the highest dose levels of 3mg/kg & 10mg/kg
  • · PK analysis revealed non-linearity, modeling recommended continuing administration of higher doses to reach saturation, consistent with observed PK showing high clearance at doses <10 mg/kg
  • · 10 mg/kg has a broad range of saturation
  • · Q2W regimen preferable to Q3W

Simulated TMDD1 saturation

Predictions with Q3W regimen

4Torget-mediated drug disposition. 2Ctrough is the drug concentration reached by CM24 before the next dase is administered

| 34

CM24 Phase 1 Combination Study (NCT04731467) Demographics

In the Phase 1 part, patients with indicated refractory cancers were administered CM24 at 10, 15, and 20mg/kg q2w and nivolumab 480mg q4w.

  • · The primary objective of this part was to evaluate safety, tolerability, pharmacokinetics and determine the RP2D
  • · Safety was assessed according to CTCAE v5 and preliminary anti-tumor activity was assessed by the investigators according to RECISTv1.1 using CT/MRI
  • . CM24 and CEACAM1 measurements in serum, biopsy specimens, and TILs, as well as tumor and TILs PD-L1 levels are being determined

As of March 8th, 2022, a total of 13 patients were enrolled and 11 patients were evaluable for dose-limiting toxicity (DLT) determination (8 PDAC, 2 CRC and 1 PTC)

. 9 patients had received 2 prior regimens for metastatic disease and 2 patients had one previous line.

Demographics of patients treated with CM24 (10, 15, 20mg/kg) in combination with nivolumab (480mg)

Median age, years (range) 65 (49-76) Prior Lines of Therapy, n (%)
Sex, n (%) 1 2 (18%)
Male 5 (45%) 2 9 (82%)
Female 6 (55%) Diagnosis , n (%)
Ethnicity, n (%) Pancreatic cancer 8 (73%)
Not Hispanic or Latino 10 (91%) Papillary Thyroid cancer 1 (9%)
Hispanic or Latino 1 (9%) Colorectal cancer 2 (18%)
Race, n (%) Median Time from Initial
Diagnosis months (range)
23 (11-73)
White 10 (91%) ECOG, n (%)
Black or African American 1 (9%) 0 7 (64%)
1 4 (36%

Appendix B | NT219

Selected Publications

NT219 | Suppresses β-Catenin activity in CRC Cells and Inhibited CRC Brain Metastasis

Colon cancer LS-513 cells overexpressing IRS2 demonstrate enhanced ß-catenin activity. Targeted inhibition of IRS2 by NT219 or IRS2-SH RNA, suppresses the increased ß-catenin activity and inhibit LS-513 cell viability. Combination of 5-FU and NT219 significantly inhibited the growth of CRC tumors in brain, using intracranial model and extended mice survival.

AACR Annuol Meeting, April 2021, AACR Virtual Special Conference on Epigenetics and Metabolism, Oct 2020, Ido Wolf, MD, Head of Oncology Division, Tel Aviv Sourasky Medical Center

PDX model Pancreatic Cancer Drug Gemcitabine (Gemzar ® ) NT219 | Pancreatic Cancer in Combination with Gemcitabine | 39 Highly effective anti cancer activity exhibited by NT219 in combination with Gemcitabine

Reduced expression of IRS1, Ki67, FOXM1 & TGFb is RNA Sequencing | exhibited by pancreatic cancer treated with NT219 alone and Analysis of Tumors in combination with gemcitabine Following Treatment Ki67 (Proliferation marker) IRS1 PDX model 17% 17% Control NT219 Gemzar Gemzar Pancreatic Cancer Gemzar Control NT219 Gemzar +NT219 +NT219 TGFbeta (EMT Driver) FOXM1 100% 1009 101% Drug Gemcitabine (Gemzar®) Control NT219 Gemzar Gemzar Control NT219 Gemzar Gemzar +NT219 +NT219 | 40

NT219 Phase 1 Dose Escalation Monotherapy Demographics

As of data cutoff date of May 12th , 2022, a total of 14 patients were enrolled to 4 NT219 dose levels (3 - 24mg/kg)

  • · 12 patients were evaluable for DLT determination including 4 CRC, 3 pancreatic cancer, 2 breast cancer, and one of each of the following cancers: GEJ, esophageal and appendiceal cancer
  • · Median number of prior treatment regimens for metastatic disease was 4 (2-11)
PURPLE
Demographics of patients treated with NT219 (3, 6, 12, 24mg/kg)
Median age, years (range) 67 (39-79) Diagnosis _ n (%)
Sex, n (%) Pancreatic 3(25%)
Male 4(33%) GE Junction 118%)
Fernale 8 (67%) Breast 2(17%)
Ethnicity, n (%) Colorectal 4(33%)
Not Hispanic or Latino 11 (92%) Appendiceal 1(8%)
Hispanic or Latino 1 (8%) SCC of the esophagus 1(8%)
Race, n (%) Prior Lines of Therapy, n (%)
White 10 (83%) 2 2 (17%)
Black or African American 2 (17%) 3 3 (25%)
ECOG, n (%) 4 2(17%)
0 5 (42%) 5 2(17%)
1 7 (58%) б 1(8%)
Median Time from Initial Diagnosis
months (range) 36(10-153) 8 118%)
11 118%1

Talk to a Data Expert

Have a question? We'll get back to you promptly.