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Purple Biotech Ltd.

Foreign Filer Report Nov 10, 2022

7004_rns_2022-11-09_e93c3c57-e09a-48a3-9e30-25ce415b5ad7.pdf

Foreign Filer Report

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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 November 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 – November 2022

Incorporation by Reference

This Report on 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.

1

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.

November 9, 2022 PURPLE BIOTECH LTD.

By: /s/ Gil Efron

Gil Efron Chief Executive Officer

Forward-looking Statements and Safe Harbor

Certain statements in this presentation that and not statements of historical fact are forward-looking statements within the meaning of the safe hardor provisions of the Private Securities Litigation Reform Act of 1995. Such entry include, but are not initied to, statements of historical fact, and may be identified by words such as "believ", "ened", "nten", "nay", "should", "might", "seel", "toreast", "continu" or "anticipat" or their negatives or variations of these words or other comparable words. You should reliance on these forward-looking statements, which are not guarantees of tuture performance. Foward-looking statements reflect our current views, expections with respect of future events, and are subject to a number of assumptions, incole known isks, may of which are beyond our control, as well as uncertaining and our actual results, performance or achievenents to be significantly different from any future esults, performance or achievenents expressed or implied by the towards. Important factors that could cause or contribute to such differences include, among others, risks relating to the plans, strategies and objectives of nanagement for tuture development for NT219 and CM24; the process by wicits early stage therapeutic candidates such as NTZ19 and CMZ4 could potentially lead to an approved drighty significant risk, particularly with respect to a joint development collaboration; the fact that drug development and commercialization involves a lengthy and expense; our ability to successilly develop and commercialize our pharmaceutical product; the experse, lergh, progress and results of any clinical tinate the clinical tiols; the impact of any changes in regulation and legislation that could affect the pharmaceuical industry the difficulty in receiving approvals neessary in order to commercialize our products; the difficulty of predicting actions of the U.S. Food and Drug Admisistation o other applicable regulator of pharmaced and changes in the health policies and regims in the countries in which we operate, the uneratiny surounding the actual market reception to our cleared for marketing in a particular market; the introduction of compeint products; patents atained by competitors; dependence on the effections of our protections for inrovative probility to obtain, maintain and defent issued patents; the commencement of any patent interference or infingenent action agains and our ablity to prevall, obtain a favorable decision or recover damages in any such action, and the exposure to fitigation, including patent litigation, and other factors that are discussed in our in our Anual 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 cationary discussion of risk and uncertaintes under "Risk Factor" in our Registration Statements and Annual Reports. These are factors that we believe our actual results. Other factors besides those we have lised could also adversely affect us Anv forward-looking statenent in this presentation it is nade. We distain any intention or obligition to publicy update or revise any forward-looking statenert, on other information contained herein whether future events or otherwise, except as required by applicable low You are advised, however, 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 clinical stage drugs
  • · 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: 18.4M

\$35.7M cash as of September 30, 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

14

· 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 TME

1 47-68, 3 Jun, 2020, doi:10,1002/mco2,6

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") V Initiation of phase II in 2L PDAC
Follow up OS data from P1
CM24
(CEACAM-1)
Pancreatic Cancer (combination with
nivolumab+chemo")
Interim analysis P2 2H23
Top line P2 2H24
Combination with SOC, undisclosed indication Investigation in a second indication
Solid tumors (monotherapy) RP2D monotherapy & combination
1H23
NT219
R/M SCCHN & CRC (dose escalation + P2 with
(IRSI/2 & STAT3) cetuximab)
Initiation of P2 combination with
cetuximab 2Q23
Combination with SOC, undisclosed indication Investigation in a second indication
Planned study
Ongoing
*Clinical collaboration and supply agreement with: (1) Bristol Myers Squibb

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

02| IMMUNE CELLS/ 03 | IMMUNO-ONCOLOGY 01 | ADHESION IMMUNE EXCLUSION Tsuzuki, 2020 Blumberg, 2015 Horst, 2011 இல் Oncogene nature "CEACAM1 creates a pro-angiogenic "Immune-checkpoint molecules on "CEACAM1 regulates tumor microenvironment that regulatory T-cells as a potential TIM-3-mediated tolerance and therapeutic target in head and neck supports tumor vessel maturation" exhaustion" squamous cell cancers" Ferri, 2020 Tsang, 2020 Shively, 2013 @ Immunology Cancer Biotherapy = Experimental "Neutrophil extracellular trap-"[Blockade] enhances natural "CEACAM1 regulates Fas-mediated associated CEACAM1 as a putative killer cell cytotoxicity against apoptosis in Jurkat T-cells via its therapeutic target to prevent tumor cells through blockade of the interaction with в-catenin" metastatic progression of colon inhibitory CEACAM1 / CEACAM5 carcinoma" immune checkpoint pathway"

18

CM24 MOA | Immuno-Oncology & Adhesion

Market d, Inmund 2002, 2005; Inmunol immunther 2012; Otenberg et al, Mol Concer The 2012; 200; 200; Hung, 2015; Hung, 2015; Adaryo N, et al. J Immundheroy Cac 8:e11-22, 2020, Royes R, et al. Neutrophil Extrand Crum (1974) 1978) by Preven Metstole Progresion of Colon Corcinoma. I mmund. 2020, Gersel, P. g.
el. CEACM1 cerates a pro-n

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

CEACAM1 is Over-Expressed in PDAC

and normal (10 cases/20 cores) tissues

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.
  • eg Grade 3 AEs were noted in 6/13 patients (46%).
AE Term Total Grade
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 Colitis 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 has 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 11.5%¹

• I/O approaches have been limited to patients with high microsatellite instability (MS-H) or high tumor mutational burden (TMB-H)

  • 21 SoC regimens efficacy data: Gemcitabine/Nab-pacitaxel³: OS 7.9 months or Nal-RI/5FU/LV": OS 6.2 months, PFS 3.1 months
  • · 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

(Illı Bristol Myers Squibb"

ﺎ ﺍﻟﻤﺴﺎﻋﺔ ﺍﻟﺴﻴﺎﺭﻳﺔ ﺍﻟﺴﻴﺎﺳﻴﺔ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ | 15

CM24 Phase 2 Combination Study Design (NCT04731467)

A study of CM24 in combination with nivolumab plus chemotherapy in PDAC patients in 2L 11 centers are currently active in US, EU & Israel

Primary efficacy endpoint of the randomized sub-study: OS

Secondary endpoints:

PFS, OS rate @ 6 & 12 months, PFS rate @ 3 & 6 months, ORR

Interim analysis: - PFS rate @ 6M planned in 2H23 Top line data: - planned in 2H24 Measurement of CEACAM1 and other biomarkers is ongoing Planning of further studies in other tumor types is ongoing

Advancing First-in-Class Oncology Therapies

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

| 18 NT219 - A Novel Approach to Overcome Resistance to EGFRi and Beyond • NT219 is a First - in - Class , small molecule • Dual inhibitor of IRS1/2 and STAT3 Innovative MOA • Outstanding efficacy in various PDX models in monotherapy and in combination • Modulation of the tumor microenvironment • Uniquely suited to tackle resistance to EGFRi and other agents Robust preclinical package • Early signs of clinical efficacy as single agent • No DLTs observed to date, RP2D has not been determined yet Clinical Stage • Short path to registration in 2L r/ mSCCHN and m ultiple market upsides Broad Market Potential

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/B-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

STATB

  • · 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

menner at a 10, 2014 20:47 Andre de A. Chic 2017, 10:06 Planes (R. M.) Roman of t. M. M. 2020 2022 2222 2222 222 222 222 222 222 222 222 222 222 222 222 222 222 222 222 222 2

| 19

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.

| 22 Simultaneous Blockade of STAT 3 and AKT Pathways are Required to Overcome Resistance to EGFRi Overcoming drug resistance NT 219 NT 219 STAT 3 IRS EGFR EGFRi MEK / ERK TUMOR REGRESSION Proof of Concept: PDX model of Head and Neck Cancer Erlotinib+Ruxolitinib (n= 6 ) Erlotinib+Buparlisib (n= 6 ) Control (n= 6 ) Erlotinib (n= 8 ) Erlotinib+NT 219 (n= 6 ) Erlotinib+Ruxolitinib+Buparlisib (n= 8 ) STAT 3 IRS EGFR MEK Tumor Regression ERK PI 3 K AKT Tumor Survival Tumor Survival Buparlisib Ruxolitinib Erlotinib NT 219 NT 219 JAK By blocking both STAT 3 and IRS resistance pathways, NT 219 re - sensitizes tumors to anti - cancer therapies

NT219 is Effective as Monotherapy

1 NSG mice were injected SC with SCC-9 cells. PBMCs were injected to the mousl not treatments initiated when
tumors were established. (NT219) and IP (α-PD1 and cetuximab) twi 2020 Multidisciplinary Head and Neck Cancers Symposium Poster presentation

NT219 Restores Sensitivity to EGFRi in PDX Models

NSCLC Exon 19 deletion EGFR and

T790M, biopsy of bone marrow metastasis, patient previously progressed on afatinib and osimertinib

metastasis, patient previously progressed on chemoradiation, several chemotherapies, and pembrolizumab

R/M SCCHN

Osimertinib 5 mg/kg, NT219 65 mg/kg, mean tumor volume at the end point, 3 mice/group;

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
Abdominal 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
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).

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.

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 clinical stage drugs
  • · 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: 18.4M

\$35.7M cash as of September 30, 2022

Multiple data read-outs expected in the next 12 months

EURPILE

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 TMDD4 saturation at Ctrough2 with Q2W

Predictions with Q3W regimen

1 Target-mediated drug disposition. 3 trough is the drug concentration reached by CM24 before the next dose 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.

cs of patients treated with CM24 (10, 15, 20mg/kg)
n 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%)

Demograph

Appendix B | NT219

Selected Publications

NT219 | Suppresses ß-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 β-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 exurvival.

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

| 40 PDX model Pancreatic Cancer Drug Gemcitabine ( Gemzar ®) RNA Sequencing | Analysis of Tumors Following Treatment Reduced expression of IRS1, Ki67, FOXM1 & TGFb is exhibited by pancreatic cancer treated with NT219 alone and in combination with gemcitabine

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 1(8%)
Female 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%) 6 1(8%)
Median Time from Initial Diagnosis
months (range) 36(10-153) 8 1(8%)
11 1(8%)

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