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Purple Biotech Ltd.

Regulatory Filings Mar 7, 2024

7004_rns_2024-03-06_81cd7c8d-8590-4549-9865-48ddc406439c.pdf

Regulatory Filings

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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 March 2024 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 ☐

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 Purple Biotech Corporate Presentation March 2024

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-1 filed with the Securities and Exchange Commission on December 27, 2019 (Registration file number 333-235729), 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), 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) and the Registrant's Registration Statement on Form F-3 filed with the Securities and Exchange Commission on March 23, 2023 (Registration file number 333-270769), the Registrant's Registration Statement on Form F-3, as amended, originally filed with the Securities and Exchange Commission on December 8, 2022 (Registration file number 333-268710) and the Registrant's Registration Statement on Form F-1 filed with the Securities and Exchange Commission on October 30, 2023 (Registration file number 333-275216), 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.

March 6, 2024 PURPLE BIOTECH LTD.

By: /s/ Lior Fhima

Lior Fhima Chief Financial Officer

Forward-looking Statements and Safe Harbor

Certain stateneus in this presention that are forvard of historical for are forvant-looking statements within the neaming of the safe include of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements that are not satements of historial finct and navy be identified by words soul as "believe", "sipen", "intend", "plan", "tould", "week", "trage", "will", "will", "will", "tropes", "tomine" or "anticipate" or their negative or wannions of thes words of thes other comparative words or by the first there strictly to historial natters. You should not place under celiance on these forward-looking statements, which are not guarantees of fiture performate for ourent view, expectations, belief or intentions with respect to fitture evens, and an events, and an expect to annuve of assupplion, involve laown and uklown risks, many of will as well as uncertaintes and other factors that realse our actual results, performance or actively and our active sensements of e different from any fine results, performants expensed or implied by the forward-looling statements. Inportant factors that could cause or contribute to such differences inclu anong obest risks relating to: the plans, strangement for fittere opentions; poduct development for NT219, CM24 and M1240; the process by which such sage therapettic candidates could potentials long and subject to lights significant inks, particularly with respect on joint development onlaboration, the fort that drug development and commercialization involves a leagues with uncome; our ability to successfuly develop and commercialize our phamacentical poduct; the expense, length, pogess and reals, the impact of any changes in regultion and legistation that could affect the plammentical industry the difficulty in receining the regulatory appovals neessary in oder to commercialize of predicting actions of the U.S. Food and Drug Administation or any other applicable of phamacentical products; the regulatory environment and regimes in the countes in which we perate; the meetainly surrounding the actual narket reseption o our pharmaceuical products one cleared for market the introducion of compeing products; patents obtained by competitors; dependence of our patent and other products; our ability to obtain and defend issued patents; the commencement of any patent interference or infingener or infinisment or infinisment or informa patents, and ou ability to prevail, obtain a favored damages in any such action, and the exposure to lingtion, and or regulatory actions; the inpact of the economic political and security situation in I.S. and other commiss in which ve nay operate or obtain approvals for our products or our products or our business, and ober are discussed in our Annual Report on Form 20-7 for the year ended December 31, 2023 and in our official to the U.S. Securities and Exchange Commission ("SE"), including on cantionary discussion of fisk Focus" in our Registration Statemats and Annual Reports. These are factors that we believe could case our actual results to differ naterially four expected results. Other lised could also adversely affect us. Any forward-ooking statener in this press release speals only as of the date which i is nade. We disclaim any intention or oblight to public to revise any forward-looking statement or other as a result of new information, fittre events or otherwise, except as required by applical law. You are anditional disclosures we make in our reports o the SEC, which are wailable on the SEC's website, https://www.sec.gov.

Corporate Highlights

Purple Biotech identifies promising first-in-class drug candidates to treat cancers with high unmet medical need

  • · Multiple data read-outs expected in 2024
  • · Two First-in-Class clinical stage drugs
  • · A preclinical tri-specific immuno-engagers platform
  • · Lean & global operation
  • · Cash runway into 1H25

Purple Biotech (NASDAQ/TASE: PPBT)

As of December 31, 2023

  • ADS Outstanding: 25.2 M .
  • Cash Balance: \$15.3 M

Strong position to reach short and mid term value creating clinical data catalysts

A Pipeline Dedicated to Advancing Oncology Therapies

| 4

Advancing First-in-Class Oncology Therapies

CM24: an α-CEACAM1* mAb

Lead indication: Pancreatic Ductal Adenocarcinoma (PDAC)

*Carcinoembryonic Antigen Cell Adhesion Molecule

CM24: a New Multi-Functional Immune Checkpoint Inhibitor

Attractive
new target
· CEACAM1 is overexpressed on certain tumor cells and infiltrating immune cells
· CEACAM1 interacts with CEACAM1 and CEACAM5 and creates a
tumor-protective environment
Demonstrated
mechanism
of action
· CM24 increases T cell and NK cells cytotoxicity against tumors
· CM24 shows benefit in combination with immuno-oncology treatments
· CM24 blocks adhesion of tumor cells to Neutrophil Extra cellular Traps (NETs)
Signals of
clinical
efficacy
· Favorable safety profile in monotherapy and in combination with nivolumab
• Partial response and stable disease in dose escalation study with nivolumab
· Potential biomarkers identified such as NETs and CEACAM1 levels on TILs
Randomized Phase 2 is ongoing, last patient enrolled in Dec-23, top line data 2H24
Sizable
market
potential
· Significant unmet medical need in pancreatic ductal adenocarcinoma (PDAC),
most common form of pancreatic cancer
· Strong IP position and well ahead of competitors
Multiple opportunities to leverage the MoA in other clinical settings

CM24 MOA lmmune Check Point Inhibitor & Anti-Metastatic Activity

Medel d. J. hmmode, 2006, innunder 2000, Orceiner et 1, McCorer in 1, McCorer The 202, 2007, Mor 2012, Arier, 202, 2007, Mor, 202, 2007, Mor, 202, 2007, Mor, 202, 2007, Moren

CEACAM1 is Over-Expressed in Pancreatic Cancer

and normal (10 cases/20 cores) tissues

Large Market Opportunity in Pancreatic Cancer

  • Pancreatic Cancer accounts for ~60K new cases/year in the US alone; with a 5-year relative survival rate of 12%¹
  • Immuno-oncology approaches have been limited to patients with high microsatellite instability (MS-H) or high tumor mutational burden (TMB-H) • 5-year overall survival rate with chemotherapy in 2nd line patients is 3%¹
  • 3 L standard of care regimens efficacy data: patients treapy: Overall Survival (OS) 2 months, OS of 3-4 months with chemotherapy
  • 2 L standard of care regimens efficacy data: Gemcitaxel? OS 7.9 months, Progression Free Survival (PFS) 4.3 months or Nal-RK/5FU/V+ OS 6.2 months, PFS 3.1 months
  • · CEACAM1 expression correlates with poor prognosis in Pancreatic cancer2
  • Preclinical data support significant synergy of CM24 with currently marketed immuno-oncology therapies

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

("Ill Bristol Myers Squibb"

  1. km², manuplaciones and militar del closed of the colored control on concerne mont control on concerne mont control concerne mont concerner menours and concerner. Menor Mer

CM24 Phase 1 Dose Escalation Results Encouraging data in 2L/3L Pancreatic Ductal Adenocarcinoma (PDAC) patients

Study Results

14 patients were evaluable for efficacy:

  • . Best overall response included 1 Partial Response (PR) (PDAC) and 4 Stable Disease (SD) (3 PDAC and 1 papillary thyroid cancer (PTC))
  • · Pharmacokinetic analysis of CM24 shows exposure is dose-proportional across the 3 doses in this study
  • · Well tolerated with no Dose Limiting Toxicities (DLTs) and no grade ≥ 4 Adverse Events (AEs)
  • · Median Overall Survival 4.5 months (95% Cl 2.0-11.1) for 11 PDAC patients

Phase 1 study results (cont.): Identification of potential exploratory biomarkers supporting CM24's mechanism of action

Higher pre-treatment levels of tumor infiltrating lymphocytes that express CEACAM1 are associated with longer survival

  • · consistent with the CM24 MoA in suppressing the immune evasion
  • · suggest CEACAM1 expressing lymphocytes as a potential biomarker

CM24 treatment significantly reduced NET marker in serum

  • · especially relevant in PDAC patients
  • . may be used as a pharmacodynamic marker

Phase 2 Combination Study Design (NCT04731467)

A study of CM24 in combination with nivolumab plus chemotherapy in PDAC patients in 2L treatment

18 centers are currently active in US, EU & Israel

Primary endpoint :

OS Secondary endpoints:

PFS, OS rate @ 6 & 12 months, PFS rate @ 3 & 6 months, ORR Interim analysis: 1H24 Top line data: 2H24

Measurement of CEACAM1 and other bio-markers is ongoing

Advancing First-in-Class Oncology Therapies

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

Lead indication: Recurrent/Metastatic Head & Neck Cancer (SCCHN)

NT219, a new solution to improve treatment outcome for cancer patients

NT219 blocks 2 critical signalling pathways at once

IRS1/2

  • · Scaffold proteins, mediating mitogenic, metastatic, angiogenic and antiapoptotic 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/βcatenin
  • Activated as a feedback response to anti-cancer therapies
  • IRS plays an important role in promoting a tumor-protective microenvironment, by mediating upregulation of TAMs and CAFs

STAT3

  • 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

veni et al. Cancer Res 2013;73:4383-4394; Machado-38-434; Marialo et al. Cinis 2010; 21:41 PM (14) 14) 414 How in t. Mc Career in: 2014; 121) 2020-03-20 (36) 255-2 Filmer 4. Clinci news: Clinci andrevs, Clincle on Clincle o Reuveni Hadas, Levitzki Alexander et al. Or

| 15

NT219 Restores Sensitivity to EGFRi in PDX Models

Lung Cancer

Non-small cell lung cancer (NSCLC) Exon 19 deletion EGFR and T790M, biopsy of bone marrow metastasis, patient previously progressed on afatinib and osimertinib

Head & Neck Cancer

Recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) metastasis, patient progressed on chemoradiation, several chemotherapies and pembrolizumab

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

| 16

NT219 induces PDL1 and re-sensitizes aPD1-refractory model

NT219 combination with αPD1 achieves a profound reprograming of the TME

First Market Opportunity

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

Targeting the unmet medical need

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

Phase 1 dose escalation in combination with cetuximab: Well tolerated, target exposure reached, patient's responses observed

  • No DLTs reported, NT219 was well tolerated as monotherapy and in combination with cetuximab
  • Dose-proportional increase in AUC and Cmax values
  • Human Equivalent Dose exposure was reached at 50 mg/kg
  • · Target engagement demonstrated in patients' biopsies

SCCHN patient 50 mg/kg NT219 + cetuximab

Post-treatmen

Phase 1 Dose Escalation (cont.): Anti-tumor activity at target exposure level, 2 confirmed responses in SCCHN patients

60

50

40 30

20

10 o

-10

-20 -30

-40

-50 -60

-70

6 24 12 24 50 100 24 12 100 12 (P)

Numbers under horizontal line designate NT219 dose in mg/kg; P = HPV positive; N = HPV negative

Best % change from baseline

Efficacy overview of monotherapy arm:

· 20 evaluable patients (all doses): 2 PR (confirmed-GEJ, unconfirmed-PDAC), 5 SD

Efficacy overview of combination arm in SCCHN patients*:

  • · 15 evaluable patients (all doses 6, 12, 24, 50, 100 mg/kg)
  • · Median follow-up of 9.4 months (95% Cl: 3.4-10.0)
  • Out of 7 treated with 50&100 mg/kg:
    • 2 confirmed PR
    • 3 SD .
    • ORR:29%, DCR: 71% .

* Interim data analysis, cut-off date Jan 25, 2024

In preparation of a phase 2 study of NT219 in combination with cetuximab w/wo chemotherapy in 2L R/M SCCHN

| 21

Advancing First-in-Class Oncology Therapies

Conditionally-Activated Tri-Specific Antibody Platform

Lead candidate: IM1240 (CD3x5T4xNIKG2A)

A Novel Mechanism of Action Tri-Specific Antibody

  • · Multi-specific biologics is an expanding class of drugs getting a lot of interest in the industry
  • · After initial success in hemato-oncology, new formats are being investigated in solid tumors
  • · Technology displays several distinctive features:
    • · Dual engagement of T cells and NK cells to mount an optimal anti-tumoral immune response
    • · A tumor-restricted activation through a cleavable capping system designed to provide a wide therapeutic index
    • · Carefully selected Tumor Associated Antigens allowing patient-centric development

| 24 N K - c ells CD4 + - T - cells CD8 + - NKG2A + - T - cells NK cell activation by inhibition of HLAE - NKG 2 A/CD 94 binding CD4 + - T - cells activation through CD3 binding CD8 + - NKG2A + T - cells double activation through CD3 binding and NKG2A - HLA - E axis blocking Unleashing both Innate and Adaptive Immune Systems

Promising Proof of Concept Data

  • · Tribody induces pM EC50 against A549 cells
  • 20-fold more potent than CD3x5T4 variant .
  • . Cell killing validated on multiple 5T4* cell lines (MDA-MB-231, HCT116, NCI-H226)

  • · Sustained tumor regressions in Breast Cancer xenograft humanized model (MDA-MB-231)
  • . The Pro-Tribody Capped-CD3x5T4xNKG2A performed better than the uncapped variant
  • . No change in body weight
  • PK analysis in normal mice shows 3-fold higher exposure of the capped tribody compared to the non-capped

| 25

Corporate Highlights

Purple Biotech identifies promising first-in-class drug candidates to treat cancers with high unmet medical need

  • · Multiple data read-outs expected in 2024
  • · Two First-in-Class clinical stage drugs
  • · A preclinical tri-specific immuno-engagers platform
  • · Lean & global operation
  • · Cash runway into 1H25

Purple Biotech (NASDAQ/TASE: PPBT)

As of December 31, 2023

  • ADS Outstanding: 25.2 M .
  • Cash Balance: \$15.3 M

Strong position to reach short and mid term value creating clinical data catalysts

| 27

Appendix A | CM24

CEACAM1 Plays a Key Role in Cancer Biology

URP

02| IMMUNE CELLS/ оз | IMMUNO-ONCOLOGY 01 | ADHESION IMMUNE EXCLUSION Tsuzuki, 2020 Horst, 2011 Blumberg, 2015 ្រឹត្តិស្ថិតនៅ 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" Shively, 2013 Ferri, 2020 Tsang, 2020 @ ™Journal』

Immunology Cancer Biotherupya Experimental "Neutrophil extracellular trap-"[Blockade] enhances natural "CEACAM1 regulates Fas-mediated associated CEACAM1 as a putative killer cell cytotoxicity aqainst 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"

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

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%).
AE Term Grade
Total 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 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%)

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

Appendix B | NT219

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.

Zou, S., Tong, Q., Liu, B. et al. Targeting STAT3 in Cancer Immunotherapy. Mol Cancer 19, 145 (2020). https://doi.org/10.1186/s12943-020-01258-7

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 β-catenin activity and inhibit LS-513 cell viability. Combination of 5-FU and NT219 significantly inhibited the growth of CRC tumors in tracranial model and extended mice survival.

AACR Annual 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®) RN A Seq u enc i n g | Analysis of Tumors Fo l lo w ing Treatment Reduced expression of IRS1, Ki67, FOXM1 & TGFb is exhibited by pancreatic cancer treated with NT219 alone and in combination with gemcitabine | 43

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