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(1)

Vecchi anticorpi per nuove terapie biologiche

Rita De Santis PhD

Head Biotech Products, R&D

rita.desantis@sigma-tau.it

(2)

49%

22%

6%

24%

Sales Force Manufacturing

R&D Others

1856 1177

0 500 1000 1500 2000 2500 3000 3500

People

Domestic International 3033

3033

83,3%

12,9%

3,6% 0,1%

Alfasigma headcounts

(3)

Alfasigma 2016 Turnover: 940 M€

560; 60%

380; 40%

Domestic International

(4)

Phage

Bacteriophages or phages are viruses that infect

bacteria

They represent most

abundant biological entities on earth

They are GRAS

(5)

ST Biotech: competitive advantages on phage technologies

In house expertise:

1. Consolidated use of phage libraries for human antibody selection (Biobetters)

 Patents

 Several antibody selected and patented (i.e. recent anti-ErbB3, anti-PD1/PDL1)

2. Possible easy connection with originator Countries where phage therapy is approved and marketed as OTCs (Russia)

To evaluate partnerships/collaborations

(6)

Biotech pipeline

2018 2020

2017 2019 2021

AvOX-ST2210 EU AvOX-ST2210 US

Clinical PoC HM

Clinical PoC inoperable tumors AvOX-bCet

AvOX-bMabs

CP clinical development lung cancer

CP pre-clinical development (ErbB2, ErbB3, CPIs)

ADCs Candidate pre-clinical development ADC1

Candidate pre-clinical development ADC2

Biobetters Phage tech

Candidate pre-clinical development (hscFvs)

Business opportunity………

(7)

ST discontinued projects on small molecule chemotherapeutics

• Blockbuster Mabs out of patent with validated clinical targets (i.e. Cetuximab, Trastuzumab; biosimilars approved)

• Thousands of Proprietary molecules from different classes acting in the nano/micromolar range

ADCs: “old Mabs/new toxins” model

Betting on crashing the ADC paradigm

“high payload toxicity good ADC efficacy”

(8)

• Selected 2 ADC leads from a dozen different conjugates

• Pharmacology studies ongoing

ADCs: status 2Q2017

Active collaborations

• Siena University, Italy

• Toscana Life Science, Italy

• Takis, Italy

• Accelera, Italy

• Ephoran, Italy

• Crown Bioscience, USA

• University of Tallahassee, USA

• IrsiCaixa Institute, Badalona, Spain

Search for collaborations

• Formulation and delivery

• GMP development

• Pre-clinical regulatory package

• Biomarkers for selecting best target population

• Clinical development

(9)

Biotech pipeline

2018 2020

2017 2019 2021

AvOX-ST2210 EU AvOX-ST2210 US

Clinical PoC HM

Clinical PoC inoperable tumors AvOX-bCet

AvOX-bMabs

CP clinical development lung cancer

CP pre-clinical development (ErbB2, ErbB3, CPIs)

ADCs Candidate pre-clinical development ADC1

Candidate pre-clinical development ADC2

Biobetters Phage tech

Candidate pre-clinical development (hscFvs)

Business opportunity………

(10)

H/N Brain

Prostate Bladder

AvidinOX for RNT with radioactive biotin: status 2Q2017

Sarcoma Breast

Albertoni C, et al Radionuclide therapy of unresectable tumors with AvidinOX and 90Y-biotinDOTA: tongue cancer paradigm. Cancer Biother Radiopharmaceuticals, 30(7):291-298, 2015

De Santis R, et al AvidinOX for highly efficient tissue pre-targeted radionuclide therapy. Cancer Biother Radiopharmaceuticals, 2010

Clinical trials

• Phase I EU HM from CRC 177 Lu-ST2210 (ClinicalTrials.gov NCT02053324) 13 patients treated:

 no side effects

 highly specific uptake

 preliminary signs of efficacy

• Phase I various indications (MD Anderson Cancer Center, Houston, Tx, USA), FPI May 2017

Pre-clinical PoCs

Liver mets

(11)

Paul Ehrlich’s magic bullets are finally coming of age?

Cetuximab Trastuzumab Ipilimumab Nivolumab

Pembrolizumab

Increase TTP or OS Few months Efficacy:

Safety:

Cost:

Significant side effects Very high

Space for improvements

(12)

AvidinOX-anchored biotinylated antibodies exhibit strong anti-

tumor efficacy

(13)

Chemical/physical Naples Univ, Italy

Rome Univ, Tor Vergata, Italy Turin Univ, Italy

Toscana Life Science, Italy Parma Univ, Italy

Ronzoni Institute, Milan, Italy

AvidinOX

active collaborations

GMP

Areta, Varese, Italy Chelab, Treviso, Italy

Radiochemistry ABX, Austria

Targeting pharmacology Takis, Rome, Italy

Turin University, Italy Immunology

La Sapienza Univ, Rome, Italy Takis, Rome, Italy

Clinical development Ospedale Latina, Italy Sant’Andrea Rome, Italy Ospedale Mestre, Italy Vienna hospital, AU

MD Anderson Cancer Center, Tx, USA

(14)

AvidinOX

search for collaboration

Radiochemistry

Alternative radionuclides Labeling optimization

Aerosol delivery Formulation and device Tissue regeneration

Stem cell delivery

Immunotherapy and oncology models

CPIs PDX

Clinical development

Clinical protocol with bMabs

To find collaborations is not an option

Thank you!!!

Riferimenti

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