Formation Biologics. A clinical-stage biopharmaceutical company Lead program projected to achieve clinical validation in 2018

Transcription

1 Formation Biologics A clinical-stage biopharmaceutical company Lead program projected to achieve clinical validation in 2018

2 Formation Biologics Corporate Summary Clinical-stage development company based in Austin Management-led spin-out from YM BioSciences prior to acquisition of YM by Gilead Engineers and develops biotherapeutics for life-threatening cancers and rare diseases Lead product: AVID100: anti-egfr antibody-drug conjugate currently in Phase I/II trials; Designed under leadership of Dr. Walter Blättler, formerly EVP of R&D and scientific founder of ImmunoGen Team with track-record of developing drugs, including up to approval Kadcyla, Tarceva, momelotinib, as well as hematopoetins, cytokines and interleukins (EPO, GM-CSF, IL-3, IL-6) Nominated as Best New Drug Developer by World ADC Summit 2

3 Lead Progogram: AVID100 Mechanism of Action AVID100 targets EGFR and incorporates clinically validated components anti-microtubule chemo payload, clinically validated AVID100 EGFR anti-egfr mab, clinically validated class EGFR, clinically validated target EGFR 3

4 AVID100 Market: Select Approved anti-egfr Therapeutics Large market and significant unmet medical need Marketed Anti-EGFR Agent Approval Large Market: Approx. Annual Sales Unmet Need: Single Agent Response Rate Erbitux (cetuximab) Eli Lilly, Merck KGaA KRAS-, EGFR+ CRC Head & Neck $2 billion ~11% Vectibix (panitumumab) Amgen KRAS- CRC $0.5 billion <10% Tarceva (erlotinib) Astellas/OSI, Roche NSCLC, Pancreatic $1.4 billion <10% Total: ~$4 billion Average: <10% 4

5 AVID100 Discovery: In vitro: AVID100 shows increased cytotoxicity on cancer cells but not enhanced toxicity on normal skin cells when compared to naked anti-egfr antibody (MAB100 or cetuximab). M D A - M B b r e a s t a d e n o c a r c i n o m a Potency: Killing of EGFR+ Cancer Cells* Toxicity: Killing of EGFR+ Skin Cells* H a C a T - n o r m a l i m m o r t a l i z e d k e r a t i n o c y t e % c e l l s u r v i v a l AVID100 MAB100 % c e l l s u r v i v a l AVID100 MAB l o g c o n c ( n M ) c e t u x i m a b A V I D A D C l o g c o n c ( n M ) c e t u x i m a b A V I D A D C * Data by the National Research Council of Canada 5

6 In Vivo: AVID100 is More Efficacious than Cetuximab, the Market-Leading anti-egfr Agent, in Human Xenograft Tumor Models Head & Neck Cancer* 25% CR rate in 10mg/kg group Triple-Negative Breast Cancer* CR in majority of animals Control Cetuximab groups Control Cetuximab groups AVID100 groups AVID100 groups single injection * Data by Dr. Koropatnick lab, Western University single injection 6

7 Primate Studies Confirm In Vitro Skin Cell Finding: AVID100-Induced Rash is Similar to That of Naked Antibody (Cetuximab) Rash For anti-egfr agents, toxicology findings in primates, including rash, are correlated with safety profile in humans (well established with the two approved anti-egfr mabs Prior to IND submission, the safety of AVID100 was studied extensively in non-human primates: 5 studies comprising single and repeat-dosing Conclusions from preclinical studies: AVID100 was well-tolerated with rash similar to that observed with cetuximab AVID100 demonstrated significant anti-cancer activity and potential for a wide therapeutic index 7

8 AVID100 Phase I/IIa: Currently Ongoing Phase I dose-escalation already achieved AVID100 doses that are expected to be clinically active in Phase IIa trials in patients EGFR IHC3+ tumor types Phase I goals: safety assessment and determination of recommended Phase II dose Phase I design: Accelerated dose-escalation with single patient cohorts, followed by standard 3+3 Patients not selected for EGFR expression during Phase I Status: 5 th cohort completed (180 mg/m 2 ; ~5 mg/kg) without protocol-defined DLT s in first cycle Currently enrolling 6 th cohort (220 mg/m 2 ; ~6 mg/kg administered Q3W) Comments: Preclinical data suggest that AVID100 is active at clinical doses >2 mg/kg The marketed ADC, Trastuzumab-DM1 (similar PK and payload technology to that of AVID100) is approved on a 3.6 mg/kg Q3W regimen and demonstrated approx. a 40% response rate 8

9 Initial PK Results: AVID100 Comparison with Kadcyla In the ongoing Phase I dose-escalation trial, AVID100 achieved AUC levels similar to that of Kadcyla, which are associated with significant anti-cancer activity AUC AUC ug*hr/ml ** * ADC AVID100 Cetuximab Kadcyla dose mg/m2 * Krop et al Journal of Clinical Oncology Phase I Study of Trastuzumab-DM1 ** Weighted average of all the other studies reported in the BLA (TDM4258g, TDM4374g, TDM4450g, TDM4688g, TDM4370g) 9

10 AVID100 Potential Path to Market in Breast Cancer and Squamous Carcinoma of Head and Neck Metastatic Breast Cancer Phase IIa EGFR IHC3+ Potential breakthrough designation* BLA Phase III (confirmatory) in USA & EU EGFR IHC2+ and/or earlier lines of treatment MA (EU) SCCHN Phase IIa EGFR IHC 3+ Phase III EGFR IHC 3+ BLA & MA EGFR IHC2+ and/or earlier lines of treatment Other Additional indications: NSCLC, Ovarian, Esophageal, other Speed to market Expansion & post-marketing * Based on Kadcyla and IMMU-132 ADCs development in breast cancer 10

11 AVID100 Targets a Large Number of Indications: Tumors That Overexpress EGFR and Are Sensitive to Anti-Microtubule Agents Breast Head and Neck anti-microtubule chemo payload anti-egfr mab AVID100 Lung Esophageal Ovarian Endometrial Cervical Pancreatic Gastric 11