1JPM-Conference-Presentation-FINAL5 ADC.pdf

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1、Ameet Mallik,CEOJanuary 11,2023J.P.Morgan Healthcare Conference2Forward-Looking StatementsThis presentation and any accompanying oral presentation have been prepared by ADC Therapeutics SA(ADC Therapeutics“,“we”or“us”)for informational purposes only and not for any other purpose.Nothing contained in

2、 this presentation is,or should be construed as,a recommendation,promise or representation by the presenter or ADC Therapeutics or any officer,director,employee,agent or advisor of ADC Therapeutics.This presentation does not purport to be all-inclusive or to contain all of the information you may de

3、sire.Information provided in this presentation and any accompanying oral presentation speak only as of the date hereof.This presentation contains statements that constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of

4、1995.Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described.Factors that may cause such differences include,but are not limited to:the Companys ability to continue to commercialize ZYNLONTA in the United State

5、s and future revenue from the same;Swedish Orphan Biovitrum AB(Sobi)ability to successfully commercialize ZYNLONTA in the European Economic Area and market acceptance,adequate reimbursement coverage,and future revenue from the same;our strategic partners,including Mitsubishi Tanabe Pharma Corporatio

6、n and Overland Pharmaceuticals,ability to obtain regulatory approval for ZYNLONTA in foreign jurisdictions,and the timing and amount of future revenue and payments to us from such partnerships;the Companys ability to market its products in compliance with applicable laws and regulations;the timing a

7、nd results of the Companys or its partners research projects or clinical trials including LOTIS 2,5,7 and 9,ADCT 901,701,601,602 and 212,the timing and outcome of regulatory submissions and actions by the FDA or other regulatory agencies with respect to the Companys products or product candidates;pr

8、ojected revenue and expenses,the Companys indebtedness including Healthcare Royalty Management and Oak Tree facilities and the restrictions imposed on the Companys activities by such indebtedness,the ability to repay such indebtedness and the significant cash required to service such indebtedness;th

9、e Companys ability to obtain financial and other resources for its research,development,clinical,and commercial activities and other statements regarding matters that are not historical facts,and involve predictions.These statements involve known and unknown risks,uncertainties and other factors tha

10、t may cause actual results,performance,achievements or prospects to be materially different from any future results,performance,achievements or prospects expressed in or implied by such forward-looking statements.All statements other than statements of historical facts contained in this presentation

11、,including statements regarding our future catalysts,results of operations and financial position,business and commercialization strategy,market opportunities,revenue,products and product candidates,research pipeline,ongoing and planned preclinical studies and clinical trials,regulatory submissions

12、and approvals,research and development costs,timing and likelihood of success,as well as plans and objectives of management for future operations are forward-looking statements.These statements involve known and unknown risks,uncertainties and other factors that may cause actual results,performance,

13、achievements,or prospects to be materially different from any future results,performance,achievements,or prospects expressed or implied by such forward looking statements.In some cases,you can identify forward looking statements by terminology such as“may”,“will”,“should”,“would”,“expect”,“intend”,“

14、plan”,”anticipate”,“believe”,“estimate”,“predict”,“potential”,“seem”,“seek”,“future”,“continue”,or”appear”or the negative of these terms or similar expressions,although not all forward-looking statements contain these words.Forward-looking statements are based on our managements beliefs and assumpti

15、ons and on information currently available to our management.Such statements are subject to risks and uncertainties,and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors,including those described in the“Risk Factor”section o

16、f the Companys annual report on Form 20-F and in the Companys other filings with the US Securities and Exchange Commission.No assurance can be given that such future results will be achieved.Investors are cautioned not to place to undue reliance on the forward-looking statements contained in this pr

17、esentation.Such forward-looking statements contained in this presentation speak only as of the date of this presentation.We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this presentation to reflect any change in our expectations or any chan

18、ge in events,conditions,or circumstances on which such statements are based unless required to do so by applicable law.No representations or warranties(expressed or implied)are made about the accuracy of any such forward-looking statements.Certain information contained in this presentation relates t

19、o or is based on studies,publications,surveys,and other data derived from third-party sources and our own internal estimates and research.While we believe these third-party sources to be reliable as of the date of this presentation,we have not independently verified,and we make no representation as

20、to the adequacy,fairness,accuracy or completeness of,any information obtained from third-party sources.In addition,all of the market data included in this presentation involve a number of assumptions and limitations,and there can be no guarantee as to the accuracy or reliability of such assumptions.

21、Finally,although we believe our own internal research is reliable,such research has not been verified by any independent source.3About ADC TherapeuticsStrong validated technology platform in highly-potent PBD-based ADCs and a growing toolbox to develop next-generation assetsFully-integrated organiza

22、tion with specialized capabilities unique to ADCsCash runway into 2Q 2025 with multiple value-driving catalysts in the next 12-24 monthsPioneer and leader in the ADC field as one of a few companies with product approval and multiple clinical-stage programs4ADCT FoundationA purpose-built organization

23、 with specialized capabilities unique to ADCs3211)Discovery|Intelligent choice of targeting moiety+linker+payload permutation3)CMC|High quality,consistent and scalable drug manufacturing for complex,highly potent molecules2)Early Development|Efficientlymove from research to the early clinic with opt

24、imized therapeutic windowADCT Represents Purpose-Built ADC Engine with Best-in-Class Capability and Executional Track Record ADCT Proven Track Record3 clinical POC+assets and 2 additional assets in the clinicSuccess with PBD payload despite failures from othersValidated and integrated capabilities e

25、nabling FDA and EMA approval and launch of ZYNLONTA5Three Core Pillars to Unlock ValueADC:Antibody Drug Conjugate;DLBCL:Diffuse Large B-Cell Lymphoma;PBD:Pyrrolobenzodiazepine.*Have received European Commission approval for r/r DLBCLShort-Mid TermMid-long TermMaximizing the ZYNLONTA Opportunity Adva

26、ncing the PBD-Based PipelineBroadening the ADC Platform and Leadership Establish ZYNLONTA as 3L+DLBCL standard of care Expand treatable patient population in earlier lines as combination agent of choice Commercialize in U.S.and collaborate with strategic partners internationally*Focus on 3 company-s

27、ponsored programsADCT-901(KAAG1)ADCT-601(AXL)ADCT-212(PSMA)Advance 2 programs in collaboration ADCT-602(CD22)ADCT-701(DLK1)Pursue partnership for Cami(Phase 2 complete)Expand platform with new antibody constructs and payloads Advance differentiated next-generation assets1236Deep Pipeline in Hematolo

28、gy and Solid TumorsAnticipated milestones set forth in this chart are subject to further future adjustment based on,among other factors,the impact of the COVID-19 pandemic.NTE:Non-Transplant EligibleADCT-212|Targeting PSMAr/r Hodgkin LymphomaVarious Solid TumorsVarious Solid TumorsPreclinicalPhase 1

29、aPhase 1bPhase 2ZYNLONTA|Targeting CD19Camidanlumab Tesirine(Cami)|Targeting CD25ADCT-602|Targeting CD22Acute Lymphoblastic LeukemiaADCT-601|Targeting AXLADCT-901|Targeting KAAG1ADCT-701|Targeting DLK1Expected Milestones2024:LOTIS-5:Complete enrollment LOTIS-7 and LOTIS-9:Preliminary safety and effi

30、cacy data Exploring partnershipsComplete Phase 1 single-agent dose expansion study in 1H 2024Preliminary results of Phase 1 single-agent dose escalation study in 2H 2023Preliminary results of Phase 1b combo study and single-agent dose escalation complete in 1H 2024Initiate Phase 1 in 1H 2024PBD-Base

31、dPhase 3/Confirmatory*ZYNLONTAConfirmatoryLOTIS-5 with rituximab in 2L NTE DLBCLLOTIS-2 in 3L+patients with r/r DLBCLMultiple programsNew clinical candidatesVarious Solid TumorsInitiate Phase 1 in 2H 2023FDA approvedLOTIS-7 in non-Hodgkin LymphomaLOTIS-9 in 1L DLBCL unfit/frailExpanded platformCompl

32、eted with positive results Single-agent armCombination armMetastatic Prostate Cancer 7Three Horizons to Grow ZYNLONTA to$500m-$1B in Potential Peak Sales1.Cerner Envizas CancerMPact Epi Database,Patient Metrics&Treatment Architecture,NH Lymphoma(2022)2.Clarivates Disease Market Landscape&Forecast,No

33、n-Hodgkins Lymphoma and Chronic Lymphocytic Leukemia,Epidemiology(2022)3.Francesco Merli,et.Al.,Simplified Geriatric Assessment in Older Patients With Diffuse Large B-Cell Lymphoma:The Prospective Elderly Project of the Fondazione Italiana Linfomi Journal of Clinical Oncology 39,no.11(2021),https:/a

34、scopubs.org/doi/full/10.1200/JCO.20.024653.4,000 1L frail and unfit patients in the U.S.2,35,000 2L SCT ineligible patients in the U.S.1,26,000 patients in the U.S.1,212,000(2L patients in the U.S.)1,2Level of OpportunityTotal eligible patients for ZYNLONTA 22,0003L/3L+monotherapyApprovedHorizon 21L

35、 and 2L in chemo-free combination with rituximabIn developmentHorizon 3Early-line novel combinationsIn developmentHorizon 1High unmet medical need remainsZYNLONTA is well-positioned for growth in both academic andcommunity settingsZYNLONTA+rituximab chemo-free combination being studied in 1L frail a

36、nd unfit and 2L SCT ineligibleRituximab-based combinations are most commonly-used regimenZYNLONTA+newer therapies including BsAbs in developmentPotential for ZYNLONTA to add efficacy without additional toxicityMAXIMIZING THE ZYNLONTA OPPORTUNITY8ZYNLONTAs Differentiated Product Profile1.Based on piv

37、otal LOTIS-2 trial.Full prescribing information available at www.ZYNLONTA.com,including warnings and precautions.2.Includes patients who did not respond to first-line therapy,patients refractory to all prior lines of therapy,patients with double/triple hit genetics ORR:Overall Response Rate;CR:Compl

38、ete Response;mDOR:Median Duration of Response;CRS:Cytokine Release SyndromeLOTIS-2 primarily in heavily pre-treated patients with difficult-to-treat disease2(including those with prior CAR-T and prior SCT)Deep and durable single agent efficacy 48.3%ORR/24.8%CROR mDOR of 13.4 months,CR mDOR not reach

39、ed1Fast time to response(median 41 days1)and treatment-free responseManageable safety profile,with no CRS1Ease of administration with 30 minute infusion every 3 weeks9ZYNLONTA:Well-Positioned to Lead in 3L/3L+DLBCL1.Symphony Health NonRetailSource and PatientSource data,2.Internal ADC Therapeutics m

40、arket research and sales data,3.Gloria Iacoboni,Salvage Treatment with Novel Agents Is Preferable to Standard Chemotherapy in Patients with DLBCL Progressing after CAR-T,ASH 2022,4.Caroline Helwick,Tackling a Growing Need:Options After CAR T-Cell Therapy for Lymphoma,The ASCO Post,https:/ centers ac

41、count for 60%of DLBCL patient volume1,2 600 adult B-ALL patients start new therapy in 3L+1-CD22 is expressed in 90%of B-cell ALL1 Incremental areas of potential application in NHL,CLLHumanized anti-CD22 Antibody Site Specific Conjugation Tesirine:Optimized CD22 targeted ADC enabling utilization acro

42、ss multiple ALL segments of unmet need without VOD complication18ADCT-701 targeting DLK11.Cancer.org-Lung Cancer;Cerner Envizas CancerMPact Epi Database,Patient Metrics&Treatment Architecture,SCLC(2022).ACC:Adenoid Cystic Carcinoma;NB:Neuroblastoma;PHEO:Pheochromocytoma;SCLC:Small Cell Lung CancerDi

43、fferentiation DLK1 is highly expressed in various neuroendocrine tumors:ACC,NB,PHEO,PGL and SCLC ADCT-701 has the potential to effectively suppress tumor growth in neuroendocrine tumors ADCT-701 showed potent,specific,and dose-dependent anti-tumor activity in neuroblastoma and hepatocellular carcino

44、ma PDX modelsStatus/Next Steps Collaboration with NCI-NCI developing Phase 1 protocol-IND submission in 2Q23-Phase 1 initiation late 2023-Focus in rare neuroendocrine malignancies and SCLC Opportunity 30 K incident SCLC patients in the U.S.,of which the majority have extensive disease1-50%of patents

45、 become platinum resistant in 2L and have worse outcomes1 Other neuroendocrine malignancies have very limited treatment options and poor prognosis in the metastatic settingHumanized anti-DLK1 Antibody Site Specific Conjugation PL1601:Potential first-in-class ADC against a unique,novel target express

46、ed in various solid tumors19Substantial Opportunity for ADCs in Oncology1.Seer 2022 Numbers represent the total incidence of tumors where ADCs are approved.2.Key marketed agents limited to Enhertu,Padcev,Trodelvy,Polivy,Adcetris,Kadcyla,Blenrep,Zylonta,and Besponsa.3.Evaluate Pharma Sales projection

47、s reflect Bladder Cancer,Breast Cancer,HL,ALL,MM,NHL,and Stomach Cancer.2022 Incident Cancer Cases1of Key Marketed ADC Agents22022 Incidence of Current ADC Indications2022 Total IncidenceProjected to reach$20 B in WW Sales by 20283Requires increasingly elegant targeting moiety+linker+payload permuta

48、tions-to effectively treat solid tumors Requires capabilities necessary to exercise a sophisticated toolbox from R&D to commercializationUnlock Full Potential of ADCsMaximize Opportunity in OncologyDespite recent successes,ADC class penetration into large epidemiological segments of unmet medical ne

49、ed remains modestBROADENING THE ADCT PLATFORM AND LEADERSHIP20ADCT Proven Track Record3 clinical POC+assetsSuccess with PBD payloadADCT FoundationA purpose-built organization with specialized capabilities unique to ADCs3211)Discovery|Intelligent choice of targeting moiety+linker+payload permutation3

50、)CMC|High quality,consistent and scalable drug manufacturing for complex,highly potent molecules2)Early Development|Efficiently move from research to the early clinic with optimized therapeutic windowADCT Technology PlatformA diverse toolbox of complementary technologies to address the challenges of

51、 each targetConditional BindingBispecificsBiparatopicsCleavable linkersReducible linkersNon-cleavable linkerspH sensitive linkersSite-specific conjugationDNA alkylating:Camptothecins,next gen PBD Immune agonistsDual payloadsOthers not disclosedLinker&ConjugationTargeting MoietyPayloadADCT Has the To

52、ols and Foundation Needed to Help Unlock the Opportunity for ADCsValidated and integrated capabilities 21Multiple Value-Driving Catalysts Expectedin 2023 and 2024Advancing the PipelineMaximizing the ZYNLONTA OpportunityADCT-901(KAAG1):q 2H 2023:Preliminary results of Phase 1 dose escalation studyADC

53、T-601(AXL):q 1H 2024:Preliminary results of Phase 1 dose escalation/expansion studyADCT-212(PSMA):q 1H 2024:Initiate Phase 1 study ADCT-602(CD22):q 1H 2024:Complete Phase 1 dose expansion studyADCT-701(DLK1):q 2H 2023:Initiate Phase 1 studyq 2023:Grow U.S.ZYNLONTA sales double-digit year-over-year and achieve commercial brand profitabilityq 1H 2023:European launch by partner Sobi q 2024:Complete enrollment of LOTIS-5 studyq 2024:Preliminary safety and efficacy data from LOTIS-9 studyq 2024:Preliminary safety and efficacy data from LOTIS-7 study in novel combinationsThank you