NORDIC IMMUNO-ONCOLOGY MISSION—NIOM 2018
Participant description Boston – New York – Washington D.C. March 19th — 23rd
The goal of NIOM 2018 is to create collaborations between US industrial/academic partners and a group of Nordic companies advancing preclinical and clinical I-O assets. Through open and one-on-one meetings with potential US partners, the March 2018 visit will create novel contacts and interactions which NIOM will help advance into full-fledged collaborations. NIOM is organized by Oslo Cancer Cluster and Innovation Norway with the assistance of US based expert advisors. To arrange for meetings with your organization or for more information about the mission, please contact one of the NIOM organizers or advisors below.
Oslo Cancer Cluster is a non-profit member organization dedicated to accelerating the development of new cancer therapeutics and diagnostics. The cluster’s biotechs and academic Centers of Excellence are developing a growing pipeline of preclinical and clinical product candidates mainly in Immuno-Oncology and Precision Oncology. The cluster has over 90 members covering the entire value chain and include academic centers, university hospitals, technology transfer organizations, start-ups, biotechs and international pharma companies, as well as service providers and investors. www.oslocancercluster.no
Contact: Jutta Heix, [email protected]; +47 94 16 30 89
Innovation Norway is the Norwegian Government agency for identifying and promoting innovation and for development of Norwegian enterprises and industry. Innovation Norway supports companies in developing their competitive advantage and helps enhance innovation. www.innovationnorway.no/en/start-page
Contact: Hanne M D Kristensen, [email protected]; +47 97 19 74 49
Expert Advisor: O. Prem Das, PhD, Principal, Das Advisors: [email protected]; Ph: +1 781 248 5699
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CONTENT
PAGE 3: Alligator Bioscience
PAGE 4: BerGenBio
PAGE 5: Immunovia
PAGE 6: Lytix Biopharma
PAGE 7: Nextera
PAGE 8: Nordic Nanovector
PAGE 9: OncoImmunity
PAGE 10: PCI Biotech
PAGE 11: Ultimovacs
PAGE 12: Zelluna Immunotherapy
PAGE 13: Inven2
Tumor-directed immunotherapies for safe and efficacious treatment of cancerAlligator’s project portfolio comprises five programs, including ADC-1013 in clinical phase I, ATOR-1015, ATOR-1017, and ALG.APV-527 in preclinical phase. The drug candidates are mono- or bispecific anti-bodies for tumor-directed immunotherapy, i.e. designed to primarily activate the tumor infiltrating immune cells. Thereby, systemic toxicity is minimized whereas a high efficacy is maintained. All candida-tes have the potential to be ‘first-in-class’.
Research project
N.D. x TNFRSF
ALG.APV-527
4-1BB x 5T4
ATOR-1017
4-1BB
ATOR-1015
CTLA-4 x OX40
ADC-1013
CD40
Alligator’s research projects include a bispecific immuno stimulating antibody that binds to a protein in the TNFR super family and another immunostimula-ting target protein.
ALG.APV527 is a bispecific 41BB x 5T4 antibody directing immunostimula-tion to 5T4-expressing tu-mor cells. ALG.APV527 is co-developed with Aptevo Therapeutics Inc.
ATOR1017 is an immunostimulating antibody that binds to the costimulatory receptor 4-1BB. 4-1BB is highly expressed on tumorspecific T cells and supports effective tumor immunity.
ATOR-1015 is a bispeci-fic (CTLA4 and OX40) antibody developed for tumordirected immunotherapy. The antibody has been created with Alligator’s unique bispecific technology format.
ADC1013 is an immunostimulating antibody, de-veloped for the treatment of metastatic cancer. The drug candidate has been outlicensed to Janssen Biotech, Inc.
ResearchPreclinical development Phase I clinical trial Phase II clinical trialForskning Preklinisk utveckling Klinisk studie fas I Klinisk studie fas IIForskning Preklinisk utveckling Klinisk studie fas I Klinisk studie fas II
ATOR-1015• Next generation CTLA4 bispecific antibody
with augmented Treg depletion• First in class dual immune activator• Targets: OX40 and CTLA-4• Attractive MoA: Depletion of regulatory T cells
and activation of effector T cells• Tumordirected immune activation• Expected synergy with PD1 in melanoma and
RCC based on clinical precedence• Excellent bispecific format• Clinical trial to start 2018
ATOR-1017• Bestinclass 41BB agonistic antibody due to
superior safety/efficacy profile compared to other 4-1BB antibodies
• 41BB activation is dependent on FcγR mediated crosslinking
• 41BB as well as relevant FcγR s are upregulated in tumor environment compared to nontumor tissue
• This results in a tumordirected T cell activation and thus favorable safety and efficacy
• Clinical trial to start 2019
Alligator is seeking partnerships for the drug candidates ATOR-1015 and ATOR-1017
Alligator Bioscience AB (publ) • Adress: Medicon Village, Scheelevägen 2, SE223 81, SwedenContact person: Per Norlén, CEO, email: [email protected] • Web: www.alligatorbioscience.se
Corporate Profile
BerGenBio is a clinical-stage biopharmaceutical
company focused on developing a pipeline of
first-in-class selective AXL kinase inhibitors to treat
multiple aggressive cancers.
BerGenBio is listed on the Oslo Stock exchaneg
($BGBIO) with headquarters in Bergen, Norway and
a research & clinical development presence in
Oxford, UK.
Bemcentinib (BGB324): First-in-class, selective, orally bioavailable AXL inhibitor in 10 phase II clinical trial settings
Preclinical Phase I Phase II Phase IIITimeline
Non-small cell lung cancer (adenocarcinoma)Combination with pembrolizumab - in collaboration with MSD
Non-small cell lung cancer (EGFR+)Combination with erlotinib
Non-small cell lung cancer (eligible for chemo)Combination with docetaxel
Triple negative breast cancer Combination with pembrolizumab - in collaboration with MSD
MelanomaCombinations with dabrafenib and trametinib or pembrolizumab
AML & MDS (not elegible for intensive chemo)Monotherapy & combinations with decitabine and cytarabine
Bemcentinib(BGB324)
Phase II results reporting in 2018
BerGenBio clinical development focuses on establishing AXL inhibition as a cornerstone of cancer therapy with immune-, targeted and chemotherapy.
Bemcentinib is an orally bioavailable small molecule with high selectivity for the receptor tyrosine kinase AXL.
AXL has important roles in suppressing anti-tumour innate immunity, drives immune evasion, drug-resis-tance, and cancer metastasis representing an attractive immunomodulatory target in numerous cancers.
A broad translational research programme is coupled to the clinical studies evaluating numerous candidate biomarkers to predict response to bemcentinib.
Established: 2008
Employees: 35
Public Company
Oslo Stock Exchange
$130m market cap (Dec ‘17)
Locations: Norway & UK
Pipeline
Phase II
Bemcentinib (BGB324):
IND enabling
BGB149: BGB601:
Preclinical
BGB002 & 003:
Bemcentinib: Early efficacy and predictive biomarker candidatesKey upcoming milestones
Management
www.bergenbio.com • [email protected] • Jonas Lies vei 91, 5009 Bergen, Norway • +47 559 61 159
Richard GodfreyCEO
Prof James Lorens CSO
Murray Yule (MD, PhD)CDO
NSCLC:
• 66% CBR including 2 PR in combo w/ docetaxel in advanced NSCLC (all comers; World Lung, ‘17)• 50% CBR including 1 PR in combo w/ erlotinib in EGFRm advanced NSCLC (World Lung, ’17)• 25% CBR as monotherapy in advanced NSCLC (all comers; ENA-EORTC, ‘16)
R/R AML & MDS:
• 19% RR including 2 CRi & 4 PR as monotherapy in R/R AML and MDS (ASH, ’17)
Proprietary predictive biomarker candidates correlating with benefit (ASH, ‘17):
• 2 plasma based protein candidate biomarkers • 1 tissue protein candidate biomarker• 1 RNA candidate biomarker
CBR = Clinical Benefit Rate (CR+PR+SD), CR = complete response; CRi = CR with incomplete blood count recovery, PR = partial response, SD = stable disease
ASCO 2018:
• NSCLC: Bemcen + Pembro (interim)• NSCLC: Bemcen + erlotinib (interim) • NSCLC: Bemcen + docetaxel (interim)• TNBC: Bemcen + Pembro (interim)• Melanoma: Bemcen + Pembro or TKI (interim)• AML/MDS: Bemcen mono & combo w/ LDAC (interim)
2H 2018:
• NSCLC: Bemcen + Pembro (final)• NSCLC: Bemcen + erlotinib (final) • TNBC: Bemcen + Pembro (final)• AML/MDS: Bemcen mono & combo w/ LDAC (final)• FIM: BGB149
immunomodulatory small molecule, selective orally available AXL inhibitor
AXL mAbAXL ADC (outlicensed)
immunodulatory small molecules
INTRO: IMMrayTM, Immunovia’s innovativemultiplex-ing technology uses a single drop of serumto measure 500 biomarkers for establishingcondensed diagno-stic-, prognostic- and predictivebiomarker signatures.
TECHNOLOGY SOLUTION: IMMrayTM is atechnology for clinical serum proteomics, developedand opti-mized over 17 years at LundUniversity/Create Health. In contrast to genomicstechnologies (e.g. NGS) that measures the potentialrisk of a future disease/drug (Rx) response,IMMrayTM multiplexes the patient serum proteomeand assess the actual current state of thedisease/treatment response. We have a propri-etaryset (currently 970) of a new generation of in-housedesigned and developed recombinant single chainfragment variant (scFV) antibodies from our ownphage-display library, detecting changes in immuno-regulatory factors, cytokines, enzymes, complementproteins, innate factors, and cancer associatedproteins. Our scFV antibodies are spotted ontoslides with a carefully pre-selected coating, allowingfor long term stability of the test-slides.
THE COMPANY: Immunovia is a listed companysince 2015 with shares (as IMMNOV), traded onNasdaq First North in Stockholm and now heading forthe Nasdaq Stockholm main-list (Q1 2018). Thecompany has 40+ employees; is HQ’ed in Lund,Sweden; has a reference lab in Lund, Sweden, as wellas a reference lab in Boston, US.
OFFERINGS: For our pharma partners, we designcusto-mized Discovery Chips and IMMrayTM CDxTest solu-tions. After initial surveying of 500 serumbiomarkers, we use our proprietary bioinformaticstools to derive a specific condensedsignature/algorithm of 7-30 pro-teins capable ofdifferentiating disease- positive or ne-gative groups,or Rx responders/non-responders, al-lowing forpatient selection with sensitivities and specificitiesabove 95%. Initially, IMMrayTM testing is performedthrough our reference labs in Sweden and US (CLIA),with cloud-based access to test results.
Contact person:Henrik Winther, SVP Precision Diagnostics & Pharma Collaboration; [email protected]; cell: +46 (0)70 966 8662
Immunovia AB, Medicon Village, Scheelevägen 2, 22381 Lund, Sweden, www.immunovia.com
IMMrayTM Array slide
IMMrayTM
Scanner
IMMrayTM Cluster Analysis
IMMrayTM
Algorithm
IMMrayTM
Biomarker Signature
DIAGNOSTIC WORKFLOW: IMMrayTM runs in anoptimal routine diagnostic lab workflow with a 4,5 hrsactual testing and 3 mins slide scanning followed byimmediate test-reading in our cloud-based algorithm.
AUC 0.98
98% accuracy for Pancreatic Cancer
Stage I to IV
Specificity
Sens
itivi
ty
IMMrayTM
Dichotomization PowerHealthy controlsPancreatic cancer
SUMMARY: Lytix focuses on Oncolytic Peptides; Lead molecule (LTX-315) entering Phase II studies; Pipeline project LTX-401 targeting deep-seated tumors is in preclinical stage. Technology: LTX-315, triggers a personal immune response through an effective release of potent immune stimulants and tumor antigens turning cold tumors hot, i.e. converts tumor microenvironment from a low inflammation to a high inflammation state through an effective release of potent immune stimulating molecules and tumor antigens following intra-tumoral drug delivery. The ‘release and reshape’ effect of LTX-315 sensitize tumors to other types of therapies enabling a cornerstone position within immuno-oncology.
LTX-315: • LTX-315 derived from host defense peptides is composed of
five cationic residues and four lipophilic residues, including one synthetic
• Able to form an amphipathic structure upon interaction with anionic membranes
MODE OF ACTION
LTX-315 induces immunogenic cell death through a powerful release of a broad range of tumor-specific antigens and immune stimulants from the disintegration of the tumor cells mitochondria and other organelles. This results in an increase of diverse T-cell clones recognizing the tumors. LTX-315 DEMONSTRATES SYSTEMIC IMMUNE RESPONSE – COMPLETE REGRESSION WITH TUMOR SPECIFIC MEMORY
CLINICAL DATA: LTX-315 is entering phase II following promising phase I trials, demonstrating a favorable safety profile and promising efficacy signals both in monotherapy and combination therapy. In monotherapy, significant CD8 T-cell infiltration was observed in ~90% (15 out of 17 evaluable patients with paired biopsies before and after treatment. LTX-315 TURNS COLD TUMORS HOT AND PRIMES THE TUMOR
In a heavily pre-treated popluation, ~50% of evaluable patients achieved stable disease after LTX-315 for approximately three months. Early combination data indicates increased response rates. LTX-315DEMONSTRATES SYNERGY WITH CHECKPOINT INHIBITORS
CLINICAL DEVELOPMENT PLAN
PIPELINE
PARTNERING OBJECTIVES
1. Establish US clinical study partner 2. Industry collaboration partner
CONTACT INFORMATION: Håkan Wickholm, Chief Business Officer, Phone: +46 72 7172526, [email protected] Web: www.lytixbiopharma.com Lytix Biopharma ASA, Gaustadalléen 21, 0349, Oslo, Norway
Nextera AS Telephone: +47 22 95 81 94 www.nextera.no Gaustadalléen 21, Fax: +47 22 60 44 27 N-0349 OSLO, Norway Org. No.: 994 486 594 MVA
NexterahaveanongoingprojectinleukemiawherewearedevelopinganovelpMHC-specificleadcandidatedrugthatinadiseasespecificmannerwilltargetandkillcancercells.
ThehighaffinityengineeredTCRtargetingunitdevelopedinthisprojectcanbefusedtovariousmodalitiesforeffectivecellkilling-flexibilitylaterindevelopmentandforapartner.TargetingMHCclassIImayhaveseveraladvantagescomparedtoMHCclassItargeting,especiallyrelatedtoefficacyandsafety.
Nexterasbusinessmodelistoutilizetheplatformasour“innovationengine”andincollaborationwithpartnersdotargetdiscovery,leadcandidatedevelopmentandimmunestratificationwithinautoimmunediseases,cancerandchronicinfections.
Weareinterestedinmeetingandtalkingtopotentialpartnersandcollaboratorswithinourfieldofinterest.Contactinformation:ThomasAndersen,CEOê[email protected]êTel:+4797190312
Nextera– uniqueplatformenabling:Description How does it work? Utilization/differentiator
Soluble T Cell Receptors –ongoing project targeting leukemia
Use Nexteras novel phage display platform to affinity maturate T cell receptors which will comprise the target seeking entity of the drug candidate. The affinity maturated TCR can again be fused to a suitable effector function enabling cell killing.
• Affecting only cancer cell with minimal off-target activity
• Not subject to tolerizing mechanisms seen in ACT
• May lead to breaching of tolerance • Less likelihood of cross reactivity compared to
MHC class I targeting• Less likelihood of tumor escape compared
with MHC class I targeting?
Target discovery of novel disease specific targets presented in the context of MHC class II molecules (pMHC II)
Use Nexteras novel phage display platform to make large diverse libraries of stabilized pMHC II with different antigenic peptides in the binding groove. Use pMHC II libraries to screen for CD4 T cells with unknown specificity.
• What is “triggering/driving” the CD4 T cell response and thereby causing the inflammation?
• Help understand disease etiology and identify new targets for therapy
• Disease specific targeting – could lead to more efficacious and safe treatments for patients
Immune monitoring and patient stratification
Use Nexteras novel phage display platform to make specific stabilized pMHC II complexes (not libraries) which further can be utilized for detecting specific CD4 T cells in flow.
• Monitor vaccines or to identify patients for treatment or clinical studies
• Measure the amount of specific TCRs from a given patient
• Ability to measure both central and peripheral memory compartment
Nextera
Partner Concept/
discovery
Clinical/ Commercial
Nordic Nanovector is a public biotech company, listed on the Oslo Stock Exchange (OSE: NANO). The company is committed to develop and deliver to patients innovative Antibody-Radionuclide-Conjugate (ARC) therapies, to address major unmet medical needs and advance cancer care.
Clinical results (ASH 2017)• In a Phase 1/2 study Betalutin® has shown to-date
a promising efficacy of 64% ORR and 23% CR in FL, 66% ORR and 25% CR in FL patients with more than 2 prior therapies. 90% of patients have shown a tumour reduction.
• Median Duration of Response was 13.3 months (20.5 months for those with a CR).
• The product was generally well tolerated; main G3/4 toxicities were reversible neutropenia and thrombocytopenia.
Current development and discovery pipelineNordic Nanovector is actively developing a pipeline of targeted therapies beyond Betalutin® by leveraging the company’s proprietary technology (ARC) and expertise (radiopharmaceuticals, onco-haematology).
Company at a glanceFounded: 2009OSE: NANOOutstanding shares: 49 M Market capitalization: USD 477 M 1)
Cash position: USD 101 M 2)
Lead product candidate: Betalutin®Betalutin® is a novel CD37-targeting Antibody-Radionuclide-Conjugate (ARC) designed to advance the treatment of non-Hodgkin’s Lymphoma. Betalutin® consists of a specific anti-CD37 antibody (lilotomab) conjugated to lutetium-177 (177Lu), a beta-emitting radionuclide payload, via a DOTA chelating molecule.
Clinical indicationsBetalutin® is developed for the treatment of indolent and aggressive forms of non-Hodgkin’s Lymphoma, including second and third line treatment of Follicular Lymphoma, as well as relapsed/refractory Diffuse Large B-Cell Lymphoma ineligible for Stem Cell Transplant. Betalutin® has received Orphan Drug Designation both in the USA and in Europe for the treatment of Follicular Lymphoma.
Key benefits• Betalutin® targets a novel antigen CD37. CD37
is an attractive target for antibody-mediated radioimmunotherapy in NHL patients, who have relapsed to previous anti-CD20-based therapies.
• The CD37 antibody (lilotomab) is rapidly internalized, and has a similar biological half-life as the 177Lu radionuclide payload.
• 177Lu emits low energy beta particles with a mean penetration range of approx. 0.23mm. Preclinical data indicate a potential synergism with rituximab in decreasing tumour growth and improving overall survival.
• Betalutin® is delivered as a ready-to-use acquous formulation, for one-time administration in an out-patient setting.
Executive Summary
1) As of 1 December 2017 2) As of 30 September 2017
Company strategy• Achieve first regulatory filing with Betalutin® in 3rd
Line FL by 2H 2019, and in parallel run additional trials in 2nd Line FL with a combination of Betalutin® and rituximab.
• Expand Betalutin® label in R/R DLBCL patients ineligible for Stem Cell Transplant.
• Independently commercialize Betalutin® and follow-on compounds in core markets, yet opportunistically consider partnerships to further enhance shareholder return.
• Leverage the company’s proprietary technology to selectively extend its pipeline, through focused investments in discovery research and strategic collaborations
• Reinforce the company’s organization by attracting key talents with strong technical and international experience, while maintaining flexibility and efficiency.
For BD enquiries please contact: Marco Renoldi, MD • e-mail: [email protected]• phone: +41 78 859 6989
Nordic Nanovector ASA • Kjelsåsveien 168 B • 0884 Oslo • Norway • phone: (+47) 22 18 33 01 e-mail: [email protected] • web: www.nordicnanovector.com
Product Targeted indication Discovery Preclinical Phase 1 Phase 2 Phase 3
BETALUTIN®
currently targeted indications
FL, 3rd lineFL, 2nd line, combination with rituximabR/R DLBCL, SCT ineligible
BETALUTIN®
LCM indicationsR/R DLBCL, conditioningOther NHL subtypes
HUMALUTIN® NHL, 1st line
Chimeric lilotomab with novel payloads (ARCs, ADCs) Leukaemia, multiple partnered projects
AFFILUTIN Multiple myeloma
Advancing a promising pipeline of targeted therapies for haematological cancers
1
* Chimeric anti-CD37 ARC, LCM: Life Cycle Management
Advancing a promising pipeline of targeted therapies for haematological cancers
Machine learning software empowering personalized cancer immunotherapy
Company overview• Founded in 2014 and based in Oslo, Norway
• A growing team of experienced data-scientists, bioinformaticians, and software engineers
• Technology based on proprietary machine learning solutions
• Backed by commited software and biotech investors
• Vision: To be the world leading provider of machine learning software in personalized cancer immunotherapy
Universally available neoantigen prediction software
Neoantigen prediction: proprietary modules and an integrated approach
HLA Class I and Class II prediction engine: deployable in any personalized immunotherapy program
Customizing neoantigen prediction for your speci�c vaccine platform OncoImmunity is further strengthening
and di�erentiating its solutionsScienti�c milestones for 2018:
• Improved HLA typing for class I and class II
• The leading variant caller from NGS data
• Innovative solution for non-classical neoantigens
• Predictive signatures of epitope spreading
• Certi�cation (CE-IVD) as a medical device
What we are looking for• Collaborate with scienti�c and commercial organizations,
with access to clinical data, to further validate our customize-able neoantigen prediction technology
• Commercial, academic and clinical collaborations that integrate the OncoImmunity software into our collaborators bioinformatics pipeline; to mutually enhance discovery
The OncoImmunity model: after a period of collaboration, a unique and customized machine-learning engine remains in the hands of our collaborators, to empower their neoantigen prediction
Source of test data:Nat Med. 2013 Jun;19(6):747-52
Results as of October 2017
• Many stakeholders have now entered the �eld of personalized cancer vaccines
• However “there is a problem with neoantigen prediction” in that the existing tools are not �t for puporse
• OncoImmunity o�ers, to all stakeholders, a unique and high-performing machine learning solution customizeable to speci�c vaccine delivery systems
Ongoing collaborations
OncoImmmunity AS - Ullernchausseen 64/66, 0379 Oslo, Norway - www.OncoImmunity.com Richard Stratford, CEO - email: [email protected] - phone: +47 90 01 52 42
OncoImmunity outperforms existing solutions
• Fixed fee for customized development
• Charge per analysis
• Fixed charge per analysis• Additional product support
Introduction PCI Biotech is a clinical stage biotechnology company listed on the Oslo Stock Exchange (Axess). The company is developing therapeutic products based on its proprietary photochemical internalisation (PCI) platform for light-triggered endosomal release. Two products are in the clinic, the first in bile duct cancer as an enhanced chemotherapeutic, and the second in healthy volunteers as a first step for the development as a cancer vaccination platform.
The Challenge – and the PCI Solution Both chemotherapies and vaccine antigens need access to the inside of target cells, e.g. tumour or immune cells, to be effective. Unfortunately, many drugs are encapsulated in endosomes as they enter the target cell and remain entrapped or degraded in the endosomes, unable to exert their therapeutic effects. PCI Biotech’s patented investigational compound fimaporfin opens endosomes. It can therefore deliver to the inside of the cell peptide and protein based therapeutic vaccines, RNA therapeutics, as well as established chemotherapeutics. Photochemical Internalisation Fimaporfin is a photosensitising compound, designed to attach to the cell membrane of target cells. During uptake by endocytosis, fimaporfin becomes incorporated in the membrane of the endosomes encapsulating the drug. When activated by light, the endosomal membrane is permeabilized and the drug or antigen is released into the cell cytosol. This is light-dependent, so PCI is a localised targeted therapy to enhance drug effects solely in the illuminated area of the body.
Three Applications of PCI Technology fimaCHEM (localised chemotherapeutic enhancement) fimaVACC (T-cell induction for therapeutic vaccination), and fimaNAC (nucleic acid therapeutics delivery)
fimaCHEM programme consists of a Phase I/II clinical study in bile duct cancer, an orphan indication with a high unmet need and without approved products. The Phase I part is finished. The treatment was well tolerated, with promising early signs of efficacy, showing that treatment with increasing doses of fimaCHEM (from Cohort 1 to 4) induced
increasing tumour responses.
fimaVACC vaccination gives strong induction of cytotoxic T-cell response to peptide/protein vaccination by enhanced MHC I presentation. Impressive preclinical (mice) results have been established.
On-going Phase I study in healthy volunteers with promising interim results, suggesting earlier, stronger and more consistent T-cell responses. fimaNAC provides efficient intracellular delivery of a range of nucleic acid based technologies, working both with naked molecules and in synergy with delivery vehicles. Four established research collaborations with key commercial players in the field.
Well positioned for attractive development opportunities PCI Biotech has built a multi-layered patent strategy with a composition of matter filing on fimaporfin at the core. PCI Biotech seeks partners to:
- Jointly conduct combination and other clinical studies on its two clinical candidates
- Apply PCI technology to vaccines and other products of interest to academia and industry
- Licensing or joint pivotal bile duct cancer development
2
PCI BIOTECH AT A GLANCE► Unlocking the potential of innovative medicines
► A listed (PCIB:NO) cancer-focused biotech company
► Photochemical internalisation(“PCI”) technology, originating from the Norwegian Radium Hospital
Programme Indications / Therapeutics Preclinical Phase I Phase II Status
fimaCHEMBile duct cancer / gemcitabine
Phase I extension initiated to evaluatesafety of repeated treatment in theorphan indication bile duct cancer
fimaVACCTherapeutic cancer vaccines
Phase I study in healthy volunteersOne active R&D collaboration
fimaNAC Nucleic acid therapeutics Four active R&D collaborations
An oncology focused company with three well differentiated assets
OVALBUMIN ANTIGEN IN JAWSII DENDRITIC CELLS
Ultimovacs’ hTERT vaccine UV1 is a general cancer vaccine which provides a platform for other immuno-oncology drugs that require an ongoing T cell response for their mode of action. UV1 is a second generation vaccine based on epitope spreading analysis of blood samples from long term surviving cancer patients following treatment with a first generation hTERT vaccine. The synthetic peptides comprising UV1 are thus associated with therapeutic benefit also in a monotherapy setting. Since telomerase is a universal cancer antigen, we have initiated a broad clinical development program, as summarized below.
Ultimovacs UV1 A novel cancer vaccine targeting hTERT
Clinical development
I/IIa trials finalized in Norway, follow up ongoing to 5 yearsProstate cancer (n=22)- Newly diagnosed, androgen sensitive, metastatic PCa
UV1 treatment concomitant with anti-androgen therapy
Non small cell lung cancer (n= 18)- Stage IIIb – IV disease.
Malignant melanoma combination with ipilimumab (n=12)- Stage IIIb – IV disease.
US clinical trials Phase I/IIa, Malignant melanoma UV1 in combination with pembrolizumab- Stage IIIb – IV disease, first line - n = 20, patient inclusion planned to start 1Q18Phase 2b, NSCLC UV1 in combination with PD-(L)1 inhibitor
Ultimovacs has performed three clinical trials with UV1 as listed below. The company has opened an IND in the US and is initating a trial investigating UV1 in combination with a PD-1 checkpoint inhibitor in patients with advanced malignant melanoma. A large controlled efficacy study in lung cancer is planned started in 2019.
UV1 – ipilimumab combination in advanced malignant melanomaAvailable data indicates a synergistic effect of UV1 in combination with checkpoint inhibitor- Specific immune repsonses in 91% of patients unselected for HLA
type- Immune responses appear earlier and in a larger proportion of
patients when UV1 is given in combination with ipilimumab compared to UV1 monotherapy
- 75% Overall Survival at 2 years (Median Survival not reached)
ContactUltimovacs is seeking corporate and academic partners as well as investors for development of UV1 in combination regimens across different cancer indications.
Please contact:
Audun Tornes, COO Ultimovacs ASPhone: +47 9951 0951Email: [email protected]
Clinical trial results summary, 52 patients
- The majority of the patients experienced injection site reactions (main AE)
- Five serious allergic reactions (4 PC, 1 MM). All resolved without sequeale
- Immune response towards the UV1 peptides observed in majority of patients (67-91%)
- Clinical efficacy data
- 75% 2 yr. OS in first line advanced MM patients
- 50% 2 yr. OS in NSCLC (pre-treated chemo/radio)
- Clinical outcome results in PCa trial still immature
ProductUV1 constitues three long synthetic peptides for intradermal injection. GM-CSF is used as adjuvant
- Lyophilized product for reconstitution with WFI
- Excellent stability
- Large scale manufacturing possible at very low unit cost
- Clincal grade product available. Manufacturing process optimized and scalable to commercial production.
- Manufacturing by Corden Pharma, Switzerland and Italy
AboutZelluna Immunotherapy is a Norwegian biopharma company with a global focus, developing T-cellreceptor (TCR) based immunotherapies for a broad range of solid cancers with high unmet need.Zelluna is looking for partnerships with biotech/pharma industry and academic groups to accelerateclinical translation and commercialization of our pipeline
TechnologyIn contrast to chimeric antigen receptors (CARs), TCRs recognize not only surface proteins, but also intracellular antigens. We currently have three active development programs with a basis in the TCR portfolio:
• Adoptive cell therapy (ACT)• Off-the-shelf cell therapy products• Soluble TCR based drugs (sTCR
conjugates, fusions, bispecifics)
PipelineWe are currently building a comprehensive clinicalpipeline of ACT products expected to enter theclinic in 2018
Competitive AdvantagesOur portfolio contains TCRs recognizing peptides in the context of high frequency HLA Class I and Class II alleles such as e.g. HLA-A2 and HLA-DP4:
• High affinity and co-receptor independence• Fully human – not engineered for higher affinity• Shown safety and efficacy in a patient
Core AssetThe company core asset is a portfolio of non-engineered tumor specific T-cell receptors (TCRs)isolated from long term surviving patients frompeptide based cancer vaccine trials.Zelluna’s TCRs have been tailored by the humanimmune system to ensure an optimal combinationof specificity and affinity for safe and efficienttherapy
Market OpportunitiesOur TCRs targets validated cancer driver antigens.
These antigens are expressed in a large number ofcancers that lack efficient treatment options.
InvestorsZelluna’s investor base consists of a consortium with a strong track record within life science: Radforsk, Birk Venture, Inven2, RO Invest and Prieta.
Contact information: Miguel Forte, [email protected]: +32 478 464640www.zelluna.com
OrganizationManagement team and Board of Directors with extensive experience in cell therapy and medicinal product development. Zelluna has a long term research and development agreement with the Department of Cell Therapy at the Oslo University Hospital with access to GMP accredited production facilities.
Contact: Kristin Sandereid, Business Development: [email protected] , +47 930 37 222 Inven2 AS, Gaustadalléen 21, 0349 Oslo, Norway, www.inven2.com
Inven2 is the largest technology transfer office in Norway. Situated in Oslo and responsible for transforming excellent research into services and products that benefit society, Inven2 serve 6000 scientists at the University of Oslo and all the hospitals in South-Eastern Norway. We are responsible for clinical study agreements on behalf of the hospitals in South-Eastern Norway Regional Health Authority and the University Hospital in Northern Norway.
PORTFOLIO We have 46 companies in our portfolio, 6 are within immuno-oncology. Our company portfolio is worth about 1.2 billion USD and raised 86 million USD in private capital in 2017 from local and international investors. Our immuno-oncology companies are:
LICENSING OPPORTUNITIES WITHIN IMMUNO-ONCOLOGY
DRUGS
CAR/TCR
MOC31PE: An EpCAM-targeted immunotoxin that demonstrated dramatic survival benefit for mCRC patients in a phase 1 study. MOC31PE may be an attractive agent in combination therapy with checkpoint inhibitors. Tankyrase: Novel WNT inhibitor compounds exhibiting high specificity for tankyrase. Proof-of-concept demonstrated in mouse models by effectively reducing catenin levels in selected cancer cells when targeting the pathway gatekeeper tankyrase. Universal immunotherapeutic targeting of solid tumors: An engineered protein that induces anti-tumor immune responses through targeted delivery of IL15 to the tumor stroma. It is a non-personalized strategy that is potentially is applicable to a wide range of tumor types.
CD37: A new chimeric antigen receptor (CAR) targeting CD37. Osteosarcoma: A CAR targeting two markers for Osteosarcoma in humans. IgKappa: A Chimeric Antigen Receptor (CAR) T cell construct with the sequence targeting Immunoglobulin Light chain (type kappa). CD20: T-cell receptor (TCR) constructs targeting CD20. Potential therapy for patients suffering from CD20 positive B-cell lymphoma. TdT: T-cell receptor (TCR) constructs reactive to TdT, an intracellular protein selectively expressed in hematopoietic and leukemia stem cells and represents a promising novel TCR target for lymphoid malignancies.
TOOLS
Dummy T-cells: A dummy T cell that can recognize the target but do not kill it. When labeled these cells are efficient for safety validation of new therapeutic TCRs. Lymphocyte booster: A new method for increasing the killing effect and proliferation of NK cells and T cells. Incubation of NK cells and T cells with certain chemical substances are found to increase the cells killing effect by threefold thus making the cells more efficient when used in immunotherapy.
LOOKING FOR
Collaborators (corporate and academic), connection to other TTOS, investors, entrepreneurs, consultants.