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2020 Media Kit
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Dealmaking in oncology diversifies
Biopharma’s big year for M&As
Originally published as an advertising feature in the March 2020 editions of
March 2020 biopharmadealmakers.nature.com — Nurturing biopharma partnerships
A D V E R T I S E M E N T F E A T U R E
A D V E R T I S E R R E TA I N S S O L E R E S P O N S I B I L I T Y F O R C O N T E N T
VCN Biosciences SLwww.vcnbiosciences.com
Oncolytic adenovirus VCN-01 turns cold tumors hotVCN Biosciences is developing a highly selective, advanced generation of oncolytic adenoviruses.
Intriguing historical observations that some viralinfections can promote cancer remission have ledto investigations of the therapeutic potential ofoncolytic viruses that replicate, infect and selectivelylyse tumor cells. This interest has increased dramati-cally in recent years with the recognition that suchapproaches may help tackle tumors that have thus farproved less responsive to immune checkpoint inhibi-tors, by turning immunologically ‘cold’ tumors ‘hot’.
Clinical-stage immuno-oncology company VCNBiosciences is developing a portfolio of its ownuniquely designed therapeutic oncolytic adenovi-ruses. The company’s experienced team is currentlypursuing four clinical trials of its lead candidateVCN-01, focusing on different tumor indications,that have shown promising results in refractorytumors such as pancreatic adenocarcinomas,retinoblastoma, and metastatic squamous cellcarcinoma of the head and neck.
VCN’s proprietary PH20 hyaluronidase expres-sion technology is at the core of its oncolytic viruspipeline, including VCN-01. PH20 hyaluronidasebreaks down hyaluronan, a component of the tumorextracellular matrix. In desmoplastic tumors, suchas pancreatic cancer, this hyaluronan-rich matrixblocks the perfusion of anticancer therapeutics. Thehyaluronidase expression technology thus enablesunique tumor remodelling properties that improveintratumoral viral spreading, immune system infiltra-tion, and tumor uptake of drugs. Importantly, theexpression of PH20 requires an actively replicatingvirus; nontumor cells that may be infected with VCN-01 do not allow viral replication nor PH20 expression.
Furthermore, the resulting adenovirus candidatesalso exhibit a range of beneficial properties, includingthe possibility of systemic administration, incorpora-tion of a variety of expression cassettes, and a goodtoxicity profile. This allows for the administration ofextremely high doses of the virus, which dispersethrough the bloodstream toward the body’s differentmetastatic sites. Once the virus reaches and infectsthe tumor cell, its highly cytopathic nature enablesthe efficient generation of tumor neoantigens thatcan boost the innate immune response (Fig. 1).
Unlike other companies in the fast-moving viraloncolytic field that have developed products toexpress immune-stimulatory transgenes, VCNbelieves its adenoviruses naturally contain suffi-cient immune-stimulatory elements, and that theexpression of hyaluronidase by its candidates andremodelling of the matrix are crucial to the inductionof effective immune responses.
VCN-01 leading the wayin pancreatic cancerVCN-01, VCN’s lead candidate, is being developedto target a range of solid tumors, focusing initially
on pancreatic cancer. Virus penetration withinthe tumor is improved through the expression ofhyaluronidase by VCN-01, which simultaneouslydecreases intratumoral fluid pressure and facilitatesthe uptake of the chemotherapy or biologic drug.In addition, VCN’s capsid has been engineered toensure the virus evades liver tropism and selectivelytargets the tumor once administered intravenously.
Clinical data from patients with pancreatic cancerdemonstrated an extremely good safety profile,and also showed that VCN-01 induced CD8+
T cell infiltration and activation of interferon-γ-mediated transcription, effectively converting apoorly immunogenic tumor into an inflamed tumor.In addition, in a subset of patients, the expression ofprogrammed cell death1/programmed cell death1ligand 1 was upregulated.
Additional data obtained to date in patients withpancreatic cancer have shown higher responserates and longer survival with VCN-01 than withthe standard of care. More importantly, long-termsurvivors (more than 3.5years) showed delayed sig-nificant responses that were indicative of immune-mediated activity.
To further confirm its antitumoral activity and toassess its potential, in addition to a trial investigatingits use in combination with nab-paclitaxel and gem-citabine for pancreatic cancer, VCN-01 is currentlybeing tested in combination with immune checkpointinhibitors in metastatic squamous cell carcinoma ofthe head and neck refractory to checkpoint inhibitors.Results from these trials are expected soon.
Next steps and partneringHaving originated from the Virotherapy Group ofthe Catalan Institute of Oncology (ICO-IDIBELL),VCN still benefits from a tight collaboration withthe institute, which has resulted in a very promisingsecond candidate (VCN-11). VCN-11 has been spe-cifically designed to overcome one of the theoreticallimitations for adenovirus: the blocking of the virusby neutralizing antibodies. This candidate is cur-rently in the late preclinical stage and is expectedto enter the clinic soon.
Following the very strong data from its trialsof VCN-01, the company is interested in furtherexploring the combination of this candidate withimmune checkpoint inhibitors to target immuno-logical cold tumors including pancreatic cancer.According to VCN’s CEO Manel Cascalló, ‘’VCN-01is ready for combination trials and we are thereforeinterested in collaborating with interested partiesin the field.”
CAF
Tumor-associatedimmune cell
ECMVCN-01
Tumorvasculature
Stroma
VCN’s viruses areadministeredintravenously,circulate withinthe blood streamand targetmetastatic sites
PH20-expressingVCN-01 replicates intumor cells, degradingthe tumor’s denseHA-containing ECM
Tumor
When tumorcells are killed, neoantigensare released,which attractimmune cells
PH20
Neoantigen
Fig.1 | Expression and replication by VCN Biosciences’ unique products. VCN-01 is designed to selectivelytarget and replicate only in cancer cells, leading to the release of tumor neoantigens. CAF, cancer-associatedfibroblast; ECM, extracellular matrix; HA, hyaluronan. Image modified from original source: Park, K., Han, B. &Korc, M. in Cancer Nanotechnology Plan 2015 (ed. Hartshorn, C. M.) 25–28 (National Cancer Institute, 2015).
Manel Cascalló, CEOVCN Biosciences SLBarcelona, SpainTel: +34 93 571 2359Email: [email protected]
CON
TACT
biopharmadealmakers.nature.com | March 2020 | B13
A D V E R T I S E M E N T F E A T U R E
A D V E R T I S E R R E TA I N S S O L E R E S P O N S I B I L I T Y F O R C O N T E N T
Korea Drug Development Fundwww.eng.kddf.org
Propelling Korea’s oncology science globallyBy supporting research, development and licensing behind its portfolio of companiesKDDF is translating Korean science into breakthrough oncology treatments.
Korea Drug Development Fund (KDDF) is helpingturn cutting-edge science into breakthrough cancertreatments. With a budget of $1 billion, KDDF hasfunded 162 drug development projects, helping itsportfolio companies strike licensing deals worth$9.1billion and bring a medicine to the global market.
KDDF, a government-funded organization, hasspent the past 9years supporting people at each stepof the drug development process, from academicsaiming to translate scientific advances into clinicalcandidates to established biopharma companiesseeking global partners. Along the way, KDDF hasreviewed 590 proposals and backed 162 programs.
Of those programs, 46 have been the subject oflicensing deals, including 18 agreements involvingglobal companies. KDDF success stories includethe 2018 oncology deal that granted Janssen globalrights to Yuhan’s lazertinib and a 2019 deal for theEuropean rights to SKBiopharmaceutical’s antiepi-leptic drug cenobamate.
Fifty-one KDDF-backed anti-cancer programsare in development in Korea. Here, we look at threecancer programs in KDDF’s portfolio.
IntoCellIntoCell has improved two key components ofantibody–drug conjugates (ADCs) to create new,better treatments for solid tumors such as breastand lung cancer.
The first breakthrough involved the linker thatconnects targeting antibodies to cytotoxic payloads.Through the discovery of a new self-immolativegroup, IntoCell created a linker that can be attachedto toxins with phenolic and non-phenolic functionalgroups. That advance led to the development ofbenzodiazepines that are much more soluble thanmolecules that share similar chemical structures.
IntoCell has combined its linker and payload in ananti-B7-H3 ADC. B7-H3 is an immune checkpoint.Notably, B7-H3 expression inversely correlates withthat of PD-1, the most commonly targeted immunecheckpoint, creating the potential for dual therapy.
Preclinical tests show that the ADC binds toB7-H3 on cancer cells with high affinity and rapidlyreleases its payload, resulting in antitumour activityin mouse models of breast, colon and non-small-celllung cancer. IntoCell is now running investigationalnew drug (IND)-enabling studies while lookingfor partners interested in licensing its B7-H3 ADCand other technologies with different cell bindingmodalities such as fusion albumins.
CellBionCellBion is applying linker technology to a differentmodality, namely radiopharmaceuticals that tar-get prostate-specific membrane antigen (PSMA).
Anti-PSMA radiopharmaceuticals typically useamide bonds and a long linker to connect theligand and chelator. However, enzymes can breakthe bonds, causing side effects.
Those problems led CellBion to create a shorterlinker that connects the ligand and chelator with-out the use of amide bonds. These diagnostic andtherapeutic radiopharmaceuticals, 177Lu-DGUL and68Ga-NGUL, appear to have better drug-like proper-ties than other anti-PSMA products.
In tests in mice, CellBion’s diagnostic PET imag-ing compound, 68Ga-NGUL, was stable in blood,readily taken up into tumors and quickly excreted.A preliminary clinical trial in metastatic castration-resistant prostate cancer provided early evidenceof safety and efficacy in humans.
CellBion plans to build on its progress by filing anIND with the Korean FDA. Based on data gener-ated to date, CellBion thinks 177Lu-DGUL may havesuperior efficacy and fewer side effects, resultingin improved survival and quality of life for cancerpatients.
ImmuneOnciaImmuneOncia also aims to improve on a promisingbut flawed class of cancer candidates, anti-CD47antibodies. Cancer cells use CD47 to protect them-selves from immune attack. By blocking the signal,researchers hypothesized that they could help theimmune system destroy tumors.
However, the presence of CD47 on normal hostcells including red blood cells has caused antibod-ies against the target to trigger adverse events suchas anemia. To avoid side effects, ImmuneOncia
developed a CD47-targeting drug that has affin-ity that does not cause hemagglutination, whilekeeping the efficacy profile.
That therapy, IMC-002, showed a similar effi-cacy profile and superior safety/pharmacokineticprofiles in preclinical tests to competitor agents.ImmuneOncia is planning an IND filing to test thedrug in humans in the first half of 2020 in the USA.
IMC-002 is part of ImmuneOncia’s pipeline ofimmune checkpoint modulators. Lead asset IMC-001, an anti-PD-L1 therapy, is entering a multi-regional phase2 study. Other candidates, includingbispecific antibodies, are in earlier development.ImmuneOncia sees synergies in its pipeline and isopen to partnering opportunities, including R&Dcollaborations and business alliances.
A track record of successKDDF thinks IntoCell, CellBion and ImmuneOnciaare poised to join its list of successes. That listnow includes an approval from the US FDA, whichcleared SKBiopharmaceuticals’ anti-epileptic drugcenobamate in 2019. The approval further validatedKorean science and KDDF’s model, which collec-tively are making innovative, first-in-class drugsavailable for licensing by global companies.
46 licensing deals(18 global, 28 domestic)
1 FDA approval(1 US FDA, 1 MFDS)
$9.1 billiontotal deal value
8 FDAODD
KDDF’s achievements
totalinvestment
$1B 590reviewedproposals
162fundedprograms
Business Development TeamKorea Drug Development FundSeoul, KoreaTel: +82 2 6379 3069Email: [email protected]
CON
TACT
KDDF’s achievements. Through its portfolio of companies KDDF has achieved a number of majormilestones in its evolving history. FDA, Food and Drug Administration; MFDS, Ministry of Food and DrugSafety; ODD, orphan drug designation.
B6 | March 2020 | biopharmadealmakers.nature.com
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