Data presented at the AACR Virtual Annual Meeting II – June 22-24
Company Product Description Indication Status
Acepodia Inc., of San Francisco and Taipei, Taiwan ACE-1702 NK cell therapy  HER2-expressing solid tumors Preclinical data showed the antibody-cell-conjugation technology was shown to effectively conjugate trastuzumab (Herceptin, Roche Holding AG), an anti-HER2 antibody, to the surface of Acepodia’s off-the-shelf NK cells and confer HER2 specificity; drug demonstrated cytotoxicity against multiple cancerous cell lines expressing HER2 at varying levels
Agenus Inc., of Lexington, Mass. AGEN-1181 Fc enhanced anti-CTLA4 drug  Cancer Combinations with AGEN-1181 demonstrated curative responses in preclinical models resistant to anti-PD-1; data illustrate the potential of combining allogeneic cell therapies with checkpoint antibodies
Aimm Therapeutics BV, of Amsterdam, the Netherlands AT-1412 CD9-targeted antibody  B-cell lymphoblastic leukemia/lymphoma and CD9+ solid tumors Preclinical data in B-ALL and melanoma tumor models show monotherapy treatment induced full tumor rejection that in the case of melanoma can be further sustained in combination with Opdivo (nivolumab, Bristol Myers Squibb Co.); AT-1412 has potential to induce death and facilitate trafficking of immune cells into the tumor microenvironment
Alkermes plc, of Dublin ALKS-4230 Engineered interleukin-2 (IL-2) variant immunotherapy Colon cancer Preclinical data showed combination with lucitanib (Clovis Oncology Inc.) in a syngeneic mouse model resulted in dose-dependent, durable complete responses and enhanced survival compared with monotherapy treatment 
Amunix Pharmaceuticals Inc., of Mountain View., Calif. AMX-818 T-cell engager targeting HER2 Cancer Data demonstrate the potential of the XPAT platform to significantly widen the therapeutic index of T-cell engagers and overcome the challenge of on-target, off-tumor toxicity that has hindered the use of potent immune activators to treat solid tumors so far; results showed, in a non-human primate model, that XPAT technology can improve the toxicity profile of T-cell engagers while maintaining their potency against solid tumors; in vitro data showed that protease-activated XPATs had potent cytotoxicity against tumor lines with EC50s in the single-digit pM range, with masking reducing target-directed T-cell cytotoxicity and T-cell activation by up to 15,000-fold
Ascendis Pharma A/S, of Copenhagen, Denmark Transcon IL-2 β/γ Designed to provide sustained systemic release of a receptor-biased IL-2  Cancer Preclinical results showed drug selectively binds and activates the IL-2 β/γ receptor and provides sustained and long-lasting exposure
Atyr Pharma Inc., of San Diego NRP2 monoclonal antibodies  NRP2 monoclonal antibodies  Solid tumors Preclinical data from panel of anti-human NRP2 monoclonal antibodies showed differential binding to specific domains of NRP2, selectively inhibiting binding of either VEGF or Sema3F; in combination with chemotherapy, an antibody blocking the VEGF binding site of NRP2 was effective in preventing mammosphere formation in organoids derived from triple-negative breast cancer patients
Autolus Therapeutics plc, of London AUTO-7  Anti-PSMA humanized CAR T cell  Metastatic castration-resistant prostate cancer Preclinical data demonstrated drug is highly potent in cytotoxicity assays against cells expressing PSMA, even at low levels, and demonstrate the feasibility of the multimodular cell programming approach in overcoming the immunotherapeutic challenges presented by advanced prostate cancer
Beigene Ltd., of Beijing, and Springworks Therapeutics Inc., of Stamford, Conn. Lifirafenib and mirdametinib RAF dimer inhibitor and MEK inhibitor Advanced or refractory solid tumors harboring mutations in the MAPK pathway Preclinical data demonstrated potent and synergistic activity in vitro and in vivo across a panel of RAS-mutated cancer models harboring a variety of mutations using clinically relevant concentrations of the compounds; in KRAS Q61K and KRAS G12C xenograft models, the combination demonstrated synergy as validated by pharmacodynamic pathway inhibition and tumor regressions
Bicycle Therapeutics plc, of Cambridge, U.K. BT-5528 Second-generation Bicycle Toxin Conjugate that targets EphA2 Solid tumors Reported data describing an assay to be used to support patient selection and assess EphA2 expression levels in tumor samples collected in the ongoing phase I/II trial
Bicycle Therapeutics plc, of Cambridge, U.K. BT-7480 Tumor-targeted immune cell agonist targeting Nectin-4 and agonizing CD137  Cancer Preclinical data indicated antitumor responses in a syngeneic mouse model can be achieved with an intermittent dosing regimen, which suggests that continuous target coverage may be unnecessary for efficacy
Bioinvent International AB, of Lund, Sweden BI-1808 and BI-1910 2 types of monoclonal antibodies targeting TNFR2 Cancer Reported preclinical data from in vivo studies showing both ligand-blocking and agonistic antibodies regress large established tumors and synergize with anti-PD-1 therapy; further mode-of-action dissection demonstrated that while the ligand-blocking antibody depleted intratumoral Tregs, the agonist increased intratumoral CD8+ T effector cells; both antibodies expanded tumor-specific CD8+ T cells and induced long-lasting T-cell memory
Bioinvent International AB, of Lund, Sweden, and Transgene SA, of Strasbourg, France BT-001 Anti-CLTA4 antibody-encoding oncolytic virus Solid tumors Preclinical data showed cure rates exceeding 70% in multiple mouse models
Briacell Therapeutics Corp., of Berkeley, Calif. Bria-IMT Designed to secrete GM-CSF Advanced breast cancer In monotherapy phase I/II study, 1 patient with “poorly” differentiated tumor showed tumor regression, while 2 patients with “well” or “moderately” differentiated tumors had tumor regression; responders have a high tendency to develop T-cell proliferative responses per se compared to nonresponders; in phase I/II combination study with Keytruda (pembrolizumab, Merck & Co. Inc.), tumor regression observed in 2 patients, both of whom had “moderately” differentiated tumors
Calidi Biotherapeutics Inc., of San Diego CAL-1 vaccinia virus Version of ACAM2000 smallpox vaccine delivered via an allogeneic adipose-derived mesenchymal stem cell system Solid tumors and hematologic malignancies Preclinical data showed modified vaccinia virus strain demonstrated efficacy as an oncolytic agent, exhibiting heightened therapeutic capacity when loaded into adipose-derived mesenchymal stem cells to create Calidi’s Supernova product; phase I data showed safety and tolerability
Delmar Pharmaceuticals Inc., of San Diego VAL-083 Bifunctional alkylating agent Glioblastoma multiforme Interim data from 2 phase II trials demonstrated improved outcomes over standard of care as both first-line treatment and for recurrent GBM; in newly diagnosed patients at intended dose for pivotal study, median progression-free survival was 8.7 months as of May 15, 2020, cutoff; study in patients in recurrent adjuvant setting, at intended pivotal dose, showed median overall survival (mOS) of 8.5 months as of May 28, 2020, cutoff; overall mOS for 72 patients who have completed at least 1 cycle of treatment was 7.1 months
Epimab Biotherapeutics Inc., of Shanghai EMB-101 Bispecific antibody targeting EGFR and cMet Solid tumors Preclinical data show EMB-01 binds to EGFR and cMet simultaneously and induces co-degradation of both targets in various tumor cells, an effect unattainable by parental monoclonal antibodies alone or in combination; also shown to exhibit more extensive inhibition of EGFR and cMet downstream signals, and a more potent and durable in vivo efficacy in various PDX tumor models compared to parental Mabs
Essa Pharma Inc., of Houston EPI-7386 Second-generation N-terminal domain androgen receptor inhibitor Prostate cancer Preclinical data showed full-length androgen receptor (AR) target engagement confirmed in cellular thermal shift assay; in vitro cellular gene expression analyses demonstrated drug inhibits AR transcriptional activity similar to enzalutamide but with few notable qualitative and quantitative differences in enzalutamide-sensitive cellular model, while combination with enzalutamide showed broader and deeper inhibition of AR-associated transcriptional activity than higher doses of each single agent alone
Exicure Inc., of Chicago Cavrotolimod (AST-008) Intratumoral TLR9 agonist spherical nucleic acid Tumors Data from phase Ib/II study in combination with Keytruda (pembrolizumab, Merck & Co. Inc.) showed gene expression analysis data from patient tumor biopsies demonstrated increases in leukocytes in injected tumors after AST-008 alone and in combination with pembrolizumab vs. baseline; uninjected tumors also showed increased immune cell levels after combo treatment, suggesting immune cell trafficking
F-star Therapeutics Ltd., of Cambridge, U.K. FS-222 Bispecific antibody targeting CD137 and PD-L1 Solid tumors Preclinical data showed drug simultaneously binds PD-L1 and multimeric CD137 with subnanomolar affinity resulting in potent T-cell activation, superior to a combination of monoclonal antibodies; data also showed the bispecific antibody’s tetravalency enhances its activity by providing optimal PD-L1 blockade, as well as potent CD137 agonism, resulting in significant T-cell activation
Genocea Biosciences Inc., of Cambridge, Mass. Inhibigens Inhibitory neoantigens Tumors Preclinical data showed pro-tumor Inhibigen effects were found to be correlated with an increasingly immune-suppressive tumor microenvironment, including reduced TILs and enhanced expression of T-cell exhaustion markers; vaccination of tumor-bearing mice with a formulation containing an Inhibigen impaired both tumor antigen-specific and nonspecific T-cell function by blocking their ability to secrete cytokines and kill tumor cells 
Ikena Oncology Inc., of Boston TEAD inhibitors Small molecules targeting TEA domain family of transcription factors downstream of Hippo signaling pathway Tumors Preclinical data showed anti-proliferative properties in Hippo pathway-driven cancer cell lines, but not in Hippo pathway wildtype cancer cell lines in in vitro testing; in vivo experiments in human tumor xenograft mouse models showed oral administration was well-tolerated and TEAD-dependent transcription in tumors was inhibited; robust antitumor activity was observed in 2 separate Hippo pathway-mutated mesothelioma xenografts
Immunogen Inc., of Waltham, Mass. IMGN-151 Anti-folate receptor alpha antibody-drug conjugate Tumors with FRalpha expression Preclinical data showed the protease-cleavable linker deployed in IMGN-151 improves stability and ADC exposure; as compared to mirvetuximab soravtansine, pharmacokinetic studies in cynomolgus monkeys showed increased ADC half-life by 60 hours and conjugate exposure in vivo by 40%; the IMGN-151 biparatopic format boosted antibody binding events and DM21 payload delivery in tumor cell lines; the increased payload delivery and greater membrane permeability of DM21 enhanced bystander killing activity
Immunsys Inc., of Fort Lauderdale, Fla. Yourvaccx Cancer immunotherapy Metastatic cancers Data from retrospective, IRB-approved case series showed, for all evaluable patients, there was 38% (9/24) complete response rate (CR) and a 4% (1/24) partial response rate (PR), for an objective response rate (ORR) of 42%; among 18 evaluable metastatic prostate cancer patients, there was a 50% (9/18) CR, a 50% (9/18) ORR and 62% (13/21) had post-therapy PSA reductions of ≥ 50%
Iteos Therapeutics Inc., of Cambridge, Mass. EOS-448 FcgR-engaging anti-TIGIT antibody Tumors Preclinical data showed antitumor activity and clean safety profile; in addition to reversing immunosuppression of NK and effector T cells, drug has been able to induce potent and preferential cytotoxicity directed against Tregs as compared to CD4 and CD8 effector cells; in models of pre-established tumors, demonstrated strong tumor growth delay activity as single agent and when combined with anti-PD-1 antibody; in nonhuman primates, demonstrated dose-proportional increase in exposure with a classical human IgG1 profile
Jounce Therapeutics Inc., of Cambridge, Mass. JTX-1811 Anti-CCR8 antibody Tumors Preclinical data showed tumor-infiltrating T-regulatory (TITR) cells suppress antitumor immunity in the tumor microenvironment and CCR8 may be superior target for TITR cells because it is expressed at high densities on the cell surface of tumor T-regulatory cells; surrogate antibody specific for mouse CCR8 showed single agent and synergistic combination activity with PD-1 inhibitors in anti-PD-1 resistant murine tumor models
Jounce Therapeutics Inc., of Cambridge, Mass. Vopratelimab ICOS agonist Tumors Preclinical data showed emergence of a peripheral blood ICOS hi CD4 T-cell population is associated with durable responses to vopratelimab alone and in combination with Opdivo (nivolumab, Bristol Myers Squibb Co.); in a hCTLA4 knock-in mouse model, preliminary assessment of antitumor efficacy demonstrated added activity when scheduled dosing of an ICOS agonist included administration following ICOS hi induction by Yervoy (ipilimumab, Bristol Myers Squibb Co.)
Jubilant Therapeutics Inc., of Bedminster, N.J. JBI-802 Dual inhibitor of HDAC6 and LSD1 Cancer Preclinical data showed strong efficacy in multiple in vivo models mediated by LSD1 and HDAC6 inhibition, while demonstrating selectivity against other HDACs and superior in vivo efficacy compared to single agents targeting LSD1 or HDAC6
Kazia Therapeutics Ltd., of Sydney Paxalisib (GDC-0084) PI3K pathway inhibitor Glioblastoma Interim phase II data showed progression-free survival of 8.5 months vs. 8.4 months for previous analysis (ASCO 2020); overall survival remains 17.7 months 
Kazia Therapeutics Ltd., of Sydney Cantrixil  Novel chemotherapy agent Ovarian cancer Phase I data showed 1 complete response to treatment and 2 partial responses, for overall response rate of 19% (3/16)
Macrogenics Inc., of Rockville, Md. MGC-018 Duocarmycin-based antibody-drug conjugate targeting B7-H3 Advanced solid tumors Preclinical data demonstrated targeted activity against tumors expressing human B7-H3 in mouse model; in vitro data suggested drug induced immunogenic cell death of target cells with the translocation of calreticulin to the cell surface during apoptosis; treatment with MGC-018 in that model system led to an increased infiltration of T cells into the tumor microenvironment; combined with anti-PD-1 antibody, drug showed enhanced antitumor activity; mice that achieved complete response to initial treatment with MGC-018 with or without checkpoint blockade survived longer when re-challenged with tumor without subsequent treatment vs. mice that had not received treatment with MGC-018, suggesting immunological memory
Macrogenics Inc., of Rockville, Md. DART molecule CD25 x CTLA4 bispecific DART molecule Tumors Preclinical data showed Fc-engineered bispecific depleted regulatory T cells in vitro, with minimal effect on effector T cells; bispecific also preserved cytotoxic T-cell effector function in vitro compared to combination of Fc-engineered monoclonal antibodies independently targeting CD25 and CTLA4

Notes

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