10th Annual Oncology Innovation Forum

ImmunoMet Therapeutics is a clinical stage biotech targeting cellular metabolism to advance novel anti-cancer and/or anti-fibrosis therapies to patients. Our lead molecule, lixumistat (IM156), is an orally bioavailable small molecule protein complex 1 (PC1) inhibitor that targets Oxidative Phosphorylation (OxPhos) and decreases aberrant cell growth and proliferation in targeted cancer cells and fibrosis. Lixumistat has been characterized in Phase 1 dose escalation and food effect studies in healthy subjects and in patients with advanced solid tumors. These studies provided characterization of the pharmacokinetics and safety profile of lixumistat and demonstrated target inhibition in healthy human subjects with once-daily dosing.

Preclinical studies show that the development of resistance to anti-cancer therapies is often associated with a metabolic shift to dependence on OxPhos. As such, lixumistat has the potential to inhibit the development of acquired resistance across multiple tumor types. Additionally, lixumistat may be a mechanistically novel treatment for cancer patients whose tumors are dependent on OxPhos, including immunotherapies whose efficacy is limited by tumor microenvironment hypoxia.

A clinical study characterizing the safety and efficacy of lixumistat in combination with gemcitabine/nab-paclitaxel in patients with advanced pancreatic cancer is ongoing (NCT05497778), with a data update expected near year end. Additionally, using precision medicine-guided patient selection, patients with GBM will receive lixumistat in a study that will begin dosing shortly. These two studies investigate the use of lixumistat in the settings of acquired and intrinsic resistance, respectively.

ImmunoMet Therapeutics, founded in 2015 as a spin-off from the Korean company HanAll Biopharma, owns a large library of biguanides with the potential for development, internally or with partners, as novel treatments for cancer and/or diseases of fibrosis. The company, headquartered in JLABS @ TMC in Houston has raised $39 MM since its inception. For more information about the company, please visit company's website.

Nutcracker Therapeutics is an early-stage company that is pioneering a revolutionary therapeutic development and manufacturing platform designed to enable the advancement of RNA-based treatments for as many diseases as possible, as fast as possible.

Promontory Therapeutics Inc. is a privately held, clinical stage pharmaceutical company focused on small molecule immunotherapy. The company's lead candidate, PT-112, is the first small molecule conjugate of pyrophosphate in oncology, and possesses a novel mechanism of action focused on the ribosomal biogenesis inhibition. Resulting cancer cell stresses promote immunogenic cell death (ICD), characterized by the release of damage associated molecular patterns (DAMPs) that bind to pattern recognition receptors on dendritic cells and natural killer cells. The result is the activation of an anti-cancer immune response.

Clinical data generated across three Phase 1 studies have demonstrated single-agent and combination anti-cancer activity and an attractive safety and tolerability profile, including both solid tumors and hematological malignancy.
Phase 2 studies include non-small cell lung cancer (NSCLC, reported at ESMO I-O 2022) and metastatic castration-resistant prostate cancer (mCRPC, presented at ASCO GU 2023). The company's research and development work has been conducted in the United States, Europe and Asia. Under a formal CRADA with NIH, the Company supports an active Phase 2 trial under sponsorship of the National Cancer Institute (NCI) utilizing PT-112 in thymic epithelial tumors, where PT-112 has received Orphan Drug designation.

QBiotics is an Australian life sciences company that discovers and develops novel cell signalling small molecules. Our current clinical focus is solid tumors and chronic wounds.

QBiotics’ business model is to develop drug candidates to proof of concept/clinical Phase II and then partner for late-stage development and commercialisation.

QBiotics’ anticancer drug candidate, tigilanol tiglate, is an intratumoral, oncolytic small molecule with potential in the treatment of a range of solid tumors, either as a monotherapy, or in combination with checkpoint inhibitors, chemotherapy and radiotherapy. Tigilanol tiglate is currently in clinical Phase II development for the treatment of soft tissue sarcomas (USA) (awarded FDA Orphan Drug Designation) and head and neck cancers (UK and Australia).

A 22 patient clinical Phase I safety trial demonstrated that tigilanol tiglate was well tolerated with an MTD not reached, and signs of efficacy in nine different tumor types including 18% of patients achieving CR, 9% PR, 45% SD and abscopal responses reported in two metastatic melanoma patients. A Phase I/II window-of-opportunity before surgery trial in HNSCC demonstrated that tigilanol tiglate induced immunogenic cell death (ICD) and T-cell infiltration in untreated areas of target tumors.

Tigilanol tiglate has a multifactorial MOA that rapidly destroys the target tumor through disruption of the tumor vasculature and direct oncolysis of tumours cells, resulting in rapid tumor destruction and healing of the site with minimal scarring. The drug also induces ICD (via a caspase/gasdermin E-dependent pyroptopic pathway), promoting the development of systemic T-cell mediated immune responses. Whilst the induction of ICD is largely Protein Kinase C (PKC) independent in vitro, PKC/C1 domain signaling (targeting PKC β isoforms) induced by tigilanol tiglate also appears necessary for efficacious tumor ablation in vivo and is partly responsible for the strong wound healing response, at the site post tumor removal, induced by this drug.

Scancell is a clinical stage immunoncology company that is leveraging its proprietary research, built up over many years of studying the human adaptive immune system, to generate truly novel medicines to treat significant unmet needs in cancer. Adaptive immune responses include antibodies and T cells (CD4 and CD8), both of which can recognise damaged or infected cells. In order to destroy such cancerous or infected cells, Scancell uses either vaccines to induce immune responses or monoclonal antibodies to redirect immune cells or drugs.

Scancell's lead asset SCIB1, a cancer vaccine being evaluated in first line unresectable metastatic melanoma and has impressive early clinical results as a monotherapy (88% DFS) and in combination with checkpoint inhibitors (85% ORR). The next data is anticipated in Q3 2024.

Theriva Biologics (TOVX) is a diversified clinical-stage company developing therapeutics to treat cancer and related diseases in areas of high unmet need. The Company’s transformed pipeline includes lead drug candidate, VCN-01, a systemically-administered oncolytic adenovirus (OV) engineered to break down the stroma barrier, which protects tumors from cancer therapies and hides them from the patient’s immune system. These unique and differentiated mechanisms are intended to improve the anti-tumor effect of the OV with co-administered chemotherapy and immuno-oncology products. Importantly, degrading the stroma can also expose tumor antigens, turning “cold” tumors “hot” and enabling a sustained anti-tumor response by the patient’s immune system.

Angiex is a developer of first-in-class Nuclear Delivered Antibody-Drug Conjugates for the treatment of solid cancers. Angiex's mission is to make cancer a nonlethal disease by making drugs with three mechanisms of action: (1) activating anti-cancer immunity, (2) destroying the angiogenic tumor vasculature to turn cancers into "cancer without disease", and (3) killing invasive and metastatic tumor cells to turn malignant cancers benign. Angiex's lead drug, AGX101, is now in Phase 1 clinical trials.

Heidelberg Pharma develops novel drugs based on its ADC technologies for the targeted and highly effective treatment of cancer. ADCs are antibody-drug conjugates that combine the high affinity and specificity of antibodies with the efficacy of toxins to fight cancer. Selected antibodies are loaded with various toxins, the so-called payloads, that are transported into diseased cells. Inside the cells, the toxins then unleash their effect and kills the diseased cells.

Heidelberg Pharma is the first company to use the mushroom toxin Amanitin in cancer therapies by exploiting the toxin's biological mechanism of action with its innovative ATAC technology as a new therapeutic modality. It offers the opportunity to not only overcome resistance of cancer cells against therapeutic agents currently used, but also has the ability to eliminate dormant tumor cells. This could lead to significant advances in cancer therapy - even for patients who no longer respond to any other treatment. The most advanced product candidate HDP-101 is a BCMA-ATAC for the indication multiple myeloma, which is currently in clinical development.

In addition to Amanitin, alternative payloads also expand the ADC platform technologies of Heidelberg Pharma to develop targeted and highly effective ADCs for the treatment of a variety of malignant hematologic and solid tumors.

Heidelberg Pharma AG is a biopharmaceutical company based in Ladenburg, Germany, and is listed on the Frankfurt Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol HPHA.

ATAC® is a registered trademark of Heidelberg Pharma Research GmbH.

Scandion Oncology is a pioneering biotechnology company headquartered in Copenhagen, Denmark, with a strategic focus on addressing the critical issue of treatment resistance in cancer therapy.

AIVITA Biomedical is a biotechnology company developing personalized vaccines that target multiple pathogens and tumor-initiating cells—the seed of all cancers—using our autologous personal immunotherapy platform. Founded in 2016 by pioneers in the stem cell industry, AIVITA utilizes its expertise in stem cell growth and directed, high-purity differentiation to enable safe, efficient, and economical manufacturing systems that support its commercial products and therapeutic pipeline.

AIVITA’s vaccine platform consists of autologous dendritic cells loaded with either (1) autologous tumor cells or (2) multiple pathogen antigens for SARS-CoV-2, influenza, HPV, HSV, Dengue, malaria, and meningitis, with more pathogens being added quarterly. This vaccine directs the patient’s own immune system to seek out and destroy the very cells responsible for the growth and spread of the cancer or pathogen. In cancer, AIVITA takes a unique pan-antigenic approach—targeting all neoantigens of tumor-initiating cells, rather than a select few — allowing the treatment to better target the cells responsible for the spread of cancer and overcome its tendency to mutate over time. The multi-pathogen vaccine targets multiple pathogens in one shot; sold as a kit, this platform technology can be rapidly adapted and scaled to meet emerging pathogens.

Based on clinical trial results showing tremendous promise in eradicating tumors without harmful side effects, the cancer technology has been cleared for an upcoming US-based Phase 2/3 clinical trial in glioblastoma and is the subject of a US-based Phase 1B clinical trial for melanoma with checkpoint inhibitors.