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20-minute presenters

Cullinan Therapeutics, Inc.
[NASDAQ: CGEM]

Cullinan Therapeutics is a biopharmaceutical company dedicated to creating new standards of care for patients. We have strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both oncology and autoimmune diseases. Our portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class. Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of cancer and autoimmune indications. We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization. With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients.
​
www.cullinantherapeutics.com

Geneos Therapeutics, Inc.

Geneos Therapeutics is a privately held Phase 2 biotherapeutics company developing DNA-based personalized therapeutic cancer vaccines (PTCVs) as novel immunotherapeutics for cancer. The company’s proprietary GT-EPIC™ platform targets neoantigens from each individual patient’s tumor to develop a uniquely personalized treatment and is differentiated by industry-leading speed of vaccine manufacture (currently 5 weeks with a path to 3 – 4 weeks) and neoantigen capacity (currently up to 40 and with a path to 80). Clinical data from the ongoing 36 patient Phase 1b/2a clinical trial in 2L hepatocellular carcinoma met the pre-specified ORR efficacy endpoint and include 3 CRs and a 4th cancer free patient among 36 enrolled (Yarchoan et al Nature Medicine (2024)).The platform is tumor-agnostic and, unlike other cancer vaccine platforms under development in adjuvant settings, has demonstrated an ability to shrink established large, bulky, metastatic tumors down to zero with minimal side effects. Planning is underway for an upcoming Phase 2b which may have the potential to be registrational.

www.geneostx.com

ImmunoMet Therapeutics, Inc.

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.

www.immunomet.com

Lisata Therapeutics Inc.
[​NASDAQ: LSTA]

Lisata Therapeutics is a clinical-stage pharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for the treatment of advanced solid tumors and other major diseases. Lisata’s lead product candidate, certepetide (formerly LSTA1), is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to selectively target and penetrate solid tumors more effectively. Lisata has already established noteworthy commercial and R&D partnerships based on its CendR Platform® technology. The Company expects to announce numerous milestones over the next two years and believes that its projected capital will fund operations into early 2026, encompassing anticipated data milestones from its ongoing and planned clinical trials.

www.lisata.com

Medicenna Therapeutics Corp.
[TSX: MDNA] [OTCQB: MDNAF]

Medicenna Therapeutics Corp., an immunotherapy company, engages in the development and commercialization of Superkines and empowered Superkines for the treatment of cancer and other diseases. The company has two clinical stage assets, and several pre-clinical assets. MDNA55 is a phase 3-ready interleukin-4 (IL-4) immunotherapy for the treatment of recurrent glioblastoma. MDNA11 is an IL-2 super agonist, with differentiated ‘non-alpha’ and ‘’enhanced-beta’ features. MDNA11 is currently being evaluated as a monotherapy and in combination with pembrolizumab in patients with advanced solid tumors in the Phase 1/2 ABILITY-1 Trial. The company is also developing MDNA209, an IL-2/IL-15 pathway antagonist for autoimmune diseases, such as multiple sclerosis and graft versus host disease; MDNA413, a dual IL-4/IL-13 antagonist to treat other inflammatory diseases; and MDNA113, an anti-PD-1 IL-2 bi-specific Superkine for solid tumors. In addition, the company has a proprietary BiSKITs platform to develop Superkines by fusing them to other proteins, antibodies, cytokines, or other Superkines. The company is headquartered in Toronto, Canada.

www.medicenna.com

NanoCell Therapeutics, Inc.

Innovative Non-Viral DNA-based In Vivo Gene Therapy

At NanoCell, we envision a future where cell engineering is transformed by pioneering vectors, adept at safely and precisely modifying target cells right within the patient’s body. Our ambition is distinct and audacious. While many in the field focus on viral or RNA-based methods, we uniquely harness the lasting potential of DNA, delivered through our advanced non-viral vector technology. Our goal is to revolutionize current cell and gene therapy practices by eliminating the need for ex-vivo cell manipulations. With the power of DNA and cell-directed lipid nanoparticles (LNPs) – a combination that sets us apart from others – we’re trailblazing a path to durably modify immune-effector cells, such as T cells, directly within patients. This isn’t just innovation—it’s a leap forward, paving the way for cell and gene therapies that are more affordable, scalable, and accessible to individuals across the globe.

www.nanocelltx.com

Nutcracker Therapeutics, Inc.

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.​

www.nutcrackerx.com

Promontory Therapeutics Inc.

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.

www.promontorytx.com

QBiotics Group Limited

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.

www.qbiotics.com/

Scancell Holdings PLC
[​LON: SCLP]

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. 

www.scancell.co.uk

Theriva Biologics, Inc.
[​NYSEAMERICAN: TOVX]

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.

www.therivabio.com

10-minute presenters

7 Hills Pharma Inc.

7 Hills Pharma is a Houston-based, clinical-stage drug development company advancing first-in-class, oral small molecules leveraging the novel mechanism of selective allosteric integrin activation (SAIA), pioneered by 7HP's co-founders, to safely enhance the effectiveness of immunotherapies against solid tumors, blood cancers, and genetic disorders with no added toxicities.

Launched in 2016, 7 Hills Pharma has received over $29 million in state and federal grants to accelerate our programs, including over $20 million since 2022, following an intensive due diligence process for each award.  Our proven management team has deep experience from discovery through approval, enabling 7 Hills to efficiently advance novel small molecule integrin activators from discovery through Phase II clinical proof-of-concept, our preferred exit point.

We are advancing two developmental programs, each with a dedicated first-in-class molecule, toward significant value inflection milestones offering liquidity potential within 2-3 years.

www.7hillspharma.com

Angiex, Inc.

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.​

www.angiex.com

Avstera Therapeutics Corp.

Avstera is an oncology-focused, clinical stage biotech headquartered in Malvern, PA developing a pipeline including next gen immunomodulators and a novel myeloid discovery platform.  Tumor associated macrophages (TAMs), make up to 50% or more of solid tumor cell mass; and are a key immune effector cell responsible for resistance mechanisms across therapeutic classes, especially with immunotherapy.  At Avstera, we are able to harness the power of the immune system within the TME to reprogram these cells into being strong anti-cancer agents.  The company's lead program, AVS100, is a highly selective orally bioavailable, brain penetrable HDAC6i immunomodulator with a proven ability to polarize macrophages within the TME.  It has been IND cleared for FIH Phase Ia/b trials by US FDA with initiation at MD Anderson Cancer Center.​

www.avstera.com

Carina Biotech Limited

Immuno-oncology company Carina Biotech is developing CAR-T and other adoptive cell therapies for the treatment of solid cancers. In addition to its LGR5-targeted CAR-T cell therapy CNA3103 for advanced colorectal cancer, Carina has a deep pipeline of CAR-T programs.​

www.carinabiotech.com

Heidelberg Pharma AG
[​ETR: HPHA]

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.

www.heidelberg-pharma.com/en

Ryvu Therapeutics S.A.
[​WSE: RVU]

Ryvu Therapeutics is a clinical-stage drug discovery and development company focused on novel small molecule therapies that address emerging targets in oncology. Ryvu’s work is defined by deep scientific knowledge, organizational efficiency, and a high throughput "ONCO Prime" discovery platform. Ryvu’s wholly owned lead candidate, RVU120, is a selective CDK8/CDK19 kinase inhibitor currently in Phase II clinical development for the treatment of AML/HR-MDS, LR-MDS, and MF. Ryvu’s wholly owned preclinical pipeline is focused on synthetic lethality, including a PRMT5 program and a WRN program, both of which are advancing to the development candidate stage. There are several additional assets in preclinical development aimed at novel targets in synthetic lethality, leveraging Ryvu’s efficient and productive discovery efforts and a proprietary ONCO Prime platform. Ryvu's technological expertise is validated by global partnerships with BioNTech, Exelixis, Menarini Group and the Leukemia & Lymphoma Society. The partnership with BioNTech is a multi-target small molecule immunotherapy research collaboration, including a license to standalone STING agonists. The partnership with Exelixis utilizes Ryvu’s STING agonist portfolio as a novel payload for antibody-drug conjugates (ADCs). Ryvu Therapeutics was founded in 2007 and currently has over 290 employees, including over 90 Ph.Ds. The company is headquartered in Kraków, Poland.​

www.ryvu.com

Scandion Oncology A/S
[​STO: SCOL]

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.​

www.scandiononcology.com

virtual showcase

AIVITA Biomedical, Inc.

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.

www.aivitabiomedical.com