Codagenix Inc. is a clinical-stage synthetic virology company developing codon-modified viruses for infectious disease prophylaxis and as virotherapy for cancer.
All of Codagenix’s viruses are rationally designed using the proprietary machine learning-enabled platform SAVE (Synthetic Attenuated Virus Engineering), that utilizes the redundancy in the genetic code to finetune the balance between replication and immune stimulation. Codon-modified live-attenuated viral vaccines for SARS-CoV-2, influenza and RSV elicit robust humoral and cellular immune responses and have shown excellent safety profiles in clinical trials.
When used in the context of immunotherapy for cancer, codon-modified viruses were able to induce anti-tumor immune responses translating to anti-tumor efficacy, tumor regression and long-term survival in multiple preclinical models, including those resistant to immune checkpoint inhibition. The lead asset CodaLytic represents a promising immunotherapeutic candidate with the potential to deepen or broaden responses to checkpoint inhibitors and is ready for clinical development in breast cancer indications. In parallel, a differentiated approach to discovery of novel virotherapeutics is being implemented to expand the immuno-oncology pipeline and address unmet patient need.
Codagenix is headquartered in Farmingdale, NY with a second growing presence in Cambridge, MA.
Cytovia focuses on harnessing the innate immune system by developing complementary and disruptive FLEX-NK™ bispecific antibody and iPSC-derived, TALEN® gene-edited NK-cell platforms for patients with HCC, Multiple Myeloma, and other solid and hematological tumors. FLEX-NK™ bispecific antibodies are built on a quadrivalent multifunctional antibody platform designed to engage natural killer cells by targeting NKp46 using Cytovia's proprietary FLEX-NK™ technology. The company is also developing TALEN® gene-edited iPSC-derived NK (or iNK) and CAR-iNK cells with improved function and persistence. FLEX-NK™ bispecific antibodies can be combined with iNK cells to maximize therapeutic effect in select patient groups.
Geneos Therapeutics is a privately held clinical stage 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 6-8 weeks with a path to 3 – 4 weeks) and neoantigen capacity (currently up to 40 and with a path to 80). Encouraging clinical data from the ongoing 36 patient Phase 1b/2a clinical trial in 2L hepatocellular carcinoma include 3 CRs and a 4th cancer free patient among the first 24 enrolled. 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.
MAIA Biotechnology, Inc. is a targeted therapy, immune-oncology company, focused on development of first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer.
The National Cancer Institute (NCI) is the federal government's principal agency for cancer research and training. Established under the National Cancer Institute Act of 1937, NCI is part of the National Institutes of Health (NIH), one of 11 agencies that make up the Department of Health and Human Services (HHS).
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 ribosome. 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 discovers and develops novel small molecule drug candidates from its proprietary EcoLogicTM phenotypic screening platform. Our lead oncology molecule, tigilanol tiglate, provides for single injection treatment against a broad range of solid tumors, currently in Phase II trials in patients with head and neck cancers and soft tissue sarcoma.
Tigilanol tiglate has secured regulatory and commercial validation as a marketed veterinary product STELFONTA® for canine mast cell tumors, reporting a 75% Complete Response (CR) rate in a FDA pivotal canine trial. With more than 15,000 canine patients treated globally, STELFONTA® generates milestone payments and revenues in USA, UK, EU and Australia.
QBiotics’ business model is to discover and develop novel therapeutics that have application in both veterinary and human markets, to proof of concept and then partner for late-stage development and commercialisation. Success in the veterinary programs validates QBiotics technology and de-risks human development, while generating early, non-diluting revenues.
Follow on asset, EBC-1013 for treating debilitating stubborn wounds, is currently in early clinical development for acute wounds in horses, and Phase I set-up stage for venous leg ulcers in humans. www.qbiotics.com/
RAPT Therapeutics, Inc. [NASDAQ:RAPT]
RAPT Therapeutics is a clinical stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases. Utilizing our proprietary drug discovery and development engine, we develop highly selective small molecules that are designed to modulate the critical immune responses underlying these diseases.
Since our founding, we have discovered and advanced unique two drug candidates each targeting CCR4. Our lead inflammation drug candidate, RPT193, demonstrated POC in a placebo-controlled Ph1b trial in atopic dermatitis patients and we have initiated a Ph2b trial in atopic dermatitis and a Ph2a trial in asthma. Our lead oncology drug candidate, FLX475, demonstrated POC activity as both monotherapy and in combination with Keytruda in “charged” tumors. We expect to provide a clinical update in 2H 2023.
We believe our unwavering focus, applying scientific rigor and discipline to advance oral treatments that intelligently target key drivers of the immune system, could result in drug candidates that, if approved, will combat cancer and inflamation and, importantly, improve patients’ lives.
Triumvira Immunologics, Inc. (“Triumvira”) is a clinical-stage company developing unique, non-gene edited, first-in-class targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors. The company’s proprietary T cell Antigen Coupler (TAC) technology is a robust and versatile platform that activates natural T cell functions differently from cell therapies such as CAR-T and engineered T cell receptor (TCR) therapies. TAC, our proprietary T cell Antigen Coupler, is a multi-domain chimeric molecule that works directly with the T cell receptor (TCR) to help a T cell recognize and attack cancer cells. The use of an intracellular co-receptor sequence as one of its domains is completely unique to Triumvira. This non-gene edited strategy is designed to retain the T cell’s natural control and internal feedback mechanisms. We believe TAC will become an essential tool for safely and effectively treating patients with solid malignancies.
Triumvira is headquartered in Austin, Texas with research facilities in Hamilton, Ontario, and a GMP Suite in South San Francisco.
Ultimovacs is a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines with broad applicability. Ultimovacs’ lead cancer vaccine candidate UV1 is directed against human telomerase (hTERT) an antigen that is present in 85-90% of cancers in all stages of tumor growth. With a broad Phase II program in five cancer indications enrolling more than 670 patients, Ultimovacs aims to clinically demonstrate UV1’s impact in multiple cancer types expressing telomerase. UV1 is used in combination with other immunotherapies for indications where patients have unmet medical needs. UV1 is off-the-shelf and easy to use and is a patented, proprietary technology owned by Ultimovacs.
In addition, Ultimovacs’ adjuvant platform, based on the proprietary Tetanus-Epitope-Targeting (TET) technology, combines tumor-specific peptides and adjuvant in the same molecule and entered Phase I studies in 2021.
The company is publicly listed at Euronext Oslo (ULTI).
Avstera is an oncology-focused biotech based in the Philadelphia, PA region developing a pipeline containing immunomodulators, autologous macrophage-based cell therapies, and novel mRNA-based cancer vaccines all targeting solid tumors. 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 HDAC6i immunomodulator with a proven ability to polarize macrophages within the TME. It is slated for IND filing this year targeting solid tumors.
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.
Enterome is a clinical stage company developing off-the-shelf, transformational cancer treatments targeting all tumor types. Ongoing Phase 2 trials for our most advanced program EO2401 have shown promising efficacy in recurrent glioblastoma and adrenal malignancies and good safety in more than 150 patients.
Enterome’s OncoMimics™ approach generates a powerful, long-lasting immune response from the patient’s own effector memory T-cells, overcoming the immune tolerance to self-antigens.
With 5 clinical immune-oncology projects to date, our fully integrated R&D platform has the potential to deliver multiple candidates with a rapid progression “from bench to bedside”. In addition to OncoMimics™ programs, Enterome has also established a partnership with Nestlé Health Science in inflammatory diseases and food allergy.
ISA develops targeted immune system activators to keep cancer in check.
Its lead product ISA101b is in 3 phase 2 clinical trials, including a landmark randomized, placebo controlled phase 2 trial in head- and neck cancer involving 200 patients. All 3 trials will have read-outs in 2023. During ASCO, initial data will be presented from a trial in head- and neck cancer patients that failed prior aPD-1 therapy.
Next products in the development are ISA 103 targeting PRAME and ISA104 targeting chronic hepatitis B and Hep B induced HCC. ISA104 entered the clinical phase in Q2 2023 and clinical trials for ISA104 are planned for 2024.
Furthermore, ISA is developing additional pre-clinical products based on its technology platform. www.isa-pharma.com/
Nammi Therapeutics, inc.
Nammi Therapeutics, Inc. is a Los Angeles-based immunotherapy company developing first-in-class products for the treatment of cancer. Founded in 2019, Nammi's mission is to develop products that focus immune activation at the site of tumors while sparing the life-changing side effects of systemic immune activation. Nammi's immunotherapies incorporate three key principles:
1) The redundancy of immune regulatory pathways requires synergistic combinations for robust and broad efficacy;
2) Potent immune stimulators must be dampened in circulation to avoid systemic toxicities;
3) Optimal therapies must employ mechanisms to selectively deliver and activate them within tumors to focus activated immune cells on killing the tumor rather than the healthy tissue.
Nammi scientists have created two proprietary therapeutic platforms, each of which offers the opportunity for multiple candidates. The first platform, Masked ImmunoCytokines (MICs), are tumor antigen-targeting antibodies fused to a masked cytokine delivering direct anti-tumor killing capability and immune response-initiating activity. The mask inhibits systemic cytokine activation, and is selectively cleaved within the tumor microenvironment. A US Phase 1 trial starting in 4Q23 is planned for Nammi's lead MIC candidate, QXL138AM. The second platform, Nammisomes, are prodrugs of immune modulators formulated as combinations in lipid-based nanoparticles. Nammisomes enable incorporation of multiple immunotherapy mechanisms of action into a single drug product, enhancing efficacy and reducing development cost. Nammi's lead Nammisome candidate, NTI-121, is in preclinical development and scheduled to begin a US Phase 1 trial in late 2024.
Nammi is currently soliciting investors for its Series B Preferred shares (approx. $17 million raised to date, target $25-30 million).
The Sensius systems offer unparalleled fulfilment in supporting solid tumour treatment by the use of thermotherapy in combination with radiation therapy, immunotherapy or chemotherapy.
Sensius saves cancer patients from the dilemma between treatment and toxicity: improving balance in outcome and quality of life through personalized thermotherapy.
Sensius’ mission is to demonstrate the value of personalized thermotherapy, engaging the medical field to adopt it as adjuvant therapy for a range of different cancer types, starting with head and neck cancer to find the right balance between treatment outcome and quality of life for cancer patients.
Tactical Therapeutics, Inc is a private clinical stage company in New York, developing Carboxyamidotriazole Orotate (CTO) a First-in class inhibitor of non-voltage calcium (Ca2+) signaling linked on oncolytic pathways and Ca2+ calcium channels. Carboxyamidotriazole (CAI) binds to and inhibits Ca2+ channels, blocking both Ca2+ influx into cells and Ca2+ release from intracellular stores resulting in Ca2+-mediated signal transduction and inhibition of vascular endothelial growth factor, endothelial proliferation, angiogenesis, inflammation, tumor cell growth, invasion, and metastasis. Preclinical studies of CTO demonstrated modulation of multiple signal transduction pathways including PI3-kinase/Akt/PTEN/mTOR, RAS/RAF/MAPK/MEK, Wnt-β-catenin, HDAC, HSP-90, Bcr-Abl and others. CTO also include inhibition of inflammatory cytokines in microenvironment including Cytokines-VEGF, GM-CSF, INF-ɤ, IL-2, IL-6, IL-8, MIP1-α, IL1-β, TNF-α.
CTO is orally administered, has favorable bioavailability, brain penetration, and safe toxicity profile. CTO studied in three Phase I trials: i) in 44 advanced cancer patients with undruggable tumors CTO showed clinical benefit as durable Stable Disease up to 14 months, ii) in 27 recurrent glioblastoma (rGBM) patients CTO plus temozolomide (TMZ) showed 1 Complete Response and 6 Partial Responses in tumors with resistant mutations IDH wt, EGFR, -ve MGMT, iii) in 15 newly diagnosed GBM (nGBM) most with unresectable tumors, CTO with chemo-radiation and adjuvant TMZ significantly improved the Progression Free Survival to 15 month, and Overall Survival to 28 months not reached. 62% OS at 24 months. 2 patients are recurrence free at 5 years. End-of-Phase 1 meeting was held with FDA and two Phase 2 randomized trials in rGBM and nGBM planned on the Orphan Fast Track. Tactical Therapeutics is raising capital to run Phase 2 randomized trial in rGBM patients and pursuing partnering, licensing strategies.
Phase 2 trials are planned in nGBM and other solid cancers: ovarian, NSCLC, SCLC, metastatic CRC, renal, head & neck, brain metastases, and pediatric brain cancers.