Cancer Vaccine Breaking News

OSE Immunotherapeutics SA today provided a regulatory update on the clinical development plan of Tedopi®, a immunotherapy activating tumor-specific T-cells, in phase 3 in monotherapy in advanced or metastatic non-small cell lung cancer (NSCLC) after checkpoint inhibitor failure (ICI).

Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, commented in a press release on February 15, 2023, “We are pleased with the positive outcomes from the US Food & Drug Administration Type C Meeting following the supportive European Medicines Agency advice, as we are actively preparing a confirmatory phase 3 trial to support the regulatory registration of Tedopi®."

Both Agencies supported the continuation of the clinical development for Tedopi® through a new confirmatory phase 3 clinical trial versus standard of care in second-line treatment for HLA-A2+ patients in advanced in NSCLC.

Tedopi® is the first cancer vaccine to show positive and clinically meaningful efficacy results associated with a better safety and quality of life profile in monotherapy versus active comparator (chemotherapy-based standard of care) in the third line with secondary resistance to ICI in advanced or metastatic NSCLC.

Evaxion Biotech A/S recently announced that the U.S. Food and Drug Administration (FDA) determined that the Company may proceed with its Phase 2b clinical trial of EVX-01 targeting malignant melanoma.

The Phase 2b study will be conducted at clinical sites across the U.S., Europe, and Australia and in collaboration with Merck, supplying its PD-1 inhibitor KEYTRUDA®. 

The trial was first initiated in Australia with the enrollment of the first patient in September 2022.

In November 2022, the Company submitted an Investigational New Drug Application along with a Fast Track designation application to the FDA for a Phase 2b clinical trial.

The Company anticipates a response from the FDA to the Fast Track designation submission in the first quarter of 2023.

“Receiving a green light from the FDA is a tremendous boost for our personalized cancer vaccine program. EVX-01 is already actively enrolling patients in Australia, and the FDA approval expands our ability to move forward quickly with our lead program in malignant melanoma. Moreover, the FDA is a universally recognized national authority, and its endorsement is an important step towards demonstrating a clinically meaningful benefit of our first personalized cancer vaccine,” says Erik Heegaard, Chief Medical Officer at Evaxion, in a press release on January 3, 2023.

Health Canada recently approved Enhertu™ for treating adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received at least one prior line of chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.

Patients with hormone receptor-positive (HR+) breast cancer should have received at least one and be no longer considered eligible for endocrine therapy.1 

Enhertu (trastuzumab deruxtecan) is a specifically engineered HER2-directed antibody-drug conjugate (ADC) jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

The approval by Health Canada on January 6, 2023, was based on the DESTINY-Breast04 Phase III trial results.

"Since the approval of HER2-targeted therapies in breast cancer more than twenty years ago, only patients with HER2-positive disease have been eligible for these therapies – leaving those with tumors with lower levels of HER2 expression with limited effective treatment options," said Dr. Jan-Willem Henning, Medical Oncologist, Tom Baker Cancer Centre, and Clinical Associate Professor, Cumming School of Medicine, University of Calgary, in a press release on January 12, 2023.

"The recent Health Canada approval of Enhertu in the HER2-low patient population is a significant milestone in the treatment of metastatic breast cancer and is the first anti-HER2 molecule to demonstrate efficacy outside of traditional HER2-positive breast cancer.

"Based on the promising data from the DESTINY-Breast04 trial, we're now able to differentiate levels of HER2 expression to redefine how we classify and treat metastatic breast cancer, providing additional patients with the opportunity to benefit from HER2-directed therapy."

In Canada, 10% of newly diagnosed breast cancers are metastatic; for those initially diagnosed with early-stage breast cancer, approximately 30% will progress to metastatic disease.

HER2 expression is currently defined as either positive or negative and is determined by an IHC test which estimates the amount of HER2 protein on a cancer cell, and/or an ISH test, which counts the copies of the HER2 gene in cancer cells.

However, approximately half of all breast cancers are HER2-low, and previously these patients had limited effective treatment options following progression on endocrine (hormone) therapy.

Health Canada reviewed and approved Enhertu for this indication under the Priority Review and Project Orbis FDA collaboration pathways seven months from filing, enabling the timely availability to bring this new treatment option to HER2-low breast cancer patients as quickly as possible.

Note: ENHERTU is U.S. FDA-approved for treating several types of cancer.

Immunomic Therapeutics, Inc., a clinical-stage biotechnology company pioneering the development of LAMP-mediated nucleic acid-based immunotherapy, today announced that the U.S. FDA granted Fast Track Designation to the ITI-3000 program for treating patients with Merkel cell carcinoma.

The company is currently enrolling a phase 1 study evaluating ITI-3000, a plasmid DNA vaccine targeting patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer typically caused by the Merkel cell polyomavirus.

Dr. William Hearl, Chief Executive Officer of ITI, stated in a press release, "We are committed to unlocking the full potential of ITI-3000 in patients with this aggressive form of skin cancer."

"We expect to report top-line data from our ongoing phase 1 trial of ITI-3000 in MCC patients next year and look forward to working closely with the FDA on a potential next-phase clinical study design while simultaneously continuing dialogue with possible partners."

Apros Therapeutics, Inc. today announced that they would present interim pharmacokinetic and pharmacodynamic Phase 1 clinical data for APR003, a first-in-class orally-administered gastrointestinal (GI)- and liver-targeted TLR7 agonist.

It is currently being evaluated in an ongoing Phase 1 dose-escalation clinical trial in relapsed/refractory colorectal cancer (CRC) patients with hepatic metastasis.

Pharmacodynamic analysis revealed that upon weekly dosing, APR003 elicited robust Interferon-alpha, Interferon-gamma inducible protein 10 (IP-10), and Interferon Stimulated Gene 15 (ISG15) responses, suggesting strong immune priming.

In addition, APR003 achieved a similar or greater IP-10 response compared to other (non-targeted) agents of the same class, indicating that the tissue-targeted approach may have an increased safety window.

These data support further clinical investigation of APR003 in other GI and Liver malignancies and metastatic disease as a single agent and in combination with checkpoint inhibitors or complementary therapies.

Sonnet BioTherapeutics Holdings, Inc. announced today that the safety of SON-1010 dosing in several study cohorts had been formally reviewed in both Phase 1 clinical trials and that dose escalation is continuing as early data becomes available.

"We have now dosed 12 cancer patients at increasing drug levels in the SB101 study and 24 healthy volunteers in SB102," said Richard Kenney, M.D., Sonnet's Chief Medical Officer, in a press release on November 2, 2022.

SON-1010 is a proprietary version of human interleukin-12 (IL-12), configured using Sonnet's Fully Human Albumin Binding (FHAB®) platform.

SB101 is a multiple-dose trial for adult patients with advanced solid tumors (NCT05352750) that commenced in April 2022 and has now started treating the fourth dose cohort.

SB102 is a single-ascending dose trial in healthy volunteers (NCT05408572) that started in July and is dosing the third cohort.

Safety Review Committees found no safety concerns and approved advancing to the next higher dose levels for both studies.

"No dose-limiting toxicities have occurred to date using this novel approach to enhance the safety of cytokine-based immunotherapy, and we are starting to get encouraging data back on the pharmacokinetic and pharmacodynamic  responses."

"By linking the IL-12 cytokine to an albumin-binding domain that can target tumor tissue and extend the cytokine half-life in the body, we believe our proprietary FHAB technology will allow us to use higher doses of cytokines without triggering unacceptable toxicity."

"This could be the key to inducing a successful local immune response to Il-12 in the tumor microenvironment."

The data will be presented at a webinar at 8:30 am ET today.

Vaccitech plc announced yesterday the publication of research in preclinical animal models demonstrating the potential of SNAPvax for use in a novel paradigm for cancer treatment referred to as "VAX-INNATE."

The results show that intravenous administration of SNAPvax not only primes and expands tumor-specific cytotoxic T cells that mediate tumor killing but also reverses suppression in the tumor microenvironment associated with significantly improved tumor regression.

The research evaluated SNAPvax co-delivering tumor antigens and a powerful Toll-like receptor (TLR)-7/8 adjuvant by two different routes (IV or subcutaneous) in tumor-bearing mice.

While SNAPvax primed and expanded a high magnitude of antigen-specific T cells by both routes of administration, SNAPvax administered by the IV route induced systemic Type I interferon that markedly reduced the number of immunosuppressive monocytes and macrophages in the TME leading to improved T cell-mediated tumor regression.

"The research by Baharom and the Seder Lab at NIH offers new insights as to how cancer vaccines can be best leveraged to maximize therapeutic effect," said Andrew Ishizuka, M.D., Ph.D., SVP at Vaccitech, in a press release on October 27, 2022.

"It is broadly recognized that T cells and checkpoint inhibitors that unleash their potential are essential, but this study highlights the critical importance of engaging the innate immune system to reverse suppressor populations in the TME that can otherwise inhibit T cells."

"SNAPvax and our viral platforms, ChAdOx and MVA, are ideal for providing these essential ingredients."

"We look forward to validating SNAPvax's potential alone and combined with ChAdOx in upcoming clinical studies."