On August 15, 2024 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, reported positive feedback from its end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for amezalpat (TPST-1120) in combination with atezolizumab and bevacizumab to treat first-line unresectable or metastatic hepatocellular carcinoma (HCC) (Press release, Tempest Therapeutics, AUG 15, 2024, View Source [SID1234645946]).

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"We are thrilled with the positive outcome of our end-of-Phase 2 meeting with the FDA," said Sam Whiting, M.D., Ph.D., chief medical officer and head of R&D at Tempest. "Tempest and the FDA are in broad agreement on all major aspects of the proposed pivotal Phase 3 clinical trial for amezalpat in patients with hepatocellular carcinoma in the first line setting. This planned Phase 3 study closely mirrors the randomized Phase 2 study and the strongly favorable hazard ratio for overall survival observed at top-line analysis of the Phase 2, confirmed at the latest survival follow-up, give us confidence in the potential success of the Phase 3."

Key outcomes of the FDA meeting include:

Agreement on Phase 3 study design, including the standard-of-care control arm and the primary and secondary study endpoints
Agreement on appropriateness of the current amezalpat dose and schedule for the Phase 3 study
Agreement on the Phase 3 statistical plan including a pre-specified early efficacy analysis that the company currently estimates could shorten the time to primary analysis by up to 8 months
About the TPST-1120-301 Study

The planned Phase 3 study is a global, blinded, 1:1 randomized study of amezalpat plus atezolizumab and bevacizumab vs. atezolizumab and bevacizumab, the standard of care, in patients with unresectable or metastatic HCC treated in the first line setting. The company is preparing for the Phase 3 study start in the first quarter of 2025.

About Amezalpat (TPST-1120)

Amezalpat is an oral, small molecule, selective PPAR⍺ antagonist. Tempest’s data suggest that amezalpat treats cancer by targeting tumor cells directly and by modulating immune suppressive cells and angiogenesis in the tumor microenvironment. In an ongoing global randomized phase 1b/2 study of amezalpat in combination with atezolizumab and bevacizumab in first-line patients with advanced HCC, the amezalpat arm showed clinical superiority across multiple study endpoints when compared to atezolizumab and bevacizumab alone, the standard of care. These randomized data were supported by positive results observed in the Phase 1 clinical trial in patients with heavily pretreated advanced solid tumors.

On August 15, 2024 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, reported the closing of its previously announced public offering of 2,000,000 shares of its American Depository Shares ("ADSs")(or pre-funded warrants in lieu thereof), together with Series G warrants ("Series G Warrants") to purchase up to 2,000,000 ADSs at a combined public offering price of $1 per ADS (or pre-funded warrant in lieu thereof) and associated Series G Warrant (Press release, TC Biopharm, AUG 15, 2024, View Source [SID1234645948]). The Series G Warrants have an exercise price of £0.78 per ADS, are exercisable upon issuance and will expire one year from the date of issuance. Each ADS represents two hundred ordinary shares of the Company.

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The gross proceeds to the Company from the offering were $2.0 million, before deducting offering expenses payable by the Company. The Company intends to use the net proceeds from this offering to support its upcoming clinical trial focusing on relapse/refractory Acute Myeloid Leukemia, and for continuing operating expenses and working capital.

A registration statement on Form F-1 (File No. 333-280659) relating to these securities described above was filed with the Securities and Exchange Commission, or the SEC, and was declared effective by the SEC on August 12, 2024. The offering was made only by means of a prospectus, which is part of the effective registration statement. A final prospectus relating to the offering was filed with the SEC. Electronic copies of the final prospectus may be obtained for free on the SEC’s website located at View Source

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

On August 14, 2024 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported positive clinical study updates for its Acclaim-1 and Acclaim-3 clinical trials for the treatment of non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), respectively, and plans to re-focus its oncology clinical development program (Press release, Genprex, AUG 14, 2024, View Source [SID1234645896]).

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Patients in the Company’s lung cancer clinical trials are being treated with the Company’s lead drug candidate, Reqorsa (quaratusugene ozeplasmid) Gene Therapy. Two patients in the Acclaim-1 study have had prolonged Progression Free Survival (PFS) and importantly, the first treated patient in the Acclaim-3 study attained a Partial Remission (PR) from the start of maintenance therapy.

Ryan Confer, President and Chief Executive Officer of Genprex, commented on the update:

"We are excited by these early and promising patient responses to REQORSA treatment, particularly as these patients represent some of the most difficult to treat lung cancer patient populations. There is significant unmet medical need for patients afflicted with lung cancer, as nearly all patients’ disease progresses following treatment, even when treated with today’s most advanced targeted therapies and immunotherapies. This leaves patients with limited therapeutic options. We are thrilled our novel gene therapy treatment for lung cancer, REQORSA, is demonstrating early evidence of efficacy with a favorable safety profile. We look forward to continuing to evaluate REQORSA in our lung cancer clinical trials while we advance our efforts to bring new therapies to those battling cancer."

Acclaim-1

The Acclaim-1 clinical trial is evaluating the combination of REQORSA and AstraZeneca’s Tagrisso to treat patients with late-stage NSCLC who have activating EGFR mutations and disease progression after treatment with Tagrisso. The Acclaim-1 clinical trial has received an U.S. Food and Drug Administration (FDA) Fast Track Designation for late-stage NSCLC patients whose disease progressed after treatment with Tagrisso.

Two patients from the Phase 1 dose escalation portion of the study have had prolonged PFS and are still continuing to receive treatment on the study. One of them has received the treatment combination of REQORSA and Tagrisso for more than two years. This patient, who was previously treated with Tagrisso and chemotherapy and who continues to receive REQORSA and Tagrisso treatment, attained a PR after the second course of REQORSA and Tagrisso, and has maintained this response for more than two years. The second patient has had stable disease without disease progression for more than 15 months, and is also continuing to receive REQORSA and Tagrisso treatment.

Mark Berger, MD, Chief Medical Officer of Genprex, discussed the positive outcomes:

"We are very pleased with the positive early efficacy results for these patients. It is very compelling that one of the patients in our Acclaim-1 clinical trial has continued to see benefit from REQORSA treatment for more than two years and it’s been documented that the side effects of REQORSA have diminished, rather than increased, over time."

The Phase 2a expansion portion of the study was designed to have two cohorts with 33 patients each. One cohort was for patients who have previously received only Tagrisso treatment, and one cohort was for patients who had previously received both Tagrisso treatment and chemotherapy. Based on resource prioritization and to focus on the patients for whom REQORSA is most likely to show a benefit, the Company has decided to limit its enrollment efforts moving forward to patients who received only prior Tagrisso treatment and to cease enrollment of the second cohort (patients who received prior Tagrisso treatment and chemotherapy). The Phase 2a expansion portion of the trial with one cohort is now expected to enroll approximately 33 patients. The Phase 2b randomized portion of the study, in which patients progressing on prior Tagrisso treatment will be randomized 1:1 to either REQORSA and Tagrisso combination therapy or to platinum-based chemotherapy, will remain unchanged.

Genprex will conduct an interim analysis following the treatment of 19 patients in the Phase 2a expansion portion who had previously received only Tagrisso treatment. The Company expects to complete the enrollment of the first 19 patients in the Phase 2a expansion portion of the study and conduct an interim analysis in the first half of 2025.

Acclaim-3

The Acclaim-3 clinical trial is evaluating the combination of REQORSA and Genentech’s Tecentriq as a maintenance therapy to treat patients with extensive stage small cell lung cancer (ES-SCLC) who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. The FDA has granted Fast Track Designationfor the Acclaim-3 population of patients and has also granted Orphan Drug Designation for the treatment of SCLC.

In this study, patients receive maintenance therapy with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. Following completion of the Phase 1 dose escalation portion of the study, which the Company expects to complete during the second half of 2024, Genprex then expects to start the Phase 2 expansion portion of the study in the second half of 2024.

The first patient treated in the Phase 1 dose escalation portion of the Acclaim-3 clinical trial experienced an initial positive response after enrollment and dosing commenced in May. The patient had a PR, which is defined as at least a thirty percent (30%) decrease in tumor size, from the time the patient had a baseline CT scan after induction therapy and prior to the start of maintenance therapy, to the time of the CT scan performed after two cycles of maintenance therapy. As the maintenance therapy consists of REQORSA and Tecentriq, and the patient had already received four cycles of Tecentriq during induction therapy and thus responses to Tecentriq would likely have occurred earlier, which suggests that REQORSA may be providing clinical benefit. A recent CT scan, performed after four cycles of maintenance therapy (three months), confirms that the patient had a 30% decrease in tumor size in measurable lesions; however one lesion not previously measurable had grown in size, thus leading to a conclusion of disease progression at three months.

Dr. Berger commented on these compelling results:

"This patient’s response was not expected during maintenance therapy with Tecentriq alone, and we believe these results are promising and a positive early indication for the study. Once ES-SCLC patients begin maintenance therapy with Tecentriq, median PFS is very short; only 2.6 months, and further tumor regression rarely occurs. The ES-SCLC patient in the Acclaim-3 clinical trial treated with our combination therapy experienced PR, but asymptomatic disease progression was diagnosed by CT scan three months after the start of maintenance therapy. We find this positive result to be promising, particularly because this patient was treated with the lower of two doses planned for the Phase 1 portion of this clinical trial, and we are hopeful that the combination of REQORSA and Tecentriq will improve outcomes and help extend the lives of these very difficult to treat lung cancer patients."

Genprex’s novel cancer treatment platform re-expresses tumor suppressor genes in cancers. Tumor suppressor genes are often deleted or inactivated early in the process of cancer development. The key component of REQORSA is a plasmid that expresses TUSC2, a tumor suppressor gene protein which plays a vital role in cancer suppression and normal cell metabolism. Nearly 100% of SCLCs have reduced or no TUSC2 protein expression, and 41% completely lack TUSC2 protein expression, thus restoring TUSC2 expression in SCLC has a strong biologic rationale. Nonclinical studies in mice support the hypothesis that re-expressing the TUSC2 protein in combination with Tecentriq may lead to improved clinical efficacy in SCLC.

Oncology Program Update

Mr. Confer and the executive team have evaluated resource allocations to ensure streamlined, focused strategies to support expeditious regulatory submissions for REQORSA and will implement the following changes to the Company’s oncology clinical development plans in order to prioritize resources and focus on the most promising aspects of the Acclaim-1 and Acclaim-3 lung cancer clinical trials.

The Acclaim-2 clinical trial, a Phase 1/2 trial evaluating the combination of REQORSA and Merck & Co’s Keytruda in patients with late-stage NSCLC whose disease has progressed after treatment with Keytruda, will cease enrollment of new NSCLC patients. Current patients in the Phase 1 dose escalation portion of the study will continue to be treated until disease progression. The Company made this decision based on a number of factors, including enrollment challenges and delays due to competition for eligible patients with numerous other trials involving the same patient population.
As described above, the Company will limit its enrollment efforts for the Phase 2a expansion portion of the Acclaim-1 study moving forward to patients who received only prior Tagrisso treatment and cease enrollment of the second cohort (patients who received prior Tagrisso treatment and chemotherapy). The Phase 2a expansion portion of the trial with one cohort is now expected to enroll approximately 33 patients. The Company continues to evaluate ways to optimize its clinical and research programs and operational strategies, as part of its ongoing prioritization initiative.
Commenting on the decision, Mr. Confer stated:

"The decision to discontinue the Acclaim-2 clinical trial is driven in part by the fact that there are hundreds of Keytruda combination lung cancer clinical trials, which made it difficult to recruit patients and investigators due to the volume of competing trials. We thank the clinicians and patients who participated in this study and look forward to potentially reviewing this patient population again at a future time, as we fully stand behind REQORSA’s potential to treat late-stage NSCLC patients whose disease progressed after treatment with Keytruda."

Additionally, Genprex reports that the Company is collaborating with an academic research partner to discover, develop and utilize biomarkers to:

select the patient population most likely to respond to REQORSA;
predict and measure target engagement; and
enable decisions on progression of the Company’s drug candidates to the next phase of development.
The Company’s academic research partner is currently analyzing biomarkers that would indicate lack of response in lung cancer that could enrich the Company’s population of responders in its clinical trials and enhance patient screening and enrollment in order to increase the likelihood of potential success of the Acclaim studies.

On August 14, 2024 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, reported positive Phase 2 NAVAL-1 trial results from Stages 1 and 2 of the relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) peripheral T-cell lymphoma (PTCL) cohort (Press release, Viracta Therapeutics, AUG 14, 2024, View Source,-Regulatory-Progress,-and-Updated-Nana-val-Clinical-Development-Plan [SID1234645931]). Additionally, the Company received productive feedback from its meeting with the U.S. Food and Drug Administration (FDA), providing clarity on the potential regulatory path to initial registration of Nana-val in patients with R/R EBV+ PTCL. Based on FDA’s feedback, Viracta plans to begin a randomized controlled trial (RCT) of Nana-val in the second half of 2025.

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"We are pleased to present important additional data from our NAVAL-1 trial, which further supports Nana-val’s potential to address the high unmet medical needs of patients living with relapsed or refractory EBV-positive PTCL," said Darrel P. Cohen, M.D., Ph.D., Chief Medical Officer of Viracta. "Nana-val demonstrated substantial antitumor activity with a generally well-tolerated safety profile across Stage 1 and Stage 2 of the relapsed or refractory EBV-positive PTCL cohort, with a median duration of response that has not yet been reached. We are also encouraged by the particularly robust clinical responses observed in the second-line EBV-positive PTCL subgroup."

Mark Rothera, President and Chief Executive Officer of Viracta, added, "Aligning with the FDA on the potential path forward in relapsed or refractory EBV-positive PTCL marks a critical step towards bringing Nana-val to patients. EBV-positive PTCL is an aggressive cancer with survival rates that decline precipitously 12-24 months after diagnosis. Published literature suggests that EBV-positive lymphomas are a distinct oncological disease associated with poorer survival outcomes than EBV-negative lymphomas. We believe it is critical to treat these patients as early as possible with an EBV-targeted therapy to improve patient outcomes. Our updated Nana-val clinical development plan is designed to address this urgent need and expedite a randomized controlled trial, which we plan to initiate in 2025 to support potential registration."

Key Takeaways from the R/R EBV+ PTCL Cohort of the Phase 2 NAVAL-1 Trial
Overview: A total of 21 patients with primarily Stage III-IV disease (who had received ≥1 [median 2] prior systemic PTCL therapies) received nanatinostat (20 mg orally once daily, 4 days/week) in combination with valganciclovir (900 mg orally once daily, 7 days/week) across the first two stages of the study. Data generated from the expansion phase of the R/R EBV+ PTCL cohort may be shared in future updates.

As of the June 28, 2024 data cutoff, combined Stages 1 and 2 data demonstrated:

In the R/R EBV+ PTCL population:
The overall response rate (ORR) was 33% and the complete response rate (CRR) was 19% in the intent-to-treat (ITT) population (n=21); the ORR was 41% and the CRR was 24% in the efficacy-evaluable (EE) population (n=17).
In the second-line EBV+ PTCL subpopulation:
The ORR was 60% and the CRR was 30% in the ITT population (n=10); the ORR was 67% and the CRR was 33% in the EE population (n=9).
Median duration of response (DOR) has not yet been reached.
Two responding patients proceeded to hematopoietic stem-cell transplant without relapse, one of whom remains in response over 16 months.
Nana-val was generally well-tolerated:
The most common treatment-related adverse events were fatigue, nausea, decreased appetite, diarrhea, platelet count decreased, and anemia. These adverse events were primarily mild to moderate in severity and generally manageable or reversible.
Nana-val Clinical Development Plan: Next Steps
Based on the Company’s meeting with FDA and the particularly robust response rates observed in the second-line treatment setting, Viracta will focus Nana-val’s clinical development on patients with R/R EBV+ PTCL as follows: First, the Company will focus the primary analysis on the second-line EBV+ PTCL subpopulation in the ongoing NAVAL-1 trial’s expansion phase. Second, the Company plans to begin an RCT of Nana-val in the second-line treatment of EBV+ PTCL patients in 2025. Viracta believes this strategy will best position Nana-val for a potential NDA filing in 2026 for accelerated approval based on an interim analysis of second-line EBV+ PTCL patient data from the NAVAL-1 trial, provided that the ORR and DOR are compelling and the RCT is well underway. In addition, it creates the opportunity for accelerated approval based on final analysis of NAVAL-1 trial data, or for accelerated or full approval based on the outcomes of the RCT at interim or final analysis, respectively.

Corporate Update
Viracta has aligned resources to prioritize its EBV+ lymphoma program and plans to deliver on key potential Nana-val development milestones as follows:

Pause the EBV+ solid tumor program to focus resources on the more advanced EBV+ lymphoma program.
The recommended Phase 2 dose in patients with advanced EBV+ solid tumors is expected to be determined in the second half of 2024.
Report additional data from the ongoing expansion phase of the NAVAL-1 trial in second-line EBV+ PTCL patients in the fourth quarter of 2024.
Report Stage 1 data from patients with R/R EBV+ diffuse large B-cell lymphoma (DLBCL) in the first half of 2025.
Meet with the FDA to finalize the proposed RCT design in the second-line treatment of patients with EBV+ PTCL in the first half of 2025.
Initiate the RCT in the second half of 2025.
Present interim analysis outcomes from the expansion phase of the NAVAL-1 trial in second-line EBV+ PTCL patients in 2026.
File NDA for accelerated approval in 2026 based on interim analysis of the NAVAL-1 trial’s expansion cohort.
Along with this pipeline reprioritization, a reduction in force has been implemented that impacts approximately 23% of the Company’s employees.

Conference Call
Viracta will host an investor call on Wednesday, August 14 at 8:30 a.m. ET to discuss the positive Phase 2 NAVAL-1 trial results from Stages 1 and 2 of the R/R EBV+ PTCL cohort. A live question and answer session will follow the formal presentation. To register, click here.

About the NAVAL-1 Trial
NAVAL-1 (NCT05011058) is a global, multicenter, clinical trial of Nana-val in patients with relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) lymphoma. This trial employs a Simon two-stage design where, in Stage 1, participants are enrolled into one of three indication cohorts based on EBV+ lymphoma subtype. If two objective responses are achieved within a lymphoma subtype in Stage 1 (n=10), then additional patients will be enrolled in Stage 2 for a total of 21 patients. EBV+ lymphoma subtypes demonstrating promising antitumor activity in Stage 2 may be further expanded following discussion with regulators to potentially support registration.

About Nana-val (Nanatinostat and Valganciclovir)
Nanatinostat is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which are key to inducing viral genes that are epigenetically silenced in Epstein-Barr virus (EBV)-associated malignancies. Nanatinostat is currently being investigated in combination with the antiviral agent valganciclovir as an all-oral combination therapy, Nana-val, in various subtypes of EBV-associated malignancies. Ongoing trials include a potentially registrational, global, multicenter, open-label Phase 2 basket trial in multiple subtypes of relapsed or refractory (R/R) EBV+ lymphoma (NAVAL-1) as well as a multinational Phase 1b/2 clinical trial in patients with recurrent or metastatic (R/M) EBV+ NPC and other advanced EBV+ solid tumors.

About Peripheral T-Cell Lymphoma
T-cell lymphomas comprise a heterogeneous group of rare and aggressive malignancies, including peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) and angioimmunoblastic T-cell lymphoma (AITL). There are approximately 5,600 newly diagnosed T-cell lymphoma patients and approximately 2,600 newly diagnosed PTCL-NOS and AITL patients in the U.S. annually. Approximately 70% of these patients are either refractory to first-line therapy, or eventually experience relapse of their disease. Clinical trials are currently recommended for all lines of PTCL therapy, and most patients with R/R PTCL have poor outcomes, with median progression-free survival and median overall survival times reported to be 3.7 and 6.5 months, respectively. Approximately 40% to 65% of PTCL is associated with EBV, the incidence of EBV+ PTCL varies by geography, and reported outcomes for patients with EBV+ PTCL are inferior to those whose disease is EBV-negative. There is no approved targeted treatment specific for EBV+ PTCL, and therefore this represents a high unmet medical need.

About EBV-Associated Cancers
Approximately 90% of the world’s adult population is infected with EBV. Infections are commonly asymptomatic or associated with mononucleosis. Following infection, the virus remains latent in a small subset of cells for the duration of the patient’s life. Cells containing latent virus are increasingly susceptible to malignant transformation. Patients who are immunocompromised are at an increased risk of developing EBV-positive (EBV+) lymphomas. EBV is estimated to be associated with approximately 2% of the global cancer burden including lymphoma, nasopharyngeal carcinoma (NPC), and gastric cancer.

On August 14, 2024 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 12,059,459, entitled, "Therapeutic Anticancer Neoepitope Vaccine" (Press release, Nykode Therapeutics, AUG 14, 2024, View Source [SID1234645817]).

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The newly issued patent describes Nykode’s fully individualized neoantigen based vaccine, VB10.NEO, which is in development for the treatment of locally advanced or metastatic solid tumours. The 20 year expiration date of this patent is January 5, 2037. Related patents were previously granted to the company in Russia, India, and Australia.

Michael Engsig, CEO of Nykode, said, ‘We are very pleased with the granting of this important patent in the U.S., a key market for Nykode. Continuously expanding our patent protection is a core strategy for us. The granting of this patent is a testament to the world-class innovation taking place in Nykode’s labs. We remain dedicated to pushing the boundaries of what’s possible in medicine, bringing hope to patients and their families around the globe."

About VB10.NEO

VB10.NEO is a proprietary individualized neoantigen vaccine in development for the treatment of locally advanced or metastatic solid tumors under an exclusive, worldwide clinical collaboration with Genentech, a member of the Roche Group. The vaccine is designed to be produced on-demand according to the neoantigen profile of an individual patient. Neoantigens are proteins generated by tumor-specific mutations not present in normal tissues and are thus an attractive target for cancer immunotherapy as they may be recognized as foreign by the immune system.

Nykode is currently conducting a clinical study evaluating VB10.NEO: VB N-02, an open-label Phase 1b, dose-escalation study of the safety and antigen-specific immune responses elicited by VB10.NEO in combination with Roche’s checkpoint inhibitor atezolizumab in patients with locally advanced and metastatic tumors (NCT05018273).