On December 6, 2021 Bavarian Nordic A/S ("Bavarian Nordic" or the "Company") reported its intention to raise new capital through an accelerated bookbuilding process. The offering (the "Offering") of new shares (the "New Shares") in Bavarian Nordic has now been successfully completed. Reference is made to company announcement no. 40 of 6 December 2021 (Press release, Bavarian Nordic, DEC 6, 2021, View Source [SID1234596505]).

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Bavarian Nordic has successfully completed a directed issue and private placement of 6,373,680 new shares at an offer price of DKK 268 per share, raising gross proceeds to Bavarian Nordic of DKK 1,708 million.

The Offering has not been registered under the U.S. Securities Act and was made pursuant to applicable exemptions from the obligation to publish a prospectus in Denmark as well as exemptions from the U.S. Securities Act and the securities laws of other applicable jurisdictions in a directed issue and private placement and subscribed for by eligible qualified institutional and professional investors in Denmark and in certain other jurisdictions at market price and without pre-emption rights for Bavarian Nordic’s existing shareholders.

The net proceeds from the Offering will be used in accordance with company announcement no. 40 of 6 December 2021.

As the Offering was oversubscribed, an individual allocation of the New Shares was made.

Bavarian Nordic has in connection with the Offering, agreed to undertake a lock-up commitment for 180 calendar days following settlement of the Offering (subject to certain exceptions). In addition, members elected at the general meeting of Bavarian Nordic’s board of directors as well as members of the executive management have in connection with the Offering, agreed to undertake a lock-up commitment for 90 calendar days following settlement of the Offering (subject to certain exceptions).

CAPITAL INCREASE
Subject to settlement, a share capital increase will be registered with the Danish Business Authority and the share capital of Bavarian Nordic will hereafter consist of 70,468,393 shares of DKK 10 each, equivalent to a registered share capital of DKK 704,683,930.

The New Shares represent approximately 9.94 % of Bavarian Nordic’s registered share capital before the capital increase and will account for approximately 9.04 % of Bavarian Nordic’s registered share capital upon completion of the capital increase.

ADMISSION TO TRADING AND OFFICIAL LISTING
The New Shares will be issued under the temporary ISIN code DK0061682721. No application for admission to trading and official listing has been, or will be, filed for the New Shares issued under the temporary ISIN code, and the temporary ISIN code will only be registered with VP Securities A/S for subscription of the New Shares. The temporary ISIN code in VP Securities A/S will be merged with the permanent ISIN code for the existing shares, DK0015998017, as soon as possible following registration of the share capital increase with the Danish Business Authority. The New Shares are expected to be admitted to trading and official listing on Nasdaq Copenhagen A/S, in the permanent ISIN code for the existing shares, DK0015998017, on or around 10 December 2021.

The admission to trading and official listing of the New Shares is subject to the Offering not being withdrawn prior to the settlement of the Offering and the Company making an announcement to that effect.

EXPECTED TIMETABLE FOR THE OFFERING

Date Event
Thursday 9 December 2021 Settlement and payment for the New Shares
Thursday 9 December 2021 Registration of the capital increase with the Danish Business Authority
Friday 10 December 2021 Admission to trading and official listing of the New Shares on Nasdaq Copenhagen A/S
Monday 13 December 2021 Merger of the temporary ISIN code with the permanent ISIN code in the system of VP Securities A/S
NEW SHARES
The decision to launch an offering of new shares in a directed issue was made pursuant to Article 5a(2) in Bavarian Nordic’s articles of association pursuant to which its board of directors is authorised to make share capital increases without pre-emption rights for the existing shareholders at market price.

The New Shares will rank pari passu in all respects with existing shares in Bavarian Nordic. The New Shares will be negotiable instruments, and no restrictions will apply to their transferability. No shares, including the New Shares, carry or will carry any special rights. Rights conferred by the New Shares, including voting rights and dividend rights, will apply from the time when the capital increase is registered with the Danish Business Authority. The New Shares must be registered in the name of the holder in the Company’s register of shareholders.

JOINT GLOBAL COORDINATORS AND JOINT BOOKRUNNERS
Citigroup Global Markets Limited and Nordea Danmark, filial af Nordea Bank Abp, Finland are acting as Joint Global Coordinators and Joint Bookrunners in connection with the Offering (jointly the "Joint Global Coordinators and Joint Bookrunners").

Kromann Reumert and Latham & Watkins LLP act as Danish and U.S. legal advisors respectively to the Company. Plesner acts as Danish legal advisors to the Joint Global Coordinators and Joint Bookrunners.

On December 6, 2021 Blueprint Medicines Corporation (NASDAQ: BPMC) reported two Nature Medicine publications on the registration-enabling EXPLORER and PATHFINDER trials of AYVAKIT (avapritinib), highlighting its robust efficacy and safety datasets in advanced systemic mastocytosis (Advanced SM) (Press release, Blueprint Medicines, DEC 6, 2021, View Source [SID1234596524]). The publications feature overall response, patient-reported outcomes and survival data, which reinforce the durable activity of AYVAKIT. Additional new analyses underscore the treatment’s impact regardless of patient subgroup or disease pathology. Based on these data, AYVAKIT was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with advanced SM in June 2021.

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SM is a rare hematologic disorder driven by the KIT D816V mutation in nearly all cases. In advanced SM, the median overall survival with previously available treatment options ranges from less than six months to approximately 3.5 years, depending on the subtype.1

"Targeting the primary genetic driver of systemic mastocytosis, avapritinib has shown rapid and durable improvements in mast cell burden, patient-reported symptoms and quality of life, with a generally well-tolerated safety profile," said Daniel DeAngelo, M.D., Ph.D., Chief of the Division of Leukemia at Dana-Farber Cancer Institute, lead and senior author on the EXPLORER and PATHFINDER trial publications, respectively. "I am highly encouraged by the survival benefits observed with this therapy, including in patients with mast cell leukemia who have a particularly poor prognosis. The depth of activity achieved by avapritinib, including molecular remission of KIT D816V, sets a new benchmark for the treatment of advanced systemic mastocytosis."

"The data published today in Nature Medicine comprise the largest therapeutic dataset ever reported in advanced systemic mastocytosis, encompassing two studies enrolling approximately 150 patients with up to four years of follow-up, and reflecting our deep commitment to pioneer new science and improve outcomes for patients living with this devastating disease," said Becker Hewes, M.D., Chief Medical Officer at Blueprint Medicines.

In addition, Blueprint Medicines announced plans to report four SM data presentations, including an oral presentation on the EXPLORER trial, at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in Atlanta on December 11-14, 2021. These datasets further illustrate the significant impact of AYVAKIT in advanced SM, showcase Blueprint Medicines’ clinical leadership in SM and reflect the company’s ongoing collaboration with the community to improve patient care.

Nature Medicine Publication Highlights

Across the EXPLORER and PATHFINDER studies, 148 patients with advanced SM were enrolled as of the data cutoff dates. Treatment response was evaluated using modified IWG-MRT-ECNM criteria, with the overall response rate defined as complete remission with full or partial recovery of peripheral blood counts, partial remission or clinical improvement. All responses were confirmed. The results were reported as of a data cutoff date of May 27, 2020 for the EXPLORER trial and June 23, 2020 for the PATHFINDER trial.

EXPLORER

PATHFINDER

Response evaluable patients

n=53

n=32

Overall response rate

75% (95% CI: 62%, 86%)

75% (95% CI: 57%, 89%)

Median duration of response

38 months (95% CI, 22 months, NEa)

NEa (95% CI: NEa, NEa)

Overall survival

76% estimated 24-month rate

86% estimated 12-month rate

Note: (a) NE, not estimable.

Across both studies, statistically significant improvements in patient-reported symptoms were observed, as measured by the Advanced SM Symptom Assessment Form Total Symptom Score.

AYVAKIT showed broad activity across all advanced SM subtypes, including SM with an associated hematological neoplasm (SM-AHN). For example, substantial reductions were observed in monocytosis in patients with SM and chronic myelomonocytic leukemia, and in eosinophilia in patients with SM and chronic eosinophilic leukemia, potentially reflecting the multi-lineage involvement of the KIT D816V mutation.
AYVAKIT was generally well-tolerated, and most adverse events (AEs) were Grade 1 or 2. The most common AEs included edema, thrombocytopenia, anemia, diarrhea, nausea, fatigue, vomiting, neutropenia, headache, cognitive effects and abdominal pain. Overall, 10 percent of patients in the EXPLORER trial and 5 percent of patients in the PATHFINDER trial discontinued AYVAKIT due to treatment-related AEs. AYVAKIT is not recommended for the treatment of patients with advanced SM with low platelet counts (less than 50,000/µL), which is consistent with current patient eligibility criteria in the EXPLORER and PATHFINDER trials.

The papers, titled "Safety and efficacy of avapritinib in advanced systemic mastocytosis: the phase 1 EXPLORER trial," and "Efficacy and safety of avapritinib in advanced systemic mastocytosis: interim analysis of the phase 2 PATHFINDER trial," were published online in Nature Medicine on December 6, 2021.

About AYVAKIT (avapritinib)

AYVAKIT (avapritinib) is a kinase inhibitor approved by the FDA for the treatment of two indications: adults with Advanced SM, including aggressive SM (ASM), SM-AHN and mast cell leukemia (MCL), and adults with unresectable or metastatic gastrointestinal stromal tumors (GIST) harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations. For more information, visit AYVAKIT.com. This medicine is approved in Europe (AYVAKYT) for the treatment of adults with unresectable or metastatic GIST harboring the PDGFRA D842V mutation, and in Mainland China (AYVAKIT) for the treatment of adults with unresectable or metastatic PDGFRA exon 18 mutant GIST.

AYVAKIT/AYVAKYT is not approved for the treatment of any other indication in the U.S., Europe or Greater China, or for any indication in any other jurisdiction by any other health authority.

Blueprint Medicines is developing AYVAKIT globally for the treatment of advanced and non-advanced SM. The FDA granted breakthrough therapy designation to AYVAKIT for the treatment of advanced SM, including the subtypes of ASM, SM-AHN and MCL, and for the treatment of moderate to severe indolent SM.

To learn about ongoing or planned clinical trials, contact Blueprint Medicines at [email protected] or 1-888-BLU-PRNT (1-888-258-7768). Additional information is available at clinicaltrials.gov.

Blueprint Medicines has an exclusive collaboration and license agreement with CStone Pharmaceuticals for the development and commercialization of AYVAKIT in Greater China, which encompasses Mainland China, Hong Kong, Macau and Taiwan. Blueprint Medicines retains development and commercial rights for AYVAKIT in the rest of the world.

About SM

SM is a rare disease driven by the KIT D816V mutation. Uncontrolled proliferation and activation of mast cells result in chronic, severe and often unpredictable symptoms for patients across the spectrum of SM. The vast majority of those affected have non-advanced (indolent or smoldering) SM, with debilitating symptoms that lead to a profound, negative impact on quality of life. A minority of patients have advanced SM, which encompasses a group of high-risk SM subtypes including ASM, SM-AHN and MCL. In addition to mast cell activation symptoms, advanced SM is associated with organ damage due to mast cell infiltration and poor survival.

Debilitating symptoms, including anaphylaxis, maculopapular rash, pruritis, diarrhea, brain fog, fatigue and bone pain, often persist across all forms of SM despite treatment with a number of symptomatic therapies. Patients often live in fear of severe, unexpected symptoms, have limited ability to work or perform daily activities, and isolate themselves to protect against unpredictable triggers. Historically, there had been no approved therapies for the treatment of SM that selectively inhibit D816V mutant KIT.

Important Safety Information

Serious intracranial hemorrhage (ICH) may occur with AYVAKIT treatment; fatal events occurred in <1% of patients. Overall, ICH (eg, subdural hematoma, ICH, and cerebral hemorrhage) occurred in 2.9% of 749 patients who received AYVAKIT. In Advanced SM patients who received AYVAKIT at 200 mg daily, ICH occurred in 2 of 75 patients (2.7%) who had platelet counts ≥50 x 109/L prior to initiation of therapy and in 3 of 80 patients (3.8%) regardless of platelet counts. Monitor patients closely for risk of ICH including those with thrombocytopenia, vascular aneurysm or a history of ICH or cerebrovascular accident within the prior year. Permanently discontinue AYVAKIT if ICH of any grade occurs. A platelet count must be performed prior to initiating therapy. AYVAKIT is not recommended in Advanced SM patients with platelet counts <50 x 109/L. Following treatment initiation, platelet counts must be performed every 2 weeks for the first 8 weeks. After 8 weeks of treatment, monitor platelet counts every 2 weeks or as clinically indicated based on platelet counts. Manage platelet counts of <50 x 109/L by treatment interruption or dose reduction.

Cognitive adverse reactions can occur in patients receiving AYVAKIT. Cognitive adverse reactions occurred in 39% of 749 patients and in 28% of 148 SM patients (3% were Grade >3). Memory impairment occurred in 16% of patients; all events were Grade 1 or 2. Cognitive disorder occurred in 10% of patients; <1% of these events were Grade 3. Confusional state occurred in 6% of patients; <1% of these events were Grade 3. Other events occurred in <2% of patients. Depending on the severity, withhold AYVAKIT and then resume at same dose or at a reduced dose upon improvement, or permanently discontinue.

AYVAKIT can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females and males of reproductive potential to use an effective method of contraception during treatment with AYVAKIT and for 6 weeks after the final dose of AYVAKIT. Advise women not to breastfeed during treatment with AYVAKIT and for 2 weeks after the final dose.

The most common adverse reactions (≥20%) at all doses were edema, diarrhea, nausea, and fatigue/asthenia.

Avoid coadministration of AYVAKIT with strong and moderate CYP3A inhibitors. If coadministration with a moderate CYP3A inhibitor cannot be avoided, reduce dose of AYVAKIT. Avoid coadministration of AYVAKIT with strong and moderate CYP3A inducers.

On December 6, 2021 Cancer Advances, Inc., a clinical stage biopharmaceutical company developing therapeutics for gastrointestinal cancers, reported a new publication in Frontiers in Oncology, section Gastrointestinal Cancers: Gastric & Esophageal Cancers (Press release, Cancer Advances, DEC 6, 2021, View Source [SID1234597367]).

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The gastrointestinal peptide gastrin has been shown to stimulate growth of gastric cancer through the cholecystokinin-B receptor (CCK-BR), a receptor that is expressed in at least 56.6% of human gastric cancers. The researchers evaluated the effects of PAS (Polyclonal Antibody Stimulator), a Phase 3 ready cancer vaccine that induces antibodies to gastrin, alone or in combination with a Programed Death-1 antibody (PD-1 Ab) in immune competent mice bearing YTN-16 gastric tumors.

Tumor growth was significantly slower than controls in PAS-treated mice, and tumor growth rate was decreased even more in combination-treated mice.
There were no metastases in any of the mice treated with PAS either alone or in combination with PD-1 Ab.
PAS monotherapy or combined with PD-1 Ab increased tumor CD8+ T-lymphocytes and decreased the number of immunosuppressive M2-polarized tumor-associated macrophages.
PAS monotherapy or combined with PD-1 Ab significantly decreased fibrosis in the tumor microenvironment.
These results show that the addition of PAS to therapy with an immune checkpoint antibody may decrease growth and metastases of gastric cancer by altering the tumor microenvironment and interrupting the autocrine pathway between gastrin and the CCKB receptor.

The study was conducted in collaboration with the manuscript’s lead author, Jill P. Smith, MD, professor of medicine and oncology at Georgetown University Medical Center, through a sponsored agreement with Cancer Advances, Inc. Cancer Advances plans to seek approval for PAS in the treatment of gastric and pancreatic cancers.

Link to publication:
https://www.frontiersin.org/articles/10.3389/fonc.2021.788875/full

On December 6, 2021 Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, reported that the first patient has been dosed in the registrational Phase 3 AGILITY clinical trial of entospletinib, a selective inhibitor targeting spleen tyrosine kinase (SYK), in combination with standard of care anthracycline and cytarabine (7+3) chemotherapy (Press release, Kronos Bio, DEC 6, 2021, View Source [SID1234596475]). This trial is the first in acute myeloid leukemia (AML) to use measurable residual disease (MRD) as the primary endpoint and has the potential to support accelerated approval of entospletinib by the U.S. Food and Drug Administration (FDA) as a treatment for patients newly diagnosed with NPM1-mutated AML who are fit for intensive induction.

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"With the initiation of this trial, we are taking an important step forward for patients with AML, a form of blood cancer that has been difficult to treat historically," said Norbert Bischofberger, Ph.D., president and chief executive officer of Kronos Bio. "Even with current therapies, about half of people newly diagnosed with NPM1-mutated AML will die from the disease within five years. The use of the novel endpoint of MRD provides a pathway to potentially bring entospletinib to patients more quickly."

Entospletinib is Kronos Bio’s lead product candidate, and the company expects to share data from the trial in the second half of 2023. The randomized, double-blind, placebo-controlled trial is designed to assess the efficacy and safety of entospletinib in combination with intensive induction and consolidation chemotherapy in approximately 180 adults who have been newly diagnosed with NPM1-mutated AML. This trial will test the hypothesis, based on robust preclinical and Phase 2 clinical data, that NPM1 mutation leads to dependency on SYK signaling. The NPM1 mutation is present in about 30% of all adult patients with AML.

"We are pleased to be participating in this trial, with the goal of improving outcomes for patients with AML," said Karamjeet S. Sandhu, M.D., assistant professor in the Department of Hematology and Hematopoietic Cell Transplantation at City of Hope, a world-renowned research and treatment organization near Los Angeles that was the first to dose a patient in the trial. "Patients with NPM1-mutated AML are in need of better treatment options, and we are excited that we are the first center to begin treating a patient in this trial."

The primary endpoint of the trial is MRD negative complete response (CR), as measured by molecular detection of mutant NPM1 alleles in bone marrow, which affords a high degree of sensitivity to detect MRD. Numerous clinical studies have shown that patients with NPM1 mutations who achieve MRD negative CR after induction chemotherapy survive longer than patients who achieve CR but have detectable MRD. If successful, this would be the first time MRD is used as the basis for seeking accelerated approval in AML.

The decision to proceed with this trial design was made after an End-of-Phase 2 discussion with the FDA. In the trial, patients will be randomized 1:1 to receive either entospletinib or placebo in combination with standard induction and consolidation chemotherapy. Remission and MRD status will be assessed after the first two cycles of chemotherapy and patients may receive up to a total of five cycles. Event-free survival (EFS) is a key secondary endpoint, and mature EFS data will potentially be used to support full approval.

Kronos Bio acquired entospletinib and another SYK inhibitor, lanraplenib, from Gilead Sciences in July 2020. As previously announced, under the agreement with Gilead, the initiation of the Phase 3 trial triggers a $29 million milestone payment from Kronos Bio to Gilead. The payment will be recorded in the fourth quarter.

Lanraplenib is being developed for the treatment of patients with relapsed/refractory FLT3-mutated AML and patients newly diagnosed with NPM1-mutated and/or​ FLT3-mutated AML ​who are older than 75 years old or are not eligible for intensive induction chemotherapy.

About Acute Myeloid Leukemia
Acute myeloid leukemia (AML) primarily affects adults and is one of the most difficult-to-treat blood cancers. AML starts in the bone marrow, impairing its ability to produce mature red blood cells, white blood cells and platelets. Without treatment, patients die within weeks to months from progressive bone marrow failure leading to infections, bleeding and heart failure. Approximately 20,000 people are diagnosed with AML in the United States each year, with the NPM1 genetic mutation found in approximately 30% of cases. Relapse in AML is common, and despite available treatments, nearly 11,000 people die from the disease each year in the United States.

About Measurable Residual Disease
Measurable residual disease (MRD) is a term that describes small numbers of leukemic cells that are still detectable during or after treatment, even when a patient has achieved complete response by standard criteria. Remaining leukemic cells in the body can become active and start to multiply, resulting in a relapse of the disease, which is fatal for most patients. Achieving MRD negativity, which is associated with longer remissions and improved survival, means that a treatment has reduced the number of leukemic cells to below the limit of detection by the most sensitive analytical methods. MRD can be detected using fluorescently labeled antibodies that recognize specific proteins on the surface of the leukemic cells (multi-parameter flow cytometry (MFC)) or by molecular methods such as DNA sequencing or polymerase chain reaction (PCR). Molecular methods are viewed as more sensitive and reliable than MFC, but require a unique mutation or DNA sequence that is only found in the leukemic cells. NPM1 mutations provide that unique sequence in patients with NPM1-mutated AML.

About Entospletinib
Kronos Bio is developing entospletinib for the frontline treatment of NPM1-mutated acute myeloid leukemia (AML). Entospletinib is a selective inhibitor targeting spleen tyrosine kinase (SYK), a critical node in a dysregulated transcription regulatory network within AML defined by persistent high expression of the transcription factors HOXA9 and MEIS1 (HOX/MEIS). Multiple AML driver mutations, including NPM1 and MLL gene rearrangements, have been associated with elevation of HOX/MEIS. Entospletinib has been investigated in more than 700 patients with a variety of hematologic malignancies, including AML, with clinical results observed in patients with AML who have NPM1 mutations and MLL rearrangements that support further development of the therapy.

On December 6, 2021 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune T-cell activating technology, reported the reopening of recruitment in the National Cancer Institute (NCI)-led Phase 2 clinical trial (NCT04287868) evaluating PDS0101 (Versamune-HPV16) in combination with two investigational immune-modulating agents in advanced HPV cancers (Press release, PDS Biotechnology, DEC 6, 2021, View Source [SID1234596490]).

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The suspension of recruitment was administrative in nature and was unrelated to any specific safety or efficacy concerns associated with the triple combination being studied. As a result, during the recruitment suspension, patients already enrolled in the study continued to receive scheduled treatment. The timing of clinical results from this trial is not expected to be affected by the pause in recruitment of new patients.

The trial is evaluating the novel triple combination in two groups of patients. Firstly, in second line treatment of recurrent or metastatic HPV-positive cancers including anal, cervical, head and neck, penile, vaginal, and vulvar cancers in patients who are naïve to checkpoint inhibitors and have not responded to at least one standard of care therapy. Secondly in third line treatment of the above recurrent or metastatic HPV-positive cancers in patients who have not responded to at least two standard of care therapies including checkpoint inhibitor treatment.

"We are pleased that the NCI, part of the National Institutes of Health, quickly obtained IRB approval to resume recruitment in this important trial. We believe the interim data demonstrated that this combination has the potential to significantly improve clinical outcomes for patients with advanced, refractory HPV16-positive cancers who have limited treatment options. Our approach of treating multiple types of cancer based on their molecular profiles rather than tissue location, may have the potential to provide safe Versamune-based treatment options to an expanded population of patients suffering from multiple types of cancer and at different stages of disease." said Dr. Lauren V. Wood, PDS Biotech’s Chief Medical Officer.

For patients interested in enrolling in this clinical study, please call NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615), email [email protected], and/or visit the website: View Source