On December 7, 2020 TG Therapeutics, Inc. (NASDAQ: TGTX), reported two triple therapy combination data presentations (Press release, TG Therapeutics, DEC 7, 2020, View Source [SID1234572320]). The first evaluated the investigational combination of umbralisib plus ublituximab (U2) plus venetoclax in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL); and the second evaluated the investigational combination of U2 plus TG-1701, the Company’s once daily, oral, BTK inhibitor, in patients with R/R CLL or B-cell lymphoma. Data from these trials were presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting and exposition. Presentation highlights are included below.

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Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "We are extremely pleased by the triple therapy data presented today demonstrating the potential of U2 with both venetoclax and our BTK inhibitor, TG-1701." Mr. Weiss continued, "Our mission continues to be to drive toward better outcomes for patients with B-cell malignancies by developing multi-drug combinations. We believe the data with these triple combinations highlights our approach of leveraging our portfolio and standard of care therapies to build on the U2 backbone with the goal of creating potentially best in class treatments for patients in need."

PRESENTATION HIGHLIGHTS:

Poster Presentation Title: A Phase 1/2 Study of Umbralisib, Ublituximab, and Venetoclax (U2-Ven) in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Regimen was administered with 3 cycles of U2 as induction in cycles 1 through 3, U2 plus venetoclax in cycles 4, 5 and 6, followed by umbralisib plus venetoclax in cycles 7 through 12 in patients with R/R CLL. Patients with centrally confirmed undetectable minimal residual disease (uMRD) in the bone marrow after cycle 12 were permitted to stop all therapy, while MRD detectable patients continued on single agent umbralisib.
43 patients have been treated as of the data cutoff with 58% of patients previously exposed to a BTK inhibitor
Among evaluable patients, ORR was 77% (30/39) after cycle 3 (U2 only), 100% (31/31) after cycle 7, and 100% (27/27) after cycle 12
Among the 27 patients who finished 12 cycles of therapy:
• 41% achieved Complete Response (CR) by iwCLL criteria
• 96% achieved undetectable MRD in the peripheral blood
• 77% achieved undetectable MRD in the bone marrow
At a median follow up of 15.6 months (n=43), only 1 patient has progressed 10 months after stopping treatment
Grade 3/4 adverse events occurring in > 5% of patients were neutropenia (21%), leukopenia (12%), infusion related reactions (7%), anemia (5%), and diarrhea (5%). No TLS events were observed during venetoclax administration, with one TLS event occurring prior to venetoclax administration.
Poster Presentation Title: Clinical Activity of TG-1701, As Monotherapy and in Combination with Ublituximab and Umbralisib (U2), in Patients with B-Cell Malignancies

A total of 102 patients with R/R CLL or b-cell lymphoma have been treated with TG-1701, with patients receiving monotherapy in the dose-escalation cohort (n=25) or in the 200 mg dose-expansion cohort (n=61), or TG-1701 in combination with U2 in the dose escalation cohort (n=16)
TG-1701 monotherapy was well tolerated and the maximum tolerated dose was not reached up through 400 mg QD
Grade 3/4 adverse events (AE) occurring in >10% of patients treated with TG-1701 monotherapy were limited and included ALT increase (12%), all of which were patients treated with 400 mg QD. At the target single-agent Phase 2 dose of 200mg (QD) (n=61), AEs of special interest included Grade 3 hypertension (1.6%), atrial fibrillation (1.6%), and no instances of major bleeding observed. Grade 3/4 AEs occurring in >10% of patients treated with U2+1701 were ALT increase (25%), AST increase (19%) and neutropenia (12%).
At a median follow up of 7 months in the 200 mg QD monotherapy expansion cohorts, preliminary overall response rates (ORR) were: 95% (19/20) in CLL, 50% (6/12) in mantle cell lymphoma (MCL), and 95% (18/19) in Waldenstrom macroglobulinemia (WM)
At a median follow up of 12 months, the 1701+U2 dose escalation (using doses of 100mg to 300 mg QD of TG-1701) resulted in 79% ORR, with 22% CR rate across patients with WM, CLL, marginal zone lymphoma (MZL), diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) (n=14)
Data presented at ASH (Free ASH Whitepaper) 2020 will be available on the Publications page of the Company’s website at View Source

CONFERENCE CALL REPLAY INFORMATION
The Company hosted a conference call on November 5, 2020, with leading investigators from the UNITY-NHL and UNITY-CLL trials to discuss the data included in the ASH (Free ASH Whitepaper) 2020 abstracts. A recording of the conference call is available for replay at View Source

On December 7, 2020 Teneobio, Inc., a clinical stage biotech company focused on discovery and development of novel multi-specific biotherapeutic antibodies, reported initial results of a Phase I trial (View Source) evaluating TNB-383B in Relapsed Refractory Multiple Myeloma (R/R MM) on December 5 at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Conference (Press release, TeneoBio, DEC 7, 2020, View Source;utm_medium=rss&utm_campaign=teneobio-reports-initial-data-phase-study-of-tnb-383b-in-relapsed-refactory-multiple_myeloma [SID1234572319]). TNB-383B is a fully human bispecific antibody that targets BCMA on the surface of multiple myeloma (MM) cells and CD3 on the surface of T cells in order to trigger lysis of MM cells in MM patients. The ongoing open-label multi-center trial is designed to assess the safety, pharmacokinetics and preliminary efficacy of TNB-383B administered intravenously once every 21 days.

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TNB-383B demonstrated a favorable safety profile in patients with R/R MM and achieved an overall response rate (ORR) of 80% at doses ≥ 40 mg every three weeks (QW3). The most common adverse events were cytokine release syndrome (CRS), fatigue, headache, anemia, infection, and nausea. Notably, at all doses, CRS was limited to Grade 1-2, with no patient experiencing a Grade 3 CRS. No step-dosing or dose splitting was necessary in any patient. Among the responders, over 75% had very good partial response (VGPR) or better. The median Time to Response (TTR) was 3 weeks (1 cycle) and responses deepened with additional time on therapy. The multi-center escalation and expansion cohorts are ongoing so that the median Duration of Response (DOR) has not been reached.

"Immunotherapy represents the next frontier in the management of myeloma, with many different approaches being explored in clinical trials. The results with TNB-383B have been very promising with high response rates in patients with relapsed refractory myeloma and very manageable toxicity that allows for outpatient management of these patients," said Dr. Shaji Kumar of Mayo Clinic, Rochester, and one of the Principal Investigators on this trial. "We are pleased to announce these compelling initial results. The safety profile and response rates we have seen in this initial trial validate our differentiated CD3 platform and support further development of TNB-383B in R/R MM patients," said Ben Buelow, Teneobio’s Chief Medical Officer. "In addition to TNB-383B, we look forward to advancing multiple CD3 engaging bi-specific antibodies into the clinic, both in hematologic malignancies and solid tumors."

About TNB-383B

TNB-383B is a fully human bispecific monoclonal antibody being developed for MM. TNB-383B was designed to bind to BCMA with high affinity and simultaneously result in T-cell binding/activation to cause destruction of tumor cells accompanied by markedly attenuated cytokine production. TNB-383B is being developed in collaboration with AbbVie Inc.

On December 7, 2020 Arch Oncology, Inc., a clinical-stage immuno-oncology company focused on the discovery and development of anti-CD47 antibody therapies, reported that the first patient has been dosed in a new Phase 1/2 clinical trial for AO-176 in relapsed/refractory multiple myeloma (Press release, Arch Oncology, DEC 7, 2020, View Source;utm_medium=rss&utm_campaign=arch-oncology-announces-first-patient-dosed-in-phase-1-2-clinical-trial-of-anti-cd47-antibody-ao-176-in-multiple-myeloma [SID1234572317]). AO-176 is an anti-CD47 antibody with a potential best-in-class profile that works by blocking the "don’t eat me" signal and also by directly killing tumor cells, with preferential binding to tumor versus normal cells. In preclinical myeloma models involving large tumors, AO-176 has demonstrated promising activity as a single agent as well as in combination with standard approved therapies used to treat this disease.

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"We are excited to begin dosing patients in our second clinical trial for AO-176," said Julie Hambleton, M.D., Interim President and Chief Executive Officer of Arch Oncology. "This is an important milestone for AO-176 and for patients as this is the first dedicated trial of an anti-CD47 antibody exclusively in patients with multiple myeloma. In our first clinical trial of AO-176, we saw encouraging anti-tumor activity as a single agent in patients with solid tumors and we are excited to evaluate our therapy for patients with multiple myeloma. With this second clinical trial initiated, we are making progress advancing AO-176 for both solid tumors and hematologic malignancies as we aim to deliver new cancer treatments to broader groups of patients."

Paul Richardson, M.D., Director of Clinical Research at the Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute and Co-Principal Investigator for this clinical trial, commented, "Research shows AO-176 has a highly-differentiated mechanism among this promising new class of anti-CD47 agents. We look forward to evaluating AO-176 as a monotherapy and in combination with standard therapies for patients with relapsed and refractory multiple myeloma. Patients who have progressed despite multiple lines of prior treatment urgently need new treatment options, and we are eager to assess the safety and preliminary efficacy profile of this exciting novel agent."

This open-label, multi-center, dose-escalation Phase 1/2 trial is evaluating the safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy of AO-176 in patients with relapsed/refractory multiple myeloma. Up to 100 patients whose disease has progressed following at least three prior lines of treatment will be enrolled. In Phase 1, patients enrolled in up to four dose-escalation cohorts will receive AO-176 monotherapy. Next, patients will receive AO-176 in combination with dexamethasone and bortezomib. Then, in Phase 2, patients will receive a recommended dose of AO-176 in combination with dexamethasone and bortezomib to evaluate the safety and preliminary efficacy of this combination.

Parameswaran Hari, MD, MRCP, MS, Chief of the Division of Hematology and Oncology in the Department of Medicine and Professor at Medical College of Wisconsin and Principal Investigator for this clinical trial, added, "We are pleased to dose the first patient in this new multiple myeloma clinical trial. As we treat patients with multiple myeloma, an incurable disease for many patients, we look forward to evaluating AO-176 as a potential new treatment option for patients living with this disease. Given the mechanism and profile of AO-176, we envision additional future combinations with AO-176 to evaluate as future treatments for patients."

Recent Preclinical Data Presentations on AO-176 in Multiple Myeloma

Event: ASH (Free ASH Whitepaper) Annual Meeting & Exposition 2020

Date: December 5, 2020 7:00 am – 3:30 pm PT
Abstract Title: Pre-clinical Combination of AO-176, a Highly Differentiated Clinical Stage CD47 Antibody, with Either Azacitidine or Venetoclax Significantly Enhances DAMP Induction and Phagocytosis of Acute Myeloid Leukemia

Date: December 6, 2020 7:00 am – 3:30 pm PT
Abstract Title: AO-176, a Highly Differentiated Clinical Stage Anti-CD47 Antibody, Exerts Potent Anti-Tumor Activity in Preclinical Models of Multiple Myeloma as a Single Agent and in Combination With Approved Therapeutics

About AO-176

AO-176 is a humanized anti-CD47 IgG2 antibody with a potential best-in-class profile. AO-176 is highly differentiated, with the potential to improve upon the safety and efficacy profile relative to other agents in this class of innate checkpoint inhibitors. AO-176 works by blocking the "don’t eat me" signal, the standard mechanism of anti-CD47 antibodies. Beyond blocking this signal, AO-176 has additional mechanisms, including directly killing tumor cells and inducing DAMPs (Damage Associated Molecular Patterns), resulting in Immunogenic Cell Death. Importantly, AO-176 binds preferentially to tumor cells, instead of to normal cells, and binds even more potently to tumors in their acidic microenvironment (low pH). Publications and presentations on AO-176 can be found at View Source

AO-176 is being evaluated in Phase 1/2 clinical trials for the treatment of patients with select solid tumors and multiple myeloma, both as monotherapy and in combination with standard therapies. In a Phase 1 trial in solid tumors, AO-176 demonstrated encouraging safety and evidence of anti-tumor activity when administered as a single agent. Additional information about these trials may be found at www.clinicaltrials.gov using the trial identification number NCT03834948 (solid tumors) or NCT04445701 (multiple myeloma).

On December 7, 2020 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS"), a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, and 3D Medicines Inc. ("3DMed"), a China-based biopharmaceutical company developing next-generation immuno-oncology drugs, reported that they have entered into an Exclusive License Agreement granting rights to 3DMed to develop and commercialize SELLAS’ lead late-stage clinical candidate, galinpepimut-S (GPS), as well as its next generation heptavalent immunotherapeuatic, GPS+, which is at preclinical stage, across all therapeutic and diagnostic uses in the Greater China territory (mainland China, Hong Kong, Macau and Taiwan) (Press release, Sellas Life Sciences, DEC 7, 2020, View Source [SID1234572315]). SELLAS retains sole rights to GPS and GPS+ outside of the Greater China area. Potential payments to SELLAS under the agreement could total $202 million in license fees and milestone payments, not including future royalties.

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GPS is an innovative potentially first-in-class WT1-targeting artificially engineered synthetic heteroclitic immunotherapeutic in development for hematological malignancies and solid tumors characterized by an overexpression of the WT1 (Wilms Tumor Protein) antigen. In 2020, SELLAS commenced a Phase 3 clinical trial (the REGAL study) of GPS in patients with acute myeloid leukemia (AML) who have reached second complete remission.

"This agreement represents an important achievement for SELLAS as we continue to progress our clinical development program for GPS. We are excited to collaborate with 3DMed on the development and commercialization of GPS in China. 3DMed, an ambitious biopharmaceutical company with development, registration and commercialization capabilities with a focus on developing next-generation immuno-oncology drugs and an experienced team, is a wonderfully complementary partner in bringing the potential of GPS to patients in Greater China. The collaboration begins to put in place essential elements designed to expand the reach of GPS outside the United States, following potential regulatory approvals," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "The completion of this agreement, amid the COVID-19 pandemic, shows the execution strength of our team. We are also pleased to have strengthened our balance sheet with the non-dilutive upfront license fee of $7.5 million with other potential milestones over the next several months."

"We are very pleased to execute this exclusive license agreement of GPS and GPS+ in the Greater China area with SELLAS," said John Gong, M.D., Ph.D., Chairman and Chief Executive Officer of 3DMed. "GPS and GPS+ are innovative therapeutics and, with growing need for new treatments, GPS’ potential use as a monotherapy as well as in combination with our Envafolimab, an innovative subcutaneous PD-L1 antibody which we have just filed for marketing approval in China, could create significant value for both 3DMed and SELLAS. This partnership highly reflects the vision of 3DMed to help patients with cancer to live longer and better. We believe that the addition of the GPS and GPS+ assets to our clinical portfolio is an important synergistic and strategic step for 3DMed as this partnership will expand our company’s therapeutic area expertise and improve our competitiveness."

Under the financial terms of the agreement:

SELLAS could potentially receive up to $202 million in license and milestone payments during the course of the collaboration, not including future royalties.

SELLAS will receive payment of an upfront license fee of $7.5 million payable this quarter and is eligible to receive potential near-term milestones totaling up to an additional $8.0 million.

SELLAS is entitled to receive royalties on Chinese sales on a tiered basis, dependent on sales levels, ranging from the high single to low double-digit percentage.

3DMed will be responsible for the costs of all development and regulatory activity for Greater China.
Torreya acted as a financial advisor to SELLAS.

About Galinpepimut -S

Galinpepimut-S (GPS) is an innovative and potentially first in class heteroclitic immunotherapy targeting Wilms Tumor 1 (WT1) which is ranked as the #1 cancer antigen by the National Cancer Institute. GPS consists of a mixture of four peptide fragments derived from the WT1 whole-length protein, two of which are artificially mutated by design utilizing the heteroclitic technology principle, aiming at optimal immunogenicity and mitigation of immune tolerance by the vaccinated host. GPS targets 25 carefully selected and validated WT1 antigenic epitopes and is applicable across the majority of HLA types on a global scale. GPS has an off-the-shelf lyophilized formulation and is administered subcutaneously to patients. GPS is optimally positioned either as a maintenance monotherapy in various clinical settings where the residual disease burden after prior debulking is very low, such as complete remission status in AML, or in combination with other therapeutic agents, most notably immune checkpoint inhibitors. In clinical trials, GPS has shown, both as monotherapy and in combination with checkpoint inhibitors, high rates of induction of immunogenicity and the abiitiy to delay disease relapse with an overall low incidence of adverse events, mainly low grade local inoculation reactions, and is currently being evaluated in a Phase 3 clinical trial as monotherapy for AML patients who are in second complete remission and in Phase 1 and Phase 2 studies in combination with checkpoint inhibitors. GPS was granted Orphan Drug Product Designations from the U.S. Food and Drug Administration (FDA), as well as Orphan Medicinal Product Designations from the European Medicines Agency, in AML, malignant pleural mesothelioma (MPM), and multiple myeloma (MM), as well as Fast Track Designation for AML, MPM, and MM from the FDA.

On December 7, 2020 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported positive interim Phase 1 data on HB-201, its replicating monotherapy for the treatment of HPV16+ cancers (Press release, Hookipa Pharma, DEC 7, 2020, View Source [SID1234572314]). The results are from the initial dose escalation cohorts of an ongoing Phase 1/2 clinical trial (NCT04180215) evaluating HB- 201 as therapy for patients with advanced HPV16+ metastatic cancers. HOOKIPA will host a conference call and live audio webcast today at 8:30am EST.

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These interim data support proof of concept for HB-201 monotherapy as a new immunotherapy for a difficult-to-treat patient population with multiple prior treatment failures. As of December 4, 2020, 22 patients have been enrolled in the first two cohorts, of which 15 were eligible for evaluation. Among the 15 evaluable patients, 11 patients had relapsed/refractory metastatic squamous cell head and neck cancer (HNSCC), all of whom had progressed on prior therapy with a PD1 inhibitor. As per RECIST1.1, in patients with third-line or later HNSCC, HB-201 demonstrated an unconfirmed response rate of 18% (one unconfirmed complete responder and one unconfirmed partial responder) and a 73% disease control rate (six stable disease patients, in addition to the two unconfirmed responses referenced above).

Median progression-free survival (mPFS) is currently measured at 72 days and is ongoing. Although not demonstrated in a head-to-head trial, these HB-201 results, in more heavily treated patients who progressed on a PD1 inhibitor, compare favorably to the benchmark data of a 13% overall response rate and a 60-day mPFS1 for nivolumab in second-line PD1 inhibitor naïve HNSCC patients, based on data published from the third-party registrational study.

Encouraging efficacy signals were also seen in the more heterogeneous group of all 15 evaluable patients with HPV16+ cancers treated in this trial, comprised of the 11 HNSCC patients summarized above and four other patients with HPV16+ cervical, anal, or vaginal tumors. In these 15 patients, HB-201 demonstrated an unconfirmed response rate of 13%, a disease control rate of 67%, and a median PFS that is also ongoing and currently measured at 72 days.

"We are thrilled by these preliminary HB-201 data, as they show the potential of our arenavirus platform in oncology and represent future possible therapeutic options for patients with HPV16+ cancers," said Joern Aldag, Chief Executive Officer of HOOKIPA. "The early response with our single-vector HB-201 therapy highlights the potential of our replicating technology, especially as we explore alternating two-vector therapy with HB-201/HB-202, and a future combination with a PD-1 inhibitor, both of which we hope will deliver even greater responses."

Of the 22 patients enrolled on the trial as of December 4th, preliminary safety data show that HB-201 has been well tolerated. Treatment-related adverse events were reported by 41% of participants. Almost all reported events were Grade 1 and 2 and included fatigue, fever, decreased appetite, constipation, nausea, and itching. Only one serious adverse event deemed related to HB-201, Grade 3 fatigue leading to hospitalization, has been reported to date. The rate of adverse events was consistent regardless of administration route.

"There remains a considerable unmet need in the treatment of HPV16+ cancers, particularly those in head and neck, and these preliminary data on HB-201 as a monotherapy are encouraging," said Alan L. Ho, MD, PhD, a medical oncologist at Memorial Sloan Kettering Cancer Center and an investigator on the trial.

About the trial
This Phase 1/2 clinical trial is an open-label dose-escalation and dose-expansion trial in individuals with treatment-refractory HPV16+ cancers. The primary endpoint of the Phase 1 trial is a recommended Phase 2 dose based on safety and tolerability. Secondary endpoints include anti-tumor activity as defined by RECIST 1.1, immunogenicity, safety, and tolerability.

The trial is designed to evaluate different dose levels of HB-201 as a single-vector therapy, as an alternating two-vector therapy together with HB-202, and in combination with a PD-1 inhibitor. Dosing frequencies of every three weeks and every two weeks are being explored during dose escalation.

Since the trial opened in December 2019, 22 patients with metastatic HPV16+ tumors have been enrolled in the HB-201 monotherapy segment: 17 with squamous cell head and neck tumors, two with cervical, one with nasopharyngeal, one with anal, and one with vaginal. Patients had received at least two prior therapies, and most patients progressed on a PD-1 inhibitor, a platinum-containing regimen or both. Enrollment is ongoing and HOOKIPA expects to share additional interim clinical data from the HB-201/HB-202 alternating two-vector therapy segment in mid-2021.

About HB-201/HB-202
HB-201 and HB-202 are engineered using HOOKIPA’s replicating arenaviral vector platform. They are designed to use different arenavirus backbones (LCMV for HB- 201 and PICV for HB-202), while expressing the same antigen, an E7/E6 fusion protein derived from HPV16. In pre-clinical studies, alternating administration of HB-202 and HB-201 resulted in a ten-fold increase in immune response and better disease control than either compound alone.

Conference call
HOOKIPA will host a conference call and live audio webcast today at 8:30am EST to discuss the HB-201 monotherapy data from the interim analysis of the Phase 1 trial. To access the conference call, please dial +1 877 870 9135 (from the US) or +44 2071 928338 (international) and refer to conference ID 9747865. The webcast and the presentation will be available within the Investors & Media section of HOOKIPA’s website at View Source An archived replay will be accessible for 30 days following the event.

About Human Papillomavirus
Human Papillomavirus, or HPV, is estimated to cause about 5 percent of the worldwide burden of cancers. This includes approximately 99 percent of cases in cervical, up to 60 percent of head and neck, 70 percent of vaginal and 88 percent of anal cancers.

The majority of these cancers are caused by the HPV serotype 16. Most infections with HPV are cleared from the body with no lasting consequences. However, in some cases, HPV DNA becomes integrated into chromosomal DNA. When host cells take up this DNA, they express the HPV E6 and E7 proteins. This uptake can potentially lead to cancer since expression of these proteins leads to alterations in cell cycle control, which in turn predisposes these cells to become cancerous.