On May 26, 2022 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported promising initial data from a Phase 1/2 study evaluating selinexor in combination with ruxolitinib in patients with treatment-naïve myelofibrosis and subgroup analyses and molecular classification data from the SIENDO study evaluating selinexor in endometrial cancer (Press release, Karyopharm, MAY 26, 2022, View Source [SID1234615090]). These data, and four additional abstracts, will be presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO 2022), being held in Chicago from June 3-7, 2022.

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Results from Phase 1/2 Study Evaluating Selinexor in Combination with Ruxolitinib in Patients with Treatment-Naïve Myelofibrosis
The initial data to be presented at ASCO (Free ASCO Whitepaper) 2022 were based on the Phase 1 portion of the Phase 1/2 study evaluating the safety and preliminary efficacy of once-weekly selinexor in combination with standard dose ruxolitinib in patients with treatment-naïve myelofibrosis. As of May 1, 2022, 15 patients had been dosed with one of two dose levels of selinexor, 40 mg (n=3) and 60 mg (n=12), in combination with ruxolitinib 15/20 mg BID.

Seventy-five percent of evaluable patients (6 out of 8) demonstrated ≥35% reduction in spleen volume (SVR35) at week 12. Five out of 10 transfusion independent patients who had at least eight weeks of treatment maintained stable hemoglobin (± 2g/dL) or improved hemoglobin level (>2g/dL increase) at last follow up. In addition, all of the evaluable 7 patients, who had been at least 12 weeks on treatment and had complete data, experienced rapid reductions in their symptom scores with 3 of 7 patients having ≥50% reduction (TSS50) at week 12.

There were two patients who discontinued therapy in the trial: One patient discontinued after 5 months of therapy due to unrelated AEs (dizziness, atrial fibrillation, and pulmonary hypertension) and another patient discontinued after 8 weeks of therapy due to progression to AML.

The combination of selinexor and ruxolitinib was generally well-tolerated and manageable. No dose-limiting toxicities were reported at either dose level of selinexor, and the most common adverse event (AE) was nausea (40%), the majority of which were grade 1/2. Both the 40 mg and 60 mg dose levels were generally well tolerated, with the most common reported Grade 3-4 treatment-emergent AEs being thrombocytopenia (27%), anemia (20%), neutropenia (20%) and atrial fibrillation (20%). Hematologic adverse events were reversible with dose interruptions and reductions.

The trial is currently enrolling patients in the Phase 1b dose expansion part of the study.

"Despite tremendous improvements in the lives of patients with myelofibrosis with the introduction of the JAK inhibitors, there remains a significant unmet need. We are excited to develop a novel combination that may further improve outcomes for these patients," said Reshma Rangwala, MD, PhD, Chief Medical Officer of Karyopharm. "Following the promising initial results of selinexor in relapsed and refractory myelofibrosis, we are very excited with these preliminary data in treatment-naïve myelofibrosis patients in combination with ruxolitinib, with encouraging results seen across multiple measures including spleen volume reductions, improvements in symptom scores and management of anemia. We look forward to sharing these promising initial data with the broader medical and scientific community at ASCO (Free ASCO Whitepaper) 2022."

SIENDO Study Subgroup Analysis
A preliminary analysis of exploratory subgroups of the SIENDO study assessed four distinct molecular subtypes in endometrial cancer using The Cancer Genome Atlas (TCGA), one of the accepted gynecologic oncology algorithms that is used to calculate prognostic risk scores. This analysis indicated that patients with p53 wild-type endometrial cancer treated with selinexor showed a median progression-free survival of 13.7 months compared to 3.7 months for patients on placebo.

"These data suggest that selinexor may provide meaningful benefit to patients with p53 wild-type endometrial cancer and reinforce the need to further evaluate selinexor’s potential in a registration-enabling Phase 3 study, that we are planning to initiate in the second half of this year," added Dr. Rangwala.

Details for the ASCO (Free ASCO Whitepaper) 2022 selinexor presentations are as follows:
Oral Presentation

Title: Randomized phase III study of maintenance selinexor versus placebo in endometrial cancer (ENGOT – EN5/GOG-3055/SIENDO): Impact of subgroup analysis and molecular classification
Presenter: Vicky Makker, Memorial Sloan Kettering Cancer Center
Abstract #: 5511
Date and time: Tuesday, June 7, 2022, 9:48 a.m. – 10:00 a.m. EDT
Session: Clinical Science Symposium/Molecular-Based Treatment for Endometrial Cancer

Poster Presentations

Title: A phase 1, open-label, dose-escalation study of selinexor plus ruxolitinib in patients with treatment-naïve myelofibrosis
Presenter: Haris Ali, City of Hope
Abstract #: 7060
Date and time: Saturday, June 4, 2022, 9:00 a.m. – 12:00 p.m. EDT
Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Title: Phase Ib trial of selinexor (SEL) in combination with nivolumab (NIVO) alone or nivolumab plus ipilimumab (NIVO+IPI) in patients (pts) with advanced malignancies: The renal cell carcinoma (RCC) experience.
Presenter: Omar Alhalabi, The University of Texas MD Anderson Cancer Center
Abstract #: 4551
Date and time: Saturday, June 4, 2022, 2:15 p.m. – 5:15 p.m. EDT
Session: Genitourinary Cancer–Kidney and Bladder

Title: Phase 1b study of weekly split-dose selinexor in soft tissue sarcoma (STS)
Presenter: Abdulazeez Salawu, University Health Network
Abstract #: 11563
Date and time: Sunday, June 5, 2022, 9:00 a.m. – 12:00 p.m. EDT
Session: Sarcoma

Title: Digital monitoring and assessments in patients with glioblastoma
Presenter: Yasaman Damestani, Karyopharm Therapeutics, Inc.
Abstract #: 2045
Date and time: Sunday, June 5, 2022, 9:00 a.m. – 12:00 p.m. EDT
Session: Central Nervous System Tumors

Title: Phase Ib study of selinexor and eribulin combination in advanced solid tumors and triple-negative breast cancer
Presenter: Blessie Elizabeth Nelson, University of Texas MD Anderson Cancer Center
Abstract #: 3108
Date and time: Sunday, June 5, 2022, 9:00 a.m. – 12:00 p.m. EDT
Session: Developmental Therapeutics–Molecularly Targeted Agents and Tumor Biology

About the SIENDO Study
The Phase 3 SIENDO study (ENGOT-EN5/GOG-3055) is a multicenter, blinded, placebo-controlled, randomized study evaluating the efficacy and safety of selinexor as a maintenance therapy following chemotherapy in patients with advanced or recurrent endometrial cancer. The study enrolled 263 patients with primary stage IV or recurrent disease who had a partial or complete response after at least 12 weeks of standard taxane-platinum combination chemotherapy. Patients were randomized 2:1 to receive either maintenance therapy of 80mg of selinexor taken once weekly, or placebo, until disease progression. The primary endpoint of the study was statistically significant improvement of progression-free survival compared to placebo. The goal of the study was to demonstrate a hazard ratio of 0.6 or better. In partnership with Karyopharm, the study was initiated by the European Network for Gynaecological Oncological Trial (ENGOT) group. In the U.S., the collaboration includes the GOG Foundation, Inc. (GOG-F).

About XPOVIO (selinexor)
XPOVIO is a first-in-class, oral exportin 1 (XPO1) inhibitor and the first of Karyopharm’s Selective Inhibitor of Nuclear Export (SINE) compounds to be approved for the treatment of cancer. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein XPO1. XPOVIO is approved in the U.S. and marketed by Karyopharm in multiple oncology indications, including: (i) in combination with Velcade (bortezomib) and dexamethasone (XVd) in patients with multiple myeloma after at least one prior therapy; (ii) in combination with dexamethasone in patients with heavily pre-treated multiple myeloma; and (iii) in patients with diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. XPOVIO (also known as NEXPOVIO in certain countries) has received regulatory approvals in a growing number of ex-U.S. territories and countries, including Europe, the United Kingdom, China, South Korea, Singapore and Israel, and is marketed in those areas by Karyopharm’s global partners. Selinexor is also being investigated in several other mid- and late-stage clinical trials across multiple high unmet need cancer indications, including multiple myeloma, endometrial cancer and myelofibrosis. For more information about Karyopharm’s products or clinical trials, please contact the Medical Information department at:

Tel: +1 (888) 209-9326
Email: [email protected]

XPOVIO (selinexor) is a prescription medicine approved:

In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (XVd).
In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti–CD38 monoclonal antibody (Xd).
For the treatment of adult patients with relapsed or refractory diffuse large B–cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
SELECT IMPORTANT SAFETY INFORMATION
Warnings and Precautions

Thrombocytopenia: Monitor platelet counts throughout treatment. Manage with dose interruption and/or reduction and supportive care.
Neutropenia: Monitor neutrophil counts throughout treatment. Manage with dose interruption and/or reduction and granulocyte colony–stimulating factors.
Gastrointestinal Toxicity: Nausea, vomiting, diarrhea, anorexia, and weight loss may occur. Provide antiemetic prophylaxis. Manage with dose interruption and/or reduction, antiemetics, and supportive care.
Hyponatremia: Monitor serum sodium levels throughout treatment. Correct for concurrent hyperglycemia and high serum paraprotein levels. Manage with dose interruption, reduction, or discontinuation, and supportive care.
Serious Infection: Monitor for infection and treat promptly.
Neurological Toxicity: Advise patients to refrain from driving and engaging in hazardous occupations or activities until neurological toxicity resolves. Optimize hydration status and concomitant medications to avoid dizziness or mental status changes.
Embryo–Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential and males with a female partner of reproductive potential, of the potential risk to a fetus and use of effective contraception.
Cataract: Cataracts may develop or progress. Treatment of cataracts usually requires surgical removal of the cataract.
Adverse Reactions

The most common adverse reactions (≥20%) in patients with multiple myeloma who receive XVd are fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, decreased weight, cataract and vomiting. Grade 3–4 laboratory abnormalities (≥10%) are thrombocytopenia, lymphopenia, hypophosphatemia, anemia, hyponatremia and neutropenia. In the BOSTON trial, fatal adverse reactions occurred in 6% of patients within 30 days of last treatment. Serious adverse reactions occurred in 52% of patients. Treatment discontinuation rate due to adverse reactions was 19%.
The most common adverse reactions (≥20%) in patients with multiple myeloma who receive Xd are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea and upper respiratory tract infection. In the STORM trial, fatal adverse reactions occurred in 9% of patients. Serious adverse reactions occurred in 58% of patients. Treatment discontinuation rate due to adverse reactions was 27%.
The most common adverse reactions (incidence ≥20%) in patients with DLBCL, excluding laboratory abnormalities, are fatigue, nausea, diarrhea, appetite decrease, weight decrease, constipation, vomiting, and pyrexia. Grade 3–4 laboratory abnormalities (≥15%) are thrombocytopenia, lymphopenia, neutropenia, anemia, and hyponatremia. In the SADAL trial, fatal adverse reactions occurred in 3.7% of patients within 30 days, and 5% of patients within 60 days of last treatment; the most frequent fatal adverse reactions were infection (4.5% of patients). Serious adverse reactions occurred in 46% of patients; the most frequent serious adverse reaction was infection (21% of patients). Discontinuation due to adverse reactions occurred in 17% of patients.

On May 26, 2022 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies (tumor infiltrating lymphocyte, TIL, and peripheral-blood lymphocyte, PBL), reported clinical results from its C-144-01 clinical study in patients with advanced (unresectable or metastatic) melanoma who progressed on prior anti-PD-1/L1 therapy, and if BRAF mutation positive, also on prior BRAF or BRAF/MEK inhibitor therapy (Press release, Iovance Biotherapeutics, MAY 26, 2022, View Source [SID1234615089]).

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In registrational Cohort 4 (n=87), the objective response rate (ORR) by an independent review committee (IRC) using RECIST 1.1 criteria was 29% (95% confidence interval (CI): 19.5%, 39.4%) with three complete responses and 22 partial responses. The median duration of response (DOR) in Cohort 4 by IRC was 10.4 months with a median study follow-up of 23.5 months. These data demonstrate that one-time treatment with lifileucel therapy may provide meaningful benefit in heavily pre-treated patients. Cohort 4’s findings are supported by Cohort 2 (n=66), where the ORR by IRC was 35% (95% CI: 23.5%, 47.6%) with five complete responses and 18 partial responses. The median DOR in Cohort 2 was not reached with a median study follow-up of 36.6 months. The ORR by IRC for pooled patients (n=153) from both Cohorts 2 and 4 was 31% (95% CI: 24.1%, 39.4%) and median DOR was not reached at a median study follow up of 27.6 months.

Patients in Cohort 4 exhibited higher baseline disease burden in comparison to patients in Cohort 2, including a substantially higher proportion of patients with elevated baseline lactate dehydrogenase (LDH) levels, a well-known negative prognostic factor (64.4% versus 40.9%), as well as a greater number of tumor lesions at baseline (83.9% versus 65.2% with more than three lesions). In addition, patients in Cohort 2 also had approximately half the cumulative duration of anti-PD-1 therapy before lifileucel therapy in comparison to patients in Cohort 4. Reduced duration of prior anti-PD-1 therapy was shown1 to be associated with an increase of DOR to lifileucel. The treatment-emergent adverse event profile in both cohorts was consistent with the underlying disease and known adverse event profiles of non-myeloablative lymphodepletion and interleukin-2 (IL-2) and was also consistent between Cohorts 2 and 4.

Iovance plans to present additional data from Cohorts 2 and 4 at a medical meeting in the second half of 2022. The planned BLA submission for lifileucel in advanced melanoma using these data remains on track for August 2022.

Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, "We are pleased to report positive results for lifileucel from the registrational Cohort 4 data from the C-144-01 study. Iovance is proceeding towards submission of a BLA in August 2022 using these results as well as the potentially supportive results from Cohort 2 of the C-144-01 study. We thank our patients, their families, and our investigators, employees, shareholders, and advocates for their support. We look forward to reporting further progress with our lifileucel BLA and launch preparations in 2022."

Friedrich Graf Finckenstein, M.D., Chief Medical Officer of Iovance, commented, "Treatment of melanoma patients after failure of anti-PD-1 therapy remains a critical unmet medical need without an approved therapeutic option. Available care for metastatic melanoma patients in this setting is chemotherapy, which has been reported to offer a four to ten percent response rate with a very short median duration of response. We are excited about the results from registrational Cohort 4 of the C-144-01 study and the potential of lifileucel as a new treatment option for these patients."

Webcast and Conference Call

Iovance will host a conference call today at 5:00 p.m. ET to discuss the updates for the C-144-01 clinical study. The conference call dial-in numbers are 1 (844) 646-4465 (domestic) or 1 (615) 247-0257 (international) and the conference ID is #5945054. The live webcast can be accessed in the Investors section of the company’s website at View Source The archived webcast will be available for a year in the Investors section at www.iovance.com.

1Larkin, J.M.G., et al., Lifileucel (LN-144), a Cryopreserved Autologous Tumor Infiltrating Lymphocyte (TIL) Therapy in Patients with Advanced Melanoma: Evaluation of Impact of Prior Anti–PD-1 Therapy, ASCO (Free ASCO Whitepaper) Annual Meeting, June 6, 2021. Presentation.

On May 26, 2022 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported additional efficacy data from the pivotal SORAYA study evaluating mirvetuximab soravtansine (mirvetuximab) monotherapy in patients with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with Avastin (bevacizumab) and an integrated safety summary of single-agent mirvetuximab across multiple studies in patients with FRα-positive recurrent ovarian cancer (Press release, ImmunoGen, MAY 26, 2022, View Source [SID1234615088]). These findings will be highlighted in two posters at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is being held June 3-7, 2022. The data from SORAYA have been selected for the Best of ASCO (Free ASCO Whitepaper) Program.

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"Treatment options remain limited for patients with platinum-resistant ovarian cancer, particularly for those who have received prior bevacizumab, and are associated with low response rates, short durations of response, and considerable toxicities," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. "We believe these data further reinforce mirvetuximab’s potential to become a new standard of care in this population. With our biologics license application accepted and filed by FDA with Priority Review, we look forward to bringing mirvetuximab to patients with the most urgent need later this year."

CHARACTERIZATION OF ANTI-TUMOR ACTIVITY IN THE SORAYA STUDY
SORAYA enrolled 106 platinum-resistant ovarian cancer patients with high FRα expression who have been previously treated with 1 to 3 prior systemic treatments, at least one of which included bevacizumab. The primary endpoint was confirmed objective response rate (ORR) as assessed by investigator. Secondary endpoints included duration of response (DOR) as assessed by investigator, CA-125 response, safety and tolerability, progression-free survival (PFS), overall survival (OS); ORR, DOR, and PFS by blinded independent central review were sensitivity analyses. Data from SORAYA were first presented at the Society of Gynecologic Oncology (SGO) 2022 Annual Meeting; the updated analyses to be presented at ASCO (Free ASCO Whitepaper) are based on the 120-day cut-off date of April 29, 2022.

ORR by investigator was 32.4% (95% confidence interval [CI]: 23.6%, 42.2%), including 5 complete responses. Median time to response was 1.5 months (range 1.0 to 5.6) and 71.4% of patients demonstrated tumor reduction.
The disease control rate (DCR), defined as complete response (CR), partial response, or stable disease maintained for ≥12 weeks, was 51.4%.
The median DOR was 6.9 months (95% CI: 5.6, 9.7) by investigator, with 5 responders continuing on mirvetuximab as of April 29, 2022.
The median PFS assessed by investigator was 4.3 months (95% CI: 3.7, 5.2).
The preliminary median OS was 13.8 months, with 54% of the evaluable patient population event-free.
In the sensitivity analyses by blinded independent central review, outcomes were similar: ORR 30.2% (95% CI: 21.3%, 40.4%) with 6 CRs; mDOR not reached (95% CI: 5.0, NR); mPFS 5.5 months (95% CI: 3.8, 6.9).
In responders, depth and duration of response did not appear to be affected by dose reductions.
Mirvetuximab was well-tolerated, consistent with previous studies. The most common treatment-related adverse events (TRAE) included blurred vision (41% all grade, 6% grade 3+), keratopathy (29% all grade, 9% grade 3+), and nausea (29% all grade, 0% grade 3+).
TRAEs generally resolved with supportive care or, if needed, dose modifications; the discontinuation rate due to TRAEs was 9%.
Kaplan-Meier plots for PFS and OS to be included in poster.
"I believe these additional analyses from SORAYA further support mirvetuximab’s potential to become the first biomarker-directed agent indicated for patients with platinum-resistant ovarian cancer," said Ursula Matulonis, MD, Chief of the Division of Gynecologic Oncology at the Dana-Farber Cancer Institute, Professor of Medicine at the Harvard Medical School, and SORAYA Co-Principal Investigator. "The tumor reduction observed in over 70% of patients, along with the PFS curve and the preliminary median overall survival of 13.8 months, are impressive. If approved, I look forward to being able to offer mirvetuximab to my patients and continuing to support its further development in patients with ovarian cancer."

INTEGRATED SAFETY SUMMARY OF SINGLE-AGENT MIRVETUXIMAB SORAVTANSINE
This retrospective pooled analysis included 464 patients with FRα-positive, recurrent ovarian cancer across three studies: a Phase 1 first-in-human trial, the Phase 3 FORWARD I trial, and the pivotal Phase 3 SORAYA trial.

Mirvetuximab monotherapy has a differentiated safety profile consisting primarily of low-grade gastrointestinal and ocular events; adverse events generally resolved and were managed with supportive care and, if needed, dose modifications. The discontinuation rate due to TRAEs was 7%.
The most common TRAEs included blurred vision (42% all grade, 3% grade 3+), nausea (40% all grade, 2% grade 3+), diarrhea (33% all grade, 2% grade 3+), fatigue (31% all grade, 2% grade 3+), keratopathy (26% all grade, 3% grade 3+), and dry eye (22% all grade, 1% grade 3+).
Mirvetuximab monotherapy did not result in any corneal ulcers or perforations, and no patients had permanent ocular sequelae.
The majority of patients with ocular events did not require dose delay or dose reduction; <1% of patients discontinued mirvetuximab due to an ocular event.
"Having personally treated over 100 patients with mirvetuximab, I have helped my colleagues better understand how to manage the associated ocular events," said Kathleen Moore, Director of the Oklahoma TSET Phase I Program, Professor of the Section of Gynecologic Oncology at The University of Oklahoma College of Medicine, and MIRASOL Principal Investigator. "With prevention and mitigation strategies in place, patients presenting with ocular events have been able to complete their treatment, maintain their responses, and had no permanent sequelae from these events. These data demonstrate mirvetuximab’s differentiated safety profile and I look forward to the potential approval and launch later this year."

POSTER SESSION DETAILS
The following posters will be available on Saturday, June 4 in the ASCO (Free ASCO Whitepaper) Meeting Library:

Additional information can be found at www.asco.org.

ABOUT MIRVETUXIMAB SORAVTANSINE
Mirvetuximab soravtansine (IMGN853) is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin-targeting agent, to kill the targeted cancer cells.

On May 26, 2022 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that complete HB-200 Phase 1 results (NCT04180215) for single-vector HB-201 and alternating 2-vector HB-202/HB-201 in patients with advanced Human Papillomavirus 16-positive (HPV16+) cancers, including the recommended Phase 2 dose for HB-202/HB-201, will be shared in a poster presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 3-7, 2022 (Press release, Hookipa Biotech, MAY 26, 2022, https://ir.hookipapharma.com/news-releases/news-release-details/hookipa-present-complete-hb-200-phase-1-results-and-recommended [SID1234615087]). Data as of March 31, 2022 will be presented on 68 patients, 54 of whom had head and neck squamous cell carcinoma (HNSCC).

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"We look forward to sharing the full Phase 1 data results on our HB-200 program at ASCO (Free ASCO Whitepaper). The final analysis shows that HB-201 and 2-vector HB-202/HB-201 were generally well tolerated and showed anti-tumor activity in these difficult-to-treat patients. We also will share additional translational data that continue to show robust tumor-specific T cell responses from use of our HB-200 therapies," said Joern Aldag, Chief Executive Officer at HOOKIPA. "We are continuing to advance this truly novel science through the clinic, and the learnings from this phase help deepen our understanding of the potential of our technology. These insights inform our path as we advance the 2-vector HB-202/HB-201 immunotherapy into the ongoing Phase 2 HNSCC portion of the study, as well as our approach to our HB-300 program in prostate cancer."

The abstract is available on the ASCO (Free ASCO Whitepaper) website with key details noted below:

Recommended Phase 2 dose (RP2D) of HB-200 arenavirus-based cancer immunotherapies in patients with HPV16+ cancers

Abstract # 2517, Developmental Therapeutics – Immunotherapy

Poster session: Sunday, June 5, 8:00 a.m. – 11:00 a.m. CDT
Poster discussion session: Sunday, June 5, 11:30 a.m. – 1:00 p.m. CDT in Hall D2
Presenter: Siqing Fu, M.D., Ph.D., Professor of Investigational Cancer Therapeutics and principal investigator at The University of Texas MD Anderson Cancer Center
Key findings:

Single-vector HB-201 and 2-vector HB-202/HB-201 immunotherapies were generally well tolerated and showed anti-tumor activity in heavily pre-treated patients with HPV16+ head and neck cancer

HB-201 was evaluated at three dose levels, with two dosing schedules and two administration routes for safety, efficacy and immunogenicity

HB-202/HB-201 was evaluated at four dose levels and two administration routes for safety, efficacy, and the recommended Phase 2 dose

Anti-tumor activity in this heavily pre-treated patient population was observed with HB-201 and HB-202/HB-201 treatments alone, including sustained tumor control and partial responses.
About HB-202/HB-201
HB-201 and HB-202/HB-201 are HOOKIPA’s lead oncology candidates engineered with the company’s proprietary replicating arenaviral vector platform. HB-201 is a single-vector compound that uses Lymphocytic Choriomeningitis Virus as its arenaviral backbone. HB-202 is a single-vector compound that uses Pichinde Virus as its arenaviral backbone. Both express the same antigen, an E7E6 fusion protein derived from HPV16. HB-202/HB-201 is an alternating 2-vector immunotherapy designed to further focus the immune response against the target antigen. In pre-clinical studies, alternating administration of HB-201 and HB-202 resulted in a ten-fold increase in immune response and better disease control than either compound alone. Both novel immunotherapy candidates, in combination with pembrolizumab, received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of 1st-line advanced/metastatic HPV16+ head and neck cancers.

About the HB-200 trial (NCT04180215)
This Phase 1/2 clinical trial is an open-label trial exploring different dose levels and dosing schedules in individuals with treatment-refractory HPV16+ head and neck cancers who progressed on standard of care, including checkpoint inhibitors. The HB-200 trial is evaluating two HOOKIPA compounds: HB-201 as single-vector therapy, HB-202/HB-201 as an alternating 2-vector therapy, and both in combination with a PD-1 inhibitor. The primary endpoint of Phase 1 is a recommended Phase 2 dose. Secondary endpoints include safety and tolerability, as well as preliminary efficacy defined by RECIST 1.1. The trial also includes exploratory objectives on T cell response and pharmacodynamic biomarkers.

The Phase 2 part of the trial is open-label with a primary endpoint of preliminary anti-tumor activity, defined by RECIST 1.1, for objective response rate and disease control rate. Secondary endpoints including safety, overall survival, progression-free survival and duration of response. Phase 2 is ongoing, evaluating HB-201 in combination with pembrolizumab in 1st– and 2nd-line plus settings, with additional arms planned based on final Phase 1 results.

About Human Papillomavirus-driven Cancers
Human Papillomavirus, or HPV, is a common viral infection estimated to cause about 5 percent of the worldwide cancer burden. This includes up to 60 percent of head and neck, 89 percent of cervical, 78 percent of vaginal, 88 percent of anal, 67 percent of vulvar and 50 percent of penile cancers.

While there are numerous HPV types associated with cancer, HPV16 is the most common cause of cancer. Most HPV infections 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.

On May 26, 2022 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care, reported that company management will participate in a fireside chat at the 2022 Jefferies Global Healthcare Conference on Wednesday, June 8, 2022 at 8:30 am ET (Press release, Heron Therapeutics, MAY 26, 2022, View Source [SID1234615086]). The conference is taking place June 8-10th, 2022 in New York, NY.

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A live webcast of the fireside chat will be available on the Company’s website at www.herontx.com in the Investor Resources section.