On May 20, 2021 Nippon Kayaku reported that Financial Results for the Fiscal Year Ending March 31, 2021 (FY 2021) (Press release, Nippon Kayaku, MAY 20, 2021, View Source_fiscal_ym14/100505/00.pdf" target="_blank" title="View Source_fiscal_ym14/100505/00.pdf" rel="nofollow">View Source [SID1234580346])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

FY 2021 : Topics
(1) 4 Consolidated Results
• Net sales and profit was decreased from the previous fiscal year. But net sales and profit was increased from the forecast in January, 2021
• Sales of Functional Chemicals and Safety systems in 1st half declined due to COVID-19 pandemic, but sales in 2nd half was rapidly recovered with automobile market demand
• Catalyst of Functional Chemicals achieved 10.9 billion yen sales, record high
• Biosimilars was 10.4 billion yen sales, record high, while the drug price revisions

FY 2021 : Topics (2) Functional Chemicals Business
• Sales of epoxy resins were strong for semiconductor and circuit board due to the growth in 5G base stations and IT devices, and recovered for automobile applications from 3rd quarter
• Sales of epoxy resins for use in automobile applications were strong
• The cleaner for LCD and semiconductor industry business acquired from Henkel AG &Co. KGaA was performed well for semiconductor usage
• Teikoku Taping Systems Co., Ltd were acquired, to spread the semiconductor applications
• Sales of colorants for inkjet printers for consumer use were strong, owing to the positive impact of working from home during the COVID-19 pandemic
• Sales of colorants for inkjet printers used in industrial applications declined abruptly due to the decrease in demand for printed advertising, sales for textile dyes declined due to the clothing sales decrease, and thermal developer declined due to the decrease in demand for movie and theater ticket, but all applications slightly recovered from 3rd quarter • Sales of Catalyst achieved 10.9 billion yen sales, record high
• Polatechno Co., Ltd was made a wholly owned subsidiary, was integrated from October and proceeded the strength of the governance and integrated operations. The sales slightly recovered for automobile application from 3rd quarter

5 FY 2021 : Topics (3) Pharmaceuticals Business
• Biosimilars: Sales growth for INFLIXIMAB BS and TRASTUZUMAB BS was strong
New products: The cancer-related generic drug APREPITANT recorded strong growth The biomedicine PORTRAZZA achieved market penetration, increased its adaption Approach for the domestic manufacturing with Calitivecs Inc. Continue to focus on co-promotion of NUBEQA Tab., a therapeutic drug for prostate cancer
• Products under development: NK105 (Polymeric micelle paclitaxel) was canceled to develop for breast cancer due to Phase II clinical trial results Launch for development related bio and polymeric technology with Biomedical companies 6 FY 2021 : Topics (4) Safety Systems Business
Rapidly decline due to the stagnation of global automobile market
• Demands rapidly recovered in China from 1st quarter, in Japan and North America from 2nd quarter
Sales rapidly recovered in all regions from 3rd quarter, although there were regional differences
• Total shipment of automobile safety devices glowed to 80 million devices in 3rd quarter
• Safety equipment for drones, PARASAFE progress to develop on schedule towards the start of sales in December, 2021 Agrochemicals and Other Businesses
• Domestic sales was strong, but oversea sales declined due to the procurement difficulty of some of raw materials
• Acquired sales rights of "Teron" and "Ashahi D-D," then started of those sales from 4th quarter 7 ESG :

FY 2021 Topics 8
▸ Enlargement and Strengthened of Corporate Governance
・Increased the number of independent outside directors by one
・Established the Nomination and Remuneration Advisory Committee Members: five directors, the majority are independent outside directors (3 out of 5) Roles: strengthen the fairness, transparency and objectivity of the procedures related to the nomination and remuneration etc. of directors etc.
・Formulated our Basic Policy on Corporate Governance
・Enlargement on Corporate Governance (consider to enlargement towards the general meeting in June)
▸ Environment target FY 2031 NK groups’ GHG emission target in FY 2031 (Scope 1+2)setting at 32.5% decrease via FY 2019
▸ Further information-CSR information: View Source report: View Source _fiscal_ym17/88077/00.pdf

On May 19, 2021 MorphoSys AG (FSE:MOR; NASDAQ:MOR) reported that new data from the tafasitamab (Monjuvi(R)) development program will be presented at the upcoming 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 4-8, 2021 (Press release, MorphoSys, MAY 20, 2021, View Source [SID1234580345]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, which was approved as Monjuvi(R) (tafasitamab-cxix) in July 2020 by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

"We are proud to present important findings from our comprehensive development program for tafasitamab at the ASCO (Free ASCO Whitepaper) Annual Meeting, including three-year follow-up data from the Phase 2 L-MIND study showing a long durability of responses and overall survival in patients with R/R DLBCL," commented Dr. Malte Peters, Chief Research and Development Officer at MorphoSys. "In addition, we will show details from our First-MIND study in front-line DLBCL, indicating our ambition to position Monjuvi as a back-bone strategy in DLBCL and to increase cure rates or duration of remission in DLBCL across all lines of therapy."

Abstracts accepted for presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting include:

Poster Discussion

LONG-TERM ANALYSES FROM L-MIND, A PHASE 2 STUDY OF TAFASITAMAB (MOR208) COMBINED WITH LENALIDOMIDE (LEN) IN PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (R/R DLBCL)

Abstract Number: 7513
Session: Hematologic Malignancies-Lymphoma and Chronic Lymphocytic Leukemia

ePosters

First-MIND: A PHASE 1B, OPEN-LABEL, RANDOMIZED STUDY TO ASSESS SAFETY OF TAFASITAMAB (TAFA) OR TAFA + LENALIDOMIDE (LEN) IN ADDITION TO R‑CHOP IN PATIENTS WITH NEWLY DIAGNOSED DLBCL

Abstract Number: 7540
Session: Hematologic Malignancies-Lymphoma and Chronic Lymphocytic Leukemia

A PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TAFASITAMAB PLUS LENALIDOMIDE AND RITUXIMAB VERSUS PLACEBO PLUS LENALIDOMIDE AND RITUXIMAB IN PATIENTS WITH RELAPSED/REFRACTORY (R/R) FOLLICULAR LYMPHOMA (FL) OR MARGINAL ZONE LYMPHOMA (MZL)[1]

Abstract Number: TPS7568
Session: Hematologic Malignancies-Lymphoma and Chronic Lymphocytic Leukemia

Please refer to the ASCO (Free ASCO Whitepaper) online program for full session details and data presentation listings: View Source All presentations will be available on demand starting June 4, 2021.

MorphoSys is looking forward to meeting registered ASCO (Free ASCO Whitepaper)21 Virtual attendees at its virtual booth accessible through the conference website and through the company’s ASCO (Free ASCO Whitepaper) microsite at www.morphosysevents.com.

About Tafasitamab
Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

Monjuvi(R) (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi(R) is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

A marketing authorization application (MAA) seeking the approval of tafasitamab in combination with lenalidomide in the EU has been validated by the European Medicines Agency (EMA) and is currently under review for the treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low grade lymphoma, who are not candidates for ASCT.

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

Monjuvi(R) is a registered trademark of MorphoSys AG.

XmAb(R) is a registered trademark of Xencor, Inc.

Important Safety Information

What are the possible side effects of MONJUVI?

MONJUVI may cause serious side effects, including:

– Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get chills, flushing, headache, or shortness of breath during an infusion of MONJUVI.

– Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4 F (38 C) or above, or any bruising or bleeding.

– Infections. Serious infections, including infections that can cause death, have happened in people during treatments with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4 F (38 C) or above, or develop any signs and symptoms of an infection.

The most common side effects of MONJUVI include:

– Feeling tired or weak

– Diarrhea

– Cough

– Fever

– Swelling of lower legs or hands

– Respiratory tract infection

– Decreased appetite

These are not all the possible side effects of MONJUVI.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before you receive MONJUVI, tell your healthcare provider about all your medical conditions, including if you:

– Have an active infection or have had one recently.

– Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.

– You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of MONJUVI.

– Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI.

– Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment for at least 3 months after your last dose of MONJUVI.

You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Please see the full Prescribing Information for Monjuvi, including Patient Information, for additional Important Safety Information.

On May 20, 2021 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported an upcoming poster presentation highlighting its chemotherapy free regimen of interleukin-15 (IL-15) superagonist Anktiva (also called N-803) in combination with checkpoint therapy in patients who had relapsed from checkpoint inhibitors, at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place virtually this year from June 4 through June 8, 2021 (Press release, ImmunityBio, MAY 20, 2021, View Source [SID1234580344]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Phase 2 study, titled "Preliminary data from QUILT 3.055: A Phase 2 multi-cohort study of N-803 (IL-15 superagonist) in combination with Checkpoint Inhibitors (CPI)", details data highlighting the safety and clinical benefit of adding Anktiva to checkpoint inhibitor therapy in second-line or greater treatment regimens in multiple cancer types, a basket trial.

Anktiva is designed to activate natural killer cells and CD8+ T cells, without the activation of T-reg cells that can suppress anti-tumor activity. In this Phase 2 study, Anktiva was administered to each patient in combination with a checkpoint inhibitor that had previously yielded a complete response, partial response, or six months of stable disease in that patient in the setting of first-, second- and third-line therapy before disease progression resumed.

"We are encouraged by the trend to date toward Anktiva’s safety, tolerability and clinical benefit that is robust across several types of historically difficult-to-treat cancers, which aligns with Anktiva’s mechanism of action being agnostic with respect to cancer type," said Patrick Soon-Shiong, M.D., Founder and Executive Chairman of ImmunityBio. "We hope to see durable benefit as the study progresses, which would suggest that Anktiva can confer long-term re-sensitization of tumor tissue to checkpoint inhibitor therapy across several cancer types and patterns of patient history."

Human solid tumors are made of multiple clones of tumor cells, some of which harbor genomic alterations that make them invisible to T cells. These resistant clones accomplish this "cloaking ability" by preventing the presentation of the tumor antigens on MHC-I receptors, thus "hiding" from killer T cells. For these patients, maximum activation of T cells with immunotherapy is unlikely to lead to durable tumor control or a cure. However, when NK cells are activated, tumor recognition and targeting is restored. Anktiva activates both NK and T cells and a potential mechanism of rescuing patients from checkpoint relapse is the administration of Anktiva together with the same checkpoint therapy.

"We hypothesize that checkpoint therapy alone is insufficient and that the combination of Anktiva with or without PD-L1 t-haNK may advance the strategy of developing a chemotherapy free immunotherapy protocol for the treatment of multiple tumors. We have previously demonstrated that PD-L1 t-haNK plays an important role in checkpoint failures. The encouraging data from this Phase 2 exploratory trial has formed the basis of our randomized Phase 3 clinical trials in lung cancer (QUILT 2.023, NCT03520686)" said Dr. Soon-Shiong.

Study highlights to date include:

140 patients with checkpoint relapse accrued across multiple tumor types: NSCLC, Small Cell, Urothelial, Head & Neck, Melanoma, Renal, Gastric, and Cervical cancer
121 evaluable patients to date with preliminary data demonstrating 68% (82 out of 121) disease control (partial response and stable disease >6 weeks)
Anktiva exhibits a favorable toxicity profile in combination with several different checkpoint inhibitors in second-line or greater settings, across a variety of tumor types
Adverse events, 12% of which were grade 3 or above, that were related to the chemotherapy-free combination regimen were favorable to the historical standard of care comprising combination therapies that include chemotherapy
Treatment-related serious adverse events (SAEs) were seen in 8% of study participants
Combination regimens that included Anktiva demonstrated clinical benefit in the majority of subjects, with cessation of progression, prolonged stable disease, and occasional partial responses per RECIST were observed in different tumor types

On May 20, 2021 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM) reported that new analyses and updates on the ongoing studies of savolitinib, surufatinib, fruquintinib and HMPL-306 will be presented at the upcoming ASCO (Free ASCO Whitepaper)21 Virtual Scientific Program, taking place on June 4-8, 2021 (Press release, Hutchison China MediTech, MAY 20, 2021, View Source [SID1234580343]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Aspects of these clinical data disclosures, alongside its PD-1/L1 combination study strategy and corporate update will be discussed part of the previously announced call. For more details, please visit: View Source

SAVOLITINIB

Title:

Clinical activity of durvalumab and savolitinib in MET-driven, metastatic papillary renal cancer

Lead Author:

Cristina Suárez, MD, Hospital Univ. Vall D Hebron General

Session:

Poster Discussion Session: Genitourinary Cancer—Kidney and Bladder

Abstract Number:

4511

SURUFATINIB

Title:

Interim analysis results of surufatinib in U.S. patients with neuroendocrine tumors (NETs).

Lead Author

Scott Paulson, MD, Baylor Sammons Cancer Center

Session:

Poster Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Abstract Number:

4114

Title:

Surufatinib in combination with toripalimab in patients with advanced neuroendocrine carcinoma: results from a multicenter, open-label, single-arm, phase II trial

Lead Author

Lin Shen, MD, Peking University Cancer Hospital & Institute

Session:

Online publication only

Number:

e16199

Title:

Phase II trial of surufatinib plus toripalimab for disease progression after first-line chemotherapy with platinum and fluoropyrimidine in advanced gastric or gastroesophageal junction adenocarcinoma

Lead Author

Lin Shen, MD, Peking University Cancer Hospital & Institute

Session:

Online publication only

Number:

e16040

Title:

A single-arm, multi-center, open-label phase 2 trial of surufatinib in patients with unresectable or metastatic biliary tract cancer.

Lead Author

Yuxian Bai, MD, PhD, Harbin Medical University Cancer Hospital

Session:

Online publication only

Number:

e16123

Title:

Subgroup analysis by Ki-67 and baseline CgA of the randomized, placebo-controlled phase 3 study of surufatinib in advanced well-differentiated pancreatic neuroendocrine tumors (SANET-p)

Lead Author

Xianjun Yu, MD, Fudan University Shanghai Cancer Center

Session:

Poster Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Abstract Number:

4111

Title:

An open-label phase 1b/2 study of surufatinib in combination with tislelizumab in subjects with advanced solid tumors

Lead Author

Arvind Dasari, MD, MS, MD Anderson Cancer Center

Session:

Poster Session: Developmental Therapeutics—Immunotherapy

Abstract Number:

TPS2677

FRUQUINTINIB

Title:

Preliminary results of a phase 1b study of fruquintinib plus sintilimab in advanced colorectal cancer

Lead Author

Ye Guo, MD, Shanghai East Hospital

Session:

Poster Discussion Session: Gastrointestinal Cancer—Colorectal and Anal

Abstract Number:

2514

Title:

A phase Ib trial of assessing the safety and preliminary efficacy of a combination therapy of Geptanolimab (GB 226) plus Fruquintinib in patients with metastatic colorectal cancer (mCRC)

Lead Author

Yanzhi Cui, MD, Tumour Institute, Fourth Hospital of Hebei Medical University

Session:

Online publication only

Number:

e15551

HMPL-306

Title:

A multicenter open-label phase 1 study evaluating the safety and tolerability of HMPL-306 in patients with locally advanced or metastatic solid tumors with IDH mutations.

Lead Author

Filip Janku, MD, MD Anderson Cancer Center

Session:

Poster Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

Abstract Number:

TPS3159

About Savolitinib

Savolitinib is an oral, potent, and highly selective small molecule inhibitor of MET, a receptor tyrosine kinase which has been shown to function abnormally in many types of solid tumors promoting tumor growth, angiogenesis, and metastasis. Savolitinib has been studied in over 1,100 patients to date. In clinical studies, it has shown promising clinical efficacy in patients with MET gene alterations in multiple tumor types with an acceptable safety profile.

In 2011, HUTCHMED entered into a global licensing and joint development and commercialization agreement with AstraZeneca PLC (LSE/STO/NYSE: AZN) for savolitinib. Savolitinib’s global development plan includes non-small cell lung cancer (NSCLC) and kidney cancer, and additional MET-driven tumors are being explored.

About Surufatinib

Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor ("VEGFR") and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.

HUTCHMED currently retains all rights to surufatinib worldwide.

About Fruquintinib

Fruquintinib is a highly selective and potent oral inhibitor of VEGFRs -1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may also be highly suitable for combinations with other anti-cancer therapies.

HUTCHMED retains all rights to fruquintinib outside of China. In China, HUTCHMED is partnered with Eli Lilly and Company and is responsible for development and execution of all on-the-ground medical detailing, promotion and local and regional marketing.

About HMPL-306

HMPL-306 is HUTCHMED’s ninth innovative oncology drug candidate that it has discovered that has entered clinical development and the sixth to enter global clinical development. Cytoplasmic mutant IDH1 and mitochondrial mutant IDH2 have been known to switch to the other form when targeted by an inhibitor of IDH1 mutant alone or IDH2 mutant alone. By targeting both IDH1 and IDH2 mutations, HMPL-306 could potentially provide therapeutic benefits in cancer patients harboring either IDH mutation, and may address acquired resistance to IDH inhibition through isoform switching.

HUTCHMED currently retains all rights to HMPL-306 worldwide.

On May 20, 2021 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that the first data on HB-201/HB-202 alternating 2-vector therapy and expanded data on HB-201 will be featured as an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 4-8, 2021 (Press release, Hookipa Biotech, MAY 20, 2021, View Source [SID1234580342]). HB-201 and HB-202, novel arenaviral therapeutics and HOOKIPA’s lead oncology candidates, are being evaluated in an ongoing, first-in-human Phase 1/2 clinical trial (NCT04180215) for the treatment of advanced Human Papillomavirus 16-positive (HPV16+) cancers. The oral presentation will highlight safety, tolerability, immunogenicity and preliminary anti-tumor activity data from about 40 evaluable patients as of March 31.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We’re thrilled that our novel arenaviral immunotherapeutics for HPV16+ cancers, HB-201 and HB-202, are being featured at ASCO (Free ASCO Whitepaper). We believe our selection as an oral presentation speaks to the strength of the data and the potential of our arenaviral therapeutics to redefine success in cancer treatment," said Joern Aldag, Chief Executive Officer at HOOKIPA. "Following the preliminary HB-201 data shared in December and our translational data presentation at AACR (Free AACR Whitepaper), we’re excited to share expanded data from more patients and additional doses, including first results on HB-201/HB-202 alternating 2-vector therapy, as well as detailed safety, tolerability, translational data and preliminary anti-tumor activity results. We believe these data are very encouraging for such an early-stage program."

The abstract, outlined below, is available on the ASCO (Free ASCO Whitepaper) website:

First report of the safety/tolerability and preliminary anti-tumor activity of HB-201 and HB-202, an arenavirus-based cancer immunotherapy, in patients with HPV16+ cancers
Abstract # 2502, oral presentation
Monday, June 7, 3:00 – 6:00pm EDT
Presenter: Alan L. Ho, M.D., Ph.D., Memorial Sloan Kettering Cancer Center
Investor Event
At the conclusion of the planned ASCO (Free ASCO Whitepaper) conference events on June 7, 2021, HOOKIPA will host a live webcast event "Advancing Novel Immunotherapies: HOOKIPA ASCO (Free ASCO Whitepaper) Data Review" at 6:30 p.m. EDT. Joern Aldag, Chief Executive Officer, and Igor Matushansky, Chief Medical Officer, will provide an overview of the ASCO (Free ASCO Whitepaper) oral data and future plans for HOOKIPA’s oncology program. Dmitriy Zamarin, M.D., Ph.D., Translational Research Director in Gynecologic Medical Oncology at Memorial Sloan Kettering Cancer Center and co-investigator in this study, will also offer commentary on the significance and implications of the translational findings. The webcast and the presentation will be available within the Investors & Media section of HOOKIPA’s website at View Source To participate in a live Q&A at the end of the prepared remarks, please register here. An archived replay will be accessible for 30 days following the event.

About HB-201/HB-202
HB-201 and HB-202 are HOOKIPA’s lead oncology candidates engineered with the company’s proprietary replicating arenaviral vector platform. Each single-vector compound uses a different arenavirus backbone (LCMV for HB-201 and PICV for HB-202), while expressing the same antigen, an E7E6 fusion protein derived from HPV16. 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.

About the trial
This Phase 1/2 clinical trial is an open-label trial exploring different dose levels and dosing schedules in individuals with treatment-refractory HPV16+ cancers who progressed on standard of care, including check point inhibitors. The primary endpoint of the Phase 1 is a recommended Phase 2 dose based on safety and tolerability. Secondary endpoints include anti-tumor activity as defined by RECIST 1.1 and immunogenicity.

The trial is evaluating HB-201 as a single-vector monotherapy, as an alternating two-vector therapy with HB-202, and in combination with a PD-1 inhibitor. Participants receive HB-201/HB-202 intravenously or, for patients with an accessible lesion, the first dose can be delivered via intratumoral injection followed by intravenous dosing. Dosing every three weeks and every two weeks is being explored, as well as different dose levels.

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.