On February 9, 2021 Kuraray Co., Ltd. reported it has made the following revisions to the forecast of financial results for the fiscal year ended December 31, 2020 (January 1, 2020 through December 31, 2020) which was announced on December 23, 2020 (Press release, Kuraray, FEB 9, 2021, https://pdf.irpocket.com/C3405/HTFv/ZRb6/LmzE.pdf [SID1234574772]).

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1. Revisions to consolidated earnings forecast for the fiscal 2020 (January 1-December 31, 2020)

2. Reason for the revisions For the full fiscal year, net sales and all the earnings accounts following operating income should exceed the previous forecast due to a recovery in demand in automotive, display, and electronic and electrical device applications, and a higher volume than initially expected in the Vinyl acetate and Isoprene segments.

On February 9, 2021 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, reported positive interim data of the Company’s fully-enrolled Phase 2 trial of HS-110, in combination with Bristol-Myers Squibb’s (BMS) OPDIVO (nivolumab) in advanced non-small cell lung cancer (NSCLC) (Press release, Heat Biologics, FEB 9, 2021, View Source [SID1234574771]). HS-110 is an "off-the-shelf" allogeneic cell-based therapy designed to activate patients’ immune system against multiple cancer testis antigens to elicit a diverse and robust immune response against tumor cells.

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Substantial survival benefit was observed in a cohort of previously treated, checkpoint inhibitor naïve patients with advanced NSCLC (Cohort A, N = 47). A median progression free survival (PFS) of 1.8 months and a median overall survival (OS) of 24.6 months was observed with a median follow-up time of 19.4 months. The one-year survival rate of Cohort A is 61.7%. The median OS data was 12.2 months and the 1-year survival rate was 50.7% in previously treated, advanced NSCLC patients who received nivolumab as a single agent, according to published data of the BMS CheckMate 057 study1. Our data suggests that addition of HS-110 to a checkpoint inhibitor has the potential to improve survival benefit for checkpoint inhibitor naïve NSCLC patients.

For NSCLC patients who had previously been treated with a checkpoint inhibitor and whose disease had subsequently progressed (Cohort B, N = 68), a median PFS of 2.8 months and median OS of 11.9 months was observed with a median follow-up time of 11.9 months. NSCLC patients whose disease progresses following checkpoint inhibitor therapy have limited treatment options2. Published data from other studies reported median OS of 6.8 to 9.0 months for NSCLC patients treated with chemotherapies after PD-(L)1 progression3,4. Our data of HS-110 in combination with nivolumab in Cohort B suggests potential treatment benefit for NSCLC patients whose disease progressed following treatment with PD-(L)1 therapy.

As of this data cut, 30% of the patients in Cohort A and 26% of the patients in Cohort B are still alive. HS-110 has a favorable safety profile and has been administered in approximately 200 patients to date. As of this data cut, there have been no treatment-related serious adverse reactions. A review of immune-related adverse events reported in the study raised no safety concerns. The data to date demonstrate that combination of HS-110 and nivolumab is well-tolerated.

"We are thrilled to report this latest positive survival data from our Phase 2 trial of HS-110, in combination with Bristol-Myers Squibb’s OPDIVO (nivolumab) in advanced non-small cell lung cancer demonstrating HS-110’s broad potential for providing multiple treatment options to NSCLC patients," stated Jeff Wolf, Chief Executive Officer of Heat Biologics. "HS-110 is the lead candidate in our portfolio of therapeutic products and vaccines utilizing Heat’s gp96 technology platform and showcases the broad utility of this platform for NSCLC and potentially other types of cancer. We are currently evaluating possible Phase 3 registration pathways for HS-110 in combination with a checkpoint inhibitor and intend to review these plans with the FDA as well as potential partners."

On February 9, 2021 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported new clinical developments for its first-in-class, proprietary investigational asset, lacutamab, an anti-KIR3DL2 cytotoxicity-inducing antibody in development for T-cell lymphomas (Press release, Innate Pharma, FEB 9, 2021, View Source [SID1234574768]). This includes advancement of the KIR3DL2-expressing mycosis fungoides (MF) cohort (cohort 2) to Stage 2 in the TELLOMAK study, as well as the initiation of the peripheral T-cell lymphoma (PTCL) clinical program.

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Mycosis Fungoides: Advancing TELLOMAK Cohort 2 to Stage 2
In TELLOMAK, an open-label, multi-cohort, Phase 2 trial, lacutamab demonstrated a positive early signal in cohort 2. This cohort reached the pre-determined number of responses needed to advance to stage 2, allowing the Company to recruit additional patients. The Company plans to present this preliminary data at a scientific meeting in 2021.

Recruitment is ongoing in cohort 3, evaluating lacutamab as a monotherapy in KIR3DL2 non-expressing MF patients.

Peripheral T-Cell Lymphoma: Introducing a Data-Driven Clinical Strategy
The Company reported plans to initiate two parallel clinical trials to study lacutamab in KIR3DL2-expressing patients with relapsed/refractory PTCL. Together these trials offer a data-driven strategy to identify potential opportunities for lacutamab in the relapsed setting, and potential expansion into earlier lines of therapy for PTCL in the future.

Phase 1b trial: a Company-sponsored Phase 1b clinical trial to evaluate lacutamab as a monotherapy in KIR3DL2-expressing patients with relapsed PTCL.

Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial: The Lymphoma Study Association (LYSA) will launch an investigator-sponsored, randomized trial to evaluate lacutamab in combination with chemotherapy GEMOX (gemcitabine in combination with oxaliplatin) versus GEMOX alone in KIR3DL2-expressing relapsed/refractory patients.
"Lacutamab is our priority clinical asset, and we are pleased to share important progress of this program. The early signal seen in the KIR3DL2-expressing mycosis fungoides patient population is encouraging and moves us past the pre-determined threshold for the cohort earlier than anticipated," said Joyson Karakunnel, M.D., MSc, FACP, Chief Medical Officer Innate Pharma. "In addition, our PTCL trials announced today demonstrate our strategy to first explore lacutamab’s potential in the relapsed/refractory setting, then potentially in earlier lines of treatment. Partnering with LYSA will provide invaluable expertise given their track record in advancing therapeutics for the lymphoma community."

"Relapsed PTCL patients are in need of alternative, effective options and we are pleased to partner with Innate Pharma on this important study," said Franck Morschhauser, Professor of Hematology in Lille (France) and President of LYSA. "KIR3DL2 represents a meaningful target, as it is expressed in up to 50% of PTCL across subtypes. Through our global network and deep expertise in lymphoma, we believe this study will help us better understand the potential for lacutamab to help these patients."

To learn more about these updates, join Innate’s executive leadership team, as well as Pierluigi Porcu, M.D., Professor of Medical Oncology, Dermatology and Cutaneous Biology and Director, Division of Hematologic Malignancies and Hematopoietic Stem Cell Transplantation at Jefferson University Hospital and principal investigator of Innate’s Phase 2 TELLOMAK study, and Olivier Hermine, M.D., Professor of Hematology at the University of Paris Descartes, Director, Division of Adult Hematology at Hôpital Universitaire Necker Enfants Malades and principal investigator of the LYSA Phase 2 KILT study for a virtual presentation today.

Webcast and conference call will be held today at 2:00 p.m. CET / 8:00 a.m. ET

Access to live webcast: View Source

Participants may also join via telephone by registering in advance of the event at View Source Upon registration, participants will be provided with dial-in numbers, a direct event passcode and a unique registrant id that they may use 10 minutes prior to the event start to access the call.

This information can also be found on the Investors section of the Innate Pharma website, www.innate-pharma.com. A replay of the webcast will be available on the Company website for 90 days following the event.

About Lacutamab:

Lacutamab (IPH4102) is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody, which is currently in clinical trials for treatment of cutaneous T-cell lymphoma (CTCL), an orphan disease. This group of rare cutaneous lymphomas of T lymphocytes has a poor prognosis with few efficacious and safe therapeutic options at advanced stages.

KIR3DL2 is an inhibitory receptor of the KIR family, expressed by approximately 65% of patients across all CTCL subtypes and expressed by up 90% of patients with certain aggressive CTCL subtypes, in particular, Sézary syndrome. It is expressed by up to 50% of patients with peripheral t-cell lymphoma (PTCL). It has a restricted expression on normal tissues.

About TELLOMAK:

TELLOMAK is a global, open-label, multi-cohort Phase 2 clinical trial recruiting patients with advanced T-cell lymphomas (TCL) in the United States and Europe. TELLOMAK is expected to recruit up to 150 patients, with lacutamab evaluated:

As a single agent in approximately 60 patients with Sézary syndrome who have received at least two prior systemic therapies, including mogamulizumab.
As a single agent in approximately 90 patients with mycosis fungoides (MF) who have received at least two systemic therapies.
In patients with MF, the study is designed to evaluate the benefit of lacutamab according to KIR3DL2 expression. The study comprises two cohorts in MF, testing lacutamab in KIR3DL2 expressing and non-expressing patients determined at baseline. These cohorts follow a Simon 2-stage design that will terminate early if treatment is considered futile. The Sézary syndrome cohort of the study could enable the registration of lacutamab in this indication.

The primary endpoint of the trial is objective response rate. Key secondary endpoints are progression-free survival, duration of response, quality of life and adverse events.

About Lacutamab in PTCL:

Two clinical trials will investigate lacutamab in KIR3DL2-expressing PTCL patients who have received at least one prior systemic therapy. Lacutamab is being evaluated:

In a multi-center, Phase 1b clinical trial as a single agent in approximately 20 relapsed patients expressing KIR3DL2. The trial is designed to evaluate safety, as well as characterize clinical outcomes, pharmacokinetics and immunogenicity of lacutamab alone in PTCL. Further expansion will be determined based on preliminary efficacy signals.
In a multi-center, randomized Phase 2 trial in combination with GEMOX in relapsed/refractory patients expressing KIR3DL2. This study will include approximately 60 patients. The combination trial, KILT (anti-KIR in T-Cell Lymphoma), is being conducted by the Lymphoma Study Association (LYSA) and its operational organization Lymphoma Academic Research Organisation (LYSARC); it will evaluate the efficacy and safety of lacutamab in combination with chemotherapy GEMOX in prescreened patients, with progression-free survival as the primary endpoint.

On February 9, 2021 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported that collaboration partner SOTIO has stopped the combination trial assessing the combination of ONCOS-102 and DCVAC/PCa in prostate cancer (Press release, Targovax, FEB 9, 2021, View Source [SID1234574767]). Only a very limited patient population fulfilled the strict inclusion criteria. Therefore, the recruitment could not meet originally planned numbers.

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The phase I trial prostate cancer study was paid for and run by the Czech biotech company SOTIO, investigating whether ONCOS-102 could enhance the efficacy of SOTIO´s dendritic cell vaccine DCVAC/PCa. Targovax has generated promising data in melanoma and mesothelioma, and the decision will not impact the further development of ONCOS-102.

Patient recruitment has been slow due to limited patient population availability. In combination with additional COVID-19 related challenges, SOTIO has decided to stop the trial after four patients enrolled. This was a phase I safety trial, and an analysis of clinical outcomes will be submitted at a future scientific conference.

On February 8th, 2021 CStone Pharmaceuticals, a leading biopharmaceutical company focused on developing and commercializing innovative immuno-oncology therapies and precision medicines, reported that anti-PD-L1 antibody sugemalimab has been granted Breakthrough Therapy Designation (BTD) by the China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) for the treatment of patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL) (Press release, CStone Pharmaceauticals, FEB 8, 2021, View Source [SID1234633505]). In addition to this major milestone, sugemalimab was granted Orphan Drug Designation (ODD) for the treatment of T-cell lymphoma and BTD for the treatment of R/R ENKTL by the U.S. Food and Drug Administration (FDA) in October 2020.

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The NMPA’s BTD is designed to facilitate the development and expedite the review of novel medicines to treat serious conditions and fulfill an unmet medical need, specifically for novel or "me-better" candidates at the clinical stage, which has demonstrated significant clinical advantages over the available treatment options. The BTD approval from the China NMPA is expected to substantially accelerate the development and commercialization of sugemalimab in China.

The BTD is supported by the promising CS1001-201 Phase II results in patients with R/R ENKTL, which were presented at the annual meeting of the Chinese Society of Clinical Oncology (CSCO) in 2020. Among 38 evaluable patients, the objective response rate (ORR) was 44.7%, the complete response (CR) rate was 31.6%, and the median duration of response (mDoR) was 16.8 months. Of all 43 patients who received sugemalimab, the median overall survival (mOS) was 19.7 months, and the one-year OS rate was 55.5%. Additionally, sugemalimab demonstrated favorable safety and tolerability.

Professor Huiqiang Huang of Sun Yat-sen University Cancer Center, the Principal Investigator of CS1001-201 study said, "R/R ENKTL is a highly malignant and aggressive disease, in addition to the lack of efficacious treatment options, which often leads to poor prognosis, low cure rate, and severe unmet medical needs of patients. The preliminary results have indicated that sugemalimab could potentially become a new treatment option for patients with R/R ENKTL."

Dr. Jason Yang, Chief Medical Officer of CStone, commented, "We are excited that sugemalimab has been granted BTD by the China NMPA, which also makes sugemalimab one of the very few domestic novel drugs that have obtained BTD from the Agencies in both the U.S. and China. This designation underscores the remarkable clinical value of sugemalimab, and we look forward to working closely with the NMPA in China to maximize the benefit of sugemalimab to patients in the nearest future."

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About ENKTL

Extranodal natural killer/T-cell lymphoma (ENKTL) is a subtype of mature T cell and NK cell lymphoma. There is no existing effective salvage treatment for patients with R/R ENKTL who failed L-asparaginase-based standard regimen. Patients also respond poorly to conventional treatments. Clinicians often have limited treatment options for such patients due to rapid disease progression and poor survival outcomes with a one-year survival rate of less than 20%. In China, the currently available targeted monotherapy for these patients has a complete response (CR) rate of approximately 6%. Thus, there are significant unmet medical needs in patient who failed first-line treatment.

About CS1001-201 Study

CS1001-201 is a single-arm, multicenter, Phase II pivotal study designed to evaluate the efficacy and safety of sugemalimab as monotherapy for the treatment of adult patients with R/R ENKTL. The primary endpoint of this study is ORR as assessed by the Independent Radiology Review Committee (IRRC). On August 14th, 2020, CS1001-201 has received a Study May Proceed (SMP) letter from the U.S. FDA for the Investigational New Drug (IND) application. CS1001-201 was currently ongoing in the U.S. and China.

About Sugemalimab

Sugemalimab is an investigational anti-PD-L1 monoclonal antibody discovered by CStone. Authorized by the U.S.-based Ligand Corporation, sugemalimab is developed by the OmniRat transgenic animal platform, which can generate fully human antibodies in one stop. As a fully human, full-length anti-PD-L1 monoclonal antibody, sugemalimab mirrors the natural G-type immunoglobulin 4 (IgG4) human antibody, which reduce the risk of immunogenicity and potential toxicities in patients, a unique advantage over similar drugs.

Sugemalimab has completed a Phase 1 dose-escalation study in China. During Phase 1a and Phase 1b of the study, sugemalimab showed good antitumor activity and tolerability in multiple tumor types.

Currently, sugemalimab is being investigated in a number of ongoing clinical trials. In addition to a Phase 1 bridging study in the U.S., the clinical program in China includes one multi-arm Phase 1b study for several tumor types, one Phase 2 registration studies for lymphoma, and four Phase 3 registration studies, respectively, for stage III/IV NSCLC, gastric cancer, and esophageal cancer. The phase 3 trial of sugemalimab in the treatment of stage IV non-small cell lung cancer reached the primary endpoint. The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to anti-PD-L1 antibody sugemalimab for the treatment of adult patients with relapsed or refractory extranodal natural killer/T-cell lymphoma in October 2020. The China National Medical Products Administration has accepted the company’s New Drug Application for sugemalimab.