On December 27, 2021 VLP Therapeutics, Inc. (VLPT) reported that it has signed an agreement for an investment of US$21 million in a Series A-1 round from six investors, consisting of two new investors: Nobelpharma Co., Ltd. and MUFG Bank, Ltd., and four existing investors: Sojitz Corporation, MIYAKO Capital Co., Ltd., Mr. Robert G. Hisaoka and SK Impact Fund, LLC (Press release, VLP Therapeutics, DEC 27, 2021, View Source [SID1234597776]).

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With this funding, VLPT aims to further accelerate the research and development of a cancer treatment vaccine as well as prophylactic vaccines against malaria, dengue, etc. and move into clinical trials at the earliest date possible. This is an additional investment following US$16 million raised in a Series A round in March 2021.

With this funding VLPT aims to accelerate the R&D of a cancer treatment vaccine as well as malaria and dengue vaccines.

"I have long committed to the research and development of vaccines against cancer and infectious diseases so the people across the globe can lead normal lives," says Wataru Akahata, CEO and co-founder of VLPT. "We were fortunate enough to be able to raise funding in March to facilitate our cancer treatment vaccine R&D. This additional funding will now allow us to further accelerate our other R&D efforts in infectious diseases area as well. This means a lot as it helps us to push our scientific endeavors forward at much faster pace, enabling us to get one step closer in making a greater social impact."

On December 24, 2021 Eisai (Headquarters: Tokyo, CEO: Haruo Naito) and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) reported that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the combination of LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A., for the treatment of patients with unresectable, advanced or recurrent endometrial carcinoma that progressed after cancer chemotherapy (Press release, Eisai, DEC 24, 2021, View Source [SID1234597690]). This approval marks the first time the combination of LENVIMA plus KEYTRUDA has been approved in Japan. LENVIMA plus KEYTRUDA is now approved in Japan, the U.S. and Europe for certain types of advanced endometrial carcinoma.

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"Rates of endometrial carcinoma have been steadily increasing in Japan each year1, and there are limited options for patients who are diagnosed at an advanced stage or find their disease has returned," said Dr. Gregory Lubiniecki, Vice President, Clinical Research, Merck & Co., Inc., Kenilworth, N.J., U.S.A. Research Laboratories. "With today’s approval, patients in Japan with unresectable, advanced or recurrent endometrial carcinoma now have the option of the first immunotherapy and tyrosine kinase inhibitor combination that has significantly improved overall survival and progression-free survival compared to chemotherapy."

"This is the first approval of the LENVIMA plus KEYTRUDA combination in Japan," said Terushige Iike, President of Eisai Japan, Senior Vice President, Eisai. "We thank the patients, families and healthcare providers who made this approval possible. By delivering this combination-2-therapy, we are proud to provide patients with advanced or recurrent endometrial carcinoma an additional treatment option."

The approval is based on results from the pivotal Phase 3 Study 309/KEYNOTE-775 trial, in which LENVIMA plus KEYTRUDA demonstrated statistically significant improvements in overall survival (OS), reducing the risk of death by 38% (HR=0.62 [95% CI, 0.51-0.75]; p<0.0001), and progression-free survival (PFS), reducing the risk of disease progression or death by 44% (HR=0.56 [95% CI, 0.47-0.66]; p<0.0001), versus chemotherapy (investigator’s choice of doxorubicin or paclitaxel). The median OS was 18.3 months (95% CI, 15.2-20.5) for LENVIMA plus KEYTRUDA versus 11.4 months (95% CI, 10.5-12.9) for chemotherapy. The median PFS was 7.2 months (95% CI, 5.7-7.6) for LENVIMA plus KEYTRUDA versus 3.8 months (95% CI, 3.6-4.2) for chemotherapy.

The Japanese package inserts for KEYTRUDA and LENVIMA note that in the Study 309/KEYNOTE-775 trial, adverse reactions were observed in 395 patients (97.3%) out of the safety analysis set of 406 patients (including 51 out of 52 Japanese patients) receiving LENVIMA plus KEYTRUDA. The most common adverse reactions were hypertension in 249 patients (61.3%), hypothyroidism in 222 patients (54.7%), diarrhea in 171 patients (42.1%), nausea in 158 patients (38.9%), decreased appetite in 151 patients (37.2%), fatigue in 113 patients (27.8%), proteinuria in 105 patients (25.9%), vomiting in 98 patients (24.1%), weight decreased in 91 patients (22.4%), arthralgia in 87 patients (21.4%) and palmar-plantar erythrodysesthesia syndrome in 84 patients (20.7%).

Endometrial carcinoma begins in the inner lining of the uterus, which is known as the endometrium, and accounts for more than 90% of uterine cancers2. In Japan, it is estimated there were more than 17,000 new cases of uterine cancer and more than 3,000 deaths in 2020 alone3. LENVIMA and KEYTRUDA have each received orphan drug designation in Japan for endometrial carcinoma.

In addition to advanced endometrial carcinoma, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. continue to study the LENVIMA plus KEYTRUDA combination across several types of cancer with more than 20 clinical trials. About Study 309/KEYNOTE-775 Trial The approval was based on data from Study 309/KEYNOTE-775 (ClinicalTrials.gov, NCT03517449), a Phase 3 multicenter, open-label, randomized, active-controlled study conducted in 827 patients (including 104 Japanese patients) with advanced endometrial carcinoma who had been previously treated with at least one prior platinum-based chemotherapy-3-regimen in any setting, including in the neoadjuvant and adjuvant settings. The primary efficacy outcome measures were OS, and PFS as assessed by blinded independent central review (BICR) according to RECIST v1.1. Patients were randomized 1:1 to receive LENVIMA (20 mg orally once daily) plus KEYTRUDA (200 mg intravenously every three weeks) or investigator’s choice, consisting of either doxorubicin (60 mg/m2 every three weeks) or paclitaxel (80 mg/m2 given weekly, three weeks on/one week off). Treatment with LENVIMA plus KEYTRUDA continued until RECIST v1.1-defined progression of disease as verified by BICR, unacceptable toxicity, or for KEYTRUDA, a maximum of 24 months. Administration of LENVIMA plus KEYTRUDA was permitted beyond RECIST-defined disease progression if the treating investigator considered the patient to be deriving clinical benefit and the treatment was tolerated.

About LENVIMA (lenvatinib) Capsules LENVIMA, discovered and developed by Eisai, is an orally available kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4, the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. In syngeneic mouse tumor models, LENVIMA decreased tumor-associated macrophages, increased activated cytotoxic T cells, and demonstrated greater antitumor activity in combination with an anti-PD-1 monoclonal antibody compared to either treatment alone.

Currently, LENVIMA has been approved for monotherapy as a treatment for thyroid cancer in over 75 countries including Japan, in Europe, China and in Asia, and in the United States for locally recurrent or metastatic, progressive, radioiodine-refractory differentiated thyroid cancer. In addition, LENVIMA has been approved for monotherapy as a treatment for unresectable hepatocellular carcinoma in over 70 countries including Japan, in Europe, China and in Asia, and in the United States for first-line unresectable hepatocellular carcinoma. LENVIMA has been approved for monotherapy as a treatment for unresectable thymic carcinoma in Japan. It is also approved in combination with everolimus as a treatment for renal cell carcinoma following prior antiangiogenic therapy in over 60 countries, including in Europe and Asia, and in the United States the treatment of adult patients with advanced renal cell carcinoma following one prior antiangiogenic therapy. In Europe, the agent was launched under the brand name Kisplyx for renal cell carcinoma. LENVIMA has been approved in combination with KEYTRUDA (generic name:-4-pembrolizumab), for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) in United States and in Europe. LENVIMA has been approved in combination with KEYTRUDA as a treatment for advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation in the United States, and has been approved for the similar indication (including conditional approval) in over 10 countries such as Canada and Australia. In some regions, continued approval for this indication is contingent upon verification and description of clinical benefit in the confirmatory trials. In Europe, it has been approved in combination with KEYTRUDA (generic name: pembrolizumab) as the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. In Japan, it is approved in combination with KEYTRUDA (generic name: pembrolizumab) as the treatment of patients with unresectable advanced or recurrent endometrial carcinoma that progressed after cancer chemotherapy.

About KEYTRUDA (pembrolizumab) Injection, 100mg
KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. Merck & Co., Inc., Kenilworth, N.J., U.S.A. has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

About the Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Strategic Collaboration
In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., known as MSD outside the United States and Canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA. Under the agreement,-5-the companies will jointly develop, manufacture and commercialize LENVIMA, both as monotherapy and in combination with KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A. In addition to ongoing clinical studies evaluating the LENVIMA plus KEYTRUDA combination across several different tumor types, the companies have jointly initiated new clinical studies through the LEAP (LEnvatinib And Pembrolizumab) clinical program and are evaluating the combination in more than 10 different tumor types across more than 20 clinical trials.

Eisai’s Focus on Cancer
Eisai focuses on the development of anticancer drugs, targeting the tumor microenvironment (with experience and knowledge from existing in-house discovered compounds) and the driver gene mutation and aberrant splicing (leveraging RNA Splicing Platform) as areas (Ricchi) where real patient needs are still unmet, and where Eisai can aim to become a frontrunner in oncology. Eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these Ricchi, with the aim of contributing to the cure of cancers.

On December 24, 2021 Accutar Biotechnology, Inc., a biotechnology company focusing on artificial intelligence (AI)-empowered drug discovery, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug application (IND) for AC0176 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) (Press release, Accutar Biotechnology, DEC 24, 2021, View Source [SID1234597699]). AC0176 is an orally bioavailable, chimeric degrader molecule designed to target and degrade androgen receptor (AR) with high potency, selectivity, and broad mutant coverage. AR is a hormone-regulated transcription factor, and its activation plays a critical role in prostate cancer initiation and progression. Accutar expects to begin enrollment of a Phase 1 clinical trial for AC0176 in the first quarter of 2022.

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"The IND clearance for AC0176 is another important validation, after our AC0682 entered the clinic recently, that our AI platform can support and advance the discovery of potentially differentiated clinical candidates quickly, especially complex compounds such as chimeric degraders," said Jie Fan, Ph.D., Chief Executive Officer of Accutar Biotechnology, Inc. "The IND clearance for AC0176 is also critical towards offering a potential new treatment for prostate cancer based on a differentiated mechanism of action from second generation nonsteroidal AR antagonists, which are the current standard of care for this patient population. We look forward to the clinical benefit that AC0176 treatment can potentially provide to prostate cancer patients."

The Phase 1 study will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC0176 treatment in mCRPC patients.

About AC0176

AC0176 is an investigational orally bioavailable, chimeric degrader of androgen receptor (AR) for the potential treatment of prostate cancers. In preclinical studies, AC0176 has demonstrated potent and selective AR protein degradation with broad coverage of AR mutants, favorable pharmacological properties, as well as promising anti-tumor activities in animal models.

On December 24, 2021 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, reported that the National Medical Products Administration (NMPA) of China has accepted the supplemental New Drug Application (sNDA) for sintilimab plus bevacizumab biosimilar injection and chemotherapy in patients with EGFR-mutated non-squamous non-small cell lung-cancer (nsqNSCLC) who progressed after EGFR-TKI therapy (Press release, Innovent Biologics, DEC 24, 2021, View Source [SID1234597701]).

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The sNDA is based on the first interim analysis of ORIENT-31, the randomized, double-blind, multi-center Phase 3 clinical trial – which evaluated sintilimab in combination with or without bevacizumab biosimilar and chemotherapy compared to placebo in combination with chemotherapy for patients with EGFR-mutated nsqNSCLC who had disease progression after EGFR-TKI therapy. Based on the first interim analysis conducted by the Independent Data Monitoring Committee (IDMC), Arm A (sintilimab in combination with bevacizumab and chemotherapy) demonstrated a statistically significant improvement in the primary endpoint of IRRC-assessed progression-free survival (PFS) compared to Arm C (placebo in combination with chemotherapy). Additionally, key secondary endpoints of objective response rate (ORR) and duration of response (DOR) were improved in Arm A compared with Arm C, which was immature yet. A numerical improvement of IRRC-assessed PFS of Arm A compared to Arm B (sintilimab and chemotherapy combination) was observed, while a trend of PFS benefit was also observed in Arm B versus Arm C, though data was immature yet. The safety profile was consistent with that observed in previously reported studies of sintilimab and bevacizumab biosimilar, without new or unexpected safety signals. The combination of sintilimab and chemotherapy with or without bevacizumab biosimilar was well tolerated. The results of ORIENT-31 had been reported as an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Plenary 2021 in November.

The principal investigator of the ORIENT-31 study, Prof. Shun Lu from the Oncology Department of Shanghai Chest Hospital, stated, "In China, the incidence and mortality of lung cancer ranks top among all malignancies, and about 40%-50% nsqNSCLC patients have an EGFR mutation. The standard first-line treatment for patients with advanced EGFR-mutated nsqNSCLC is EGFR-TKI therapy. However, the therapeutic options after progression on EGFR-TKI are limited, representing a large unmet medical need. ORIENT-31 was the first prospective, double-blind Phase 3 study globally to demonstrate the PFS benefit of immunotherapy in combination with antiangiogenic agents and chemotherapy in patients with EGFR-mutated nsqNSCLC who progressed after EGFR-TKI therapy."

Dr. Hui Zhou, Senior Vice President of Innovent, stated, "While immunotherapy has been approved for treatment of many malignancies, it has not yet been proven to be sufficiently efficacious for oncogene driven cancers. The acceptance of this sNDA by China’s NMPA represents an important milestone in demonstrating the potential value of sintilimab plus bevacizumab and chemotherapy in patients with EGFR-mutated nsqNSCLC who progressed after EGFR-TKI therapy. We look forward to working with the China regulatory authorities on the sNDA review and we hope to bring the new regimen to patients with EGFR-mutated nsqNSCLC who progressed after EGFR-TKI therapy as quickly as possible."

About Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is the leading cause of cancer death worldwide and the second most commonly diagnosed tumor type. Non-small cell lung cancer (NSCLC) accounts for about 80% to 85% of all lung cancer, in which about 70% of NSCLC patients present with locally advanced or metastatic disease that is not suitable for surgical resection at diagnosis. In China, nsqNSCLC accounts for 70% of NSCLC, in which about 40% to 50% of nsqNSCLC patients have an EGFR mutation. The standard first-line treatment for patients with advanced EGFR-mutated NSCLC is a third generation EGFR TKI, or first or second generation EGFR TKI. For patients who have progressed following EGFR-TKI treatment, platinum-based chemotherapy is still the standard therapy with limited benefit, representing a large unmet medical need.

About the ORIENT-31 Study

ORIENT-31 is a randomized, double-blind, multi-center Phase 3 clinical study conducted in China evaluating sintilimab, with or without bevacizumab biosimilar, combined with chemotherapy (pemetrexed and cisplatin) in patients with EGFR-mutated locally advanced or metastatic nsqNSCLC who have progressed following EGFR TKI treatment (ClinicalTrials.gov, NCT003802240). The primary endpoint is PFS as assessed by BIRRC based on RECIST v1.1. The secondary endpoints include overall survival (OS), PFS as assessed by investigators, ORR and safety.

Eligible patients included: patients with disease progression following first or second generation EGFR TKI and confirmed as T790M negative, or T790M positive but further progressed on third generation EGFR-TKI treatment, or patients with disease progression following third generation EGFR TKI as first line treatment.

Patients were randomized in a 1:1:1 ratio to receive sintilimab plus bevacizumab biosimilar combined with pemetrexed and cisplatin (Arm A), sintilimab plus placebo 2 combined with pemetrexed and cisplatin (Arm B), or placebo 1 plus placebo 2 combined with pemetrexed and cisplatin (Arm C). After 4 cycles of combination treatment, patients will receive maintenance treatment of sintilimab plus bevacizumab biosimilar and pemetrexed, sintilimab plus placebo 2 and pemetrexed, placebo 1 plus placebo 2 and pemetrexed, until radiographic disease progression, unacceptable toxicity or any other conditions that required treatment discontinuation. Target accrual is 480 patients. By the data cutoff date of the first interim analysis, 444 patients were enrolled.

About Sintilimab

Sintilimab, marketed as TYVYT (sintilimab injection) in China, is an innovative PD-1 inhibitor with global quality standards jointly developed by Innovent and Eli Lilly and Company. Sintilimab is an immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies of sintilimab worldwide, to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.

In China, sintilimab has been approved and included in the National Reimbursement Drug List (NRDL) for four indications, including:

The treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy;
In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of non-squamous non-small cell lung cancer;
In combination with gemcitabine and platinum chemotherapy, for the first-line treatment of squamous non-small cell lung cancer;
In combination with BYVASDA (bevacizumab biosimilar injection) for the first-line treatment of unresectable or advanced hepatocellular carcinoma.
Additionally, sintilimab currently has three regulatory submissions accepted for review in NMPA, including:

In combination with cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil for the first-line treatment of esophageal squamous cell carcinoma;
In combination with chemotherapy for the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma;
In combination with bevacizumab biosimilar and chemotherapy for EGFR-mutated non-squamous NSCLC following EGFR-TKI treatment.
Additionally, two clinical studies of sintilimab have met their primary endpoints:

Phase 2 study as second-line treatment of esophageal squamous cell carcinoma;
Phase 3 study as second-line treatment for squamous NSCLC with disease progression following platinum-based chemotherapy.
In May 2021, the U.S. FDA accepted for review the Biologics License Application (BLA) for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of non-squamous non-small cell lung cancer.

About BYVASDA (bevacizumab biosimilar injection)

BYVASDA, also known as IBI305, is a bevacizumab biosimilar and a recombinant humanized anti-VEGF monoclonal antibody drug. Vascular endothelial growth factor (VEGF) is an important factor in angiogenesis that is highly expressed by the endothelial cells in most human tumors. An anti-VEGF antibody binds VEGF-A selectively with high affinity and blocks its binding to VEGF-2 receptors on the surface of vascular endothelial cells, thereby inhibiting signaling pathways such as PI3K-Akt/PKB and Ras-Raf-MEK-ERK. BYVASDA produces anti-tumor effects by inhibiting the growth, proliferation and migration of vascular endothelial cells, blocking angiogenesis, reducing vascular permeability, blocking blood supply to tumor tissues, inhibiting the proliferation and metastasis of tumor cells and inducing apoptosis in tumor cells. Since its launch, bevacizumab has been approved for the treatment of patients with multiple malignant tumors globally, including non-small cell lung cancer, metastatic colorectal cancer, glioblastoma, renal cell carcinoma, cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer. The efficacy and safety of bevacizumab in these tumor types have been well recognized worldwide.

In China, BYVASDA (bevacizumab biosimilar injection) is approved for indications including advanced non-small cell lung cancer, metastatic colorectal cancer, adult recurrent glioblastoma, and advanced or unresectable hepatocellular carcinoma.

On December 24, 2021 Shanghai Huaota Biopharmaceutical Co., Ltd. (Huaota) reported that HB0030 (anti-TIGIT monoclonal antibody) completed the first-in-human administration in China at the First Affiliated Hospital of Bengbu Medical College (Press release, Huabo Biopharm, DEC 24, 2021, View Source [SID1234656057]). This is an open label, single-center, dose-escalation Phase Ia clinical study in order to assess the safety and pharmacokinetics in patients with advanced solid tumors. The main The purpose of the study is to comprehensively evaluate the safety, tolerability and antitumor activity of HB0030 in patients with advanced malignant solid tumors.

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About TIGIT

TIGIT, T cell immune receptor with Ig and ITIM domains, is an inhibitory receptor expressed on lymphocytes belonging to the Ig superfamily with multi-characteristic structure of immunoregulatory proteins including CD96 and CD226. They interact with Nectin and nectin-like molecules with different affinities.

TIGIT, CD226, CD96 and their ligands CD155 and CD11 form a complex regulatory network. As TIGIT/CD155 deliver the immunosuppressive signal, CD155 interaction with CD226 deliver an immunostimulating signal. The CD155 and CD112 are highly expressed on the surface of many malignant tumors, such as colorectal cancer and melanoma.

About HB0030

HB0030 is a humanized monoclone antibody designed by Huaota Biopharm to bind TIGIT with high-affinity, thereby blocking the binding of TIGIT to its ligand (such as CD155). By binding to TIGIT, highly expressed on the surface of T cells and NK cells, HB0030 blocks its interaction with CD155, relieves immunosuppression and reactivate the tumor-killing effect of T cells and NK cells.

Preclinical studies have shown that HB0030 has higher affinity and strong ADCC/CDC activity. It can relieve the T-cell immunosuppression and enhance the anti-tumor activity.