On July 7, 2021 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it filed regulatory application with the Ministry of Health, Labour and Welfare for the anti-cancer agent/humanized anti-PD-L1 monoclonal antibody Tecentriq Intravenous Infusion 1200 mg [generic name: atezolizumab (genetical recombination)] for the adjuvant treatment of non-small cell lung cancer (NSCLC) on July 6, 2021 (Press release, Chugai, JUL 7, 2021, View Source [SID1234584651]).

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"Approximately 50% of patients with early-stage lung cancer experience relapse following surgery. It is very important to prevent recurrence in order to improve the cure rate. Tecentriq is the first cancer immunotherapy which reduced the risk of disease recurrence or death in NSCLC as adjuvant therapy following surgery," said Chugai’s President and CEO, Dr. Osamu Okuda. "We are working to obtain regulatory approval to deliver Tecentriq, which has been shown to reduce the rate of recurrence or death, to patients as soon as possible as a new adjuvant treatment for early-stage lung cancer."

This filing is based on the results from phase III IMpower010 study examining Tecentriq as an adjuvant treatment in NSCLC. The study showed for the first time that treatment with Tecentriq following surgery and chemotherapy reduced the risk of disease recurrence or death (disease-free survival; DFS) by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50–0.88) in people with Stage II-IIIA NSCLC, whose tumors express PD-L1≥1%, compared with best supportive care (BSC). VENTANA OptiView PD-L1 (SP263) Assay, a pathological testing kit marketed by Roche Diagnostics K.K., was used to detect PD-L1 expression. Safety data for Tecentriq were consistent with its known safety profile and no new safety signals were identified.

Pivotal Phase III data at ASCO (Free ASCO Whitepaper) show Roche’s Tecentriq helps certain people with early lung cancer live significantly longer without their disease returning (Press release by Roche issued on May 20, 2021)
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About IMpower010 study
IMpower010 is a Phase III, global, multicenter, open-label, randomized study evaluating the efficacy and safety of Tecentriq compared with BSC, in participants with Stage IB-IIIA NSCLC (UICC 7th edition), following surgical resection and up to 4 cycles of adjuvant cisplatin-based chemotherapy. The study randomized 1,005 people with a ratio of 1:1 to receive either at most 16 cycles of Tecentriq or BSC. The primary endpoint is investigator-determined DFS in the PD-L1-positive Stage II-IIIA, all randomized Stage II-IIIA and ITT Stage IB-IIIA populations. Key secondary endpoints include OS in the overall study population, ITT Stage IB-IIIA NSCLC.

About non-small cell lung cancer (NSCLC)
In Japan, 130,000 people (86,800 men and 43,100 women; 2020 predicted values) are estimated to be afflicted with lung cancer each year. 75,600 people in Japan (53,200 men and 22,300 women; 2020 predicted values) die as a result of the disease. Lung cancer is the leading cause of cancer death. Lung cancer can be broadly divided into small cell lung cancer and NSCLC according to the tissue type. NSCLC has the largest number of patients, accounting for about 85% of all lung cancer cases.

About approval status of Tecentriq in Japan
Tecentriq was launched in April 2018 with an indication of unresectable, advanced or recurrent non-small cell lung cancer (NSCLC), followed by an approval for the additional dosing for the treatment of untreated unresectable, advanced or recurrent NSCLC in December 2018. In addition, an approval of extensive-stage small cell lung cancer has been obtained in August 2019, an approval of PD-L1 positive hormone receptor-negative and HER2-negative inoperable or recurrent breast cancer has been obtained in September 2019, and an approval for the additional dosing for the treatment of chemotherapy-naïve unresectable advanced or recurrent non-squamous NSCLC has been obtained in November 2019. Tecentriq was approved for the treatment of unresectable hepatocellular carcinoma in September 2020, followed by an approval for the additional dosing for the treatment of untreated PD-L1 positive, unresectable, advanced or recurrent NSCLC in December 2020.

On July 7, 2021 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, reported a clinical trial and supply agreement with an affiliate of BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160) to evaluate BeiGene’s tislelizumab, an anti-PD-1 immune checkpoint inhibitor, in combination with PureTech’s LYT-200, an investigational monoclonal antibody targeting galectin-9, for the potential treatment of difficult-to-treat solid tumor indications that are associated with poor survival rates (Press release, PureTech Health, JUL 7, 2021, View Source [SID1234584667]).

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Galectin-9 is a pivotal immune modulator widely expressed in multiple difficult-to-treat tumor types and involved in the regulation of tumor promoting inflammatory and immunosuppressive pathways. Inhibition of galectin-9 with targeted antibodies leads to upregulation of immunostimulatory cytokines and anti-tumor activity in preclinical cancer models. LYT-200 is currently being evaluated as a single agent in the first phase of an adaptive Phase 1/2 clinical trial, which, based upon the trial protocol, will be followed by the portion of the trial intended to investigate LYT-200 in combination with tislelizumab. PureTech expects to report topline Phase 1 results in the fourth quarter of 2021. In addition, PureTech plans to investigate LYT-200 as a single agent and in combination with other anti-cancer treatments, including chemotherapy and other immunotherapies.

Tislelizumab is potentially differentiated from the currently approved programmed cell death protein 1 (PD-1) antibodies in an engineered fragment crystallizable region (Fc region), which in preclinical studies has been shown to minimize potentially negative interactions with other immune cells. Tislelizumab has been approved in China for four solid tumor indications and regulatory decisions are pending for two additional indications. In January 2021, BeiGene and Novartis entered into a collaboration and license agreement granting Novartis rights to develop, manufacture and commercialize tislelizumab in North America, Europe and Japan.

"After a decade of optimizing use of immuno-oncology therapies, such as the checkpoint inhibitors that have certainly provided a paradigm shift in treating malignant diseases, we in the industry are eager to advance novel breakthrough agents and combinations to serve a wider range of cancer patients. Patients need new options as the first wave of immunotherapies work only in a small percentage of them. Well thought-out combination immunotherapy regimens may be that way forward," said Aleksandra Filipovic, M.D., Ph.D., Head of Oncology at PureTech. "We believe LYT-200 has the potential to engage the immune system against what are currently intractable cancers, both as a single agent and in combination with checkpoint inhibitors. We look forward to evaluating whether LYT-200 in combination with BeiGene’s tislelizumab can improve outcomes for patients with metastatic solid tumors."

Under the terms of the agreement, PureTech will maintain control of the LYT-200 program, including global R&D and commercial rights. BeiGene has agreed to supply tislelizumab for use in combination with LYT-200.

About LYT-200
LYT-200 is a monoclonal antibody targeting a foundational immunosuppressive protein, galectin-9, for the potential treatment of solid tumors, including pancreatic ductal adenocarcinoma, colorectal cancer and cholangiocarcinoma, that are difficult to treat and have poor survival rates. PureTech has presented preclinical data demonstrating high expression of galectin-9 across breast cancer, pancreatic cancer and cholangiocarcinoma samples and found that the highest levels of galectin-9 correlated with shorter time to disease relapse and poor survival. These data suggest that galectin-9 could be significant both as a therapeutic target for solid tumors for a range of cancers and as a cancer biomarker. Preclinical animal and patient-derived organoid tumor models also showed the potential efficacy of LYT-200 and the importance of galectin-9 as a target. LYT-200 is currently being evaluated in a Phase 1/2 adaptive design trial, and results from the Phase 1 portion are expected in the fourth quarter of 2021.

About Tislelizumab
Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

The China National Medical Products Administration (NMPA) has granted tislelizumab in five indications, including full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy and for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy; and conditional approval for the treatment of patients with classical Hodgkin’s lymphoma (cHL) who received at least two prior therapies, for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, and for the treatment of patients with hepatocellular carcinoma (HCC) who have received at least one systemic therapy. Full approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

In addition, two supplemental Biologics License Applications for tislelizumab have been accepted by the Center for Drug Evaluation (CDE) of the NMPA and are under review for second- or third-line treatment of patients with locally advanced or metastatic NSCLC who progressed on prior platinum-based chemotherapy and for patients with previously treated, locally advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) solid tumors.

BeiGene has initiated or completed 17 potentially registration-enabling clinical trials in China and globally, including 13 Phase 3 trials and four pivotal Phase 2 trials.

In January 2021, BeiGene and Novartis entered into a collaboration and license agreement granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe and Japan.

Tislelizumab is not approved for use outside of China.

On July 7, 2021 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ("Silverback"), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases, reported a clinical supply agreement with Regeneron for Libtayo (cemiplimab) (Press release, Silverback Therapeutics, JUL 7, 2021, View Source [SID1234584668]). The supply agreement supports the evaluation of Libtayo, a PD-1 inhibitor, in combination with SBT6050, the first of a new class of targeted immuno-oncology agents designed to direct a TLR8 agonist linker-payload to activate myeloid cells in tumors expressing moderate to high levels of HER2.

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"SBT6050’s unique ability to activate both innate and adaptive immune responses has the potential to enhance and expand the effectiveness of a PD-1 inhibitor in HER2-expressing solid tumors," said Naomi Hunder, M.D., Chief Medical Officer of Silverback. "We are eager to complete the ongoing dose escalation of SBT6050 combined with a PD-1 inhibitor, and look forward to working with Regeneron as we begin tumor-specific expansion cohorts."

In the first quarter of 2021, Silverback initiated treatment in Part 3 of the Phase 1/1b study to evaluate the activity of SBT6050 in combination with a PD-1 inhibitor in dose escalation. Under the terms of the agreement, Silverback will expand the ongoing Phase 1/1b trial to evaluate the combination of SBT6050 and Libtayo in tumor-specific dose expansion cohorts, initially in HER2-expressing non small cell lung cancer ("NSCLC") and gastric cancer.

Libtayo is a PD-1 blocking antibody being jointly developed and commercialized by Regeneron and Sanofi. Libtayo is approved for the first-line treatment of patients with advanced NSCLC whose tumors have high PD-L1 expression (tumor proportion score ≥50%), as determined by an FDA-approved test, with no EGFR, ALK, or ROS1 aberrations, for adults with metastatic cutaneous squamous cell carcinoma ("CSCC") or locally advanced CSCC who are not candidates for curative surgery or curative radiation, and for patients with advanced basal cell carcinoma previously treated with a hedgehog pathway inhibitor ("HHI") or for whom an HHI is not appropriate that is either locally advanced (full approval) or metastatic (accelerated approval).

On July 7, 2021 Viewpoint Molecular Targeting, Inc. ("Viewpoint" or the "Company"), a radiopharmaceutical company developing precision lead-212-based α-particle oncology therapeutics and complementary diagnostic imaging agents, reported it has entered into a collaborative partnership with Netherlands-based Pepscan Therapeutics B.V. ("Pepscan"), the all-in-one peptide service provider with proprietary peptide constraining technologies (Press release, Viewpoint Molecular Targeting, JUL 7, 2021, https://viewpointmt.com/viewpoint-molecular-targetingr-partners-with-industry-leader-pepscan-to-accelerate-peptide-discovery-program/ [SID1234585493]).

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"Pepscan is clearly a world leader in peptide discovery and lead optimization, and we are delighted to have taken the first step on this journey," commented Michael K. Schultz, PhD, Chief Science Officer and Co-Founder of Viewpoint. "In our diligence, the Pepscan team is technically and professionally the strongest we’ve had the pleasure to work with. We are particularly excited to see how their CLIPS innovative scaffold technology results in superior synthetic peptide candidates for us to develop."

Peptide-based radiopharmaceuticals have recently emerged as an exciting therapeutic and diagnostic platform in the areas of neuroendocrine tumors, prostate cancer, and other solid tumors. Pepscan’s world-leading libraries of CLIPS (Chemical Linkage of Peptides onto Scaffolds) constrained peptides combined with its screening technologies and deep knowledge of the discovery process will result in optimal ligands which bind cancer-specific cellular targets with high affinity and selectivity. In post-discovery the candidates can be modified with Viewpoint’s proprietary linker and chelator technology which is specific for the lead-212 therapeutic isotope and lead-203 imaging isotope. This allows Viewpoint’s in-house scientists to optimize the pharmacokinetic "tuning" of the peptides to ensure high tumor uptake and reduced healthy organ uptake.

"We are excited to join Viewpoint’s journey and enable them to develop life-improving breakthroughs. Ultimately, the success of our peptide discovery and optimization for radiopharmaceuticals lies in the technical strength, expertise, and understanding of the team that transitions our candidates into clinically relevant radiopharmaceutical drugs," added Pepscan’s Director of Peptide Discovery, Michael Goldflam. "Given Viewpoint’s track-record in translating its two lead products through development to clinic-ready status, we have great confidence that the Viewpoint team will achieve success based on our discovery results."

This collaborative partnership agreement provides an avenue for both Viewpoint and Pepscan to focus on their world-leading expertise and technologies in order to accelerate the process from discovery phase to clinic-ready radiopharmaceuticals. The terms of the agreement are to remain confidential.

On July 6, 2021 The South Korean biotech company Y-Biologics and the French pharmaceutical group Pierre Fabre reported that they have entered into a license agreement granting worldwide exclusive rights to Pierre Fabre to develop and commercialize a family of human antibodies generated through the phage display human antibody Ymax-ABL library owned by Y-Biologics (Press release, Pierre Fabre, JUL 6, 2021, View Source [SID1234584653]).

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These antibodies have been functionally validated by the Pierre Fabre R&D teams for their specific properties on a pivotal immuno-oncology target acting on the tumoral microenvironment. Pierre Fabre intends to select a new therapeutic candidate in immuno-oncology for further developments.

This licensing agreement results from the strong and now proven complementarity between the two companies who have been collaborating since 2018. The final objective pursued by Y-Biologics and Pierre Fabre is to provide patients with innovative drugs to target refractory or relapsing cancer, taking advantage of the immune infiltrate to inhibit the growth of tumor cells.

This new milestone reached by the two companies reveals the effectiveness of the scientific means put in place by Y-Biologics, associated with the high expertise of Pierre Fabre in oncology.

Young Woo Park, CEO of Y-Biologics, stated: "We are very pleased to sign our first license agreement with Pierre Fabre. The collaboration between Y-Biologics and Pierre Fabre which is being conducted based on mutual trust, is expected to further advance the development of innovative immuno-oncology therapeutics targeting the tumor microenvironment."

"Since the beginning of our partnership, the collaboration with Y-Biologics has been very efficient and fruitful. Their library has allowed us to identify a family of human antibodies against a promising target defined by our researchers at our dedicated Center of Immunology. This new exciting license agreement will allow us to further support the development of this therapy for the benefit of patients," added Nathalie Corvaïa, Head of Immuno-Oncology Research, Center of Immunology Pierre Fabre (CIPF).