On September 21, 2018 Seattle Genetics, Inc. (Nasdaq: SGEN) reported that its collaborator, Takeda Pharmaceutical Company Limited (Takeda), has received approval from the Japanese Ministry of Health, Labour and Welfare for ADCETRIS (brentuximab vedotin) in combination with doxorubicin, vinblastine and dacarbazine (AVD) as a frontline treatment option for CD30-positive Hodgkin lymphoma patients in Japan (Press release, Seattle Genetics, SEP 21, 2018, View Source [SID1234529517]). As a result, Seattle Genetics will receive a milestone payment from Takeda of $10 million. The approval in Japan was based on the positive outcome from the phase 3 ECHELON-1 trial.

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"This approval marks another important milestone in expanding the ADCETRIS brand globally and redefining the way newly diagnosed Hodgkin lymphoma patients are treated around the world," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "ADCETRIS is approved in 71 countries and generated global sales of approximately $640 million in 2017, underscoring its progress toward becoming the foundation of therapy for patients with CD30-expressing lymphomas."

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs. Seattle Genetics is entitled to receive progress- and sales-dependent milestone payments. In addition, Seattle Genetics receives tiered double-digit royalties with percentages ranging from the mid-teens to mid-twenties based on net sales of ADCETRIS within Takeda’s territories.

About Hodgkin Lymphoma

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Classical Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. The Reed-Sternberg cell expresses CD30. According to the Lymphoma Coalition, over 62,000 people worldwide are diagnosed with Hodgkin lymphoma each year and approximately 25,000 people die each year from this cancer.

About ADCETRIS (brentuximab vedotin)

ADCETRIS is being evaluated broadly in more than 70 clinical trials, including the ongoing phase 3 ECHELON-2 trial in frontline peripheral T-cell lymphomas (also known as mature T-cell lymphoma), the completed phase 3 ALCANZA trial in cutaneous T-cell lymphoma (CTCL) and the completed ECHELON-1 trial in previously untreated Hodgkin lymphoma, as well as trials in many additional types of CD30-positive lymphomas.

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream, but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS injection for intravenous infusion has received FDA approval for five indications in adult patients with: (1) previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy, (2) cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (3) cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (4) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (5) primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL in 2013, and non-conditional approval for post-autologous stem cell transplantation (ASCT) consolidation treatment of Hodgkin lymphoma patients at increased risk of relapse or progression.

ADCETRIS received conditional marketing authorization from the European Commission in October 2012. The approved indications in Europe are: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (2) the treatment of adult patients with relapsed or refractory sALCL, (3) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, and (4) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

ADCETRIS has received marketing authorization by regulatory authorities in 71 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See select important safety information, including Boxed Warning, below.

On September 20, 2018: ENB Therapeutics Inc., a biopharmaceutical company pioneering pathways in endothelin-based oncologics, reported that it has closed its Series A private equity financing (Press release, ENB Therapeutics, SEP 21, 2018, View Source [SID1234634055]). Proceeds from the financing will be used to advance the company’s lead investigational drug compound, ENB-003,a first-in-class, selective inhibitor of the endothelin B receptor ("ETBR") through pre-clinical and early clinical development for the treatment of immunotherapy-resistant cancers.

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Remiges Ventures served as lead investor for the financing with participation from New York State Development, BioAdvance and Alexandria Ventures.

"We are extremely gratified to have attracted a leading group of investors to complete our Series A financing who recognize the potential of ENB-003 to overcome resistance to immunotherapy across multiple tumor types and indications," said Sumayah Jamal, Founder, President and Chief Scientific Officer of ENB. "We have already demonstrated robust pre-clinical efficacy in relevant mouse models across multiple resistant cancers and a favorable safety profile. We now have the capital necessary to advance ENB-003 into Phase 1 clinical trials during the second half of 2019."

Taro Inaba, Managing Partner at Remiges, added, "We believe that ENB Therapeutics’ novel compounds have the potential to enhance the efficacy of immunotherapies and potentially prolong patient survival and thereby address the high unmet medical need which still exists despite the successful development and widespread use of immunotherapies. Therefore, we are very pleased to have the opportunity to support the continued clinical development of ENB-003, which could improve the lives of patients with cancer."

On September 21, 2018 Takeda Pharmaceutical Company Limited ( TSE: 4502 ) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the unreserved approval of ALUNBRIG (brigatinib) used as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) positive for anaplastic lymphoma kinase (ALK +) previously treated with crizotinib (Press release, Takeda, SEP 21, 2018, View Source [SID1234529518]).

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The original text of this announcement, written in the source language, is the official version that is authentic. Translations are offered solely for the convenience of the reader and must refer to the original text, which is the only legally valid one.

On September 21, 2018 XOMA Corporation (NASDAQ: XOMA), reported that for $15.0 million, it has acquired from Agenus (NASDAQ: AGEN) a partial interest position in the rights to potential milestone and royalty payments associated with seven immuno-oncology antibodies currently being developed by Merck and Incyte under their collaborations with Agenus (Press release, Xoma, SEP 21, 2018, View Source [SID1234529553]).

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"This is an important deal reflecting our new royalty-aggregator strategy to acquire milestone and royalty payments associated with therapeutic candidates partnered by others. The basket of Agenus immuno-oncology assets is advancing in the hands of two of the leading companies in oncology drug development," said Jim Neal, Chief Executive Officer at XOMA. "These assets possess all the characteristics we have established for our business model: outstanding development partners, mid-stage to early stage assets, important therapeutic categories, and sizable royalty commitments. We believe this investment could generate potential future cash flows over an extended period from milestones and royalties on some exciting potential commercial opportunities."

The seven royalty interest antibodies are:

One Phase 1 antibody being developed by Merck on an undisclosed novel target;

Incyte’s INCAGN1876, a GITR agonist in Phase 1/2 studies;

Incyte’s INCAGN1949, an OX-40 agonist in Phase 1/2 studies;

Incyte’s INCAGN2385, a LAG-3 antagonist in Phase 1 studies;

Incyte’s INCAGN02390, a TIM-3 antagonist expected to enter the clinic in 2018; and,

Two preclinical antibodies being developed by Incyte on undisclosed targets.

Under the terms of the agreement, XOMA will receive low- to mid-single-digit royalties on future sales of these seven immuno-oncology assets. Additionally, XOMA is entitled to a portion of milestone payments associated with the assets. XOMA has drawn $7.5 million from its line of credit with Silicon Valley Bank ("SVB") to partially fund this transaction.

On September 20, 2018 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported its preliminary clinical data from Chinese patients with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) solid tumors enrolled in an ongoing Phase 1/2 clinical trial of tislelizumab, an investigational anti-PD-1 antibody, at the 21st Annual Meeting of the Chinese Society of Clinical Oncology (CSCO) in Xiamen, China.

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"Tislelizumab is being developed in a broad clinical program as both a monotherapy and in combination with other treatments for a number of potential clinical indications. We are encouraged by the preliminary results presented today with tislelizumab for patients with MSI-H or dMMR solid tumors and are excited about starting a Phase 2 trial in China in patients with advanced forms of these tumors to test our belief that they are sensitive to immune checkpoint inhibition. We hope this further enables the availability of new treatments options, which are urgently needed, especially in China," commented Amy Peterson, M.D., Chief Medical Officer, Immuno-Oncology, at BeiGene.

"This is the first presentation of tislelizumab data in the population of patients with MSI-H or dMMR solid tumors, and we are encouraged by the objective response rate of 29 percent in a difficult-to-treat patient population. Tislelizumab was also generally well-tolerated in these patients," said Lin Shen, M.D., Vice President of Clinical Oncology at Beijing Cancer Hospital and Peking University, and study presenter. "We hope that further study of tislelizumab may lead to a new treatment for patients with these tumors."

Summary of Results from the MSI-H and dMMR Cohorts in the Phase 1/2 Trial

The multi-center, open-label Phase 1/2 trial of tislelizumab as monotherapy in advanced solid tumors in China (CTR20160872) consists of a Phase 1 dose verification component and a Phase 2 component of indication expansion in disease-specific cohorts, which includes MSI-H and dMMR solid tumors.

Data presented at CSCO today are from 22 patients enrolled in the cohort, of which 14 patients with centrally confirmed MSI-H/dMMR tumors were evaluable for antitumor activity per RECIST v1.1 criteria. Patients were treated with tislelizumab at a dose of 200 mg every three weeks. Colorectal cancer was the most common primary tumor type and 82 percent of the study population received one or more prior lines of systemic therapy. At the time of the data cutoff on May 11, 2018, median treatment duration was 2.2 months (0.69-11.1 months), median follow-up time was 4.4 months (0.10-10.7 months), and ten patients remained on treatment.

Adverse events (AEs) assessed by the investigator to be related to treatment occurred in 18 patients (82%). Of those, the most common treatment-related AEs (TRAEs) (occurring in ≥ 15% of patients) were increased bilirubin (36%), increased transaminase (27%), increased blood creatine phosphokinase (23%), anemia (23%) and decreased white blood cell and/or neutrophil count (18%). All of the TRAEs were grades 1 or 2. Immune-related AEs (irAEs) occurred in 13 patients (59%) and many were overlapping with the TRAE cases. All irAEs were grade 1 or 2 as well.

At the time of the data cutoff, the efficacy evaluation was early and 14 patients, including 12 patients with colorectal cancer, with centrally confirmed MSI-H/dMMR tumors were evaluable for response. The objective response rate was 29 percent (four patients, all with colorectal cancer), with the median duration of response still maturing. Additionally, three patients centrally confirmed as negative for MSI-H/dMMR were evaluable for response, and progressive disease was the best response in all three of these patients.

In addition to this Phase 1/2 trial, tislelizumab is being investigated in two pivotal Phase 2 clinical trials in China in relapsed/refractory (R/R) classical Hodgkin’s lymphoma and in urothelial cancer, Phase 3 trials in China and globally in a number of malignancies including non-small cell lung cancer, hepatocellular carcinoma, and esophageal squamous cell carcinoma; as well as two global Phase 2 trials in patients with previously treated hepatocellular carcinoma or with R/R mature T- and NK-cell lymphomas.

About Microsatellite Instability-High or Mismatch Repair Deficient Solid Tumors
Microsatellite instability-high (MSI-H) cancer cells have a greater than normal number of genetic markers called microsatellites, which are short, repeated sequences of DNA. Cancer cells that have large numbers of microsatellites may have defects in the ability to correct mistakes (also known as mismatch repair deficiency, or dMMR) that occur when DNA is copied in the cell. MSI-H and dMMR tumors are found most often in colorectal cancer, other types of gastrointestinal cancer and endometrial cancer, although they may also be found in cancers of the breast, prostate, bladder and thyroid.

About Tislelizumab
Tislelizumab (BGB-A317) is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. Discovered by BeiGene scientists in Beijing, tislelizumab is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. Tislelizumab has demonstrated high affinity and specificity for PD-1. It is potentially differentiated from the currently approved PD-1 antibodies in an engineered Fc region, which is believed to minimize potentially negative interactions with other immune cells, based on preclinical data. Tislelizumab is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. BeiGene and Celgene Corporation have a global strategic collaboration for the development of tislelizumab in solid tumor cancers outside of Asia (except Japan).