Transgene Announces Investor Meetings for January 2020

On December 9, 2019 Transgene (Paris:TNG) reported that Management will participate in the upcoming investor events set out below (Press release, Transgene, DEC 9, 2019, View Source [SID1234552144]).

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Transgene will meet institutional investors at the LifeSci Advisors Corporate Access Event from January 13 to 16, 2020, in San Francisco, USA, concurrent with the J.P. Morgan Healthcare conference.

The Company will also attend:

Oddo Forum: January 9 & 10, 2020 – Lyon, France
Biomed Event: January 28, 2020 – Paris, France

BostonGene and Weill Cornell Medicine Reveal Results from Cancer Microenvironment Study

On December 9, 2019 BostonGene Corporation (BostonGene), a Boston-based biomedical software company, reported the results of its recent cancer microenvironment study during the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition held on December 7-10, 2019 (Press release, BostonGene, DEC 9, 2019, View Source [SID1234552143]). The research study examined the role of the tumor microenvironment of Diffuse Large B-Cell Lymphoma (DLBCL).

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The study, conducted as part of BostonGene’s collaboration with Weill Cornell Medicine, combined whole exome and transcriptome analyses from an integrated cohort of 3,026 DLBCL patients. The cohort includes publically available data as well as prospective patients.

The study revealed that a new classification based on the tumor microenvironment is associated with clinical outcomes independently of existing molecular subtypes.Computationally predicted results demonstrated a strong correlation with response therapy obtained in murine DLBCL models for subtypes based on stromal, immune and malignant composition.

"Improving treatment outcomes for individual DLBCL patients by integrated analysis of large-scale next-generation sequencing (NGS) data including somatic variants and gene expression changes in the tumor and the tumor microenvironment is our top priority," said Leandro Cerchietti, M.D., Associate Professor of Medicine and a member of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine. "These promising findings bring us one step closer to achieving that goal."

"We are proud to collaborate with Weill Cornell Medicine to provide advanced computational analytics for the integration of big data sets generated for each patient," said Andrew Feinberg, President and CEO of BostonGene. "We look forward to continuing our collaboration to further identify the best treatment options for cancer patients."

Samyang Biopharm USA, Inc. and Talix Therapeutics NV Announce Global Strategic Collaboration to Advance Novel Immuno-Oncology Therapeutic

On December 9, 2019 Samyang Biopharm USA, Inc. (View Source) a global biotech subsidiary of the Samyang Pharmaceuticals Corp. (View Source), reported that the company has entered into a research collaboration with the exclusive option to a worldwide licensing agreement with Talix Therapeutics NV (Press release, Samyang Biopharmaceuticals, DEC 9, 2019, View Source [SID1234552142]). Financial terms of the agreement were not disclosed.

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Under the terms of the agreement, Talix grants Samyang research rights with the exclusive option to worldwide rights for the development, manufacturing and commercialization of Talix’s anti-CD96 antibody, a first-in-class compound currently engaged in preclinical studies.

"We are excited to establish this alliance with Talix, an innovative biotechnology company who has made great strides in the preclinical development of its lead oncology compound," said Helen Hyun Jung Lee M.D., President/CEO, Samyang Biopharm USA, Inc. "Talix shares Samyang’s passion and commitment to discovering breakthrough medicines with the potential to improve the lives of cancer patients worldwide and this collaboration provides our company with a promising preclinical candidate to add to our emerging pipeline of Immuno-Oncology candidates."

Talix discovered the co-stimulatory role of human CD96 on T cells and NK cells, including Tumor Infiltrating Lymphocytes (TILs). Antibodies to CD96 have been reported to protect mice from tumors by activating T cells. In vivo data indicate such antibodies can synergize with PD-1 checkpoint blocking molecules.

"Talix is very enthusiastic with the prospect of Samyang’s research and development team advancing the Talix’s anti-CD96 antibody and we feel that the company has the established management experience and proven scientific acumen within oncology to deliver a drug candidate with great promise," said Jack Elands, CEO of Talix.

Samyang’s collaboration with Talix Therapeutics is the second partnership disclosed by the company in recent weeks. On December 2, Samyang announced a global partnership with CanCure LLC in the immune-oncology therapeutic area which included the license of a first in class immune stimulatory monoclonal antibody targeting soluble MHC class 1 chain-related protein (sMIC). [View Source/downloads/Samyang-USA-CanCure-Collaboration.pdf]

Celularity Presents Pre-Clinical and Clinical Data from its Allogeneic, Placental-Derived, Off-the-Shelf Cell Therapy Platform at the 2019 ASH Annual Meeting

On December 9, 2019 Celularity, Inc. ("Celularity"), a clinical-stage cell therapeutics company focused on the development of innovative allogeneic cellular therapies derived from post partum human placentas, reported data introducing an extensive platform in genetically-modified NK- and T cell-based programs, and highlighting long-term safety and efficacy results from the Phase 1 study of PNK-007 in patients with multiple myeloma (MM) (Press release, Celularity, DEC 9, 2019, View Source [SID1234552141]). These data were announced at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando, F.L.

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In pre-clinical studies, Celularity’s allogeneic, placental-derived CD19 CAR T cell-based product candidate demonstrated in vivo anti-tumor efficacy in a lymphoma tumor model. Additionally, the Company’s CD38 CAR NK cell-based product candidate showed in vitro and in vivo anti-tumor activity against CD38+ lymphoma and multiple myeloma cell lines without any on-target, off-tumor effect. Moreover, the Company’s allogeneic, placental CD34+ cell-derived NK product candidate overexpressing a CD16 variant demonstrated its versatile combination potential with monoclonal antibodies to elicit in vitro and in vivo enhanced antibody-dependent cell mediated cytotoxicity (ADCC) function against lymphoma cell lines.

Results from a Phase 1 clinical study evaluating PNK-007 in patients with multiple myeloma demonstrated a single infusion of PNK-007 was well tolerated after autologous stem cell transplant (ASCT) for up to one year. PNK-007 is a first-generation investigational allogeneic off-the-shelf NK cell therapy. No serious adverse events (AEs) were attributable to PNK‐007, and no dose-limiting toxicity, graft-verse-host disease (GvHD), cytokine release syndrome (CRS), graft failure or graft rejection was observed.

"We are excited about the pre-clinical and clinical findings presented at ASH (Free ASH Whitepaper) this year which adds to a growing body of evidence about the range and versatility of our allogeneic, off-the-shelf, placental-derived cell therapy platform, and its potential uses against a range of devastating cancers which today have limited treatment options," said Robert Hariri, M.D., Ph.D., Founder, Chairman and CEO at Celularity. "At Celularity we believe the next evolution in immunotherapy for cancer demands scalable, high quality and economical solutions which provide fully allogeneic, off-the-shelf products. The Celularity technology platform can provide that solution. We look forward to rapidly advancing multiple placental-derived NK- and T cell-based product candidates with potential as more tolerable, more accessible immunotherapies."

About PNK-007

PNK‐007 is the only allogeneic, off-the-shelf NK cell therapy being developed from placental hematopoietic stem cells as a potential treatment option for various hematologic cancers and solid tumors. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and interacting with adaptive immunity. When derived from the placenta, these cells offer intrinsic safety and versatility, allowing potential use across a range of organs and tissues. PNK cells are currently being investigated as a treatment for acute myeloid leukemia (AML) and multiple myeloma (MM).

Seattle Genetics and Takeda Announce Additional Analyses of ADCETRIS® (Brentuximab Vedotin) ECHELON-1 and ECHELON-2 Phase 3 Clinical Trials at the 2019 ASH Annual Meeting

On December 9, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) and Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) reported additional analyses of results from the ECHELON-1 and ECHELON-2 frontline phase 3 trials of ADCETRIS (brentuximab vedotin) (Press release, Seattle Genetics, DEC 9, 2019, View Source [SID1234552140]). These analyses were presented at the 61st Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) taking place December 7-10, 2019 in Orlando, Fla. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical Hodgkin lymphoma and expressed on the surface of several types of peripheral T-cell lymphomas (PTCL).

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The ECHELON-1 analysis highlighted a four-year update of the phase 3 clinical trial in a poster presentation. ECHELON-1 is evaluating ADCETRIS in combination with AVD (Adriamycin [doxorubicin], vinblastine and dacarbazine) compared to ABVD (Adriamycin [doxorubicin], bleomycin, vinblastine and dacarbazine) in patients with Stage III or IV frontline classical Hodgkin lymphoma.

The ECHELON-2 phase 3 clinical trial data were presented in an oral session at ASH (Free ASH Whitepaper) and focused on the outcomes of the subset of patients who underwent consolidative stem cell transplant. ECHELON-2 is evaluating ADCETRIS in combination with CHP (cyclophosphamide, doxorubicin, prednisone) compared to CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) in frontline CD30-expressing PTCL.

"For decades, the standard of care for the treatment of frontline Hodgkin lymphoma has been combination chemotherapy, called ABVD. Unfortunately, approximately 30 percent of patients with advanced stage Hodgkin lymphoma do not respond or relapse following treatment with this therapy," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. "The four-year update from the ECHELON-1 trial continues to support the robust and durable frontline treatment benefit of ADCETRIS plus AVD, including in both Stage III and IV disease settings, compared to ABVD across subgroups, regardless of PET2 status. These data reinforce ADCETRIS plus AVD as a treatment option that should be offered to all newly diagnosed advanced stage patients with Hodgkin lymphoma."

"Updated data from the ECHELON-1 trial and further insights from ECHELON-2 build upon our continued understanding of the potential ADCETRIS offers patients with CD30-positive lymphomas," said Phil Rowlands, Ph.D., Head, Oncology Therapeutic Area Unit, Takeda. "We’re especially encouraged by the promising four-year follow-up ECHELON-1 results being presented at ASH (Free ASH Whitepaper), as approximately one in three patients with advanced Hodgkin lymphoma do not achieve long-term remission after standard frontline therapy."

Brentuximab Vedotin with Chemotherapy for Stage 3/4 Classical Hodgkin Lymphoma (cHL): 4-Year Update of the ECHELON-1 Study (Abstract #4026, poster presentation on Monday, December 9, 2019)

As previously reported, the ECHELON-1 trial achieved its primary endpoint with the combination of ADCETRIS plus AVD resulting in a statistically significant improvement in modified progression-free survival (PFS) compared to the control arm of ABVD as assessed by independent review facility (IRF; hazard ratio (HR), 0.77; p=0.035). A four-year post-hoc exploratory analysis was conducted to examine PFS outcomes per investigator assessment in the intent-to-treat population of 1,334 patients, including results by PET2 status, age, stage and prognostic risk scores. Results include:

The four-year PFS rate for patients in the ADCETRIS plus AVD arm was 81.7 percent compared to 75.1 percent in the ABVD arm, a difference of 6.6 percent (HR, 0.69 [95% CI: 0.542, 0.881]). This represents a 31 percent reduction in the risk of progression or death. Median follow-up time was 48.4 months.
A PFS benefit at four-years for ADCETRIS plus AVD was observed for all patients independent of PET2 status, including in patients who are less than 60 years old.
PET2-negative result was 86.2 percent in the ADCETRIS plus AVD arm compared to 81.0 percent in the ABVD arm (HR, 0.69), a difference of 5.2 percent.
PET2-positive result was 62.1 percent in the ADCETRIS plus AVD arm compared to 47.7 percent in the ABVD arm (HR, 0.65), a difference of 14.4 percent.
Consistent improvement in PFS was observed among patients treated with ADCETRIS plus AVD compared with ABVD across the majority of pre-specified subgroups, including disease stage, age and prognostic score.
Notably, improvements compared to ABVD were observed in patients with Stage III (HR, 0.595; [95% CI: 0.386, 0.917]) and Stage IV (HR, 0.745; [95% CI: 0.555, 1.001]) disease.
As previously reported for the primary analysis, on the ADCETRIS plus AVD arm, peripheral neuropathy events were observed in 67 percent of patients compared to 43 percent in the ABVD arm. The four-year update shows that among patients with peripheral neuropathy, 83 percent in the ADCETRIS plus AVD arm and 84 percent in the ABVD arm reported complete resolution or improvement at last follow-up.
More than 45 countries and regions have approved ADCETRIS in combination with AVD for the treatment of patients with previously untreated Stage III or IV Hodgkin lymphoma. The U.S. Food and Drug Administration (FDA) approved ADCETRIS in combination with AVD for the treatment of adult patients with previously untreated stage III or IV classical Hodgkin lymphoma in March 2018, based on the results of the ECHELON-1 phase 3 clinical trial in which the primary endpoint was modified PFS. In February 2019, the European Commission (EC) approved ADCETRIS for the treatment of adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma in combination with AVD.

An Exploratory Analysis of Brentuximab Vedotin plus CHP (A+CHP) in the Frontline Treatment of Patients with CD30+ Peripheral T-Cell Lymphomas (ECHELON-2): Impact of Consolidative Stem Cell Transplant (Abstract #464, oral presentation on Sunday, December 8, 2019)

As previously reported, the ECHELON-2 trial met its primary endpoint with the combination of ADCETRIS plus CHP resulting in a statistically significant improvement in PFS versus the control arm of CHOP per blinded independent central review (HR, 0.71; p=0.0110). In addition, the overall survival benefit in the ADCETRIS plus CHP arm was statistically significant compared to CHOP (HR, 0.66; p=0.0244). A post-hoc exploratory analysis evaluated the impact of consolidative stem cell transplant in the ECHELON-2 study for the patients who achieved CR treated with ADCETRIS plus CHP. In the ADCETRIS plus CHP arm, this included 38 patients in CR who received a stem cell transplant and 76 patients in CR who did not. Key findings of this analysis include:

The PFS estimate favored the use of stem cell transplant (HR, 0.38; [95% CI: 0.18, 0.82]). After a median follow-up time of 35.9 months, the three-year PFS rate for the 38 patients who received a stem cell transplant was 76.1 percent. After a median follow-up time of 41.6 months, the three-year PFS rate for the 76 patients who did not receive a stem cell transplant was 53.3 percent.
As previously reported, the safety profile of ADCETRIS plus CHP in the ECHELON-2 trial was comparable to CHOP and consistent with the established safety profile of ADCETRIS in combination with chemotherapy.
About Classical 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 American Cancer Society, approximately 8,110 cases of Hodgkin lymphoma will be diagnosed in the United States during 2019 and 1,000 will die from the disease. Approximately half of all newly diagnosed Hodgkin lymphoma patients have Stage III/IV disease. 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 T-Cell Lymphomas

There are more than 60 subtypes of non-Hodgkin lymphomas which are broadly divided into two major groups: B-cell lymphomas, which develop from abnormal B-lymphocytes, and T-cell lymphomas, which develop from abnormal T-lymphocytes. There are many different forms of T-cell lymphomas, some of which are extremely rare. T-cell lymphomas can be aggressive (fast-growing) or indolent (slow-growing). PTCL accounts for approximately 10 percent of non-Hodgkin lymphoma cases in the U.S. and Europe and may be as high as 24 percent in parts of Asia.

About ADCETRIS

ADCETRIS is being evaluated broadly in more than 70 clinical trials in CD30-expressing lymphomas. These include three completed phase 3 trials: ECHELON-2 trial in frontline peripheral T-cell lymphomas, ECHELON-1 in previously untreated Hodgkin lymphoma, and ALCANZA in cutaneous T-cell lymphoma.

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 six indications in adult patients with: (1) previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone, (2) previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine, (3) cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (4) 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, (5) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (6) 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 in 2013 for patients with (1) HL after failure of autologous stem cell transplant (ASCT) or after failure of at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates and (2) sALCL after failure of at least one multi-agent chemotherapy regimen. Non-conditional approval was granted for (3) post-ASCT consolidation treatment of patients with HL at increased risk of relapse or progression in 2017, (4) adult patients with pcALCL or CD30-expressing MF who have received prior systemic therapy in 2018, (5) for previously untreated patients with Stage IV HL in combination with doxorubicin, vinblastine, and dacarbazine in 2019, and (6) for previously untreated adult patients with sALCL, peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS) or angioimmunoblastic T-cell lymphoma (AITL), whose tumors express CD30, in combination with cyclophosphamide, doxorubicin, prednisone in 2019.

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) for 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, (4) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy and (5) for the treatment of adult patients with previously untreated CD30-positive Stage IV Hodgkin lymphoma in combination with AVD (Adriamycin, vinblastine and dacarbazine).

ADCETRIS has received marketing authorization by regulatory authorities in 73 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See select important safety information, including Boxed Warning, below.

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.