On December 27, 2018 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported an update from several clinical development programs and a 2019 business overview (Press release, Bio-Path Holdings, DEC 27, 2018, View Source [SID1234532290]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Over the last year, we made solid progress across our growing development pipeline, highlighted by positive interim data from our Phase 2 study of prexigebersen in de novo acute myeloid leukemia (AML) patients," stated Peter H. Nielsen, chief executive officer of Bio-Path Holdings. "We enter 2019 focused and optimistic about our prospects for the clinical advancement of our pipeline of RNAi nanoparticle drugs in patients suffering from a variety of cancers of unmet medical need."

Phase 2 Study of Prexigebersen in De Novo AML Patients

In August 2018, Bio-Path announced first patient dosed in Stage 2 of the open-label Phase 2 study evaluating the efficacy and safety of prexigebersen (an antisense RNAi nanoparticle against Grb2 protein) in combination with LDAC and a second cohort of prexigebersen and decitabine, both therapeutic regimens well established in treatment of acute myeloid leukemia (AML) patients who cannot or elect not to be treated with more intensive chemotherapy. The primary objective of the study is to determine whether these combinations with prexigebersen provide greater efficacy than what would be expected with low-dose cytarabine (LDAC) or decitabine alone in this de novo patient population. In 2019, Bio-Path expects to open three trial sites in the EU, which Bio-Path expects will accelerate patient enrollment.

As previously announced, a planned interim analysis of Stage 1 of the study was performed on 17 evaluable patients, with four patients achieving complete responses (24%) and four patients achieving stable disease, including one patient achieving a morphologic leukemia free state and one patient who showed significantly reduced bone marrow blasts. In total, 47% of the evaluable patients showed some form of response, including stable disease, to the prexigebersen and LDAC combination treatment.

Efficacy data are encouraging in this challenging population in which the majority of patients had secondary AML or adverse-risk AML, and compares favorably to the reported CR (complete remission), CRp (complete remission with incomplete platelet recovery), and CRi (complete remission with incomplete hematologic recovery) rate with LDAC alone of 7-13%1.

Plans for a pivotal trial are expected to be discussed with the FDA if these results exceed expectations for current standard-of-care therapy.

Phase 2a Study of Prexigebersen in Accelerated and Blast Phase CML Patients

Bio-Path plans to continue enrolling patients in 2019 in a Phase 2a clinical study of prexigebersen in combination with the frontline therapy, dasatinib, for the treatment of chronic myeloid leukemia (CML) in accelerated and blast phase patients. For 2019, additional sites are planned to be added and enrollment planned to be opened across both phases of the disease, including imatinib-resistant chronic phase patients. The trial is currently being conducted at The University of Texas MD Anderson Cancer Center as a potential salvage therapy for accelerated and blast phase CML patients.

Two cohorts of three evaluable patients each are expected to be enrolled to evaluate two doses (60 mg/m2 and 90 mg/m2) of prexigebersen in combination with dasatinib.

Phase 1 Study of Prexigebersen in Patients with Advanced Solid Tumors

In 2019, Bio-Path intends to initiate a Phase 1 clinical trial of prexigebersen in patients with advanced solid tumors, including ovarian and uterine, pancreatic and hormone refractory breast cancer. This trial is expected to be conducted at several leading cancer centers and is planned to evaluate the safety of prexigebersen in combination with standard-of-care for each tumor type.

Phase 1 Study of BP1002 in Refractory or Relapsed Lymphoma Patients

Bio-Path expects to initiate a Phase 1 clinical trial of BP1002, an antisense RNAi nanoparticle targeting the Bcl-2 protein, in refractory or relapsed lymphoma and chronic lymphocytic leukemia (CLL) patients in 2019. The clinical trial is expected to be conducted at several premier cancer centers and is planned to evaluate the safety of BP1002 in several dose escalating cohorts to determine a maximum tolerated dose.

Preclinical Development of BP1003

The Company continues to advance its third investigation drug candidate, BP1003, for the treatment of advanced solid tumors, including pancreatic cancer. BP1003 is an antisense RNAi nanoparticle targeting the Stat3 protein. Bio-Path intends to initiate several Investigational New Drug application (IND) enabling studies for BP1003 in 2019.

1 Heiblig, Mediterr J Hematol 2016; Kantarjian, J Clin Oncol 2012; Dohner, Blood 2014.

On December 27, 2018 Pfizer Inc. reported that invites investors and the general public to listen to a webcast of a discussion with Albert Bourla, Chief Operating Officer, at the Goldman Sachs 11th Annual Healthcare CEOs Unscripted: A View from the Top on Thursday, January 3, 2019 at 10:15 a.m. Eastern Standard Time (Press release, Pfizer, DEC 27, 2018, View Source [SID1234532289]). Effective January 1, 2019, Albert Bourla will become Chief Executive Officer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

To listen to the webcast, visit our web site at www.pfizer.com/investors. Information on accessing and pre-registering for the webcast will be available at www.pfizer.com/investors beginning today.

Visitors will be able to listen to an archived copy of the webcast at www.pfizer.com/investors.

On December 27, 2018 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for "FoundationOne CDx Cancer Genomic Profile," a next-generation sequencing based program for the purpose of gene mutation analysis program (for use in cancer genome profiling) for solid tumors and somatic gene mutation analysis program (for use in assessing anticancer drug indications) (Press release, Chugai, DEC 27, 2018, View Source [SID1234532288]). This is the first cancer genomic test granted expedited review in May 2018 and approved by the MHLW with the two functions of cancer genomic profiling and companion diagnostics for molecular-targeted drugs.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As a function of comprehensive genomic profiling of cancer-related genes, FoundationOne CDx Cancer Genomic Profile allows to identify mutation status of 324 cancer-related genes for solid tumors at once by using the patient’s tumor tissues. As a comprehensive companion diagnostic function, it can be used as a companion diagnostic for the domestically approved molecular-targeted drugs listed in the following table. The report provided from this program includes information that supports physicians’ decisions to develop treatment strategies for patients, and provides a summary of gene-mutation data, information on the relevant molecular-targeted drugs, their approval status and ongoing clinical studies as well as the relevant references.

"It is said that cancer is a disease caused by gene mutation, and the gene mutation status is different from patient to patient. Clarifying the profile of each cancer enables us to understand the characteristics of cancer, and is very important in order to select appropriate treatment approaches," said Tatsuro Kosaka, Chugai’s President and CEO. "The conventional concept of cancer treatment is based on the treatment for each tumor organ. However, we will have a completely new approach since comprehensive genomic profiling would provide tumor agnostic treatment tailored to each patient’s gene mutation. In order to realize more advanced personalized healthcare through this paradigm shift, we seek to obtain the national health insurance reimbursement coverage for this program in view of the universal healthcare system in Japan in order to contribute to many healthcare professionals and patients."

"The approval of FoundationOne CDx in Japan is yet another testament to its validation and is critical to enabling patient access to comprehensive genomic profiling," said Melanie Nallicheri, chief business officer and head of biopharma at Foundation Medicine. "Similar to our FDA approval in the United States, the MHLW has approved FoundationOne CDx as a comprehensive genomic profiling tool for all solid tumors and a broad companion diagnostic, a first of its kind comprehensive diagnostic test for individuals living with cancer in Japan. This is also an important milestone for our biopharma partners who can leverage FoundationOne CDx to accelerate companion diagnostic development and improve access to personalized oncology care in Japan."

About FoundationOne CDx Cancer Genomic Profile
FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx Cancer Genomic Profile is intended to be used as a comprehensive companion diagnostic for patients with certain types of cancers to identify those patients that may benefit from domestically approved molecular targeted therapies.

On December 27, 2018 Sesen Bio, Inc. (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of people with cancer, reported that company management will host a conference call on Thursday, Jan. 3, 2018 at 8:30 a.m. ET to review updated data from its Phase 3 VISTA Trial of Vicinium for the treatment of patients with high-grade non-muscle invasive bladder cancer who have been previously treated with bacillus Calmette-Guérin (Press release, Eleven Biotherapeutics, DEC 27, 2018, http://ir.elevenbio.com/news-releases/news-release-details/sesen-bio-host-conference-call-review-updated-vista-trial-data [SID1234532287]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

To participate in the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) and refer to conference ID 4263106. The webcast can be accessed in the Investor Relations section of the company’s website at www.sesenbio.com. The replay of the webcast will be available in the investor section of the company’s website at www.sesenbio.com for 60 days following the call.

On December 27, 2018 Innovent Biologics, Inc. (Innovent) (HKEX: 01801) and Eli Lilly and Company ("Lilly") jointly reported that the co-developed Tyvyt (fully human anti-PD-1 therapeutic monoclonal antibody, generic name: sintilimab injection) has been granted approval for market authorization by the National Medical Products Administration of China ("NMPA", formerly the China Food and Drug Administration) for the treatment of patients with classical Hodgkin’s lymphoma (cHL) that has relapsed or refractory (r/r) after two or more lines of systemic chemotherapy (r/r cHL) (Press release, Innovent Biologics, DEC 27, 2018, View Source [SID1234532284]). The approval of Tyvyt (sintilimab injection) highlights the emergence of China in the field of Immuno-Oncology.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

According to Cancer Today from the WHO’s International Agency for Research for Cancer, China will have about 4.28 million newly diagnosed cancer patients and 2.86 million deaths from cancer in 2018[1]. Thus China faces massive challenges from its growing burden of cancer. Lymphoma is one of the common cancers in China, and cHL, a type of B-cell lymphoma affects young and middle-aged people. Although the combination therapy of chemotherapy and radiation has a good likelihood of inducing a complete response, patients have a 15- 20% chance of recurrence after the first line treatment. Therefore, patients urgently need new innovative medications and treatment solutions. Delivering effective treatment for r/r cHL is a serious challenge for the oncology and hematology community.

Dr. Michael Yu, the Founder, Chief Executive Officer and Chairman of Innovent, said, "Tyvyt (sintilimab injection) is an example of our success with the National Mega Innovation Program, and its approval highlights our achievements in immunotherapy and contributions to China’s efforts to deliver innovative medicines. Innovent has shown its ability to develop large molecule drug and this approval is also a validation and the recognition of Innovent’s R&D capabilities. I have confidence that Tyvyt (sintilimab injection), with its global quality and cost-effectiveness, will bring better treatment to cancer patients in China."

Dr. Wang Li, Senior Vice-President of Lilly China and Head of Lilly China Drug Development and Medical Affairs, said, "The efficacy and safety profile of Tyvyt (sintilimab injection) is well proven in the ORIENT-1 trial. The drug provides a new immuno-oncology treatment option for patients with relapsed/refractory classical Hodgkin’s lymphoma (r/r cHL). Lilly will continue to collaborate with outstanding local pharmaceutical companies to bring more innovative medicines to patients and help in demonstrating local R&D capabilities in global oncology community."

Currently, Tyvyt (sintilimab injection) is being studied in more than twenty clinical trials, including studies in first line non-squamous non-small cell lung cancer (NSCLC), first line squamous NSCLC, second line squamous NSCLC, EGFR mutant NSCLC after EGFR TKI treatment failure, first line gastric cancer, first line liver cancer, first line esophageal cancer, and second line esophageal cancer.

About Tyvyt (sintilimab injection)

Tyvyt (sintilimab injection) is an innovative drug co-discovered by Innovent and Adimab, jointly developed by Innovent and Eli Lilly and Company in China. Tyvyt (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to the PD-1 molecule on the surface of T-cells, blocks the PD-L1 (Programmed Cell Death-1 Ligand-1, PD-L1 pathway) and reactivates T-cells to kill cancer cells. Tyvyt (sintilimab injection) is the only PD-1 antibody in China branded by both a local biopharmaceutical company and a global pharmaceutical company.