On January 6, 2019 Roivant Sciences reported its corporate updates across its family of companies in advance of the 37th Annual J.P. Morgan Healthcare Conference (Press release, Roivant Sciences, JAN 6, 2019, View Source [SID1234532490]).

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Launch of Alyvant

Roivant announced the launch of Alyvant, a new Vant focused on technology-enabled pharmaceutical commercialization which has entered into an agreement with a pharmaceutical partner to co-promote three approved branded medicines. Alyvant’s long-range vision is to reduce the cost of commercializing all medicines through technology, generating savings for the healthcare system at large.

Alyvant is led by President Gillian Cannon, who joined the company with over 30 years of leadership experience in the pharmaceutical industry, including at Merck, Otsuka, and UCB. Alyvant’s Chief Technology Officer, Mitchell Mittman, previously worked in senior roles at Amazon, Expedia, Goldman Sachs, and other financial institutions where he built industry-leading software and data science platforms.

"Alyvant’s technology integrates market research, sales force optimization, and digital engagement into a single platform to connect patients and physicians with relevant medicines as cost-effectively as possible," said Benjamin Zimmer, President of Roivant Health. "This technology platform allows us to engage new market segments that are underserved by traditional pharma commercial models, while also reducing the need for expensive and wasteful mass-market DTC campaigns that inflate the cost of delivering new medicines to patients."

Additional Updates

Urovant reported that the first patient has been dosed in its Phase 2a trial of vibegron in patients with abdominal pain due to irritable bowel syndrome
Axovant announced the creation of its Scientific Advisory Board and provided clinical trial timelines for four of its investigational gene therapies
Dermavant and Altavant announced appointments of senior executives
Vivek Ramaswamy, Founder and Chief Executive Officer of Roivant, will provide further business updates, including new data from Immunovant’s ongoing Phase 1 study of subcutaneous anti-FcRn antibody RVT-1401, at the J.P. Morgan Healthcare Conference tomorrow, Monday, January 7th, at 9:30 a.m. PT at the Westin St. Francis. His presentation will be webcast here.

On January 6, 2019 Solasia Pharma K.K. (TOKYO:4597, Headquarters: Tokyo, Japan, President & CEO: Yoshihiro Arai, hereinafter "Solasia") reported the initiation of Phase III clinical trial for PledOx in Japan (Press release, Solasia, JAN 6, 2019, View Source [SID1234532489]).

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In November 2017, Solasia acquired exclusive development and commercialization rights for PledOx in Japan, China, Hong Kong, Macau, South Korea and Taiwan from PledPharma.

This Phase III clinical trial in Asia (Japan, South Korea, Taiwan and Hong Kong) is an expansion of the Global Phase III trial led by PledPharma in the rest of the world where the first patient was included in the United States in November. The Asian region including Japan is now officially part of this Global Phase III clinical trial.
Following Japan, Solasia will also initiate in South Korea, Taiwan and Hong Kong successively.

This trial is for colorectal cancer patients treated with mFOLFOX6 (*1) which contains antioxidant drug "oxaliplatin" and to examine the effect of suppressing the development of peripheral neuropathy by administering PledOx. Oxaliplatin is a platinum-based drug and is indicated for colorectal cancer, pancreatic cancer, gastric cancer etc.
Peripheral neuropathy is known as one of the serious side effects caused by administration of oxaliplatin, and one of the causes is that neurons develop by being damaged due to oxidative stress induced by the drug. Peripheral neuropathy is also known as the main side effect of other platinum-based drugs such as cisplatin. There are currently no drugs approved for the treatment of chemotherapy induced peripheral neuropathy. PledOx is a superoxide dismutase analogue that is an enzyme that degrades active oxygen generated in cells and has the effect of protecting nerve cells from damage caused by drug-induced oxidative stress.
The initiation of this trial is a significant milestone for Solasia as this trial is positioned as a registration trial and its success is expected to contribute to patients suffering from peripheral neuropathy due to cancer chemotherapy.

Study description:

Phase III, International, multicenter, double-blind, randomized, placebo-controlled study
Purpose of the study:

The effect of reduce the peripheral neuropathy associated with administration of oxaliplatin by PledOx administration compared with placebo.
Study design:

POLAR-M study: Colorectal cancer patients who undergo mFOLFOX6 therapy with distant metastases are included.
POLAR-A study: Colorectal cancer patients who undergo mFOLFOX6 therapy as an adjuvant therapy for postoperative surgery are included.
Primary outcome measures:

Both the POLAR-M and POLAR-A studies will evaluate the proportion of patients with moderate or severe chronic peripheral neuropathy at 9 months after (first day of FOLFOX therapy) the initial administration of PledOx.
Estimated enrollment:

POLAR-M study: 420 patients (of which 120 patients in Asian region)
POLAR-A study: 280 patients (of which 80 patients in Asian region)
About chemotherapy induced peripheral neuropathy (CIPN) in Japan

Cancer chemotherapy has side effects such as nausea and vomiting and onset of stomatitis, but peripheral neuropathy is also a serious side effect. Peripheral neuropathy is known to be markedly expressed in major drugs of cancer chemotherapy such as plant alkaloid drugs and platinum-based drugs (*2). FOLFOX therapy including oxaliplatin, is a combination of a chemotherapy for advanced and recurrent cancer and a typical anticancer drug for postoperative adjuvant chemotherapy as a treatment for colorectal cancer, which is difficult to heal surgically. Almost all patients (85% – 95%) of oxaliplatin prescribed patients develop peripheral nerve disorder, and the disorder brings about the following symptoms (*2).

Acute symptoms: abnormal sensations such as hands, feet and lip peripheral parts, strangulation of pharyngeal larynx accompanied with dyspnea and dysphagia
Chronic symptoms: numbness in the periphery of the limbs, decreased sensation, decreased tendon reflexes, sensory ataxia
When such side effects occur, it is considered that some symptom improvement is seen in 80% of patients due to discontinuation of medicine and completely recovered in 6 to 8 months in 40% of cases (*2). However, discontinuation of the drug results in discontinuation of cancer treatment or change in treatment regimen which is an important medical issue. There is currently no approved drug to prevent or treat CIPN.

* 1: mFOLFOX6 therapy refers to cancer chemotherapy using three agents, fluorouracil, folinic acid, and oxaliplatin. It is adopted as standard therapy for high risk Stage II colorectal cancer or postoperative adjuvant chemotherapy for Stage III colorectal cancer and systemic chemotherapy for Stage IV recurrent colorectal cancer.

* 2: Reference: Ministry of Health, Labor and Welfare "Corresponding manual for severe side effects disease Peripheral neuropathy"

About PledOx

PledOx is a "first in class" drug candidate developed to provide patients, that are treated adjuvantly or for metastatic colorectal cancer, prevention against the nerve damage that can occur in conjunction with chemotherapy treatment. The results from a completed Phase IIb trial (PLIANT), where patients with metastatic colorectal cancer were treated with the chemotherapy combination FOLFOX and PledOx, indicates that the patients who received PledOx had a lower risk than the placebo group to suffer from nerve damage during the chemotherapy. The presence of the investigator reported sensory nerve damage, the primary endpoint, was after treatment 38% lower in the group of patients treated with PledOx compared with the placebo group (p = 0.16). This was not statistically significant, but a difference of this magnitude is considered to be clinically relevant. After completion of chemotherapy, the patient-reported incidence of moderate and severe neuropathy was 77% lower in patients treated with PledOx compared to the placebo group (exploratory analysis; p = 0.014). This is considered valuable for the success of the forthcoming POLAR studies, where patient-reported symptoms after completion of treatment will be the primary efficacy parameter. No apparent negative effect on the efficacy of the cancer treatment was observed.

On January 6, 2019 Samsung Bioepis Co., Ltd. reported that its rapidly growing biosimilar business will expand into mainland China through a licensing agreement with 3SBio Inc (Press release, Samsung Bioepis, JAN 6, 2019, View Source [SID1234532488]). The agreement covers multiple biosimilar candidates from Samsung Bioepis, including SB8, a biosimilar candidate referencing AVASTIN 1 (bevacizumab).

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Under the agreement, Samsung Bioepis and 3SBio will collaborate across a number of areas, including clinical development, regulatory registration and commercialization in China. Samsung Bioepis will receive upfront and milestone payments, as well as royalties on sales. Additional financial details were not disclosed.

"We are very excited to expand our biosimilar business into China, where we hope to see our biosimilars play an important role in widening patient access to high-quality healthcare. We are confident we will achieve this goal through our partnership with 3SBio, which brings together Samsung Bioepis’ proven development platform with 3SBio’s strong commercialization platform," said Christopher Hansung Ko, President and Chief Executive Officer, Samsung Bioepis. "At Samsung Bioepis, we will continue to demonstrate our enduring commitment to biosimilars by further strengthening our pipeline and widening their availability for patients and healthcare systems across the world."

Established in February 2012, Samsung Bioepis currently has four biosimilars approved and marketed across Europe, which include the anti-TNF trio of BENEPALI (etanercept), FLIXABI (infliximab) and IMRALDI (adalimumab), as well as an oncologic biosimilar, ONTRUZANT (trastuzumab). In the United States, the company has one biosimilar approved and marketed, RENFLEXIS (infliximab), with both SB5 (adalimumab) and SB3 (trastuzumab) biosimilar candidates currently under regulatory review.

In total, over 100,000 patients across the world are currently under treatment with Samsung Bioepis’ biosimilars, with over 6 million doses administered.

On January 6, 2019 GE Healthcare and Vanderbilt University Medical Center (VUMC) reported a five-year partnership to enable safer and more precise cancer immunotherapies (Press release, GE Healthcare, JAN 6, 2019, View Source [SID1234532487]). Multiple diagnostic tools will be developed to help predict both the efficacy of an immunotherapy treatment and its adverse effects for a specific patient before the therapy is administered. This would allow physicians to better target immunotherapies to the right patients and avoid potentially damaging, ineffective and costly courses of treatments.

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Immunotherapies use the immune system to recognize and attack cancer cells and can be more effective than traditional treatments, but response rates are often low and side effects can be severe1. GE Healthcare and VUMC will retrospectively analyze and correlate the immunotherapy treatment response of thousands of VUMC cancer patients, with their anonymized demographic, genomic, tumor, cellular, proteomic and imaging data. They will then develop AI-powered apps that draw on this data to help physicians identify the most suitable treatment for each individual patient.

Simultaneously, GE Healthcare and VUMC will develop new positron-emission tomography (PET) imaging tracers, which together with the apps, will help physicians to stratify cancer patients for clinical trials. It currently takes an average of 12 years2 and costs almost $2bn3 to bring a drug to market. In many cases, inappropriate patients are recruited to participate in immunotherapy trials, incurring unnecessary expense and slowing down approvals of new therapies. It is hoped that the PET tracers will ultimately also be used to monitor the efficacy of immunotherapies in everyday practice.

"Immunotherapy offers tremendous promise but given the current unpredictability of some patients’ reactions to treatments, it is also associated with increased morbidity and cost. This partnership provides the opportunity to leverage strengths of both of our organizations to further personalize cancer care by creating new tools that allow clinicians to more accurately predict how patients will respond to a specific therapy," said Jeff Balser, MD, PhD, President and Chief Executive Officer, Vanderbilt University Medical Center and Dean of the Vanderbilt University School of Medicine.

"GE Healthcare and Vanderbilt will combine their data science, genomic, imaging and cellular analysis capabilities to help improve clinical decision making. This partnership is a great example of the increasing convergence of the tools, technologies and data used by therapy innovators and healthcare providers," said Kieran Murphy, President and Chief Executive Officer, GE Healthcare.

GE Healthcare and the Vanderbilt-Ingram Cancer Center, a world-renowned stem cell transplant facility, will also collaborate on methods to improve productivity, efficiency and cost of stem cell transplant processing operations by automating processes, digitizing workflows, improving throughput and industrializing operations.

The first analytics application prototype will be available by the end of 2019 and the PET tracer proof-of-concept by the end of 2020.

On January 6, 2019 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported its key 2018 accomplishments and outlined the Company’s priorities for 2019 (Press release, Zymeworks, JAN 6, 2019, View Source [SID1234532473]).

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"With our clinical, preclinical, and business development achievements in 2018, along with a robust balance sheet, we believe we are in a strong position to continue delivering on our corporate objectives in 2019 and beyond," said Ali Tehrani, Ph.D., President and CEO of Zymeworks. "Our priorities include aggressively advancing our clinical and preclinical programs and continuing the development of our therapeutic platforms, which not only underpin our in-house pipeline but have also served as the basis of eight major pharmaceutical partnerships. We remain committed to our mission of creating novel biotherapeutics that allow patients worldwide to return home to their loved ones, disease free."

2018 Achievements

Presented Expanded ZW25 Data, Underscoring its Anti-Tumor Activity and Tolerability
Zymeworks reported clinical results for ZW25, a novel Azymetric bispecific HER2-targeting antibody, at multiple medical meetings. Data continues to demonstrate ZW25’s robust single-agent anti-tumor activity and tolerability in heavily pretreated patients across a variety of HER2-expressing cancers.

ZW49 Investigational New Drug (IND) Application Accepted by the FDA
ZW49, Zymeworks’ second clinical candidate, is a novel bispecific HER2-targeting antibody drug conjugate. IND-enabling studies demonstrated promising efficacy and tolerability, suggesting a wide therapeutic window.

New Corporate Partnerships Established and Existing Ones Expanded
Zymeworks entered into new collaborations with BeiGene, which includes a licensing agreement in the Asia Pacific region (excluding Japan) for ZW25 and ZW49, and with LEO Pharma, which expands Zymeworks’ pipeline into new disease areas. The Company also expanded its existing collaborations with Daiichi Sankyoand Celgene. Zymeworks currently has eight active collaborations that offer up to US$7.6 billion in potential milestone payments plus royalties.
Drug Candidate from First Corporate Partnership Poised to Enter Clinical Studies

Eli Lilly submitted an IND application for one of its bispecific antibodies enabled by Zymeworks’ Azymetric platform resulting in a milestone payment to the Company.

Introduced Robust Immune Oncology (IO) Preclinical Pipeline
Zymeworks unveiled a number of IO programs showcasing the versatility of its platform technologies. Leveraging the Azymetric platform, Zymeworks showed how optimizing bispecific geometry and formats can maximize activity, potentially creating new classes of precision therapeutics.

Expanded Executive Leadership Team
Tony Polverino, Ph.D., joined Zymeworks as Executive VP of Early Development and CSO. In this newly created role, he oversees the Company’s R&D strategy and advances product candidates from discovery through translational research/early development.

Built Strong Balance Sheet
Zymeworks completed a US$97.8 million public financing and added non-dilutive capital from its corporate partnerships totaling US$89 million in 2018.

2019 Corporate Priorities

Zymeworks will focus on achieving the following in 2019:

Initiating multiple Phase 2 studies for ZW25
Expanding the global clinical development of ZW25 into Asia and Europe
Reporting ZW25 data from combination studies (chemotherapy and/or targeted agents)
Reporting data from the Phase 1 trial for ZW49
Establishing additional drug development collaborations with a focus on new platforms
In addition, Zymeworks expects its pharmaceutical partners to continue nominating new Azymetric bispecific antibody therapeutic candidates for clinical development in 2019.