1stOncology™: Cancer Intelligence Service – Page 14319 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Bristol-Myers Squibb and H3 Biomedicine Announce Research Collaboration to Advance Novel Therapeutics Leveraging H3’s RNA Splicing Platform

On December 17, 2018 Bristol-Myers Squibb Company (NYSE: BMY), Eisai Co., Ltd (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai").and its U.S.-based precision medicine research & development subsidiary H3 Biomedicine, Inc(Massachusetts, "H3") reported a multi-year research collaboration focused on evaluating whether novel therapeutics leveraging H3’s RNA splicing platform can provide a more powerful response against cancer (Press release, H3 Biomedicine, DEC 17, 2018, View Source [SID1234532086]).

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!

The new collaboration will explore modulating RNA splicing to develop potential first-in-class therapies that would direct the immune system to target cancer cells and help more patients experience the benefits of immunotherapy.

Under the terms of the multi-year agreement, H3 and Bristol-Myers Squibb will jointly conduct the research focused on developing immune therapies using H3’s RNA splicing platform. Bristol-Myers Squibb will be responsible for development and commercialization of selected compounds, and H3 is eligible to receive an upfront payment, development, regulatory and sales milestones as well as certain royalties according to sales revenue after launch. Eisai retains an option to co-develop and co-commercialize certain compounds that emerge from the collaborative research effort.

"We are excited to enter into this collaboration with Bristol-Myers Squibb, as we share a mutual commitment to discover and develop innovations that will help improve outcomes for patients," said Lihua Yu, Ph.D., President and Chief Data Sciences Officer at H3. "We have already advanced the first application of our RNA splicing platform into the clinic and look forward to building on that track record with research on this potential new immuno-oncology application together with Bristol-Myers Squibb, a leader in immuno-oncology. We believe this collaboration will help us better understand whether our RNA splicing platform can help enhance the immune system’s ability to more effectively fight cancer."

"Bristol-Myers Squibb is looking forward to collaborating with H3 to advance the science and research around RNA splicing," said Percy Carter, Head of Discovery Chemistry and Molecular Technologies, Bristol-Myers Squibb. "H3 has deep expertise in defining the role of changes in RNA homeostasis that contribute to cancer. This collaboration will allow both companies to gain a deeper understanding about alterations in RNA splicing and an opportunity to discover new medicines that can potentially improve outcomes for patients."

"Since its inception, H3 has discovered potential new therapeutic options that leverage breakthroughs from cancer genomics and biotechnologies. We’re very proud of this new research collaboration with Bristol-Myers Squibb, as it represents another critical milestone for H3 and an opportunity for patients," said Terushige Iike, President, Oncology Business Group at Eisai and Chief Executive Officer at H3.

Innovation Pharmaceuticals Completes End-of-Phase 2 Meeting with FDA; Brilacidin Oral Rinse to Advance Into Phase 3 Clinical Trials for Prevention of Severe Oral Mucositis

On December 17, 2018 Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage pharmaceutical company, reported that the Company and the U.S. Food and Drug Administration (FDA) have completed an End-of-Phase 2 meeting concerning the continuing development of Brilacidin oral rinse to decrease the incidence of Severe Oral Mucositis (SOM) in Head and Neck Cancer (HNC) patients receiving chemoradiation (Press release, Innovation Pharmaceuticals, DEC 17, 2018, View Source [SID1234532085]). Brilacidin oral rinse is being developed under FDA Fast Track designation for Oral Mucositis (OM).

Both parties agreed to an acceptable Brilacidin Phase 3 development pathway, including studying Brilacidin oral rinse effects on SOM when cisplatin is administered in higher concentrations (80-100 mg/m2) every 21 days, and at lower concentrations (30-40 mg/m2) administered weekly as part of the chemoradiation regimen.

Once official meeting minutes are received from the FDA, the Company expects to release more details regarding planned Phase 3 trials of Brilacidin as a novel oral SOM treatment. Conducted in accordance with the FDA guidance, the goal of the upcoming studies will be to satisfy requirements for a New Drug Application and, ultimately, obtain marketing approval of Brilacidin for SOM. Management further intends to solicit international regulatory bodies for the purpose of expanded registration globally.

"Our interactions with the FDA have been highly collaborative and constructive, providing us with clear guidance to help inform our Phase 3 development plans," commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. "We are in alignment as to necessary key pivotal trial design features and Phase 3 clinical outcomes needed to support a NDA filing. We look forward to continue working closely with FDA on our Brilacidin oral rinse program as we prepare to enter the pivotal stage of clinical evaluation."

"This is an extremely exciting moment for Innovation Pharmaceuticals and its shareholders," commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. "In Brilacidin oral rinse, we now have a Phase 3-ready drug candidate targeting an area of large unmet need—comprising a worldwide annual market opportunity estimated to approach $1 billion—for which currently there are no FDA-approved treatments. Brilacidin is further advantageously differentiated from the two other OM drug candidates in Phase 3 testing which require being taken intravenously, whereas Brilacidin is easily administered as an oral rinse and conveniently packaged in sachet form, similar in design to a sugar packet. With a sachet, patients simply would mix the contents of the Brilacidin sachet with water for a quick-and-easy treatment at home or on-the-go."

Mr. Ehrlich continued, "This result further validates the breadth of the Brilacidin franchise. Our novel defensin-mimetic drug candidate is anchored with mid-and-late-stage trials in three clinical indications—oral mucositis, inflammatory bowel disease, and serious skin infections—and planned extensions into dermatological diseases, such as atopic dermatitis and acne. Effectively, we have a multi-indication drug platform in Brilacidin, now planning for Phase 3 testing for the first indication, thus moving us a significant step closer to bringing Brilacidin to market."

About Brilacidin Phase 2 OM Trial/Comparison with Other OM Drugs in Development

The Company’s Brilacidin oral rinse demonstrated a strong therapeutic benefit in patients receiving the aggressive chemotherapy regimen (cisplatin administered 80-100 mg/m2, every 21 days), which currently is in common use. In this patient population, incidence of Severe OM (WHO Grade ≥ 3) was reduced to 25.0 percent in the modified Intent-to-Treat (mITT) population, versus 71.4 percent of placebo patients. In the Per Protocol (PP) patient group, incidence of Severe OM dropped to 14.3 percent for patients receiving Brilacidin, compared to 72.7 percent among those receiving placebo.

The completed Phase 2 study (see NCT02324335) met its primary endpoint, showing a reduction of Severe OM incidence versus placebo, as well as beneficial treatment effects in reducing the duration of Severe OM and in delaying the onset of Severe OM. Furthermore, Brilacidin showed a favorable safety profile and -was well-tolerated.

Linked below is information, published in a blog on the Company’s website, elaborating on how Brilacidin is positioned compared to other investigational Oral Mucositis drugs in clinical development.

View Source

About Brilacidin and Severe Oral Mucositis

There currently are no FDA-approved drugs for the prevention of Severe OM (SOM) (WHO Grade ≥ 3) in HNC patients receiving chemoradiation. The additional expenses incurred by patients suffering from SOM are estimated to be as high as $18,000 to $25,000 per case in the U.S. when hospitalization is required. These factors contribute to SOM qualifying as an area of significant unmet medical need. According to published statistics, the number of new annual HNC cases in the U.S. is estimated to be 65,000, and worldwide, ~750,000 cases. Between 60 and 70 percent of these HNC patients typically will develop Severe OM, with the overall incidence of HNC patients developing some grade of OM (WHO Grades 1 to 4) approaching 100 percent. Because it cannot be predicted which patients will develop SOM, a preventative treatment, such as Brilacidin oral rinse, would begin in all patients as soon as starting chemoradiation and continue until its completion (typically a seven-week course). Given Brilacidin is administered as a convenient oral rinse, with plans to package it in an easily transportable sachet form, the Company believes it would be attractive both to doctors and patients—likely translating to widespread and rapid market adoption should Brilacidin oral rinse gain regulatory approval.

AbbVie Announces Executive Leadership Changes

On December 17, 2018 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported a new Executive Leadership Team structure designed to streamline its organizational structure and support its long-term growth strategy (Press release, AbbVie, DEC 17, 2018, View Source [SID1234532084]). Effective immediately, the new Team will consist of the following individuals, all of whom report to AbbVie Chairman and Chief Executive Officer Richard A. Gonzalez:

Michael E. Severino, M.D., AbbVie’s Executive Vice President, Research & Development and Chief Scientific Officer, has been named Vice Chairman and President. In his role, Dr. Severino will be responsible for research and development, human resources, operations, and the corporate strategy office.

Laura J. Schumacher has been named Vice Chairman, External Affairs and Chief Legal Officer. Ms. Schumacher currently serves as Executive Vice President, External Affairs, General Counsel and Corporate Secretary. In her new role, Ms. Schumacher will be responsible for legal, ethics and compliance, corporate governance, corporate aviation and all externally facing functions including health economics outcomes research, government affairs, corporate responsibility, brand and communications.
Carlos Alban, who currently serves as Executive Vice President, Commercial Operations, has been named Vice Chairman, Chief Commercial Officer. Mr. Alban will be responsible for global commercial operations of the Company, including the addition of Pharmacyclics commercial functions.
William J. Chase will continue in his role as Executive Vice President, Finance and Administration, responsible for all financial and administrative functions of the Company.
"AbbVie has grown significantly since our founding six years ago, and now is the right time to evolve our senior executive leadership structure to match our talent and our operating model as well as support our long-term growth strategy," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "We are fortunate to have a deep pool of senior leadership talent, and this streamlined structure will enhance our ability to execute against our long term strategies, provide additional scope for our senior leaders and facilitate our ability to meet our commitment to continuing to deliver value to all of our stakeholders, including patients, employees, shareholders and the communities we serve."

RhoVac announces that the first patient completed the follow-up phase of the clinical phase I / II study

On December 17, 2018 RhoVac AB ("RhoVac") reported that the first prostate cancer patient included in the clinical phase I / II study with RhoVac’s drug candidate RV001 has completed it’s 12-month follow-up and thus the entire clinical phase I / II- study (Press release, RhoVac, DEC 17, 2018, https://www.rhovac.com/rhovac-announces-that-the-first-patient-completed-the-follow-up-phase-of-the-clinical-phase-i-ii-study/ [SID1234532083]).

Prior to the clinical phase I / II study, conducted between 2017 and 2018, 22 patients with diagnosed prostate cancer and prostatectomized. Blood samples were taken before, during and after the study to analyse the product mediated immune response to treatments. The results, reported earlier this year, showed a significant immune response in 86% of the patients. Patients have also participated in a 3-, 6-, 9- and 12-month follow-up phase of the study, to assess the duration of the immune response.

RhoVac announces that the first patient has completed his 12-month follow-up and thus also completed his participation in RhoVac’s phase I / II clinical study. The samples for immunological analysis have been sent to the University of Tübingen. The interim report on the duration of the immunological responses, from all participating patients’ 3- and 6-month follow-up will be published in January 2019.

The last patient is expected to complete his 12-month follow-up in March 2019. The final report on the duration of the immunological responses is expected in the second quarter of 2019.

The company’s drug candidate RV001 activates T cells of the immune system to identify and eliminate cancer cells expressing the protein RhoC. As RhoC is generally overexpressed in metastatic cancer cells, RV001 can potentially be used in the treatment of several different cancer indications. It is the company’s ambition that the product being developed shall be used as a preventive treatment against metastases, thus preventing, or limiting the spread and recurrence of cancer

Innovent and Incyte Announce Strategic Collaboration and Licensing Agreement for Three Clinical-stage Product Candidates in China

On December 16, 2018 Innovent Biologics, Inc. (Innovent) (HKEX: 01801) and Incyte (NASDAQ:INCY) reported that the companies, through their respective subsidiaries, have entered into a strategic collaboration agreement for three clinical-stage product candidates discovered and developed by Incyte—pemigatinib (FGFR1/2/3 inhibitor), itacitinib (JAK1 inhibitor) and parsaclisib (PI3Kδ inhibitor) (Press release, Incyte, DEC 16, 2018, View Source [SID1234532118]). Under the terms of the agreement, Innovent will pay Incyte US$40 million in cash up front, and Incyte shall be eligible to receive an additional US$20 million in consideration in connection with the first investigational new drug (IND) application by Innovent in China, which is expected to be achieved in 2019. Innovent will receive the rights to develop and commercialize the three assets in hematology and oncology in Mainland China, Hong Kong, Macau and Taiwan.

"The collaboration and partnership with Innovent provides us with an important and strategic opportunity to further serve the oncology community around the world by potentially bringing new, innovative medicines to patients with high unmet medical needs in China," said Hervé Hoppenot, Chief Executive Officer of Incyte. "We believe Innovent’s experienced leadership team and sizeable clinical network will expand our clinical trials for itacitinib, pemigatinib and parsaclisib, and, if any of these product candidates are approved, will provide access to our innovative therapies to patients and healthcare providers in China."

"We’re very pleased to enter into this collaboration with Incyte, a well-recognized innovative global biopharmaceutical company. This collaboration not only strengthens our portfolio by adding three potentially best-in-class clinical-stage targeted therapies, but, we believe, also proves that Innovent is an ideal partner for world-class pharmaceutical companies coming to China—transforming Innovent from a company primarily focused on monoclonal antibodies to one with a broader oncology focus that develops potentially innovative treatments regardless of molecule size," said Michael DC Yu., Ph.D., Chief Executive Officer and President of Innovent. "Based on the compelling clinical data reported to-date, we believe pemigatinib, itacitinib and parsaclisib may be poised, if further development is successful and approvals in China are granted, to dramatically alter the treatment landscape for patients in China with FGFR-altered cholangiocarcinoma and urothelial carcinoma, graft-versus-host-disease after bone marrow transplant and non-Hodgkin lymphoma, respectively, and other cancers. These three novel medicines from Incyte complement our rich pipeline of immune-oncology-focused monoclonal antibodies and also enable the exploration of combination treatment approaches with the potential to further improve patient outcomes worldwide."

Per the terms of the collaboration agreement, Innovent will pay Incyte US$40 million in cash up front and Incyte will be eligible to receive an additional US$20 million in consideration in connection with the first IND filing in China, which is expected to be achieved in 2019. Innovent will receive rights to develop and commercialize three product candidates (pemigatinib, itacitinib and parsaclisib) in hematology and oncology in the Innovent territory of Mainland China, Hong Kong, Macau and Taiwan. In addition, Incyte will be eligible to receive up to US$129 million in potential development and regulatory milestones, and up to US$202.5 million in potential commercial milestones. Incyte will also be eligible to receive tiered royalties from the high teens to the low twenties on future sales of products resulting from the collaboration. Incyte retains an option to assist in the promotion of the three product candidates in China.

The transaction is effective immediately upon the execution of the strategic collaboration agreement. Further financial details were not disclosed.

About Pemigatinib (INCB54828, FGFR inhibitor)

Fibroblast growth factor receptors (FGFRs) play an important role in tumor cell proliferation and survival, migration and angiogenesis (the formation of new blood vessels). Activating mutations, translocations and gene amplifications in FGFRs are closely correlated with the development of various cancers. Pemigatinib is an oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated potency and selective pharmacologic activity against cancer cells with FGFR alterations. Phase 2 studies investigating the safety and efficacy of pemigatinib monotherapy across several FGFR-driven malignancies are ongoing—the FIGHT (FIbroblast Growth factor receptor in oncology and Hematology Trials) clinical trial program currently comprises FIGHT-201 in patients with metastatic or surgically unresectable bladder cancer, including with activating FGFR3 alterations; FIGHT-202 in patients with metastatic or surgically unresectable cholangiocarcinoma who have failed previous therapy, including with activating FGFR2 translocations; and FIGHT-203 in patients with myeloproliferative neoplasms with activating FGFR1 translocations. FIGHT-302, a randomized Phase 3 trial in newly-diagnosed patients with cholangiocarcinoma and activating FGFR2 translocations, is expected to be initiated before the end of 2018 (NCT03656536).

About Itacitinib（INCB39110, JAK1 inhibitor）

Itacitinib (INCB039110) is a novel, potent, and selective JAK1 inhibitor currently in clinical studies for the treatment of treatment naïve acute and chronic GVHD, and non-small cell lung cancer in combination with osimertinib, an EGFR inhibitor. A Phase 3 study (GRAVITAS-301) of itacitinib for the treatment of acute GVHD is underway, with data expected in 2019. GRAVITAS-309 (NCT03584516) is a randomized, double-blind, placebo-controlled pivotal Phase 3 study evaluating itacitinib or placebo in combination with corticosteroids as a first-line treatment for patients with chronic graft-versus-host disease (cGVHD) which is expected to be initiated early in 2019.

About Parsaclisib (INCB50465, PI3Kδ inhibitor)

Parsaclisib (INCB50465) is an investigational novel oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ) isoforms. PI3Kδ is an important anticancer target implicated in malignant B-cell growth, survival and proliferation which, in preclinical studies, has demonstrated potency and selectivity in preclinical studies and has potential therapeutic utility in the treatment of patients with hematologic malignancies such as lymphoma. Emerging data suggest that PI3Kδ may also be an important target in the solid tumor microenvironment. The CITADEL (Clinical Investigation of TArgeted PI3K-DELta Inhibition in Lymphomas) clinical trial program is currently evaluating parsaclisib in several ongoing Phase 2 trials as a treatment for non-Hodgkin lymphomas (follicular, marginal zone and mantle cell) Parsaclisib is also being studied in Phase 1 and Phase 2 trials as part of a combination therapy for patients with myelofibrosis, advanced or metastatic solid tumors and diffuse large B-cell lymphoma.