On January 3, 2019 Marker Therapeutics, Inc. (NASDAQ: MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported a year-end update in five clinical trials using the Company’s therapeutic products, LAPP and MAPP multi-antigen targeted T cell (MultiTAA) therapies and TPIV200, its Folate Receptor Alpha (FRα) peptide cancer vaccine product candidate (Press release, Marker Therapeutics, JAN 3, 2019, View Source [SID1234532426]).

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"We are pleased to provide an update on our progress in advancing clinical trials using our therapeutic platform," stated Peter L. Hoang, President & CEO of Marker Therapeutics. "With our MultiTAA cell therapies, we continue to build on the size and depth of our patient dataset. These updates now bring our total reported number of patients to 72, up from 57 in our previously reported results. I believe this represents one of the most extensive sets of clinical results in cell therapy for cancer treatment and illustrates the potential safety and clinical effects of MultiTAA T cells for patients suffering from a number of terrible cancers."

"In our vaccine program, we continue to demonstrate our commitment to excellence in our clinical execution," Mr. Hoang continued. "Last year when I joined the company, I expressed that we would work to improve our clinical efficiency, and I believe that the completion of enrollment of our FRV-004 study in ovarian cancer over six months ahead of schedule reflects our dedication to that objective. In fact, we have now completed enrollment of our last two clinical trials significantly ahead of projections, reflecting the commitment of our management and clinical team to execute multi-center studies effectively."

The Company reported clinical updates in three Baylor College of Medicine (BCM)-sponsored Phase I/II clinical trials using its MultiTAA T cell therapies, LAPP and MAPP:

Lymphoma

In the Phase I/II clinical trial in lymphoma, BCM has now treated 15 patients with active disease who have failed an average of four lines of prior therapy. Of these patients, five patients experienced transient disease stabilization followed by disease progression. Four patients have ongoing stable disease of between 9 to 24+ months following infusion of the MultiTAA-specific T cells, while the remaining six have all had complete and durable responses (4 months to 60+ months), as assessed by PET imaging.

No relapses observed to date for any patient entering a complete response (CR).
Patients with active disease who have ongoing complete responses after infusion of MultiTAA cells are now between 1 and 5 years in CR (ongoing).
Several patients with stable disease show potential for durable disease stabilization, with two patients observed to have stable disease for over 9 months and 24 months, respectively.
Responses in all six patients who entered a CR were associated with an expansion of infused T cells as well as the induction of antigen spreading.
None of the treated patients developed cytokine release syndrome, neurotoxicity or any other infusion-related adverse events.
BCM has also treated 17 patients who had developed a CR following their last treatment (adjuvant therapy) for lymphoma, and all but two of these patients remain in remission (3-42 months post-infusion). Monitoring has continued on all patients previously reported, and none of these patients have yet relapsed with disease. Average duration of remission for patients with a continuing complete response (CCR) is over 26 months (ongoing), versus 16 months (ongoing) as of the last patient update.

Multiple Myeloma

Marker Therapeutics also provided an update to the BCM-sponsored Phase I/II clinical trial in multiple myeloma. Results were presented at an oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2018 Annual Meeting.

Ten patients with active disease were treated, including:
One patient with a CR durable for approximately 29 months before relapse, was subsequently given a second treatment infusion of MultiTAA T cells, resulting in stable disease for 3 months (ongoing) after the second treatment.
Two patients achieved partial responses (PR) of between 14 and 22 months (ongoing) as of last follow-up.
All seven remaining patients experienced stabilization of disease following infusion of MultiTAA cells initially. Three patients developed transient disease stabilization of between 3-7 months with subsequent progression, and four patients have ongoing stable disease.
Eight patients were treated in remission, with a median follow up of 21 months. Only one patient has relapsed to date.
Correlative studies show significant expansion of MultiTAA T cells, as well as significant evidence of epitope spreading with expansion of endogenous T cells specific for tumor-associated antigens that were not targeted by the MultiTAA product.
MultiTAA therapy appears to be safe and well-tolerated, with no incidence of cytokine release syndrome, neurotoxicity or any other serious adverse events related to the therapy.
Acute Lymphoblastic Leukemia

Marker Therapeutics also reported initial results from the BCM-sponsored Phase I clinical trial in acute lymphoblastic leukemia (ALL). In this study, patients were treated with MultiTAA T cells as a maintenance therapy for patients in CR post-allogeneic stem cell transplant. Leukemic relapse remains the major cause of treatment failure in hematopoietic stem cell transplant (HSCT) recipients.

10 patients have been enrolled and treated in this clinical trial, with eight patients evaluable for response. To date, all but one remains in CR, with patients ranging from 1 to 22 months in CCR (ongoing). Because of the highly refractory nature of these patients, the length of CCRs and the low rate of relapse amongst these patients, the Company believes that these early results are promising and may represent meaningful clinical benefit.
Marker Therapeutics also reported key updates from clinical studies of TPIV200, its Folate Receptor Alpha (FRα) peptide cancer vaccine product candidate.

Ovarian Cancer

Marker Therapeutics reported that it had completed enrollment in its Phase II study in ovarian cancer (Study FRV-004), using TPIV200 as a maintenance therapy for patients in their first remission after surgery and platinum-based chemotherapy. Marker has enrolled, randomized, and treated 120 patients at 17 clinical sites. The study completed enrollment six months faster than anticipated. The Company expects to reach its planned interim analysis trigger of 50 patients who have progressed by the end of the second quarter of 2019, with interim data reported by year end.

Enrollment of this study was completed over six months ahead of schedule, reflecting ongoing management initiatives to improve and enhance clinical operations efficiency.
Marker had previously projected the initiation of its interim analysis to begin in Q4 2018, triggered by the 50th patient to progress following treatment. Despite faster than expected enrollment of patients in this study, as of the end of December fewer than 50 patients had progressive disease. As a result, Marker now expects to reach its planned interim analysis trigger by end of the second quarter of 2019, with interim data reported by year end.
Triple Negative Breast Cancer

Marker Therapeutics also reported initial findings from its interim analysis of its dose-finding study (Study FRV-002) in patients with triple negative breast cancer, using TPIV200 as a maintenance therapy for patients in remission following first-line therapy. The four-arm study included low and high dose TPIV200 with or without cyclophosphamide.

Of 27 patients evaluated to date for immunogenicity, 26 showed significant immune response to the vaccine treatment. Of 80 patients treated at 11 clinical sites, 11 have shown disease progression to date following treatment with TPIV200.
"These additional clinical results strongly augment our existing, previously disclosed patient dataset. In patients who were treated for active disease in lymphoma, we continue to see long-lived, ongoing complete responses that are now durable beyond five years and have yet to observe a patient who achieves a CR subsequently relapse," said Dr. Richard Kenney, Acting Chief Medical Officer of Marker Therapeutics. "Notably, in the adjuvant lymphoma patients we have also not seen any additional relapses, with several patients now beyond four years in their continuing complete response. While the median progression-free survival has not yet been reached in any of these trials, observationally it appears that the time to progression for patients receiving MultiTAA T cell therapy may compare favorably with results reported in CD19 and BCMA-targeted CAR-T studies in lymphoma and multiple myeloma, without inducing the toxicities normally associated with gene-modified adoptive cell therapies."

"Given the highly refractory nature of the patients with acute lymphoblastic leukemia treated, we believe the preliminary results appear to be very promising, with only one patient having relapsed to date," continued Dr. Kenney. "These early results may indicate that MultiTAA therapy may be able to drive clinical benefit for these patients without the need for donor-lymphocyte infusions (DLIs), and the associated risk of graft versus host disease (GvHD). Finally, our clinical sites have been very supportive of our Phase II vaccine studies in ovarian and breast cancer, and their rapid enrollment is a credit to our Principal Investigators and clinical investigative sites, as well as our clinical operations team. We are pleased with the progress in building our clinical development infrastructure and believe we can leverage that experience to drive our upcoming MultiTAA T cell studies efficiently."

On January 3, 2019 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported that Raul Rodriguez, the company’s president and CEO, is scheduled to present a company overview at the 37th Annual J.P. Morgan Healthcare Conference on Wednesday, January 9, 2019 at 11:00am PT in San Francisco, CA (Press release, Rigel, JAN 3, 2019, View Source [SID1234532425]).

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To access the live webcast of the presentation or the subsequent archived recording, log on to www.rigel.com. Please connect to Rigel’s website several minutes prior to the start of the live webcast to ensure adequate time for any software download that may be necessary.

On January 3, 2019 Verastem, Inc. (Nasdaq: VSTM) (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, reported the company’s recent progress and outlined strategic priorities for 2019 (Press release, Verastem, JAN 3, 2019, View Source [SID1234532424]).

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"2018 was a pivotal year for Verastem Oncology, as the U.S. Food and Drug Administration’s (FDA) approval of COPIKTRA and other key accomplishments strongly positioned us to execute on our 2019 corporate priorities that are focused on increasing revenues, initiating additional clinical studies of COPIKTRA and advancing our pipeline," said Robert Forrester, President and Chief Executive Officer of Verastem Oncology. "We are pleased with the strong vote of confidence we have received in duvelisib, including validating licensing agreements in key Asian markets, recognition of our pivotal Phase 3 data in the medical journal Blood, and more. We are also entering 2019 with a strong balance sheet derived from the successful completion of multiple financing transactions, which we believe provides us with important financial strength to achieve our planned corporate objectives. We look forward to keeping the momentum going, and to sharing ongoing updates on our progress."

"Since the launch of COPIKTRA, we’ve been encouraged by the positive feedback we are hearing from physicians and other healthcare providers about this important new oral monotherapy within the treatment landscape," said Joseph Lobacki, Executive Vice President and Chief Commercial Officer of Verastem Oncology. "Following the approval, COPIKTRA was quickly added to the National Comprehensive Cancer Network (NCCN) guidelines, which has led to its inclusion on formularies and extensive reimbursement coverage, including on the top national health plans, reaching approximately 75% of U.S. Pharmacy lives and providing critical access to treatment for appropriate patients. In 2019, the commercial team will be diligently working to engage with physicians and other health care professionals to focus on ensuring COPIKTRA reaches the patients who need it."

2018 Accomplishments

COPIKTRA (duvelisib) Capsules Approved by the U.S. FDA – On September 24, 2018, the FDA approved COPIKTRA, an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma. COPIKTRA was approved for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies. COPIKTRA also received accelerated approval for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. The indication in FL is approved under accelerated approval based on overall response rate. Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial. The commercial launch of COPIKTRA is ongoing.

Use of COPIKTRA is associated with a BOXED WARNING for four fatal and/or serious toxicities: infections, diarrhea or colitis, cutaneous reactions, and pneumonitis. Verastem Oncology is implementing an informational Risk Evaluation and Mitigation Strategy to provide appropriate dosing and safety information to better support physicians in managing their patients on COPIKTRA.

Additionally, use of COPIKTRA is also associated with adverse reactions which may require dose reduction, treatment delay or discontinuation of COPIKTRA.

Please see www.COPIKTRAHCP.com/prescribinginformation for full Prescribing Information including BOXED WARNING and Medication Guide in addition to the Important Safety Information provided below.
Established a Commercial Franchise in the U.S. – In 2018, the Company established a full commercial infrastructure in the U.S. The sales, market access and medical affairs teams are fully deployed and calling on medical institutions, oncology healthcare professionals and payors in support of the COPIKTRA launch. COPIKTRA product was available at specialty distributors and specialty pharmaceutical providers immediately following approval. Top national health plans are now offering reimbursement coverage and the majority of COPIKTRA sales territories have patients being treated. The Company also successfully launched Verastem Cares, a comprehensive, personalized program designed to provide information and assistance to patients who have been prescribed COPIKTRA, which is now fully operational nationwide.
COPIKTRA Added to NCCN Guidelines for CLL/SLL and FL – The NCCN added COPIKTRA to the Clinical Practice Guidelines in Oncology (NCCN Guidelines), the standard physician resource for determining the appropriate course of treatment for patients. The Company believes these updated guidelines will increase awareness for COPIKTRA and help health care providers make informed decisions for patients battling these difficult to treat advanced cancers.
Phase 3 DUO Study Results Published in the Journal Blood – The results of the randomized, multicenter, open-label Phase 3 DUO study (NCT02004522), which evaluated COPIKTRA versus ofatumumab in patients with relapsed or refractory CLL/SLL, were published in the peer-reviewed journal Blood (Flinn at al). The publication was accompanied by a review article by Jennifer R. Brown, M.D., Ph.D., Director of the Chronic Lymphocytic Leukemia Center at Dana-Farber Cancer Center, discussing the role of PI3K inhibitors and duvelisib in current CLL therapy. The full manuscript titled "The phase 3 DUO trial: duvelisib versus ofatumumab in relapsed and refractory CLL/SLL," is available at www.bloodjournal.org.
Eight Abstracts Presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2018 Annual Meeting (ASH 2018) – The Company presented eight abstracts, including one oral presentation, at ASH (Free ASH Whitepaper) 2018 in San Diego. The oral presentation highlighted data from the Phase 1 study evaluating duvelisib in combination with romidepsin in relapsed or refractory peripheral T-cell lymphoma. Additional poster presentations showcased preclinical and clinical data reinforcing the potential of duvelisib.
Signed Exclusive License Agreements in China and Japan – Verastem Oncology entered into exclusive license agreements with CSPC Pharmaceutical Group Limited (CSPC) to develop and commercialize COPIKTRA in China, Hong Kong, Macau and Taiwan, and Yakult Honsha Co., Ltd. (Yakult) to develop and commercialize COPIKTRA in Japan. Both agreements are for the treatment, prevention or diagnosis of all oncology indications.
Under the terms of the agreement with CSPC, Verastem Oncology received an upfront payment of $15 million and is entitled to receive aggregate payments of up to $160 million if certain development, regulatory and commercial milestones are successfully achieved, plus double-digit royalties on net sales of products containing duvelisib in the CSPC Territory. CSPC is a leading pharmaceutical group in China.
The transaction with Yakult carries a total deal value of up to $100 million, includes a one-time upfront payment of $10 million and up to an additional $90 million if certain future pre-specified development, regulatory and commercial milestones are successfully achieved by Yakult. In addition, Verastem Oncology is also eligible to receive double-digit royalties based on future net sales of duvelisib in Japan.
Collaboration with The Leukemia & Lymphoma Society for Development of Duvelisib in Peripheral T-Cell Lymphoma – Duvelisib was selected for The Leukemia & Lymphoma Society’s (LLS) Therapy Acceleration Program (TAP) which provides additional resources to support the development of therapies for patients with blood cancers. The Company plans to use the TAP funds to conduct certain translational and clinical activities relating to the development of duvelisib for the treatment of Peripheral T-Cell Lymphoma (PTCL). LLS and Verastem Oncology will share the cost of the PTCL development program, portions of which will be conducted in collaboration with Memorial Sloan Kettering Cancer Center, The Dana-Farber Cancer Institute, The Washington University in St. Louis and Stanford University.
Entering 2019 with a Strong Balance Sheet– In May 2018, Verastem Oncology successfully completed multiple fundraising transactions, including an underwritten registered offering in May 2018, a registered offering in June 2018, and a registered direct offering of 5.00% convertible senior notes in October 2018. The Company also raised funds through the sale of shares of common stock under its at-the-market equity offering program. The Company has approximately $279 million in cash and cash equivalents pro-forma to the close of the third quarter of 20181.
2019 Priorities

Verastem Oncology’s 2019 focus is to execute on business priorities aimed at increasing the company’s sales and revenues:

Continuing to expand on the commercial traction of COPIKTRA in CLL/SLL and FL for appropriate patients;
Expansion of the open-label, multicenter, Phase 2 clinical trial (the PRIMO study) evaluating the efficacy and safety of duvelisib monotherapy in adult patients with histologically confirmed relapsed or refractory PTCL. This study is expected to enroll approximately 120 patients;
Initiating a confirmatory Phase 3 study evaluating duvelisib for the treatment of patients with relapsed or refractory FL after at least two prior systemic therapies. The confirmatory study is expected to start in the second half of 2019;
Initiating additional investigational studies of duvelisib as a monotherapy and in combination with other anti-cancer agents, such as checkpoint inhibitors, in both hematological and solid tumor malignancies;
Working with the LLS to advance the PTCL program including the expansion of the Phase 2 combination study of duvelisib and romidepsin for patients with relapsed or refractory PTCL;
Additional ex-U.S. partnerships for duvelisib;
Presenting and publishing additional duvelisib data; and
Advancing the Company’s focal adhesion kinase (FAK) inhibitor defactinib, which is designed to treat cancer through modulation of the tumor microenvironment and enhancement of anti-tumor immunity. Defactinib is currently being evaluated in three separate clinical collaborations in combination with immunotherapeutic agents for the treatment of several different cancer types including pancreatic cancer, non-small cell lung cancer (NSCLC), and mesothelioma.
For more information about Verastem Oncology, including its leadership, product and pipeline, please visit verastem.com

COPIKTRA (duvelisib)- Select Important Safety Information

WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS

See full prescribing information for complete boxed warning

Fatal and/or serious infections occurred in 31% of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected.
Fatal and/or serious diarrhea or colitis occurred in 18% of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA.
Fatal and/or serious cutaneous reactions occurred in 5% of COPIKTRA-treated patients. Withhold COPIKTRA.
Fatal and/or serious pneumonitis occurred in 5% of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA.
WARNINGS AND PRECAUTIONS

Hepatotoxicity: Monitor hepatic function.
Neutropenia: Monitor blood counts.
Embryo-Fetal toxicity: COPIKTRA can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.
ADVERSE REACTIONS

The most common adverse reactions (> 20%) are diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Verastem, Inc. (Verastem) at 877-7RXVSTM or 1-877-779-8786, or U.S. Food and Drug Administration (FDA) at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

CYP3A inducers: Avoid co-administration with strong CYP3A inducers.
CYP3A inhibitors: Monitor for COPIKTRA toxicities when co-administered with strong or moderate CYP3A inhibitors. Reduce COPIKTRA dose to 15 mg twice daily when co-administered with strong CYP3A4 inhibitors.
CYP3A substrates: Monitor for signs of toxicities when co-administering COPIKTRA with sensitive CYP3A substrates.

About Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are cancers that affect lymphocytes and are essentially the same disease, with the only difference being the location where the cancer primarily occurs. When most of the cancer cells are located in the bloodstream and the bone marrow, the disease is referred to as CLL, although the lymph nodes and spleen are often involved. When the cancer cells are located mostly in the lymph nodes, the disease is called SLL. The symptoms of CLL/SLL include a tender, swollen abdomen and feeling full even after eating only a small amount. Other symptoms can include fatigue, shortness of breath, anemia, bruising easily, night sweats, weight loss, and frequent infections. However, many patients with CLL/SLL will live for years without symptoms. There are approximately 200,000 patients in the US affected by CLL/SLL with nearly 20,000 new diagnoses this year alone. While there are therapies currently available, real-world data reveals that a significant number of patients either relapse following treatment, become refractory to current agents, or are unable to tolerate treatment, representing a significant medical need. The potential of additional oral agents, particularly as a monotherapy that can be used in the general community physician’s armamentarium, may hold significant value in the treatment of patients with CLL/SLL.

About Follicular Lymphoma

Follicular lymphoma (FL) is typically a slow-growing or indolent form of non-Hodgkin lymphoma (NHL) that arises from B-lymphocytes, making it a B-cell lymphoma. This lymphoma subtype accounts for 20 to 30 percent of all NHL cases, with more than 140,000 people in the US with FL and more than 13,000 newly diagnosed patients this year. Common symptoms of FL include enlargement of the lymph nodes in the neck, underarms, abdomen, or groin, as well as fatigue, shortness of breath, night sweats, and weight loss. Often, patients with FL have no obvious symptoms of the disease at diagnosis. Follicular lymphoma is usually not considered to be curable, but more of a chronic disease, with patients living for many years with this form of lymphoma. The potential of additional oral agents, particularly as a monotherapy that can be used in the general community physician’s armamentarium, may hold significant value in the treatment of patients with FL.

About Peripheral T-Cell Lymphoma

Peripheral T-cell lymphoma (PTCL) is a rare, aggressive type of non-Hodgkin lymphoma (NHL) that develops in mature white blood cells called "T cells" and "natural killer (NK) cells"2 which circulate with the lymphatic system.3 PTCL accounts for between 10-15% of all non-Hodgkin lymphomas (NHLs) and generally affects people aged 60 years and older.2 Although there are many different subtypes of peripheral T-cell lymphoma, they often present in a similar way, with widespread, enlarged, painless lymph nodes in the neck, armpit or groin.3 There is currently no established standard of care for patients with relapsed or refractory disease.2

About COPIKTRA (duvelisib)

COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.4,5,6 COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies and relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. COPIKTRA is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track status, and is being investigated in combination with other agents through investigator-sponsored studies.7 For more information on COPIKTRA, please visit www.COPIKTRA.com. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

About Defactinib

Defactinib is an investigational inhibitor of focal adhesion kinase (FAK), a non-receptor tyrosine kinase that mediates oncogenic signaling in response to cellular adhesion and growth factors.8 Based on the multi-faceted roles of FAK, defactinib is used to treat cancer through modulation of the tumor microenvironment and enhancement of anti-tumor immunity.9,10 Defactinib is currently being evaluated in three separate clinical collaborations in combination with immunotherapeutic agents for the treatment of several different cancer types including pancreatic cancer, ovarian cancer, non-small cell lung cancer (NSCLC), and mesothelioma. These studies are combination clinical trials with pembrolizumab and avelumab from Merck & Co. and Pfizer/Merck KGaA, respectively.11,12,13 Information about these and additional clinical trials evaluating the safety and efficacy of defactinib can be found on www.clinicaltrials.gov.

On January 3, 2019 Amunix Pharmaceuticals Inc. ("Amunix"), a biopharmaceutical company focused on the discovery and development of novel immuno-oncology therapeutics, reported that it has entered into a licensing agreement with Merck, known as MSD outside the United States and Canada, for rights to develop therapeutics against an undisclosed target using Amunix’s proprietary protease-triggered immune activator (ProTIA) technology platform (Press release, Amunix, JAN 3, 2019, View Source [SID1234532423]).

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"We are very pleased to enter into the collaboration with Merck, an acknowledged leader in the field of novel cancer therapeutics," said Volker Schellenberger, Ph.D., President and CTO of Amunix. "The agreement with Merck is a testament to Amunix’s protein engineering expertise reflected in our ProTIA platform. This powerful new platform technology enables the rapid generation of tumor activatable cytokines, signaling peptides/proteins or immune cell engagers. We look forward to a productive and successful relationship."

"Amunix’s ProTIA technology offers the potential to create novel tumor-targeted molecules for evaluation in our immuno-oncology clinical development programs," said Rob Kastelein, Ph.D., Associate Vice President, Immune-Oncology Discovery, Merck Research Laboratories. "We look forward to working with the Amunix team."

Under terms of the agreement, Amunix will receive an upfront payment from Merck and is eligible to receive payments associated with the achievement of certain developmental milestones as well as royalties on sales of any products derived from the collaboration. Further financial details were not disclosed.

On January 3, 2019 GeneCentric Therapeutics, Inc. reported the appointment of Michael V. Milburn, PhD, as Chief Executive Officer and President, and he will join GeneCentric’s Board of Directors (Press release, GeneCentric Therapeutics, JAN 3, 2019, View Source [SID1234532422]). Dr. Myla Lai-Goldman, founder, current CEO and President, will assume the newly-created role of Executive Chairperson of the Board of Directors, succeeding Clay Thorp, Founder and General Partner at Hatteras Venture Partners, as Board Chair.

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"We founded GeneCentric, with UNC researchers Chuck Perou and Neil Hayes, with a vision to develop cancer tests to match a drug to an individual patient in order to maximize the efficacy of cancer treatments and reduce adverse events," said Dr. Lai-Goldman. "We have made great progress in establishing a subtyping platform built around an expanding array of pan-cancer tests, applying the platform to lung, head and neck, bladder, and pancreatic cancer, and entering initial partnerships with pharmaceutical companies to enable precision drug development in oncology. Michael is well positioned to build on the scientific base we have established and drive our commercial efforts with pharmaceutical companies."

In addition to GeneCentric, Dr. Lai Goldman serves on the Board of Directors at West Pharmaceutical Services and Qvella Corporation as well as a Venture Partner with Hatteras Venture Partners.

"GeneCentric is at the forefront of developing RNA-based informatics and data science which will be key to developing the next generation cancer immunotherapies and chemotherapies," said Milburn. "Myla and the scientific founders and team have been instrumental in building a technology that is highly valued by our pharmaceutical partners to get the right cancer treatment to the right patient. This is a very exciting time for GeneCentric as we begin to deploy our cancer tests alongside cancer drugs."

Dr. Milburn joined GeneCentric in September of 2018 as Chief Scientific Officer and leads the development of its RNA-based technology platform for developing new cancer tests focused on pharmaceutical drug development. Previously, Dr. Milburn was CSO at Metabolon and led the R&D efforts that established the company as a premier metabolomics technology. Prior to Metabolon, he served as Senior Vice President of Research and Corporate Development at Sirtris Pharmaceuticals and Senior Vice President of Research at Plexxikon. He also held senior research positions at Structural Genomix and GlaxoWellcome.

Dr. Milburn received his PhD in Biophysical Chemistry from the University of California at Berkeley and was a post-doctoral research fellow at Harvard Medical School. Dr. Milburn has published over 100 peer-reviewed scientific articles and is an Adjunct Professor in the Department of Molecular and Structural Biochemistry at NCSU.

"Michael brings a broad range of expertise that spans drug development, biomarker discovery and diagnostic development and commercialization, along with a strong track record commercial execution that built significant value," said Clay Thorp, Founder and General Partner at Hatteras Venture Partners. "We look forward to his new leadership role at GeneCentric as they expand their cancer technology and expertise with pharmaceutical partners."