On June 4, 2019 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported that the Company’s collaborators at Memorial Sloan Kettering Cancer Center (MSK), Prasad S. Adusumilli, M.D. and Michel Sadelain, M.D., Ph.D., presented an update on encouraging results from an ongoing MSK investigator-sponsored Phase 1 clinical study (NCT02414269) of a mesothelin-targeted CAR T immunotherapy for patients with mesothelin-associated malignant pleural solid tumors, primarily mesothelioma, who progressed following platinum-containing chemotherapy (Press release, Atara Biotherapeutics, JUN 4, 2019, View Source [SID1234536855]). Mesothelin-targeted, autologous CAR T cells delivered regionally were well-tolerated and showed encouraging anti-tumor activity in combination with pembrolizumab, a PD-1 checkpoint inhibitor. The findings were presented today at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2019 in Chicago.

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"The updates to this study presented by our MSK collaborators reaffirm mesothelin as a promising target for patients with advanced mesothelioma and establishes an important proof-of-concept advancement for CAR T immunotherapy in solid tumors," said Christopher Haqq, M.D., Ph.D., Executive Vice President and Chief Scientific Officer of Atara Biotherapeutics. "Based on these continued encouraging safety results and anti-tumor responses, Atara recently prioritized our mesothelin-targeted CAR T program and anticipate autologous ATA2271 will be Atara’s first next-generation CAR T IND in advanced mesothelioma."

The MSK Phase 1 clinical study has recruited 27 patients, 25 with malignant pleural mesothelioma (MPM), one with metastatic lung cancer and one with metastatic breast cancer, who had a median of 3 prior treatment regimens, to evaluate the safety and potential anti-tumor activity of a CD28-costimulated, mesothelin-targeted autologous CAR T immunotherapy. The study added two higher dose cohorts to the six-dose cohorts reported in March 2019 with administration directly to the tumor site. Twenty-two of the 27 patients were subsequently treated with pembrolizumab, a PD-1 checkpoint inhibitor.

Mesothelin-targeted, autologous CAR T administration was found to be generally well tolerated, with no CAR T-related toxicities higher than grade 2 observed based on monitoring multiple clinical, radiological, and laboratory parameters.

In a subset of 16 MPM patients who also received lymphodepleting chemotherapy and at least 3 doses of pembrolizumab with a minimum follow-up of 3 months following the final dose of PD-1, the 12-month overall survival (OS) was 80% and best overall response rate (ORR) was 63% (10 of 16), consisting of 3 durable investigator-assessed complete responses (CR) and seven partial responses (PR). Eleven of the 16 patients in this subset were programmed cell death ligand 1 (PD-L1) negative, defined as undetectable expression of PD-L1 in tumor cells by immunohistochemistry, with 6 of the 10 total responses observed in PD-L1 negative patients (1 CR and 5 PR). CAR T cells persisted in the pleural fluid and trafficked to the peripheral blood in these 16 patients for up to 42 weeks.

Following progression on standard platinum-containing chemotherapy, the expected 12-month OS, median OS and ORR for patients with MPM treated with a PD-1 containing regimen is 63%, 11-18 months and 5%-29%, respectively.1-5

MSK is also investigating mesothelin-targeted CAR T cells for patients with mesothelin-associated advanced breast cancer (NCT02792114). Additional results from these ongoing studies are expected to be presented at upcoming scientific congresses.

Abstract 2511: Regional delivery of mesothelin-targeted CAR T cells for pleural cancers: Safety and preliminary efficacy in combination with anti-PD-1 agent
Oral Presentation Date and Time:Tuesday, June 4, 2019, 8:36 a.m. – 8:48 a.m. CDT
Session Title: The Who, What, and Where of CAR T
Location: S406, McCormick Place, South Building, Chicago, IL
Authors:Prasad S. Adusumilli, Marjorie G Zauderer, Valerie W Rusch, Roisin E O’Cearbhaill, Amy Zhu, Daniel Ngai, Erin McGee, Navin Chintala, John Messinger, Waseem Cheema, Elizabeth F Halton, Claudia R Diamonte, John Pineda, Alain Vincent, Shanu Modi, Steve Solomon, David R Jones, Renier J Brentjens, Isabelle C Riviere, Michel W Sadelain
Affiliations:Memorial Sloan Kettering Cancer Center

On June 4, 2019 Oncology Venture A/S ("OV" or "the Company") reported that an e-abstract has been published in Journal of Clinical Oncology – an ASCO (Free ASCO Whitepaper) Journal –, describing that DRP (Drug Response Prediction) is able to predict which breast cancer patients will be high likelihood responders to neoadjuvant (early) treatment with doxorubicin (Press release, Oncology Venture, JUN 4, 2019, View Source [SID1234536872]).

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Neoadjuvant treatment of breast cancer is an important remedy if the tumors are responding adequately. The current lack of adequate biomarker guidance results in many patients receiving chemotherapy without an efficient antitumor effect. The e-abstract in Journal of Clinical Oncology reports positive results from a study of Oncology Venture’s multigene mRNA-based technology for drug response prediction (DRP). DRP has been thoroughly validated in other settings, most recently in prediction of epirubicin – a sister molecule – efficacy in advanced breast cancer [1].

Based on analyses performed by the authors, it is concluded that DRP can predict which patients will be high likelihood responders to neoadjuvant doxorubicin. Modern multigene technologies may help assist clinicians in choosing between upfront surgery or neoadjuvant chemotherapy.

The e-abstract "Doxorubicin response prediction in neoadjuvant breast cancer therapy" can be accessed her

1. Buhl ASK, et al. (2018): Predicting efficacy of epirubicin by a multigene assay in advanced breast cancer within a Danish Breast Cancer Cooperative Group (DBCG) cohort: a retrospective-prospective blinded study. Breast cancer research and treatment. doi: 10.1007/s10549-018-4918-4.

For further information, please contact:

For investor inquiries
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E-mail: [email protected]
Telephone +45 21 70 10 49 For media inquiries
Thomas Pedersen, Carrotize PR & Communications

E-mail: [email protected]
Telephone +45 60 62 93 90

On June 4, 2019 Phoenix Molecular Designs (PhoenixMD), a privately-held biotechnology company designing precise cancer therapeutics targeting essential kinases, reported the completion of clinical trial supply manufacture for PMD-026 (Press release, Phoenix Molecular Designs, JUN 4, 2019, View Source [SID1234536888]).

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PhoenixMD’s lead program, PMD-026, is the first RSK inhibitor built for the treatment of triple-negative breast cancer (TNBC). The clinical trial supply was undertaken by STA Pharmaceutical (WuXi STA), a subsidiary of WuXi AppTec, and is being used to support IND-enabling toxicology studies and an upcoming Phase I/Ib study in women with breast cancer.

In March 2018, the companies entered into a major manufacturing agreement, and have since produced a multi kilogram drug supply for PMD-026 under GMP manufacturing practices. This represents a significant milestone, accelerating PhoenixMD’s Phase I readiness.

In order to further the collaboration, WuXi STA expanded its USA operations to include capsule production under GMP regulatory compliance. Dr. Minzhang Chen, CEO of WuXi STA, commented "The opportunity to enable PhoenixMD’s first-in-man studies came at an opportune moment for STA’s San Diego facility."

"Our partnership with WuXi STA has been critical for PhoenixMD to advance this stage of our development. Working with such a high quality, globally recognized manufacturing partner has allowed us to rapidly advance PMD-026 through IND-enabling GLP toxicology studies and has enabled us to be ready to initiate our Phase I/Ib study with high quality API in capsules," said Sandra E. Dunn, CEO of PhoenixMD. "The rapid achievement of this milestone brings us one step closer to initiating our study for women suffering from breast cancer. More specifically, metastatic triple-negative breast cancer, which is the most deadly type of breast cancer. RSK2 is a promising new drug target for the treatment of TNBC, and PMD-026 is the first drug to ever reach clinical use against this novel target."

"The secret sauce in our success – teamwork. We truly appreciate the collaborative approach and commitment that WuXi STA has brought to the PMD-026 project," notes Dr. Dunn.

The drug supply is sufficient to treat all of the patients in the Phase 1 study. This is coupled with the completion of PhoenixMD’s CDx for measuring activated RSK2 in tumors signals, enabling the two key elements needed for this precisely designed clinical trial to advance.

About RSK kinases in refractory cancers such as Triple Negative Breast Cancer (TNBC)

RSK is commonly associated with refractory cancers such as TNBC, hormone-refractory prostate cancer and resistant melanoma. Beyond these cancers, it is commonly activated in ovarian and colorectal cancers. RSK1 and RSK2 have been proven critical to the survival of patients with TNBC. Over 90% of primary TNBC express high levels of RSK1 and RSK2 mRNA and at the protein level RSK2 is activated in ~89% of primary tumors. Inhibiting RSK2 induces cell death in TNBC cells and is synergistic with standard of care chemotherapies such as paclitaxel. PhoenixMD, with its novel, targeted approach, is focused on creating patented RSK inhibitors and companion diagnostics for cancer indications – initially in breast cancer – with the potential to treat blood, brain, ovarian, lung, skin, prostate, colon, head and neck cancers.

Approximately 400,000 cases of TNBC are diagnosed every year worldwide and it is one of the most difficult breast cancer subtypes to treat due to lack of effective, targeted therapies. TNBC also claims the lives of young women more than any other type of breast cancer due to a lack of understanding around the therapeutic bullseye. This refractory disease is also a very heterogeneous disease, therefore a common denominator across TNBC types was necessary to identify the bullseye. Through genome-wide screens, RSK was identified as the prime target for TNBC by scientists at PhoenixMD. Currently, there are limited targeted therapies available for TNBC making RSK a leading opportunity.

There are four types of RSK involved in cancer, known as RSK1-4, and each type has a unique role in the development of the disease. RSK1 is responsible for cancer cell invasion and is an important driver in the spread of cancer. RSK2 controls cancer cell growth, and RSK3 and RSK4 are associated with drug resistance.

Currently, there are a limited number of approved targeted therapies for TNBC, however tumor progression continues to be eminent in most patients. PhoenixMD is addressing this unmet medical need through a novel, targeted approach by inhibiting critical kinases, such as RSK1-4, a group of highly conserved Ser/Thr kinases that promote cell proliferation, growth, motility and survival. For this target, PhoenixMD developed PMD-026, a first-in-class, specific RSK inhibitor that blocks downstream signaling of RSK and induces apoptosis.

About PMD-026 for TNBC

PhoenixMD’s lead program, PMD-026, is the first RSK inhibitor built for the treatment of triple-negative breast cancer (TNBC). PMD-026 was precisely designed for TNBC because RSK2 was specifically identified as the key kinase that drives the growth of this breast cancer subtype relative to hormone positive or Her-2 positive breast cancers. RSK2 was identified in a functional screen profiling 519 potential kinases. PMD-026 is the first drug to specifically arise from functional dependency screens in TNBC. PMD-026 is applicable to greater than 14 different types of cancers including those resistant to a wide range of therapies.

The first in human clinical trial for PMD-026 is a Phase I/Ib that is scheduled to initiate in Q3- 2019. Importantly, the clinical trial will include a companion diagnostic (CDx) that links PMD-026 to RSK2 activation in tumors, which PMD is developing in collaboration with Roche. In preclinical studies, PMD-026 shrinks tumors by over 70% as a single agent after only two weeks of treatment in tumors with high RSK2 activation using their CDx for model selection.

PMD-026 is shown to unlock the potential of tumor resistance by synergizing with chemotherapies such as paclitaxel. More recently, PMD-026 demonstrated the potential to reprogram the way that TNBC is recognized by the immune system, in part, by inhibiting PD-L1.

On June 4, 2019 Amarantus Bioscience Holdings, Inc. (OTC Pink: AMBS) (the "Company," or AMBS), a US-based JLABS-alumnus biotechnology holding company developing first-in-class orphan neurologic, regenerative medicine and ophthalmic therapies and diagnostics through its subsidiaries, reported that President & CEO Gerald Commissiong will make a corporate presentation at the 9th Annual LD Micro Invitational Conference. The presentation will be at 8:20am Pacific time on Wednesday, June 5th, 2019 in Track 5 at the Luxe Sunset Bel Air Hotel in Los Angeles (Press release, Amarantus Biosciences, JUN 4, 2019, View Source [SID1234536905]).

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On June 4, 2019 Agilent Technologies Inc. (NYSE: A) reported the following upcoming webcasts for the investment community (Press release, Agilent, JUN 4, 2019, https://www.agilent.com/about/newsroom/presrel/2019/04jun-gp19013.html [SID1234536856]):

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Jefferies 2019 Healthcare Conference
Thursday, June 6, at 11:00 a.m. (ET)
Grand Hyatt, New York
Bob McMahon, Agilent chief financial officer

Goldman Sachs 40th Annual Global Healthcare Conference
Tuesday, June 11, at 8:00 a.m. (PT)
Terranea Resort, Rancho Palos Verdes, Calif.
Bob McMahon, Agilent chief financial officer

Links to each webcast will be available at www.investor.agilent.com.