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Adaptimmune Presents Safety Data with Evidence of Tumor Necrosis in One Patient from ADP-A2AFP Study at American Association for Cancer Research (AACR) Meeting

On April 2, 2019 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported its initial safety data from two patients with advanced hepatocellular carcinoma (HCC), liver cancer, from the first dose cohort of the ADP-A2AFP study at the annual AACR (Free AACR Whitepaper) meeting (Press release, Adaptimmune, APR 2, 2019, View Source;p=RssLanding&cat=news&id=2393177 [SID1234534979]).

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"We did not observe clinically significant liver toxicity in the two patients treated at a dose of 100 million transduced cells, and these data supported dose escalation to the second cohort. Even though data are preliminary, we are encouraged by the evidence of tumor necrosis we saw in one of the two patients. We have started dosing patients with higher cell doses and there continues to be no evidence of hepatotoxicity or other dose limiting toxicities. We will give an update on this study as well as our other ongoing trials during our May quarterly call," said Rafael Amado, Adaptimmune’s President of Research & Development.

There was no evidence of clinically significant hepatotoxicity, off-target toxicity, or alloreactivity, and no protocol-defined dose limiting toxicities were observed. Most adverse events were consistent with those typically experienced by cancer patients undergoing cytotoxic chemotherapy or other cancer immunotherapies.

Imaging and a post-treatment biopsy for one patient showed evidence of tumor necrosis with lymphocytic infiltration, concurrent with a transient decrease in serum AFP. In addition, ADP-A2AFP SPEAR T-cells were detectable in the peripheral blood. The patient later progressed at Week 16.

Based on these initial safety data, the Safety Review Committee (SRC) endorsed advancing to Cohort 2 (https://bit.ly/2M0oQxe).

Overview of study design:

This is a first-in-human study to evaluate safety and antitumor activity of SPEAR T-cells (ADP-A2AFP) directed towards AFP in patients with HCC not amenable to transplant, resection, or loco-regional therapy and failed/intolerant/refused standard of care treatment (NCT03132792)
Up to 20 patients will be enrolled using a modified 3+3 design, in three dose escalation cohorts followed by an expansion phase:
• Cohort 1: target dose of 100 million transduced cells (range: 80-120 million); lymphodepletion regimen of cyclophosphamide (Cy) (500 mg/m2) and fludarabine (Flu) (20 mg/m2) x 3 days: stagger of 21 days between patients to evaluate dose limiting toxicities (DLTs)
• Cohort 2: target dose of 1 billion transduced cells (range: 500 million to 1.2 billion); lymphodepletion regimen of Cy (500 mg/m2) and Flu (20 mg/m2) x 3 days: stagger of 7 days between patients to evaluate DLTs
• Cohort 3: target dose of 5 billion transduced cells (range: 1.2 to 6 billion); lymphodepletion regimen of Cy (600 mg/m2) x 3 days and Flu (30 mg/m2) x 4 days; stagger of 7 days between patients to evaluate DLTs
• Expansion Phase: target dose of 5 billion transduced cells (range: 1.2 to 10 billion); lymphodepletion regimen of Cy (600 mg/m2) x 3 days and Flu (30 mg/m2) x 4 days; no stagger between patients
Poster presentation details:

Title: Initial safety of AFP SPEAR T-cells in patients with advanced hepatocellular carcinoma
Session Title: Adoptive Cell Therapy 3
Session Date and Time: Tuesday Apr 2, 2019 8:00 AM – 12:00 PM ET
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 22
Poster Board Number: 6
Abstract Number: 3183

Infinity Pharmaceuticals To Present At The 18th Annual Needham Healthcare Conference

On April 2, 2019 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that Adelene Perkins, Infinity Pharmaceutical’s Chief Executive Officer, will present at the 18th Annual Needham Healthcare Conference on Tuesday, April 9, 2019, at 3:30 p.m. ET at the Westin NY Grand Central Hotel in New York, NY (Press release, Infinity Pharmaceuticals, APR 2, 2019, View Source [SID1234534978]). A live webcast of the presentation will be available on the Investors/Media section of Infinity’s website at www.infi.com, and will be available for 30 days following the event

Massive Bio and Admera Health Partnership

On April 2, 2019 Massive Bio, Inc., a leader in providing simplified and affordable access to clinical trials and precision oncology to cancer patients treated at community-based oncology practices, reported that its Trials-in-Progress poster titled "SYNERGY-AI: Artificial intelligence based precision oncology clinical trial matching and registry" will be presented by Dr. Selin Kurnaz, a lead investigator, at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 in Atlanta, GA, USA, during the Phase I-III Trials in Progress session on April 2nd, 2019 (Press release, Massive Bio, APR 2, 2019, View Source [SID1234534977]).

The poster (Abstract #CT218), View Source!/6812/presentation/10031 discusses the ongoing, pivotal global registry for cancer patients evaluating the feasibility and clinical utility of an Artificial Intelligence-based precision oncology clinical trial matching tool powered by a virtual tumor board (VTB) program. The SYNERGY-AI registry is the first of its kind to combine artificial intelligence, genomic biomarkers and multi-variate analysis to accelerate clinical trial matching and promote access to promising cancer therapies.

"We continue active enrollment in this innovative precision oncology and artificial intelligence project, and we are honored and excited to be among the highly selected group of clinical trials to be presented at AACR (Free AACR Whitepaper). Moreover, we are the only company in the market that operationalizes technology – we not only pre-screen patients, we find sites to the patients, eliminate insurance barriers and truly close the last mile in oncology clinical trial enrollment. We clean massive operational inefficiencies and we are making a leap frog in clinical research," said Selin Kurnaz, PhD., CEO and Co-Founder of Massive Bio.

In addition, today, Massive Bio and Admera Health announced a non-exclusive collaborative agreement as active participants in SYNERGY-AI registry. Under the terms of the agreement, Massive Bio and Admera Health will focus on real world evidence, biomarker data and clinical trial matching in precision oncology studies. In addition, Admera Health also provides genomics and bioinformatics services to customers wishing to conduct research in a CLIA environment.

"By combining the expansive technology and precision oncology capabilities of Massive Bio with Admera Health’s specialization in genomics and bioinformatics, we hope to develop and provide the next wave of molecular-based portfolio of technology innovations and services," stated Jeffrey R. Mitchell, Associate Director of Strategy and Marketing of Admera Health. Mitchell continued, "In addition, given the geographic strengths of our respective companies, there will also be opportunities to expand clinical trials using each other’s proprietary technology around the globe."

Commenting on the announcement, Chief Medical Advisor and Co-Founder of Massive Bio Inc., Dr. Arturo Loaiza-Bonilla, MD, MSEd, stated, "Massive Bio’s Artificial Intelligence technology platform is extremely well positioned to enable just-in-time clinical trial matching and enrollment, with a targeted therapy and immunotherapy focus, and is proven to accelerate access to innovative therapies, sponsor and CRO efficiency, as well as time to market. We certainly welcome collaborations with all stakeholders in the diagnostics and research space, aiming to close existing gaps in cancer research." Chief Business Officer of Massive Bio Inc, Harry Buchman also stated, "With a growing number of successful development applications, it is our goal to continue to promote precision oncology approaches at the point-of-care, and to ease access to clinical trials, while reducing patient and provider burden and overall cancer care costs."

About the Study

The SYNERGY-AI Registry is an international prospective, observational cohort study of adult and pediatric patients with advanced solid and hematological malignancies. Using a proprietary application programming interface (API) linked to existing electronic health records (EHR) platforms, individual clinical data is extracted, analyzed and matched to a parametric database of existing institutional and non-institutional CT. Machine learning algorithms allow for optimized matching based on CT allocation and availability. Enrollment is ongoing, with a target of ≥1,500 patients. Please refer to View Source for details.

MEI Pharma to Present at the 18th Annual Needham Healthcare Conference

On April 2, 2019 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported that Daniel P. Gold, Ph.D., president and chief executive officer, will present at the 18th Annual Needham Healthcare Conference on Tuesday, April 9, 2019 at 10:40 a.m. ET (Press release, MEI Pharma, APR 2, 2019, View Source [SID1234534953]). The conference will take place April 9-10, in New York, N.Y.

A live audio webcast of the event can be accessed on the Events & Presentations page of the Investors section of MEI Pharma’s website at View Source

An archived replay of the webcast will be available on MEI Pharma’s website for at least 30 days after the live event concludes.

BerGenBio: Preclinical data presented at AACR reinforces bemcentinib’s potential to reverse tumour immunosuppression and therapy resistance

On April 2, 2019 BerGenBio ASA (OSE: BGBIO) a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, reported its preclinical data strengthening bemcentinib’s broad potential in reversing tumour-mediated immunosuppression and therapy resistance, presented by the Company’s academic collaborators at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 (March 29 – April 3, Atlanta, Georgia) (Press release, BerGenBio, APR 2, 2019, View Source [SID1234534952]).

Leading academic groups from the Gustave Roussy Cancer Centre in Paris, France, MD Anderson Cancer Center in Houston, TX, and UT Southwestern Medical Center in Dallas, TX, presented three posters describing pre-clinical findings generated in collaboration with BerGenBio on AXL’s role in aggressive cancer and bemcentinib’s therapeutic effect. The data presented lend further support to the Company’s ongoing clinical proof-of-concept programme and planned late stage strategy evaluating bemcentinib’s potential as a monotherapy and in combination across several indications.

A summary of results presented is given below.

(1) Salem Chouaib et al, Gustave Roussy Cancer Centre, Paris, France: AXL targeting enhances lymphocyte-mediated cytotoxicity of lung cancer cells. Abstract – 1200

Summary of results presented:

NSCLC cells expressing AXL were less prone to cell lysis mediated by cytotoxic T-lymphocytes (CTL) or NK-cells
Bemcentinib treatment led to increased CTL and NK-cell mediated killing of these AXL expressing NSCLC cells
(2) Kavya Ramkumar et al, The University of Texas, MD Anderson Cancer Center, Houston, TX: Targeting AXL sensitizes non-small cell lung cancer to ATR inhibitors by enhancing replication stress. Abstract – 276

Summary of results presented:

Bemcentinib treatment induces DNA damage and a subsequent DNA-damage response in NSCLC cells in a dose-dependent manner
Bemcentinib acts synergistically with DNA-damage-repair targeting agents (ATR inhibitors VX-970 or AZD6738) in reducing viability of NSCLC cells
(3) Wenting Du et al, The University of Texas Southwestern Medical Center, Dallas, TX: AXL is critical for pancreatic cancer progression and metastasis. Abstract –1037

Summary of results presented:

Downregulation of AXL via genetic engineering of pancreatic tumour models resulted in a more active immune microenvironment, prolonged survival and improved response to gemcitabine
Pharmacological intervention with bemcentinib similarly achieves immune activation and potentiates the effect of gemcitabine in pancreatic models where AXL is present on tumour and stroma cells
About AXL
AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases. In cancer, AXL suppresses the body’s immune response to tumours and drives cancer treatment failure across many indications. AXL inhibitors, therefore, have potential high value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities. Research has also shown that AXL mediates other aggressive diseases.

About Bemcentinib
Bemcentinib (formerly known as BGB324), is a potentially first-in-class selective AXL inhibitor in a broad phase II clinical development programme. Ongoing clinical trials are investigating bemcentinib in multiple solid and haematological tumours, in combination with current and emerging therapies (including immunotherapies, targeted therapies and chemotherapy), and as a single agent.Bemcentinib targets and binds to the intracellular catalytic kinase domain of AXL receptor tyrosine kinase and inhibits its activity. Increase in AXL function has been linked to key mechanisms of drug resistance and immune escape by tumour cells, leading to aggressive metastatic cancers.