On November 8, 2019 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, reported comprehensive clinical and translational data from Cohort A of its Phase II clinical trial (BGBC008) evaluating bemcentinib, its first in class selective AXL inhibitor, in combination with MSD’s, (a tradename of Merck & Co., Inc., Kenilworth, NJ., USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab), as a potential new treatment regimen for previously treated advanced non-small cell lung cancer (NSCLC) at an oral presentation at the prestigious High Impact Clinical Trial session at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (6-10 November 2019) conference in Washington DC (Press release, BerGenBio, NOV 8, 2019, View Source [SID1234550772]).

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In cohort A, 44 patients were evaluable for response; of IHC evaluable patients: 50% were composite AXL positive, 52% were PD-L1 negative (<1%TPS), and 38% patients were PD-L1 low positive (1-49% TPS). The primary endpoint of Overall Response Rate (ORR) was met, with 33% ORR in AXL positive patients; five times the response rate of AXL negative patients (7%).

A secondary endpoint of median Progression Free Survival (mPFS) reported significant 3-fold improvement in AXL positive vs negative patients – 8.4 months in composite AXL positive patients significantly surpassing what has been shown historically in second line treatment with PD-1 inhibitor monotherapy.

Dr. Matthew Krebs, MD, PhD, the lead investigator who will give the presentation at SITC (Free SITC Whitepaper) said: "The clinical benefit seen with the drug combination in AXL positive patients is impressive and provides a potential new treatment approach for patients with low or negative PD-L1 status. The mPFS observed for the AXL positive patients is far higher than that seen with pembrolizumab monotherapy results from earlier clinical trials for patients with PD-L1<50%. Furthermore, the combination is well tolerated by patients."

RNA sequence analysis of pretreatment patient biopsies revealed that clinical benefit from the combination therapy correlates with total tumor AXL expression. A proprietary predictive signature for response to bemcentinib and pembrolizumab combination derived from the transcriptional analysis is enriched for genes associated with epithelial-to-mesenchymal transition (EMT) and myeloid cell activation. "This is exactly where we know AXL is important." added Professor James Lorens PhD, Chief Scientific Officer of BerGenBio.

The gene expression measured in responding patients correlates with gene signatures known to be associated with poor prognosis and lack of response to immunotherapy. This indicates that previously treated patients are particularly benefiting despite exhibiting these adverse traits. Professor Hani Gabra MD PhD, Chief Medical Officer of BerGenBio said: "This indicates that bemcentinib is conditioning the tumor microenvironment in AXL positive patients and optimizing pembrolizumab response in these previously treated patients."

Multispectral immunofluorescence analysis detected tumor infiltrating AXL-expressing macrophages closely adjacent to T cells in the tumors of patients who responded to the combination therapy. "Seeing the AXL expressing macrophages interacting with T regulatory cells in the tumor of a patient who responded to the treatment really underscores the potential." added Dr. Krebs.

Prof. Lorens added: "Previously we only considered AXL expression in the tumor cells, ignoring the immune cell compartment of the tumor. Our deeper biomarker analysis clearly shows that our earlier tumor cell-only score did not fully capture the population of patients who benefit from the combination." A proprietary composite AXL tumor-immune score has now been developed, derived from gene expression and immunohistochemistry analysis that selects patients likely to benefit from bemcentinib.

Richard Godfrey, Chief Executive Officer of BerGenBio, said: "Our improved ability to select and predict patients with durable clinical benefit with a refined AXL composite biomarker is an important development for our AXL targeting clinical programs. Importantly for patients is the prolonged duration of benefit or mPFS and improved Overall Survival (mOS), which is still maturing, these are also critical regulatory end points. I look forward to reporting mOS and data from additional cohorts in the coming months."

Presentation details

A phase II study of bemcentinib (BGB324), a first-in-class selective AXL inhibitor, in combination with pembrolizumab in patients with advanced NSCLC: Updated analysis

Matthew G. Krebs, MD, PhD –The University of Manchester
Concurrent Session 206: High Impact Clinical Trials
Oral Session
08 November 2019: Prince George’s Exhibition Hall C
5:10 – 5:25 p.m. EST (Session runs from 4:50 – 6:15 p.m.)
Presentation will be available at www.bergenbio.com in the section: Investors/Presentations when the presentation starts.

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. Tumour AXL expression is associated with poor prognosis in NSCLC and most other cancer types. 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.

On November 8, 2019 The Janssen Pharmaceutical Companies of Johnson & Johnson reported the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval to expand the IMBRUVICA (ibrutinib) label to include the combination with rituximab for the first-line treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (Press release, Johnson & Johnson, NOV 8, 2019, View Source [SID1234550771]). The submission is based on positive results from the investigational Phase 3 E1912 study designed and conducted by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the National Cancer Institute (NCI), which is part of the National Institutes of Health. The study met the primary endpoints of progression-free survival (PFS) and overall survival (OS) in patients aged 70 years or younger treated with IMBRUVICA plus rituximab, compared to the chemoimmunotherapy regimen of fludarabine, cyclophosphamide and rituximab (FCR). Results from the study were presented at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and were recently published in The New England Journal of Medicine August 2019 issue.

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"ECOG-ACRIN’s E1912 is a landmark head-to-head clinical trial of an IMBRUVICA-based regimen versus FCR, the most common chemoimmunotherapy regimen established to date for the frontline treatment of younger adult patients with CLL," said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Janssen Research & Development, LLC. "We look forward to working closely with the FDA to bring this new IMBRUVICA-based chemotherapy-free option to younger adult CLL patients based on the significant delay in disease progression and survival benefit as demonstrated in the E1912 study."

The sNDA is being reviewed by the U.S. FDA under the Real-Time Oncology Review (RTOR) pilot program. The program is designed to explore a more efficient review process, ensuring safe and effective treatments become available to patients earlier, while maintaining quality of review.

IMBRUVICA is a once-daily, first-in-class Bruton’s tyrosine kinase (BTK) inhibitor that is administered orally, and is jointly developed and commercialized by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company.

About IMBRUVICA
IMBRUVICA (ibrutinib) is a once-daily oral medicine that works differently than chemotherapy as it blocks the Bruton’s tyrosine kinase (BTK) protein. The BTK protein sends important signals that tell B cells to mature and produce antibodies. BTK signaling is needed by specific cancer cells to multiply and spread.1,2 By blocking BTK, IMBRUVICA may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs.3

IMBRUVICA is approved in more than 95 countries for at least one indication, and, to date, has been used to treat more than 170,000 patients worldwide across approved indications. It was first approved by the U.S. Food and Drug Administration (FDA) in November 2013, and today is indicated in six disease areas, including five hematologic cancers – chronic lymphocytic leukemia (CLL) with or without 17p deletion (del17p); small lymphocytic lymphoma (SLL) with or without del17p; Waldenström’s macroglobulinemia (WM); previously-treated patients with mantle cell lymphoma (MCL)*; previously-treated patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy*; and previously-treated patients with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.4

* Accelerated approval was granted for MCL and MZL based on overall response rate. Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.

As of early 2019, the National Comprehensive Cancer Network (NCCN), a not-for-profit alliance of 28 leading cancer centers devoted to patient care, research, and education, recommends ibrutinib (IMBRUVICA) as a preferred regimen for the initial treatment of CLL/SLL, and it is the only Category 1 single-agent regimen for treatment-naïve patients without deletion 17p. IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA has been granted four Breakthrough Therapy Designations by the FDA, and it was one of the first medicines to receive U.S. approval with the Breakthrough Therapy Designation.

IMBRUVICA is a comprehensively studied molecule, with more than 150 active clinical trials studying IMBRUVICA alone and in combination with other medicines in several blood cancers and other serious diseases. For more information, visit www.IMBRUVICA.com.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hemorrhage: Fatal bleeding events have occurred in patients treated with IMBRUVICA. Major hemorrhage (≥ Grade 3, serious, or any central nervous system events; e.g., intracranial hemorrhage [including subdural hematoma], gastrointestinal bleeding, hematuria, and post procedural hemorrhage) have occurred in 4% of patients, with fatalities occurring in 0.4% of 2,838 patients exposed to IMBRUVICA in 27 clinical trials. Bleeding events of any grade, including bruising and petechiae, occurred in 39% of patients treated with IMBRUVICA.

The mechanism for the bleeding events is not well understood.

Use of either anticoagulant or antiplatelet agents concomitantly with IMBRUVICA increases the risk of major hemorrhage. In IMBRUVICA clinical trials, 3.1% of patients taking IMBRUVICA without antiplatelet or anticoagulant therapy experienced major hemorrhage. The addition of antiplatelet therapy with or without anticoagulant therapy increased this percentage to 4.4%, and the addition of anticoagulant therapy with or without antiplatelet therapy increased this percentage to 6.1%. Consider the risks and benefits of anticoagulant or antiplatelet therapy when co-administered with IMBRUVICA. Monitor for signs and symptoms of bleeding.

Consider the benefit-risk of withholding IMBRUVICA for at least 3 to 7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.

Infections: Fatal and non-fatal infections (including bacterial, viral, or fungal) have occurred with IMBRUVICA therapy. Grade 3 or greater infections occurred in 24% of 1,124 patients exposed to IMBRUVICA in clinical trials. Cases of progressive multifocal leukoencephalopathy (PML) and Pneumocystis jirovecii pneumonia (PJP) have occurred in patients treated with IMBRUVICA. Consider prophylaxis according to standard of care in patients who are at increased risk for opportunistic infections.

Monitor and evaluate patients for fever and infections and treat appropriately.

Cytopenias: Treatment-emergent Grade 3 or 4 cytopenias including neutropenia (23%), thrombocytopenia (8%), and anemia (3%) based on laboratory measurements occurred in patients with B-cell malignancies treated with single agent IMBRUVICA.

Monitor complete blood counts monthly.

Cardiac Arrhythmias: Fatal and serious cardiac arrhythmias have occurred with IMBRUVICA therapy. Grade 3 or greater ventricular tachyarrhythmias occurred in 0.2% of patients, and Grade 3 or greater atrial fibrillation and atrial flutter occurred in 4% of 1,124 patients exposed to IMBRUVICA in clinical trials. These events have occurred particularly in patients with cardiac risk factors, hypertension, acute infections, and a previous history of cardiac arrhythmias.

Periodically monitor patients clinically for cardiac arrhythmias. Obtain an ECG for patients who develop arrhythmic symptoms (e.g., palpitations, lightheadedness, syncope, chest pain) or new onset dyspnea. Manage cardiac arrhythmias appropriately, and if it persists, consider the risks and benefits of IMBRUVICA treatment and follow dose modification guidelines.

Hypertension: Hypertension of any grade occurred in 12% of 1,124 patients treated with IMBRUVICA in clinical trials. Grade 3 or greater hypertension occurred in 5% of patients with a median time to onset of 5.9 months (range, 0.03 to 24 months).

Monitor blood pressure in patients treated with IMBRUVICA and initiate or adjust anti-hypertensive medication throughout treatment with IMBRUVICA as appropriate.

Second Primary Malignancies: Other malignancies (10%) including non-skin carcinomas (4%) have occurred in 1,124 patients treated with IMBRUVICA in clinical trials. The most frequent second primary malignancy was non-melanoma skin cancer (6%).

Tumor Lysis Syndrome: Tumor lysis syndrome has been infrequently reported with IMBRUVICA therapy. Assess the baseline risk (e.g., high tumor burden) and take appropriate precautions.

Monitor patients closely and treat as appropriate.

Embryo-Fetal Toxicity: Based on findings in animals, IMBRUVICA can cause fetal harm when administered to a pregnant woman. Advise women to avoid becoming pregnant while taking IMBRUVICA and for 1 month after cessation of therapy. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Advise men to avoid fathering a child during the same time period.

ADVERSE REACTIONS

B-cell malignancies: The most common adverse reactions (≥20%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were thrombocytopenia (58%)*, diarrhea (41%), anemia (38%)*, neutropenia (35%)*, musculoskeletal pain (32%), rash (32%), bruising (31%), nausea (26%), fatigue (26%), hemorrhage (24%), and pyrexia (20%).

The most common Grade 3 or 4 adverse reactions (≥5%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were neutropenia (18%)*, thrombocytopenia (16%)*, and pneumonia (14%).

Approximately 7% (CLL/SLL), 14% (MCL), 14% (WM) and 10% (MZL) of patients had a dose reduction due to adverse reactions. Approximately 4-10% (CLL/SLL), 9% (MCL), and 7% (WM [5%] and MZL [13%]) of patients discontinued due to adverse reactions.

cGVHD: The most common adverse reactions (≥20%) in patients with cGVHD were fatigue (57%), bruising (40%), diarrhea (36%), thrombocytopenia (33%)*, muscle spasms (29%), stomatitis (29%), nausea (26%), hemorrhage (26%), anemia (24%)*, and pneumonia (21%).

The most common Grade 3 or higher adverse reactions (≥5%) reported in patients with cGVHD were pneumonia (14%), fatigue (12%), diarrhea (10%), neutropenia (10%)*, sepsis (10%), hypokalemia (7%), headache (5%), musculoskeletal pain (5%), and pyrexia (5%).

Twenty-four percent of patients receiving IMBRUVICA in the cGVHD trial discontinued treatment due to adverse reactions. Adverse reactions leading to dose reduction occurred in 26% of patients.

*Treatment-emergent decreases (all grades) were based on laboratory measurements.

DRUG INTERACTIONS

CYP3A Inhibitors: Co-administration of IMBRUVICA with strong or moderate CYP3A inhibitors may increase ibrutinib plasma concentrations. Dose modifications of IMBRUVICA may be recommended when used concomitantly with posaconazole, voriconazole, and moderate CYP3A inhibitors. Avoid concomitant use of other strong CYP3A inhibitors. Interrupt IMBRUVICA if strong inhibitors are used short-term (e.g., for ≤ 7 days). See dose modification guidelines in USPI sections 2.4 and 7.1.

CYP3A Inducers: Avoid coadministration with strong CYP3A inducers.

SPECIFIC POPULATIONS

Hepatic Impairment (based on Child-Pugh criteria): Avoid use of IMBRUVICA in patients with severe baseline hepatic impairment. In patients with mild or moderate impairment, reduce IMBRUVICA dose.

On November 8, 2019 Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) ("Citius" or the "Company"), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, reported that the Company has issued its October 2019 Corporate Update Letter (Press release, Citius Pharmaceuticals, NOV 8, 2019, View Source [SID1234550770]). The Letter highlights the progress of the Company’s product candidates Mino-Lok, Mino-Wrap, and Halo-Lido, along with details on its strategic goals to develop breakthrough technologies to improve and enhance the lives of patients.

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Recent Company Highlights include:

Closing on a recent $7 million capital raise to advance ongoing research
A recent modification to the primary endpoint of the pivotal Phase III trial for Mino-Lok that substantially reduced the required trial sample size from 700 to approximately 144 subjects, significantly reducing the trial’s expense and accelerating its completion
An expanded relationship with MD Anderson Cancer Center for a worldwide license for Mino-Wrap and the preparation for a pre-IND meeting with the FDA
Reformulating the topical formulation (now Halo-Lido) for the treatment of hemorrhoids based on results from an initial Phase II study. A toxicology study will be initiated by year-end ahead of an expanded Phase II study to start in 2020
Other corporate initiatives that include industry events and investor outreach
To view the Company’s Corporate Update Letter in its entirety, please visit: View Source

On November 8, 2019 Aptevo Therapeutics Inc. (Nasdaq: APVO), a biotechnology company focused on developing novel immuno-oncology and hematology therapeutics and Alligator Bioscience (Nasdaq Stockholm: ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy reported that new preclinical data for ALG.APV-527 are being presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 34th Annual Meeting at the National Harbor, Maryland, November 6-10, 2019 (Press release, Aptevo Therapeutics, NOV 8, 2019, View Source [SID1234550769]).

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ALG.APV-527 is a novel immunotherapeutic candidate intended for the treatment of a variety of 5T4-positive solid tumors. It is designed to induce signaling through the co-stimulatory receptor 4-1BB (CD137), which is present on activated cytotoxic T cells and natural killer (NK) cells. Once activated, it is designed to promote potent and selective tumor-directed immune activation in the presence of the tumor associated antigen, 5T4, which is present on many different types of solid tumors.

The preclinical data presented at SITC (Free SITC Whitepaper) show that ALG.APV-527 selectively enhances T cell and NK cell responses in the presence of 5T4 in vitro and displays potent and sustained tumor suppression in vivo. The preclinical studies demonstrate that ALG.APV-527:

Enhances CD8+ T cell and NK function and proliferation preferentially over that of CD4+ T cells, upon 5T4-mediated crosslinking
In preliminary in vivo studies in a human 4-1BB knock in model, induces rejection of established murine bladder cancer cells expressing human 5T4 at doses of 20 µg in mice and induces anti-tumor immunological memory responses
Is well tolerated after repeated dosing in a GLP toxicology study above the expected human dose and displays an antibody-like half-life of up to 9.5 days
"We’re pleased that ALG.APV-527 continues to show promising preclinical results," said Jane Gross, Ph.D., Chief Scientific Officer for Aptevo. "The ability of ALG.APV-527 to induce potent anti-tumor T cell and NK cell activity suggests 4-1BB is an attractive target for designing new immuno-oncology therapeutics. Monospecific 4-1BB-directed antibodies have been challenged by dose-limiting liver toxicities. As a novel bispecific antibody ALG.APV-527 may circumvent these challenges and minimize systemic toxicity by stimulating 4-1BB function only when co-engaged with the tumor antigen, 5T4."

"The presented preclinical data strongly support a potent effect of ALG.APV-527 without compromising on safety. The data further strengthens our CTA package and we are eagerly looking forward to discuss this candidate with potential partners to take this exciting asset further into clinical development," commented Christina Furebring, Ph.D., Vice President Preclinical Development at Alligator.

The Alligator/Aptevo poster presentation, entitled "Potent Tumor-Directed T Cell Activation and Tumor Inhibition Induced by a 4-1BB x 5T4 ADAPTIR Bispecific Antibody" is being presented on Saturday, November 9, 2019 from 7:00 am – 8:30 pm ET.

About ALG.APV-527

ALG.APV-527 is a bispecific antibody (4-1BB x 5T4) intended for tumor-directed treatment of solid cancers. ALG.APV-527 was built using Aptevo’s ADAPTIR bispecific platform and combines binding domains sourced from the ALLIGATOR-GOLD human scFv library. The ALG.APV-527 bispecific antibody consists of two parts, one part activating tumor-specific T cells through the co-stimulatory receptor 4-1BB, the other part binding to the 5T4 protein displayed on the surface of tumor cells. This enables the immune-activating effect of ALG.APV-527 to be directed specifically to the tumor and not against normal tissue.

On November 8, 2019 eHealth, Inc. (NASDAQ: EHTH), a leading private online health insurance exchange, reported that its senior management will deliver presentations at the following upcoming investor conferences (Press release, eHealthInsurance, NOV 8, 2019, View Source [SID1234550768]):

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28th Annual Credit Suisse Healthcare Conference, on Tuesday, November 12, 2019 at 11:30 a.m. M.T. The conference is being held at The Phoenician Resort in Scottsdale, Arizona.
Stephens Nashville Investment Conference, on Thursday, November 14, 2019 at 1:00 p.m. C.T. The conference is being held at the Omni Nashville, Nashville, TN.
Interested investors can access the live audio webcast of the presentations at www.ehealthinsurance.com under Investor Relations. Please visit the website at least 15 minutes early to register, download, and install any necessary software. A replay of this event will be available on the company’s website shortly after the conclusion of the event and will remain available for 14 days.

eHealth will also hold one-on-one and small group meetings with institutional investors at the 10th Annual Craig-Hallum Alpha Select Conference, on Tuesday, November 12th, 2019. The conference is being held at Sheraton Times Square Hotel, New York, NY.