Oncbiomune has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Oncbiomune, 2018, MAY 31, 2018, View Source [SID1234526982]).

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On May 31, 2018 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported it will present data from clinical trials across multiple blood cancers evaluating venetoclax, a first-in-class oral B-cell lymphoma-2 (BCL-2) inhibitor, as monotherapy and in combination with other therapies at the 23rd European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress, June 14-17, in Stockholm, Sweden (Press release, AbbVie, MAY 31, 2018, View Source [SID1234526983]). A total of 11 abstracts will be presented, including results of venetoclax in chronic lymphocytic leukemia (CLL), acute myeloid leukemia (AML), multiple myeloma (MM) and acute lymphoblastic leukemia (ALL). Venetoclax is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

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Studies of venetoclax in CLL and AML have been chosen for oral presentations, including an undetectable minimal residual disease (uMRD) sub-analysis from the pivotal Phase 3 MURANO study of venetoclax in combination with rituximab in patients with relapsed/refractory (R/R) CLL. Minimal residual disease is an objective measure of disease defined by the presence of less than one CLL cell in 10,000 white blood cells remaining in the blood or bone marrow following treatment.1 Prospective clinical trials have suggested that achieving undetectable minimal residual disease, also known as MRD negativity (MRD-), may have a prognostic impact on clinical outcomes.2

"The breadth of venetoclax studies being presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress, across four blood cancers, is an indicator of the utility, versatility and potential to advance care for patients living with blood cancer around the world,"3 said Neil Gallagher, M.D., Ph.D., head of oncology clinical development, AbbVie. "As a company, we are committed to exploring additional therapeutic applications for venetoclax in our efforts to address major unmet medical needs, and develop novel treatments that work against key pathways of disease progression."

Key presentations featuring venetoclax include:

Venetoclax in CLL

High, Durable Minimal Residual Disease Negativity (MRD-) with Venetoclax + Rituximab (VenR) in Relapsed/Refractory (R/R) CLL: MRD Kinetics from Phase 3 MURANO Study. Hillmen et al.; Abstract S805; Oral Presentation; Saturday, June 16, 2018, 11:45 a.m.-12:00 p.m. CEST
Durability Response to Venetoclax (VEN) in Patients with CLL Who Are Relapsed/Refractory after Ibrutinib and/or Idelalisib. Byrd et al.; Abstract PF340; Poster Session; Friday, June 15, 2018; 5:30-7:00 p.m. CEST
Impact of TP53 Mutated Clone Size on Outcome of Relapsed/Refractory (R/R) CLL Patients Treated with Venetoclax plus Rituximab within the Phase 3 MURANO Study. Kater et al.; Abstract PF344; Poster Session; Friday, June 15, 2018; 5:30-7:00 p.m. CEST
Venetoclax Improves Quality of Life for Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia. Cochrane et al.; Abstract PS1438; Poster Session; Saturday, June 16, 2018; 5:30-7:00 p.m. CEST
Indirect Treatment Comparison of Venetoclax Plus Rituximab with B-Cell Receptor Inhibitors in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia. Mato et al.; Abstract PF358; Poster Session; Friday, June 15, 2018; 5:30-7:00 p.m. CEST
Management, Adverse Events, and Outcomes of 282 CLL Patients Treated with Venetoclax in the Real World. Nabhan et al.; Abstract PF342; Poster Session; Friday, June 15, 2018; 5:30-7:00 p.m. CEST
Venetoclax in AML

Durable Response with Venetoclax in Combination with Decitabine or Azacitadine in Elderly Patients with Acute Myeloid Leukemia (AML). DiNardo et al.; Abstract S1563; Oral Presentation; Sunday, June 17, 2018; 8:45-9:00 a.m. CEST
Cytogenic and Molecular Drivers of Outcome with Venetoclax-Based Combination Therapies in Treatment-Naïve Elderly Patients with AML. Strickland et al.; Abstract PS982; Poster Session; Saturday, June 16, 2018; 5:30-7:00 p.m. CEST
Venetoclax in MM

Phase 2 Study of Venetoclax Plus Carfilzomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma. Costa et al.; Abstract PF558; Poster Session; Friday, June 15, 2018; 5:30-7:00 p.m. CEST
Venetoclax Monotherapy and Combined with Dexamethasone as Targeted Therapy for Relapsed/Refractory t(11;14) Multiple Myeloma. Kaufman et al.; Abstract PS1317; Poster Session; Saturday, June 16, 2018; 5:30-7:00 p.m. CEST
Venetoclax in ALL

Venetoclax and Navitoclax with Chemotherapy is Efficacious in Patients with Relapsed Acute Lymphoblastic Leukemia. Alexander et al.; Abstract PS928; Poster Session, Saturday, June 16, 2018; 5:30-7:00 p.m. CEST
The EHA (Free EHA Whitepaper) 2018 Annual Congress abstracts are available at www.ehaweb.org.

About VENCLYXTO (venetoclax)
VENCLYXTO (venetoclax), an oral B-cell lymphoma-2 (BCL-2) inhibitor, is indicated for the treatment of chronic lymphocytic leukemia (CLL) in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor; and for the treatment of CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.4 It is also being evaluated for the treatment of patients with various blood cancer types.4,5,6,7,8 The BCL-2 protein prevents apoptosis (programmed cell death) of some cells, including lymphocytes, and can be overexpressed in CLL cells.4 VENCLYXTO, which is given once-daily, is designed to selectively inhibit the function of the BCL-2 protein.4

VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research with venetoclax, which is currently being evaluated in Phase 3 clinical trials for the treatment of relapsed/refractory CLL, along with studies in several other cancers.

Venetoclax is currently approved in the European Union, Switzerland, Argentina, Australia, Mexico, Puerto Rico, Israel, USA, and Canada. AbbVie, in collaboration with Roche and Genentech, is currently working with regulatory agencies around the world to bring this medicine to eligible patients in need.

For more information on AbbVie’s research in oncology, please read, "Breaking the Rules of Science to Treat Cancer," on www.abbvie.com.

Important Venclyxto (venetoclax) EU Safety Information

Contraindications
Hypersensitivity to the active substance or to any of the excipients is contraindicated. Concomitant use of strong CYP3A inhibitors at initiation and during the dose-titration phase due to increased risk for tumor lysis syndrome (TLS). Concomitant use of preparations containing St. John’s wort as VENCLYXTO efficacy may be reduced.

Special Warnings & Precautions for Use
Tumor lysis syndrome (TLS), including fatal events, has occurred in patients with previously treated CLL with high tumor burden when treated with VENCLYXTO. VENCLYXTO poses a risk for TLS in the initial 5-week dose-titration phase. Changes in electrolytes consistent with TLS that require prompt management can occur as early as 6 to 8 hours following the first dose of VENCLYXTO and at each dose increase. Patients should be assessed for risk and should receive appropriate prophylaxis for TLS. Blood chemistries should be monitored and abnormalities managed promptly. More intensive measures (including IV hydration, frequent monitoring and hospitalization) should be employed as overall risk increases.

Neutropenia (grade 3 or 4) has been reported and complete blood counts should be monitored throughout the treatment period.

Live vaccines should not be administered during treatment or thereafter until B-cell recovery.

Drug Interactions
CYP3A inhibitors may increase VENCLYXTO plasma concentrations. At initiation and dose-titration phase: Strong CYP3A inhibitors are contraindicated due to increased risk for TLS and moderate CYP3A inhibitors should be avoided. If moderate CYP3A inhibitors must be used, physicians should refer to the SmPC for dose adjustment recommendations. At steady daily dose: If moderate or strong CYP3A inhibitors must be used, physicians should refer to the SmPC for dose adjustment recommendations.

Avoid concomitant use of P-gp and BCRP inhibitors at initiation and during the dose titration phase.

CYP3A4 inducers may decrease VENCLYXTO plasma concentrations.

Avoid coadministration with strong or moderate CYP3A inducers. These agents may decrease venetoclax plasma concentrations.

Co-administration of bile acid sequestrants with VENCLYXTO is not recommended as this may reduce the absorption of VENCLYXTO.

Adverse Reactions
The most commonly occurring adverse reactions (>=20%) of any grade were neutropenia/neutrophil count decreased, diarrhea, nausea, anemia, upper respiratory tract infection, fatigue, hyperphosphatemia, vomiting and constipation.

The most frequently occurring adverse reactions (>=2%) were pneumonia, febrile neutropenia and TLS.

Discontinuations due to adverse reactions occurred in 9.1% of patients and dosage adjustments due to adverse reactions occurred in 11.8% of patients.

Specific Populations
Patients with reduced renal function (CrCl <80 mL/min) may require more intensive prophylaxis and monitoring to reduce the risk of TLS. Safety in patients with severe renal impairment (CrCl <30 mL/min) or on dialysis has not been established, and a recommended dose for these patients has not been determined. VENCLYXTO should be administered to patients with severe renal impairment only if the benefit outweighs the risk and patients should be monitored closely for signs of toxicity due to increased risk of TLS.

VENCLYXTO may cause embryo-fetal harm when administered to a pregnant woman. Advise females of reproductive potential to avoid pregnancy during treatment. Advise nursing women to discontinue breastfeeding during treatment.

This is not a complete summary of all safety information. See VENCLYXTO full summary of product characteristics (SmPC) at www.ema.europa.eu. Globally, prescribing information varies; refer to the individual country product label for complete information.

On May 31, 2018 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that it will be presenting at two upcoming investor conferences (Press release, Myriad Genetics, MAY 31, 2018, View Source [SID1234527000]).

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On June 12, 2018, Mark C. Capone, president and CEO, will present at the 39th Annual Goldman Sachs Healthcare Conference in Palos Verdes, California at 4:00 p.m. ET.

On June 13, 2018, R. Bryan Riggsbee, chief financial officer, will present at the William Blair 38th Annual Growth Stock Conference in Chicago, Illinois at 3:40 p.m. ET.

The presentations will be available to interested parties through a live audio webcast accessible through a link in the investor information section of Myriad’s website at www.myriad.com.

On June 1, 2018 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that preliminary data from the dose escalation part of an ongoing phase 1/2 study with investigational U3-1402 in heavily pretreated patients with HER3-positive metastatic breast cancer will be presented during a Poster Discussion Session on Monday, June 4 at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL (Abstract 2512; 3:00 – 4:15 PM CDT) (Press release, Daiichi Sankyo, MAY 31, 2018, View Source [SID1234527019]).

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Safety results were reported for 34 patients receiving U3-1402 in dose levels between 1.6 mg/kg to 8.0 mg/kg given every three weeks. A maximum tolerated dose has not yet been reached. The most common adverse events (>30 percent, any Grade) included nausea (82 percent), platelet count decreased/thrombocytopenia (68 percent), decreased appetite (62 percent), neutrophil count decreased/neutropenia (59 percent), white blood cell count decreased (53 percent), vomiting (50 percent), ALT increased (38 percent), AST increased (38 percent), anemia (38 percent), stomatitis (32 percent) and diarrhea (32 percent). The most common adverse events Grade ≥3 (>10 percent of patients) were thrombocytopenia (29 percent), neutrophil count decreased/neutropenia (27 percent), white blood cell count decreased (18 percent) and anemia (12 percent). The following dose-limiting toxicities were observed: Grade 4 platelet count decreased (3 patients), Grade 3 ALT increased (2 patients), and Grade 2 AST increased (1 patient).

Preliminary results in 32 efficacy evaluable patients showed that U3-1402 demonstrated a confirmed overall response rate of 47 percent (15/32 patients) and a disease control rate of 94 percent (30/32 patients).

"There is a clinical need for additional treatments for metastatic breast cancer, especially for those tumors that express HER3, which is associated with poor prognosis and for which no targeted therapies are currently available," said Takahiro Kogawa, MD, PhD, National Cancer Center Hospital East in Japan, and an investigator for the study. "These preliminary results suggest that U3-1402 could be a potential new treatment approach for metastatic breast tumors that express HER3, and the study will move forward to determine the most suitable dosing regimen for further clinical evaluation."

"These findings with U3-1402, which are the first reported clinical data evaluating an ADC in HER3-expressing cancer, build upon our historical understanding of exploring the role of HER3 as a potential target," said Kouichi Akahane, PhD, MBA, Executive Officer, Head of Oncology Function, R&D Division, Daiichi Sankyo. "Furthermore, these results seen with U3-1402 offer proof-of-concept of the portability of our proprietary DXd and linker ADC technology, which has been specifically designed to smartly deliver chemotherapy with the precision of a targeted therapy."

About the Phase 1 Study

In this three-part open-label global phase 1/2 study, U3-1402 is given as an intravenous infusion every three weeks. The first part of the study (dose escalation) is assessing the safety, tolerability and maximum tolerated dose of U3-1402 in HER3-positive (defined as IHC 2+/3+) metastatic breast cancer patients who are refractory or intolerant to standard treatment, or for whom no standard treatment is available. The second part of the study (dose-finding) will assess the safety and efficacy of U3-1402 and determine the recommended phase 2 dose in HER3-positive metastatic breast cancer patients who have received six or fewer prior chemotherapy regimens. The third part of the study (phase 2) will assess the safety and efficacy of the recommended dose of U3-1402 in HER3-positive metastatic breast cancer patients who have received six or fewer prior chemotherapy regimens. The study is currently enrolling patients in Japan and is preparing to expand to include patients in the U.S. For more information about this study, please visit ClinicalTrials.gov.

About HER3-Positive Metastatic Breast Cancer

Breast cancer is typically classified and treated based on one of three types of biomarker status classifications: hormone-receptor positive (HR+), where the tumor cells contain either estrogen receptors (ER) or progesterone receptors (PR); HER2-positive (HER2+), where the tumor cells overexpress HER2; and triple negative, where the tumor cells do not have estrogen or progesterone receptors and are HER2-negative.[1]However, human epidermal growth factor receptor 3 (known as HER3 or ERBB3) is a tyrosine kinase receptor that is increasingly being recognized as important to tumor growth in certain cancers including breast cancer.[2] Patients living with invasive breast cancer with high levels of HER3 face a significantly worse prognosis and decreased survival, and to date there is no approved HER3-directed therapy option.[3]

About U3-1402

Part of the investigational ADC Franchise of the Daiichi Sankyo Cancer Enterprise, U3-1402 is an investigational and potential first-in-class HER3-targeting ADC. ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Designed using Daiichi Sankyo’s proprietary ADC technology, U3-1402 is a smart chemotherapy comprised of a human anti-HER3 antibody attached to a novel topoisomerase I inhibitor payload by a tetrapeptide-based linker. It is designed to target and deliver chemotherapy inside cancer cells and reduce systemic exposure to the cytotoxic payload (or chemotherapy) compared to the way chemotherapy is commonly delivered.

U3-1402 is currently being evaluated in two phase 1 clinical studies, including a phase 1/2 study for HER3-expressing metastatic or unresectable breast cancer in Japan and a phase 1 study for metastatic or unresectable EGFR-mutated non-small cell lung cancer (NSCLC) in the U.S.

U3-1402 is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.

On May 31, 2018 Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported the upcoming release of financial results for the six months ended April 30, 2018, to take place on Thursday, June 7, 2018 (Press release, Advaxis, MAY 31, 2018, View Source [SID1234526984]).

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Advaxis’ senior management will host a conference call to review its financial results and provide a business update. The conference call and live audio webcast will begin at 11:00 a.m. Eastern time on Thursday, June 7, 2018.

Conference Call & Webcast Information

WHEN: Thursday, June 7, 2018 at 11:00 a.m. Eastern time.
DOMESTIC DIAL-IN: (844) 348-6133
INTERNATIONAL DIAL-IN: (631) 485-4564
CONFERENCE ID: 8975538
WEBCAST: ir.advaxis.com/events-presentations

For those unable to participate in the live conference call or webcast, a digital recording will be available beginning June 7, two hours after the close of the conference call. To access the recording, dial (855) 859-2056 or (404) 537-3406 and provide the operator with the conference ID: 8975538. In addition, the audio webcast will be archived on the Company’s website for a period of time at ir.advaxis.com/events-presentations.