On October 16, 2018 Tiziana Life Sciences plc (AIM: TILS), a clinical stage biotechnology company developing targeted drugs for cancer and inflammatory diseases, reported that it will present results from preclinical studies demonstrating synergistic activity of milciclib with sorafenib (NexavarR) to suppress tumor growth in an orthotopic mouse model of HCC (Press release, Tiziana Life Sciences, OCT 16, 2018, View Source [SID1234530004]). Additional preclinical studies will be presented which also demonstrated synergism between Milciclib and other tyrosine kinase inhibitors (TKIs) such as Regorafenib (StivargaR) and Lenvatinib (LenvimaR). The presentation will take place at the American Association for the Study of Liver Diseases (AASLD) Meetingin San Francisco on 9-11 November 2018.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The details of the presentation are:

Poster #1543 entitled "Oral Treatment with Milciclib Either Alone or in Combination with Sorafenib Inhibited Tumor Growth in an Orthotopic Model ofHepatocellular Carcinoma"will be presented at the Poster Session III on November 11, 2018.

The data results from pre-clinic studies in mouse models which will inform future research but the information to be presented is an extension of previously announced research and does not, in the view of the Company and its directors, constitute material data requiring dissemination via a regulatory news service. According this information is being released via RNS Reach to inform interested parties of the direction and results of our continuing research activity.

MAJOR HIGHLIGHTS OF THE DATA

· Oral treatment with milciclib (30mg/kg/day) in combination with sorafenib (20mg/kg/day) produced synergistic effect on reduction of HCC-tumor growth in an orthotopic animal model. Since, the doses of milciclib and sorafenib used were sub-optimal, it is possible that the combination treatment at sub-optimal doses may reduce the toxicities of sorafenib or other TKIs.

· While treatment with milciclib as a single agent significantly suppressed growth in cell cultures as well as in animal models, it also exhibited strong synergistic anti-HCC effects with TKIs such as sorafenib, regorafenib and lenvatinib in other pre-clinical studies

· Mechanism of action studies suggest that milciclib exhibits broad-spectrum anti-HCC activity through a different mechanism from TKIs to produce the pronounced synergism.

"We reported earlier that oral treatment with Milciclib was found to be well-tolerated and it achieved both primary and secondary clinical endpoints in two separate phase 2 trials in thymic carcinoma and thymoma. The new pre-clinical research data demonstrating synergism with TKIs is exciting and suggests the potential of Milciclib in combination with one of these approved TKIs to develop a safe and an improved treatment option for HCC patients" said Gabriele Cerrone, Chairman of Tiziana Life Sciences

The complex multi-factorial etiology of HCC warrants an immediate need for drugs with different mechanisms that may produce improved efficacy and safety. The data we have announced from the interim analysis of the ongoing phase 2a clinical study of orally administered milciclib in sorafenib-resistant patients suggests that the treatment is well-tolerated and seems to provide clinical benefits to these patients. We are pleased to see that milciclib produces strong synergistic anti-HCC activity in preclinical studies as these data are important milestones to move forward in our evaluation the potential of Milciclib in combination with one of the approved TKIs to improve safety, efficacy and clinical response rate in HCC patients" said Kunwar Shailubhai, CEO & CSO of Tiziana Life Sciences.

About Hepatocellular Carcinoma

Hepatocellular cancer is the 5th most common cancer and the 3rd cause of cancer mortality worldwide. In 2007 the approval by the European Medical Agency (EMA) and Food and Drug Administration (FDA) of sorafenib in HCC represented the first systemic therapy for improving outcome in patients unsuitable for loco-regional and surgical therapies and created a new standard of treatment for the disease. However, although significant in respect to placebo, the benefits of sorafenib are modest; the response rate is less than 3%, the improvement in median survival is 2-3 months and the drug-related symptoms are not ordinary. Therefore, more effective systemic therapy is required for both naive patients presenting with unresectable, advanced stage and those who suffer recurrence after curative treatments (resection, ablation and transplantation).

About Milciclib

Milciclib (PHA-848125AC) is a small molecule inhibitor of several cyclin dependent kinases such as CDK1, CDK4, CDK5 and CDK7. CDKs are serine threonine kinases that play crucial roles in progression of the cell cycle from G1 to S phase. Overexpression of CDKs and other downstream signaling pathways that regulate cell cycles have been frequently found to be associated with development of resistance towards chemotherapies. In a phase I study, oral treatment with Milciclib was found to be well-tolerated and the drug showed promising clinical responses in patients with advanced solid malignancies such as in NSCLC, Pancreatic and colon cancer, thymic carcinoma and thymoma.

A phase 2a multi-centre and multi-country clinical trial (CDKO-125A-010) in sorafenib-refractory or -intolerable patients with unresectable or metastatic HCC is currently being conducted in Greece, Italy and Israel.

On October 16, 2018 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary therapeutic cancer vaccine immunotherapy and targeted cancer therapies, reported the signing of a work order with leading Contract Research Organization, Theradex Oncology ("Theradex"), detailing the scope to be provided by Theradex for a clinical trial titled, "A Phase 2 Study of a PSA/IL-2/GM-CSF Vaccine for the Treatment of PSA-Recurrent Prostate Cancer in Hormone-Naïve Patients (Press release, Oncbiomune, OCT 16, 2018, View Source [SID1234530471])." The trial, expected to enroll 30 patients, is being hosted At Urology Clinics of North Texas, a ten center 40 physician practice with 12 physicians honored with inclusion in the peer-selected "The Best Doctors in America" list.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We’re extremely pleased to have Theradex once again working with us on the further development of ProscaVax," commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "Theradex is highly sought after for their experience and expertise in advancing promising cancer therapies and we are fortunate to have them on board to provide oversight and the necessary documentation to move this important trial efficiently forward. We expect to treat our first patient in early December."

OncBioMune has submitted the protocol to the FDA and expects a quick review by the outside IRB. Once approved by the FDA and IRB, the clinical trial information will be submitted to clinicaltrials.gov, with the expectation that the summary of the clinical trial will soon be available for public viewing.

ProscaVax is OncBioMune’s lead immunotherapy platform candidate consisting of a combination of prostate cancer associated prostate specific antigen (PSA) with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF).

Per the Phase 2 study protocol, patients to be enrolled will be in "biochemical progression," a disease state with few management options. The goal of treating the recurrent prostate cancer patients with ProscaVax is to inhibit the progression of the disease and prevent or delay treatment with more toxic therapies.

About Prostate Cancer

According to the American Cancer Society (ACS), prostate cancer is the most common type of cancer in men other than skin cancer, with about 1 in 9 men diagnosed during their lifetime. ACS estimates that about 164,690 new cases of prostate cancer will be diagnosed during 2018 and approximately 29,430 men will die from the disease this year. Prostate cancer is the second leading cause of cancer death in men, trailing only lung cancer. Approximately 2.9 million men are living with prostate cancer today. The average age of diagnosis is 66, with the disease considered rare in men under the age of 40.

On October 16, 2018 Johnson & Johnson (NYSE: JNJ) reported sales of $20.3 billion for the third quarter of 2018, an increase of 3.6% as compared to the third quarter of 2017 (Press release, Johnson & Johnson, OCT 16, 2018, View Source [SID1234529991]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Operational sales results increased 5.5%, partially offset by the negative impact of currency of 1.9%. Domestic sales increased 3.6%. International sales increased 3.5%, reflecting operational growth of 7.5% and a negative currency impact of 4.0%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 6.1%, domestic sales increased 3.9% and international sales increased 8.5%.*

Net earnings and diluted earnings per share for the third quarter of 2018 were $3.9 billion and $1.44, respectively. Third-quarter 2018 net earnings included after-tax intangible amortization expense of approximately $1.0 billion and a net charge for after-tax special items of approximately $0.7 billion, primarily consisting of a non-cash charge attributed to a partial write-down of an in-process research and development asset associated with the acquisition of Alios BioPharma Inc. Third-quarter 2017 net earnings included after-tax intangible amortization expense of approximately $0.9 billion and a charge for after-tax special items of approximately $0.5 billion. Excluding after-tax intangible amortization expense and special items, adjusted net earnings for the current quarter were $5.6 billion and adjusted diluted earnings per share were $2.05, representing increases of 7.3% and 7.9%, respectively, as compared to the same period in 2017.* On an operational basis, adjusted diluted earnings per share also increased 9.5%.* A reconciliation of non-GAAP financial measures is included as an accompanying schedule.

"We are pleased with our strong third-quarter performance, which reflects continued above-market growth in our Pharmaceutical business, accelerating sales momentum in our Consumer business and consistent progress in our Medical Devices business," said Alex Gorsky, Chairman and Chief Executive Officer. "I’m confident that with our collaborative and inspired J&J colleagues around the world, unique broad-based business model and strategic investments in innovation, we are well positioned for success today and into the future."

The Company issued sales guidance for the full-year 2018 in a range of $81.0 to $81.4 billion. This reflects an increase in expected operational growth to a range of 5.5% to 6.0%, partially offset by the estimated lower favorable impact of currency. Additionally, the Company increased its adjusted earnings guidance for full-year 2018 to a range of $8.13 to $8.18 per share. This reflects an increase in expected operational EPS growth to a range of 9.3% to 10.0%.

Segment Sales Performance
Worldwide Consumer sales of $3.4 billion for the third quarter 2018 represented an increase of 1.8% versus the prior year, consisting of an operational increase of 4.9% and a negative impact from currency of 3.1%. Domestic sales increased 6.6%, while international sales decreased 1.3%, which reflected an operational increase of 3.7% and a negative currency impact of 5.0%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 6.1%, with domestic sales increasing 6.4% and international sales increasing 5.9%.*

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by over-the-counter products including MOTRIN and TYLENOL analgesics, ZYRTEC upper respiratory and IMODIUM digestive health products; beauty products including NEUTROGENA, OGX and DR. CI LABO; as well as domestic sales of JOHNSON’s baby care products.

During the quarter, the acquisition of Zarbee’s, Inc., a leader in naturally-based healthcare products, was completed.

Worldwide Pharmaceutical sales of $10.3 billion for the third quarter 2018 represented an increase of 6.7% versus the prior year with an operational increase of 8.2% and a negative impact from currency of 1.5%. Domestic sales increased 4.8%, international sales increased 9.5%, which reflected an operational increase of 13.2% and a negative currency impact of 3.7%. Acquisitions and divestitures had a negligible impact to sales growth in the quarter.

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by ZYTIGA (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic, castration-resistant prostate cancer, IMBRUVICA (ibrutinib), an oral, once-daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer, STELARA (ustekinumab), a biologic for the treatment of a number of immune-mediated inflammatory diseases, DARZALEX (daratumumab), for the treatment of multiple myeloma, TREMFYA (guselkumab), for the treatment of adults living with moderate to severe plaque psoriasis, INVEGA SUSTENNA/XEPLION/INVEGA TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults, SIMPONI/SIMPONI ARIA (golimumab), a biologic for the treatment of a number of immune-mediated inflammatory diseases, OPSUMIT (macitentan), an oral endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension to delay disease progression, and UPTRAVI (selexipag), an oral prostacyclin receptor agonist used to treat pulmonary arterial hypertension and reduce hospitalization.

During the quarter, the U.S. Food and Drug Administration (FDA) approved an additional indication for IMBRUVICA (ibrutinib) in combination with rituximab as a non-chemotherapy combination regimen for patients with Waldenström’s Macroglobulinemia, a rare blood cancer. The European Commission (EC) granted marketing authorization for DARZALEX (daratumumab) in combination with VELCADE (bortezomib), a proteasome inhibitor, melphalan, an alkylating agent, and prednisone for the treatment of newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant. In addition, the FDA approved and the EC granted marketing authorization for SYMTUZA (D/C/F/TAF), a complete darunavir-based single-tablet regimen for the treatment of HIV-1 infection.

A New Drug Application was submitted to the FDA for esketamine nasal spray, a rapidly acting antidepressant for treatment-resistant depression in adults and erdafitinib, a once-daily, oral pan-fibroblast growth factor receptor (FGFR) inhibitor for the treatment of locally advanced or metastatic urothelial cancer. A supplemental New Drug Application was submitted to the FDA seeking to broaden the use of IMBRUVICA (ibrutinib) in chronic lymphocytic leukemia or small lymphocytic lymphoma to include combination use with a non-chemotherapy agent, obinutuzumab, in the frontline setting. A Type II Variation was submitted to the European Medicines Agency (EMA) seeking to expand the indication of OPSUMIT (macitentan) to include the treatment of adults with inoperable chronic thromboembolic pulmonary hypertension (CTEPH), WHO Group 4, to improve exercise capacity and pulmonary vascular resistance. In addition, the Company also submitted a supplemental Biologics License Application to the FDA and a Type II Variation to the EMA seeking approval of a split dosing regimen for DARZALEX (daratumumab).

Subsequent to the quarter, the FDA approved an additional indication for XARELTO (rivaroxaban) to reduce the risk of major cardiovascular (CV) events, such as CV death, myocardial infarction and stroke, in people with chronic coronary or peripheral artery disease. Additionally, a Marketing Authorization Application was submitted to the EMA for esketamine nasal spray, a rapidly acting antidepressant for treatment-resistant depression in adults. The Company also entered into an exclusive worldwide license agreement with Arrowhead Pharmaceuticals, Inc. to develop and commercialize a new treatment for chronic Hepatitis B viral infection.

Worldwide Medical Devices sales of $6.6 billion for the third quarter 2018 represented a decrease of 0.2% versus the prior year consisting of an operational increase of 1.7% and a negative currency impact of 1.9%. Domestic sales increased 0.3%, while international sales decreased 0.6%, which reflected an operational increase of 3.0% and a negative currency impact of 3.6%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 2.9%, domestic sales increased 1.2% and international sales increased 4.4%.*

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by the growth of electrophysiology products in the Interventional Solutions business; ACUVUE contact lenses in the Vision business; endocutters and biosurgicals in the Advanced Surgery business; and wound closure products in the General Surgery business, partially offset by declines in the Diabetes Care business.

During the quarter, the Company received European CE mark approval for its BRAVO Flow Diverter for use in the treatment of patients suffering from intracranial aneurysms. In addition, the acquisition of Emerging Implant Technologies GmbH, a privately held manufacturer of 3D-printed titanium interbody implants for spinal fusion surgery, was completed. Lastly, the Company accepted the binding offer from Fortive Corporation to acquire its Advanced Sterilization Products business for an aggregate value of approximately $2.8 billion, subject to customary adjustments.

Subsequent to the quarter, the Company announced the completion of the divestiture of its LifeScan business to Platinum Equity for approximately $2.1 billion, subject to customary adjustments.

On October 16, 2018 Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, reported it welcomed the approval of Verastem Oncology’s COPIKTRA (duvelisib) capsules by the U.S. Food and Drug Administration (FDA) (Press release, Catalent, OCT 16, 2018, https://www.catalent.com/index.php/news-events/news/Catalent-and-Verastem-Oncology-Partner-on-Newly-Launched-FDA-Approved-COPIKTRA-duvelisib-Capsules [SID1234530088]). COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 may be contingent upon verification and description of clinical benefit in confirmatory trials.

Catalent has had a multi-year collaboration with Verastem Oncology, initially providing development and analytical support, and later clinical development and manufacturing services from its facility at Kansas City, Missouri.

"We are proud to partner with Verastem as part of the team delivering COPIKTRA capsules to patients. Catalent’s Kansas City facility is focused on oral and biologic programs, primarily with smaller pharmaceutical firms, to deliver products to patients with poorly met or unmet disease states," commented Matt Mollan, Catalent’s General Manager at Kansas City. "Like Verastem, Catalent is committed to advancing therapies with the potential to make a significant impact for patients, their caregivers and physicians. We look forward to building on this strong relationship through supplying clinical trial materials as well as commercial manufacturing and testing."

Robert Forrester, President and Chief Executive Officer of Verastem Oncology, added, "We selected Catalent as our development partner because of their experience and record of bringing similar therapies through clinical trials and on to successful commercialization. We are pleased to partner with Catalent in order to deliver this important new medicine to patients."

Catalent’s 450,000 square-feet Kansas City, Missouri facility provides a range of fully integrated support services, from formulation development and analytical testing, to clinical- and commercial-scale manufacturing and packaging of various oral dose forms.

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. WARNINGS AND PRECAUTIONS are provided for infections, diarrhea or colitis, cutaneous reactions, pneumonitis, hepatotoxicity, neutropenia, and embryo-fetal toxicity. The most common ADVERSE REACTIONS (reported in ≥ 20% of patients) were diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.

On October 16, 2018 Five Prime Therapeutics, Inc. (Nasdaq: FPRX), a biotechnology company discovering and developing innovative immuno-oncology protein therapeutics, reported that it initiated patient dosing in the dose exploration cohort of its ongoing Phase 1 clinical trial of FPA150 (FPA150-001; NCT03514121), a targeted, first-in-class immuno-oncology antibody that targets B7-H4 (Press release, Five Prime Therapeutics, OCT 16, 2018, View Source [SID1234529927]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We’re excited to be ahead of schedule in opening up our dose exploration basket cohort for FPA150, our first-in-class B7-H4 antibody, in patients whose tumors overexpress B7-H4," said Helen Collins, M.D., Senior Vice President and Chief Medical Officer of Five Prime. "B7-H4 is generating excitement in investigators because it’s expressed in tumor types that are currently not well served by immunotherapy, including breast and gynecologic cancers. We’re hopeful that a targeted therapy like FPA150 will provide clinical benefit in these patients who have limited treatment options."

B7-H4 is in the same family of checkpoint molecules as PD-L1 and, like PD-L1, appears to inhibit T-cells in preclinical models. FPA150 has a dual mechanism of action: it blocks a T cell checkpoint pathway and delivers antibody-dependent cell-mediated cytotoxicity (ADCC) against B7-H4-expressing tumor cells.

FPA150-001 is an ongoing Phase 1a/1b dose escalation and expansion clinical trial of FPA150 monotherapy in patients with advanced solid tumors. The exploratory basket cohort is a part of that trial and will include up to 10 patients whose tumors overexpress B7-H4, as assessed by an immunohistochemistry (IHC) assay. The objective of this cohort is to evaluate a range of FPA150 doses to gain additional data on safety, pharmacokinetics (PK) and potential preliminary clinical activity. All patients will undergo pre- and on-treatment biopsies to assess the pharmacodynamic effects of FPA150 on the tumor and the tumor microenvironment.

The Phase 1a dose-escalation portion of FPA150-001 in unselected patients with any solid tumor is currently ongoing. The primary objective of this portion of the trial is to identify a maximum tolerated dose (MTD) or recommended dose (RD) for FPA150 monotherapy.

Once the MTD/RTD has been identified, the company will initiate a Phase 1b dose-expansion portion of the trial in B7-H4 positive tumors, including in breast cancer, ovarian cancer and endometrial cancer. The Phase 1b dose expansion endpoints include objective response rate, as well as safety and PK.

About FPA150

FPA150 is a novel, fully human, afucosylated monoclonal antibody targeting B7-H4. B7-H4 expression is observed in multiple solid tumors, including breast and gynecologic cancers. FPA150 is designed with a dual mechanism of action: blocking the T cell checkpoint activity of B7-H4 as well as delivering ADCC against tumor cells expressing B7-H4.