On May 21, 2018 PharmaCyte Biotech (OTCQB: PMCB) reported it has reached the proverbial "home stretch" regarding its efforts to submit an Investigational New Drug Application (IND) to the U.S. FDA (Press release, PharmaCyte Biotech, MAY 21, 2018, View Source [SID1234526825]). It’s an IND that has been eagerly anticipated by the company’s shareholders since PharmaCyte met with the FDA in early 2017, and it would lay out PharmaCyte’s planned Phase 2b clinical trial for the treatment of locally advanced, non-metastatic, inoperable pancreatic cancer or LAPC.

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The key to submitting the IND is and always has been satisfying regulatory requirements. In short, PharmaCyte must generate the necessary data that the FDA requires for any treatment—but especially a treatment that is deemed a "biologic" by the FDA and comprised of living cells that would be placed inside a human’s body.

PharmaCyte just announced that it has completed and passed 29 different tests from its Master Cell Bank (MCB), which is made up of cells that will be used in its planned clinical trial in patients with LAPC. The successful completion of these tests is the final hurdle before encapsulation and testing of the encapsulated cells can begin at Austrianova.

Vials of cells from the MCB have already been supplied to the company’s partner, Austrianova, for encapsulation. Austrianova will now be charged with completing the encapsulation process using PharmaCyte’s signature live-cell encapsulation technology, Cell-in-a-Box, to create the thousands of capsules that will be necessary to conduct its planned clinical trial. Each capsule will contain 10,000 live cells, and then each syringe will be filled with 300 capsules—making up the finished product that will be sent to clinical trial sites.

The encapsulation process will be followed by a battery of tests that will generate the necessary data to satisfy regulatory requirements and should complete what has been a long, meticulous process and allow PharmaCyte to finally submit it’s IND to the FDA.

In addition to the 29 successful tests that PharmaCyte announced last week, the company has stated that a number of additional tests have also been a success (See www.PharmaCyte.com/news). This is all very good news for shareholders who have been clamoring for the start of a clinical trial, and it should bode well for a company that is trying to win the FDA’s approval when it does submit its IND.

PharmaCyte’s goal of starting a Phase 2b clinical trial to meet an unmet medical need in the treatment of patients with LAPC is a remarkable milestone for such a small company, and because their first ever trip inside the clinic involves presenting the FDA with a biologic treatment, the sheer complexity of this journey explains why the process has been so time consuming. PharmaCyte’s treatment for LAPC utilizes genetically engineered live human cells that produce a particularly potent cytochrome P450 enzyme that is able to activate the chemotherapy prodrug ifosfamide.

As previously mentioned, these cells are encapsulated using the Cell-in-a-Box technology, and the tiny, pinhead-sized capsules are implanted near the cancerous tumor so that a high local concentration of the cancer-killing ifosfamide metabolite is produced near the tumor.

PharmaCyte’s treatment is not a single molecule drug. It’s not a drug at all actually. And because the treatment is made up of live human cells that are responsible for activating an already FDA-approved chemotherapy drug, the FDA expects every single cell to act exactly the same way, every single time, in every single test that PharmaCyte is required to conduct.

The FDA simply wants to know that the capsules and the cells that live inside them will remain exactly the same at all times when they are eventually placed inside the human body. And unfortunately there is no short cut when it comes to satisfying regulatory requirements.

The unmet medical need that PharmaCyte expects to address in its clinical trial is for those patients who no longer see any benefit from using the preferred standard of care, Abraxane combined with gemcitabine, or FOLFIRINOX, another combination chemotherapy that is increasingly being used in the U.S. as the preferred standard of care. These patients must have tumors that no longer respond to these combination chemotherapies after they’ve been on the treatment for a period of between 4 and 6 months.

The good news for PharmaCyte’s patient shareholders is that the company has reached the "end of the line" in what has been a very long process. But, when it comes to the FDA and success in a clinical trial—especially for a small company like PharmaCyte—there is only one true shot at getting it right.

Stock Market Media Group will be interviewing PharmaCyte’s CEO, Kenneth L. Waggoner, and its Chief Scientific Officer, Prof. Dr. Walter H. Günzburg, to discuss the IND, encapsulation, testing, preparations for the upcoming planned clinical trial, among other topics. The radio-style interview will be released and announced publicly via a press release within the next 2 weeks.

On May 21, 2018 GRAIL, Inc., a healthcare company whose mission is to detect cancer early, when it can be cured, reported it has raised USD$300 million in an oversubscribed Series C financing (Press release, Grail, MAY 21, 2018, View Source [SID1234526850]). The financing is led by Ally Bridge Group, co-led by Hillhouse Capital Group and 6 Dimensions Capital, and includes Blue Pool Capital, China Merchant Securities International, CRF Investment, HuangPu River Capital (HPR), ICBC International, Sequoia Capital China, and WuXi NextCODE.

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Since early 2016, GRAIL has raised more than $1.5 billion in three rounds of equity financing to pursue its vision of transforming the way cancer is diagnosed and reducing global cancer mortality. The Series C funding will add to the company’s balance sheet and support ongoing development and validation of products for the early detection of cancer in GRAIL’s clinical research program.

"GRAIL has continued to execute at a rapid pace towards its goal of saving lives through early detection of cancer. We have enrolled more than 73,000 participants in our population-scale clinical studies, CCGA and STRIVE, and are on-track to complete enrollment in both studies this year," said Jennifer Cook, Chief Executive Officer of GRAIL. "We recently reported data supporting the potential for development of a highly specific and sensitive blood test, and are now continuing our development programs to optimize and validate a product for early detection of multiple cancer types."

"We are fortunate to partner with new international investors who share our vision of delivering early detection products to people globally," said Ken Drazan, President of GRAIL. "Many of our new investors have a focus in Asia, which we believe is a natural fit as we plan to grow our capabilities and operations in the region, following the planned launch of our first product for early detection of nasopharyngeal cancer in Hong Kong this year."

"We are very impressed with the scientific, clinical, and software engineering achievements the team at GRAIL has made in just over two years. Our significant investment in GRAIL aligns well with Ally Bridge’s strong focus on investing in some of the world’s most innovative life science technologies and enhancing value-creation across geographies," said Frank Yu, Founder and Chief Executive Officer, Ally Bridge Group.

On May 21, 2018 Verastem, Inc. (NASDAQ: VSTM) (Verastem Oncology or the Company), focused on developing and commercializing drugs to improve the survival and quality of life of cancer patients, reported that Jonathan Pachter, PhD, the Company’s Chief Scientific Officer, will give an oral presentation and moderate a roundtable discussion at the 3rd Annual Advances in Immuno-Oncology Congress being held May 24-25, 2018 in London, UK (Press release, Verastem, MAY 21, 2018, View Source;p=RssLanding&cat=news&id=2350086 [SID1234526826]).

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"The data that will be presented at the Immuno-Oncology Congress demonstrate the unique potential of duvelisib, as a dual inhibitor of PI3K-delta and PI3K-gamma, to enhance the efficacy of immune checkpoint and co-stimulatory antibodies in preclinical models of both hematological malignancies and solid tumors," said Dr. Pachter. "These results support continued research and lend particular importance as we move toward the commercialization of duvelisib, Verastem’s lead candidate an oral, dual inhibitor of PI3K-delta and PI3K-gamma. The duvelisib New Drug Application (NDA) is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of patients with relapsed or refractory CLL/SLL, and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma. I will also give an update on the scientific rationale and clinical progress of our FAK inhibitor defactinib in combination with PD-1 and PD-L1 inhibitors in solid tumors."

Details for the presentation and round table discussion at the Congress are as follows:

Oral Presentation Title: Immunological Effects of Clinical Stage FAK & PI3K-Delta/Gamma Inhibitors
Session: Translational Immuno-Oncology
Date and time: Thursday, May 24, 2018 at 5:40 – 6:10 PM BST

Round Table Discussion Title: Novel Checkpoint Pathways & Strategies for Combined Modality Treatment
Date and time: Friday, May 25, 2018 at 7:30 – 8:00 AM BST

A copy of the oral presentation will be available following the presentation.

About Duvelisib
Duvelisib is a first-in-class investigational oral, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells and T-cells. PI3K signaling may lead to the proliferation of malignant B- and T-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 Duvelisib was evaluated in late- and mid-stage extension trials, including DUO, a randomized, Phase 3 monotherapy study in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL),4 and DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL).5 Both DUO and DYNAMO achieved their primary endpoints. Verastem Oncology’s New Drug Application (NDA) requesting the full approval of duvelisib for the treatment of patients with relapsed or refractory CLL/SLL, and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma (FL) was accepted for filing by the U.S. Food and Drug Administration (FDA), granted Priority Review and assigned a target action date of October 5, 2018. Duvelisib is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), and is being investigated in combination with other agents through investigator-sponsored studies.6 Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

About Defactinib
Defactinib is an investigational inhibitor of focal adhesion kinase (FAK), a non-receptor tyrosine kinase that mediates oncogenic signaling in response to cellular adhesion and growth factors.7 Based on the multi-faceted roles of FAK, defactinib is used to treat cancer through modulation of the tumor microenvironment and enhancement of anti-tumor immunity.8,9 Defactinib is currently being evaluated in three separate clinical collaborations in combination with immunotherapeutic agents for the treatment of several different cancer types including pancreatic cancer, ovarian cancer, non-small cell lung cancer (NSCLC), and mesothelioma. These studies are combination clinical trials with pembrolizumab and avelumab from Merck & Co. and Pfizer/Merck KGaA, respectively.10,11,12 Information about these and additional clinical trials evaluating the safety and efficacy of defactinib can be found on www.clinicaltrials.gov.

On May 21, 2018 Immedica Group reported that it has entered into an exclusive supply and distribution agreement with German based Oncoscience GmbH regarding the distribution, marketing and sale of CIMAher (Nimotuzumab) in the Nordics (Press release, Immedica Pharma, MAY 21, 2018, View Source [SID1234555254]). Under the agreement, Medical Need AB gains the rights to distribute CIMAher in Denmark, Finland, Iceland, Norway and Sweden, and will initially do so on a named patient basis in the territories.

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Tomas Gloveus, the Head of Marketing and Sales at Medical Need AB said, "CIMAher addresses a significant unmet medical need for many patients with severe cancers, who are currently left to treatment alternatives with severe side-effects and we look forward to making CIMAher available in the Nordic countries."

Dr. Dirk Reuter, the Managing Director of Oncoscience GmbH added, "The niche focus combined with their capabilities within oncology, makes Medical Need a very suitable partner for us in the Nordics, and we look forward to working together to improve the access of CIMAher in the Nordic region."

Nimotuzumab is a well-established monoclonal antibody within oncology that targets the epidermal growth factor receptor (EGFR) on cancer cells and inhibits their signalling pathway which stops cancer cells from growing and proliferating. To date, Nimotuzumab has been administered to more than 65,000 patients globally and has undergone 82 clinical studies. Nimotuzumab is already approved in 25 countries around the world for a variety of cancers, such as head & neck cancer, oesophageal cancer, highly malignant brain tumours and pancreatic cancer.

Nimotuzumab has an EU orphan designation for the treatment of pancreatic cancer and glioma and has been used in EU under named patient basis, following special individual approvals from a national regulatory authority as it does not yet hold a EU marketing authorization.

About CIMAher (Nimotuzumab)
Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR). Nimotuzumab’s capacity to bind to EGFR is strongly dependant on cell receptor density and it’s bivalent binding mechanism. EGRF is overexpressed in many cancer cells as compared to normal tissue and nimotuzumabs bivalent binding mechanism results in more specific bonds and therefore, potentially increases anti-tumor activity with decreased toxicity in normal tissue (i.e. skin and healthy organ toxicity).

Nimotuzumab is currently available as a registered treatment in 25 countries around the world for a variety of cancers, including head & neck cancers in advanced stages, nasopharyngeal carcinoma, oesophageal cancer, high-malignant glial cancers (glioblastoma multiforme and anaplastic astrocytoma), and locally advanced or metastatic pancreatic cancer (adenocarcinoma). Nimotuzumab has also been approved in a number of countries for high-grade gliomas in children and adolescents (newly diagnosed, recurrent and refractory).

On May 18, 2018 The Janssen Pharmaceutical Companies of Johnson & Johnson, reported 21 company-sponsored abstracts will be presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL on June 1-5 (Press release, Johnson & Johnson, MAY 18, 2018, View Source [SID1234526805]). New data analyses in support of a portfolio of products, including the investigational treatments erdafitinib and apalutamide, as well as approved treatments Imbruvica (ibrutinib), Darzalex (daratumumab), and Zytiga (abiraterone acetate) will be highlighted across urothelial, haematologic and prostate cancers.

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Notably, Phase 2 trial results for the investigational compound erdafitinib, which received U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation, will be presented during an oral presentation on Sunday, June 3 (Abstract #4503).1,2 For haematologic cancers, Phase 3 data from the iNNOVATE study will provide the first look at ibrutinib plus rituximab versus placebo plus rituximab in patients with newly diagnosed and relapsed/refractory Waldenström’s macroglobulinemia (WM) (Abstract #8003).3 In addition, Phase 2 data from the CAPTIVATE study will be presented evaluating ibrutinib plus venetoclax in first-line chronic lymphocytic leukaemia (CLL) (Abstract #7502).4 Oral presentations for erdafitinib and ibrutinib have been selected to be featured at the Best of ASCO (Free ASCO Whitepaper) 2018 Meetings, which highlight cutting-edge science and reflect the leading research in oncology.

"The breadth of new data from our portfolio shows our commitment to finding solutions for patients living with cancer according to their specific treatment needs," said Dr Ivo Winiger-Candolfi, Oncology Therapeutic Area Lead, Janssen Europe, Middle East and Africa. "It reinforces our dedication to work with our partners and move a step closer to making cancer a preventable, chronic or curable disease."

Selected data presentations include:

Erdafitinib: Results from the primary analysis of the Phase 2 study of erdafitinib (ERDA; JNJ-42756493) in patients with metastatic or unresectable urothelial carcinoma (mUC) and Fibroblast Growth Factor Receptor alterations (FGFRalt).
These data will be featured in an oral presentation from 9:00 – 9:12 a.m. CDT on Sunday, June 3 (Abstract #4503)1 and have been selected for the Best of ASCO (Free ASCO Whitepaper) 2018 Meetings.
Ibrutinib: Findings from the Phase 3 placebo-controlled iNNOVATE study will be presented, assessing ibrutinib plus rituximab versus placebo plus rituximab in patients with newly diagnosed and relapsed/refractory WM.*
These data will be featured in an oral presentation from 3:45 – 3:57 p.m. CDT on Friday, June 1 (Abstract #8003)3 and have been selected for the Best of ASCO (Free ASCO Whitepaper) 2018 Meetings.
Ibrutinib: Early results from the Phase 2 CAPTIVATE study will be presented, evaluating ibrutinib in combination with venetoclax in first-line CLL.*
These data will be featured in an oral presentation from 10:09 – 10:21 a.m. CDT on Sunday, June 3 (Abstract #7502) and have been selected for the Best of ASCO (Free ASCO Whitepaper) 2018 Meetings.4
Daratumumab: Phase 1 data from the MMY1001 study will report on the efficacy and safety of daratumumab in combination with carfilzomib and dexamethasone in lenalidomide-refractory patients with relapsed multiple myeloma.
These data will be presented in an oral presentation from 3:09 – 3:21 p.m. CDT on Friday, June 1 (Abstract #8002).5
Daratumumab: Follow-up efficacy and safety data from the pivotal Phase 3 ALCYONE study will be presented for daratumumab in combination with bortezomib, melphalan and prednisone in patients with newly diagnosed multiple myeloma who are transplant ineligible.
These data will be presented in a poster presentation from 8:00 – 11:30 a.m. CDT on Monday, June 4 (Abstract #8031).6
Daratumumab: Safety run-in results from the Phase 3 ANDROMEDA study will be presented evaluating the subcutaneous use of daratumumab in combination with cyclophosphamide, bortezomib, and dexamethasone in patients with newly diagnosed amyloid light chain (AL) amyloidosis.7 Amyloidosis is an incurable disease in which cells that normally produce antibodies make an abnormal protein that deposits in and causes damage to organs such as the heart and kidneys.8
These data will be presented in a poster discussion presentation from 3:00 – 4:15 p.m. CDT on Monday, June 4 (Abstract #8011).
Apalutamide: New analyses from the pivotal Phase 3 SPARTAN clinical trial will be presented examining the relationship between time to metastasis (TTM) and site of metastases in patients with non-metastatic castration-resistant prostate cancer (nmCRPC).
These data will be presented in a poster presentation from 1:15 – 4:45 p.m. CDT on Saturday, June 2 (Abstract #5033).9
Abiraterone acetate: New findings from the pivotal Phase 3 LATITUDE clinical trial in patients with metastatic high-risk castration-sensitive prostate cancer (CSPC) will be presented.
These data will be presented in a poster presentation from 1:15 – 4:45 p.m. CDT on Saturday, June 2 (Abstract #5028).10
Prostate Cancer: New analysis exploring the association between metastasis-free survival (MFS) and overall survival (OS) will be presented in nmCRPC for the first time.
These data will be presented in a poster presentation from 1:15 – 4:45 p.m. CDT on Saturday, June 2 (Abstract #5032).11
For more information on the abstracts presented by Janssen, please click here.

*Abstracts were submitted by ibrutinib co-developer partner, Pharmacyclics, an AbbVie company.

#ENDS#

About erdafitinib

Erdafitinib is an investigational, once-daily pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor being evaluated by Janssen Research and Development in Phase 2 and 3 clinical trials in patients with advanced urothelial cancer and other solid tumours. FGFRs are a family of receptor tyrosine kinases which may be upregulated in various tumour cell types and may be involved in tumour cell differentiation and proliferation, tumour angiogenesis, and tumour cell survival.12 In 2008, Janssen entered into an exclusive worldwide license and collaboration agreement with Astex Therapeutics Ltd. to develop and commercialise erdafitinib.

About ibrutinib

Ibrutinib is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, which works by forming a strong covalent bond with BTK to block the transmission of cell survival signals within the malignant B-cells.13 By blocking this BTK protein, ibrutinib helps kill and reduce the number of cancer cells, thereby delaying progression of the cancer.14

Ibrutinib is currently approved in Europe for the following uses:15

Chronic lymphocytic leukaemia (CLL): As a single agent for the treatment of adult patients with previously untreated CLL, and as a single agent or in combination with bendamustine and rituximab (BR) for the treatment of adult patients with CLL who have received at least one prior therapy.
Mantle cell lymphoma (MCL): Adult patients with relapsed or refractory mantle cell MCL.
Waldenström’s macroglobulinemia (WM): Adult patients who have received at least one prior therapy or in first-line treatment for patients unsuitable for chemo-immunotherapy.
The most common adverse reactions seen with ibrutinib include diarrhoea, neutropenia, haemorrhage (e.g., bruising), musculoskeletal pain, nausea, rash, and pyrexia.15

For a full list of side effects and for further information on dosage and administration, contraindications and other precautions when using ibrutinib please refer to the Summary of Product Characteristics for further information.15

About daratumumab

Daratumumab is a first-in-class biologic targeting CD38, a surface protein that is highly expressed across multiple myeloma cells, regardless of disease stage.16,17,18 Daratumumab is believed to induce tumour cell death through multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), as well as through apoptosis, in which a series of molecular steps in a cell lead to its death.19 A subset of myeloid derived suppressor cells (MDSCs), CD38+ regulatory T cells (Tregs) and CD38+ B cells (Bregs) were decreased by daratumumab.19 Daratumumab is being evaluated in a comprehensive clinical development program across a range of treatment settings in multiple myeloma, such as in frontline and relapsed settings.20,21,22,23,24,25,26,27,28 Additional studies are ongoing or planned to assess its potential for a solid tumour indication and in other malignant and pre-malignant diseases in which CD38 is expressed, such as smouldering myeloma.29,30,31,32 For more information, please see www.clinicaltrials.gov.

Daratumumab is currently approved in Europe for the following uses:19

As monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.
In combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
The most common adverse reactions seen with daratumumab include infusion reactions, fatigue, nausea, diarrhoea, muscle spasms, pyrexia, cough, dyspnoea, neutropenia, thrombocytopenia and upper respiratory tract infection. In addition, in combination with bortezomib, peripheral oedema and peripheral sensory neuropathy were frequently reported.19

For a full list of side effects and for further information on dosage and administration, contraindications and other precautions when using daratumumab please refer to the Summary of Product Characteristics.19

In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialise daratumumab.33

About apalutamide

Apalutamide is an investigational, next-generation oral androgen receptor (AR) inhibitor that blocks the androgen signalling pathway in prostate cancer cells.34 Apalutamide inhibits the growth of cancer cells in three ways: by preventing the binding of androgen to the AR; by stopping the AR from entering the cancer cells; and by preventing the AR from binding to the DNA of the cancer cell.34 Apalutamide received US FDA approval on February 14, 2018 for the treatment of non-metastatic CRPC.35 On February 9, 2018 Janssen submitted a Marketing Authorisation Application to the European Medicines Agency (EMA).36

About abiraterone acetate

Abiraterone acetate plus prednisone / prednisolone is the only approved therapy in mCRPC that inhibits production of androgens (which fuel prostate cancer growth) at all three sources that are important in prostate cancer – the testes, adrenals and the tumour itself.37,38

Abiraterone acetate with prednisone / prednisolone is currently approved in Europe for the following uses:37

The treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT).
The treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.
The treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
The most common adverse reactions seen with abiraterone acetate plus prednisone / prednisolone include urinary tract infection, hypokalemia, hypertension, and peripheral oedema.37

For a full list of side effects and for further information on dosage and administration, contraindications and other precautions when using abiraterone acetate plus prednisone / prednisolone please refer to the Summary of Product Characteristics.37