On November 29, 2016 PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that a Pre-Investigational New Drug (Pre-IND) meeting with the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) has been granted by the FDA (Press release, PharmaCyte Biotech, NOV 29, 2016, View Source [SID1234516834]). During the meeting with representatives from CBER, they will respond to PharmaCyte’s previously submitted questions to the FDA as part of a Pre-IND information package related to PharmaCyte’s clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).

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PharmaCyte will be submitting a full Pre-IND package of information to the FDA that describes what PharmaCyte intends on submitting in its Investigational New Drug (IND) application. The FDA will review PharmaCyte’s manufacturing, preclinical pharmacology and toxicology and clinical trial plans for the company’s therapy to treat LAPC. After the FDA has responded to the questions and issued comments, PharmaCyte will undertake steps to address them to the FDA’s satisfaction which will lead directly to the preparation of the IND application itself. Once the IND application is found to be acceptable to the FDA, patients can be enrolled in PharmaCyte’s clinical trial.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented about the Pre-IND meeting saying, "We are pleased that the FDA has granted us a Pre-IND meeting in connection with our planned clinical trial for LAPC patients whose disease has already received maximum response from the gold standard of care – the combination therapy of Abraxane plus gemcitabine. Our Pre-IND meeting is the next step in getting our pancreatic cancer therapy into a clinical trial and approved by the FDA. We believe PharmaCyte is well on its way to accomplishing this goal."

PharmaCyte’s clinical trial in patients with LAPC is designed to meet a clear unmet medical need for those whose cancer no longer responds after 4-6 months of treatment with the combination of Abraxane plus gemcitabine. The trial will be open-label and multi-site in nature, with sites in the U.S. and Europe. Patients with LAPC will be randomized equally into two groups. One group will receive gemcitabine chemotherapy alone, and the other group will receive PharmaCyte’s pancreatic cancer therapy (encapsulated genetically modified live human cells that can activate the cancer prodrug ifosfamide plus low doses of the prodrug to eliminate side effects from the chemotherapy). In addition to comparing the anticancer activity and safety of the two therapies, a major aspect of the trial will be to determine if, and how well, PharmaCyte’s therapy can shrink inoperable tumors so that they may become operable.

On November 29, 2016 Celldex Therapeutics, Inc. (Nasdaq:CLDX) reported it has completed its previously announced acquisition of Kolltan Pharmaceuticals, Inc., a privately held company focused on the discovery and development of novel, antibody-based drugs targeting receptor tyrosine kinases (RTKs) (Press release, Celldex Therapeutics, NOV 29, 2016, View Source [SID1234516835]).

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"Celldex has added a unique platform of antibodies targeting receptor tyrosine kinases, which are validated targets in oncology, to our pipeline. Clinical and preclinical data suggest these candidates can help overcome tumor resistance mechanisms associated with current tyrosine kinase inhibitors and seen in patients who have failed other cancer therapies," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex. "We believe these programs are highly compatible with our scientific approach and can be developed independently and in combination with Celldex’s existing product candidates. We are finalizing our integrated clinical development strategy and look forward to outlining these plans in the coming weeks."

The following programs have been added to the Celldex pipeline:

CDX-0158 (formerly KTN0158) — a humanized monoclonal antibody that is a potent inhibitor of KIT activation and receptor dimerization in tumor cells and mast cells, which is currently in a Phase 1 dose escalation study in refractory gastrointestinal stromal tumors (GIST).

CDX-3379 (formerly KTN3379) — a human monoclonal antibody designed to block the activity of ErbB3 (HER3), which recently completed a Phase 1b study with combination cohorts where meaningful responses and stable disease were observed in cetuximab (Erbitux) refractory patients in head and neck squamous cell carcinoma and in BRAF-mutant non-small cell lung cancer (NSCLC).

A multi-faceted TAM program — a broad antibody discovery effort underway to generate antibodies that modulate the TAM family of RTKs, comprised of Tyro3, AXL and MerTK, which are expressed on tumor-infiltrating macrophages, dendritic cells and some tumors. Research supports TAMs having broad application and potential across immuno-oncology and inflammatory diseases.

On November 29, 2016 Astex Pharmaceuticals, a member of the Otsuka group, reported that investigators collaborating with Astex will present results from several studies evaluating guadecitabine, its subcutaneous, next-generation hypomethylating agent; and ASTX727, its novel, oral hypomethylating agent at the 2016 Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in San Diego, California, December 3 to 6 (Press release, Astex Pharmaceuticals, NOV 29, 2016, View Source [SID1234516839]).

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The oral presentations are as follows:

Initial results of a Phase 2 Study of Guadecitabine (SGI-110), A Novel Subcutaneous (sc) Hypomethylating Agent, for Patients with Previously Untreated Intermediate-2 or High Risk Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML) (Abstract #346). Dr. Guillermo Montalban-Bravo et al. Sunday, December 4, 10:15 am; Manchester Grand Hyatt, Grand Hall C.
Results of a Phase II study of Guadecitabine (SGI-110) in higher risk MDS, CMML or low-blast- count AML patients refractory to or relapsing after Azacitidine (AZA) treatment (Abstract #347). Dr. Marie Sebert et al. Sunday, December 4, 10:30 am; Manchester Grand Hyatt, Grand Hall C.
Long Term Survival and Clinical Complete Responses of Various Prognostic Subgroups in 103 Relapsed/Refractory Acute Myeloid Leukemia (r/r AML) Patients Treated with Guadecitabine (SGI-110) in Phase 2 Studies (Abstract #904). Dr. Naval Daver et al. Monday, December 5, 3:30 pm; Marriott Marquis San Diego Marina, San Diego Ballroom AB.
Successful Emulation of IV Decitabine Pharmacokinetics with an Oral Fixed-Dose Combination of the Oral Cytidine Deaminase Inhibitor (CDAi) E7727 with Oral Decitabine, in Subjects with Myelodysplastic Syndromes (MDS): Final Data of Phase 1 Study (Abstract #114). Dr. Guillermo Garcia-Manero et al. Saturday December 3, 10:45 am; Manchester Grand Hyatt, Grand Hall C.
In addition, a poster presentation entitled: Genetic determinants of response to guadecitabine (SGI-110) in AML (Abstract #1680), Dr. Patricia L. Kropf et al., will be made on Saturday, December 3, 9:30 am to 11 am in the San Diego Convention Center, Hall GH.

Data from the guadecitabine Phase 2 study (www.clinicaltrials.gov, NCT01261312) has helped to inform the design of the 800-patient, global Phase 3 study of guadecitabine in adults with previously untreated AML who are not considered candidates for intensive induction chemotherapy (ASTRAL-1, www.clinicaltrials.gov, NCT02348489), and the newly announced global Phase 3 studies in relapsed / refractory AML (ASTRAL-2, www.clinicaltrials.gov, NCT02920008), and relapsed / refractory MDS or CMML (ASTRAL-3, www.clinicaltrials.gov, NCT02907359). Astex also announced today that enrollment into the ASTRAL-1 study is now complete. The data on ASTX727 being reported at ASH (Free ASH Whitepaper) also informed the design of a Phase 2 randomized, cross-over study comparing ASTX727 to decitabine IV in higher risk MDS, which is ongoing.

"The data from these clinical studies helps to validate the development of these agents for the treatment of AML and MDS, potentially providing new treatment options for patients with these aggressive hematological malignancies," said Mohammad Azab, President and Chief Medical Officer of Astex. "We are delighted to be working with some of the world’s leading experts in the treatment of hematological malignancies in bringing these next-generation therapies to patients."

About Guadecitabine (SGI-110)

Guadecitabine is a novel next-generation, small-molecule DNA hypomethylating agent formulated as a single, small-volume, subcutaneous injection. The product was designed to deliver longer exposure to the active metabolite, decitabine, compared to IV decitabine, and more efficient delivery into key tissues, including the bone marrow. Guadecitabine demonstrated activity in restoring silenced tumor suppressor gene expression in cancer cells by reversal of DNA methylation and inducing responses in previously treated MDS and AML patients. Guadecitabine is currently being investigated in multiple clinical trials, including the ASTRAL series of studies and an extensive program of investigational studies in combination with immunotherapy and other anti-neoplastic agents, for the treatment or a range of hematological malignancies and solid tumors.

About ASTX727

ASTX727 is a unique fixed-dose combination of the hypomethylating agent decitabine, the active ingredient in Dacogen, and the novel cytidine deaminase inhibitor, E7727. ASTX727 was designed to deliver decitabine by oral administration. By inhibiting cytidine deaminase, E7727 inhibits the major mechanism by which decitabine is degraded in the gut, and the combination therefore permits the efficient oral delivery of decitabine at a low dose. Astex is completing a Phase 2 clinical study of ASTX727 in the treatment of intermediate and high risk myelodysplastic syndromes (MDS).

Guadecitabine and ASTX727 are investigational agents, and efficacy and safety have not been established. There is no certainty that these agents will become commercially available.

On November 29, 2016 Argos Therapeutics Inc. (Nasdaq:ARGS) ("Argos"), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis technology platform, reported that the company will be presenting at the EORTC-AACR-NCI Symposium being held November 29-December 1 at the Internationales Congress Center München in Munich, Germany (Press release, Argos Therapeutics, NOV 29, 2016, View Source [SID1234516822]).

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Irina Tcherepanova, Ph.D., senior director of research and development for Argos, will give a poster presentation entitled "Development of an RNA loaded Dendritic Cell (DC) immunotherapy starting from tissue obtained via needle biopsy". The poster will be exhibited in the meeting exhibition hall throughout the day on November 30th.

The EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium is hosted by the European Organisation for Research and Treatment of Cancer (EORTC), the National Cancer Institute (NCI), and the American Association of Cancer Research (AACR) (Free AACR Whitepaper), and brings together academics, scientists, and industry representatives from around the world to review the latest innovations in drug development, target selection and the impact of new discoveries in molecular biology.

For more information visit View Source

About the Arcelis Technology Platform
Arcelis is a precision immunotherapy technology that captures both mutated and variant antigens that are specific to each patient’s individual disease. It is designed to overcome immunosuppression by producing a specifically targeted, durable memory T-cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to the treatment of a wide range of different cancers and infectious diseases and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized immunotherapies. The Arcelis process uses only a small disease sample or biopsy as the source of disease-specific antigens and the patient’s own dendritic cells, which are optimized from cells collected by a leukapheresis procedure. The proprietary process uses RNA isolated from the patient’s disease sample to program dendritic cells to target disease-specific antigens. These activated, antigen-loaded dendritic cells are then formulated with the patient’s plasma and administered via intradermal injection as an individualized immunotherapy.

On November 29, 2016 AstraZeneca and its global biologics research and development arm, MedImmune, will continue the oncology momentum built during 2016 with a strong end-of-year presence at three major congresses (Press release, AstraZeneca, NOV 29, 2016, View Source [SID1234516824]). In total, 50 abstracts – including 15 oral presentations – have been accepted across:
ASH: The 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, 3-6 December 2016, San Diego, USA
WCLC: The 17th World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer, 4-7 December 2016, Vienna, Austria
SABCS: The 2016 San Antonio Breast Cancer Symposium, 6-10 December 2016, San Antonio, USA
The December congresses will offer a comprehensive update on AstraZeneca’s portfolio progress and highlight the scientific strength and clinical potential of the company’s cancer medicines – in particular Iressa, Tagrisso and Faslodex – as well as the company’s emerging presence in blood cancers.

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Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: "At the end of a memorable year for AstraZeneca in oncology, we will reinforce our leadership in lung and breast cancer research and our growing late-stage pipeline of potential medicines for life-threatening blood cancers. Our data will confirm the superiority of Tagrisso over standard of care chemotherapy in EGFR T790M mutation-positive non-small cell lung cancer and of Faslodex over Arimidex as 1st-line treatment in advanced breast cancer. New data will add to the emerging safety and efficacy profile of acalabrutinib, our potential best-in-class investigational therapy for the treatment of a range of B-cell malignancies."

At ASH (Free ASH Whitepaper): Rapid progress in haematology research
Less than a year after announcing a majority investment in Acerta Pharma, which is becoming AstraZeneca’s haematology Centre of Excellence, the Company will demonstrate momentum in blood cancers with new clinical data on acalabrutinib, its investigational, highly selective, potent Bruton tyrosine-kinase (BTK) inhibitor in Phase III development for B-cell malignancies. The 2016 ASH (Free ASH Whitepaper) Annual Meeting will feature two oral presentations on acalabrutinib:

Acalabrutinib monotherapy in patients with Richter transformation from the Phase I/II ACE-CL-001 clinical study (Oral presentation, Abstract #60, 3 December 2016, 08:45 PST, Room 6AB)
Acalabrutinib monotherapy in patients with ibrutinib intolerance: results from the Phase I/II ACE-CL-001 clinical study (Oral presentation, Abstract #638, 5 December 2016, 07:15 PST, Room 5AB)
The Company will also report new pre-clinical data on a range of investigational treatment mechanisms with potential to address unmet medical needs in blood cancers.

At WCLC: Tagrisso data show clinical benefit in EGFR T790M-positive NSCLC in confirmatory Phase III trial
With 26 abstracts and nine oral presentations – including a presentation on AURA3 which will be part of the Presidential Symposium – AstraZeneca will showcase the breadth and potential of its lung cancer portfolio. Tagrisso will be a particularly strong focus, with detailed data from the positive AURA3 trial in patients with EGFR T790M mutation-positive NSCLC who have progressed after EGFR tyrosine kinase inhibitor treatment. This is the first randomised, controlled Phase III trial for Tagrisso against standard-of-care chemotherapy, and includes results from plasma ctDNA testing. Analyses will also be presented on Phase II data in patients with CNS metastases:

Randomised Phase III study of osimertinib vs platinum-pemetrexed for EGFR T790M-positive advanced NSCLC (AURA3) (Oral presentation, Abstract PL03.03, 6 December 2016, 09:05 CET, Hall D)
Osimertinib vs platinum-pemetrexed for T790M-positive advanced NSCLC (AURA3): plasma ctDNA analysis (Mini-oral presentation, Abstract MA08.03, 6 December 2016, 11:12 CET, Lehar 3-4)
CNS response to osimertinib in patients with T790M-positive advanced NSCLC: pooled data from two Phase II trials (Mini-oral presentation, Abstract MA16.11, 7 December 2016, 15:32 CET, Strauss 2)
Iressa presentations at WCLC include an oral ‘late breaker’ report of over 10 years experience with the US Iressa Clinical Access Program (ICAP):

Analysis of Outcomes in US IRESSA Clinical Access Program (ICAP) Patients on Gefitinib for More Than 10 Years (Oral presentation, Abstract OA23.07, 7 December 2016, 15:25 CET, Stolz 2)
In addition, data from the Phase II ATLANTIC trial of durvalumab in ≥3rd-line treatment of locally advanced or metastatic, EGFR/ALK wild type NSCLC will also be presented.

At SABCS: Phase III Faslodex data extend understanding in advanced breast cancer
Latest data from the Phase III FALCON trial to be presented at the SABCS 2016 congress will build on previous findings demonstrating superior progression-free survival (PFS) with Faslodex over Arimidex in the 1st-line treatment of women with advanced hormone receptor positive (HR+) breast cancer, including an analysis in women with and without metastases that have spread to the liver and/or lung, so-called visceral disease.

Key presentations among the 14 abstracts at SABCS include:

Progression-free survival results in postmenopausal Asian women: subgroup analysis from a Phase III randomised trial of fulvestrant 500mg vs anastrozole for hormone receptor-positive advanced breast cancer (FALCON) (Poster presentation number: P2-08-09, Poster Session 2, 8 December 2016, 07:30-09:00 CST, Hall 1)
A real-world evidence study to define the prevalence of endocrine therapy-naïve hormone receptor-positive locally advanced or metastatic breast cancer in the US (Poster presentation number: P5-08-20, Poster Session 5, 9 December 2016, 17:00-19:00 CST, Hall 1)