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Kura Oncology Announces Upcoming Presentation at AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

On October 16, 2019 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for the treatment of cancer, reported that an abstract related to the Company’s Phase 2 clinical trial of tipifarnib in HRAS mutant head and neck squamous cell carcinomas (HNSCC) has been accepted for presentation at the upcoming AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), which will be held from October 26-30, 2019 in Boston (Press release, Kura Oncology, OCT 16, 2019, View Source [SID1234542302]). Details are as follows:

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Title: Preliminary results from a phase 2 trial of tipifarnib in squamous cell carcinomas (SCCs) with HRAS mutations
Session Title: Clinical Trials
Session Date: Sunday, October 27
Session Start Time: 12:30
Session End Time: 16:00
Location: Hall D, Hynes Convention Center
Abstract Number: A087

The abstract has been selected as a newsworthy candidate for the meeting’s official press program and will be embargoed until 11:00 a.m. ET on Friday, October 25, 2019. A copy of the poster will be available at www.kuraoncology.com following presentation at the meeting.

PharmaCyte Biotech Closer to Submitting IND with Successful Completion of Clinical Trial Product

On October 16, 2019 PharmaCyte Biotech (OTCQB: PMCB) reported that it has now moved one step closer to submitting an Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) to request a clinical trial in locally advanced, inoperable pancreatic cancer (LAPC) in the United States (Press release, PharmaCyte Biotech, OCT 16, 2019, View Source [SID1234542301]). The company has successfully completed the first of two manufacturing runs to produce the clinical trial product (Cell-in-a-Box capsules) it needs for its upcoming Phase 2b clinical trial in LAPC.

Kenneth L. Waggoner, PharmaCyte’s Chief Executive Officer, said that the completion of the first manufacturing run "is a major milestone" towards the completion of the IND.

A few other key events will play themselves out in the weeks to come—all leading to the submission of the IND. The first of which has already begun. PharmaCyte stated this week that the second of two staggered and back-to-back manufacturing runs is already underway, and that the cells from the company’s Master Cell Bank (MCB) are growing well in this second run and will be encapsulated within the next week or two.

A successful second run should be regarded as an even greater milestone and extremely good news for the company and its shareholders as it will represent the conclusion of all necessary manufacturing runs on the way to submitting an IND. cGMP Validation is the company that will take responsibility for PharmaCyte’s clinical trial product coming into the United States and being used in human patients, so two successful manufacturing runs undoubtedly gives cGMP Validation the comfort level it needs to take on this responsibility.

Waggoner said of the second manufacturing run, "Our cGMP expert has recommended that a second manufacturing run be done because, by doing so, we can firmly validate to the FDA that our manufacturing process is both reproducible and robust. Also, additional information on duplicate manufacturing runs may be beneficial to our cGMP expert, who will also serve as our ‘Release Agent’ so that our clinical trial product can be used in human patients in the U.S. in a clinical trial."

Validating that the company’s manufacturing process is both "reproducible and robust" to the FDA is significant today and well into the future for PharmaCyte, according to the company’s CEO.

"Although we have been advised that the IND for a Phase 2 clinical trial doesn’t require information related to successful duplicate manufacturing runs, it’s important for us to take the extra time to complete the second manufacturing run because the manufactured product is not only the ‘centerpiece’ of our planned clinical trial in LAPC, but it will also likely play a similar role in the treatment of other forms of cancer."

The most important event left to complete outside of the final manufacturing run is "release testing" of the clinical trial product. PharmaCyte said that a representative sample of frozen syringes from the first successful manufacturing run, which are filled with 300 Cell-in-a-Box capsules each, are in the process of being shipped to external testing labs for the release testing that is required by the FDA.

The data that those tests will produce are all that remains for the company to complete the IND and then submit it to the FDA.

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, watch the company’s documentary video complete with medical animations at: View Source

Xenetic Biosciences, Inc. to Present at BIO Investor Forum

On October 16, 2019 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing XCART, a personalized chimeric antigen receptor T cell ("CAR T") platform technology engineered to target patient-specific tumor neoantigens, reported that Jeffrey Eisenberg, Chief Executive Officer of Xenetic, will present at BIO Investor Forum on Wednesday, October 23, 2019 at 2:45 PM PT in San Francisco, CA (Press release, Xenetic Biosciences, OCT 16, 2019, View Source [SID1234542300]).

As part of his presentation, Mr. Eisenberg will provide a Company overview and discuss the Company’s novel CAR T platform technology, called "XCART," a proximity-based screening platform capable of identifying CAR constructs that can target patient-specific tumor neoantigens, with a demonstrated proof of mechanism in B-cell Non-Hodgkin lymphomas. Xenetic is currently advancing the development program for XCART to confirm the positive preclinical results shown to date and to demonstrate a more attractive safety profile than existing therapies.

In addition to the presentation, management will also be available to participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference.

A live audio webcast of the presentation will be available on the IR Calendar in the Investors section of Xenetic’s website (www.xeneticbio.com) or by accessing the conference website here. Within three days of the event, a webcast replay will be made available on the Company’s website.

About BIO Investor Forum

Now in its 17th year, the BIO Investor Forum is an international biotech investor conference focused on early and established private companies as well as emerging public companies. The event features plenary sessions, business roundtables, therapeutic workshops, company presentations, and BIO One-on-One Partnering meetings. For more information, please visit the conference website here.

Intellia Therapeutics Announces Presentations at the 2019 Annual Congress of the European Society of Gene and Cell Therapy (ESGCT)

On October 16, 2019 Intellia Therapeutics, Inc. (NASDAQ: NTLA), a leading genome editing company focused on the development of curative therapeutics using CRISPR/Cas9 technology both in vivo and ex vivo, reported one oral presentation and four poster presentations were accepted for the 27th Annual Congress of the European Society of Gene and Cell Therapy (ESGCT) taking place October 22-25, 2019, in Barcelona, Spain (Press release, Intellia Therapeutics, OCT 16, 2019, View Source [SID1234542299]).

Intellia’s data includes important updates about the company’s programs and platform development activities:

Oral Presentation:

"In Vivo Gene Knockout Followed by Targeted Gene Insertion Results in Simultaneous Reduced Mutant Protein Levels and Durable Transgene Expression"

Intellia will present data on its alpha-1 antitrypsin deficiency (AATD) program, which uses a modular hybrid delivery system combining lipid nanoparticle (LNP) encapsulated CRISPR/Cas9 with an adeno-associated virus (AAV) donor DNA template. Intellia’s gene knockout approach eliminates the production of the faulty PiZ variant of the protein, while targeted insertion of a wild-type gene copy facilitates production of a functional circulating protein. This builds on Intellia’s similar approach for targeted gene insertion of Factor 9, which achieved increased levels of circulating human Factor IX protein through two months in non-human primates and sustained through 12 months in mice.

Presenter: Anthony Forget, Ph.D.
Abstract number: OR48
Session 5b: New delivery systems and technologies
Presentation date/time: Friday, October 25, 2019, 11:30 a.m. – 1:30 p.m. CET
Location: Room 113-115

Poster Presentations:

"In Silico, Biochemical and Cell-Based Integrative Genomics Identifies Precise CRISPR/Cas9 Targets for Human Therapeutics"

This poster presentation will highlight Intellia’s approach to assess off-target activity to identify highly specific CRISPR/Cas9 guides. Researchers demonstrated that potential off-target editing profiles discovered through empirical data from biochemical approaches were the most sensitive and accurate.

Presenter: Daniel O’Connell, Ph.D.
Poster ID Number: P655
Date: Wednesday, October 23, 2019

"Generation of a Library of WT1-Specific T Cell Receptors (TCR) for TCR Gene Edited T Cell Therapy of Acute Leukemia"

This poster presentation focuses on Intellia’s ongoing research collaboration with IRCCS Ospedale San Raffaele to develop CRISPR/Cas9-edited T cell therapies to address intractable cancers, such as acute myeloid leukemia (AML). Researchers have successfully established a protocol enabling consistent and efficient tumor-specific TCR isolation and characterization from healthy donors. Based on these results, Intellia has selected multiple lead TCRs, which are undergoing development candidate evaluation.

Presenter: Erica Carnevale, Ph.D., Ospedale San Raffaele
Poster ID Number: P111
Date: Wednesday, October 23, 2019

"Engineering of Highly Functional and Specific Transgenic T Cell Receptor (TCR) T Cells Using CRISPR-Mediated In-Locus Insertion Combined with Endogenous TCR Knockout"

This poster presentation focuses on the company’s T cell engineering technology, which is being applied in its Wilms’ Tumor 1 (WT1) lead ex vivo program. Intellia has identified an efficient CRISPR/Cas9-mediated process that inserts tumor-specific TCRs with high yield into the TRAC locus. Simultaneous knockout of the TRBC1 and TRBC2 loci substantially eliminates production of the endogenous T cell receptors.

Presenter: Birgit Schultes, Ph.D.
Poster ID Number: P162
Date: Thursday, October 24, 2019

"CRISPR/Cas9-Mediated Gene Knockout to Address Primary Hyperoxaluria"

This poster presentation will demonstrate the effects of independent CRISPR/Cas9-mediated knockout of each of two target genes involved in oxalate formation, lactate dehydrogenase A (LDHA) and hydroxyacid oxidase 1 (HAO1), to address primary hyperoxaluria type 1 (PH1).

Presenter: Sean Burns, M.D.
Poster ID Number: P552
Date: Thursday, October 24, 2019

Lilly Announces Phase 3 Study in Patients with Metastatic Pancreatic Cancer Did Not Meet Primary Endpoint of Overall Survival

On October 16, 2019 Eli Lilly and Company (NYSE: LLY) reported top-line results from its Phase 3 SEQUOIA trial evaluating pegilodecakin plus FOLFOX (folinic acid, 5-FU, oxaliplatin) compared to FOLFOX alone in patients with metastatic pancreatic cancer whose disease had progressed during or following a first-line gemcitabine-containing regimen (Press release, Eli Lilly, OCT 16, 2019, View Source [SID1234542298]). The SEQUOIA trial did not meet its primary endpoint of overall survival.

The most common Grade 3/4 adverse events occurring at a higher rate (>5% difference) on the pegilodecakin-plus-FOLFOX arm compared to the FOLFOX arm were neutropenia, thrombocytopenia, fatigue and anemia. Detailed efficacy and safety results will be submitted for presentation at a future medical meeting.

Metastatic pancreatic cancer is one of the deadliest major cancers, with just three percent of patients in the U.S. living five years after the cancer is diagnosed. In the U.S., pancreatic cancer is the third leading cause of cancer death and is expected to become the second leading cause of cancer-related death in the next decade.1 Globally, pancreatic cancer is the seventh leading cause of cancer-related death.2

"More than 56,700 Americans – mothers, daughters, fathers, sons, colleagues and friends – will be diagnosed with pancreatic cancer this year alone," said Julie Fleshman, JD, MBA, president and CEO of the Pancreatic Cancer Action Network (PanCAN). "Because this is an aggressive disease and the current scope of treatment options is limited, there remains an urgent need for meaningful solutions to improve outcomes for pancreatic cancer patients."

"Pancreatic cancer has proven to be one of the most difficult tumor types to treat and there have been very few recent treatment advancements in the later-line metastatic setting. We are grateful to the patients, investigators and researchers who participated in the study," said Maura Dickler, M.D., vice president, late phase development, Lilly Oncology. "While we are disappointed by the outcome of the SEQUOIA study, we look forward to the upcoming results in lung cancer, learning from those results and increasing our understanding of pegilodecakin’s novel mechanism of action in cancer immunotherapy."

Lilly gained pegilodecakin with the acquisition of ARMO BioSciences in June 2018. SEQUOIA was initiated by ARMO in March 2017 based on results of the Phase 1/1b IVY study, which evaluated pegilodecakin – used as a single agent and in combination with chemotherapy and with checkpoint inhibitor therapy – across multiple tumor types including pancreatic, non-small cell lung and renal cell cancers. Results from the IVY trial were also the basis for the ongoing Phase 2 CYPRESS 1 and CYPRESS 2 studies of pegilodecakin in combination with checkpoint inhibitors in non-small cell lung cancer (NSCLC). The CYPRESS studies were initiated by ARMO in March 2018 and results, expected in early 2020, will inform future studies of pegilodecakin in NSCLC. For the next stage of pegilodecakin’s clinical development, Lilly is focused on assessing biomarkers and conducting studies in NSCLC and other tumor types including renal cell carcinoma, where the molecule has shown promising activity.

Notes to Editors

About SEQUOIA
SEQUOIA is a global, multi-center, randomized Phase 3 study designed to compare the efficacy and safety of pegilodecakin in combination with FOLFOX (folinic acid, 5-FU, oxaliplatin) compared to FOLFOX alone in participants with metastatic adenocarcinoma of the pancreas whose disease had progressed on one prior gemcitabine-containing regimen. The primary endpoint of the study is overall survival and key secondary endpoints are progression-free survival and objective response rate. SEQUOIA was initiated by ARMO BioSciences in March 2017 and enrolled 567 patients.

About Pancreatic Cancer
Metastatic pancreatic cancer is one of the deadliest major cancers, with just three percent of patients in the U.S. living five years after the cancer is diagnosed. In the U.S., pancreatic cancer is the third leading cause of cancer death and is expected to become the second leading cause of cancer-related death in the next decade.1 Globally, pancreatic cancer is the seventh leading cause of cancer-related death.2

About Pegilodecakin
Pegilodecakin is an immunotherapy which stimulates the body’s natural defenses against cancer and expands tumor-attacking T cells. This class of T cells can infiltrate and destroy cancer cells. Pegilodecakin, a pegylated IL-10, has shown clinical activity as a single agent in renal cancer and promising results in combination with both chemotherapy and checkpoint inhibitor therapy across several tumor types including non-small cell lung cancer and renal cell carcinoma.