On September 23, 2019 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company focused on the development of female-specific oncology products in the precision medicine metastatic breast cancer arena, reported the enrollment and dosing of the first patient into a Phase 2 clinical trial of its lead investigational drug, lasofoxifene (Press release, Sermonix Pharmaceuticals, SEP 23, 2019, View Source [SID1234539705]).

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The open-label, randomized, multi-center Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE, NCT03781063) study will assess the efficacy of oral lasofoxifene versus intramuscular fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic estrogen receptor-positive (ER+)/HER2- breast cancer with an ESR1 mutation and progression-free survival as the primary endpoint.

"To address this unique population, the landmark ELAINE study of women with advanced metastatic breast cancer is the first of its kind to select all patients for participation prospectively based on ESR1 mutation status," said Paul Plourde, M.D., vice president of clinical oncology development at Sermonix. "A potential targeted therapy for ER+/HER2- breast cancer patients could greatly advance our approach to this complex disease."

Assessment of ESR1 mutations is difficult in patients with advanced disease, as molecular heterogeneity can confound results and tissue biopsies of multiple tumor sites are impractical. To address this challenge, Sermonix partnered with Sysmex Inostics to identify appropriate study participants using the OncoBEAM ESR1 test. The liquid biopsy test has demonstrated proven clinical performance in screening patient plasma for ESR1 mutations.

"The OncoBEAM ESR1 technology allows us to determine if a mutation exists in the binding domain of the tumor’s estrogen receptor gene via a minimally invasive peripheral blood draw," said Dr. Plourde. "We are delighted to collaborate with Sysmex Inostics to quickly and accurately identify appropriate study candidates."

Sermonix’s mission to develop lasofoxifene as a precision medicine for women in great medical need is one important step closer to fruition with the initiation of the ELAINE study, according to Dr. David Portman, Sermonix founder and chief executive officer.

"The dosing of our first patient, which closely follows the completion of our Series A financing, marks a pivotal milestone and truly gratifying moment for Sermonix," said Dr. Portman. "ESR1 mutations are highly prevalent in ER+ metastatic breast cancer and confer a poor prognosis. We are encouraged to be able to offer women the opportunity to participate in the ELAINE study, and for Sermonix to deliver on the promise of demonstrating lasofoxifene’s potential as a novel endocrine treatment option in the fight against this incurable disease."

About Lasofoxifene
Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed from Ligand Pharmaceuticals Inc. (NASDAQ: LGND) and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance and ESR1 mutations, a common mutation in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was recently discovered at Duke University and Sermonix has exclusive rights to develop and commercialize it in this area. Lasofoxifene, a potent, oral SERM could, if approved, play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.

On September 23, 2019 PharmaCyte Biotech (OTCQB: PMCB) and its partner, reported that Austrianova, along with the company’s cellular biologist, David Judd, are all more confident than ever that they have a product that can succeed in a U.S. FDA clinical trial for locally advanced, inoperable pancreatic cancer (LAPC) (Press release, PharmaCyte Biotech, SEP 23, 2019, View Source [SID1234539704]). It’s now up to the company to produce its signature live-cell encapsulation product, Cell-in-a-Box, successfully, test it, and then use the data from those tests to complete an Investigational New Drug application (IND). The aim, of course, is to submit the IND to the FDA to gain approval to begin its planned Phase 2b clinical trial in the United States.

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During a conference call with shareholders late last week, PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, told shareholders that the company is in the final days of the first of two back-to-back, staggered manufacturing runs, and that he is "very encouraged" by the reports he’s getting from Austrianova—the company conducting the manufacturing runs to produce the Cell-in-a-Box capsules for PharmaCyte’s upcoming clinical trial.

Once this first manufacturing run is completed successfully, the final stage in the process—testing those capsules and the live cells inside that make up the Cell-in-a-Box technology—can begin. The capsules will be placed into syringes and then those syringes will be frozen and stored in a freezer at Austrianova’s manufacturing facility in Thailand. Soon thereafter, a representative sample of the Cell-in-a-Box syringes will be thawed and a series of tests (release testing) will begin. These FDA-required tests are necessary for PharmaCyte to be able to use its product in human beings in a clinical trial.

Also, PharmaCyte informed shareholders that Austrianova scheduled the second of two manufacturing runs to begin last Friday. This news confirms the extreme confidence that both PharmaCyte and Austrianova have in the many changes they’ve made to the production process this past year, and it also marks the first time that a second manufacturing run has received the go-ahead to begin. There were 7 changes that were incorporated into the manufacturing process and each of those "tweaks" or changes to the production process were also discussed on the company’s shareholder conference call.

Regarding an upcoming second manufacturing run, PharmaCyte said, "If the first run is successful from start to finish, and all things are mimicked from the first run in this upcoming second run, then we’re confident that we’ll see a successful second run. From there, the company will move to a second round of release testing."

Why is the company insisting on two manufacturing runs? Well, PharmaCyte’s CEO explained to shareholders that cGMP Validation, the company that is taking responsibility for releasing the company’s clinical trial product into the U.S., believes PharmaCyte’s chances for FDA approval of its IND are much more likely with the successful completion of these two runs.

"Releasing clinical trial product" means that cGMP Validation will be taking responsibility for the product’s GMP compliance with the manufacturing standards that apply to the company’s clinical trial product, which will be placed inside human beings.

The FDA wants a "reliable" and a "reproducible" clinical trial product. To demonstrate those two components, PharmaCyte believes that conducting a second staggered and back-to-back manufacturing run – which means the second run is being conducted while the first run is finishing up – optimizes its chances for a successful IND submission.

In last week’s conference call, Kenneth Waggoner explained to shareholders, "We have a product that we’re completely satisfied with — meaning that the cells we have genetically engineered do exactly what they were designed to do and our encapsulation process is exactly how we want it to be."

The CEO stated, "The viability of the cells from our Master Cell Bank is well within the normal range. Cells from our Master Cell Bank produce the amount of enzymatic activity we designed them to produce and that is necessary to convert the prodrug we currently use to treat pancreatic cancer from its inactive form to its cancer killing form. We are satisfied with everything in the ‘design’ of the manufacturing process."

The confidence shown by PharmaCyte’s CEO during last week’s conference call will only continue to grow, if, in the coming days, the first manufacturing run is completed successfully, and testing can begin.

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

On September 23, 2019 Molecular Templates, Inc. (Nasdaq: MTEM), a clinical-stage biopharmaceutical company focused on the discovery and development of the company’s proprietary engineered toxin bodies (ETBs), which are differentiated, targeted, biologic therapeutics for cancer, reported that Eric Poma, Ph.D., Chief Executive Officer and Chief Scientific Officer, will present a corporate overview at the Ladenburg Thalmann 2019 Healthcare Conference, and the Cantor Fitzgerald 2019 Healthcare Conference, both taking place in New York City (Press release, Molecular Templates, SEP 23, 2019, View Source [SID1234539703]).

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Ladenburg Thalmann 2019 Healthcare Conference
Date: Tuesday, September 24
Time: 10:00am Eastern Time
Webcast: View Source

Cantor Fitzgerald 2019 Healthcare Conference
Date: Friday, October 4
Time: 12:00pm Eastern Time
Webcast: View Source

On September 23, 2019 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported that it will host an investor and analyst event on Friday, October 4, 2019 from 8:00 a.m. to 11:30 a.m. ET in New York City, entitled "A New Chapter in PI3Kδ Inhibition to Treat B-cell Malignancies (Press release, MEI Pharma, SEP 23, 2019, View Source [SID1234539702])."

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The agenda will include an in-depth review of the PI3K pathway, an overview of the B-cell malignancy treatment landscape, and an update on the MEI Pharma pipeline with a focus on ME-401, a differentiated inhibitor of PI3Kδ.

The event will also feature key opinion leaders in PI3K inhibition and the treatment of B-cell malignancies, including guest speakers:

Lewis C. Cantley, Ph.D.
Meyer Director of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medical College, Professor of Cancer Biology in Medicine
Nishitha M. Reddy, M.D., M.B.B.S.
Associate Professor of Medicine at Vanderbilt University Medical Center
Matthew J. Matasar, M.D.
Medical Director, Memorial Sloan Kettering Bergen
Webcast Information
You can access the live webcast under the investor relations section of MEI’s website on the "Events and Presentation" page at: www.meipharma.com. A replay of the webcast will be archived for at least 30 days after the conclusion of the live event.

On September 23, 2019 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology company, reported that preliminary results from its ongoing Phase 2 basket trial, evaluating DPX-Survivac in combination with Merck’s Keytruda (pembrolizumab) and intermittent low dose cyclophosphamide (CPA) in patients with advanced and metastatic solid tumors, will be presented during the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) poster session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress, being held September 27 – October 1, 2019, in Barcelona, Spain (Press release, IMV, SEP 23, 2019, View Source [SID1234539701]).

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Presentation Details

Poster Title: "Safety and efficacy results of the combination of DPX-Survivac, pembrolizumab and intermittent low dose cyclophosphamide (CPA) in subjects with advanced and metastatic solid tumours (preliminary results)"

Presenter: Henry J Conter, M.D., Medical Oncology Director, William Osler Cancer Centre Date and Time: Sept. 30, 2019, 12:00-13:00 CEST – poster will be displayed all day

Abstract Number: 1208P
Session Title: Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)
Poster Display: Session 3, Poster Area – Hall 4

ESMO has published the official abstracts on its meeting website in advance of the ESMO (Free ESMO Whitepaper) Annual Meeting at 00:05 CEST on Sept. 23rd, 2019. The cut-off date for inclusion of data in the abstract was August 21st, 2019.

About the Phase 2 Basket Trial

IMV’s Phase 2 basket trial is an open label, multi-center study, evaluating DPX-Survivac across five cohorts of patients with bladder cancer, liver cancer (hepatocellular carcinoma), ovarian cancer, non-small cell lung cancer (NSCLC) and tumors shown to be positive for the microsatellite instability high (MSI-H) biomarker.

Subjects will receive DPX-Survivac (SC: 2 x 0.25 mL every three weeks, followed by up to 11 x 0.1 mL every nine weeks), in combination with pembrolizumab (IV: 200 mg every 3 weeks cycle)

and CPA (oral: 50 mg BID on alternating weeks) across the five cohorts. The study is designed to assess primary endpoints of safety and objective response rate (ORR), with multiple secondary and exploratory measures.

The study included a safety lead-in, which included 20 patients from all five cohorts. The five cohorts are now expanded to recruit additional subjects following a Simon two stage design. Enrollment in the ovarian cancer cohort will be randomized 1:1 into two arms with and without CPA. All other cohorts will utilize a single-arm design and administer treatment with the triple combination. IMV expects to enroll 184 patients across clinical sites in the U.S. and Canada.

About DPX-Survivac

DPX-Survivac is the lead candidate in IMV’s new class of immunotherapies that programs targeted T cells in vivo. It has demonstrated the potential for industry-leading targeted, persistent, and durable T cell activation. IMV believes this mechanism of action (MOA) is key to generating durable solid tumor regressions. DPX-Survivac consists of survivin-based peptides formulated in IMV’s proprietary DPX drug delivery platform. DPX-Survivac is designed to work by eliciting a cytotoxic T cell immune response against cancer cells presenting survivin peptides on their surface.

Survivin, recognized by the National Cancer Institute (NCI) as a promising tumor-associated antigen, is broadly over-expressed in most cancer types, and plays an essential role in antagonizing cell death, supporting tumor-associated angiogenesis, and promoting resistance to chemotherapies. IMV has identified over 20 cancer indications in which survivin can be targeted by DPX-Survivac.

DPX-Survivac has received Fast Track designation from the U.S. Food and Drug Administration (FDA) as maintenance therapy in advanced ovarian cancer, as well as orphan drug designation status from the U.S. FDA and the European Medicines Agency (EMA) in the ovarian cancer indication.