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 Nektar Therapeutics (Nasdaq: NKTR) reported that new data from a cohort of patients with metastatic triple-negative breast cancer who were enrolled in the PIVOT-02 study will be presented at the upcoming 5th CRI-CIMT-EATI-AACR Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper), which is being held from September 25 to September 28, 2019, at the Espace Grand Arche de la Defense in Paris, France (Press release, Nektar Therapeutics, SEP 23, 2019, View Source [SID1234539720]). The PIVOT-02 study is evaluating bempegaldesleukin (bempeg, NKTR-214) in combination with nivolumab in a range of advanced and/or metastatic solid tumor settings.

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Poster Presentation:

Abstract #A001: "Clinical activity of BEMPEG plus NIVO observed in metastatic TNBC: preliminary results from the TNBC cohort of the Ph1/2 PIVOT-02 study", Tolaney, S., et al.

Session Date and Time: Thursday, September 26th from 1:00 p.m. – 3:00 p.m. and 6:30 p.m. – 8:00 p.m. Central European Time

Company to Host Webcast Conference Call at CRI-CIMT-EATI-AACR:
The company will host a webcast conference call with Dr. Sara M. Tolaney, MPH, Associate Director of the Susan F. Smith Center for Women’s Cancers and Assistant Professor of Medicine at Harvard Medical School and company management on Thursday, September 26th at 8:30 a.m. Eastern time during the CRI-CIMT-EATI-AACR conference following presentation of data. The webcast conference call will be accessible from the Investor Events page of Nektar’s website at View Source

On September 23, 2019 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium") reported that a poster highlighting Iomab-B, its pivotal Phase 3 targeted conditioning candidate, was awarded Honorable Distinction at the 2019 SOHO (Society of Hematologic Oncology) Annual Meeting (Press release, Actinium Pharmaceuticals, SEP 23, 2019, View Source [SID1234539688]). SOHO is the only international society specific to the field of hematologic oncology and has grown to over 3,000 members. This year’s SOHO annual meeting was attended by nearly 1,400 physicians, nurses and healthcare professionals and nearly four hundred abstracts and posters were presented including over 70 focused on AML or acute myeloid leukemia.

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Benjamin Tomlinson, M.D., Assistant Professor, Adult Hematologic and Stem Cell Transplant Section, Seidman Cancer Center, University Hospitals Case Medical Center (Cleveland, OH) and lead author of the poster, said, "It is an honor for our work to be recognized by SOHO’s scientific committee from the significant number of posters and abstracts that were submitted. The AML therapeutic landscape has evolved rapidly in recent years with eight therapies gaining approval since 2017 including targeted agents like Bcl-2, FLT3 and IDH inhibitors. While these therapies are important advancements for patients with AML, they are not curative, and bone marrow transplant remains the only curative treatment option for patients with active relapsed or refractory AML. Iomab-B is highly differentiated as a targeted agent with a strong anti-leukemic effect as we have demonstrated in this poster selected by SOHO and targeted conditioning ability that led to all patients receiving Iomab-B achieving successful bone marrow transplant and engraftment. These findings are highly encouraging as I am not aware of any other agents that offer such a high probability of bone marrow transplant for this patient population. I look forward to continuing to participate in the SIERRA study and am excited for additional data in the future."

Mark Berger, M.D., Actinium’s Chief Medical Officer, said, "This Honorable Distinction award from SOHO adds to the growing recognition for Iomab-B’s value proposition as the only late-stage targeted conditioning agent for the older relapsed or refractory AML patient population. Since achieving twenty-five percent enrollment and making important changes to the trial protocol, including adding targeted therapies like venetoclax as options in the control arm and reducing the time to crossover evaluation to fourteen days, we have seen a dramatic increase in physician interest and enthusiasm for the SIERRA trial. This groundswell of interest continued to build after preliminary data from the first twenty-five percent of patients was presented in an oral presentation at the ASH (Free ASH Whitepaper) annual meeting in 2018 and a late-breaking oral presentation at the TCT annual meeting in February 2019. These data demonstrated Iomab-B’s ability to enable transplant universally, with deep donor chimerism and no non-relapse mortality at one hundred days post-transplant in the Iomab-B arm. Additionally, Iomab-B’s ability as a single agent to rapidly deplete all circulating leukemic blasts prior to transplant has drawn strong recognition from the medical community, as evidenced by this award from SOHO. These data gained widespread visibility throughout the transplant and hematology communities and as a result, we have seen new sites come into the SIERRA trial bringing us to twenty sites in total at present. There has also been significant physician engagement, which drove us powerfully past fifty-percent enrollment. With the important fifty percent enrollment milestone achieved, we look forward to completing the SIERRA study and further demonstrating Iomab-B’s value proposition at future medical meetings."

The poster presented at SOHO highlighted Iomab-B’s ability as a single agent activity to rapidly deplete peripheral blasts leading to lower circulating leukemia tumor burden prior to BMT, which is critical for successful engraftment. It was observed that a single therapeutic infusion of Iomab-B resulted in a median reduction of peripheral blasts of 98% by day 3 and 100% reduction by day 8 following administration and prior to any other pre-BMT conditioning in the sixteen patients who were evaluated. Rapid reduction of peripheral blasts has been observed as an independent prognostic marker that is predictive of both CR or Complete Response and RFS or Relapse-Free Survival in patients with AML after receiving cytotoxic chemotherapy. Gianfaldoni et al1 performed an analysis of 30 newly diagnosed AML patients who were treated with cytotoxic induction chemotherapy and found that a rapid reduction of peripheral leukemia blasts correlated with responses and all patients that achieved CR had a rapid reduction of their peripheral blasts. Elliot et al2, performed a retrospective analysis of 86 adult patients with AML and identified time to clearance of circulating leukemia blasts as an independent prognostic marker of RFS that superseded all other known risk factors including karyotype and number of cycles of induction therapy needed to achieve CR. As previously presented, all patients receiving Iomab-B in the SIERRA trial, including cross over patients, received a BMT and achieved engraftment without delay.

The poster selected by SOHO for honorable distinction can be viewed on Actinium’s website (here) or the SOHO Annual Meeting website (here).

About the Society of Hematologic Oncology
The Society of Hematologic Oncology (SOHO) is an international society designed specifically for clinicians, research scientists and related healthcare professionals who specialize in the research and treatment of patients with hematologic malignancies. SOHO’s mission is to promote worldwide research and education through the exchange of scientific information. Organized by its founders and world class committees, SOHO is the only international society specific to this field. The 2019 SOHO Annual Meeting took place September 11-14 in Houston, Texas, with attendance from nearly 1,400 hematologic oncology professionals from across the globe. Nearly 400 abstracts were accepted for oral or poster presentation at the Annual Meeting. Published abstracts are available through the official journal of the Society, ‘Clinical Lymphoma, Myeloma and Leukemia,’ published by Elsevier. Online access is open to the public at View Source(19)X0009-9 through December 31, 2019. For more information about the Society or to sign-up for FREE membership, go to the official website at View Source

About Iomab-B
Iomab-B is an ARC or Antibody Radiation-Conjugate comprised of the anti-CD45 antibody apamistamab and the radioisotope iodine-131 that is intended to be a targeted conditioning agent prior to a BMT or bone marrow transplant. Iomab-B was developed at the Fred Hutchinson Cancer Research Center and has been studied in over 300 patients in multiple hematologic indications across 12 clinical trials in addition to the ongoing SIERRA study in older patients with active, relapsed or refractory AML or Acute Myeloid Leukemia prior to patients receiving an allogeneic BMT or bone marrow transplant. Iomab-B is Actinium’s lead targeting conditioning ARC in its multi-target, multi-indication targeted conditioning pipeline that includes the Iomab-B and Actimab-MDS programs for BMT and the Iomab-ACT program that will study a lower dose of Iomab-B for lymphodepletion prior to CAR-T and other cellular therapies.

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 Precision Optics Corporation, Inc. (OTCQB: PEYE) (the "Company") reported that it has scheduled a conference call to discuss fourth quarter and fiscal 2019 financial results on Thursday, September 26, 2019 at 5:00pm ET (Press release, Precision Optics, SEP 23, 2019, View Source [SID1234539721]).

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The Company intends to release its financial results and to file its 10-K after the close of the market on September 26, 2019 followed by the conference call.

Conference Call Details

Date and Time: Thursday, September 26, 2019 at 5:00pm ET

Call-in Information: Interested parties can access the conference call by dialing (877) 317-6789 or (412) 317-6789.

Live Webcast Information: Interested parties can access the conference call via a live Internet webcast, which is available at View Source

Replay: A teleconference replay of the call will be available until October 3, 2019 at (877) 344-7529 or (412) 317-0088, confirmation #10135010. A webcast replay will be available at View Source