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OncBioMune to Commence Phase 2 Trial of ProscaVax for Early Stage Prostate Cancer Patients

On June 20, 2018 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary immunotherapy cancer vaccine technology and targeted cancer therapies, reported to inform shareholders that all requisite approvals have been granted to commence a Phase 2 clinical trial of ProscaVax for early-stage prostate cancer to be hosted at Beth Israel Deaconess Medical Center a teaching hospital of Harvard University Medical School in Boston, MA (Press release, Oncbiomune, JUN 20, 2018, View Source [SID1234527408]).

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ProscaVax is OncBioMune’s lead immunotherapy platform candidate consisting of a combination of prostate cancer associated prostate specific antigen (PSA) with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF).

Per the study protocol, patients to be enrolled will be in what is termed "active surveillance," a disease management option for patients with localized prostate cancer that elect to work with their doctor to monitor the disease for progression before taking more drastic intervention measures, such as surgery or radiotherapy. To the Company’s knowledge, the trial of ProscaVax is the first ever worldwide for a prostate cancer vaccine technology addressing the active surveillance patient population.

"We are making the final preparations to initiate enrollment, including planned site visits," commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "Underscored by the compelling data derived from the successfully completed Phase 1a clinical trial and our other research, we are eager to proceed with this study. Our goal is simple: to provide a safe, nontoxic. front-line therapy for prostate cancer patients that are otherwise left with either no therapy or with much more invasive options that typically have very unpleasant side effects, such as impotence or urinary incontinence. I’d like to express my gratitude for all the shareholders that have supported us throughout the process to advance our company to this next stage of ProscaVax development. I believe there is a bright future ahead of us."

Concurrent with the Phase 2 trial of patients in active surveillance, the Company is undergoing the approval process to initiate a Phase 2 trial of ProscaVax in hormone-naïve recurrent prostate cancer patients with increasing PSA at theUrology Clinics of North Texas. More updates on the status of this study are expected soon.

About Prostate Cancer

According to the American Cancer Society (ACS), prostate cancer is the most common type of cancer in men other than skin cancer, with about 1 in 9 men diagnosed during their lifetime. ACS estimates that about 164,690 new cases of prostate cancer will be diagnosed during 2018 and approximately 29,430 men will die from the disease this year. Prostate cancer is the second leading cause of cancer death in men, trailing only lung cancer. Approximately 2.9 million men are living with prostate cancer today. The average age of diagnosis is 66, with the disease considered rare in men under the age of 40.

NewLink Genetics Announces Updated Data for Indoximod Plus Radio-Immunotherapy in DIPG to be Presented at ISPNO 2018 Meeting

On June 20, 2018 NewLink Genetics Corporation (NASDAQ:NLNK) reported that updated data for patients with diffuse intrinsic pontine glioma (DIPG) from NLG2105, a Phase 1 study evaluating indoximod in combination with radiation and chemotherapy for the treatment of pediatric patients with progressive brain tumors, will be presented at the International Symposium on Pediatric Neuro-Oncology (ISPNO) in Denver, Colorado (Press release, NewLink Genetics, JUN 20, 2018, View Source [SID1234527407]). The presentation session and time are noted below.

Poster Session 1: IMMU-25 – Radio-immunotherapy using the IDO pathway inhibitor indoximod for children with newly-diagnosed DIPG, to be presented by Theodore S. Johnson, M.D., Ph.D., Georgia Cancer Center, Augusta University, Sunday, July 1, 5:00PM – 6:30PM MT, Hyatt Regency Denver

About Indoximod
Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology target involved in regulating the tumor microenvironment and immune escape. Indoximod is being evaluated in combination with treatment regimens including chemotherapy, radiation, checkpoint blockade and cancer vaccines across multiple indications such as AML, DIPG and melanoma.

Moleculin Receives Approval for Leukemia Clinical Trial

On June 20, 2018 Moleculin Biotech, Inc., (Nasdaq:MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported it has received Polish National Office approval to begin its second Phase I/II clinical trial to study Annamycin for the treatment of relapsed or refractory acute myeloid leukemia ("AML") (Press release, Moleculin, JUN 20, 2018, View Source [SID1234527406]).

"This approval is a significant step forward to be able to treat additional patients with AML and to generate positive clinical data regarding Annamycin," commented Walter Klemp, Chairman and CEO of Moleculin. "Consent from the Polish National Office was the final step required to allow us to begin recruiting patients for this important trial. Enrollment will begin immediately and we expect patients to commence receiving treatment, at the appropriate dose, in this clinical trial during the second half of this year."

Corporate Presentation current as of June 20, 2018

On June 20, 2018 Karyopharm Therapeutics Inc presented the corporate presentation (Presentation, Karyopharm, JUN 20, 2018, View Source [SID1234527405]).

TG Therapeutics and Novimmune SA Announce Global Agreement for Development and Commercialization of a Novel Anti-CD47/ Anti-CD19 Bispecific Antibody

On June 20, 2018 TG Therapeutics, Inc. (NASDAQ:TGTX) and Novimmune SA, reported that the companies have entered into an exclusive global agreement to collaborate on the development and commercialization of Novimmune’s novel first-in-class anti-CD47/anti-CD19 bispecific antibody known as TG-1801 (previously NI-1701) (Press release, TG Therapeutics, JUN 20, 2018, View Source [SID1234527404]). The companies will jointly develop the product on a worldwide basis, focusing on indications in the area of hematologic B-cell malignancies.

TG Therapeutics will make up-front and milestones payments based on early clinical development, and will be responsible for the costs of clinical development of the products through the end of Phase II, after which TG Therapeutics and Novimmune will be jointly responsible for all development and commercialization costs of the product. TG Therapeutics and Novimmune will each maintain an exclusive option, exercisable at specific times during development, for TG Therapeutics to license the rights to TG-1801, in which case Novimmune will be eligible to receive additional payments contingent on certain clinical, regulatory and commercial milestones, totaling approximately $185MM as well as tiered royalties on net sales.

TG-1801, a fully-human IgG1, designed to target and deplete B-cells via multiple mechanisms, is based on Novimmune’s kappa-lambda -body format which allows preservation of all favorable properties of a conventional monoclonal antibody while adding bispecific functionalities. One mechanism unique to this bispecific antibody involves blocking of CD47 referred to as the "do not eat me" signal for the body’s phagocytic cells specifically directed to CD19 positive cells. The net effect is highly targeted, potent anti-B-cell tumor phagocytic activity, while avoiding the general toxicity concerns associated with earlier agents targeting the CD47 pathway. Moreover, the co-targeting of CD19 is not only expected to enhance safety but by retaining its IgG1 Fc functionality, this agent is designed to provide a secondary mechanism of anti-tumor activity through the induction of antibody dependent cellular cytotoxicity (ADCC).

TG-1801 is expected to be the first anti-CD47 bispecific antibody worldwide that will go into clinical trials, which are expected to commence later this year or early in 2019.

"We are delighted to see our first bispecific antibody move forward into the clinic with an experienced partner in the field of hematological malignancies, and to provide proof of principle for our completely novel approach," said Chairman and Chief Executive Eduard Holdener. "We are excited about the potential benefit that this new approach could bring to B-cell lymphoma patients."

"We are excited to enter into this collaboration with Novimmune, a leader in antibody engineering, and whose innovations in the field of CD47 bispecific antibodies have generated a potentially more effective and safer approach for targeting of CD47, which was recently validated in the clinical studies as a very promising pathway for tumor targeting, especially in combination with anti-CD20 monoclonal antibodies," stated Michael S. Weiss, Executive Chairman and CEO of TG Therapeutics. Mr. Weiss continued, "TG Therapeutics is focused on building the most comprehensive and effective portfolio for the treatment of hematologic malignancies and autoimmune diseases. TG-1801 has demonstrated encouraging pre-clinical anti-tumor activity both as a single agent and in combination with anti-CD20 monoclonal antibodies. With the addition of TG-1801 to our pipeline, we now have three targeted immunotherapies in-house that can potentially be used together to create a novel non-chemo treatment option that uses the body’s immune system to fight B-cell cancers, including NHL and CLL."