On January 21, 2019 AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, reported the company will be presenting at two upcoming healthcare conferences. AIVITA’s Chief Medical Officer Dr. Robert O. Dillman will be presenting at Precision Medicine World Conference on Tuesday, Jan. 22, in Santa Clara, California. AIVITA Chairman and Chief Executive Officer Dr. Hans S. Keirstead will speak at Phacilitate Leaders World on Wednesday, Jan. 23, in Miami, Florida.

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Precision Medicine World Conference in Silicon Valley is a healthcare conference for that provides attendees with an opportunity to learn about the latest developments and advancements in precision medicine. Dr. Dillman will be presenting details on AIVITA’s autologous cancer vaccine technology on Tuesday, Jan. 22, at 2:45 p.m. in a talk titled Patient-Specific Cancer Vaccines. He will share past and current clinical data in a presentation focused on antigens from autologous tumor initiating cells.

Co-located with the World Stem Cell Summit, Phacilitate Leaders World is an advanced therapies partnering event that provides attendees with a platform to build new partnerships and discuss cutting-edge therapies. On Wednesday, Jan. 23, at 2:35 p.m. Dr. Keirstead will deliver a talk titled Targeting the Cancer Stem Cell: Clinical Data and Mechanism of Action.

About ROOT OF CANCER

AIVITA’s treatment is a platform technology applicable to most solid tumor types and consists of autologous dendritic cells loaded with autologous tumor antigens from autologous self-renewing tumor-initiating cells.

AIVITA’s ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who will be randomized in a 2:1 ratio to receive either the autologous dendritic cell vaccine or autologous monocytes as a comparator.

Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), and (5) who have completed primary therapy.

For additional information about AIVITA’s AVOVA-1 trial patients can visit: www.clinicaltrials.gov/ct2/show/NCT02033616

AIVITA’s glioblastoma Phase 2 single-arm study is active and will enroll approximately 55 patients to receive the treatment candidate.

Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a Karnofsky Performance Status of > 70 and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC).

On January 21, 2019 Eli Lilly and Company (NYSE: LLY) reported that it will announce its fourth-quarter and full-year 2018 financial results on Wednesday, February 13, 2019 (Press release, Eli Lilly, JAN 21, 2019, View Source [SID1234532800]). Lilly will also conduct a conference call on that day with the investment community and media to further detail the company’s financial performance.

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The conference call will begin at 9 a.m. Eastern time. Investors, media and the general public can access a live webcast of the conference call through a link that will be posted on Lilly’s website at View Source A replay will also be available on the website following the conference call.

On January 21, 2019 Biocure Technology Corp. ("CURE" or the "Company") (CSE:CURE; OTCQB: BICTF) BiocurePharm, Korea ("BPK"), a wholly owned subsidiary of Biocure Technology Inc. ("CURE") reported that it has arranged a non- brokered private placement through its Korean Subsidiary BiocurePharm, Korea ("BPK"), BPK will be issuing up to 100,000 shares at 11,40 CAD per share for gross proceeds of $1.14 Million or more, depending on investor interest (Press release, Biocure Technology, JAN 21, 2019, View Source [SID1234628758]). Finder’s fees or commissions may be payable by the Company in connection with this Private Placement.

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The net proceeds from the non-brokered private placement are intended to be used for general working capital and research and development.

On January 21, 2019 RadioMedix Inc. is reported that the company has been awarded a two-year, $2.0 M Phase II SBIR contract award by the NIH NCI (HHSN261201800048C; UPIID:75N91018C00048) for the clinical development of Targeted Alpha-emitter Therapy (TAT) of neuroendocrine tumors (Press release, RadioMedix, JAN 21, 2019, View Source [SID1234532801]). This Phase II Contract award is a continuation of the successfully completed Phase I SBIR contract (HHSN261201600015C). This award will support the Phase I, non-randomized, open-label, dose escalation study to determine the safety, bio-distribution, and preliminary effectiveness of 212Pb-octreotate analog (AlphaMedix) in adult subjects with Somatostatin Receptor (SSTR) expressing neuroendocrine tumors (NCT03466216). Dr. Izabela Tworowska (RadioMedix) serves as a Principal Investigator of the SBIR Phase II contract and is working together with Dr. Julien Torgue (co-I, Orano Med). The clinical studies are currently on-going at the Excel Diagnostics and Nuclear Oncology Center (Houston, TX).

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"Patients with advanced Neuroendocrine Tumors (NETs) have limited treatment options available to them. Our goal is to address this unmet clinical need by using targeted alpha-emitter therapy", said Izabela Tworowska, PhD, CSO of RadioMedix. "We are grateful to NCI for acknowledging the importance of alpha-emitter therapy and supporting our clinical studies of 212Pb-octreotate analog. This SBIR Phase II Contract is the second award highlighting RadioMedix – Orano Med collaboration."

"TAT is believed to be the next generation of radiopharmaceuticals in the field of Radioligand Therapy (RLT) in oncology. Our proprietary 212Pb labeled agent has potential to advance the effectiveness of Peptide Receptor Radionuclide therapy (PRRT) as compared to currently approved PRRT agents for neuroendocrine cancers", said Dr. Ebrahim S. Delpassand, CEO of RadioMedix. "Unique properties of 212Pb can induce targeted and irreversible damage to the cancer cells, which can result in significant clinical benefits to NET patients", added Dr. Delpassand.

This project has been funded in part with Federal funds from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN261201800048C.

On January 20, 2019 Samsung Bioepis Co., Ltd. reported that the U.S. Food and Drug Administration (FDA) has approved ONTRUZANT (trastuzumab-dttb), a biosimilar referencing HERCEPTIN 1 (trastuzumab), across all eligible indications, namely adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophageal junction adenocarcinoma in patients who have not received prior treatment for metastatic disease (Press release, Samsung Bioepis, JAN 20, 2019, View Source [SID1234532794]). Please see Boxed Warnings and Important Safety Information for ONTRUZANT below.

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ONTRUZANT is Samsung Bioepis’ first oncology biosimilar to receive FDA approval, and will be marketed and distributed in the United States (US) by Merck, which is known as MSD outside of the US and Canada.

"For many cancer patients in the US, battling cancer has not only been a health issue, but a considerable financial burden brought on by cancer treatment. Biosimilars are intended to be lower cost, high-quality treatment options that have the potential to alleviate such burden. We sincerely hope our trastuzumab biosimilar will do exactly that," said Sang-Jin Pak, Senior Vice President and Head of Commercial Division, Samsung Bioepis. "At Samsung Bioepis, we will continue to demonstrate our enduring commitment to biosimilars by further strengthening our pipeline and widening the availability of approved treatments for cancer patients across the US."

ONTRUZANT was also approved by the European Commission (EC) in November 2017, and has since been launched in a growing number of European countries.

About ONTRUZANT (trastuzumab-dttb)
ONTRUZANT is indicated for adjuvant treatment of HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature*) breast cancer:

As part of a treatment regimen containing doxorubicin, cyclophosphamide and either paclitaxel or docetaxel
With docetaxel and carboplatin
As a single agent following multi-modality anthracycline-based therapy
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.
* High-risk is defined as ER/PR positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3.
ONTRUZANT is indicated:

In combination with paclitaxel for the first line treatment of HER2-overexpressing metastatic breast cancer
As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.
ONTRUZANT is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease.
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product

Select Important Safety Information

Cardiomyopathy

ONTRUZANT administration can result in sub-clinical and clinical cardiac failure manifesting as congestive heart failure and decreased left ventricular ejection fraction with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue ONTRUZANT for cardiomyopathy.
Infusion Reactions; Pulmonary Toxicity

Administration can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration. Discontinue ONTRUZANT for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.
Embryo-Fetal Toxicity

Exposure to ONTRUZANT during pregnancy can result in oligohydramnios in some cases complicated by pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception
Exacerbation of Chemotherapy-Induced Neutropenia

In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3-4 neutropenia and of febrile neutropenia were higher in patients receiving trastuzumab products in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar among patients who received trastuzumab and those who did not
Most Common Adverse Reactions

The most common adverse reactions for trastuzumab products in breast cancer were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia
The most common adverse reactions for trastuzumab products in metastatic gastric cancer were neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia
These are not all of the risks associated with ONTRUZANT. For additional information on ONTRUZANT indications, as well as Important Safety Information related to its use, including Boxed WARNINGS, please see the ONTRUZANT Prescribing Information HERE