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

On January 16, 2019 Precision BioSciences ("Precision" or the "Company"), a genome editing company dedicated to improving life (DTIL) through its proprietary ARCUS genome editing platform, reported that it has entered into an agreement for the issuance and sale of convertible promissory notes in a private placement transaction in the aggregate principal amount of approximately $40 million, which will bring the Company’s total capital generated in the last year to over $150 million and total funding since inception to over $300 million (Press release, Precision Biosciences, JAN 16, 2019, View Source [SID1234534181]). Contributors to this financing were largely first-time investors in the Company.

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Investors in Precision now include ArrowMark Partners, Franklin Templeton, Cowen Healthcare Investments, venBio, F-Prime, RA Capital Management, Brace Pharma Capital, Pontifax AgTech, OCV Partners, DSAM, Adage Capital Management, Cormorant Asset Management, Gilead Sciences, Laurion Capital Management, Vivo Capital, Lilly Asia Ventures, Alexandria Venture Investments, Ridgeback Capital, Ditch Plains Capital Management, Agent Capital, entities affiliated with Leerink Partners, Amgen Ventures, Osage University Partners, DUMAC and the Longevity Fund.

On January 19, 2019 On January 19, 2019, Shanghai Cellular Biopharmaceutical Group Ltd. ("CBMG Shanghai"), a controlled entity of Cellular Biomedicine Group, Inc. (the "Company"), reported that it has entered into a credit agreement (the "Credit Agreement") with China Merchants Bank, Shanghai Branch (the "Merchants Bank") (Filing, 8-K, Cellular Biomedicine Group, JAN 19, 2019, View Source [SID1234532905]). Pursuant to the Credit Agreement, the Merchants Bank agreed to extend credit of up to RMB 100 million (approximately $14.7 million) to CBMG Shanghai via revolving and/or one-time credit lines. The types of credit available under the Credit Agreement, include, but not limited to, working capital loans, trade financing, commercial draft acceptance, letters of guarantee and derivative transactions. The credit period under the Credit Agreement runs until December 30, 2019. As of the date of this Current Report on Form 8-K, no amounts had been drawn down under the Credit Agreement.

Pursuant to the Credit Agreement, CBMG Shanghai will enter into a supplemental agreement with the Merchants Bank prior to the applicable drawdown that will set forth the terms of each borrowing thereunder (except for working capital loans), including principal, interest rate, term of loan and use of borrowing proceeds. With regard to working capital loans to be provided pursuant to the Credit Agreement, CBMG Shanghai shall submit a withdrawal application that includes the principal amount needed, purposes of the loan and a proposed quarterly interest rate and term of the loan for the Merchants Bank’s review and approval. The terms approved by the bank will govern such working capital loans. The bank has the right to adjust the interest rate for working capital loans from time to time based on changes in national policy, changes in interest rate published by the People’s Bank of China, credit market conditions and the bank’s credit policies. Upon CBMG Shanghai’s non-compliance with the agreed use of loan proceeds, the interest rate for the amount of loan proceeds improperly used will be the original rate plus 100% starting on the first day of such use. If CBMG Shanghai fails to pay a working capital loan on time, an extra 50% interest will be charged on the outstanding balances starting on the first day of such default.

Under the Credit Agreement, CBMG Shanghai has the obligation to notify the Merchants Bank prior to certain corporate actions and assist the bank in taking measures to ensure repayment of the loans provided under the Credit Agreement upon occurrence of such events. Such corporation actions include: (i) major financial losses and assets losses, (ii) loans to or guarantees for third parties or mortgages on its properties, (iii) revocation or cancellation of business license or applications for bankruptcy, (iv) major operational or financial crises of its controlling shareholder or other related entities that affect its business operations, (v) related party transactions that involve 10% or more of CBMG Shanghai’s net assets and (vi) legal proceeding that have material adverse effects on its operations or financial condition. Pursuant to the Credit Agreement, CBMG Shanghai cannot enter into a merger, an acquisition or a joint venture, transfer its equity interest or consummate a reorganization or share ownership restructuring without prior written consent of the Merchants Bank. The Credit Agreement also contains a covenant requiring that CBMG Shanghai maintain or improve its existing operations and preserve or increase the value of its existing assets.

Events of default under the Credit Agreement include, among other matters, CBMG Shanghai’s failure to perform its obligations thereunder, untrue or inaccurate representations, use of loan proceeds for purposes that are inconsistent with the Credit Agreement or related agreements. Additionally, a default under any other loan agreement of CBMG Shanghai that is not cured within three months of such default shall be deemed an event of default under the Credit Agreement. Upon the occurrence of an event of default, the Merchant Bank has the right to reduce the credit available under the Credit Agreement, suspend the use of the remaining credit by CBMG Shanghai and declare all outstanding balance to become immediately due and payable.

Pursuant to a pledge agreement which became enforceable upon execution of the Credit Agreement, Cellular Biomedicine Group Ltd. (HK), a wholly owned subsidiary of the Company ("CBMG HK"), provided a guarantee of CBMG Shanghai’s obligations under the Credit Agreement. In connection with such guarantee, CBMG HK deposited $17,000,000 into its account at the Merchants Bank for a 12-month period starting January 7, 2019 and also granted the Merchants Bank a security interest in the cash deposited.

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On January 18, 2019 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported that it has entered into a definitive agreement with a single institutional investor to receive gross proceeds of approximately $2.35 million (Press release, Can-Fite BioPharma, JAN 18, 2019, View Source [SID1234532775]).

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In connection with the offering, the Company will issue 2,238,096 registered American Depository Shares (ADSs) of Can-Fite at a purchase price of $1.05 per ADS in a registered direct offering. Additionally, for each ADS purchased by investors, the investors will receive an unregistered warrant to purchase one ADS. The warrants will have an exercise price of $1.30 per ADS, will be immediately exercisable and will expire five and one-half years from the issuance date. The closing of the offering is expected to take place on or about January 23, 2019, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent in connection with this offering.

The ADSs described above (but not the warrants or the ADSs underlying the warrants) are being offered pursuant to a shelf registration statement (File No. 333-220644) which became effective on October 11, 2017. Such ADSs may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

The Company will file a prospectus supplement and the accompanying base prospectus with the SEC relating to such ADSs. When available, copies of the prospectus supplement and the accompanying base prospectus may be obtained at the SEC’s website at View Source, or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022, by telephone: (646) 975-6996 or by email at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ADSs issuable upon their exercise, have not been registered under the Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein. There shall not be any offer, solicitation of an offer to buy, or sale of securities in any state or jurisdiction in which such an offering, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction