On January 9, 2020 BD (Becton, Dickinson and Company) (NYSE:BDX) reported that it will conduct a live webcast of its first fiscal quarter 2020 earnings conference call on Thursday, February 6, 2020, at 8:00 a.m. (ET) (Press release, BD Pharmaceutical Systems, JAN 9, 2020, View Source [SID1234552945]). BD will issue a press release detailing the quarter’s earnings earlier that morning.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The webcast of the conference call, along with related slides, will be accessible through BD’s website at www.bd.com/investors and will be available for replay through Thursday, February 13, 2020.

On January 9, 2020 Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, reported that it will present at the 38th Annual J.P. Morgan Healthcare Conference (Press release, Novavax, JAN 9, 2020, View Source [SID1234552984]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Presentation details are as follows:

Date and Time: Thursday, January 16, 11:00 – 11:25 a.m. P.T.
Location: California West, Westin St. Francis Hotel, San Francisco
Live webcast: www.novavax.com, "Investors"/"Events"

A replay of the presentation will also be accessible under the "Investors/Events" section www.novavax.com.

On January 9, 2020 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported a regulatory update regarding its TELLOMAK Phase II trial, evaluating the efficacy and safety of lacutamab (IPH4102) in patients with advanced T-cell lymphomas (Press release, Innate Pharma, JAN 9, 2020, View Source [SID1234552893]). The Company has been in ongoing discussions with regulatory authorities regarding Good Manufacturing Practice (GMP) deficiencies at the Company’s manufacturing subcontractor site that manages the fill and finish operations of the lacutamab clinical vials. Based on these discussions, on December 13, 2019, the Company decided to suspend enrollment of new patients in the TELLOMAK trial, except in Italy where the clinical trial has been suspended.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company has received the following new regulatory feedback:

The US Food and Drug Administration (FDA) has placed the TELLOMAK trial on partial clinical hold. Currently enrolled patients can continue treatment in the trial due to the high degree of unmet medical need, once patients are re-consented. However, no new patients can enroll in the trial until a new GMP-certified batch is available.
UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has agreed for the trial to continue as planned with current available supply.
To note, the Company is awaiting final feedback from the National Agency for the Safety of Medicines and Health Products in France (ANSM).

The FDA did not cite any safety issues related to the trial medication. This is consistent with the review conducted by the Independent Data Monitoring Committee (IDMC), which concluded there were no new, unexpected safety issues related to lacutamab, and the product appeared to be well-tolerated among current patients enrolled in the trial. In addition, the IDMC determined it would be acceptable to continue recruiting additional patients in the TELLOMAK trial, if agreed by regulatory agencies.

The Company is working to transfer the lacutamab fill and finish manufacturing to another contract manufacturing organization (CMO). At this stage, it anticipates that a new clinical GMP-certified batch should be available in the second half of 2020.

At this point in time, the Company maintains its partial clinical hold guidance globally as it obtains more information from additional regulatory authorities. The Company will provide a further update in due course.

About the GMP Deficiency:
This situation is related to GMP deficiencies put forward by the Company’s manufacturing subcontractor, Rentschler Fill Solutions GmbH or "RFS" (now known as Impletio Wirkstoffabfüllung GmbH). RFS was granted a Good Manufacturing Practice (GMP) certificate by the Austrian regulatory agency in August 2018, which was further confirmed in October 2019 after two on-site inspections. In November, RFS unilaterally withdrew the Certificate of Conformity of batches they have produced, including the lacutamab batch currently used in the TELLOMAK trial. RFS also filed for bankruptcy.

The Company’s utmost priority is to ensure patient safety. An extensive internal and third-party analysis concluded that there was no evidence that the integrity of the product was questioned.

On January 9, 2020 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported the agreement by several accredited investors to exercise certain warrants to purchase up to an aggregate of 22,278,540 ordinary shares represented by 742,618 American Depositary Shares (ADSs) having exercise prices ranging from $12.90 to $78.75 per ADS issued by Can-Fite in September 2015, October 2015, March 2018, January 2019 and April 2019, at a reduced exercise price of $3.25 per ADSs (Press release, Can-Fite BioPharma, JAN 9, 2020, View Source [SID1234552919]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The ADSs and the ordinary shares issuable upon exercise of the warrants issued in March 2018, January 2019 and April 2019 are registered pursuant to a registration statement on Form F-1 (File No. 333-231209) which became effective by the Securities and Exchange Commission (SEC) on October 18, 2019 and the ADSs and the ordinary shares issuable upon exercise of the warrants issued in September 2015 and October 2015 are registered pursuant to a registration statement on Form F-3 (File No. 333-209037) which became effective on January 29, 2016. The gross proceeds to Can-Fite from the exercise of the warrants are expected to be approximately $2.4 million, prior to deducting placement agent fees and estimated offering expenses.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

In consideration for the immediate exercise of the warrants for cash, the exercising holders will receive new unregistered warrants to purchase ordinary shares represented by ADS in a private placement pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the "1933 Act"). The warrants will be exercisable into an aggregate of up to 22,278,540 ordinary shares represented by 742,618 ADS, at an exercise price of $3.45 per ADS and have a term of exercise equal to five and one-half years.

Can-Fite intends to use the net proceeds from the offering for working capital including for the progression of its Phase III psoriasis and the rheumatoid arthritis studies and the preparatory work for the Phase III liver cancer study as well as other general corporate purposes.

The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the 1933 Act and, along with the ADSs or the ordinary shares issuable upon their exercise, have not been registered under the 1933 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. The securities were offered only to accredited investors. The Company has agreed to file a registration statement with the SEC covering the resale of the ADSs and ordinary shares of issuable upon exercise of the new warrants.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

Samyang Biopharmaceuticals Corporation is developing a metabolism-modulating anticancer drug through open innovation (Press release, Samyang Biopharmaceuticals, JAN 9, 2020, View Source [SID1234570884]). A metabolism-modulating anticancer drug refers to a treatment which works on cancer cells’ energy metabolism to prevent cancer growth or induce apoptosis.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Samyang Biopharmaceuticals Corporation recently announced that the company had a signing ceremony of a technology transfer contract for a metabolism-modulating anticancer drug candidate with the innovative drug discovery biotech startup LMITO Therapeutics on January 9 in Samyang Discovery Center, Pangyo, Seongnam.

This contract allows Samyang Biopharmaceuticals Corporation to have the exclusive right to introduce the drug candidate LMT503 and its technology from LMITO Therapeutics, develop, conduct a clinical trial for, manufacture, and commercialize them. With the goal of filing an investigational new drug (IND) application in 2022 to enter the clinical phase, Samyang Biopharmaceuticals Corporation is seeking to develop a metabolism-modulating anticancer drug based on this candidate and technology.

In addition to down payment, Samyang Biopharmaceuticals Corporation pays LMITO Therapeutics for the success of each stage (milestone) including clinical trial, marketing authorization, and sales and a certain portion of revenue as operating royalties after it begins to be sold in the market. Both companies, however, agreed to not disclose the exact payment conditions including down payment.

LMT503 is a low-molecular weight compound expected to treat cancer by regulating cancer cells’ energy metabolism while activating immune cells. In particular, the cancer cell energy metabolism regulation mechanism in LMT503 was suggested for the Nobel Prize in Physiology or Medicine in 2019 as a new cancer treatment method, so many studies are being conducted in Korea and around the world.

President Tae-ung Eom of Samyang Biopharmaceuticals Corporation explained the significance of this contract, "With the aim of developing a first-in-class drug (drug with a new mechanism of action), Samyang Group is employing a two-track strategy where Samyang Biopharmaceuticals Corporation is focusing on new chemical entities and Samyang Biopharm USA is focusing on biopharmaceuticals. To increase development speed and success likelihood, we are using open innovation by actively cooperating with other companies."

CEO Whee-sung Lee of LMITO Therapeutics said, "Thanks to technology transfer to Samyang Biopharmaceuticals Corporation, LMITO Therapeutics is able to increase the development speed for a metabolism-modulating anticancer drug in our pipeline. We will be actively supporting Samyang Biopharmaceuticals Corporation so that they can successfully develop an innovative anticancer drug."

Meanwhile, Samyang Biopharm USA, a subsidiary of Samyang Biopharmaceuticals Corporation, recently cooperated with global companies, signed contracts one after another to introduce an antibody drug candidate and conduct joint research, and is speeding up biopharmaceutical drug development.