On November 12, 2018 PharmaMar (MSE:PHM) reported a new Antibody Drug Conjugate (ADC) MI180021, the result of linking trastuzumab with the marine molecule PM160057 (Press release, PharmaMar, NOV 12, 2018, View Source [SID1234531335]). This will be presented at the World ADC Congress in San Diego, from 12-15 November 2018.

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PharmaMar’s poster has been selected as one of the top five for an oral presentation at the Congress.

This ADC has shown potent and highly selective activity in tumor cells that overexpress HER2, as found in certain breast, gastric and pancreas cancers, among others.

PM160057 belongs to a new family of molecules of marine origin that kill tumor cells by binding to DNA. This family of new chemical structures with novel mechanisms of action offer the opportunity to develop a new generation of ADCs (also called "magic bullets").

This discovery reinforces the strategy of PharmaMar’s unit dedicated to obtaining compounds for the use of active agents in ADCs. This research has already led to the licensing of the first family of active molecules to Seattle Genetics, world leader in ADCs, for which PharmaMar received an initial payment of $5 million.

According to Carmen Cuevas, Director of R&D at PharmaMar, "MI180021 has a high selectivity against cancer cells that overexpress HER2 receptor, providing a new oportunity to treat patients with these types of cancers, such as breast, gastric and pancreatic."

About ADCs
ADCs are innovative, next-generation immunotherapeutic agents. ADCs consist of an antibody that identifies and targets antigens on the surface of certain tumor cells, a molecule with anti-tumor activity, and a connector that binds them together.

Despite more than 30 years of research to develop ADCs, there are currently only four FDA-approved conjugate antibodies (Kadcyla, Adcetris, Besponsa, and Mylotarg), two of which incorporate microtubule inhibitors (auristatins and maytansins) as active charge; and the other two, using a compound that interacts with DNA (calicheamicin).

Agents that interact with DNA are widely used in cancer treatment.

Legal warning
This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

On November 12, 2018 Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) ("Prometic") reported that it will report its financial results for the third quarter ended September 30, 2018 on Wednesday November 14, 2018 after market close (Press release, ProMetic Life Sciences, NOV 12, 2018, https://resources.prometic.com/latest-content/prometic-to-report-its-third-quarter-2018-financial-results-and-hold-conference-call-webcast [SID1234531241]).

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Prometic will host a conference call at 11:00am (ET) on Thursday November 15, 2018. The telephone numbers to access the conference call are 1-888-231-8191 and 647-427-7450. An audio replay of the call will be available as of Thursday November 15, 2018 at 2:00pm (ET). The numbers to access the audio replay are 416-849-0833 and 1-855-859-2056 using the following password (1190238).

On November 12, 2018 Coherus BioSciences, Inc. (Nasdaq: CHRS), reported that senior management will be presenting at the 27th Annual Credit Suisse Healthcare Conference being held in Scottsdale, Arizona on Thursday, November 15 at 9:45 am MST (Press release, Coherus Biosciences, NOV 12, 2018, View Source [SID1234531698]).

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The audio portion of the presentation will be available on the investors page of the Coherus BioSciences website at View Source

On November 12, 2018 Ziopharm Oncology, Inc. (Nasdaq: ZIOP), reported that it has entered into definitive securities purchase agreements for the sale of its common stock and warrants to purchase common stock in a private placement that is expected to result in gross proceeds to the Company of approximately $50 million, before deducting placement agent and other offering expenses (Press release, Ziopharm, NOV 12, 2018, View Source [SID1234531224]). The private placement is being led by existing stockholder, MSD Partners, L.P. Other participants include Miller Value Partners, White Rock Capital Management and Level One Partners, LLC.

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Pursuant to the terms of the securities purchase agreement, at the closing of the private placement, Ziopharm will issue and sell 18,939,394 shares of common stock and warrants to purchase up to 18,939,394 additional shares of common stock at a per unit purchase price of $2.64. The warrants will become exercisable on the date that is six months following the date of issuance, have a per share exercise price of $3.01 and will expire five years from the date of issuance. The private placement is expected to close on or about November 13, 2018, subject to the satisfaction of customary closing conditions. Additional details regarding the private placement will be included in a Form 8-K filed by Ziopharm with the Securities and Exchange Commission (the "SEC").

Neither the shares of Ziopharm common stock nor the warrants to be issued in the private placement have been registered under the Securities Act of 1933, as amended (the "Securities Act"). Accordingly, these securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. Ziopharm has agreed to file a registration statement with the SEC to register the resale of Ziopharm common stock to be issued in the private placement as well as the Ziopharm common stock issuable upon exercise of the warrants.

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

On November 12, 2018 Cellectar Biosciences, Inc. (Nasdaq: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has granted an exemption to the Import Alert placed on the Centre for Probe Development and Commercialization (CPDC), the sole supplier of the CLR 131 (Press release, Cellectar Biosciences, NOV 12, 2018, View Source [SID1234531227]). The exemption for CLR 131 is effective immediately for all hematology studies and, in response, Cellectar is preparing to dose patients in the second fractionated dose cohort of the Phase 1 relapsed refractory (R/R) multiple myeloma study and the Phase 2 study for R/R hematologic malignancies. The company awaits authorization from the FDA for any future shipments in connection with its Phase 1 study of pediatric patients with neuroblastoma, sarcomas, lymphomas (including Hodgkin’s lymphoma) and malignant brain tumors.

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"We thank the FDA for their diligence and for providing this exemption for CLR 131 hematology studies. Our ability to advance our clinical trials and achieve stated business objectives remains our top priority," said James Caruso, president and CEO of Cellectar Biosciences. "I also want to recognize our team for their outstanding execution in support of a rapid resolution."

In its efforts to obtain an exemption for CLR 131 from the Import Alert in hematology and pediatrics, Cellectar has collaborated with the various divisions within the FDA that oversee the company’s investigational new drug applications evaluating CLR 131 in multiple indications. Cellectar executed a series of actions requested by the FDA to obtain an exemption to the Import Alert for its hematology programs. Similarly, the company continues to work with the appropriate division of the FDA to secure an exemption for the pediatric program.

As background, on August 10, 2018, Cellectar announced that CPDC was informed of an FDA Import Alert that prohibited CPDC from supplying CLR 131. While the Import Alert disrupted CLR 131 supply, the basis of the Import Alert was not related to CLR 131 specifically, or to CPDC’s production facility associated with CLR 131. The company actively supported CPDC’s efforts to have the Import Alert lifted as quickly as possible. The FDA subsequently initiated direct talks with Cellectar concerning a possible exemption for CLR 131 from the Import Alert. Those discussions and subsequent actions resulted in the exemption Cellectar is announcing today.

About CLR 131

CLR 131 is Cellectar’s investigational radioiodinated PDC therapy that exploits the tumor-targeting properties of the company’s proprietary phospholipid ether (PLE) and PLE analogs to selectively deliver radiation to malignant tumor cells, thus minimizing radiation exposure to normal tissues. CLR 131 is in a Phase 2 clinical study in relapsed/refractory multiple myeloma (R/R MM) and a range of B-cell malignancies, and a Phase 1b clinical study in patients with R/R MM exploring fractionated dosing. The objective of the multicenter, open-label, Phase 1b dose-escalation study is the characterization of safety and tolerability of CLR 131 in patients with R/R MM. Patients in Cohorts 1-4 received single doses of CLR 131 ranging from 12.5 mCi/m2 to 31.25 mCi/m2 as well as a fractionated dose of 15.625 mCi/m2 given twice over seven days in Cohort 5. All study doses and regimens have been deemed safe and well tolerated by an independent Data Monitoring Committee. The company plans to initiate a Phase 1 study with CLR 131 in pediatric solid tumors and lymphoma as well as a second Phase 1 study in combination with external beam radiation for head and neck cancer.