On January 19, 2017 Immunomedics reported new data for lead drug IMMU-132 in triple-negative breast cancer (TNBC) keep it on course to file for accelerated approval in mid-2017 (Press release, FierceBiotech, JAN 19, 2017, View Source [SID1234517454]).

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Immunomedics’ chief executive, Cynthia Sullivan, told investors at an R&D day yesterday that the prospects for the program "continue to improve as more confirmed results become available for the patients enrolled into our TNBC clinical trial."

The positive assessment comes after a difficult period for the program. Last year, Immunomedics’ stock dipped after it reported preliminary data from its phase 2 trial in TNBC, and some investors have expressed concerns that manufacturing (CMC) issues could hold up the project.

Immunomedics took great pains to play down those anxieties at its R&D day, and analysts at Jefferies reckon that IMMU-132—also known as sacituzumab govitecan—"continues to look approvable in the U.S. based on phase 2 data" in TNBC, adding that there is "no apparent ‘smoking gun’ for CMC."

According to the latest data, median overall survival in patients on the drug is now almost 19 months, which lead investigator Linda Vahdat, M.D., of Weill Cornell Medical College described in a statement as "excellent results in this very advanced and heavily pre-treated group of patients who have exhausted virtually all therapeutic options."
Typically, median overall survival in patients receiving first-line therapy for TNBC is around 12 months. The latest crop of data in 85 patients also reveals that 81% of patients treated with the drug experienced tumor shrinkage with the proportion deemed to have a clinical benefit—defined as complete and partial remissions and stable disease—reaching 44% after six months, according to Immunomedics.

Vahdat was effusive about the drug, saying that she had "never seen these types of responses before" in this patient group and "if there was no alopecia, this would be a perfect therapy."

IMMU-132 is an antibody-drug conjugate, with the antibody portion of the drug latching on to tumors in order to dump a toxic payload that kills the malignant cells. It targets a receptor called Trop-2, which is found in multiple types of cancer, and Immunomedics also presented new results from trials of the drug in urothelial and lung cancers.
Immunomedics is in the throes of seeking a partner for IMMU-132, but there was little news on progress at the meeting, although the company said multiple parties were interested in licensing the drug. The company is hoping to make an announcement on that front prior to starting its phase 3 trial, which is due to get underway in the next few months.

On a sourer note for the biotech, Immunomedics is currently facing a shareholder revolt, with venBio striving to get four new directors onto the company’s board at its next annual meeting on Feb. 16.
venBio—which says it owns around 9.9% of the company’s stock and is its largest stockholder—claims Immunomedics’ nominated candidates do not have the right experience to bring IMMU-132 forward.

On January 19, 2017 Heron Therapeutics reported the pricing of an underwritten public offering of $150 million of shares of its common stock, offered at a price of $12.20 per share (Press release, Heron Therapeutics, JAN 19, 2017, View Source;p=RssLanding&cat=news&id=2238307 [SID1234517457]). Heron Therapeutics, Inc. has granted the underwriters a 30-day option to purchase up to an additional $22.5 million of shares of common stock. The offering is expected to close on or about January 24, 2017, subject to customary closing conditions. BofA Merrill Lynch, Cowen and Company, LLC and Leerink Partners LLC are acting as joint book-running managers for the offering. Cantor Fitzgerald & Co. and JMP Securities LLC are acting as lead managers and Noble Capital Markets, LifeSci Capital, Aegis Capital Corp and Lake Street Capital Markets are acting as co-managers for the offering.

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The gross offering size will be approximately $150 million before deducting customary underwriting discounts and commissions and offering expenses. Heron Therapeutics, Inc. intends to use the net proceeds from the underwritten offering primarily for general corporate purposes, which include, but are not limited to, the continued commercialization and marketing of SUSTOL, the commercial launch of CINVANTI, if approved by the U.S. Food and Drug Administration, funding the company’s ongoing and future clinical trials, including further Phase 2 studies and Phase 3 studies of HTX-011, preclinical development work, for general and administrative expenses, repayment of a portion of its outstanding debt, or other product development activities.

On January 19, 2017 Argos Therapeutics Inc. (Nasdaq:ARGS) ("Argos"), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis precision immunotherapy technology platform, reported the completion of a lease agreement with Keystone-Centennial II, LLC, for 40,000 square feet of newly constructed manufacturing space at the Center for Technology & Innovation (CTI) on the Centennial Campus of North Carolina State University in Raleigh, NC (Press release, Argos Therapeutics, JAN 19, 2017, View Source [SID1234517462]).

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Argos plans to use the manufacturing space at CTI to prepare for submission of a biologics license application (BLA) to the U.S. Food & Drug Administration and to support initial commercialization of rocapuldencel-T, the company’s most advanced product candidate, which is being evaluated for the treatment of metastatic renal cell carcinoma (mRCC) in the company’s pivotal ADAPT Phase 3 clinical trial. Because the company’s Arcelis technology platform enables broad geographic coverage from a single facility, CTI is expected to support both domestic and international launches for the first few years, pending regulatory approval of rocapuldencel-T.

"Securing a lease for the CTI facility is a critical step on our path towards becoming a fully-integrated commercial-stage biotechnology company," said Jeff Abbey, president and chief executive officer of Argos. "Our two-stage manufacturing strategy positions us to employ an established and proven-effective manual manufacturing process at CTI with the capacity to support approximately 1,800 patients per year at launch, with expansion capacity to 2,400 patients per year, pending regulatory approval. This strategy optimizes capital utilization as we prepare for a BLA submission for rocapuldencel-T and also allows us to assess early commercial uptake and better project capacity requirements for our planned 125,000 square foot Centerpoint facility in Durham, NC, which can be designed to accommodate our automated manufacturing process."

"In our role of facilitating economic development, we applaud the commitment Argos is making to extend its research partnerships and North Carolina roots to Centennial Campus," said Dr. Alan Rebar, Vice Chancellor of Research, Innovation and Economic Development, at North Carolina State University. "We are excited that Argos has chosen CTI as it seeks to develop and commercialize cutting-edge immunotherapies for people with serious illnesses and look forward to a productive partnership."

About the Arcelis Technology Platform
Arcelis is a precision immunotherapy technology that captures both mutated and variant antigens that are specific to each patient’s individual disease. It is designed to overcome immunosuppression by producing a specifically targeted, durable memory T-cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to the treatment of a wide range of different cancers and infectious diseases, and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized immunotherapies. The Arcelis process uses only a small disease sample or biopsy as the source of disease-specific antigens, and the patient’s own dendritic cells, which are optimized from cells collected by a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient’s disease sample to program dendritic cells to target disease-specific antigens. These activated, antigen-loaded dendritic cells are then formulated with the patient’s plasma, and administered via intradermal injection as an individualized immunotherapy.

On January 18, 2017 Celsion Corporation (NASDAQ:CLSN), a clinical stage oncology drug development company, reported that the United States Patent and Trademark Office has granted U.S Utility Patent No. 9,492,385 B2 – Temperature-Sensitive Liposomal Formulation, which is directly applicable to the method of treating cancer using the Company’s current ThermoDox formulation (Press release, Celsion, JAN 18, 2017, View Source [SID1234517437]). The claims cover intravenous or direct (to the tumor) administration of the formulation followed by heating and extends coverage time over ThermoDox’s current parent patents. The Company also announced the issuance of Korean Patent No. 1652126 – Novel Thermosensitive Liposomes Containing Therapeutic Agents, which relates to composition claims directed to a thermally sensitive liposome that contains all of the components in the Company’s ThermoDox liposome as well as one additional lipid (DSPG).

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These two new patents strengthen the global coverage of ThermoDox, Celsion’s proprietary dose form of doxorubicin based on a heat-activated liposomal platform technology, currently in Phase III development for the treatment of primary liver cancer, also known as hepatocellular carcinoma (HCC). The Company’s Phase III OPTIMA Study is expected to enroll up to 550 patients at up to 75 clinical sites in the North America, Europe, China, S. Korea, Taiwan, and Southeast Asia, and will evaluate ThermoDox in combination with optimized RFA, which will be standardized to a minimum of 45 minutes across all investigators and clinical sites for treating HCC lesions three to seven centimeters, versus standardized RFA alone.

"The issuance of these patents further strengthens Celsion’s growing position as a leader in the development of directed chemotherapeutics designed to address some of the most difficult-to-treat cancers. In conjunction with its composition of matter patents, these new issuances broaden our intellectual property portfolio and provides for life cycle management of ThermoDox well into the next decade. Additionally by covering the use of ThermoDox, Celsion reinforces its exclusivity in many of the major markets around the world where HCC approaches epidemic proportions," said Michael H. Tardugno, chairman, president and CEO. "HCC has the fastest rate of growth of all cancers with annual incidence of over 800,000 new cases and is projected to be the most prevalent form of cancer by 2020."

ThermoDox is currently in late stage clinical trials in primary liver cancer and recurrent chest wall breast cancer. It is positioned for use with multiple heating technologies, and has the potential for applications in the treatment of other forms of cancer including metastatic liver and non-muscle invading bladder cancers.

About ThermoDox
Celsion’s most advanced program is a heat-mediated drug delivery technology that employs a novel heat-sensitive liposome engineered to address a range of difficult-to-treat cancers. The first application of this platform is ThermoDox, a lyso-thermosensitive liposomal doxorubicin (LTLD), whose novel mechanism of action delivers high concentrations of doxorubicin to a region targeted with the application of localized heat at 40°C, just above body temperature. ThermoDox has the potential to address a broad range of cancers.

Celsion’s LTLD technology leverages two mechanisms of tumor biology to deliver higher concentrations of drug directly to the tumor site. In the first mechanism, rapidly growing tumors have leaky vasculature, which is permeable to liposomes and enables their accumulation within tumors. Leaky vasculature influences a number of factors within the tumor, including the access of therapeutic agents to tumor cells. Administered intravenously, ThermoDox is engineered with a half-life to allow significant accumulation of liposomes at the tumor site as these liposomes recirculate in the blood stream. In the second mechanism, when an external heating device heats tumor tissue to a temperature of 40°C or greater, the heat-sensitive liposome rapidly changes structure and the liposomal membrane selectively dissolves, creating openings that can release a chemotherapeutic agent directly into the tumor and into the surrounding vasculature. Drug concentration increases as a function of the accumulation of liposomes at the tumor site, but only where the heat is present. This method damages only the tumor and the area related to tumor invasion, supporting more precise drug targeting.

On Jan 18, 2017 Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology Company focused on the treatment of primary and metastatic liver cancers, reported that new data from a retrospective study of Melphalan/HDS, entitled "Percutaneous Hepatic Perfusion For Unresectable Metastatic Ocular Melanoma To The Liver: A Multi-Institutional Report Of Outcomes," has been accepted for oral presentation at the Regional Cancer Therapies 12th International Symposium, taking place February 18 – 20, 2017 at the Snowbird Ski and Summer Resort in Snowbird, UT (Press release, Delcath Systems, JAN 18, 2017, View Source;p=RssLanding&cat=news&id=2238088 [SID1234517438]).

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The retrospective study was conducted by teams from Moffitt Cancer Center in Tampa, FL and the University of Southampton in the United Kingdom. The study explores patient treatment outcomes with Percutaneous Hepatic Perfusion (PHP Therapy) with Melphalan/HDS in patients with primary metastatic ocular melanoma (OM) with liver metastasis treated between 2008 and 2016. The study was led by Dr. Alexandra Gangi of the Moffitt Cancer Center.

"We are very pleased that Dr. Gangi and her team’s research has been accepted for oral presentation at this prestigious event and believe that their research results will further inform on the use of Melphalan/HDS as a potentially viable additional option for treatment of hepatic metastases in patients with metastatic ocular melanoma," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Officer of Delcath. "We look forward to announcing the details of these new data after they are presented."