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Mateon Therapeutics to Present Data on Study OX4218 in Neuroendocrine Tumors at ASCO Gastrointestinal Cancers Symposium

On January 20, 2017 Mateon Therapeutics, Inc. (OTCQX:MATN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, reported the presentation of final data from Study OX4218 in patients with neuroendocrine tumors (NETs) at a poster session at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium being held today in San Francisco (Press release, Mateon Therapeutics, JAN 20, 2017, View Source [SID1234517469]).

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Study OX4218 was a multi-center, open label, phase 2 clinical trial to investigate the safety and activity of combretastatin A4-phosphate (CA4P) in the treatment of well-differentiated, low-to-intermediate-grade unresectable, recurrent or metastatic pancreatic or gastrointestinal neuroendocrine tumors/carcinoid (PNETs or GI-NETs) with elevated biomarkers. Following patients’ completion of Study OX4218, patients were eligible to enroll in Study OX4219, a long term extension study, if they achieved a biomarker or symptom response. In OX4218 patients were treated with CA4P 60 mg/m2 on Days 1, 8, and 15 of a 21-day cycle for 3 cycles, and in OX4219 patients received CA4P maintenance on Day 1 of a 21-day cycle until disease progression or up to one year.

A total of 18 patients were enrolled in OX4218. One patient (6%) experienced significant symptomatic improvement as measured by ECOG Status and had a partial response per investigator-assessed RECIST and an additional 7 patients (39%) had stable disease. In addition, a majority of patients (53%) experienced an improvement in patient-reported quality of life. A statistically significant mean change in biomarkers from baseline, the primary endpoint of the study, was not achieved in OX4218 due to the small sample size along with a high intra- and inter-patient variability observed in the biomarkers. A total of 7 patients were enrolled in OX4219, of which 5 patients (71%) had stable disease, including one that continued for 14 months. The partial response and stable disease analyses, as well as other measures from the trial, suggest that CA4P monotherapy has activity in this indication.

"The results of OX4218 and OX4219 confirm that CA4P monotherapy has efficacy in the indications studied, as we have seen with the investigational drug in a number of other monotherapy trials," said William D. Schwieterman, M.D., President and Chief Executive Officer of Mateon. "However, we believe that the efficacy of CA4P only becomes compelling when it is used in combination with an anti-angiogenic agent, due to the complementary mechanisms of action for the two agents. Based on the evidence of efficacy observed in this trial, plus an understanding of the benefits of combination therapy, a lead investigator in this trial is sponsoring a 20 patient study in NETs using CA4P in combination with everolimus (AFINITOR, marketed by Novartis), an anti-angiogenic agent which is already approved and commonly used in this indication."

Overall CA4P monotherapy was well tolerated. Treatment related adverse events were reported in 77% of subjects. The most common Grade 3-5 AEs ( > 10%) included: anemia, abdominal pain, fatigue, hypertension, and ALT and AST increases. One Grade 5 adverse event, carcinoid syndrome, was reported and attributed to the underlying disease.

Argos Therapeutics Completes Lease Agreement for Commercial Manufacturing Space on the Centennial Campus of North Carolina State University

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]).

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.

Heron Therapeutics Announces Pricing of Underwritten Public Offering of Common Stock

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.

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.

Immunomedics talks up IMMU-132 prospects at investor day

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]).

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.

Maryland biotechs PharmAthene and Novartis-backed Altimmune pen merger deal

On January 19, 2017 NYSE-listed small cap PharmAthene and private infectious disease biotech Altimmune have signed a merger pact that will see the pair become one in an all-stock transaction (Press release, FierceBiotech, JAN 19, 2017, View Source [SID1234517453]).

PharmAthene will merge into Altimmune, which lists Novartis Venture Fund, HealthCap, Truffle Capital and Redmont Capital as its investors, to create a new, diversified immunotherapeutics company with four clinical stage and one preclinical stage programs.

These include phase 2-ready NasoVAX, an intranasal, single-dose influenza vaccine, and HepTcell, a first-in-class immunotherapeutic for chronic hep B with "the potential to offer a functional cure," currently in phase 1.
There is also SparVax-L, billed as a next-gen lyophilized anthrax vaccine (NIAID funded), and NasoShield, an intranasal, single-dose, first-in-class anthrax vaccine that is funded by BARDA. A phase 1 trial is set to start this year, with data coming out halfway through 2018.

The preclinical program, Oncosyn, is in early testing for immuno-oncology indications.
A full financial breakdown was not given, but under the deal Altimmune will become a wholly owned subsidiary of the biotech.

The combined entity will become a public company under the name Altimmune and is slated to trade on the NYSE under the ticker symbol $ALT. The combined biotech has around $20 million in cash and cash commitments.
Bill Enright, CEO of Altimmune, and Elizabeth Czerepak, CFO and EVP of Corporate Development at Altimmune, will serve in their respective positions for the combined company, the two said in a statement.
The combined company’s headquarters will be located in Gaithersburg, Maryland.

"A merger with Altimmune is an ideal strategic match," commented John Gill, president and CEO of PharmAthene in the statement. "It fulfills our stated goal of continuing to build value for PharmAthene shareholders after we distribute the SIGA litigation proceeds on February 3. By combining forces, we will diversify our portfolio into attractive commercial product opportunities and leverage our capabilities for developing next generation anthrax vaccines."

Enright added: "The merger allows Altimmune to leverage PharmAthene’s existing U.S. public company infrastructure, providing access to the capital markets, which is essential to the continued development of immunotherapeutics clinical programs including NasoVAX, NasoShield and HepTCell that leverage Altimmune’s proprietary platform technologies."
PharmAthene currently has a market cap of $223 million and was trading at $3.40 at end of play yesterday.