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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]).

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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.

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.

Evotec enters into an integrated drug discovery collaboration with Asahi Kasei Pharma (Japan)

On January 19, 2017 Evotec reported it has entered into an integrated drug discovery collaboration on an ion channel target with Asahi Kasei Pharma Corporation, a wholly owned subsidiary of Asahi Kasei Corporation, Tokyo, Japan (Press release, Evotec, JAN 19, 2017, View Source [SID1234517452]).

Under the terms of the agreement, Evotec will apply its integrated drug discovery platform including medicinal chemistry, computational chemistry and in vitro pharmacology to optimise hit compounds identified and selected from the Evotec compound library collection through a recent successful high-throughput screening campaign executed at Evotec.

Dr Mario Polywka, Chief Operating Officer of Evotec, stated: "We are delighted to expand our collaboration with Asahi Kasei Pharma into a fully integrated drug discovery project. Evotec operates one of the most comprehensive ion channel platforms in the industry and this collaboration represents further validation of the strength of this platform and the library screened. We look forward to working closely with our colleagues at Asahi Kasei Pharma."
No financial details were disclosed.

Celsion to Present Two Posters on its GEN-1 IL-12 Gene-Mediated Immunotherapy at the ASCO-SITC Clinical Immuno-Oncology Symposium

On January 19, 2017 Celsion Corporation reported that it will present two posters at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) – Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Clinical Immuno-Oncology Symposium being held from February 23 – 25, 2017 in Orlando, FL (Press release, Celsion, JAN 19, 2017, View Source [SID1234517449]). The symposium will focus on the latest clinical and translational research in immuno-oncology and the implications for clinical care. The first poster will report clinical results from the Phase Ib dose escalating clinical trial (the OVATION Study) combining GEN-1, the Company’s IL-12 gene-mediated immunotherapy, with the standard of care for the treatment of newly-diagnosed patients with Stage III and IV ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery. The second poster will report translational data from the OVATION Study and previous GEN-1 clinical trials. The posters will be presented by Khursheed Anwer, Ph.D., Celsion’s executive vice president and chief science officer.

Poster Presentation details:

Title: Phase I study and activity of formulated IL-12 plasmid administered intraperitoneally in combination with standard neoadjuvant chemotherapy in patients with newly diagnosed advanced stage ovarian cancer
Date and Time: Poster Session A – February 23, 2017 (11:30 am – 1:00 pm ET; 5:30 pm to 6:30 pm ET)
Poster Number: 155

Title: Immunological changes following intraperitoneal administration of a formulated IL-12 plasmid in combination with standard neoadjuvant chemotherapy in patients with newly diagnosed advanced stage ovarian cancer
Date and Time: Poster Session A – February 23, 2017 (11:30 am – 1:00 pm ET; 5:30 pm to 6:30 pm ET)
Poster Number: 156

"Our hypothesis is that GEN-1 plus neoadjuvant chemotherapy treatment will reprogram the tumor immune microenvironment towards a potent antitumor immune response," said Dr. Anwer. "The available data demonstrate highly relevant immunological changes in the tumor immune environment, such as tumor infiltration of cytotoxic T-cell lymphocytes and a reduction of certain immunosuppressive signals, which supports the immune activating role of GEN-1 in this patient population. Evidence of immune activation following the treatment is also supported by increases in IFN-g, a potent mediator of the anti-tumor immune response associated with IL-12 action. We are excited to present at the ASCO (Free ASCO Whitepaper)-SITC symposium, and look forward to sharing the impressive clinical and translational results with the scientific community."

The OVATION Study is designed to enroll three to six patients per dose cohort with the goal of identifying a safe, tolerable and immunologically active dose of GEN-1 by recruiting and maximizing an immune response. Enrollment in the fourth cohort is ongoing with the goal of enrolling three additional patients in this final dose cohort. Celsion expects to complete enrollment in the OVATION Study this quarter and report final data, including translational data for all patients, in the second quarter of 2017. Future studies of GEN-1 will include a Phase I/II study combining GEN-1 with Avastin and Doxil.

ADI‑PEG 20 plus FOLFOX Shows Robust Anti-tumor Activity in Advanced Hepatocellular Carcinoma

On January 19, 2017 Polaris Group reported results from an ongoing phase 1b study conducted at Memorial Sloan Kettering Cancer Center that tests combining ADI‑PEG 20 with folinic acid (leucovorin), fluorouracil and oxaliplatin (FOLFOX) in patients with advanced hepatocellular carcinoma (HCC) and other gastrointestinal malignancies (Press release, Polaris Pharmaceuticals, JAN 19, 2017, View Source [SID1234526288]). The results will be presented at the 2017 Gastrointestinal Cancers Symposium in San Francisco.

Thirteen HCC patients, all with Child-Pugh A and progressed on sorafenib, were enrolled in the single-arm, open label study to assess the safety and preliminary activity of ADI+FOLFOX. The treatment was well tolerated, with no dose-limiting toxicities observed. The treatment brought rapid and sustained serum arginine depletion. Three HCC patients (23%) had a partial response, and 6 patients (46%) had stable disease for a disease control rate of 69%.

"We are excited to see that ADI+FOLFOX demonstrated encouraging anti-tumor activity in the 2nd-line or later setting for advanced HCC patients," said John Bomalaski, M.D., Executive Vice President, Medical Affairs at Polaris Pharmaceuticals, Inc. "We are planning for further clinical investigations in order to bring a safe and effective treatment to these patients."

About ADI‑PEG 20

ADI‑PEG 20 is a biologic being developed by Polaris Group to treat cancers carrying a major metabolic defect that renders them unable to internally synthesize arginine. Because arginine is essential for protein synthesis and survival of cells, these cancer cells become dependent upon the external supply of arginine to survive and grow. ADI‑PEG 20 is designed to deplete the external supply of arginine, causing arginine-dependent cancer cells to die while leaving the patient’s normal cells unharmed. Multiple cancers have been reported to have a high degree of arginine-dependency and can potentially be treated with ADI‑PEG 20.