On December 26, 2017 Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a company committed to improving patient lives by manufacturing and delivering high quality biologics, reported the appointment of Roger J. Lias, Ph.D., as the company’s new president and chief executive officer (Press release, Peregrine Pharmaceuticals, DEC 26, 2017, View Source [SID1234522773]). Dr. Lias, who has more than 20 years of contract development and manufacturing organization (CDMO) management experience, currently sits on the Peregrine board of directors and serves as president of Avid Bioservices, Peregrine’s wholly-owned CDMO subsidiary. Dr. Lias succeeds Steven W. King, who resigned as president and chief executive officer of Peregrine to pursue other professional interests.

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Dr. Lias’ appointment is an important step in Peregrine’s ongoing transition to a dedicated CDMO and builds upon the company’s recent appointment of several proven CDMO industry veterans to the company’s board and management team. As part of this transformation, Peregrine is actively implementing a multi-pronged strategic plan designed to diversify and broaden its customer base and project mix, expand and strengthen its CDMO service offerings, and drive increased growth and profitability. Additionally, Peregrine is in the process of officially changing the company’s name to Avid Bioservices and adopting a new NASDAQ ticker symbol. The company expects this process to be completed in early 2018.

"We believe that Roger is best equipped to lead Peregrine, including the completion of the company’s transition to a pure play CDMO operating under the Avid Bioservices name. With the demand for biologics manufacturing exceeding the industry’s current capacity and expected to continue to grow in coming years, Roger and his team have worked aggressively to establish a strategic plan that we anticipate will allow the company to take advantage of this significant market opportunity. The team has already made important progress implementing this plan and we look forward to their continued execution of the strategy to best position our CDMO business for success," said Joseph Carleone, Ph.D., chairman of Peregrine. "We would like to thank Steve King for the important contributions that he has made to both the Peregrine and Avid businesses and wish him luck with his future endeavors."

Dr. Lias has previously held senior management positions at several leading CDMOs including Cytovance Biologics, KBI BioPharma, Diosynth RTP (formerly Covance Biotechnology Services) and Lonza Biologics. At each of these companies, he was primarily charged with overseeing commercial operations, including growing and diversifying their respective client bases. During this time, Dr. Lias’ achievements ranged from building start-up Cytovance’s contract process development and biopharmaceutical cGMP production business, to increasing revenues at Diosynth from $16 million to $120 million over a four-year period.

About Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals, Inc. is a company transitioning from an R&D focused business to a pure play contract development and manufacturing organization (CDMO). Peregrine’s in-house CDMO services, including cGMP manufacturing and development capabilities, are provided through its wholly-owned subsidiary Avid Bioservices, Inc. (www.avidbio.com).

Peregrine is pursuing the licensing or sale of its proprietary R&D assets, including its lead immunotherapy candidate, bavituximab, which is currently being evaluated in clinical trials in combination with immune stimulating therapies for the treatment of various cancers. For more information, please visit www.peregrineinc.com

On December 26, 2017 Acorda Therapeutics, Inc. (Nasdaq:ACOR) reported that Ron Cohen, M.D., Acorda’s President and CEO, reported that it will present at the 36th Annual J.P. Morgan Healthcare Conference in San Francisco on Wednesday, January 10, 2018 at 9:30am PST / 12:30pm EST (Press release, Acorda Therapeutics, DEC 26, 2017, View Source [SID1234522771]).

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A live audio webcast of the presentation can be accessed under "Investor Events" in the Investor section of the Acorda website at www.acorda.com, or you may use the link:

View Source

On December 26, 2017 NANOBIOTIX (Paris:NANO) (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) Application for NBTXR3, a first-in-class nanoparticle designed for direct injection into cancerous tumors, activated by stereotactic ablative radiotherapy (SABR) and administered in combination with an anti-PD1 antibody (nivolumab or pembrolizumab) (Press release, Nanobiotix, DEC 26, 2017, View Source [SID1234526519]).

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Laurent Levy, CEO of Nanobiotix, stated: "The FDA’s approval of Nanobiotix’s IND application for this trial is a major milestone for our Company. We’re ready and excited to launch our first immuno-oncology clinical trial in the U.S. combining NBTXR3 with a checkpoint inhibitor. Advancing our demonstration of NBTXR3’s potential to turn checkpoint inhibitor non-responders into responders could be game-changing, and the approach could address the unmet medical needs of a significant number of patients. Based on existing pre-clinical and clinical data, NBTXR3 could become a backbone in immuno-oncology."

The IND approval enables Nanobiotix to initiate NBTXR3-1100, a Phase I/II prospective, multi-center, open-label, and non-randomized clinical trial evaluating the efficacy and safety of NBTXR3 activated by SABR combined with checkpoint inhibitors (nivolumab or pembrolizumab). NBTXR3-1100 includes three cohorts of patients with recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC), or with metastatic non-small cell lung cancer (NSCLC). The study will be conducted in two consecutive phases. The first of these will be dose escalation, followed by a dose expansion phase. The study will seek to enroll between 36 to 72 patients in Phase I and 40 patients in Phase II.

NBTXR3-1100’s dose escalation phase is based on a classical 3+3 Phase I study and planned as a 3-level program to identify the appropriate dose of NBTXR3 injected into the tumor as well as the activation dose of SABR. While NBTXR3 and Radiotherapy doses will be escalated, the anti-PD1 antibody dose will remain constant. One approved anti-PD1 antibody for the dose expansion phase will be selected based on the preliminary risk-benefit ratio assessment observed in Phase I portion of the trial.

Primary and secondary endpoints will evaluate efficacy and safety, while exploratory endpoints further characterize the treatment-induced genomic alterations previously reported, including enriched cytokine activity and markers of adaptive immune response and T-cell receptor signaling pathways.

The NBTXR3-1100 trial will be led by coordinating investigator Tanguy Seiwert, M.D., of The University of Chicago Medical Center, and principal investigator Jared Weiss, M.D., of The University of North Carolina – Chapel Hill.

The potential for immuno-oncology agents to boost immune system response by priming it for active attack against tumor cells has long been a source of excitement.

While the response to checkpoint inhibitors in so-called "hot" tumors, infiltrated by T-cells and characterized by an inflammatory profile, has been striking with long-lasting clinical benefits in some cancer patients, most patients exhibit little or no response to existing treatments.

According to published data, only 15% to 20% of non-small-cell lung cancer patients (NSCLC), and 13% to 22% of head and neck squamous cell carcinoma patients (NHSCC) respond to current immunotherapy treatments.

The physical mode of action by which NBTXR3 works induces a different immunogenicity and could be the key to significantly increasing the number of cancer patients who can benefit from immuno-oncology therapies.

As presented earlier this year at ASCO (Free ASCO Whitepaper) & SITC (Free SITC Whitepaper) 2017, NBTXR3 activated by radiotherapy was shown to induce a specific adaptive immune pattern that could potentially convert a non-responder into an immune-responsive patient receptive to treatment with available checkpoint inhibitors.

On top of NBTXR3’s core developments as a single agent across seven oncology indications, Nanobiotix’s immuno-oncology combination program opens the door to new developments, potential new indications, and important value creation opportunities.

The first patient first visit in the potentially paradigm changing trial is expected in Q2 2018 with with first expected results in the summer of 2019.

***

About Nanobiotix’s immuno-oncology research program

Many IO combination strategies focus on ‘priming’ the tumor, which is now becoming a prerequisite of turning a "cold" tumor into a "hot" tumor.

Compared to other modalities that could be used for priming the tumor, NBTXR3 could have a number of advantages: the physical and universal mode of action that could be used widely across oncology, the one-time local injection and good fit within existing medical practice already used as a basis for cancer treatment, as well as a promising chronic safety profile and well-established manufacturing process.

After 18 months of development, the Company presented preclinical proof of concept demonstrating that NBTXR3 actively stimulates the host immune system to attack tumor cells.

Recently, Nanobiotix presented new translational data. Taken together, these non-clinical and preliminary clinical results confirm that NBTXR3 activated by radiotherapy could efficiently prime an adaptive antitumor immune response, turning "cold" tumors in "hot" tumors. Additionally, these results suggest that the physically-induced response and subsequent immune activation triggered by the NBTXR3 treatment could be generic. Results suggest that NBTXR3 activated by radiotherapy could transform tumors into an effective in situ vaccine, opening up very promising perspectives in the treatment of local cancer and metastases.

On top of the Company’s core development activities, these findings could open new collaborations for NBTXR3 through combinations with other immuno-oncology drugs.

About NBTXR3

NBTXR3 is an injectable aqueous suspension of hafnium oxide nanoparticles designed as an innovative therapeutic agent for the treatment of solid tumors, currently in clinical development by Nanobiotix.

Once injected intratumorally, NBTXR3 can deposit high energy within tumors only when activated by an ionizing radiation source, notably radiotherapy. Upon activation, the high energy radiation is physically designed to kill the tumor cells by triggering DNA damage and cell destruction and improve clinical outcomes.

Promising results indicate that NBTXR3 activity could be applicable across solid tumors triggering immunogenic cell death, leading to an immune response, reinforcing a local and potentially systemic effect, and contributing to transform "cold" tumors into "hot" tumors. NBTXR3’s major characteristics are represented by a high degree of biocompatibility, one single administration before and during the whole therapy and the ability to fit into current standards of radiotherapy care.

NBTXR3 entered clinical development in 2011 in a Phase I/II with patients suffering from advanced soft tissue sarcoma of the extremities and is currently in the final stages of its subsequent phase II/III. In parallel, it is currently being tested in numerous Phase I/II clinical trials with patients suffering from locally advanced squamous cell carcinoma of the oral cavity or oropharynx (head and neck), liver cancer (hepatocellular carcinoma and liver metastasis), locally advanced or unresectable rectal cancer in combination with chemotherapy, head and neck cancer in combination with concurrent chemotherapy, and prostate adenocarcinoma.

On December 26, 2017 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the company’s lead product candidate, VAL-083, in recurrent glioblastoma (rGBM) (Press release, DelMar Pharmaceuticals, DEC 26, 2017, View Source [SID1234522768]).

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"The Fast Track designation marks an important milestone in the development of VAL-083 as a potential new therapy for cancer patients with limited or no treatment options," said Saiid Zarrabian, interim chief executive officer at DelMar. "We appreciate the FDA’s recognition that the VAL-083 program addresses a significant unmet need in rGBM as we continue to evaluate this agent in patients with multiple tumor types."

This Fast Track status applies to two ongoing clinical trials sponsored by DelMar Pharmaceuticals to evaluate VAL-083 as a potential treatment for rGBM. These trials include:

A Phase 2 study in bevacizumab-naïve MGMT-unmethylated GBM patients conducted in collaboration with The University of Texas MD Anderson Cancer Center; and
A Phase 3 study of patients whose disease has progressed following prior treatment with temozolomide and bevacizumab (the STAR-3 trial).
Fast track designation is designed to expedite the review of drugs that show promise in treating life-threatening diseases and address unmet medical needs, with the goal of getting new treatments to patients earlier. Fast Track designation provides sponsors with an opportunity for increased frequency of communication with FDA to ensure an optimal development plan and to collect appropriate data needed to support drug approval.

Additional benefits of the Fast Track designation may include an Accelerated Approval, a Priority Review, and a Rolling Review. Accelerated Approval is granted to drugs that demonstrate an effect on a surrogate, or intermediate endpoint reasonably likely to predict clinical benefit. Priority Review shortens the FDA review process for a new drug from ten months to six months, and is appropriate for drugs that demonstrate significant improvements in both safety and effectiveness of an existing therapy. Rolling Review provides a drug company the opportunity to submit completed sections of its New Drug Application (NDA) for review by the FDA. Typically, NDA reviews do not commence until the drug company has submitted the entire application to the FDA. Through the Fast Track designation, the FDA attempts to ensure that questions raised during the drug development process are resolved quickly, often leading to earlier approval and increased access for patients.

Outside of rGBM, DelMar has initiated a Phase 2 clinical trial of VAL-083 in newly-diagnosed MGMT-unmethylated GBM. DelMar also recently received notice of allowance from the FDA of an IND for a Phase 1/2 trial of VAL-083 in patients with recurrent platinum-resistant ovarian cancer.

"Our ongoing VAL-083 clinical development program is supported by extensive preclinical research into the agent’s unique mechanism of action, as well as promising data from prior clinical trials sponsored by DelMar and the National Cancer Institute," added Mr. Zarrabian. "We are enthusiastic about the potential of VAL-083 to offer a meaningful clinical benefit to patients with rGBM and for the opportunity to expedite the regulatory process through the FDA’s Fast Track program."

About VAL-083

VAL-083 (dianhydrogalactitol) is a "first-in-class," DNA-targeting agent that introduces interstrand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers including GBM and ovarian cancer in historical clinical trials sponsored by the U.S. National Cancer Institute (NCI). DelMar has demonstrated that VAL-083’s anti-tumor activity is unaffected by common mechanisms of chemoresistance in vitro. Further details regarding these studies can be found at View Source

VAL-083 has been granted an orphan drug designation by the U.S. FDA Office of Orphan Products for the treatment of glioma, medulloblastoma and ovarian cancer, and in Europe for the treatment of malignant gliomas.

On December 26, 2017 Dr. Reddy’s Laboratories Ltd (BSE: 500124, NSE: DRREDDY, NYSE: RDY) reported that it has launched Melphalan Hydrochloride for Injection, a therapeutic equivalent generic version of Alkeran (melphalan hydrochloride) for Injection in the United States market approved by the U.S. Food and Drug Administration (USFDA) (Press release, Dr Reddy’s, DEC 26, 2017, View Source [SID1234522769]).

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The Alkeran brand and generic had U.S. sales of approximately $107 million MAT for the most recent twelve months ending in October 2017 according to IMS Health*.

Dr. Reddy’s Melphalan Hydrochloride for Injection is available in a carton containing one singledose clear glass vial of freeze-dried melphalan hydrochloride equivalent to 50 mg melphalan and one 10 mL clear glass vial of sterile diluent.