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10-Q – Quarterly report [Sections 13 or 15(d)]

Curis has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Curis, 2017, NOV 7, 2017, View Source [SID1234521621]).

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PROVECTUS BIOPHARMACEUTICALS RECEIVES SECOND CANCER COMBINATION THERAPY PATENT FROM THE UNITED STATES PATENT AND TRADEMARK OFFICE

On November 7, 2017 Provectus Biopharmaceuticals, Inc. (OTCQB: PVCT, www.provectusbio.com), ("Provectus" or the "Company"), a clinical-stage biotechnology company leading the development of the first small molecule oncolytic immunotherapy, PV-10, as an investigational single agent for locally advanced disease as well as in combination with another agent for widely metastatic disease, both for multiple cancer indications, reported the United States Patent and Trademark Office (the "USPTO") has granted U.S. patent ("USP") 9,808,524 for the combination of intralesional ("IL") PV-10 with systemic immunomodulatory therapy, including anti-PD-1 and anti-PD-L1 agents, for the treatment of melanoma and cancers of the liver (Press release, Provectus Pharmaceuticals, NOV 7, 2017, View Source [SID1234521816]). This new patent is a continuation of USP 9,107,887, Provectus’ first cancer combination therapy patent granted by the USPTO in 2015. Pfizer, Inc. is a co-assignee on both patents.

PV-10 is an injectable formulation of rose bengal disodium, and represents nearly a decade of work by Provectus to optimize the synthetic process for manufacturing rose bengal and its related halogenated xanthene analogs to meet modern global requirements for pharmaceutical use. IL injection of PV-10 can induce immunogenic cell death that results in tumor-specific reactivity in circulating CD8+ T cells.

Provectus recently presented preliminary results from the Company’s ongoing Phase 1b/2 study of IL PV-10 in combination with KEYTRUDA (pembrolizumab), Merck’s systemic anti-PD-1 (programmed death receptor-1) antibody agent, at the Society for Melanoma Research 2017 Congress, held in Brisbane, Australia on October 18-21. Adverse events were consistent with the established patterns for each drug, and there were no unexpected toxicities or evidence of compounded toxicity. Preliminary overall efficacy included 10% complete response, 50% objective response, and 60% clinical benefit, with the highest responses observed in Stage IV M1c melanoma patients (all per RECIST 1.1).

The Phase 1b portion of the study continues to enroll patients at clinical sites in the U.S. and Australia (NCT02557321); Stage IV patients with at least one injectable lesion who are candidates for KEYTRUDA are eligible. A total of up to 24 patients would receive the combination of IL PV-10 and KEYTRUDA every three weeks for five cycles (i.e., for up to 12 weeks, with no further PV-10 administered after week 12), followed by only KEYTRUDA every three weeks for up to 24 months. The primary endpoint for the Phase 1b trial is safety and tolerability; objective response rate and progression-free survival are key secondary endpoints (both assessed via RECIST 1.1 after five treatment cycles, and then every 12 weeks thereafter).

Dominic Rodrigues, Chairman of the Company’s Board of Directors, said, "This patent continues our work to expand intellectual property protection of PV-10, and to augment the potential commercial value of Provectus’ clinical development program in cancer combination therapy."

Mr. Rodrigues also said, "Provectus’ ongoing Phase 1b study of PV-10 and KEYTRUDA is based on a rational study design for Stage IV melanoma patients with visceral disease, and provides for the investigation of the potential for small molecule oncolytic immunotherapy to demonstrate orthogonality to and synergy with checkpoint inhibition, combination therapy measures of safety and efficacy, respectively."

Mr. Rodrigues concluded, "Numerous players around the world, with approved or investigational drugs within each class of systemic immuno-oncology agent, are pursuing smaller and smaller pieces of market share because drugs within each of these classes may be similar or, indeed, equivalent. Assuming a rational clinical basis for combination, another form of differentiation is needed to gain and protect market share for cancer combination therapy. We believe this aspect of our company’s patent estate provides for proprietary combinations with protected agents."

FDA approves Roche’s Alecensa (alectinib) as first-line treatment for people with specific type of lung cancer

On November 7, 2017 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the US Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Alecensa (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test (Press release, Hoffmann-La Roche, NOV 7, 2017, View Source [SID1234521630]). The approval is based on results from the phase III ALEX study, which showed Alecensa significantly reduced the risk of disease worsening or death (progression-free survival, PFS) by 47% (HR=0.53, 95% CI: 0.38, 0.73, p<0.0001) compared to crizotinib as assessed by independent review committee (IRC). Median PFS was 25.7 months (95% CI: 19.9, not estimable) for people who received Alecensa compared with 10.4 months (95% CI: 7.7, 14.6) for people who received crizotinib. The safety profile of Alecensa was consistent with that observed in previous studies. The study also showed that Alecensa significantly reduced the risk of the cancer spreading to or growing in the brain or central nervous system (CNS) compared to crizotinib by 84% (HR=0.16, 95% CI: 0.10, 0.28, p<0.0001). This was based on a time to CNS progression analysis in which there was a lower risk of progression in the CNS as the first site of disease progression for people who received Alecensa (12%) compared to people who received crizotinib (45%).

"Our goal is to develop medicines that have the potential to significantly improve upon the standard of care," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "In our pivotal study, Alecensa significantly extended the time that people lived without their disease worsening compared to crizotinib and also showed a marked reduction in the risk of their cancer spreading to the brain."

Alecensa received Breakthrough Therapy Designation from the FDA in September 2016 for the treatment of adults with advanced ALK-positive NSCLC who have not received prior treatment with an ALK inhibitor. Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases and to help ensure people have access to them through FDA approval as soon as possible. Results from the phase III ALEX study were simultaneously presented at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and published in The New England Journal of Medicine. Subsequently, Alecensa was recommended in the National Comprehensive Cancer Network (NCCN) guidelines as a treatment option for first-line ALK-positive metastatic NSCLC (Category 1, Preferred).

In addition to today’s approval, the FDA also converted Alecensa’s initial accelerated approval in December 2015 for the treatment of people with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib (second-line) to a full approval.

About the ALEX study1
ALEX (NCT02075840/B028984) is an open-label, randomised, active-controlled, multicentre, phase III study evaluating the efficacy and safety of Alecensa versus crizotinib in people with ALK-positive NSCLC who had not received prior systemic therapy for metastatic disease and whose tumours were characterised as ALK-positive by the VENTANA ALK (D5F3) CDx Assay, a immunohistochemistry (IHC) test developed by Roche Tissue Diagnostics. People were randomised (1:1) to receive either Alecensa or crizotinib. The major efficacy outcome measure of the ALEX study is PFS according to RECIST v1.1 as determined by investigator assessment. Additional efficacy outcome measures include: PFS as determined by IRC, time to CNS progression by IRC based on RECIST v1.1, objective response rate (ORR) and duration of response (DOR), and overall survival (OS). Additional exploratory outcome measures were CNS-ORR and CNS-DOR by IRC in people with measurable CNS metastases at baseline. The multicentre study was conducted in 303 people across 161 sites in 31 countries. OS data are currently considered immature with only about a quarter of events being reported.

Grade ≥ 3 adverse reactions were reported for 41% of patients treated with Alecensa. The most common Grade 3-4 adverse reactions (≥3%) were evidence of kidney dysfunction (increased creatinine; 4.1%), evidence of liver dysfunction (hyperbilirubinemia; 5%), low levels of sodium (hyponatremia; 6%), increased liver enzymes (aspartate transaminase; 6%, and alanine transaminase; 6%), and decreased red blood cells (anaemia; 7%). Serious adverse reactions reported in ≥2% of patients treated with Alecensa were lung infection (pneumonia; 4.6%) and renal impairment (3.9%).

About Alecensa
Alecensa (RG7853/AF-802/RO5424802/CH5424802) is a highly selective, CNS active, oral medicine created at Chugai Kamakura Research Laboratories and is being developed for people with NSCLC whose tumours are identified as ALK-positive. ALK-positive NSCLC is often found in younger people who have a light or non-smoking history.1 It is almost always found in people with a specific type of NSCLC called adenocarcinoma.3
Alecensa is currently approved in the United States, Europe, Kuwait, Israel, Hong Kong, Canada, South Korea, Switzerland, India, Australia, Singapore, Taiwan, Liechtenstein, Thailand, United Arab Emirates, Saudi Arabia, Argentina and Turkey for the treatment of people with advanced (metastatic) ALK-positive NSCLC whose disease has worsened after, or who could not tolerate treatment with, crizotinib and in Japan for people with ALK-positive NSCLC.

About Roche in lung cancer
Lung cancer is a major area of focus and investment for Roche, and we are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have four approved medicines to treat certain kinds of lung cancer and more than ten medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.

OncoResponse Adds Anti-EMP2 Antibody to Oncology Pipeline Through Acquisition of Paganini Biopharma

On November 7, 2017 OncoResponse reported that it has closed the acquisition of Paganini Biopharma, acquiring all of its assets including an anti-epithelial membrane protein 2 (EMP2) fully human monoclonal antibody, ONCR-201 (Press release, OncoResponse, NOV 7, 2017, View Source [SID1234521815]). EMP2 is implicated as an oncoprotein in cancer biology and in addition to its overexpression associated with tumor-promoting activities in various tumor types, it has been shown to play a role in signaling migration and invasion of cancer stem cells.

"EMP2 is highly over expressed in breast cancer including triple negative, ovarian cancer and endometrial cancer as well as glioblastoma, and the anti-tumor effect of ONCR-201 in pre-clinical models is striking," said Clifford J. Stocks, CEO of OncoResponse. "Preclinical data support the potential of ONCR-201 to work as both a highly-targeted monotherapy as well as synergistically in combination with immunotherapy and current standard of care. ONCR-201 is now on an IND-track toward first-in-human studies to begin in 2019."

Financial terms of the acquisition were not disclosed.

Paganini Biopharma was founded on technology originated in the Department of Pathology and Laboratory Medicine of the School of Medicine at UCLA under a license agreement from the UCLA Technology Development Group. Paganini co-founder Madhuri Wadehra, Ph.D., Associate Professor at UCLA, will be a consultant to OncoResponse. "We are thrilled to put our technology and antibodies in the hands of strong drug developers and look forward to seeing this medicine reach cancer patients," said Gary Lazar, MD, CEO of Paganini.

About ONCR-201

ONCR-201 is a fully human recombinant monoclonal antibody developed to target and inhibit the function of epithelial membrane protein 2 (EMP2).

EMP2 is a cancer promoting protein, highly expressed in epithelial malignancies and associated with tumorigenesis, with triple negative breast cancer highly prominent on that list. EMP2 positive tumors have been shown to be more aggressive and invasive. Expression of EMP2 within the tumor correlates with faster disease progression and worse prognosis and is associated with the regulation of expression of several cancer stem cell-associated markers. Cancer stem cells, typically resistant to chemotherapy and radiation, are believed to be a main cause for cancer persistence and responsible for relapse, metastasis and rise of new tumors.

In preclinical studies, the administration of anti-EMP2 monoclonal antibody significantly reduces primary and secondary tumor load, and expression of cancer stem cell markers, and demonstrates benefit of survival that extends beyond cessation of treatment.

Nymox Reports on Symposium, Panel Discussion and Podium Presentation on Fexapotide at American Urological Association New York Section Annual Meeting in Havana

On November 7, 2017 Nymox Pharmaceutical Corporation (NASDAQ:NYMX) reported two data presentations which were held on Fexapotide Triflutate studies at the Annual Meeting of the American Urological Association, New York Section in Havana, November 6 (Press release, Nymox, NOV 7, 2017, View Source;fvtc=4&fvtv=6907 [SID1234521687]). The abstract from the presentation is available at [email protected].

The Podium presentation was given by Dr. Ivan Grunberger MD FACS, Professor of Clinical Urology, Weill Cornell Medical College and Chief of Urology, NYP Brooklyn Methodist Hospital. The paper was entitled "Prospective Randomized Double Blind Phase 3 Long-Term Results of U.S. Studies of Fexapotide Triflutate For BPH." Co-authors of the Podium presentation were Ronald Tutrone MD FACS of Baltimore MD, Mitchell Efros MD FACS of Garden City NY, Mohammed Bidair MD of San Diego CA, James Bailen MD FACS of Louisville KY, Franklin Gaylis MD FACS of San Diego CA, Barton Wachs MD of Long Beach CA, Richard Levin MD FACS of Baltimore MD, Susan Kalota MD of Tucson AZ, Sheldon Freedman MD FACS of Las Vegas NV, Barry Shepard MD FACS of Garden City NY, Jed Kaminetsky MD FACS of New York NY, Steven Gange MD FACS of Salt Lake City UT and Dr. Grunberger of Brooklyn NY.

Dr. Grunberger said, "Our presentation of the long-term data was very well received by the participants at the NY Section AUA meeting today. I received a lot of positive feedback following the presentation, and a great deal of interest in the use of Fexapotide Triflutate for patients with BPH once available."

The symposium "Fexapotide Triflutate: First in Class Injectable for BPH" was chaired by Dr. Tutrone. The other panel members at the Symposium were Dr. Jeffrey Snyder MD FACS of Denver CO, Dr. Kenneth Goldberg MD FACS of Carrollton TX, and Dr. Grunberger of Brooklyn NY.

Dr. Tutrone said, "I see Fexapotide Triflutate as a first line therapy for men suffering from BPH. It is a quick, painless and safe in-office procedure that takes minutes to do, and does not require a catheter. Its long term efficacy is better than oral medications, and there are no sexual side effects."

At the Symposium detailed clinical data on the Phase 3 clinical trials that have been completed for Fexapotide and that have shown excellent safety and efficacy for the treatment of BPH was presented. The main presentation was followed by a panel discussion and by an interactive question and answer session with the specialist doctors in attendance.

Dr. Snyder said, "I am most encouraged by the clinical trial data presented at the NY Section of the AUA meeting in Havana, Cuba today. This compound is a novel and effective approach to caring for men with symptoms of an enlarged prostate. It is my opinion that the drug will enhance the therapeutic armamentarium of urologists worldwide and maintain our expertise in the treatment of prostate disease. "

Fexapotide has been filed for approval in Europe and the filing was accepted for review in September 2017‎. Nymox’s lead drug Fexapotide has been in development for over 10 years and has been tested by expert clinical trial investigative teams in over 70 distinguished clinical trial centers throughout the US, and has been found after 7 years of prospective placebo controlled double blind studies of treatment of 995 U.S. men with prostate enlargement to not only show clinically meaningful and durable relief of BPH symptoms, but also to show a major reduction in the incidence of prostate cancer, compared to placebo and compared to the known and expected normal incidence of the disease. The same clinical program has also shown in a long-term blinded placebo crossover group study an 82-95% reduction in the number of these patients who required surgery after they received crossover Fexapotide in the trial, as compared to patients who did not receive Fexapotide but instead received crossover conventional approved BPH treatments (p<.0001).