Den 20 oktober, 2017 rapporterade Xspray Pharma att de har fått godkännande för ett sökt patent i USA. Patentet omfattar komposition avseende produktkandidaten HyNap-Dasa (Press release, Xspray, OCT 20, 2017, View Source [SID1234523284]). Det är Xsprays första produktpatent som godkänns på huvudmarknaden i USA. Bolaget har tidigare offentliggjort ett patentgodkännande i Japan och har pågående ansökningsärenden för motsvarande patent i USA, Japan och Europa..

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Att vi nu får patent beviljat på vår viktigaste marknad bekräftar vårt innovativa arbete samt förbättrar vår kommande förhandlingsposition med tilltänkta partners." säger Per Andersson, vd för Xspray Pharma.

Xspray Pharma har erhållit godkännande ("notice of allowance") för ett patent i USA avseende produktkandidaten HyNap-Dasa som är tänkt för behandling av vissa cancerformer. Det är det första produktrelaterade patentet som beviljas för bolagets produktkandidat på den viktigaste marknaden, USA. Beskedet kommer i enlighet med bolagets plan att söka och erhålla patent för komposition och metod för samtliga tre produktkandidater under utveckling på de tre viktigaste marknaderna, USA, Europa och Japan.

"Vi satsar primärt på att lansera våra produktkandidater på den amerikanska marknaden. En väl fungerande patentstrategi fyller en viktig funktion och det här godkännandet visar att vi har en sådan", kommenterar Xsprays vd Per Andersson.

Xspray Pharmas aktier introducerades den 28 september på Nasdaq First North, efter en lyckosamt genomförd nyemission som tillförde bolaget 132 miljoner kronor före emissionskostnader. Planen är nu att använda kapitalet för att utveckla tre produktkandidater och blivande cancerläkemedel baserade på bolagets egenutvecklade teknologi, samt att introducera de första produkterna på den amerikanska marknaden under perioden 2020-2023.

On October 19, 2017 OncoSec Medical Incorporated ("OncoSec" or "Company") (NASDAQ:ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported updated Phase 2 clinical and immune monitoring data from patients treated with its investigational therapy, ImmunoPulse IL-12 as a monotherapy versus the combination of ImmunoPulse IL-12 and the approved anti-PD-1 therapy pembrolizumab (Press release, OncoSec Medical, OCT 19, 2017, View Source [SID1234521022]). These data were presented in an oral presentation at the 2017 9th World Congress of Melanoma – A Joint Meeting with the Society for Melanoma Research, and continue to support the rationale for the Company’s recently initiated global, open-label, Phase 2b registration directed trial, PISCES/KEYNOTE-695.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Know more, wherever you are:
Latest on Melanoma, book your free 1stOncology demo here.

The Phase 2 OMS-I100 monotherapy and Phase 2 OMS-I102 combination with pembrolizumab studies included 51 and 22* patients, respectively, with metastatic melanoma. The combination study patients were selected based on their baseline biomarker data, which predicted that patients would not respond to anti-PD-1 therapy. Monotherapy patients were treated with ImmunoPulse IL-12 alone and patients in the combination study also received pembrolizumab every 3 weeks per protocol. Fewer than 10% of patients in both studies reported treatment related serious adverse events (9.8% in the monotherapy and 8.7% in the combination studies). Data also demonstrate that ImmunoPulse IL-12 can trigger key immunologic events driving a cellular response leading to an inflamed tumor with increased TIL frequency whether as a monotherapy or combined with pembrolizumab, converting "cold" tumors to "hot", which were further enhanced with the addition of an anti-PD1 antibody.

*Includes one CR with non-evaluable RECIST lesions
Key Findings

OMS-I102 Combination with Pembrolizumab

50% (11/22) BORR observed at 24 weeks (42.9% [9/21] achieved RECIST v1.1 BORR).

41% (9/22) complete responders (CR), 9% (2/22) partial responders (PR), and 9% (2/22) stable disease (SD) for a total disease control rate of 59% (38.1% [8/21] achieved RECIST v1.1 durable CR).

Data demonstrate that the combination of ImmunoPulse IL-12 and pembrolizumab prime a coordinated innate and adaptive immune response, suggesting a synergistic relationship with anti-PD-1.

OMS-I100 Monotherapy

25-34.6% best overall response rate (BORR) by a modified "skin" RECIST.

Favorable safety profile (no life threatening or grade 4 AE).

In patients (n=26) treated with ImmunoPulse IL-12 on a 90-day cycle, there were 19.2% (5/26) complete responders (CR), 15.4% (4/26) partial responders (PR), and 34.6% (9/26) stable disease (SD) for a total disease control rate of 69.2%.

In the protocol addendum where patients (n=20) were treated with ImmunoPulse IL-12 on a 6-week cycle, there were 0 complete responders (CR), 25% (5/20) partial responders (PR), and 40% (8/20) stable disease (SD) for a total disease control rate of 65%.

"We are encouraged by the data from these analyses, which continue to show that ImmunoPulse IL-12 can prime the immune system to help improve patient response to anti-PD-1," said Dr. Alain Algazi, Lead Trial Investigator, Associate Professor, Department of Medicine (Hematology/Oncology), at the University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center. "The complete response rates observed in the Phase 2 study assessing the combination of ImmunoPulse IL-12 and pembrolizumab in the predicted anti-PD-1 non-responder patient population provide compelling early evidence that the combination could lead to a clinically meaningful impact on patient outcomes."

"Collectively, these study findings reinforce the combination of ImmunoPulse IL-12 and pembrolizumab to address a significant unmet medical need in melanoma patients who are unlikely to respond to anti-PD-1 therapies," said Punit Dhillon, CEO and President of OncoSec. "We look forward to presenting additional data from our ongoing Phase 2 combination study at the upcoming 2017 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, in addition to our global, open-label, registration directed phase 2b clinical trial, PISCES/KEYNOTE-695, which we anticipate reporting initial data in mid-2018."

The full-text abstract is available and can be viewed on the World Melanoma Congress – Joint Meeting with the Society of Melanoma Research website at View Source The presentation is available in the Publications section of OncoSec’s website.

About PISCES (Anti-PD-1 IL-12 Stage III/IV Combination Electroporation Study)

PISCES is a global, multicenter phase 2b, open-label trial of intratumoral plasma encoded IL-12 (tavokinogene telseplasmid or "tavo") delivered by electroporation in combination with intravenous pembrolizumab in patients with stage III/IV melanoma who have progressed or are progressing on either pembrolizumab or nivolumab treatment. The Simon 2-stage study of intratumoral tavo plus electroporation in combination with pembrolizumab will enroll approximately 48 patients with histological diagnosis of melanoma with progressive locally advanced or metastatic disease defined as Stage III or Stage IV. The primary endpoint will be the Best Overall Response Rate (BORR).

ATOR-1017 is an agonistic IgG4 antibody that activates the co-stimulatory receptor 4-1BB (CD137, TNFRSF9) (Company Pipeline, Alligator Bioscience, OCT 19, 2017, View Source [SID1234521032]). It was developed from Alligator´s human antibody library, ALLIGATOR-GOLD. In the development of ATOR-1017, Alligator has used their extensive expertise in the TNF receptor superfamily to develop a compound with a clear differentiation compared to other 4-1BB antibodies in development. Thus, ATOR-1017 has a unique target binding profile compared to the two 4-1BB antibodies currently in clinical development. In addition, its agonistic function is dependent on cross-linking by Fcγ receptors expressed by immune cells. The properties of the antibody directs the immune activation to the tumor area where 4-1BB as well as Fcγ receptors are highly expressed, resulting in a favorable safety-efficacy profile. ATOR-1017 therefore has the potential to be a best-in-class 4-1BB antibody in terms of risk-benefit profile.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On October 19, 2017 RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, reported a planned poster presentation relating to the active metabolite of MESUPRON, WX-UK1, at the 2017 AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference, on Sunday, October 29, 2017, from 12:30 – 4:00 PM, at the Pennsylvania Convention Center in Philadelphia, PA (Press release, RedHill Biopharma, OCT 19, 2017, View Source [SID1234521042]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

MESUPRON is a proprietary, first-in-class, orally-administered protease inhibitor, with several potential mechanisms of action to inhibit tumor invasion and metastasis. MESUPRON presents a new, non-cytotoxic approach to cancer therapy and potentially to additional inflammatory gastrointestinal diseases, such as diarrhea-predominant irritable bowel syndrome (IBS-D), pancreatitis and inflammatory bowel disease (IBD).

The poster1, entitled ‘New potential therapeutic applications of WX-UK1 as a specific and potent inhibitor of human trypsin-2 and human trypsin-3′, was authored by scientists from the Department of Molecular Biology and Genetics of Aarhus University in collaboration with RedHill Biopharma. The abstract presents data from non-clinical studies, concluding that WX-UK1 is a potent and rather specific inhibitor of human trypsin-2 and human trypsin-3, suggesting new potential therapeutic applications of WX-UK1 in oncology and inflammatory gastrointestinal diseases.

RedHill acquired the exclusive worldwide development and commercialization rights to MESUPRON, excluding China, Hong Kong, Taiwan and Macao, from Germany’s WILEX AG for all indications. WILEX AG completed several clinical studies with MESUPRON for different indications, including two Phase II proof-of-concept studies, one for pancreatic cancer and one for metastatic breast cancer.

RedHill has an ongoing research collaboration agreement with the Department of Molecular Biology and Genetics of Aarhus University in Denmark for the evaluation of MESUPRON. The non-clinical studies with MESUPRON are intended to support the clinical data from previous Phase I and Phase II studies, and may allow RedHill to take a precision medicine approach going forward. Further evaluation of MESUPRON, together with Aarhus University, may allow for selection of appropriate subpopulations of patients toward demonstrating the activity of MESUPRON in planned clinical trials.

About MESUPRON:
MESUPRON is a proprietary, first-in-class, orally-administered potent protease inhibitor of human trypsin-2 and human trypsin-3, targeting pancreatic cancer and inflammatory gastrointestinal diseases. Protease inhibitors have been shown to play key roles in tumor invasion and the metastasis process. High levels of certain proteases are associated with poor prognosis in various solid tumor cancers, such as pancreatic, gastric, breast and prostate cancers. MESUPRON presents a promising new non-cytotoxic approach to cancer therapy with several potential mechanisms of action to inhibit both tumor metastasis and growth. MESUPRON has undergone several Phase I studies and two Phase II proof-of-concept studies. The first Phase II study was in locally-advanced, unresectable pancreatic cancer and the second study in metastatic breast cancer in combination with first-line chemotherapeutic agents. RedHill received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a new patent covering the use of MESUPRON and RedHill’s Phase II-stage investigational compound, YELIVA, in combination with a known antibiotic, for hard-to-treat cancers.

October 19, 2017 DCPrime BV, a clinical stage company developing dendritic cell vaccines to treat cancer, and apceth Biopharma GmbH, an established contract manufacturing organization in the field of gene and cell therapy, report that they have entered into a strategic manufacturing agreement (Press release, apceth, OCT 19, 2017, View Source [SID1234531599]). The collaboration involves clinical batch production and the development of a commercial scale manufacturing process of cancer vaccines based on DCPrime’s technology platform DCOne. The companies also announce that apceth has recently successfully passed an inspection by the District Government of Upper Bavaria and the Paul-Ehrlich-Institute for the manufacturing license for production of DCP-001, DCPrime’s lead program. This will enable DCPrime to enter into a Phase II Proof of Concept study in Acute Myeloid Leukemia.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Precisely because our platform allows, for the first time, production of dendritic cell vaccines in an off-the-shelf manner, and bypasses the costly and complicated manufacturing procedures of patient-derived dendritic cell vaccines, it is crucial for DCPrime to partner with apceth Biopharma, an experienced contract manufacturing company. This collaboration will be instrumental in bringing our innovative therapies to as many patients as possible", says Dr Ada Kruisbeek, founder and CEO & CSO of DCPrime.

"We are pleased that our manufacturing relationship with DCPrime has started in such a successful manner and that after only one year, we can already ensure production of clinical batches and product supply to patients for further development of the first off-the-shelf dendritic cell vaccine to enter Phase II clinical studies", says Dr Christine Guenther, apceth Biopharma’s CEO. "We at apceth are also very pleased that we will continue our relationship in the future, to enable large scale production and therefore product supply to even larger numbers of cancer patients".

"It has been a pleasure working with the professional staff of apceth Biopharma during the early phases of technology transfer of our current production process, and we look forward to the next steps with respect to developing a commercial scale manufacturing process", says Dr Sandra van Wetering, COO of DCPrime.