On December 12, 2018 Avacta Group plc (AIM: AVCT), the developer of Affimer biotherapeutics and reagents, is reported that Dr Jose Saro has been appointed as Chief Medical Officer to lead the Group’s therapeutic development strategy and drive the in-house programmes into the clinic (Press release, Avacta, DEC 12, 2018, View Source [SID1234532032]).

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Dr Saro brings over 20 years’ experience in the pre-clinical, translational and early clinical development of oncology assets, spanning small molecules, biologics and drug conjugates. Dr Saro joins Avacta from Roche where he held the role of Senior Translational Medicine Leader at the Roche Innovation Center Zurich in which he focused on immuno-oncology and the development of combination products.

Prior to his position at Roche, Dr Saro was Executive Director Oncology Global Development and Medical Affairs at Bristol Myers Squibb, based in Paris, where he led and contributed to many oncology clinical development programmes, including Sprycel, Ipilimumab (Yervoy anti-CTLA4), Nivolumab (anti-PD1), anti-PDL1, anti KIR, anti LAG3, Brivanib, MEK inhibitor and Elotuzumab.

Previously, Dr Saro was Executive Director of Translational Medicine and Early Clinical Development (Oncology) at Novartis. Prior to that, he held senior positions at Eisai, and Wyeth.

Dr Saro has also experience of the small biotech environment, having spent several years as Vice President Oncology Clinical Development at PharmaMar, an oncology focused biotech. There, he was Head of Clinical Research & Development teams, comprising approximately 45 people, located in both Madrid and Boston, MA.

Alastair Smith, Chief Executive of Avacta Group commented: "I am delighted that Dr Jose Saro is joining Avacta to lead the therapeutic development strategy and to drive the in-house Affimer programmes into the clinic. His extensive experience in developing pre-clinical assets and translating those into clinical development will be an invaluable asset to Avacta.

Jose joins Avacta at a hugely exciting time as we progress towards the first Affimer clinical studies, which is a significant value inflection point for both the technology and Group. We very much look forward to working with Jose on our established programmes and on leveraging his knowledge to expand the pipeline of innovative and valuable immuno-oncology assets for the future."

Dr Jose Saro commented: "Due to their simple structure, Affimer proteins can be formatted to deliver the right characteristics required for the next generation of immuno-oncology therapeutics.

There are many opportunities for such a platform technology, and the recent collaboration with Tufts University Medical School is one example of a potentially game changing approach that is possible with Affimers.

I am very excited to be part of Avacta as it continues to develop such transformative approaches using the Affimer platform, that I believe will be a huge benefit to many oncology patients who currently have limited therapeutic options."

On December 12, 2018 Blue Earth Diagnostics, a leading molecular imaging diagnostics company, reported that the first commercial production of Axumin (fluciclovine (18F)) in France occurred recently, with the first French patients being dosed (Press release, Blue Earth Diagnostics, DEC 12, 2018, View Source [SID1234532031]). Axumin is a novel molecular imaging agent approved in the European Union for use in PET imaging to detect and localize prostate cancer in men experiencing suspected recurrence based on elevated blood prostate specific antigen (PSA) levels after primary curative treatment. Axumin is the first and only PET imaging agent approved by the European Commission for use in men with suspected recurrent prostate cancer in all European Union member states as well as in Iceland, Liechtenstein and Norway. Axumin is commercially available in France, Norway, the Czech Republic, The Netherlands, United Kingdom and Austria with further European countries set to follow soon.

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Prostate cancer is a leading cause of cancer death in men. While most primary prostate cancer can be successfully treated, recurrence occurs in up to one-third of patients. Recurrent disease is typically detected by a rise in PSA levels but often the location and extent of the disease cannot be detected by conventional imaging. Of those who suffer biochemical recurrence, approximately one-third develop metastatic prostate cancer. Axumin was developed to target the increased amino acid transport that occurs in many cancers, including prostate cancer. It is labelled with the radioisotope (18F), enabling it to be visualized in the body with PET imaging.

Dr. Jonathan Allis, Chief Executive Officer of Blue Earth Diagnostics said, "Detection and localization of recurrent prostate cancer is a significant unmet medical need. Today’s announcement signifies Blue Earth Diagnostics’ commitment in maximizing access to Axumin for clinicians and their patients across Europe and a key milestone towards our goal."

On December 12, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing novel cancer immunotherapies, reported an update regarding tumor responses in its KEYNOTE-695 global, multicenter Phase 2b, open-label trial of intratumoral delivery of TAVO (tavokinogene telseplasmid / IL-12) with intravenous KEYTRUDA (pembrolizumab) in patients with unresectable, advanced melanoma (Press release, OncoSec Medical, DEC 12, 2018, View Source [SID1234532030]). The Company previously reported at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 33rd Annual Meeting (SITC) (Free SITC Whitepaper) that, of the first nine patients to complete 12 weeks of treatment and reach initial tumor evaluation (by RECIST v1.1), two patients had a partial response. The Company now reports that both responses have been confirmed by blinded independent review at the first assessment timepoint. Further, in both cases, response duration has now reached six months. Importantly, one of these previously assessed partial responses has now become a complete response per investigator assessment at the six-month tumor evaluation timepoint. Enrollment is ongoing and the Company expects to complete the study next year.

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"Complete responses in this patient population are rare. One of the first partial responses to be observed in this study now being assessed by the investigator at six months as a complete response is exciting. Durable responses reaching the six-month mark demonstrate that the benefits of TAVO are clinically meaningful," said Daniel J. O’Connor, President and CEO of OncoSec. "The evidence of the potential of TAVO in conjunction with PD-1 inhibition to improve outcomes in this patient population is mounting and we look forward to providing updates as necessary regarding the progress of this trial."

KEYNOTE-695 enrollment criteria with respect to anti-PD-1 checkpoint failure is highly restrictive. In order to be considered an anti-PD-1 checkpoint failure, all patients must have Stage III/IV metastatic melanoma progressive disease after at least four prior cycles of either KEYTRUDA or OPDIVO. Literature suggests that retreatment with a PD-1 therapy following failure of a PD-1 therapy offers approximately a 5% response rate1. Disease progression is determined according to RECIST v1.1, measured by radiologic assessment, with confirmation of progression by second assessment.

"It’s becoming clear that TAVO can reverse PD-1 resistance in refractory metastatic melanoma patients. This is important because the majority of melanoma patients do not respond to PD-1 treatment," said Adil Daud, MD, HS Clinical Professor, Department of Medicine (Hematology/Oncology), UCSF; Director, Melanoma Clinical Research, UCSF Helen Diller Family Comprehensive Cancer Center and Lead Principle Investigator of KEYNOTE-695. "Patients in KEYNOTE-695 have unequivocally failed all approved anti-PD-1 therapies. The tumor responses seen in this trial, now independently verified by a blinded review at the first assessment, deepening and continuing for months, gives us confidence in the potential of this treatment combination for patients who are non-responsive to anti-PD-1 therapy."

Eligible patients in KEYNOTE-695 had refractory, locally advanced or metastatic disease defined as unresectable Stage III/IV metastatic melanoma that had definitively progressed on a full-course of anti-PD-1 treatment with KEYTRUDA (pembrolizumab) or OPDIVO (nivolumab). As previously reported, TAVO was well-tolerated, with primarily Grade 1 adverse advents associated with injection site or procedural pain. One TAVO related Grade 3 SAE of cellulitis was reported and resolved. KEYNOTE-695 is expected to be completed in 2019. Based on the outcome of the study, the Company plans to file for accelerated approval by end of 2019 or early 2020.

TAVO has received both Orphan Drug and Fast-Track Designation by the U.S. Food & Drug Administration.

1 Long GV, Weber JS, Larkin J et al. Nivolumab for patients with advanced melanoma treated beyond progression: analysis of 2 Phase 3 clinical trials. JAMA Oncol. 3(11), 1511–1519 (2017).

On December 12, 2018 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), reported that Yuichi Iwaki, MD, PhD, President and Chief Executive Officer, and Geoffrey O’Brien, JD/MBA, Vice President and Executive Officer, will present a corporate overview at the J.P. Morgan Healthcare Conference on Wednesday, January 9, 2019 at 2:00 pm at the Westin St. Francis Hotel in San Francisco, California (Press release, MediciNova, DEC 12, 2018, View Source;p=irol-newsArticle&ID=2380360 [SID1234532029]). MediciNova’s management team, including Dr. Yuichi Iwaki, Geoffrey O’Brien, and Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer, will be available for one-on-one meetings at this conference and investors may request a one-on-one meeting through J.P. Morgan.

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On December 12, 2018 Santhera Pharmaceuticals (SIX: SANN) reported its financial results for the nine months ended September 30, 2018, and confirms its guidance and positive outlook (Press release, Santhera Pharmaceuticals, DEC 12, 2018, View Source [SID1234532027]).

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Santhera is on track to meet its strategic and financial goals for 2018. The Company further delivered on its active in-licensing strategy for high quality, late-stage rare disease assets by acquiring an exclusive sub-license option to vamorolone, the first-in-class dissociative steroid currently in development for the treatment of Duchenne muscular dystrophy (DMD). On the commercial side, the Company has further grown sales of the revenue-generating product Raxone for the treatment of Leber’s hereditary optic neuropathy (LHON) and expects to meet its 2018 full-year sales guidance in the range of CHF 30-32 million.

Santhera continued its business expansion and grew sales to CHF 23.6 million in the first nine months of 2018 which corresponds to a 45% growth rate (compared to the same period in the previous year). Development expenses increased by 49% compared to the same prior-year period, primarily driven by clinical development activities for POL6014 for the treatment of cystic fibrosis (CF) and regulatory work in preparation of filings for idebenone in the indication DMD. Efficient use of resources resulted in lower marketing and sales expenses (-6%) and a slower rise in general and administrative expenses (+18%). Taken together, this contributed to an increase of operating expenses by 20% compared to the same period of last year. In summary, Santhera closed the nine-month period under review with a net result of CHF -39.9 million (Jan.-Sept. 2017: CHF -33.3 million).

Financial highlights:

Sales of CHF 23.6 million (Jan.-Sept. 2018), reflecting an increase by 45% compared to same period last year (Jan.-Sept. 2017: CHF 16.3 million)
Operating expenses of CHF 57.2 million (Jan.-Sept. 2017: CHF 47.7 million)
Operating result of CHF -37.2 million (Jan.-Sept. 2017: CHF -34.2 million), leading to a net result of CHF -39.9 million (Jan.-Sept. 2017: CHF -33.3 million)
Cash, cash equivalents and short-term financial assets of CHF 25.4 million (as of September 30, 2018)
2018 full-year sales guidance of CHF 30-32 million confirmed
Corporate highlights:

Agreement with Idorsia Ltd under which Santhera is to acquire the option to an exclusive sub-license of the first-in-class dissociative steroid vamorolone in all indications and all countries worldwide except Japan and South Korea (November 20, 2018)
Idorsia became largest shareholder in Santhera
Extraordinary General Meeting (EGM) approval of the capital increase in connection with the vamorolone sub-license agreement (December 11, 2018)
Operational highlights (July 2018 to present day):

Analysis of new data linking study findings with idebenone in DMD to clinically relevant patient benefits for inclusion in regulatory submissions in Europe and the U.S.
Positive opinion on orphan drug designation received from European regulators for POL6014 for the treatment of CF
Start of a Phase Ib/IIa multiple ascending dose (MAD) trial with POL6014 in patients with CF
Revenue Guidance:
Santhera will continue to grow its international business, advance its pipeline programs and actively proceed with business development initiatives to expand its late stage product portfolio. Based on its sales performance to date this year, the Company confirms its previous guidance and expects to reach a full-year sales for Raxone in the range of CHF 30-32 million in 2018.

Note
The financial statements as of and for the nine months ended September 30, 2018 have been prepared and are being published exceptionally on the occasion of and in connection with the capital increase proposed to and approved by the EGM held on December 11, 2018. Santhera publishes results in line with the disclosure requirements of the SIX Swiss Exchange. Santhera does not plan on publishing quarterly reports in the future.