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Brain Cancer Patients Display Appropriate Immune Responses and Decreasing Tumor Biomarkers in AIVITA Biomedical’s Phase 2 Clinical Trial

On October 24, 2019 AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, reported updated data from its ongoing glioblastoma Phase 2 clinical trial investigating AIVITA’s platform immunotherapy targeting tumor-initiating cells (Press release, AIVITA Biomedical, OCT 24, 2019, View Source [SID1234542467]). In approximately 80% of treated patients, sequential blood plasma biomarker analyses have identified the induction of a type II hypersensitivity response, followed by a dendritic cell-mediated antibody response. This immunological response is accompanied by decreased tumor load in approximately 81% of those same patients, equivalent to 65% of the total number of treated patients.

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Blood was collected from subjects at multiple time points, one week after each dose administration, and assayed for 450 different immune and tumor biomarkers. A robust type II hypersensitivity response was noted as an acute development at 2-3 weeks post-treatment, followed by dendritic cell maturation and the induction of an antibody-mediated response by 8 weeks post-treatment. Furthermore, the response is proportional to tumor load. The oncology literature associates this immunological profile with survival; indeed, 81% of the treated patients in the AIVITA study exhibiting this immunological profile also show a decrease of tumor markers.

"Blood analyses indicate that the AIVITA immunotherapy, in the presence of tumor, triggers an acute cytotoxic hypersensitivity followed by an antibody-mediated response and tumor marker reduction," said Dr. Gabriel Nistor, Chief Science Officer at AIVITA. "While very encouraging, only time will truly validate whether the appropriate immune response and decreasing tumor markers translate into patient survival."

AIVITA is currently conducting three distinct clinical studies in the USA investigating its platform immunotherapy, in patients with ovarian cancer, glioblastoma and melanoma. AIVITA is also seeking conditional commercial approval of its melanoma treatment in Japan. AIVITA uses 100% of proceeds from the sale of its ROOT of SKIN skincare line to support the treatment of women with ovarian cancer.

CLINICAL TRIAL DETAIL

OVARIAN CANCER

AIVITA’s ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who are being randomized in a 2:1 ratio to receive either the autologous tumor-initiating cell-targeting immunotherapy or autologous monocytes as a comparator.

Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), and (5) who have completed primary therapy. The trial is not open to patients with recurrent ovarian cancer.

For additional information about AIVITA’s AVOVA-1 trial patients can visit: www.clinicaltrials.gov/ct2/show/NCT02033616

GLIOBLASTOMA

AIVITA’s glioblastoma Phase 2 single-arm study is active and is enrolling approximately 55 patients to receive the tumor-initiating cell-targeting immunotherapy.

Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a Karnofsky Performance Status of > 70 and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC). The trial is not open to patients with recurrent glioblastoma.

For additional information about AIVITA’s AV-GBM-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03400917

MELANOMA

AIVITA’s melanoma Phase 1B open-label, single-arm study will establish the safety of administering anti-PD1 monoclonal antibodies in combination with AIVITA’s tumor-initiating cell-targeting immunotherapy in patients with measurable metastatic melanoma. The study will also track efficacy of the treatment for the estimated 14 to 20 patients. This trial is not yet open for enrollment.

Patients eligible for treatment will be those (1) for whom a cell line has been established, (2) who have undergone leukapheresis from which sufficient monocytes were obtained, (3) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), (4) who have either never received treatment for metastatic melanoma or were previously treated with enzymatic inhibitors of the BRAF/MEK pathway because of BRAF600E/K mutations and (5) are about to initiate anti-PD1 monotherapy.

Alligator Bioscience AB Interim Report January-September 2019

On October 24, 2019 Alligator Bioscience AB Interim Report January-September 2019(Press release, Alligator Bioscience, OCT 24, 2019, View Source [SID1234542456])

We are now regaining the exclusive, global rights to develop and commercialize ADC-1013 and at the same time receive enough ADC-1013 substance to, with or without a new partner, bring ADC-1013 into Phase II clinical trials next year. In total, we now have three projects in clinical development, and soon another one where the first patient in Phase I will be dosed," commented CEO Per Norlén.

Significant events July-September

Alligator regains the global rights for the CD40 antibody ADC-1013 (mitazalimab) from Janssen.
Alligator continued its work on the clinical development plan for mitazalimab with the goal of starting a Phase II study in 2020.
Antibody agreement was signed with Biotheus Inc. of China, which obtained Chinese rights to an antibody from the antibody library ALLIGATOR-GOLD.
Events after the end of the period

ATOR-1015: The Phase I clinical trial is progressing well with seven dose levels evaluated for initial safety. Currently, doses of 100 mg, about 1.5 mg/kg, are given every two weeks.
ALG.APV-527: Along with co-development partner Aptevo, discussions are initiated with additional partners for the upcoming clinical development of ALG.APV-527 and, therefore, the submission of the application for permission to start clinical trial is delayed. For Alligator, this ensures that resources are available in order to bring the clinical portfolio forward with full force.
Financial information

July-September 2019

Net sales, SEK 4.3 million (0.2)
Total operating costs SEK -62.9 million (-40.6)
Operating result, SEK -58.5 million (-39.9)
Earnings per share before and after dilution, SEK -0.79 (-0.56)
Cash flow for the period, SEK -46.8 million (-39.7)
Cash, cash equivalents, incl securities, SEK 302.4 million (478.4)
January-September 2019

Net sales, SEK 4.4 million (1.4)
Total operating costs SEK -160.2 million (-125.5)
Operating result, SEK -155.2 million (-123.0)
Earnings per share before and after dilution, SEK -2.11 (-1.67)
Cash flow for the period, SEK -126.0 million (-70.0)
Read the complete report in the pdf below.

Conference call

All interested parties are invited to participate in a telephone conference, which will include a presentation of the Interim report. The event will be hosted by CEO Per Norlén and the presentation will be held in English.

When: 2:00 p.m. CEST Thursday 24, October 2019

Listen to the presentation: View Source

To participate in the telephone conference, please use the dial in details shown below:
SE: +46856642707
UK: +443333009262
US: +18335268381

The conference call will be made available on the company’s website after the call.

This information is such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 8:00 a.m. CEST on October 24, 2019.

Orexo Interim Report Q3 2019

On October 24, 2019 Orexo reported that Interim Report Q3 2019 (Press release, Orexo, OCT 24, 2019, View Source [SID1234542455]).

Total net revenues of SEK 231.2 million (216.6), up 6.7 percent
Zubsolv US net revenues of SEK 182.7 million (165.4), up 10.4 percent in SEK and 3.0 percent in local currency
EBITDA of SEK 114.1 million (39.8), up 186.7 percent. EBITDA ex Abstral of SEK 71.7 million (-8.9).
US EBIT of SEK 93.4 million (55.6), up 68.0 percent
Cash flow from operating activities of SEK 135.7 million (24.5), building a cash balance of SEK 812.9 million (516.6)
Net earnings of SEK 111.7 million (62.2), up 79.6 percent
Signed license and supply agreement for Zubsolv in Australia and New Zealand with Mundipharma Pty Ltd.
SEK 32.5 million (10 percent) of the total corporate bond loan was prepaid
Signed partnership agreement with GAIA AG to develop a digital therapy for treatment of opioid dependence

CEO comments – Strong financials driving continued focus on new product opportunities and pipeline progression

During the quarter we saw significant changes in the US market against which Zubsolv continued to perform well and the company reported another strong financial performance. These results, along with our solid cash position, provide the necessary headroom to advance our promising pipeline of opioid focused products, whilst also embracing the trend towards the adoption of complementary digital therapeutics.

All-Time-High financial performance – EBITDA reached SEK 114 million
Following a very strong second quarter, I am pleased to report another period marked by strong financial results. Also when excluding the Abstral royalty we show strong numbers, as EBITDA ex Abstral amounted to SEK 71.7 million (-8,9). This is driven by increased sales of Zubsolv in market segments with below average rebates. The results also reflect improved efficiency measures introduced at Orexo and some adjustment of lower returns and rebates relating to prior periods. The financial result has been achieved against some short-term headwinds with three payers removing exclusivity for Zubsolv and expanding reimbursement to include other products. For Zubsolv, the immediate impact is competition in the previously exclusive contracts, WellCare, Humana and United Health Group. Longer term, Zubsolv will benefit from more payers opening up for reimbursement of Zubsolv with lower rebates. I am encouraged to see continued double digit growth for Zubsolv in the plans not impacted by changes in market access and where the rebates are lower than the exclusive contracts.

Market Dynamics – increased funding of treatment will improve the business case
A topic that has attracted media attention is the ongoing lawsuits of manufacturers of opioid pain medication. Orexo is not implicated in any of these cases, but some of the damages from these lawsuits is expected to be used to improve the treatment for opioid addiction. In many states, patient advocacy groups have lobbied for universal access for all treatment options. This has resulted in legislative changes in some states to force publicly financed payers to reimburse all products, including Zubsolv. The increased funding of treatment will also encourage the introduction of new treatment options, which bodes well for Orexo’s pipeline of opioid treatments, including our recent foray into digital therapeutics – increasingly seen as critical to successfully treating opioid addiction.

Digital Therapies – an exciting, growing market set to improve patient outcomes
The use of digital therapeutics is increasing with digital poised to play a key role in most, if not all, future interactions with health care providers. Based on our existing infrastructure and our knowledge of the addiction market, Orexo is well positioned to become a leader in bringing new digital treatment solutions to the market. Our strategy is to focus on solutions with scientifically proven therapeutic effect which will benefit the healthcare system as a whole and more importantly patients. Our partnership with GAIA, announced in August, is a good example of this strategy in action. GAIA has collated evidence from more than 10,000 patients that supports the use of their digital Cognitive Behavioral Therapy in depression and alcohol addiction to improve treatment outcomes. While leveraging the synergies from our existing infrastructure in the US our strategy is to continue with our considered buy and build strategy and complement our existing offering with new digital therapeutics to bring comprehensive and effective treatment solutions to improve patient outcomes.

Summary and Outlook
2019 is on track to deliver a very strong financial result enabling the company to execute on the overarching strategy to expand the commercial platform. Our next near term milestones will be the results from our ongoing OX338 study and possibly new business development agreements. Building on the financial success of Zubsolv, we have the resources to both continue broadening our pipeline and product portfolio and to build a presence in the increasingly important and complementary digital therapeutics market.

Nikolaj Sørensen
President and CEO

For further information, please contact
Nikolaj Sørensen, CEO and President, Joseph DeFeo, EVP and CFO or Lena Wange, IR & Communications Manager Tel: +46 18 780 88 00, +1 855 982 7658 Email: [email protected]

Presentation

At 2.00 pm CET, the same day as the announcement of the report, Orexo invites analysts, investors and media to attend an audiocast with a web presentation where Nikolaj Sørensen, CEO, and Joseph DeFeo, CFO, will present the report. After the presentation a Q&A will be held. Questions can also be sent in advance to [email protected] , no later than 11.00 am CET. Please view the instructions below on how to participate.
Internet: View Source
Telephone: SE: +46 8 566 427 06 UK: +44 333 300 92 67 US: +1 833 5268 383
The presentation material will be available on Orexo´s website prior to the audiocast.

This information is information that Orexo AB (publ.) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 8.00 am CET on October 24, 2019.

Ipsen Delivers Strong Double-digit Sales Growth for the Third Quarter of 2019 and Confirms Full Year 2019 Guidance

On October 24, 2019 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, reported sales for the third quarter of 2019 (Press release, Ipsen, OCT 24, 2019, View Source [SID1234542454]).

Financial highlights

Q3 2019 Group sales growth of +16.0% as reported and +14.5%1 at constant exchange rates and consolidation scope, driven by Specialty Care sales growth of 16.5%1, reflecting strong double-digit momentum of Somatuline (lanreotide) and the continued growth from Cabometyx (cabozantinib) and Decapeptyl (triptorelin)
YTD Group sales growth of +15.7% as reported and +14.3%1 at constant exchange rates and consolidation scope fueled by strong Specialty Care sales growth of 16.8%1
Full Year 2019 guidance confirmed with Group sales growth greater than +14.0% at constant currency and consolidation scope1 and Core Operating margin at around 30.0% of net sales
Recent pipeline highlights

Positive interim Phase 1/2 clinical data evaluating Onivyde (liposomal irinotecan) as first-line treatment for metastatic pancreatic cancer presented at ESMO (Free ESMO Whitepaper) 21st World Congress on Gastrointestinal Cancer
Positive interim data from seamless Phase 2/3 clinical trial evaluating Onivyde as a second-line treatment for small cell lung cancer (SCLC) presented at the IASLC 2019 World Conference on Lung Cancer
FDA approval of Dysport (abobotulinumtoxinA) for the treatment of upper limb spasticity in children two years of age and older, excluding spasticity caused by cerebral palsy (CP)
In-licensing of BLU-782 from Blueprint Medicines, a highly selective ALK2 inhibitor in Phase 1 development for the treatment of fibrodysplasia ossificans progressiva (FOP)
Palovarotene regulatory submission to the FDA for the episodic treatment of FOP now expected in Q1 2020 as a result of the processing of additional supportive data.
Key figures

Unaudited IFRS consolidated sales

Third Quarter

Nine Months

(in million euros)

2019

2018

Variation

at constant

currency and

consolidation

scope1

2019

2018

Variation

Variation at

constant currency

and consolidation

scope 1

Specialty Care

574.2

484.1

18.6%

16.5%

1,674.1

1,404.2

19.2%

16.8%

Consumer Healthcare2

70.6

71.9

-1.8%

0.1%

200.2

216.2

-7.4%

-2.4%

Group sales

644.7

555.9

16.0%

14.5%

1,874.3

1,620.4

15.7%

14.3%

1 Subsidiaries involved in the partnership between Ipsen and Schwabe Group are consolidated in accordance with the equity method starting 1 January, 2019. Year-on-year growth excluding foreign exchange impact established by recalculating net sales for the relevant period at the rate used for the previous period.

David Meek, Chief Executive Officer of Ipsen stated: "In the third quarter, we continued to execute on our objectives with a strong performance of our Specialty Care business, including double-digit growth of Somatuline in both the U.S. and Europe. With our excellent performance year-to-date, we are increasingly confident in our ability to achieve our 2019 financial guidance.

"We remain focused on the successful execution of the palovarotene program to bring the first therapeutic treatment to FOP patients as expeditiously as possible. We also continue to deliver on our external innovation strategy. The recent in-licensing of BLU-782 reinforces our leadership in FOP with a different and potentially complementary mechanism of action to palovarotene, expands our portfolio approach in this complex ultra-rare bone disorder and leverages our clinical and commercial capabilities. Advancing our pipeline remains a key focus going forward to deliver on our growth strategy and to bring additional value to patients and shareholders."

Third quarter 2019 sales highlights

Note: Unless stated otherwise, all variations in sales are stated excluding foreign exchange impacts (currency effects established by recalculating net sales for the relevant period at the exchange rates from the previous period)

Q3 2019 Group sales grew 14.5%1 to €644.7 million.

Sales of Specialty Care products reached €574.2 million, up 16.5% year-on-year.

Somatuline sales reached €264.0 million, up 18.8%, year-on-year, driven by 20.0% growth in North America, double-digit growth in key European countries and good performance in Japan.

Decapeptyl sales reached €98.9 million, up 10.5% year-on-year, driven by volume and market share gains in Europe and double-digit growth in China.

Cabometyx sales reached €64.5 million, growing 66.3% year-on-year, driven by the good performance in all launched European countries and additional launches in Asia and Oceania.

Onivyde sales reached €26.1 million, down 7.3% year-on-year, impacted by limited shipments to Ipsen’s ex-U.S. partner in the third quarter.

Dysport sales reached €97.4 million, up 8.8% year-on-year, driven by the solid performance in the U.S. in the therapeutics and aesthetics markets, as well as growth from Galderma in Europe.

Consumer Healthcare product sales totaled €70.6 million, stable at +0.1%1, driven by Smecta growth of 2.5% year-on-year, from the good performance in France and in China despite the new hospital competitive pricing environment, and Forlax growth of 9.7% year-on-year. Tanakan sales reached €8.8 million, down 10.0% year-on-year, due to competitive pressure in emerging countries and a market slowdown in France.

Confirmation of Full Year 2019 guidance

Group sales growth greater than +14.0% at constant currency and consolidation scope1
Impact of currencies estimated at +2.0% based on the current level of exchange rates
Impact of consolidation scope reflecting the consolidation under the equity method for joint arrangements related to the Schwabe partnership estimated at -1.0%
Core Operating margin at around 30.0% of net sales
Conference call

Ipsen will hold a conference call Thursday, 24 October 2019 at 2:30 p.m. (Paris time, GMT+2). Participants should dial in to the call approximately five to ten minutes prior to its start. No reservation is required to participate in the conference call.

Standard International: +44 (0) 2071-928-000
France and continental Europe: +33 (0) 1 76 70 07 94
UK: 08-445-718-892
U.S.: 1-6315-107-495
Conference ID: 5649858

A recording will be available for seven days on Ipsen’s website.

Varian ProBeam 360 Proton Therapy System Selected by Penn Medicine for Use in Second Treatment Center

On October 23, 2019 Varian (NYSE: VAR) reported it has been selected by Penn Medicine to install a Varian ProBeam 360° proton therapy system in a single-room configuration at Lancaster General Health Ann B. Barshinger Cancer Institute in south central Pennsylvania (Press release, Varian Medical Systems, OCT 23, 2019, View Source [SID1234542494]). In addition to the equipment, Varian will also provide its ARIA information management system and Eclipse treatment planning system. Construction of the new center began in September 2019, with the first patient treatments expected in 2021.

In addition to the agreement on the proton therapy system, Penn Medicine and Varian also signed a research collaboration agreement. The goal of the collaboration is to enable global clinics to more easily adopt, use, and innovate modern proton therapy techniques.

With a 30 percent smaller footprint than the previous system, ProBeam 360° offers uncompromised clinical capabilities while reducing vault construction costs by approximately 25 percent. The new system has a 360-degree rotating gantry, the most powerful particle accelerator available today to treat cancer, iterative cone-beam CT imaging, and high-definition pencil-beam scanning technology. The system can also provide clinicians a viable path to potential next-generation treatments such as FLASH therapy.

The 360-degree rotating gantry of ProBeam 360° enables efficient Intensity Modulated Proton Therapy (IMPT), and faster treatment times by minimizing patient repositioning and re-imaging and allowing high-quality cone beam CT (CBCT) imaging from almost any angle. RapidScan technology, available on the ProBeam 360°, simplifies the process of motion management by delivering each field in a single breath-hold. This capability increases the number of patients who can comply with breath-hold treatments like lung SBRT.

"We look forward to continuing our strong partnership with Penn Medicine on the installation of the ProBeam 360° system and increasing access to this advanced technology," said Kolleen Kennedy, chief growth officer and president of Proton Therapy Solutions, Varian.