On August 22, 2019 BioInvent reported We are executing according to plan (Press release, BioInvent, AUG 22, 2019, View Source;june-30-2019-300905692.html [SID1234538954]). Our lead candidate BI-1206 has shown encouraging initial data in hematological cancers, and has now also entered clinical trials in solid cancer," Martin Welschof, CEO BioInvent

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Financial information
Second quarter 2019

Net sales SEK 32.9 (9.8) million.
Loss after tax SEK -32.8 (-43.2) million.
Loss after tax per share before and after dilution SEK -0.07 (-0.12).
Cash flow from operating activities and investment activities SEK -35.3 (-40.1) million.
January – June, 2019

Net sales SEK 50.3 (21.1) million.
Loss after tax SEK -60.6 (-68.1) million.
Loss after tax per share before and after dilution SEK -0.15 (-0.21).
Cash flow from operating activities and investment activities SEK -75.8 (-69.4) million. Liquid funds as of June 30, 2019: SEK 210.3 (144.7) million.
Events in the second quarter

Publication of first data from two parallel Phase l/lla clinical trials of BI-1206.
€0.75 million milestone payment from Mitsubishi Tanabe Pharma Corporation in connection with enrollment of the first patient in a Phase II clinical trial of an antibody identified from BioInvent’s proprietary n-CoDeR antibody library. (R)
The rights issue and directed issue completed in April, amounted to in total SEK 220.0 million after issue expenses.
Events after the reporting period

Acceptance by FDA of an IND (Investigational New Drug) application for a Phase I/IIa clinical trial of BI-1206 in combination with pembrolizumab in solid tumors.
Selection of the first target discovered by BioInvent’s proprietary F.I.R.S.T technology platform under the collaboration with Pfizer Inc, triggering a payment from Pfizer to BioInvent of $0.3 million. (R)
$0.5 million milestone payment from XOMA Corporation related to the acceptance by FDA of an IND application for TAK-169.
Notice of allowance from the USPTO for patent application relating to the lead program BI-1206. (R)
BioInvent’s partner Oxurion reported topline month 3 results of Phase lla Study Evaluating THR-317 in Combination with Ranibizumab, for Diabetic Macular Edema.
(R)= Regulatory event
Comments from the CEO

BioInvent made significant progress in the second quarter and we executed our activities according to plan.

In particular, initial data from the two parallel Phase I/IIa trials of our lead product BI-1206 further supported its development as a potential first-in-class therapeutic with a unique mechanism of action. It was encouraging to see that the analysis at current doses showed depletion of peripheral B cells. The next step is now to define the optimal dose.

We are encouraged by the current data for our lead compound BI-1206 in hematological cancer, but it is important to emphasize that BioInvent is much more than just one program. We have put tremendous efforts into our pre-clinical portfolio and especially into our BI-1206 program in solid tumors. Therefore, it was very rewarding that the FDA approved our IND application for a Phase I/IIa study and I am pleased that this program now has advanced into clinical stage.

These efforts targeting solid tumor indications demonstrate the depth of our pipeline and the productivity of our proprietary F.I.R.S.T platform technology. Through our technology we can simultaneously identify targets and high-quality antibodies that bind to them, generating potentially promising new drug candidates.

In the quarter our n-CoDeR antibody library and our F.I.R.S.T platform received further validation when Pfizer selected its first target under the agreement signed in December 2016. Furthermore, the acceptance by the FDA of an IND application for TAK-169 was another recognition for our technology.

Taken together, these milestones demonstrate the strength of our platform – producing novel antibody-based cancer therapies, broadening our own pipeline and opening up for more licensing and partnering.

Martin Welschof
CEO

Contact
Any questions regarding this report will be answered by Martin Welschof, CEO, +46 (0)46 286 85 50, [email protected]. The report is also available at www.bioinvent.com.

BioInvent International AB (publ)
Co. reg. no. 556537-7263
Address: Sölvegatan 41, 223 70 Lund
Tel.: +46 (0)46 286 85 50
[email protected]

On August 22, 2019 Perrigo Company plc (NYSE; TASE: PRGO), reported that CEO and President, Murray S. Kessler and CFO, Ray Silcock, will host one-on-one meetings at the Barclay’s Global Consumer Staples Conference on September 5, 2019 in Boston (Press release, Perrigo Company, AUG 22, 2019, View Source [SID1234538952]).

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Mr. Kessler will also present at the 17th Annual Morgan Stanley Global Healthcare Conference at 9:10 am EST on Tuesday, September 10, 2019 in New York City. Interested parties can access the presentation webcasts at View Source

On August 22, 2019 Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of patients diagnosed with cancer, reported that clinical data highlighting real-world performance of the Company’s Target Selector platform for detecting actionable biomarkers in lung cancer patients will be presented at the 2019 IASLC World Conference on Lung Cancer being held September 7-10, 2019 at the Fira Gran Via Exhibition and Conference Center in Barcelona, Spain (Press release, Biocept, AUG 22, 2019, View Source [SID1234538951]). The poster features clinical experience data from over 1,400 blood samples drawn from patients diagnosed with non-small cell lung cancer (NSCLC) and collected and shipped using Biocept’s CEE-Sure specimen collection tubes, specifically designed for liquid biopsy testing. Abstracts for posters to be presented at this conference can be found at library.iaslc.org.

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Poster presentation details are as follows:

Title: The Dynamic Range of Mutant Allele Fraction Detected in Patients with NSCLC: Clinical Experience Data and Clinical Implications
Session Category/Title: P1.14/Targeted Therapy Session
Session Date and Time: Sunday September 8, 2019, 09:45am-18:00pm (CEST)
Location: Fira Gran Via Conference Center, Exhibit Hall, Poster Session P1.14

"To date, our clinical experience has demonstrated consistent performance for detecting actionable mutations in the ctDNA of patients with NSCLC as low as 0.01% mutant allele frequency," said Biocept’s Senior Vice President and Senior Medical Director Veena Singh, MD. "The ability to detect mutations at such low levels can serve to expand the cohort of patients that could potentially benefit from the use of targeted therapies and to monitor their progression or therapeutic response, as these patients might be missed with less sensitive technologies. We are also pleased to demonstrate the robust performance of our CEE-Sure blood collection tubes which are designed to stabilize cells in a given blood sample to minimize the presence of non-tumor DNA in the plasma fraction. We believe that our collection tube technology can contribute to a higher level of sensitivity in liquid biopsy testing."

"We are very pleased to highlight the robust real-world performance of our Target Selector ctDNA assays for lung cancer, as well as the utility of our CEE-Sure blood collection tubes at this year’s World Conference on Lung Cancer," said Biocept’s President and CEO Michael Nall. "We believe that these results add to the body of evidence supporting the clinical benefits of our proprietary molecular diagnostic technologies and services, and further distinguish our novel platform in the growing liquid biopsy segment."

On August 22, 2019 Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) reported that the Company will participate in the following conferences in September (Press release, Portola Pharmaceuticals, AUG 22, 2019, View Source [SID1234538950]).

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Citi’s 14th Annual Biotech Conference on Wednesday, September 4, 2019, in Boston, MA. The Company will conduct one-on-one meetings with institutional investors at this conference.

Morgan Stanley’s 17th Annual Global Healthcare Conference on Tuesday, September 10, 2019, at 11:45 a.m. Eastern Time in New York, NY. The Company will participate in a fireside chat presentation at the conference, which will be webcast live and available for replay in the Investor Relations section of the Portola website (www.portola.com).

On August 22, 2019 Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) reported positive top-line results from a comparative clinical study evaluating the efficacy and safety of ABP 798, a biosimilar candidate to Rituxan (rituximab), compared to Rituxan in patients with CD20-positive B-cell non-Hodgkin’s lymphoma (Press release, Amgen, AUG 22, 2019, View Source [SID1234538949]). The primary endpoint, an assessment of overall response rate (ORR) by week 28, was within the prespecified margin for ABP 798 compared to Rituxan, showing clinical equivalence. Safety and immunogenicity of ABP 798 were comparable to Rituxan.

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This is the second of two studies intended to support regulatory submissions for ABP 798. The first study was conducted in patients with moderate-to-severe rheumatoid arthritis (RA) and met the primary endpoint of pharmacokinetic similarity. This RA study demonstrated clinical equivalence within the prespecified efficacy margin, and a similar safety and immunogenicity profile.

"Today’s results with ABP 798 demonstrate another positive development from Amgen’s robust pipeline of biosimilar medicines and we look forward to working with regulatory agencies to bring this treatment to patients," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We continue to leverage our deep expertise and heritage in biologics across innovative and biosimilar medicines as part of our commitment to providing a range of treatment options for patients with the most serious diseases, including cancer."

ABP 798 is being developed as a biosimilar candidate to Rituxan, an anti-CD20 monoclonal antibody that is approved in many regions for the treatment of adult patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, moderate-to-severe rheumatoid arthritis, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.

Amgen has a total of 10 biosimilars in its portfolio, including three that are approved in the United States (US).

About the JASMINE Study
The JASMINE study was a randomized, double-blind comparative clinical study (study number NCT02747043) that evaluated the efficacy, safety and immunogenicity of ABP 798 compared to rituximab in patients with non-Hodgkin’s lymphoma. There were 256 adult patients enrolled and randomized to receive either ABP 798 or rituximab at a dose of 375 mg/m2 administered as an intravenous (IV) infusion once weekly for four weeks followed by dosing at weeks 12 and 20. The primary endpoint of the study was risk difference of overall response rate.

About Non-Hodgkin’s Lymphoma
Non-Hodgkin’s lymphoma is a type of cancer that originates in the lymph system, part of the body’s immune system, and occurs when the body produces too many abnormal lymphocytes, a type of white blood cell.1,2 Non-Hodgkin’s lymphoma is one of the most common cancers in the U.S., and about 85 percent of cases originate in B cells.3,4 There are several subtypes, and follicular lymphoma is one of the most common.2

About ABP 798
ABP 798 is being developed as a biosimilar candidate to Rituxan (rituximab), an anti-CD20- monoclonal antibody that is approved in many regions for the treatment of adult patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, moderate-to-severe rheumatoid arthritis, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis. The active ingredient of ABP 798 is a monoclonal antibody that has the same amino acid sequence as Rituxan.

About the Amgen and Allergan Collaboration
In December 2011, Amgen and Allergan plc. (then Watson Pharmaceuticals, Inc.) formed a collaboration to develop and commercialize, on a worldwide basis, four oncology antibody biosimilar medicines. This collaboration reflects the shared belief that the development and commercialization of biosimilar products will not follow a pure brand or generic model and will require significant expertise, infrastructure, and investment to ensure safe, reliably supplied therapies for patients. Under the terms of the agreement, Amgen assumes primary responsibility for developing, manufacturing and initially commercializing the oncology antibody products.

About Amgen Biosimilars
Amgen is committed to building upon Amgen’s experience in the development and manufacturing of innovative human therapeutics to expand Amgen’s reach to patients with serious illnesses. Biosimilars will help to maintain Amgen’s commitment to connect patients with vital medicines, and Amgen is well positioned to leverage its nearly four decades of experience in biotechnology to create high-quality biosimilars and reliably supply them to patients worldwide.

For more information, visit www.amgenbiosimilars.com and follow us on www.twitter.com/amgenbiosim.