On January 30, 2020 Autolus Therapeutics plc (Nasdaq: AUTL) reported additional data regarding its ongoing Phase 1/2 clinical trial of its next-generation programmed T cell therapy, AUTO3, to treat adults with relapsed/refractory diffuse large B cell lymphoma (DLBCL) (Press release, Autolus, JAN 30, 2020, View Source [SID1234553737]). The data is to be presented in a keynote lecture titled "Improved CAR T cell approaches for lymphoid malignancies," by Dr. Martin Pulé, clinical senior lecturer in the Dept. of Hematology at UCL Cancer Institute and chief scientific officer of Autolus Therapeutics at the EHA (Free EHA Whitepaper)-EBMT 2nd European CAR T Cell Meeting to be held on January 30, 2020 at 17:15 P.M. CET in Stiges (Barcelona), Spain.

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"The incremental update in the AUTO3 trial presented at this year’s European CAR T Cell Meeting continue to support the encouraging early indications of durability and high level of activity previously reported. Together with the encouraging signs of a manageable safety profile in adult patients with DLBCL, these early data for AUTO3 show the potential for a differentiated product profile," said Dr. Christian Itin, chairman and chief executive officer of Autolus.

"I’m pleased to be presenting today an encouraging data update from our ALEXANDER Trial of AUTO3, our CD19/CD22 dual-targeting CAR-T product candidate in DLBCL," said Dr Martin Pulé, founder and chief scientific officer of Autolus. "Together with the data we have generated to date for AUTO1 in acute lymphoblastic leukemia (ALL) patients, we now have two programs specifically designed for the development of respective hematological malignancy."

As of the date cut-off date of January 21, 2020 (data availability as of January 28, 2020), 18 patients in the ALEXANDER Phase 1/2 clinical trial of AUTO3 were evaluable for safety and efficacy with minimum 28-day follow-up. In the cohorts dosed at 450 x 106 AUTO3 cells plus pembrolizumab, five out of seven patients (ORR=71%) achieved a response (complete response + partial response) and four out of seven patients (CRR=57%) achieved a complete response. Across all dose levels, seven out of eight complete responders (87%) had ongoing complete responses at a median follow up of six months (range of 1 month – 18 months). All seven out of seven complete responders (100%) treated with AUTO3 and pembrolizumab have ongoing complete responses as of January 21, 2020 at a median follow up of three months (range of one month – 18 months). AUTO3 was generally well tolerated, with no patients experiencing dose limiting toxicity, and there were no treatment-related deaths. One patient experienced Grade 4 lung infection due to para-influenza virus that was possibly considered to be related to treatment and the patient is recovering. Such infections are a common event in late stage DLBCL patients. No patients experiencing Grade 3 or

higher Cytokine Release Syndrome (CRS) were reported with primary treatment (one patient experienced Grade 3 CRS on retreatment), and one of 18 patients experienced a Grade 3 neurotoxicity that resolved swiftly with administration of steroids. As of the data cut-off, no patient has experienced neurotoxicity of any grade in cohorts treated with AUTO3 and pembrolizumab.

On January 30, 2020 Isofol Medical AB (publ) (Nasdaq First North Premier: ISOFOL), reported that over 200 patients of the planned 440 has been randomized in the global Phase 3 AGENT Study (Press release, Isofol Medical, JAN 30, 2020, View Source [SID1234553731]). The study has over 80 clinical sites in the U.S., Canada, Europe, Australia and Japan. The target of 330 patients randomized for the interim analysis is expected to be achieved in the second quarter of 2020.

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Over 200 patients are now randomized in the Phase 3 AGENT Study, a registration clinical trial of arfolitixorin in first-line metastatic colorectal cancer (mCRC) patients. The study is progressing according to plan at clinical sites worldwide.

Next important milestone – the start of the interim analysis process, is expected in the fourth quarter 2020. The interim analysis will commence after having received clinical data from the last treated patient of the 330 patients. It is expected that the Data Safety Monitoring Board (DSMB) will take approximately 12 weeks to conclude and report their analysis.

"We are pleased that 200 patients have been randomized and that our Phase 3 AGENT study is progressing according to plan. Our focus now is on keeping high pace to be able to start the interim analysis in mid H2 2020, which will be a significant milestone for Isofol," says Ulf Jungnelius, Chief Executive Officer.

Isofol has previously informed that the Phase 3 AGENT study will expand to clinical sites in Japan and Australia, after positive feedback from regulatory authorities in Japan (PMDA) and Australia (TGA). As announced recently, the first patient was enrolled in Australia in January 2020.

Two DSMB meetings have been conducted since the initiation of the study, the most recent in December 2019, and no safety concerns have been reported and the DSMB has recommended continuation of the study.

The information was submitted for publication, through the agency of the contact person set out above, at 08:30 CET on January 30, 2020.

About arfolitixorin

Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global Phase 3 study, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit all patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.

On January 30, 2020 Getinge reported Our organic sales growth continued in the fourth quarter and it was particularly good to see the strong performance of our three largest markets – the US, China and Germany," says Mattias Perjos, President & CEO (Press release, Getinge, JAN 30, 2020, View Source [SID1234553730]). "We improved the margins and the cash flow both in the quarter and for the full year, and the balance sheet was strengthened."

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The order intake for the business area Surgical Workflows was slightly lower than Q4 2018, mainly related to the weak start to the quarter in Americas and APAC. The quarter ended on a strong note for Getinge and total order bookings were better than at the end of 2018. In 2020 net sales is expected to increase organically by 2-4%.

The gross margin for the quarter was positively impacted by a favorable sales mix, higher productivity and currency effects.

"This has contributed to a strengthened operating margin year-on-year. It is positive that we are starting to see the results of our focused efforts and we are now entering 2020 with continuous focus on strengthening the business and on creating increased value for our customers", says Mattias Perjos.

October – December 2019 in brief

Net sales increased by 1.8% organically and the order intake rose by 0.9% organically.
Adjusted gross profit amounted to SEK 4,304 M (3,790) and the margin was 50.6% (48.0). IFRS 16 had a positive effect of SEK 31 M on adjusted gross profit.
Adjusted EBITA amounted to SEK 1,673 M (1,412) and the adjusted EBITA margin was 19.7% (17.9). IFRS 16 had a positive effect of SEK 4 M on adjusted EBITA.
Adjusted earnings per share amounted to SEK 3.84 (3.47). The effect of IFRS 16 was SEK -0.01 per share.
The acquisition of Applikon Biotechnology B.V. – a leading company in advanced bioreactor systems for biopharmaceutical research and production – was completed after the end of the reporting period (January 3, 2020).
January – December 2019 in brief

Net sales increased by 3.9% organically and the order intake rose by 4.1% organically.
Adjusted gross profit amounted to SEK 13,401 M (11,943) and the margin was 50.5% (49.4). IFRS 16 had a positive effect of SEK 116 M on adjusted gross profit.
Adjusted EBITA amounted to SEK 3,310 M (2,689) and the adjusted EBITA margin was 12.5% (11.1). IFRS 16 had a positive effect of SEK 13 M on adjusted EBITA.
Adjusted earnings per share amounted to SEK 7.02 (5.91). The effect of IFRS 16 was SEK -0.03 per share.
A dividend per share of SEK 1.50 (1.00) is proposed, which amounts to SEK 409 M (272).
Teleconference

A conference call will be held on January 30, 2020 at 10.00-11.00 a.m. CET hosted by Mattias Perjos, President & CEO and Lars Sandström, CFO.

On January 30, 2020 Isofol Medical AB (publ) (Nasdaq First North Premier: ISOFOL), reported that the recruitment and treatment of patients in the company’s Phase 1/2a study with arfolitixorin has been completed (Press release, Isofol Medical, JAN 30, 2020, View Source [SID1234553729]). Totally 101 patients have been treated at 10 hospitals in the Nordic countries and Europe. The final analysis has started and study data is expected to be presented at ESMO (Free ESMO Whitepaper) 2020.

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Ulf Jungnelius, M.D., Chief Executive Officer of Isofol, comments: "ISO-CC-005 has fulfilled its purpose by determining the dose we have chosen for further development in our Global Phase 3 AGENT study. Our focus now is taking the AGENT study in goal and submitting the results for a market approval. "

Isofol’s target with the ISO-CC-005 study was to develop an effective and safe dose of arfolitixorin for continued clinical development. An expanded patient group to determine the safety profile of arfolitixorin in combination with the today’s standard of care in first-line metastatic colorectal cancer, has now been conducted in accordance with protocol and the study has fulfilled its purpose and concluded.

The information was submitted for publication, through the agency of the contact person set out above, at 08:15 CET on January 30, 2020.

About arfolitixorin

Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global Phase 3 study, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit all patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.

On January 30, 2020 Medivir AB (Nasdaq Stockholm: MVIR) reports that the MIV-818 patent portfolio has been reinforced by the issue of notices of allowance from the European Patent Office and the Japanese Patent Office for the MIV-818 composition-of-matter and liver cancer treatment claims (Press release, Medivir, JAN 30, 2020, View Source [SID1234553728]).

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Corresponding notices of allowance or patent grants have already been issued in USA, Australia, Indonesia, Israel, Philippines, Russia, Singapore and South Africa. Applications are pending in a large number of other countries in Asia and around the world. The patents will be in force until August 2035.

– "It is comforting that our lead program MIV-818 can lean on such a solid intellectual property platform", says Dr. Uli Hacksell, CEO of Medivir.

For further information, please contact:

Uli Hacksell, CEO, Medivir AB, phone: +46(0)8-5468-3100.

About MIV-818

MIV-818 is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted, orally administered drug to benefit patients with HCC and other forms of liver cancer. A phase I study in patients with liver cancer is ongoing.