On December 11, 2023 IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, reported positive updated data from its Phase 1 investigator-sponsored trial of INB-100 in patients with hematologic malignancies (Press release, In8bio, DEC 11, 2023, View Source [SID1234638424]). The data, which will be presented in a poster presentation at the 65th ASH (Free ASH Whitepaper) Annual Meeting & Exposition this evening, demonstrated that 100% of evaluable leukemia patients (n=10) treated remained alive, progression-free, and in durable complete remission (CR) as of November 3, 2023. The Company believes this data indicate the curative potential of INB-100 to provide durable relapse free periods for high-risk or relapsed AML and other hematologic malignancies undergoing hematopoietic stem cell transplantation (HSCT). The CRs to date, combined with INB-100’s benefit/risk profile are encouraging for the treatment of hematological malignancies and the trial is being expanded by ten patients at Dose Level (DL) 2, the recommended Phase 2 dose (RP2D). Additional expansion patient enrollment is on-going and updated data is expected to be presented at medical meetings in 2024.

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"With more patients and a longer observation period, we are excited to report that 100% of evaluable dosed patients continue to remain in morphological complete remission, with six patients remaining alive and relapse free beyond one year," said Trishna Goswami, MD, Chief Medical Officer at IN8bio. "Leukemic relapse is the leading cause of death in patients undergoing HSCT and prevention of relapse remains a high unmet need. In this trial, the first three patients were high-risk or relapsed AML patients with complex cytogenetics. We are happy to report two of the patients remain alive and relapse free for over three years, and the third is now past two years. Furthermore, INB-100 has demonstrated for the first time, the in-vivo expansion and persistence of an allogeneic, or donor-derived, cellular therapy at 365 days with blood levels of gamma-delta T cells surpassing levels previously observed to be associated with greater survival."

"Our team is excited by the potential safety, efficacy and durability of this novel cellular therapy and the possibility to improve the likelihood of cure for patients with blood cancers undergoing stem cell transplantation," said Dr. Joseph McGuirk, the Schutte-Speas Professor of Hematology-Oncology, Division Director of Hematological Malignancies and Cellular Therapeutics and Medical Director, Blood and Marrow Transplant at The University of Kansas Cancer Center and the Principal Investigator on the study. "Relapse post stem cell transplant remains the primary cause of treatment failure and mortality. The results of this clinical trial are very encouraging and hold great promise that a novel cellular therapy using donor-derived gamma-delta T cells may prevent relapse, resulting in improved relapse free survival for patients with hematologic malignancies."

Summary of Data Presented at ASH (Free ASH Whitepaper)

The latest INB-100 trial data on immune reconstitution showed significant allogeneic gamma-delta T cell expansion and persistence in patients through the first 365 days post-treatment.

Patients who received INB-100 treatment at DL 2 exhibited gamma-delta T cell levels:

An average of 48.9x greater at 60 days compared with patients undergoing haploidentical HSCT without INB-100 therapy.
An average of 7.6x greater than those achieved in DL 1, which continues to demonstrate a dose-response related to the gamma-delta T cell infusion.
An average of 2.7x greater at 365 days than levels found in DL 1, which is above levels previously associated with improved survival outcomes.
Other observations:

Elevations in CD4+, CD8+ T cells, NK cells and B cells have also been observed, indicating a broad positive immune response and stable reconstitution of the immune system post-transplant.
New cytokine data following gamma-delta T cell infusion demonstrate peripheral increases in pro-inflammatory cytokines in the plasma, such as interferon-gamma, IL-6 and IL-15 early post-infusion, demonstrating broad immune activation.
Updated safety data includes three additional patients since in April 2023 (as of November 3, 2023):

Low grade (1-2) acute graft versus host disease (GvHD) observed in 60% of patients treated. Cases were all steroid responsive.
No dose limiting toxicities (DLTs) have been observed.
All evaluable patients across DL 1 and DL 2 remained on study and in CR, with two patients now remaining progression free for over 3 years.
Treated patients have remained progression free for 42.7, 40.3, 28.6, 14.3, 12.2, 12.0, 9.0, 5.6, 5.3 and 4.9 months, respectively.
Conference Call Details
IN8bio will host a conference call and webcast tomorrow, Tuesday, December 12, 2023, at 8:30 am ET to review the updated clinical data from the ASH (Free ASH Whitepaper) presentation. The webcast can be accessed by clicking this link and can also be accessed on the Events & Presentations page of the Company’s website. To participate in the live call, please register using this link. It is recommended that participants register at least 15 minutes in advance of the call. Once registered, participants will be informed of the dial-in number and will be provided a unique PIN.

About the INB-100 Phase 1 Trial
The Phase 1 clinical trial (NCT03533816) is an investigator-sponsored dose-escalation trial of allogeneic derived, gamma-delta T cells from matched related donors that have been expanded and activated ex vivo and administered systemically to patients with leukemia following HSCT. The single-institution clinical trial is currently being conducted at The University of Kansas Cancer Center (KUCC). The primary endpoints of this trial are safety and tolerability, and secondary endpoints include rates of GvHD, relapse rate and overall survival.

On December 11, 2023 IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, reported that it has entered into a securities purchase agreement with certain healthcare-focused institutional investors to raise up to $46.9 million at increasing valuations that includes initial gross proceeds of $14.4 million, extending the Company’s runway into 2025 (Press release, In8bio, DEC 11, 2023, View Source [SID1234638423]).

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Under the terms of the securities purchase agreement, the Company will sell units comprised of an aggregate of 11,249,588 shares of the Company’s common stock, par value $0.0001 per share, pre-funded warrants to purchase 574,241 shares of common stock, warrants to purchase up to 11,823,829 shares of common stock (the "Series A Ordinary Warrants") and warrants to purchase up to 11,823,829 shares of common stock (the "Series B Ordinary Warrants" and, together with the Series A Ordinary Warrants, the "Ordinary Warrants"). The units will be sold at a purchase price of $1.22 per unit. The pre-funded warrants will have an exercise price of $0.0001 per share. The Series A Ordinary Warrants will have an exercise price of $1.25 per share. The Series B Ordinary Warrants will have an exercise price of $1.50 per share.

IN8bio will receive initial gross proceeds of approximately $14.4 million as a result of the private placement. IN8bio intends to use the net proceeds from the private placement to fund the clinical development of its product candidates and for general corporate purposes.

Investors have committed to exercise the Series A Ordinary Warrants at a purchase price of $1.25 per share for aggregate proceeds of $14.8 million and the issuance of 11.8 million shares of common stock. The mandatory exercise of Series A Ordinary Warrants is subject to the Company’s public announcement of its INB-100 data for the ten currently enrolled patients, should they remain alive and evaluable, covering a period of at least 11 months of long-term follow-up for each patient, along with certain stock price and trading volume requirements.

The Series B Ordinary Warrants allow the Company to redeem such warrants, at a redemption price of $0.01 per Series B Ordinary Warrant. Holders of Class B Ordinary Warrants may choose to exercise such warrants at a purchase price of $1.50 per share prior to such mandatory redemption. The Series B Ordinary Warrant redemption is subject to the Company’s public announcement of its INB-100 data for the ten currently enrolled patients, should they remain alive and evaluable, covering a period of at least 22 months of long-term follow-up for each patient, along with certain stock price and trading volume requirements. Should all holders of Series B Ordinary Warrants choose to exercise such warrants, it would result in aggregate proceeds to the Company of $17.7 million and the issuance of 11.8 million shares of common stock.

The closing of the private placement is subject to customary closing conditions and is expected to occur on or about December 13, 2023.

Cantor Fitzgerald & Co. acted as the sole placement agent for the private placement.

The offer and sale of the foregoing securities is being made in a private placement pursuant to an exemption under the Securities Act of 1933, as amended (the "Securities Act"), and the Securities have not been registered under the Securities Act or applicable state securities laws. The Securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy the Securities, nor shall there be any sale of the Securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On December 11, 2023 Immix Biopharma, Inc. ("ImmixBio", "Company", "We" or "Us" or "IMMX"), a clinical-stage biopharmaceutical company pioneering personalized therapies for oncology and immunology, reported new clinical data from its Phase 1b/2a NEXICART-1 (NCT04720313) study of novel, autologous, BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy, NXC-201, in patients with relapsed/refractory AL Amyloidosis (R/R ALA) at an oral presentation by study investigator Moshe E. Gatt, MD at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting being held in San Diego, CA (Press release, Immix Biopharma, DEC 11, 2023, View Source [SID1234638421]). The updated results include follow-up and clinical data from one new patient. All patients were relapsed/refractory to standard-of-care Dara-CyBorD (daratumumab combined with cyclophosphamide, bortezomib, and dexamethasone) and had experienced a median of 6 prior lines of therapy that failed to stop worsening of disease prior to receiving NXC-201.

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"There is a rising prevalence of relapsed/refractory AL Amyloidosis patients who have no approved options for treatment," said Polina Stepensky, M.D., Director of the Hadassah Medical Organization’s Department of Bone Marrow Transplantation and Immunotherapy for Adults and Children, and principal study investigator. "We continue to be encouraged by NXC-201’s 100% overall response rate, including in this 10th relapsed/refractory AL amyloidosis patient."

"We believe NXC-201 is the first and only CAR-T in clinical development for AL amyloidosis. With our recent IND clearance, we are thrilled to be now activating sites to bring this first-of-a-kind study to U.S. relapsed/refractory AL Amyloidosis patients," said Ilya Rachman, M.D., Ph.D., Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, "We believe NXC-201’s favorable tolerability profile, including ‘Single Day CRS’ and the ability to overcome neurotoxicity, enables a new potential option for relapsed/refractory AL Amyloidosis patients and potential expansion into select autoimmune indications."

At the NXC-201 ASH (Free ASH Whitepaper) 2023 oral presentation, data were presented from 10 relapsed/refractory AL amyloidosis patients (including one new patient) in the ongoing Phase 1b/2a NEXICART-1 study, with median 6 lines of therapy prior to NXC-201. Patients were infused with CAR+T cells at doses of 150 x 106 (n=1), 450 x 106 (n=2), and 800 x 106 (n=7).

Patient characteristics:

90% (9/10) had high-risk cytogenetics
80% (8/10) had cardiac involvement
50% (5/10) had New York Heart Association (NYHA) stage 3 or 4 heart failure (3 stage 4, 2 stage 3)
40% (4/10) had Mayo stage 3 (1 stage 3b, 3 stage 3a) AL amyloidosis disease
40% (4/10) had t(11;14) translocation
Relapsed/refractory to a median 6 lines of prior therapy (range: 3-10)
Safety and efficacy data:

Overall response rate of 100% (10/10)
Complete response + very good partial response rate of 90% (9/10)
Complete response rate of 70% (7/10) (6 out of 7 were MRD 10-5)
Organ response rate of 60% (6/10)
Best responder had a duration of response of 23.7 months as of December 10, 2023, with response ongoing
Transformation to complete response at month 2 observed in a patient with 7 lines of prior therapy and cardiac involvement
There were no immune effector cell-associated neurotoxicity syndrome (ICANS) events
"Single Day CRS": Median CRS duration was 1 day (range: 1-4):
No grade 4 cytokine release syndrome (CRS) events
2 experienced no CRS; 2 experienced grade 1 CRS; 4 Experienced grade 2 CRS; 2 experienced grade 3 CRS
For the 8 patients with cardiac involvement:

Overall response rate of 100% (8/8)
Complete response rate of 63% (5/8) (4 out of 5 were MRD 10-5)
Organ response rate of 63% (5/8)
For the 4 patients with t(11;14) disease:

Overall response rate of 100% (4/4)
Complete response rate of 75% (3/4) (MRD 10-5)
Organ response rate of 50% (2/4)
The NXC-201 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting oral presentation video can be accessed on the ASH (Free ASH Whitepaper) website: View Source

The NXC-201 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting oral presentation can be accessed on the ImmixBio corporate website at this link: View Source

ASH Presentation Details:

Title "Feasibility of a Novel Academic Anti-BCMA Chimeric Antigen Receptor T-Cell (CART) (HBI0101) for the Treatment of Relapsed and Refractory AL Amyloidosis"
Presentation
Date/Time (Pacific Time)
Publication #538
Session Date: Sunday, December 10, 2023
Session Name: 654. MGUS, Amyloidosis and Other Non-Myeloma Plasma Cell Dyscrasias: Clinical and Epidemiological: From Light Chain to Fibril-Novel Diagnostics to Treatments for Amyloidosis
Session Time: 12:00 PM – 1:30 PM PT
Presentation Time: 12:45 PM PT
Presentation
Replay
Accessible at View Source
About NXC-201
NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed/refractory AL amyloidosis, relapsed/refractory multiple myeloma, with potential expansion into autoimmune indications.

NXC-201 has been awarded Orphan Drug Designation (ODD) by the FDA in both AL Amyloidosis and multiple myeloma.

About NEXICART-1
NEXICART-1 (NCT04720313) is an ongoing Phase 1b/2a, open-label study evaluating the safety and efficacy of NXC-201 (formerly HBI0101), in adults with relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis.
The primary objective of the Phase 1b portion of the study is to characterize the safety and confirm the recommended Phase 2 dose (RP2D) of NXC-201. The Phase 1b portion has been successfully completed, with a recommended Phase 2 dose (RP2D) of 800 million CAR+T cells.

The expected primary endpoint for NXC-201 in relapsed/refractory AL Amyloidosis is overall response rate. ImmixBio plans to submit data to the FDA in relapsed/refractory AL amyloidosis once 30-40 patients are treated with NXC-201.
The expected primary endpoint for the Phase 2 portion in relapsed/refractory multiple myeloma is overall response rate and duration of response. ImmixBio plans to submit data to the FDA in relapsed/refractory multiple myeloma once 100 patients are treated with NXC-201.
About AL Amyloidosis
U.S. observed prevalence of relapsed/refractory AL Amyloidosis is growing 12% per year according to Staron, et al Blood Cancer Journal, estimated to reach 29,712 patients in 2023.

The Amyloidosis market was $3.6 billion in 2017, expected to reach $6 billion in 2025, according to Grand View Research. AL amyloidosis is a systemic disorder caused by an abnormality of plasma cells in the bone marrow. Misfolded amyloid proteins produced by these cells cause a buildup of misfolded immunoglobulin proteins in and around tissues, nerves, and organs, gradually affecting their function. This can cause progressive and widespread organ damage and high mortality rates.

On December 11, 2023 Glycotope GmbH (Glycotope) reported that it has signed an agreement with Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) to combine Glycotope’s antibodies with Evotec’s immune cell engager platform for the development of next generation immune cell engaging bispecifics by Evotec (Press release, Glycotope, DEC 11, 2023, View Source [SID1234638420]).

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First generation immune cell engager (ICE) bispecifics have revolutionized liquid tumor therapy but have had limited success so far in solid tumors due to, among other factors, a high risk of off-target toxicity. The ability of Glycotope’s antibodies to target highly specific tumor-associated protein/carbohydrate combined glyco-epitopes (GlycoTargets) means that their combination with the Evotec platform has significant potential to develop next generation ICE bispecifics to address solid tumor indications.

"The applicability of Glycotope antibodies to many different tumor indications, combined with good tumor selectivity makes them ideal targeting moieties for our novel, proprietary immune cell engager platform," stated Dr Cord Dohrmann, Chief Scientific Officer of Evotec SE.

"We are excited about combining these two highly innovative technologies to explore the development of next generation immune cell engaging bispecifics in a range of potential indications, including solid tumors," said Henner Kollenberg, CEO, Glycotope.

"This strategic relationship significantly expands the possible areas of application for our antibodies, and we are delighted to have been able to forge this exciting partnership with Evotec. Combining the unrivaled specificity of our antibodies with Evotec’s ability to create best in class bispecifics provides us with an excellent opportunity to explore potentially life changing treatments for patients across a range of indications," commented Patrik Kehler, CSO, Glycotope.

On December 11, 2023 GSK plc (LSE/NYSE: GSK) reported the European Commission (EC) has granted marketing authorisation for Jemperli (dostarlimab) in combination with carboplatin-paclitaxel (chemotherapy), for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer and who are candidates for systemic therapy (Press release, GlaxoSmithKline, DEC 11, 2023, View Source [SID1234638419]). Additionally, with the authorisation in this indication, the EC’s conditional approval for Jemperli as a monotherapy for treating adult patients with dMMR/MSI-H recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen is now converted to full approval.

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Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: "People living with this type of endometrial cancer typically experience disease progression and poor-long term outcomes with current standard of care. With this approval, we can expand the number of patients who can potentially benefit from treatment with Jemperli in Europe, including patients who are earlier in their journey. We are proud of the recent approvals for Jemperli as we believe that it continues to transform the frontline endometrial cancer treatment landscape and shows promise as a foundational immuno-oncology therapy."

Dr Mansoor Raza Mirza, Chief Oncologist, Copenhagen University Hospital, Denmark and RUBY principal investigator, said: "Today’s European Commission approval is welcomed news as I believe it will define a new standard of care for certain patients with advanced or recurrent endometrial cancer in the EU. The results from the RUBY trial, which led to this approval, underscore the practice-changing potential of dostarlimab for these patients."

The EC authorisation of Jemperli is based on interim analysis results from the dMMR/MSI-H population of Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial, which reflected a robust median duration of follow-up of ≥ 25 months. The trial met its primary endpoint of investigator-assessed progression-free survival (PFS), demonstrating a statistically significant and clinically meaningful benefit in patients treated with Jemperli plus carboplatin and paclitaxel in the dMMR/MSI-H population. In this population, a 72% reduction in the risk of disease progression or death was observed relative to chemotherapy alone (HR: 0.28 [95% CI: 0.16-0.50]).

In a prespecified, exploratory analysis of overall survival (OS) in the dMMR/MSI-H population, the addition of Jemperli to chemotherapy resulted in a 70% reduction in the risk of death relative to chemotherapy alone (HR: 0.30 [95% CI: 0.13-0.70]).

Results were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Plenary and Society of Gynecologic Oncology (SGO) Annual Meeting on 27 March 2023, and simultaneously published in The New England Journal of Medicine.

PFS is one of two primary endpoints in the RUBY Part 1 trial. In a subsequent planned analysis, the RUBY trial met its other primary endpoint of OS, demonstrating a statistically significant and clinically meaningful benefit in the overall patient population.

The safety and tolerability profile for Jemperli plus carboplatin and paclitaxel was generally consistent with the known safety profiles of the individual agents. The most common adverse reactions (≥ 10%) in patients receiving Jemperli plus chemotherapy were rash, hypothyroidism (underactive thyroid), increased alanine aminotransferase or increased aspartate aminotransferase (increased liver enzyme levels in the blood), pyrexia (fever) and dry skin.

About endometrial cancer

Endometrial cancer is found in the inner lining of the uterus, known as the endometrium. Endometrial cancer is the most common gynaecologic cancer in developed countries, with approximately 417,000 new cases reported each year worldwide1, and incidence rates are expected to rise by almost 40% between 2020 and 2040.2,3 Approximately 15-20% of patients with endometrial cancer will be diagnosed with advanced disease at the time of diagnosis.4 An estimated 20-29% of all endometrial cancers are dMMR/MSI-H.5 In the EU4 (France, Germany, Italy and Spain), approximately 3,000 people are estimated to be diagnosed with dMMR/MSI-H primary advanced or recurrent endometrial cancer each year.6

About RUBY

RUBY is a two-part global, randomised, double-blind, multicentre phase III trial of patients with primary advanced or recurrent endometrial cancer. Part 1 is evaluating dostarlimab plus carboplatin-paclitaxel followed by dostarlimab versus carboplatin-paclitaxel plus placebo followed by placebo. Part 2 is evaluating dostarlimab plus carboplatin-paclitaxel followed by dostarlimab plus niraparib versus placebo plus carboplatin-paclitaxel followed by placebo.

The dual-primary endpoints in Part 1 are investigator-assessed PFS based on the Response Evaluation Criteria in Solid Tumours v1.1 and OS. The statistical analysis plan included pre-specified analyses of PFS in the dMMR/MSI-H and overall populations and OS in the overall population. Pre-specified exploratory analyses of PFS and OS in the mismatch repair proficient (MMRp)/microsatellite stable (MSS) population and OS in the dMMR/MSI-H populations were also performed. RUBY Part 1 included a broad population, including histologies often excluded from clinical trials and had approximately 10% of patients with carcinosarcoma and 20% with serous carcinoma. In Part 2, the primary endpoint is investigator-assessed PFS. Secondary endpoints in Part 1 and Part 2 include PFS per blinded independent central review, overall response rate, duration of response, disease control rate, patient-reported outcomes, and safety and tolerability.

RUBY is part of an international collaboration between the European Network of Gynaecological Oncological Trial groups (ENGOT), a research network of the European Society of Gynaecological Oncology (ESGO) that consists of 22 trial groups from 31 European countries that perform cooperative clinical trials, and the GOG Foundation, a non-profit organisation dedicated to transforming the standard of care in gynaecologic oncology.

About Jemperli (dostarlimab)

Jemperli is a programmed death receptor-1 (PD-1)-blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2.7

In the US, Jemperli is indicated in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H), and as a single agent for adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, as determined by a US FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation. The sBLA supporting the new indication in combination with carboplatin and paclitaxel received Breakthrough Therapy designation from the FDA. Jemperli is also indicated in the US for patients with dMMR recurrent or advanced solid tumours, as determined by a US FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. The latter indication is approved in the US under accelerated approval based on tumour response rate and durability of response. Continued approval for this indication in solid tumours may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Jemperli was discovered by AnaptysBio, Inc. and licensed to TESARO, Inc., under a collaboration and exclusive license agreement signed in March 2014. Under this agreement, GSK is responsible for the ongoing research, development, commercialisation, and manufacturing of Jemperli, as well as cobolimab (GSK4069889), a TIM-3 antagonist.

Important Information for Jemperli in the EU

Indication 

Jemperli is indicated:

in combination with carboplatin-paclitaxel, for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer and who are candidates for systemic therapy;
as monotherapy for treating adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen.
Refer to the Jemperli EMA Reference Information for a full list of adverse events and the complete important safety information in the EU.