On May 14, 2019 ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported its operational and financial results for the three months ended March 31, 2019 (Press release, ProMIS Neurosciences, MAY 14, 2019, View Source [SID1234536274]).

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"Over the course of the first quarter of 2019, the value of our unique discovery and development platform was further evidenced as we made considerable progress in expanding our portfolio of opportunities in neurodegenerative diseases," stated Eugene Williams, ProMIS’ Executive Chairman. Antibody candidates selectively targeting toxic forms of alpha synuclein for Parkinson’s disease (PD) and toxic, aggregated forms of TDP43 for amyotrophic lateral sclerosis (ALS) were identified and further characterized to support ongoing pharmaceutical partnering discussions."

Corporate Highlights

In January 2019, we completed a private placement of 9,560,000 common share units at a price of $0.23 per unit resulting in gross proceeds of approximately $2,198,800. Each unit consisted of one common share and one common share warrant. The common shares are subject to a four-month hold period from the date of issuance. The expiry of the warrant is subject to acceleration under certain conditions.
In February 2019, we announced the identification of several antibody drug candidates showing best-in-class selectivity for toxic forms of alpha synuclein compared to other therapeutic antibodies in development for PD.
Following this announcement, Dr. Neil Cashman, our CSO presented further results of the Company’s PD program at the International AD/PD 2019 Conference on March 31. The data presented showed how our novel drug discovery and development platform created antibodies that: 1) selectively bind to toxic forms of alpha synuclein while sparing healthy forms of alpha synuclein that are critical for proper cell metabolism and communication, and 2) block the neurotoxicity and the spread of the toxic forms of alpha synuclein in vitro.
In January 2019, we appointed Timothy G. Rothwell to our Business Advisory Board. Mr. Rothwell is a highly accomplished pharmaceutical leader with more than 30 years of experience directing the development and commercialization of new therapies.
Financial Results

Results of Operations – Three months ended March 31, 2019 and 2018

Net loss for the three months ended March 31, 2019 was $2,446,577, compared to a net loss of $1,556,872 for the three months ended March 31, 2018, respectively. Included in the net loss amount for the three months ended March 31, 2019 were non-cash expenses of $263,872, representing share-based compensation and amortization of an intangible asset, compared to $329,011 for the three months ended March 31, 2018. The increase in the net loss in the three months ended March 31, 2019 reflects the costs associated with operating the Company’s AD therapeutics program, increased contracted research and consultant salaries and associated costs, supporting its patent portfolio and general corporate expenditures.

Research and development expenses for the three months ended March 31, 2019 were $1,770,653, as compared to $698,007 in the three months ended March 31, 2018. The increase in research and development expense for the three months ended March 31, 2019 is primarily attributed to increased spending on external contract research organizations for internal programs, higher contracted research salaries and associated costs, patent costs, and higher share-based compensation.

General and administrative expenses for the three months ended March 31, 2019 were $675,924, as compared to $858,870 in the three months ended March 31, 2018. The decrease in general and administrative expense for the three months ended March 31, 2019 is primarily attributable to decreased share-based compensation offset by increased consultant salaries and associated costs.

Outlook

As a prelude to the first PMN310 clinical trial in AD, we anticipate using a novel biomarker approach that may show evidence of slowing of neuronal death early in the development program. To accomplish this, we plan to initiate a natural history evaluation of biomarker changes in untreated, early AD patients.

We will also continue to further characterize the potential benefits of our programs selectively targeting toxic aggregates of TDP43 in ALS and toxic forms of alpha synuclein in PD to further support ongoing pharmaceutical partnering discussions.

On May 14, 2019 Scholar Rock Holding Corporation (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported financial results for the quarter ended March 31, 2019 and highlighted recent progress and upcoming milestones for its pipeline programs (Press release, Scholar Rock, MAY 14, 2019, View Source [SID1234536295]).

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"2019 is off to a great start with the initiation of patient dosing in our Phase 2 TOPAZ trial of SRK-015 in SMA and the presentation of additional preclinical data outlining the potential of SRK-181 to expand the number of cancer patients who can benefit from checkpoint blockade therapies," said Nagesh Mahanthappa, Ph.D., President and CEO of Scholar Rock. "We remain focused on advancing these exciting programs while building an organization and team dedicated to the mission of developing novel therapies that can make a meaningful difference in the lives of patients."

Company Highlights and Upcoming Milestones

SRK-015 Program:

Commenced Patient Enrollment and Dosing in the TOPAZ Phase 2 Clinical Trial for SRK-015. In May, Scholar Rock announced the initiation of patient enrollment and dosing in the Phase 2 proof-of-concept trial to assess the safety and efficacy of SRK-015 in patients with Type 2 and Type 3 Spinal Muscular Atrophy (SMA). Approximately 55 patients are anticipated to be enrolled in the U.S., Canada, and Europe across three distinct and parallel cohorts and treated with SRK-015 either as a monotherapy or in conjunction with an approved survival motor neuron (SMN) upregulator therapy. The primary efficacy endpoints will measure motor function through clinically meaningful outcome measures validated in SMA, such as the Hammersmith Functional Motor Scale Expanded (HFMSE) in non-ambulatory SMA and the Revised Hammersmith Scale (RHS) in ambulatory SMA, over a 12-month treatment period.

Preliminary pharmacokinetics (PK) and pharmacodynamics (PD) data from a subset of patients are anticipated by the end of 2019. Interim safety and efficacy results for a subset of patients with six months of treatment exposure are expected in the first half of 2020 with top-line data for the 12-month treatment period expected beginning in the fourth quarter of 2020.

Plan to Identify Second Indication for SRK-015 in 2020. Scholar Rock continues to see multiple potential opportunities for which SRK-015 could offer clinical benefit and is assessing additional potential clinical settings in which the selective inhibition of the activation of myostatin may offer therapeutic benefit.

SRK-181 Program:

Presented Additional Preclinical Data Further Supporting the Potential of SRK-181 to Overcome Primary Resistance to Checkpoint Blockade Therapy (CBT). At the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, Scholar Rock presented additional preclinical data showing that co-administration of SRK-181-mIgG1 (murine version of SRK-181) with an anti-PD1 antibody can drive tumor regression or control, resulting in a significant survival benefit compared to anti-PD1 monotherapy. This was demonstrated in the MBT-2 (bladder cancer) and Cloudman S91 (melanoma) mouse models that express TGFβ1, as well as in the EMT6 (breast cancer) mouse model, which expresses both TGFβ1 and TGFβ3 isoforms. Immune response data also revealed that combination treatment leads to infiltration and expansion of CD8+ T cells and a reduction of immunosuppressive myeloid cells, suggesting TGFβ1’s multiple contributions to primary resistance to CBT.

Plan to Initiate Phase 1 Clinical Trial of SRK-181 in Patients with Solid Tumors in Mid-2020. In March 2019, Scholar Rock selected SRK-181, a highly specific inhibitor of TGFβ1 activation, as the first product candidate in its TGFβ1 cancer immunotherapy program based on the strength of preclinical data and human translational insights. Scholar Rock plans to develop SRK-181 for the treatment of tumors resistant to CBTs, such as anti-PD(L)1 antibodies, and to initiate a Phase 1 trial in patients with solid tumors in mid-2020.

First Quarter 2019 Financial Results

For the quarter ended March 31, 2019, net loss was $10.8 million or $0.42 per share compared to a net loss of $8.9 million or $3.18 per share for the quarter ended March 31, 2018.

Research and development expense was $10.7 million for the quarter ended March 31, 2019 compared to $6.7 million for the quarter ended March 31, 2018. The increase year-over-year reflects preclinical and manufacturing costs for SRK-181, research costs associated with earlier pipeline programs, and increased personnel-related costs, slightly offset by a decrease year-over-year in manufacturing costs associated with SRK-015.

General and administrative expense was $4.1 million for the quarter ended March 31, 2019 compared to $2.3 million for the quarter ended March 31, 2018. The increase year-over-year was primarily attributable to increased headcount, stock compensation, and higher operational fees associated with being a public company.

As of March 31, 2019, Scholar Rock had cash, cash equivalents, and marketable securities of $159.7 million, compared to $175.6 million as of December 31, 2018.

On May 14, 2019 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, reported that it will host an Investor Day in Paris to present a comprehensive corporate update, with a focus on its advancing R&D pipeline (Press release, Ipsen, MAY 14, 2019, View Source [SID1234536234]).

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David Meek, Chief Executive Officer of Ipsen stated: "The business momentum of Ipsen is strong, delivering industry-leading top-line growth and investing to build an innovative and sustainable pipeline. The execution of our R&D strategy over the last two years through accelerating key internal programs and externally sourcing innovation has significantly strengthened the focus and value of our pipeline.

"Ipsen currently has five new chemical entities in clinical development, nine significant regulatory submissions planned from 2019 to 2022 and several mid-to-late-stage program readouts in the coming months. We remain committed to executing on our top-line, bottom-line and pipeline growth strategy to create and deliver long-term value to patients and shareholders."

In Rare Diseases, palovarotene is a late-stage and largely de-risked drug candidate for the treatment of rare and extremely disabling bone disorders with no current treatment options. Palovarotene has Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations and is supported by robust clinical data. The company expects to submit an NDA to the FDA in the second half of 2019 for the first indication of fibrodysplasia ossificans progressiva (FOP).

In Neuroscience, Ipsen is pursuing two new therapeutic indications to maximize the potential of Dysport. The Company is also leveraging its research and development expertise building upon its neurotoxin franchise to advance its proprietary next-generation neurotoxin program with a fast-acting neurotoxin to enter Phase 2 clinical development in the second half of 2019 and a long-acting neurotoxin in preclinical development.

In Oncology, there are numerous ongoing mid-to-late-stage programs to broaden the scope of Cabometyx (cabozantinib) and Onivyde (irinotecan liposomal). The Phase 3 CheckMate 9ER trial in combination with nivolumab has the potential to strengthen Cabometyx’s presence in the first-line renal cell cancer market, with top-line results expected in the first half of 2020. In addition, the Phase 3 trial in combination with atezolizumab for first-line hepatocellular carcinoma has the potential to expand the use of Cabometyx earlier in the treatment paradigm and to serve as the registrational trial to enter China.

Regarding Onivyde, the interim analysis of the Phase 2 combination trial for the treatment of first-line metastatic pancreatic cancer indicates encouraging results on the disease control rate and has been accepted as an oral presentation by the ESMO (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer in July 2019. There is also an ongoing Phase 2 trial for second-line small cell lung cancer with top-line results expected in the second half of 2019.

In earlier-stage Oncology development, Ipsen is advancing its innovative Systemic Radiation Therapy program with satoreotide (IPN 1070 and IPN 1072) which is expected to move into a Phase 2/3 trial in neuroendocrine tumors by the first quarter of 2020 and IPN 1087 which is currently in Phase 1 development for pancreatic cancer. Both are platform technologies with the possibility to expand to additional solid tumors and to provide precision targeted treatment to patients.

_______________
1 Assuming current level of exchange rates

Ipsen will also execute on its external innovation and business development model in its key therapeutic areas, building on its strong balance sheet and cash flow generation to acquire assets and invest in R&D pipeline for long term shareholders’ value.

Along with an R&D pipeline update, Ipsen will also provide updates on its corporate strategy, commercial highlights of its key Specialty Care products, and new objectives on its capital allocation strategy and mid-term financial outlook.

2022 Financial outlook

Ipsen provides its 2022 financial outlook to reflect the strong momentum of its Specialty Care business and the impact from the acquisition of Clementia closed in April 2019:

Group Net Sales around €3.2 billion2
Core Operating margin greater than 32.0% of net sales
This outlook includes only the existing commercial portfolio of products under current approved indications and assumes the approval and launch of palovarotene in FOP indications3 only. It assumes the earliest possible entry of somatostatin analog (SSA) generics based on market intelligence. It does not include the potential short-term, low single-digit Core Operating margin dilution of business development transactions to further accelerate building an innovative and sustainable pipeline.

Webcast and Conference call

Ipsen will host an audio and video webcast and conference call of the Investor Day on Tuesday 14 May 2019 at 1:00 p.m. (CEST, BST+1) available at www.ipsen.com. Participants should dial in to the call approximately 5 to 10 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: 8463129

A recording will be available for 7 days on Ipsen’s website.

On May 14, 2019 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, reported its financial results for the quarter ended March 31, 2019 and provided a corporate update (Press release, BioLineRx, MAY 14, 2019, View Source;p=RssLanding&cat=news&id=2398500 [SID1234536259]).

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Highlights and achievements during the first quarter 2019 and subsequent period:

Presented successful engraftment data from Phase 3 GENESIS trial of BL-8040 in multiple myeloma patients at 45th Annual Meeting of European Society for Blood and Marrow Transplantation. These data follow previously announced successful mobilization data which led the Data Monitoring Committee to recommend proceeding to the randomized placebo-controlled Part 2 of the study.

Received FDA Orphan Drug Designation for BL-8040 for the treatment of pancreatic cancer. This is an addition to prior orphan drug designations that have been granted for BL-8040 in AML and stem cell mobilization.

Received approval from the FDA for Investigational New Drug (IND) application for AGI-134, which will enable expansion of the ongoing Phase 1/2a study, currently being carried out in the UK and Israel, to the US by the first half of 2020.

"As we progress through 2019, we are approaching important data milestones with our lead program, the CXCR4 antagonist BL-8040, in two cancer indications with high unmet medical need," said Philip Serlin, Chief Executive Officer of BioLineRx. "In pancreatic cancer, an extremely difficult cancer indication to treat, we are optimistic that we can build upon the encouraging results that we observed in the dual combination arm of our ongoing COMBAT/KEYNOTE-202 Phase 2a study of BL-8040 and Merck’s KEYTRUDA with the addition of chemotherapy, and we are eager to see top-line results for the triple combination arm of the study by the end of this year. Similarly, in consolidation AML, we look forward to important data from our Phase 2b trial that will help inform later stage development of this promising program."

"In parallel, our second clinical candidate, AGI-134, is progressing through a phase 1/2a clinical trial, and we anticipate initial safety data later this year as we look to efficiently advance this promising candidate into the second part of the study where we can assess efficacy in multiple tumor types. We continue to execute on our clinical development plan, and believe these upcoming data readouts can drive near-term value creation while generating additional partnering interest," Mr. Serlin concluded.

Expected significant milestones through end of 2019 and early 2020:

Top-line results from the Phase 2 triple combo pancreatic cancer trial of BL-8040, KEYTRUDA and chemotherapy under the Company’s collaboration with Merck in the second half of 2019;

Potential interim results from the Phase 2 AML consolidation study in the second half of 2019;

Initial safety results from part 1 of the Phase 1/2a trial of AGI-134 in the second half of 2019;

Top-line results from one or more of the ongoing solid tumor trials under the Company’s collaboration with Genentech, potentially by the end of 2019 or early 2020.

Financial Results for the Quarter Ended March 31, 2019

Research and development expenses for the quarter ended March 31, 2019 were $4.4 million, a decrease of $0.7 million, or 13.4%, compared to $5.1 million for the comparable period in 2018. The decrease resulted primarily from a decrease in share-based compensation.

Sales and marketing expenses for the quarter ended March 31, 2019 were $0.3 million, a decrease of $0.2 million, or 47%, compared to $0.5 million for the comparable period in 2018. The decrease resulted primarily from a one-time compensation payment in the 2018 period, as well as a decrease in share-based compensation.

General and administrative expenses for the quarter ended March 31, 2019 were $0.9 million, a decrease of $0.2 million, or 13.5% compared to $1.1 million for the comparable period in 2018. The decrease resulted primarily from a decrease in share-based compensation.

The Company’s operating loss for the quarter ended March 31, 2019 amounted to $5.6 million, compared with an operating loss of $6.6 million for the comparable period in 2018.

Non-operating expenses amounted to $0.3 million for the quarter ended March 31, 2019, compared with non-operating income of $0.5 million for the comparable period in 2018. Non-operating expenses for the three months ended March 31, 2019 primarily relate to warrant offering expenses offset by fair-value adjustments of warrant liabilities on our balance sheet. Non-operating income for the three months ended March 31, 2018 primarily relate to fair-value adjustments of warrant liabilities on our balance sheet. These fair-value adjustments were highly influenced by the Company’s share price at each period end (revaluation date).

Net financial expenses amounted to $0.2 million for the quarter ended March 31, 2019 compared to an immaterial amount of net financial expenses for the three months ended March 31, 2018. Net financial expenses for the 2019 period primarily relate to interest paid on loans, offset by investment income earned on bank deposits. Net financial expenses for the 2018 period primarily relate to losses recorded on foreign currency hedging transactions, offset by investment income earned on bank deposits.

The Company’s net loss for the quarter ended March 31, 2019 amounted to $6.2 million, similar to the comparable period in 2018.

The Company held $40.6 million in cash, cash equivalents and short-term bank deposits as of March 31, 2019.

Net cash used in operating activities was $4.6 million for the three months ended March 31, 2019, compared with net cash used in operating activities of $6.8 million for the three months ended March 31, 2018. The $2.2 million decrease in net cash used in operating activities during the three-month period in 2019, compared to the three-month period in 2018, was primarily the result of changes in operating asset and liability items between the two periods – i.e., a decrease in prepaid expenses and other receivables in 2019 versus an increase in 2018, as well as a decrease in accounts payable and accruals in 2018.

Net cash used in investing activities was $9.3 million for the three months ended March 31, 2019, compared to net cash provided by investing activities of $8.1 million for the three months ended March 31, 2018. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits.

Net cash provided by financing activities was $14.9 million for the three months ended March 31, 2019, compared to net cash provided by financing activities of $1.4 million for the three months ended March 31, 2018. The increase in cash flows from financing activities reflects the underwritten public offering completed in February 2019.

Conference Call and Webcast Information

BioLineRx will hold a conference call today, May 14, 2019 at 10:00 a.m. EDT. To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0644 internationally. The call will also be available via webcast and can be accessed through the Investor Relations page of BioLineRx’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.

A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx’s website. A dial-in replay of the call will be available until May 16, 2019; please dial +1-888-782-4291 from the U.S. or +972-3-925-5925 internationally.

On May 14, 2019 Medigene AG (FSE: MDG1, Frankfurt, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, reported financial results for the first three months of 2019 and provided a review of recent accomplishments and anticipated upcoming milestones (Press release, MediGene, MAY 14, 2019, View Source [SID1234536275]). The company further adjusted its financial guidance for the fiscal year 2019 following two business transactions announced in the second quarter of 2019.

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Major events since the beginning of 2019:
* Medigene treated the first patient in the Phase I/II clinical trial of the T cell receptor-modified T cell immunotherapy (TCR-T) MDG1011
* Medigene and Roivant affiliate Cytovant entered into a strategic partnership for the research and development of cell therapies in Asia
* bluebird bio presented preclinical data of first TCR candidate from ongoing collaboration with Medigene and announced plans to start clinical development of this MAGE-A4 targeting TCR in 2020
* Medigene licensed a chimeric co-stimulatory receptor to enhance TCR therapies for solid tumors
* Medigene sold the remaining rights and stocks of the legacy product Veregen
* Medigene presented positive results from in vitro tests to assess the potential TCR-mediated off-target toxicity for neuronal cells at the annual meeting of the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) and presented preclinical data on the selective killing of tumor cells by PRAME TCR-transduced T cells at the AACR (Free AACR Whitepaper) conference
* Medigene obtained two European patents for its dendritic cell (DC) vaccine platform and for the TCR building block library to develop neoantigen-specific TCRs
* Medigene appointed Axel-Sven Malkomes as CFO/CBDO

Prof. Dolores Schendel, CEO of Medigene AG, comments: "We have had a very productive start to 2019 with progress in our own clinical projects and in the development of partner programs. Patient treatment in our TCR-T study MDG1011 has started, and we anticipate accelerating patient recruitment following the upcoming expansion of the number of clinical centers in this trial. Additionally, our licensing agreement with Roivant/Cytovant will enable us to generate and deliver our TCR constructs and Dendritic Cell vaccine to Cytovant, who will ultimately develop, manufacture and commercialize these promising immunotherapies for the East Asian patient populations."
"Moreover, we were thrilled that the first TCR discovery project we developed for our partner bluebird bio yielded a TCR candidate displaying convincing preclinical data and has been selected for clinical development by bluebird bio."
"Finally, with the sale of the remaining Veregen rights, we have completed our transformation into a pure-play immuno-oncology company. With an improved financial forecast and sufficient liquid assets, we are well positioned to continue making further progress across our immunotherapy platform and development candidates."

Three months’ financial results:
* Revenue from immunotherapies stable at EUR 1.4 m
* Research and development expenses (R&D) increased as planned by 28% to EUR 5.5 m due to expansion of clinical activities
* EBITDA loss increased as planned by 31% to EUR 5.0 m due to progress in immunotherapy programs
* Net loss for the period increased as planned by 36% to EUR 5.7 m
* Cash and cash equivalents and time deposits of EUR 65.5 m as at March 31, 2019

Financial guidance 2019:

Medigene revises the financial guidance for 2019 published in the 2018 Annual Report following the Roivant/Cytovant partnership in cellular immunotherapies and the sale of remaining rights to Veregen, both closed in April 2019.
* The Company improves its revenue guidance and expects to generate total revenues of between EUR 10 – 11 m (previous guidance: EUR 5.5 – 6.5 m) in 2019, approximately EUR 5 m anticipated from the cell therapy deal with Roivant/Cytovant.
* Medigene continues to expect research and development expenses of EUR 24 -29 m in 2019 due to progress of the preclinical and clinical development programs including manufacturing costs for clinical trial material.
* The Company also confirms its EBITDA-guidance and continues to expect a loss at EBITDA level of EUR 23 – 28 m, as the additional revenue from the Roivant/Cytovant deal will be compensated by a non-cash effect of EUR -4 and -5 m resulting from the Veregen deal, as announced in the press release from April 8, 2019.

Outlook immunotherapies:
Medigene confirms its outlook for immunotherapies published in the Annual Report 2018:

T cell receptor-modified T cells (TCR-Ts)

Current Phase I/II clinical trial with MDG1011: In addition to the three active study centers to date, it is anticipated that up to five new centers will begin recruiting patients in the second quarter and early third quarter of 2019. The University Clinic of Dresden was the first new study center to open. In 2019, the focus of the trial will be the recruitment of the first dose cohorts to assess the safety and tolerability of the treatment with MDG1011.

Development of additional TCR candidates: In 2019, in addition to the MDG1011 clinical trial, Medigene will work on characterizing new TCR candidates for future clinical trials under the responsibility and funding of Medigene and collecting preclinical data to prepare further clinical TCR trials.

Evaluation of HA-1 TCR as a potential clinical candidate: Medigene is assessing the in-licensed HA-1-specific T cell receptor to determine if it is a suitable candidate for expansion of Medigene’s TCR-T clinical development program.

Optimization of future TCR therapies for solid tumors: In addition, the chimeric co-stimulatory receptor (the PD-1/4-1BB molecule) exclusively licensed from HMGU will be assessed in combination with Medigene’s tumor-specific T cells (TCR-Ts) in preclinical models in order to optimize future TCR therapies for solid tumors.

TCR partnerships: Within the framework of the collaboration entered into with Roivant/Cytovant, Medigene will now, together with the collaboration partner, undertake preparations to generate TCR constructs tailored specifically to Asian patients using its proprietary TCR discovery platform. In addition, Medigene continues the successful collaboration with bluebird bio.

IIT from academic partners: In addition to the Company’s own development activities, the start of the academic investigator initiated TCR-modified T cell therapy clinical trial (IIT) under the responsibility of Max-Delbrück-Center and Charité University Hospital in Berlin, Germany is expected.

Dendritic cell vaccines (DCs)

Conclusion of the Phase I/II clinical trial at the end of 2019: Medigene will continue the current Phase I/II clinical trial for DC vaccines for the treatment of acute myeloid leukemia (AML) as planned and bring it to a conclusion at the end of 2019. The data from the interim analysis will be presented beforehand at the Annual Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) taking place from June 13 – 16 in Amsterdam. The final data will be available towards the end of 2019/beginning of 2020.

The full version of the quarterly statement 3M-2019 can be downloaded here: View Source

Conference call and webcast: A telephone conference (webcast) in English will be held today at 3:00 pm CET (Munich/Frankfurt) / 9:00 am EST (New York) and transmitted live via webcast. Access and transmission of the synchronized presentation slides and a recording of the presentation is available on the homepage of Medigene at View Sourcewebcasts/