On March 28, 2019 Cytonus Therapeutics Inc., a biotechnology company developing new platforms for delivering biologics, reported that it will be presenting preclinical data for its Cargocyte technology platform at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting March 29 – April 3, at the Georgia World Congress Center in Atlanta (Press release, Cytonus Therapeutics, MAR 28, 2019, View Source [SID1234534723]).

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Cargocytes are engineered allogenic cell lines that can carry a variety of payloads like small molecule compounds, gene editing therapies, therapeutic RNAs, and powerful biologics such as immune modulating cytokines, antibodies and oncolytic viruses.

"Cytonus Therapeutics will be presenting preclinical data from our growing oncology pipeline that supports the versatility of our Cargocytes as a groundbreaking allogeneic, off-the-shelf, immune-therapy platform," said Remo Moomiaie-Qajar, M.D., president and CEO of Cytonus. "Our preclinical results in our Triple Negative Breast Cancer model experiments are impressive and exciting. We are able to demonstrate that 40 percent of our animals being treated with our Cargocyte associated IL-12 are showing no sign of disease more than 260 days post treatment where as our control animals are dying typically 25 to 30 days into the experiments. These experiments are still ongoing and our mice are doing well. We have replicated these studies multiple times and have found the pattern to exist."

Details of the presentation:

Abstract Title: Cargocytes: A novel cell therapy platform to drive anti-tumor immunity

Session Category: Immunology
Session Title: Late-Breaking Research: Immunology 1
Session Date and Time: Monday, April 1, 2019 8:00 AM – 12:00 PM
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 41
Poster Board Number: 12
Permanent Abstract Number: LB-067
Cytonus will also be presenting at:
Association Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper), April 29-May 2, 2019 in Washington, D.C.
Bio International Convention, June 3-6, 2019 in Philadelphia

On March 28, 2019 Evotec AG (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported financial results and corporate updates for the fiscal year ended 31 December 2018 (Press release, Evotec, MAR 28, 2019, View Source;announcements/press-releases/p/evotec-ag-fiscal-year-2018-results-accelerated-growth-and-strong-long-term-outlook-5795 [SID1234534685]).

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STRONG FINANCIAL PERFORMANCE
Group revenues up 42% to € 375.4 m (2017: € 263.8 m); € 364.0 m Revenues from customer contracts, excluding revenues from recharges according to IFRS 15
Adjusted Group EBITDA up 67% to € 95.5 m (2017: € 57.2 m); € 92.0 m excluding one-off effects from tax credits and receivables
Total R&D expenses of € 35.6 m (2017: € 17.6 m) including € 12.7 m of infectious diseases-related expenses fully reimbursed by Sanofi ("partnered R&D")
Strong strategic liquidity position of € 149.4 m
OPERATIONAL AND SCIENTIFIC EXCELLENCE – "EXCELLENCE SQUARED"
Multiple new and extended drug discovery and development alliances
INDiGO roll-out and integration of high-end CMC offering
Leading application of Artificial Intelligence ("AI") in drug discovery projects
Continued strong performance of high-throughput ADME-tox testing (Cyprotex)
Significant progress in partnered co-owned pipeline; Clinical Phase I & Phase II starts
Multiple important milestone achievements, also in iPSC-based alliances
Continued expansion of iPSC leadership and focus on patient-centric approaches
Initiation of world-leading protein degradation platform
Global roll-out and expansion of Academic BRIDGE model
CORPORATE
Creating important footprint in infectious disease through acquisition of Evotec ID (Lyon)
Conversion into European Company (SE) expected to become effective by end of March 2019
FINANCIAL GUIDANCE 2019 – CONTINUED STRONG LONG-TERM GROWTH
Group revenues expected to increase by approx. 10% (2018: € 364.0 m excluding revenues from recharges according to IFRS 15)
Adjusted Group EBITDA expected to improve by approx. 10% (2018: € 92.0 m excluding one-off effects from tax credits and receivables)
Unpartnered research and development expenses expected to be approximately € 30-40 m (2018: € 22.9 m)

1. STRONG FINANCIAL PERFORMANCE
In 2018, Evotec’s Group revenues increased by 42% to € 375.4 m (2017: € 263.8 m). This increase was driven primarily by the strong performance in the base business, increased milestone payments and a positive first full-year contribution from the acquired business of Aptuit (€ 117.7 m) while contributing only € 46.0 m in 2017 (mid-August to December 2017). Revenues from milestones, upfronts and licences amounted to € 29.5 m, an increase of 6% in comparison to the previous year (€ 27.8 m). Milestones in 2018 resulted mainly from the collaborations with Bayer in endometriosis/chronic cough and kidney diseases, and from Evotec’s iPSC-based collaborations with Celgene in neurodegeneration as well as Sanofi in diabetes.

In 2018, Evotec focused its R&D expenses of € 35.6 m primarily on its iPSC research, projects in metabolic diseases, oncology and R&D platforms (2017: € 17.6 m). Furthermore, Evotec increased its R&D expenses significantly in infectious disease (ID)-related research following the acquisition of Evotec ID (Lyon) from Sanofi. These additional ID-related R&D expenses (€ 12.7 m) are fully reimbursed by Sanofi in context of the five-year agreement and are recognised under other operating income. Thus, they are not detrimental to the operating result and the adjusted EBITDA.

In 2018, the Group’s selling, general and administrative ("SG&A") expenses increased as expected by 35% to € 57.0 m (2017: € 42.4 m). This increase resulted primarily from first full-year SG&A expenses of Aptuit, additional Evotec ID (Lyon) costs as well as M&A-related and increased business development and administrative expenses in response to overall Company growth. However, this increase remained sub-proportional to revenue and adjusted EBITDA growth rates.

Evotec recorded a significant step-up in the adjusted Group EBITDA for 2018 to € 95.5 m (2017: € 57.2 m), yielding an adjusted EBITDA margin of 25.4% (2017: 21.7%). This adjusted EBITDA contains positive one-off effects from receivables and tax credits relating to prior periods in the amount of € 3.5 m. Without this effect, the adjusted EBITDA would amount to € 92.0 m.

Evotec’s operating result amounted to € 77.5 m in 2018 (2017: operating result of € 36.7 m) being positively impacted by the income from bargain purchase and higher R&D tax credits as well as positive one-off effects from receivables and tax credits. In 2018, an income from bargain purchase of € 15.4 m was recorded for the acquisition of Evotec ID (Lyon) as the purchase price was below the net assets acquired. The Company’s net result in 2018 amounted to € 84.1 m (2017: net result of € 23.2 m), being impacted by most recent acquisitions and the strong performance of the base business.

Evotec ended 2018 with a liquidity of € 149.4 m (2017: € 91.2 m), which was composed of cash and cash equivalents (€ 109.0 m) and investments (€ 40.4 m). The strong increase in liquidity in 2018 resulted mainly from the prepayments received from Celgene and the upfront received from Sanofi for Evotec ID (Lyon) (€ 61 m), off-set by net loan repayments (€ 78.2 m).

2. OPERATIONAL AND SCIENTIFIC EXCELLENCE – "EXCELLENCE SQUARED" IN EVT EXECUTE & EVT INNOVATE
The EVT Execute segment demonstrated strong progress in 2018 with new and extended alliances (e.g. CHDI, C4X, Dermira, Ferring, Forge, LEO Pharma, Novo Nordisk). In 2018, Evotec was involved in more than 700 customer alliances and recorded a repeat business of 92%. Following the launch of its INDiGO services in early 2018, Evotec was able to sign multiple new INDiGO agreements with e.g. Ankar, Astex, Carna Biosciences, Inflazome, and Yumanity. The high-throughput ADME-tox testing business of Cyprotex continued its excellent performance.

In EVT Innovate, 2018 was characterised by important progress in its strategic partnerships (iPSC neurodegeneration alliance with Celgene; iPSC diabetes alliance with Sanofi; kidney disease alliance with Bayer) as well as the signing of new partnerships, e.g. two new partnerships with Celgene in oncology as well as a new partnership with Almirall in dermatological diseases. Furthermore, the Company is blending artificial intelligence ("AI") and machine-learning tools into many of its biology- and chemistry-driven platforms to further accelerate and increase effectiveness in the process and continues to place great emphasis on patient-centric approaches to drug discovery. The partnered clinical projects are progressing to plan.

In 2018, Evotec’s academic BRIDGE model continued to attract significant interest from academia and industry partners.

3. CORPORATE
ACQUISITION OF EVOTEC ID (LYON)

Effective 01 July 2018, Evotec acquired 100% of the shares of Evotec ID (Lyon), the former Sanofi infectious disease unit in Lyon. The collaboration resulted in an upfront payment of € 61 m (€ 43 m in cash plus € 18 m cash of the acquired company) to Evotec. Evotec is eligible for significant further long-term funding from Sanofi in order to ensure the support and progression of a world-leading portfolio in this field.

4. FINANCIAL GUIDANCE 2019 – CONTINUED STRONG LONG-TERM GROWTH
Revenues, research and development expenses and adjusted EBITDA remain the financial key performance indicators of the Evotec Group.

For the financial year 2019, the Management Board expects Evotec to show Group revenue growth from contracts with customers without revenues from recharges of approx. 10%. This revenue growth is based on visibility of the current order book, expected new contracts, contract extensions and milestone opportunities. Projections are based on constant 2018 exchange rates.

Evotec’s adjusted Group EBITDA from 2018 includes one-off effects associated to the business years 2016 and 2017 in the amount of € 3.5 m. Without these one-off effects, the adjusted Group EBITDA in 2018 would amount to € 92.0 m. Against this number, Evotec’s adjusted Group EBITDA is expected to improve by approx. 10% in 2019 compared to 2018.

Evotec will continue to significantly invest in its own "unpartnered" research and development (R&D) efforts to create a long-term pipeline of first-in class assets and platforms. In addition, the Company will also continue to invest in its infectious disease-related efforts. ID-related R&D expenses of approx. € 35 m will be completely cost-covered by its partner Sanofi ("partnered R&D"). For better comparison against previous years, Evotec will focus its guidance and reporting during the course of 2019 on the "unpartnered R&D" part, estimated at approx. € 30-40 m.

WEBCAST/CONFERENCE CALL
The Company is going to hold a conference call to discuss the results as well as to provide an update on its performance. Furthermore, the Management Board will present an outlook for fiscal year 2019. The conference call will be held in English.

Conference call details

Date: Thursday, 28 March 2019

Time: 02.00 pm CET (09.00 am EDT, 01.00 pm GMT)

From Germany: +49 69 201 744 220

From France: +33 170 709 502

From Italy: +39 02 3600 6663

From the UK: +44 20 3009 2470

From the USA: +1 877 423 0830

Access Code: 75185877#

A simultaneous slide presentation for participants dialling in via phone is available at View Source

Webcast details

To join the audio webcast and to access the presentation slides you will find a link on our home page www.evotec.com shortly before the event.

A replay of the conference call will be available for 24 hours and can be accessed in Europe by dialling +49 69 20 17 44 222 (Germany) or +44 20 3364 5150 (UK) and in the USA by dialling +1 844 307 9362. The access code is 315534320#. The on-demand version of the webcast will be available on our website: View Source

On March 28, 2019 Marker Therapeutics, Inc. (NASDAQ:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported a business and clinical update, as well as an overview of upcoming milestones for 2019 (Press release, TapImmune, MAR 28, 2019, View Source [SID1234534708]).

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"Our MultiTAA T cell therapies have continued to generate positive and compelling clinical data across various indications in several ongoing investigator-sponsored clinical trials led by Baylor College of Medicine (BCM). We plan to advance a Phase 2 Company-sponsored clinical trial in post-transplant acute myeloid leukemia (AML)—a disease area and patient population for which there are limited treatment options. We expect to finalize our clinical trial protocol in AML by the end of the second quarter of 2019 and to submit our IND in the third quarter, with the first patient enrolled by the end of the year," said Peter L. Hoang, President & CEO of Marker Therapeutics.

Continued Mr. Hoang: "While our T cell therapies remain our primary clinical focus, we are also advancing our T cell vaccine candidates, TPIV200 and TPIV100/110, for the treatment of ovarian and breast cancers. Overall, there are two Phase 2 Company-sponsored studies ongoing for TPIV200 in triple-negative breast cancer and ovarian cancer, and we anticipate reporting interim data from the ovarian cancer Phase 2 study in Q4 2019."

PROGRAM HIGHLIGHTS AND CURRENT UPDATES

Multi-Antigen Targeted (MultiTAA) T Cell Therapies

·Acute Myeloid Leukemia Data
oThe Company reported a clinical update from a Phase 1 clinical trial in post-transplant AML in oral and poster presentations at ASH (Free ASH Whitepaper) in December and ASBMT and CIBMTR in February. Results from the BCM-sponsored study showed that the treatment is safe and well-tolerated and has the potential to mediate a meaningful anti-tumor effect, as well as significant in vivo expansion of T cells. Among the highlights from the study, 11 out of 13 patients dosed with MultiTAA T cells as a maintenance therapy after receiving allogeneic stem cell transplant remain alive, ranging from 6 weeks to 2.5 years post-infusion. Nine of these patients have never relapsed after MultiTAA therapy and continue to remain in complete remission (CR). Patients with active disease, overall survival ranged from 4 and 21 months as compared to 4.5 months in historical results after standard of care.

oMarker will pursue post-transplant AML as the lead indication of its T cell therapy program. Based on findings from various dose cohorts in the Phase 1 BCM-sponsored trial, Marker has made a strategic decision to focus on post-transplant AML, and plans to initiate pre-IND discussions with the U.S. FDA in the second quarter of 2019, with an IND submission for the Company-sponsored potentially pivotal Phase 2 study in the third quarter. The multicenter study will evaluate clinical efficacy of MultiTAA specific T cells in patients with AML or myelodysplastic syndromes (MDS) in both the adjuvant and active disease setting, following an allogeneic hematopoietic stem cell transplant (HSCT). The dose administered will be the maximum tolerated dose from the BCM-sponsored Phase 1 trial. In the adjuvant setting, patients will be randomized 2:1 to either MultiTAA therapy at approximately 90 days post-transplant versus standard of care observation, while the active disease patients will receive MultiTAA T cells as part of a single-arm group.

·Lymphoma Data
As reported in January, 2019:

oTo date, no relapses have been observed for any patient entering a complete response (CR);
oPatients with active disease are now between 1 and 5+ years in CR after infusion of MultiTAA cells (ongoing);
oSeveral patients with stable disease show potential durable disease stabilization, with two patients experiencing stable disease for over 9 months and 24 months, respectively;
oResponses in all six patients who entered CR were associated with an expansion of infused T cells, as well as induction of antigen spreading.

·Acute Lymphoblastic Leukemia (ALL) Data
As reported at ASBMT and CIBMTR in February:

oPatients are now up to 28 months in continued complete remission (CCR);
oThe one patient who experienced relapse displayed mixed donor/recipient chimerism after transplant, but remained in CCR for 6 months;
oPatients who remain in CCR have been durable for between 4 to 28 months, with a median of 16 months.

·Multiple Myeloma Data
As the Company reported in January, 2019, ten patients with active disease have been treated, including:

oOne patient with a CR durable for approximately 29 months before relapse, was subsequently given a second treatment infusion of MultiTAA T cells, resulting in stable disease for 3 months (ongoing) after the second treatment;
oTwo patients achieved partial responses (PR) of between 14 and 22 months (ongoing) as of last follow-up;
oAll seven remaining patients experienced stabilization of disease following infusion of MultiTAA cells initially. Three patients developed transient disease stabilization of between 3-7 months with subsequent progression, and four patients have ongoing stable disease.
oEight patients were treated in remission, with a median follow-up of 21 months. Only one patient has relapsed to date;
oCorrelative studies show significant expansion of MultiTAA T cells, as well as significant evidence of epitope spreading with expansion of endogenous T cells specific for tumor-associated antigens that were not targeted by the MultiTAA product.

Overall, across all indications, MultiTAA therapy appears to be safe and well-tolerated, with no incidence of cytokine release syndrome, neurotoxicity or any other serious adverse events related to the therapy.

T Cell Based Vaccines

·Ovarian Cancer Data
·As the Company reported in January, 2019, it has completed enrollment in its Phase 2 study in ovarian cancer using TPIV200 as a maintenance therapy for patients in their first remission after surgery and platinum-based chemotherapy. To date, Marker has enrolled, randomized, and treated 120 patients at 17 clinical sites. The study completed enrollment six months faster than anticipated and the Company expects to reach its planned interim analysis trigger of 55 patients who have progressed before the end of 2019.

·Triple Negative Breast Cancer Data
·The Company also reported initial findings from its interim analysis of its dose-finding study in triple negative breast cancer, using TPIV200 as a maintenance therapy for patients in remission following first-line therapy. The four-arm study included low- and high-dose TPIV200 with or without cyclophosphamide. Of 27 patients evaluated to date for immunogenicity, 26 showed significant immune response to the vaccine treatment. Of 80 patients treated at 11 clinical sites, 11 have shown disease progression to date following treatment with TPIV200.

Marker continues to advance the development of its proprietary PolyStart platform, a nucleic acid-based technology with the potential to increase the potency of our vaccines by conferring a four-fold increase in expression of target-cell-specific, naturally processed antigenic epitopes on a cell’s surface. This approach boosts helper and/or long-lived killer T cells, enabling their potential to effectively seek out and destroy target cells.

CASH POSITION AND GUIDANCE

Marker reported cash and cash equivalents totaling $61.7 million as of December 31, 2018. Based on current operating plans, Marker expects that current cash resources will be sufficient to meet operating requirements into Q4 of 2020.

UPCOMING NEAR-TERM POTENTIAL MILESTONES

·Pre-IND discussions for AML with the U.S. FDA in Q2;
·First update in solid tumor program in Q2 concurrently with a major medical meeting;
·IND submission for Company-sponsored Phase 2 AML study in Q3, with first patient enrolled by end of 2019;
·Interim analysis readout in the TPIV200 ovarian trial in Q4;
·Overall update on ongoing clinical trials in cell therapy at end of 2019.

Business Update Call and Webcast

Marker management will host business update conference call and webcast today at 5:00 p.m. EDT. To access the call, participants should dial 1-855-238-2333 (domestic) or 1-412-317-5215 (international) and refer to the "Marker Therapeutics, Inc. call." The webcast will be accessible in the Investors section of the Company’s website at www.markertherapeutics.com. The archived webcast will be available for replay on the Marker website approximately two hours after the event.

On March 28, 2019 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that it has entered into a global development and commercialization agreement with AstraZeneca for Daiichi Sankyo’s lead antibody drug conjugate (ADC), [fam-] trastuzumab deruxtecan (DS-8201), currently in pivotal development for multiple HER2 expressing cancers including breast and gastric cancer, and additional development in non-small cell lung and colorectal cancer (Press release, Daiichi Sankyo, MAR 28, 2019, https://www.prnewswire.com/news-releases/daiichi-sankyo-and-astrazeneca-announce-global-development-and-commercialization-collaboration-for-daiichi-sankyos-her2-targeting-antibody-drug-conjugate-fam–trastuzumab-deruxtecan-ds-8201-300820766.html [SID1234534724]).

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Daiichi Sankyo and AstraZeneca will jointly develop and commercialize [fam-] trastuzumab deruxtecan as a monotherapy or a combination therapy worldwide, except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and the supply of [fam-] trastuzumab deruxtecan.

As announced separately by Daiichi Sankyo, a Biologics License Application (BLA) submission to U.S. FDA for [fam-] trastuzumab deruxtecan in HER2 positive metastatic breast cancer previously treated with ado trastuzumab emtansine (T-DM1) will be accelerated to the first half of fiscal year 2019.

Designed using Daiichi Sankyo’s DXd proprietary ADC technology, [fam-] trastuzumab deruxtecan is comprised of a humanized HER2 antibody attached to a novel topoisomerase I inhibitor payload by a tetrapeptide-based linker. It is designed to target and deliver chemotherapy inside cancer cells and reduce systemic exposure to the cytotoxic payload compared to the way chemotherapy is commonly delivered.

"[Fam-] trastuzumab deruxtecan is the flagship asset in our oncology pipeline created by our relentless pursuit of science and technology, the most important strengths of our company," said George Nakayama, Representative Director, Chairman and CEO of Daiichi Sankyo Company, Limited. "Through the strategic collaboration with AstraZeneca, a company with a wealth of global experience and expertise in oncology, we will combine our respective skill sets to maximize the value of [fam-] trastuzumab deruxtecan, and accelerate the establishment of our global oncology business. By aiming to provide new treatment options across a wide range of cancers as soon as possible, we will maximize our contribution to patients with cancer and their families around the world."

"We believe that [fam-] trastuzumab deruxtecan could become a transformative new medicine for the treatment of HER2 positive breast and gastric cancers," said Pascal Soriot, Chief Executive Officer, AstraZeneca. "In addition, [fam-] trastuzumab deruxtecan has the potential to redefine breast cancer treatment as the first therapy for HER2 low expressing tumors. It also has the potential to treat other HER2 mutated or HER2 overexpressing tumors, including lung and colorectal cancers. We are proud to be working with Daiichi Sankyo, a long-term collaborator of AstraZeneca in other disease areas."

Financial Terms
Under the terms of the agreement, AstraZeneca will pay Daiichi Sankyo an upfront payment of $1.35 billion. Contingent payments of up to $5.55 billion include $3.8 billion for achievement of future regulatory milestones and other contingencies, as well as sales-related milestones of up to $1.75 billion. Total payments under the agreement have the potential to reach up to $6.90 billion.

Daiichi Sankyo and AstraZeneca will share equally development and commercialization costs as well as profits from [fam-] trastuzumab deruxtecan worldwide, except for Japan. Daiichi Sankyo is expected to book sales in U.S., certain countries in Europe, and certain other markets where Daiichi Sankyo has affiliates. AstraZeneca is expected to book sales in all other markets worldwide, including China, Australia, Canada and Russia.

The impact on Daiichi Sankyo’s consolidated results for the fiscal year ending March 31, 2019 is immaterial because the upfront payment will be booked in revenue over the period in which Daiichi Sankyo has contractual performance obligations under this collaboration. The collaboration is expected to contribute to enhancing the corporate and shareholder value of Daiichi Sankyo over the medium to long term.

About [Fam-] Trastuzumab Deruxtecan
[Fam-] trastuzumab deruxtecan (DS-8201; [fam-] trastuzumab deruxtecan in U.S. only; trastuzumab deruxtecan in other regions of world) is the lead product in the investigational ADC Franchise of the Daiichi Sankyo Cancer Enterprise. ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells.

A broad and comprehensive development program with [fam-] trastuzumab deruxtecan is underway in North America, Europe and Asia including five pivotal studies. [Fam-] trastuzumab deruxtecan is in pivotal phase 3 development in previously treated HER2 low expressing metastatic breast cancer versus investigator’s choice (DESTINY-Breast04); phase 3 development in HER2 positive metastatic breast cancer versus ado-trastuzumab emtansine (T-DM1) (DESTINY-Breast03); and phase 3 development in HER2 positive metastatic breast cancer versus investigator’s choice post T-DM1 (DESTINY-Breast02). [Fam-] trastuzumab deruxtecan also is in pivotal phase 2 clinical development for HER2 positive metastatic breast cancer resistant or refractory to T-DM1 (DESTINY-Breast01); pivotal phase 2 development for HER2 positive advanced gastric cancer resistant or refractory to trastuzumab (DESTINY-Gastric01); phase 2 development for HER2 expressing advanced colorectal cancer; phase 2 development for metastatic non-squamous HER2 overexpressing or HER2 mutated NSCLC; and, phase 1 development in combination with nivolumab for HER2 expressing metastatic breast and bladder cancer.

[Fam-] trastuzumab deruxtecan has been granted Breakthrough Therapy designation for the treatment of patients with HER2 positive, locally advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab and have disease progression after T-DM1, and Fast Track designation for the treatment of HER2 positive unresectable and/or metastatic breast cancer in patients who have progressed after prior treatment with HER2 targeted therapies including T-DM1 by the U.S. Food and Drug Administration (FDA). [Fam-] trastuzumab deruxtecan has received SAKIGAKE Designation for the treatment of HER2 positive advanced gastric or gastroesophageal junction cancer by the Japan Ministry of Health, Labour and Welfare (MHLW).

[Fam-] trastuzumab deruxtecan is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.

On March 28, 2019 Biokin Pharmaceutical Co. Ltd., ("Biokin Pharma") a leading pharmaceutical company with operations in China and U.S., and Cryoport, Inc. (NASDAQ: CYRX) (NASDAQ: CYRXW) ("Cryoport"), the world’s leading temperature-controlled logistics company dedicated to the life sciences industry, reported Cryoport’s full suite of temperature-controlled solutions will support Biokin Pharma’s pending Phase I and II clinical trials in immuno-oncology in both the U.S. and China (Press release, Biokin Pharma, MAR 28, 2019, View Source [SID1234554051]).

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Biokin Pharma, is a biopharmaceutical company based in China focused on the treatment of cancer through developing novel therapeutic antibodies and antibody-drug conjugates ("ADC"s). Led by a group of highly experienced immuno-oncology scientists, the company utilizes several technology platforms to develop world class advanced antibody-based drug therapies. Its wholly-owned subsidiary SystImmune Inc. ("SystImmune"), which is funded in part by OrbiMed, was formed to advance its mission in the United States. Partnering with Cryoport will enable Biokin Pharma and SystImmune to utilize Cryoport’s full range of temperature-controlled logistics solutions to support its drug manufacturing processes across the globe. These solutions include the Cryoport Express shippers, the industry-leading Cryoportal Logistics Management Platform, Smartpak II Condition Monitoring System and 24/7/365 logistics support.

"We are pleased to choose the highly reliable condition- and time-sensitive logistics solutions provided by Cryoport to support our upcoming clinical studies using Bispecific and Multi-specific Antibody, ADC, and T-cell Therapy," said Dr. Yi Zhu, Chairman of Biokin Pharma and its U.S. subsidiary, Systimmune of Seattle, WA. "By relying on Cryoport’s excellent solutions, Biokin Pharma and Systimmune will continue to have the best possible viability and recovery of critical cells, vectors, antibodies and other materials, even after time-consuming international or domestic transportation, to ensure the best outcome for our patients."

"As the regenerative medicine market rapidly matures, the demand for our technology-driven solutions to support trials across the globe is growing. We look forward to working alongside Biokin Pharma and its U.S. subsidiary to ensure reliable, secure logistics support for their temperature-sensitive commodities as they advance the development of potentially life-saving therapies," said Mark Sawicki, PhD, Chief Commercial Officer of Cryoport.