On February 27, 2019 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported financial results for the fourth quarter and year ended December 31, 2018 and provided a business update (Press release, Adaptimmune, FEB 27, 2019, View Source [SID1234533726]).

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"2018 was a year of strong delivery across the portfolio with record numbers of patients treated in our clinical trials. We moved through the dose escalation portion of our studies with ADP-A2M4 and ADP-A2M10 and we are now treating patients in the expansion phases for both programs. Our third program, ADP-A2AFP, moved to the second dose cohort at target doses of 1 billion cells. We are very pleased to have observed an acceptable safety profile, thus far, with all three programs, showing no evidence of off-target toxicity or alloreactivity," said James Noble, Chief Executive Officer. "We are now able to devote our resources to these programs following the successful transition of NY-ESO to GSK."

"We made equally impressive progress in manufacturing with our in-house facility going from our first ever dose, at the beginning of 2018, to being able to produce target doses for up to 10 patients per month. In the UK, we started up our vector manufacturing that should begin to produce vector later this year. 2019 promises to be a significant year, with data emerging across our portfolio from May onwards. We look forward to reporting clinical data throughout the year," added James Noble.

Clinical momentum

Initial safety testing is complete in the triple tumor and non-small cell lung cancer (NSCLC) studies with ADP-A2M10, as well as the basket study with ADP-A2M4. All three studies are enrolling and treating patients with up to 10 billion cells in the expansion phases with no pre-determined stagger between dosing required.

In 2018, the Safety Review Committee (SRC) endorsed dose escalation through Cohorts 1, 2, and 3 of these studies, after reviewing safety data from 16 patients treated in the ADP-A2M10 studies and nine patients in the ADP-A2M4 study.

In the hepatocellular carcinoma study with ADP-A2AFP, the SRC endorsed escalation to safety Cohort 2 to treat patients with a target dose of 1 billion cells.

To date, across all four studies, most adverse events have been consistent with those typically experienced by cancer patients undergoing cytotoxic chemotherapy or other cancer immunotherapies with no evidence of alloreactivity or toxicity related to off-target binding.

Building an integrated company

Since the opening of the Navy Yard facility in January 2018, Adaptimmune can now manufacture cells for up to 10 patients per month, and this is scalable to 100 patients per month without significant capital expenditure. Further, an additional 10 patients per month can be treated with cells produced at a third-party vendor HCATs. Both the Navy Yard and HCATs facilities are now able to routinely produce cells to meet target doses across a broad range of solid tumors. This capacity will allow Adaptimmune to service its existing and planned clinical trials.

With respect to vector, Adaptimmune is well supplied as its own vector manufacturing has completed its first engineering run with first production anticipated in 2019, as well as production in place at a third-party vendor. The vendor has already produced vector for ADP-A2M10, ADP-A2M4, ADP-A2AFP, and next generation SPEAR T-cells.

In light of the Company’s increased clinical focus, Rafael Amado assumed the new role of President of R&D last year to bring the clinical and research functions under a single leadership, facilitating alignment and integration of all parts of the R&D structure.

The Company is working with more than 20 active clinical trial sites at leading cancer centers in the US, Canada, and the EU. In Europe, the infrastructure has been tested and has delivered the first doses to patients with additional patients being enrolled in the UK and Spain. Adaptimmune has also reached agreement on an expanded collaboration with MD Anderson Cancer Center (Houston, TX) to further enhance the Company’s translational research capabilities.

While progressing studies with ADP-A2M10, ADP-A2M4, and ADP-A2AFP as well as planning for the next stage of clinical development, including potential registration trials, Adaptimmune continues to progress developing next generation SPEAR T-cells, new targets, other HLAs, and an off-the-shelf product.

Finally, Adaptimmune is funded through to late 2020, based on management’s current estimates, with Total Liquidity(1) of $205 million (including cash and cash equivalents of $68 million) at year-end 2018.

2018 Highlights

Clinical progress with wholly-owned programs:

·ADP-A2M10 (MAGE-A10):

·January 2018: The SRC endorsed escalation to Cohort 2 (1 billion target dose) in the ADP-A2M10 triple tumor and lung studies based on favorable safety data

·ASCO: Poster presented at ASCO (Free ASCO Whitepaper) with initial safety data

·July: SRC endorsed dose escalation to Cohort 3 in the NSCLC and triple tumor studies, and treating patients at target dose of 5 billion cells commenced

·ESMO: Presentation of Cohorts 1 and 2 safety data showing dose proportionate persistence and expansion

·Q4: Escalation to expansion phase allowing for doses up to 10 billion cells with no pre-determined stagger between patients for both studies

·ADP-A2M4 (MAGE-A4) — Basket study:

·ASCO: The SRC endorsed escalation to Cohort 2 based on favorable safety data in Cohort1. Added synovial sarcoma and myxoid/round cell liposarcoma (MRCLS) indications for a total of nine solid tumors in this study

·August: Dose escalation to Cohort 3

(1) Total liquidity is a non-GAAP financial measure, which is explained and reconciled to the most directly comparable financial measures prepared in accordance with GAAP below.

· ESMO (Free ESMO Whitepaper): Presentation of Cohorts 1 and 2 safety data showing dose appropriate persistence and expansion, and early, but transient, evidence of antitumor activity in one ovarian cancer patient

· Q4: Escalation to expansion phase allowing for doses up to 10 billion cells with no pre-determined stagger between patients

·ADP-A2AFP (AFP) – Hepatocellular carcinoma:

· SRC endorsed escalation to Cohort 2 with target doses of 1 billion cells

· Clinical learnings

· AACR (Free AACR Whitepaper) 2018: Presented two posters with ADP-A2M10 and ADP-A2M4 preclinical data

· Q2: Published study in Cancer Discovery indicating that NY-ESO SPEAR T-cells are long-lived, self-renewing, and capable of persistent anti-tumor effects

· SITC (Free SITC Whitepaper): Updated data supporting further understanding of systemic and local immunity following NY-ESO treatment in synovial sarcoma, including the positive impact of a more intense pre-conditioning regimen with respect to SPEAR T-cell expansion and persistence; adjusted to a more intense pre-conditioning regimen in current trials as a result

· Q4: Published paper in Hepatology "Tuning T-cell receptor affinity to optimize clinical risk-benefit when targeting α-fetoprotein (AFP) positive liver cancer," which details the development of the SPEAR T-cells targeting AFP

Preclinical:

· Good progress with off-the-shelf product and presented progress to date at ASGCT (Free ASGCT Whitepaper) 2018

· Developing multiple next generation approaches — first candidate ready for IND submission in 2H 2019

·Investigated new targets and additional HLAs to be brought to the clinic beyond 2019

Well-developed preclinical package including proprietary methods for predicting binding of a TCR to an off-target peptide utilizing alanine scanning processes. A licensing program is available to third parties wishing to use this patented method.

Manufacturing:

· Routinely producing cell product at target doses across a broad range of solid tumor indications

· Navy Yard facility now capable of manufacturing cell product for up to 10 patients per month (scalable to 100 patients per year) with capacity for an additional 10 patients per month at a third-party supplier HCATs

· Implemented rapid sterility testing to decrease vein-to-vein time

· Routinely producing more than 5 billion cells to meet target doses

· Agreement with third-party vector manufacturer for commercial supply — batches manufactured for ADP-A2M10, ADP-A2M4, ADP-A2AFP, and next generation SPEAR T-cells

· In-house suspension vector manufacturing capacity with an engineering run completed and first production expected in 2019

NY-ESO Program (now transitioned to GSK):

· Myxoid/round cell liposarcoma: Initial responses observed in a second solid tumor indication with data presented at ASCO (Free ASCO Whitepaper) 2018 and updated at SITC (Free SITC Whitepaper) 2018

· Agreement with GSK:

· Completed transition of the NY-ESO SPEAR T-cell development program in August 2018

· GSK assumed full responsibility for future research, development, and potential commercialization of NY-ESO now called GSK3377794 (GSK ‘794)

· Adaptimmune received ~ $27.5 million (~£21.2 million) in 2018 from GSK for completion of the transition

Other corporate news:

·Completed Registered Direct Offering, raising total net proceeds of ~$100 million in September 2018

· Appointed John Furey as an independent Non-Executive Director, effective July 5, 2018, succeeding Dr. Peter Thompson

Financial Results for the fourth quarter and year ended December 31, 2018

·Cash / liquidity position: As of December 31, 2018, Adaptimmune had cash and cash equivalents of $68.4 million and Total Liquidity(1) of $205.1 million.

·Revenue: Revenue represents the upfront and milestone payments, which are recognized as delivered services to GSK. Revenue for the fourth quarter and year ended December 31, 2018 were $1.5 million and $59.5 million compared to $4.3 million and $37.8 million for the same periods of 2017. Revenue in the year ended December 31, 2018 includes $39.1 million of revenue for the license to NY-ESO, which commenced in September 2018.

·Research and development ("R&D") expenses: R&D expenses for the fourth quarter and year ended December 31, 2018 were $22.8 million and $98.3 million, compared to $25.1 million and $87.4 million for the same periods of 2017. The increase was primarily due to increased costs associated with clinical trials; costs of developing manufacturing capability in the Company’s U.S. facility and increased personnel expenses.

· General and administrative ("G&A") expenses: G&A expenses for the fourth quarter and year ended December 31, 2018 were $10.8 million and $43.6 million, compared $8.8 million and $31.1 million for the same periods of 2017. The increase was primarily due to increased personnel costs consistent with our planned growth an increase in costs associated with supporting and maintaining our IT infrastructure.

·Net loss: Net loss attributable to holders of the Company’s ordinary shares for the fourth quarter and year ended December 31, 2018 were $36.2 million and $95.5 million ($(0.16) per ordinary share) compared to $27.3 million and $70.1 million ($(0.13) per ordinary share) in the same periods of 2017.

Financial Guidance

The Company believes that its existing cash and cash equivalents, short-term deposits and marketable securities, Total Liquidity, will fund the Company’s current operating plan through to late 2020.

Conference Call Information

The Company will host a live teleconference and webcast to provide additional details at 8:00 a.m. EST (1:00 p.m. GMT) today, February 27, 2019. The live webcast of the conference call will be available via the events page of Adaptimmune’s corporate website at www.adaptimmune.com. An archive will be available after the call at the same address. To participate in the live conference call, if preferred, please dial (833) 652-5917 (U.S. or Canada) or +1 (430) 775-1624 (International). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (9455267).

On February 27, 2019 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology in both in vivo and ex vivo applications, reported operational highlights and financial results for the fourth quarter and year ended December 31, 2018 (Press release, Intellia Therapeutics, FEB 27, 2019, View Source [SID1234533717]). In addition, Intellia highlighted select corporate milestones for 2019 and upcoming events for the first quarter of 2019.

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"We are delivering on our full-spectrum strategy, and we expect to have two candidates in development in 2019. Our in vivo transthyretin amyloidosis program is on track for IND filing in 2020, and by the end of this year we anticipate having our first engineered cell therapy development candidate targeting acute myeloid leukemia," said Intellia President and Chief Executive Officer John Leonard, M.D. "We have shown that a single lipid nanoparticle administration can produce very substantial transthyretin protein reduction in non-human primates, reaching levels that we believe hold great therapeutic promise for patients. We also look forward to sharing additional data on our acute myeloid leukemia program this year. We believe our TCR-based, CRISPR-engineered cell therapy will provide a much-needed option for patients."

Recent Operational Highlights

ATTR Program: During the fourth quarter, Intellia completed confirmatory non-human primate (NHP) studies, previewed in October, using its lead candidate for the treatment of transthyretin amyloidosis (ATTR). Fifty-one days post infusion, these NHP studies verified a favorable tolerability profile across various dose levels, and a near-complete (average of >95 percent) reduction in circulating transthyretin (TTR) protein in the liver. The improvements in TTR protein reduction were the result of certain modifications made to the lipid nanoparticle (LNP) cargo components of the therapy, and these modifications have been incorporated into the ongoing, dose-range finding studies and scale-up activities. These modifications will also have application in subsequent programs. The ATTR program is being co-developed with Regeneron Pharmaceuticals, Inc. (Regeneron) with Intellia being the lead party. Intellia confirmed that it is on track for submitting an Investigational New Drug (IND) application in 2020 for ATTR.
In Vivo Insertion: In October, Intellia demonstrated in vivo CRISPR-mediated, targeted transgene insertion in mouse liver. Data shared at the Annual Congress of the European Society of Gene and Cell Therapy highlighted the use of Intellia’s bi-directional DNA template, delivered in a proprietary hybrid LNP/adeno-associated viral (AAV) template delivery system. Insertion of the human F9 gene, the gene encoding the protein deficient in hemophilia B, yielded Factor IX protein levels in mice at or above therapeutic targets in patients. This work was done in collaboration with Regeneron. Additionally, the Company demonstrated the versatility of the hybrid LNP/AAV approach by successfully inserting a functional human SERPINA1 gene (encoding alpha-1 antitrypsin) into the same locus. These experiments in mice yielded human protein expression levels consistent with those of normal individuals without alpha-1 antitrypsin deficiency.
Engineered Cell Therapies: As part of the broad engineered cell therapy platform that the Company is developing, Intellia and its partner, Ospedale San Raffaele, isolated novel active T cell receptors (TCRs) recognizing an epitope of the Wilms’ Tumor 1 (WT1) protein. This protein is overexpressed in many blood cancers, as well as in solid tumors. T cells modified with these TCRs successfully killed acute myeloid leukemia (AML) blasts in an in vitro model. This work will be the foundation for the Company’s first wholly owned ex vivo development candidate for the treatment of AML.
Novartis: In December, Intellia announced an expansion of the existing cell therapy collaboration with Novartis Institutes for Biomedical Research, Inc. (Novartis) to include ocular stem cells. The Company received a $10 million payment from Novartis in relation to the inclusion of this cell type. Regarding its proprietary LNP delivery system and improvements, Intellia also obtained expanded access to Novartis’ LNP library, including the rights to use these lipids for in vivo or ex vivo applications in any genome editing technology.
Board of Directors: In January of 2019, Intellia appointed Fred Cohen, M.D., D.Phil, F.A.C.P., to its board of directors, adding both biotechnology drug development experience and extensive medical expertise to the current knowledge base of the Company’s board.
Upcoming Milestones

The Company has set forth the following for 2019 pipeline progression:

ATTR: Complete dose-range finding studies, initiate IND-enabling toxicology studies and commence manufacturing of lipid and CRISPR/Cas9 cargo
Engineered Cell Therapy: Nominate first engineered cell therapy development candidate for acute myeloid leukemia by the end of 2019
Present additional in vivo NHP insertion data and ATTR formulation improvement data at upcoming scientific conferences
Upcoming Events

The Company will participate in the following investor events:

Leerink Healthcare Conference, February 28, New York City
Barclays Global Healthcare Conference, March 12, Miami
Fourth Quarter and Full Year 2018 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $314.1 million as of December 31, 2018, compared to $340.7 million as of December 31, 2017. The decrease was driven by cash used to fund operations of approximately $96 million, which was offset in part by $28.5 million of net equity proceeds raised from the Company’s "At the Market" (ATM) agreement, $11.7 million in proceeds from employee-based stock plans, $10.4 million of ATTR cost reimbursements made by Regeneron, and $19.0 million of funding received under the Novartis collaboration. The Novartis funding received included a $10.0 million upfront payment related to the expansion of the existing collaboration in the fourth quarter of 2018.
Collaboration Revenue: Collaboration revenue increased by $1.2 million to $7.9 million during the fourth quarter of 2018, compared to $6.7 million during the fourth quarter of 2017. The increase in collaboration revenue in 2018 was primarily driven by amounts recognized from the expansion of the existing collaboration with Novartis, as well as by amounts recognized under the Company’s ATTR Co/Co agreement with Regeneron. As previously disclosed, Regeneron is obligated to fund approximately 50 percent of the development costs for the ATTR program.
R&D Expenses: Research and development expenses decreased by $1.3 million to $19.9 million during the fourth quarter of 2018, compared to $21.2 million during the fourth quarter of 2017. This decrease was driven primarily by lower consumable costs, as well as the timing of general R&D expenses.
G&A Expenses: General and administrative expenses decreased by $1.5 million to $8.7 million during the fourth quarter of 2018, compared to $10.2 million during the fourth quarter of 2017. This decrease was driven primarily by a decrease in stock-based compensation.
Net Loss: The Company’s net loss was $19.1 million for the fourth quarter of 2018, compared to $24.0 million during the fourth quarter of 2017.

Financial Guidance

Intellia expects that its cash, cash equivalents and marketable securities as of December 31, 2018, as well as technology access and funding from Novartis and Regeneron, will enable Intellia to fund its anticipated operating expenses and capital expenditure requirements into the first half of 2021. This expectation excludes any potential milestone payments or extension fees that could be earned and distributed under the collaboration agreements with Novartis and Regeneron or any strategic use of capital not currently in the base-case planning assumptions.

On February 27, 2019 Nordic Nanovector ASA (OSE: NANO) reported its results for the fourth quarter and full year 2018 (Press release, Nordic Nanovector, FEB 27, 2019, View Source;results-for-the-fourth-quarter-and-full-year-2018-300802989.html [SID1234533702]). A presentation by the company’s senior management team will take place today in Oslo at 08:30 CET, see details below.

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Eduardo Bravo, CEO, commented:

"We believe we have made solid progress during 2018 advancing the key clinical development programmes for Betalutin as a single agent and in combination with rituximab in non-Hodgkin’s lymphoma patients. The latest results from the LYMRIT 37-01 trial, presented at ASH (Free ASH Whitepaper) in December, continue to highlight strong clinical profiles of two dosing regimens that we are now testing in the pivotal PARADIGME trial. Furthermore, the recent financing enables us to expand our preparatory activities for the future commercialisation of our exciting lead asset, pending completion of PARADIGME and successful regulatory review. Our clear priority for the coming year is on recruiting patients into PARADIGME to ensure we can achieve our goal of data read-out in the first half of 2020."

Q4’18 Highlights

• Updated results from Phase 1/2 LYMRIT 37-01 demonstrating that single-administration Betalutin is effective and well-tolerated in relapsed/refractory indolent non-Hodgkin’s lymphoma (R/R iNHL) patients reported at ASH (Free ASH Whitepaper) (December)

• Pivotal Phase 2b PARADIGME trial progressing with 69 (of 80-85) sites in 23 countries open for enrolment, as of 26 February 2019, including the first site in the US

• Promising Innovative Medicine (PIM) designation (October) in the UK granted for the treatment of advanced R/R FL, adding to US Fast Track designation (granted in June)

• First patient dosed in Phase 1b Archer-1 trial of Betalutin in combination with rituximab in second-line (2L) FL patients (November)

• Promising results from an R&D collaboration to develop a CD37-targeted alpha therapy published at ASH (Free ASH Whitepaper)

Events after Q4’18

• Approximately NOK 222 million (USD 26m) (gross) raised in an oversubscribed private placement which provides funds to support manufacturing and other activities in preparation for the commercialisation of Betalutin

• Jan H. Egberts, M.D. elected new Chairman, succeeding Ludvik Sandnes who stepped down from the board of directors

• Dr Mark Wright appointed as Head of Manufacturing to lead production of Betalutin for clinical trials and future commercialisation, and of CD37-targeting candidates emerging from the company’s pipeline

Financial Highlights Q4 and FY’18

(Figures in brackets = same period 2017 unless otherwise stated)

• Revenues for the fourth quarter amounted to NOK 0.0 million (NOK 0.05 million). Revenues for the full year 2018 were NOK 0.0 million (NOK 0.3 million).

• Total operating expenses for the fourth quarter were NOK 96.3 million (NOK 102.0 million). Total operating expenses for the full year 2018 amounted to NOK 340.0 million (NOK 316.8 million).

• Comprehensive loss for the fourth quarter amounted to NOK 87.7 million (loss of NOK 87.6 million). Comprehensive loss for the full year 2017 was NOK 336.8 million (NOK 295.6 million).

• Cash and cash equivalents amounted to NOK 440.1 million at the end of December 2018 (NOK 756.6 million).

Outlook

Nordic Nanovector aspires to become a leader in the field of targeted therapies for haematological cancers by developing, manufacturing and commercialising innovative therapies to address major unmet medical needs and advance cancer care.

Betalutin, the company’s most advanced product candidate, has a highly differentiated, competitive, clinical profile for R/R FL, based on the promising results from the LYMRIT 37-01 Phase 1/2 clinical study. The company’s pivotal Phase 2b PARADIGME trial with a once-only administration of Betalutin in 3L R/R FL is underway with the initial clinical data read-out targeted for 1H 2020 and subsequent filing in 2020 for marketing approval.

Nordic Nanovector intends to maximize the value of Betalutin and other CD37-targeting opportunities across other stages of FL, NHL and other haematological cancer indications.

The company is confident that Betalutin could become an attractive and convenient therapeutic option, which, based on detailed market research, has the potential to be commercially successful.

Current cash resources are expected to be sufficient to reach data read-out from PARADIGME in the first half of 2020.

Presentation and webcast – Q4 and Full Year 2018 results

A presentation by Nordic Nanovector’s senior management team will take place today at 8:30 am CET at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: AKER

The presentation will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investors & Media

The results report and the presentation is available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2018.

For further information, please contact:

IR enquiries

Malene Brondberg, VP Investor Relations and Corporate Communications

Cell: +44-7561-431-62

Email: [email protected]

Media Enquiries

Mark Swallow/David Dible (Citigate Dewe Rogerson)

Tel: +44-207-638-9571

Email: [email protected]

On February 26, 2019 Immatics reported a collaboration with Roche to evaluate the safety and efficacy of IMA101, Immatics’ investigational autologous cell therapy, in combination with atezolizumab (TECENTRIQ), in patients with solid cancers (Press release, immatics biotechnologies, FEB 26, 2019, View Source [SID1234554002]).

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IMA101 is a personalized, multi-targeted investigational immunotherapy for the treatment of multiple advanced/ metastatic solid tumors. IMA101 is based on Immatics’ ACTolog approach, which follows the principle of expanding target-specific endogenous T-cells, a technique pioneered by Cassian Yee, M.D., Professor of Melanoma Medical Oncology at The University of Texas MD Anderson Cancer Center.

The combination trial will evaluate potential synergistic effects generated by using the investigational immunotherapies together, as atezolizumab may enhance IMA101’s ability to kill cancer cells by blocking inhibitory immune checkpoints.

The combination clinical trial which is expected to begin later this year under an amendment to the ACTolog IMA101-101 study protocol (Clinicaltrials.gov: NCT02876510) will be conducted at MD Anderson, led by Apostolia Tsimberidou, M.D., Ph.D., Professor of Department of Investigational Cancer Therapeutics at MD Anderson.

Stephen Eck, M.D., Ph.D., Chief Medical Officer (CMO) at Immatics US, Inc., said: "Our innovative ACTolog process allows us to utilize a patient’s own T cells to generate a targeted approach for treating solid tumors with increased safety and efficacy potential. We are extremely pleased that, in collaboration with our long-term partner, we are now combining this promising personalized cell therapy with atezolizumab."

About ACTolog T-cell therapy

The ACTolog IMA101 phase 1 clinical trial is led by Prof. Apostolia Tsimberidou, Professor at the Department of Investigational Cancer Therapeutics at the University of Texas MD Anderson Cancer Center and co-funded by the Cancer Prevention and Research Institute of Texas (CPRIT). The ACTolog concept is based on the principle of endogenous T-cell therapy pioneered by Professor Cassian Yee, M.D. Unlike tumor-infiltrating lymphocytes, ACTolog T-cell products are generated from peripheral blood cells with defined target selectivity. Utilizing its proprietary antigen discovery platform XPRESIDENT, Immatics has created a warehouse of eight cancer targets. From this warehouse, the most suitable targets for each patient’s tumor are identified by analyzing the tumor biomarkers. Up to four personalized T-cell products are then activated and manufactured for each patient by isolation and enrichment of the patient’s endogenous T cells in vitro. Billions of such activated and specific T cells are then re-infused into the cancer patient to attack the tumor. The ACTolog T-cell products are manufactured at The Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory in collaboration with The University of Texas Health Science Center in Houston (UTHealth).

On February 26, 2019 Gracell Biotechnologies, Co., Ltd. ("Gracell") reported the completion of its $85 million series B funding today (Press release, Gracell Biotechnologies, FEB 26, 2019, View Source [SID1234539454]). The financing was led by Temasek with Lilly Asia Ventures, Kington Capital, King Star Capital and Chengdu Miaoji also participated in the round. This new funding will enable Gracell to enter clinical trials with several of its next generation immune cell gene therapy candidates.

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Founded by Dr. Wei (William) Cao in 2017, Gracell is an innovative biomedical company focusing on the development of next generation immune cell gene therapies. Dr. Cao was previously co-founder and CEO of a Nasdaq-listed cell therapy company. Gracell was initially supported by series A financing from 6 Dimensions shortly after its establishment.

Gracell says it is committed to developing high-quality, low-cost cellular gene therapies and solving many of the technical difficulties in the cellular gene therapy field, including complex manufacture, lack of off-the-shelf products, and short duration efficacy. To implement its vision, Gracell believes it has gathered one of the top teams in the industry from China and the U.S.

To date, Gracell has completed pre-clinical development of a series of low-cost CAR-T products and entered clinical research through Institutional Review Board (IRB) studies. Other products under development include CAR-T cell products developed on the company’s FasT(TM) CAR technology, Dual-CAR technology, Off-the-shelf CAR-T products, and CAR-T products for the treatment of refractory solid tumors.