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Oncolytics Biotech® Reports 2021 First Quarter Development Highlights and Financial Results

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– AWARE-1 clinical data validate clinical development strategy by confirming pelareorep’s anti-tumor mechanism of action known to be associated with improved patient outcomes and ability to synergize with checkpoint inhibitors

– Preclinical studies show that pelareorep’s synergistic benefits extend across multiple classes of immunotherapeutic agents, including novel CAR T approaches in solid tumors

– Phase 2 BRACELET-1 clinical trial on track for full enrollment in Q4-2021

– Strong financial foundation with over $50 million in cash on hand and cash runway to Q4-2022

SAN DIEGO and CALGARY, AB, May 7, 2021 /PRNewswire/ — Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced its financial results and development highlights for the quarter ended March 31, 2021. All dollar amounts are expressed in Canadian currency unless otherwise noted.

“Our continued progress over the past several months has substantially de-risked our lead breast cancer program and validated our broader development strategy,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. “Clinical data from our AWARE-1 trial show pelareorep alters tumor microenvironments by enabling the infiltration of anti-cancer T cells, shown to be associated with improved cancer patient outcomes, including survival, and demonstrates the synergy between pelareorep and checkpoint inhibitors. These findings support the overall survival benefit observed in our prior phase 2 breast cancer study and suggest that we can deliver additional benefits to patients with HR+/HER2- metastatic breast cancer by combining pelareorep with a checkpoint inhibitor. This hypothesis is currently being evaluated in the BRACELET-1 trial, which remains on track for full enrollment this year.”

Dr. Coffey continued, “Alongside our clinical accomplishments, we also generated compelling preclinical data demonstrating pelareorep’s potential to synergize with a broad array of immune-oncology (IO) agents such as CAR T cells and bispecific antibodies. These data suggest that pelareorep’s clinically demonstrated ability to recruit T cells into tumors may significantly boost the effectiveness of various IO agents in solid cancers, an area where they have shown limited efficacy to date. Looking forward, we plan to pursue pelareorep’s development as an enabling technology for multiple classes of IO agents through a partnership strategy, which should allow us to remain primarily focused internally on breast cancer and the execution of our stated clinical milestones.”

First Quarter and Subsequent Highlights

Breast Cancer Program

Achieved primary endpoint in AWARE-1 study

An electronic poster at the American Association for Cancer Research (AACR) Annual Meeting 2021 included data from the twenty HR+/HER2- early-stage breast cancer patients included in AWARE-1’s first two cohorts (link to PR; link to poster). Results from these patients, treated with pelareorep and letrozole without (cohort 1) or with (cohort 2) the PD-L1 inhibitor atezolizumab (Tecentriq®), showed pelareorep and letrozole treatment upregulated tumor PD-L1 expression, induced the generation and expansion of T cell clones, promoted tumor infiltration of CD8+ T cells, and increased CelTIL score, a measure of tumor cellularity and inflammation associated with favorable clinical outcomes. These desired outcomes were further enhanced by the addition of atezolizumab, demonstrating that pelareorep and atezolizumab synergistically combine to generate an anti-cancer immune response in the tumor and peripheral blood. Notably, the trial demonstrated dose-related activity of pelareorep led to the achievement of the primary endpoint, with six of ten patients achieving at least a 30% increase in CelTIL score following treatment in cohort 2. Together, these data support the results of a prior successful phase 2 trial (IND-213) that showed a near doubling of overall survival with pelareorep treatment in HR+/HER2- patients and the clinical rationale behind the phase 2 BRACELET-1 trial, which is evaluating the safety and efficacy of pelareorep and chemotherapy alone, and in combination with a PD-L1 inhibitor, in HR+/HER2- breast cancer patients.

Additional Immunotherapeutic Combinations and Opportunities

Demonstrated the potential of pelareorep to broaden the applicability of CAR T cells to solid tumors

A preclinical study from the Mayo Clinic showed that loading chimeric antigen receptor (CAR) T cells with pelareorep vastly improved their persistence and efficacy in a murine solid tumor model, in stark contrast to prior preclinical studies that showed intratumoral infection with the VSV oncolytic virus weakened CAR T cells (link to PR; link to poster). The efficacy of pelareorep-loaded CAR T cell (“CAR/Pela”) therapy was further enhanced by subsequently administering a single intravenous dose of pelareorep, which led to the generation of highly persistent CAR T cells, the inhibition of recurrent tumor growth, and ultimately tumor cures. These synergistic immune effects were notably specific to pelareorep, as intravenous boosting with VSV did not augment CAR/Pela therapy or prevent the growth of recurrent tumors. Collectively, these data demonstrate the potential of pelareorep to broaden the applicability of CAR T cells to solid tumors, an area where CAR T cell efficacy is currently limited due to immunosuppressive tumor microenvironments that promote T cell exhaustion and exclusion. 

Announced preclinical data highlighting pelareorep’s ability to synergize with multiple classes of anti-cancer agents

Data presented in two electronic poster presentations at the AACR Annual Meeting 2021 showed that pelareorep enhanced the anti-tumor efficacy of the poly(ADP)-ribose polymerase 1 (PARP-1) inhibitor talazoparib and the cyclin-dependent kinase (CDK) 4/6 inhibitor palbociclib, which are both FDA approved for the treatment of breast cancer. The observed synergistic effects between pelareorep and both talazoparib and palbociclib were notably mediated through immunologic mechanisms rather than through the molecular pathways typically associated with PARP-1 and CDK 4/6 inhibition (link to PR; link to CDK4/6 poster; link to PARP-1 poster). Together, these results suggest that pelareorep may enhance the therapeutic potential of PARP-1 and CDK 4/6 inhibitors by expanding the mechanisms by which they exert anti-tumor effects.

Initiation of a preclinical research collaboration with Leiden University Medical Center (LUMC) and Oncode Institute to evaluate pelareorep-bispecific antibody combination therapies

Collaborative preclinical studies with LUMC will evaluate the combination of pelareorep-CD3-bispecific antibody combinations in breast and pancreatic tumor models. Pelareorep’s clinically demonstrated ability to recruit T cells to solid tumors provides a strong rationale for these studies, as CD3-bispecific antibodies are designed to facilitate cancer-killing by simultaneously engaging both T cells and tumor tissue. Prior preclinical studies in breast and pancreatic cancer models also support this collaboration, as they have shown that the addition of pelareorep to CD3-bispecific antibody therapy results in cancer regression and prolonged survival.

Corporate Highlights

Hosted a key opinion leader webinar on AWARE-1 data, the immunotherapeutic effects of pelareorep in breast cancer, and its synergistic activity with CAR T cells in solid tumors

The webinar featured presentations by Key Opinion Leaders (KOLs) Aleix Prat, M.D., Ph.D. (Clínic Barcelona) and Richard Vile, Ph.D., (Mayo Clinic), as well as a corporate update by members of the Oncolytics management team. The formal presentations were followed by a question and answer session. A replay of the event can be accessed by clicking here.

Financial Highlights

  • As of March 31, 2021, the Company reported $50.4 million in cash and cash equivalents. The Company raised gross proceeds of $25.8 million during the first quarter through issuing of common stock through its ATM facility.
  • Operating expense for the first quarter of 2021 was $3.1 million, compared to $3.0 million in the first quarter of 2020.
  • R&D expense for the first quarter of 2021 was $2.8 million, compared to $2.5 million in the first quarter of 2020.
  • Net cash used in operating activities for the first quarter of 2021 was $5.6 million, compared to $4.0 million for the first quarter of 2020.
  • The net loss for the first quarter of 2021 was $6.4 million, compared to a net income of $0.4 million in the first quarter of 2020, which reflected a $4.2 million non-cash gain in fair value of warrant derivative. The basic and diluted loss per share was $0.13 in the first quarter of 2021, compared to a basic earnings and diluted loss per share of $0.01 and $0.04, respectively, in the first quarter of 2020.

Anticipated Milestones and Catalysts

  • Announcement of final data from phase 2 NU 18I01 second-line pancreatic cancer study: H1 2021
  • Dosing of the first patient in GOBLET study in gastrointestinal cancer: mid-2021
  • Final biomarker data for AWARE-1 breast cancer study in the intended target population for a registrational study: H2 2021
  • Completion of enrollment in BRACELET-1 metastatic breast cancer study: Q4 2021
  • Interim safety update from IRENE study in triple-negative breast cancer: Q4 2021
  • Interim safety data from phase 1 WINSHIP 4398-18 multiple myeloma study: Q4 2021

Oncolytics expects to provide updates on the timing of the following milestones over the coming months:

  • Interim safety update from Phase 2 BRACELET-1 metastatic breast cancer study
  • Phase 2 BRACELET-1 metastatic breast cancer study: final data

Update on COVID-19

Oncolytics continues to collaborate with its investigators to ensure the safety of patients and employees, as well as the productivity of its clinical programs. We expect these measures will allow us to build on the positive momentum of 2020, despite any COVID-19-related challenges that may arise. Moving forward, we plan to remain in contact with relevant stakeholders and keep the market apprised of any new information that may materially impact clinical timelines.

Accessing the Annual Corporate Update Presentation 

The Annual Corporate Update, which will also discuss first quarter 2021 financial results, beginning immediately following the Annual General Meeting at approximately 12:10 p.m. Eastern Daylight Time, may be accessed via the AGM webcast link, https://web.lumiagm.com/158281614, as a guest or by dialing +1-888-231-8191 for callers in North America and +1-647-427-7450 for International callers. The live webcast of the corporate update section of the call will be accessible on the Investor Relations page of Oncolytics’ website at https://ir.oncolyticsbiotech.com/events-presentations and will be archived for three months. 

ONCOLYTICS BIOTECH INC.

INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

(unaudited)

(in Canadian dollars, except share amounts)


As at

March 31,
2021
$

December 31,
2020
$

Assets



Current assets



Cash and cash equivalents

50,362,162


31,219,574


Other receivables

111,665


89,661


Prepaid expenses

2,881,730


2,427,200


Total current assets

53,355,557


33,736,435


Non-current assets



Property and equipment

215,587


236,664


Right-of-use assets

609,297


372,468


Total non-current assets

824,884


609,132





Total assets

54,180,441


34,345,567


Liabilities And Shareholders’ Equity



Current Liabilities



Accounts payable and accrued liabilities

1,918,638


1,805,015


Other liabilities


123,985


Lease liabilities

252,356


248,885


Warrant derivative

237,546


531,228


Total current liabilities

2,408,540


2,709,113


Non-current liabilities



Contract liability

6,730,287


6,730,287


Lease liabilities

371,974


153,174


Total non-current liabilities

7,102,261


6,883,461





Total liabilities

9,510,801


9,592,574


Commitments and contingencies



Shareholders’ equity



Share capital

  Authorized: unlimited

  Issued: March 31, 2021 – 52,844,210

  December 31, 2020 – 46,166,980

382,963,397


356,824,172


Warrants

3,617,570


3,617,570


Contributed surplus

31,274,835


31,022,356


Accumulated other comprehensive income

359,913


400,225


Accumulated deficit

(373,546,075)


(367,111,330)


Total shareholders’ equity

44,669,640


24,752,993


Total liabilities and shareholder’s equity

54,180,441


34,345,567


ONCOLYTICS BIOTECH INC.

INTERIM CONSOLIDATED STATEMENTS OF (LOSS) INCOME AND COMPREHENSIVE (LOSS) INCOME

(unaudited)

(in Canadian dollars, except share amounts)


For the three-month period ending March 31,

2021

$

2020

$




Expenses



   Research and development

2,759,014


2,529,646


   Operating

3,141,890


2,993,388


Loss before the following

(5,900,904)


(5,523,034)


   Change in fair value of warrant derivative

(164,780)


4,151,982


 Foreign exchange (loss) gain

(390,554)


1,704,805


   Interest income, net

21,493


65,909


Net (loss) income

(6,434,745)


399,662


Other comprehensive (loss) income items that may be reclassified to net loss



  Translation adjustment

(40,312)


295,212


Net comprehensive (loss) income

(6,475,057)


694,874





(Loss) earnings per common share



Basic

(0.13)


0.01


Diluted

(0.13)


(0.04)


ONCOLYTICS BIOTECH INC.

INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

(unaudited)

(in Canadian dollars)



Share Capital

$

Warrants

$

Contributed Surplus

$

Accumulated Other Comprehensive Income

$

Accumulated Deficit

$

Total

$

As at December 31, 2019

311,077,859


3,617,570


29,338,849


464,101


(344,606,273)


(107,894)


Net loss and other comprehensive loss




295,212


399,662


694,874


Issued pursuant to stock option plan

134,985



(49,835)




85,150


Issued pursuant to incentive share award plan

209,475



(209,475)





Issued pursuant to “At the Market” Agreement

17,529,109






17,529,109


Issued pursuant to warrant derivative exercised

5,529,266






5,529,266


Share-based compensation



392,805




392,805


Share issue costs

(691,297)






(691,297)


As at March 31, 2020

333,789,397


3,617,570


29,472,344


759,313


(344,206,611)


23,432,013









As at December 31, 2020

356,824,172


3,617,570


31,022,356


400,225


(367,111,330)


24,752,993


Net loss and other comprehensive income




(40,312)


(6,434,745)


(6,475,057)


Issued pursuant to stock option plan

302,908



(113,558)




189,350


Issued pursuant to incentive share award plan

292,039



(292,039)





Issued pursuant to “At the Market” Agreement

25,831,909






25,831,909


Issued pursuant to warrant derivative exercised

686,616






686,616


Share-based compensation



658,076




658,076


Share issue costs

(974,247)






(974,247)


As at March 31, 2021

382,963,397


3,617,570


31,274,835


359,913


(373,546,075)


44,669,640


ONCOLYTICS BIOTECH INC.

INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

(in Canadian dollars)


For the three-month period ending March 31,

2021

$

2020

$




Operating Activities



Net loss for the period

(6,434,745)


399,662


Depreciation – property and equipment

20,550


23,045


Depreciation – right-of-use-assets

86,184


91,023


Share-based compensation

658,076


392,805


Interest expense on lease liabilities

13,809


18,209


Unrealized foreign exchange loss (gain)

519,368


(1,427,756)


Change in fair value of warrant derivative

164,780


(4,151,982)


Net change in non-cash working capital

(596,479)


699,737


Cash used in operating activities

(5,568,457)


(3,955,257)


Investing Activities



Acquisition of property and equipment


(10,715)


Cash used in investing activities


(10,715)


Financing Activities



Proceeds from exercise of stock options

189,350


85,150


Proceeds from exercise of warrant derivative

230,946


1,433,142


Proceeds from “At the Market” equity distribution agreement

24,857,662


16,837,813


Payment of lease liabilities

(111,673)


(113,474)


Cash provided by financing activities

25,166,285


18,242,631


Increase in cash

19,597,828


14,276,659


Cash and cash equivalents, beginning of period

31,219,574


14,148,021


Impact of foreign exchange on cash and cash equivalents

(455,240)


2,142,800


Cash and cash equivalents, end of period

50,362,162


30,567,480


About AWARE-1

AWARE-1 is an open label window-of-opportunity study in early-stage breast cancer enrolling 38 patients into five cohorts:

  • Cohort 1 (n=10), HR+ / HER2- (pelareorep + letrozole)
  • Cohort 2 (n=10), HR+ / HER2- (pelareorep + letrozole + atezolizumab)
  • Cohort 3 (n=6), TNBC (pelareorep + atezolizumab)
  • Cohort 4 (n=6), HR+ / HER2+ (pelareorep + trastuzumab + atezolizumab)
  • Cohort 5 (n=6), HR- / HER2+ (pelareorep + trastuzumab + atezolizumab)

The study combines pelareorep, without or with atezolizumab, and the standard of care therapy according to breast cancer subtype. Tumor tissue is collected from patients as part of their initial breast cancer diagnosis, again on day three following initial treatment, and finally at three weeks following treatment, on the day of their mastectomy. Data generated from this study are intended to confirm that pelareorep is acting as a novel immunotherapy, to evaluate potential synergy between pelareorep and checkpoint blockade, and to provide comprehensive biomarker data by breast cancer subtype. The primary endpoint of the study is overall CelTIL score (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study include CelTIL by breast cancer subtype, safety, and tumor and blood-based biomarkers.

For more information about the AWARE-1 study, refer to https://clinicaltrials.gov/ct2/show/NCT04102618.

Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

About BRACELET-1

The BRACELET-1(BReast cAnCEr with the Oncolytic Reovirus PeLareorEp in CombinaTion with anti- PD-L1 and Paclitaxel) study is an open-label, phase 2, randomized study in patients with HR+/HER2-, endocrine-refractory metastatic breast cancer being conducted under a co-development agreement with Merck KGaA, Darmstadt, Germany and Pfizer. PrECOG LLC, a leading cancer research network, is managing the study. The study will take place at 20 trial sites and enroll 45 patients randomized into three cohorts. A three-patient safety run-in will be conducted with patients receiving pelareorep, paclitaxel, and avelumab prior to randomization. The three cohorts will be treated as follows:

  • Cohort 1 (n=15): paclitaxel
  • Cohort 2 (n=15): paclitaxel + pelareorep
  • Cohort 3 (n=18): paclitaxel + pelareorep + avelumab (Bavencio®)

Patients in cohort 1 will receive paclitaxel on days 1, 8, and 15 of a 28-day cycle. Patients in cohort 2 will receive the same paclitaxel regimen as cohort 1, plus pelareorep on days 1, 2, 8, 9, 15 and 16 of the 28-day cycle. Patients in cohort 3 will receive the same combination and dosing regimen as cohort 2, plus avelumab on days 3 and 17 of the 28-day cycle. The primary endpoint of the study is overall response rate. Exploratory endpoints include peripheral and tumor T cell clonality, inflammatory markers, and safety and tolerability assessments.

For more information about the BRACELET-1 study, refer to https://clinicaltrials.gov/ct2/show/NCT04215146.

About CAR T cells and CAR T therapy

The CAR T process begins when blood is drawn from a patient and their T cells are separated so they can be genetically engineered to produce chimeric antigen receptors (CARs). These receptors enable the T cells to recognize and attach to a specific protein or antigen on tumor cells. Once the engineering process is complete, a laboratory can increase the number of CAR T cells into the hundreds of millions. Finally, the CAR T cells will be infused back into the patient where, ideally, the engineered cells further multiply, and recognize and kill cancer cells. Historically, solid tumors have been considered beyond the reach of CAR T therapy due to their tumor microenvironment, which is detrimental to CAR T cell entry and activity, amongst other challenges.1

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

About Oncolytics Biotech Inc.

Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.

Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies of pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

References:

1.  National Cancer Institute. CAR T Cells: Engineering Patients’ Immune Cells to Treat Their Cancers. Updated July 31, 2019. Accessed February 18, 2021. https://www.cancer.gov/about-cancer/treatment/research/car-t-cells

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding the mode of action, potential and benefits of pelareorep as a cancer therapeutic; expectations as to the purpose, design, outcomes and benefits of its current or pending clinical trials involving pelareorep; expectations as to the enrollment in its various clinical studies; expectations regarding Oncolytics’ cash runway; beliefs regarding Oncolytics being positioned for sustained growth; plans to pursue pelareorep’s development through a  partnership strategy and the anticipated benefits therefrom; Oncolytics upcoming catalysts and milestones and Oncolytics’ expectations in relation thereto; our management of our business during the ongoing COVID-19 pandemic; the timing and content of our annual corporation presentation; and other statements related to anticipated developments in Oncolytics’ business and technologies.  In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics’ actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics’ ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how Oncolytics may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult Oncolytics’ quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

Company Contact

Jon Patton

Director of IR & Communication

+1-858-886-7813

[email protected]  

Investor Relations for Oncolytics

Timothy McCarthy

LifeSci Advisors

+1-917-679-9282

[email protected]

SOURCE Oncolytics Biotech® Inc.

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Perfect World to pioneer digital culture and creative sector in joint hands with partners

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As a world’s leading entertainment group, Perfect World proposed “Creative Thinking” strategy, aiming at breaking the barrier of the real world and virtual world, and combining new types of games with traditional industries so as to empower the development of traditional industries and promote digital upgrade of traditional industries as well.

Under the “Creative Thinking” strategy, Perfect World has made significant achievements in its cooperation with enterprises and institutions, such as implanting scenes of the Qinhuai Lantern Fair of Nanjing Confucius Temple into its famous game “Zhuxian,” and the collaboration between its mobile game Chronicle of Infinity and the famous sports brand Peak.

Perfect World CEO Dr. Robert H. Xiao said at the conference that after all the successful cases, Perfect World has been more confident about cross-over cooperation between digital culture industry and traditional industries. He promised that Perfect World will keep exploring to establish a value chain that empowers traditional industries, and incubate more new types of culture content, products, and business models.

In its collaboration with Nianhuawan scenic spot in Wuxi, Perfect World gamified the scenic spots, and brought tourists an immersive experience by combing the scenic spot and the digital world. The move helps the scenic spot to upgrade from service-based economic to experience economy.

“Not only will we explore subdivided fields with partners, but also work as a bridge to promote cross-over cooperation among companies in various fields, so as to achieve common development,” said Dr. Xiao. “And we hope to joint hands with our partners to unlock a new track in this ‘experimental production’ of the culture industry that faces the future,” he added.

Perfect World will tailor a whole set of solutions and plans on digital upgrading partners’ products based on their requirements. For example, in its cooperation with Shanghai Science and Technology Museum, Perfect World will develop a game to turn the complicated scientific knowledge into visions to help readers understand the scientific knowledge. The Group will also have an in-depth cooperation with China Audio-video and Digital Publishing Association in the field of education and vocational training such as e-sports talent cultivation.

The culture department of Beijing’s Dongcheng district, People’s Cultural Tourism of People’s Daily, a cultural & creative institute affiliated to Tsinghua University, Beijing Dongsheng Bozhan Cloud Computing Technology Co., Ltd., and Nianhuawan scenic spot, also signed strategic cooperation agreements with Perfect World in the brand cooperation conference.

SOURCE Perfect World

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European Hematology Association : la réponse humorale au vaccin Pfizer/BioNTech BNT162b2 est altérée chez les patients recevant un CAR-T ou un traitement immunosuppresseur de haute intensité

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LA HAYE, Pays-Bas, 12 juin 2021 /PRNewswire/ — Le vaccin Pfizer/BioNTech BNT162b2 a été approuvé pour la prévention de l’infection par le coronavirus 2 du syndrome respiratoire aigu sévère (SRAS-CoV-2) et est recommandé pour les patients immunodéprimés. Cependant, son efficacité et son innocuité chez les patients suivant une thérapie cellulaire immunologique n’ont pas été bien documentées. Dans le cadre de cette étude, nous avons évalué l’efficacité et l’innocuité du vaccin BNT162b2 chez les patients ayant subi une greffe de cellules hématopoïétiques (HCT) et un traitement au récepteur d’antigène chimérique (CAR)-T. Nous avons suivi prospectivement 79 patients vaccinés ayant été activement traités au Centre médical Sourasky de Tel Aviv et surveillé le profil d’innocuité et la réponse immunitaire humorale au vaccin.

Dans l’ensemble, le vaccin a été bien toléré et tous les effets indésirables se sont résorbés en quelques jours, à l’exception d’un rejet de greffe secondaire, qui fait toujours l’objet d’une enquête. Nous avons observé que seulement 36 % des patients ayant reçu un traitement CAR-T ont développé une réponse aux anticorps humoraux comparativement à 81 % des patients ayant subi une TSS allogénique. De plus, les patients atteints d’aplasie des cellules B et ceux ayant reçu le vaccin peu après la perfusion de cellules étaient moins susceptibles de développer des anticorps. Prises ensemble, ces données démontrent que la réponse humorale au vaccin BNT162b2 est significativement altérée chez les patients recevant le CAR-T, par opposition à ceux ayant reçu une TSS allogénique ayant une bonne réponse.

Présentateur : Professeur Ron Ram

Affiliation : Unité BMT, Tel Aviv Sourasky Medical Center, Tel Aviv, Israël

Résumé : #S285 INNOCUITÉ ET EFFICACITÉ DU VACCIN BNT162B2 MRNA COVID-19 CHEZ LES PATIENTS APRÈS UNE THÉRAPIE ALLOGÉNIQUE À BASE DE HCT ET DE CD19 – ÉTUDE DE COHORTE PROSPECTIVE À UN SEUL CENTRE

À propos du congrès annuel de l’AEH : Chaque année, en juin, l’AEH organise son congrès annuel dans une grande ville européenne. Cette année, en raison de la persistance de la pandémie de COVID-19, l’AEH organise pour la deuxième fois un Congrès virtuel. Le Congrès s’adresse aux professionnels de santé travaillant dans le domaine de l’hématologie ou s’y intéressant. Les sujets du programme scientifique vont de la physiologie et du développement des cellules souches à la leucémie, le lymphome, le diagnostic et le traitement, les globules rouges, les globules blancs et les troubles plaquettaires, l’hémophilie et le myélome, la thrombose et les troubles de la coagulation ainsi que la transfusion et la transplantation de cellules souches.

Site web :www.ehaweb.org

Logo – https://mma.prnewswire.com/media/622259/EHA_Logo.jpg

SOURCE European Hematology Association (EHA)

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EHA:Eficacia de la vacuna Pfizer/BioNTech BNT162b2 en pacientes que reciben CAR-T

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– European Hematology Association:La respuesta humoral a la vacuna Pfizer/BioNTech BNT162b2 se ve afectada en pacientes que reciben CAR-T o terapia inmunosupresora de alta intensidad

LA HAYA, Países Bajos, 12 de junio de 2021 /PRNewswire/ — La vacuna Pfizer/BioNTech BNT162b2 ha sido aprobada para la prevención del síndrome respiratorio agudo severo por coronavirus 2 (SARS-CoV-2) y se recomienda para pacientes inmunosuprimidos. Sin embargo, su eficacia y seguridad en pacientes sometidos a terapia celular inmunológica no han sido bien documentadas. En este estudio, evaluamos la eficacia y seguridad de la vacuna BNT162b2 en pacientes que se sometieron a trasplante de células hematopoyéticas (HCT) y terapia con receptor de antígeno quimérico (CAR) -T. Seguimos prospectivamente a 79 pacientes vacunados que fueron tratados activamente en el Centro Médico Sourasky de Tel Aviv y monitoreamos el perfil de seguridad y la respuesta inmune humoral a la vacuna.

En general, la vacuna fue bien tolerada y todos los efectos secundarios se resolvieron en unos pocos días, excepto un rechazo secundario del injerto, que aún está bajo investigación. Observamos que solo el 36% de los pacientes que recibieron terapia CAR-T desarrollaron una respuesta humoral de anticuerpos en comparación con el 81% de los pacientes que se sometieron a un HCT alogénico. Además, los pacientes con aplasia de células B y los que recibieron la vacuna poco después de la infusión de células tenían menos probabilidades de desarrollar anticuerpos. Tomados en conjunto, estos datos demuestran que la respuesta humoral a la vacuna BNT162b2 está significativamente alterada en los pacientes que reciben CAR-T, a diferencia de aquellos después de un HCT alogénico que tuvieron una buena respuesta.

Presentador:  Profesor Ron Ram

Afiliación:  BMT Unit, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

Abstract: #S285  SAFETY AND EFFICACY OF THE BNT162B2 MRNA COVID-19 VACCINE IN PATIENTS AFTER ALLOGENEIC HCT AND CD19-BASED CAR-T THERAPY – A SINGLE CENTER PROSPECTIVE COHORT STUDY

Acerca del Congreso anual de EHA: Cada junio, la EHA organiza su Congreso Anual en una de las principales ciudades europeas. Este año, debido a la persistente pandemia de COVID19, EHA organiza un Congreso virtual por segunda vez. El Congreso está dirigido a profesionales de la salud que trabajen o estén interesados en el campo de la hematología. Los temas del programa científico van desde la fisiología y el desarrollo de las células madre hasta la leucemia; linfoma diagnostico y tratamiento; las células rojas de la sangre; trastornos de los glóbulos blancos y las plaquetas; hemofilia y mieloma; trombosis y trastornos hemorrágicos; así como transfusión y trasplante de células madre.

Sitio web: www.ehaweb.org

Logo – https://mma.prnewswire.com/media/622259/EHA_Logo.jpg

SOURCE European Hematology Association (EHA)

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European Hematology Association: Overall Survival Benefit Established With Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) in Elderly Patients with Transplant-ineligible Newly Diagnosed Multiple Myeloma (NDMM): Long-Term Interim Analysis of the MAIA Study

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THE HAGUE, Netherlands, June 12, 2021 /PRNewswire/ — The phase 3 MAIA study evaluated D-Rd versus Rd in 737 patients who were ineligible for high-dose chemotherapy and autologous stem cell transplantation. The primary analysis of MAIA demonstrated a 44% reduction in the risk of disease progression or death after treatment with D-Rd compared with Rd alone. At a median follow-up of almost 5 years (56.2 months), we now report the pre-specified interim overall survival analysis of MAIA.

The addition of daratumumab to Rd treatment significantly reduced the risk of death by 32% (hazard ratio, 0.68; 95% confidence interval [CI], 0.53-0.86; P=0.0013) with an estimated 5-year overall survival rate of 66.3% in the D-Rd group compared with 53.1% in the Rd alone group. These results are despite 46% of patients who received subsequent therapy in the Rd arm receiving daratumumab. Similarly, the significant progression-free survival benefit of D-Rd versus Rd that was identified in the primary analysis was maintained, with a 47% reduction in the risk of disease progression or death (HR, 0.53; 95% CI, 0.43-0.66; P<0.0001) and an estimated 60-month progression-free survival rate of 52.5% versus 28.7%, respectively; these data provide a new PFS benchmark for patients with NDMM who are transplant ineligible. The high overall response rate (93% vs 82%) further demonstrated the added clinical benefit of D-Rd versus Rd alone. No new safety concerns were identified for D-Rd and the most common (>15%) grade 3/4 treatment-emergent adverse events for D-Rd and Rd were neutropenia (54% vs 37%), pneumonia (19% vs 11%), anemia (17% vs 22%), and lymphopenia (16% and 11%). In conclusion, the clinical benefit from the primary analysis of the MAIA study was maintained through 5 years of follow-up and the benefit of upfront D-Rd given to progression was confirmed with a significant OS improvement, further supporting the use of frontline daratumumab as a new standard of care for patients with transplant-ineligible NDMM.

The results of this study will be presented by Prof. Thierry Facon on Saturday, June 12.

Presenter: Professor Thierry Facon

Affiliation: University of Lille, CHU Lille, Service des Maladies du Sang, Lille, France

Abstract: #LB1901 OVERALL SURVIVAL RESULTS WITH DARATUMUMAB, LENALIDOMIDE, AND DEXAMETHASONE VERSUS LENALIDOMIDE AND DEXAMETHASONE IN TRANSPLANT-INELIGIBLE NEWLY DIAGNOSED MULTIPLE MYELOMA: PHASE 3 MAIA STUDY

About the EHA Annual Congress: Every year in June, EHA organizes its Annual Congress in a major European city. This year due to the persisting COVID19 pandemic, EHA organized a Virtual Congress for the second time. The Congress is aimed at health professionals working in or interested in the field of hematology.

Website: www.ehaweb.org

Logo – http://mma.prnewswire.com/media/622259/EHA_Logo.jpg

SOURCE European Hematology Association (EHA)

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