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MorphoSys’ Partner Incyte Announced Development and Commercialization Agreement with InnoCare for Tafasitamab in Greater China

On August 17, 2021 MorphoSys AG (FSE: MOR; NASDAQ: MOR) reported that Incyte, its development and commercialization partner for tafasitamab, entered into a collaboration and license agreement with a subsidiary of InnoCare for tafasitamab in Greater China (Press release, MorphoSys, AUG 17, 2021, View Source [SID1234586675]). Under the terms of the agreement, InnoCare will receive the rights to develop and exclusively commercialize tafasitamab, a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, in hematology-oncology in mainland China, Hong Kong, Macau and Taiwan.

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In January 2020, MorphoSys and Incyte entered into a collaboration and license agreement to develop and commercialize MorphoSys’ proprietary anti-CD19 antibody tafasitamab globally. MorphoSys and Incyte co-commercialize tafasitamab in the U.S., and Incyte holds the development and commercialization rights for tafasitamab outside the U.S. MorphoSys will receive tiered royalties on ex-U.S. net sales.

About Tafasitamab
Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

Monjuvi(R) (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi(R) is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

In June 2021, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the conditional marketing authorization of tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT). The CHMP opinion is currently being reviewed by the European Commission, which has the authority to grant marketing authorization for medicinal products in the European Union (EU).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

Monjuvi(R) is a registered trademark of MorphoSys AG.
XmAb(R) is a registered trademark of Xencor, Inc.

Celularity Reports Second Quarter 2021 Financial Results

On August 16, 2021 Celularity Inc. ("Celularity") (Nasdaq:CELU), a clinical-stage biotechnology company developing off-the-shelf placental-derived allogeneic therapies, reported financial results for the quarter ended June 30, 2021, and provided a summary of recent corporate highlights (Press release, Celularity, AUG 16, 2021, View Source [SID1234591816]).

"This has been an exciting time for Celularity, with the achievement of multiple transformational milestones and significant progress in our unique approach to cellular medicine," said Robert J. Hariri, M.D., Ph.D., founder, Chairperson and Chief Executive Officer of Celularity. "Most notably, this quarter marked our transition to a public company through a merger with GX Acquisition Corp., which along with a companion PIPE provided significant funds to support our work. Additionally, we made noteworthy advances in our clinical programs, including the expansion of our Phase 1 trial in patients with acute myeloid leukemia, to include difficult to treat patient populations. Beyond our program development, we forged new strategic and commercial partnerships with companies at the forefront of their respective fields that continue our legacy of pioneering new and innovative approaches to cellular medicine. We look forward to continuing to advance the field of cellular medicine and developing treatments capable of addressing significant unmet needs in cancer, autoimmune and infectious disease."

Corporate Highlights

Celularity closed the merger with GX Acquisition Corp. ("GXGX"). Proceeds from the transaction totaled approximately $138 million, which included funds held in GXGX’s trust account and a concurrent private placement investment in public equity (PIPE) financing led by existing Celularity shareholders.
Celularity expanded its ongoing Phase 1 clinical trial of CYNK-001 in patients with acute myeloid leukemia (AML) (NCT04310592) to include patients with relapsed/refractory AML (r/r AML) in addition to its ongoing trial in patients positive for minimal residual disease (MRD).
The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to Celularity’s CYNK-001, a non-genetically modified cryopreserved human placental hematopoietic stem cell-derived natural killer (NK) cell therapy, for the treatment of patients with malignant gliomas.
Celularity entered an exclusive strategic partnership with Imugene Ltd to develop a novel oncolytic virus – allogeneic chimeric antigen receptor (CAR) T-cell immunotherapy combination for the treatment of solid tumors. The collaboration will initially explore the therapeutic potential of a combination of Imugene’s CF33-CD19 oncolytic virus (onCARlytics) and Celularity’s placental-derived CD19 targeting CAR T-cell therapy, CYCART-19.
Celularity established a partnership to leverage Palantir’s next generation software and computational capabilities to analyze Celularity’s cellular data and accelerate research and development activities.
On July 1, 2021, Celularity announced its agreement with Arthrex whereby Arthrex would receive exclusive rights to distribute and commercialize Celularity’s placental-derived biomaterial products for orthopedics and sports medicine in the U.S. Under the terms of the agreement, Celularity will provide Arthrex with exclusive commercial distribution rights for orthopedic surgery and sports medicine and will continue to be responsible for product manufacturing and supply.
Second Quarter 2021 Financial Results

Revenues for the three months ended June 30, 2021, experienced a decrease of $0.3 million compared to the prior year. This was due to a decrease in product sales and rentals revenue resulting from the $24.5 million sale of the MIST/UltraMIST assets in August 2020, partially offset by (i) an increase of $0.6 million in license, royalty and other revenues related to the license arrangement with Sanuwave and (ii) an increase of $0.2 million in services revenues primarily due to higher biobanking storage revenues.
Research and development expenses for the three months ended June 30, 2021, increased $7.1 million compared to the prior year. The increase in research and development expenses was primarily due to a non-cash stock compensation charge related to the grant of fully vested senior management awards.
Selling, general and administrative expenses for the three months ended June 30, 2021, increased $21.3 million compared to the prior year, primarily due to a non-cash stock-based compensation charge related to the grant of fully vested non-employee director and senior management awards.
Net loss for the second quarter of 2021 was $64.5 million, or $2.69 per share.

Sino Biological Raises $772 Million in Shenzhen ChiNext IPO

On August 16, 2021 Sino Biological, a Beijing company that offers biological research reagents and related contract research services to global markets, reported that it has completed a $772 million IPO on Shenzhen’s ChiNext Exchange (Press release, Sino Biopharmaceutical, AUG 16, 2021, View Source [SID1234586738]). On the first day of trading, the stock closed 68% higher at a market capitalization of $5.2 billion. The company, which was founded in 2007, said the IPO funds would represent a new starting point, allowing Sino Biological to expand its existing capabilities.

Biosight Announces Initiation of Investigator Sponsored Phase 2 Clinical Trial of Aspacytarabine for Relapsed/Refractory AML and MDS with the Groupe Francophone des Myélodysplasies

On August 16, 2021 Biosight Ltd., a pharmaceutical development company developing innovative therapeutics for hematological malignancies and disorders, reported the initiation of a Phase 2 trial to evaluate aspacytarabine (BST-236), Biosight’s proprietary antimetabolite, as a second line treatment for patients with relapsed or refractory myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) (Press release, Advaxis, AUG 16, 2021, View Source [SID1234586688]). The investigator sponsored trial will be led by Dr. Pierre Fenaux of the Groupe Francophone des Myélodysplasies (GFM), the French Study Group of the European Myelodysplastic Syndromes (MDS) Cooperative Group (EMSCO). GFM is a non-profit organization comprised of most French hematology centers that conducts and sponsors clinical trials and translational research and coordinates diagnostic and therapeutic guidelines for MDS.

"This new trial is an important step forward in expanding the reach of aspacytarabine to a broader patient population, addressing the unmet needs in the treatment of relapsed/refractory AML and MDS," said Dr. Ruth Ben Yakar, Chief Executive Officer of Biosight. "Initiating an additional trial furthers our clinical momentum, building on updated, encouraging data from our ongoing first-line Phase 2b study presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the receipt of Orphan Medicinal Product Designation for the European Medicines Agency. GFM is an ideal partner to expand the clinical evaluation into MDS with their extensive network of hematology centers, including registered centers of excellence, and we look forward to applying their expertise in clinical trials, treatments and diagnostics as we advance this Phase 2 trial."

Professor Pierre Fenaux, M.D., Ph.D., Head of Hematology at Hospital Saint Louis in Paris, and founding member and Chairman of GFM, said, "The first-line Phase 2b data that were presented at ASCO (Free ASCO Whitepaper), with demonstrated efficacy across key measures including encouraging complete remission and negative minimal residual disease rates, duration of response and overall survival, further increase my conviction that aspacytarabine may serve as a more tolerable, end effective standard of care treatment for patients with both AML and MDS. We are thrilled to be collaborating with Biosight to advance this potentially transformative treatment for relapsed or refractory MDS and AML patients who currently are faced with poor prognoses and no effective standard of care treatment."

About Aspacytarabine (BST-236)

Aspacytarabine is a novel proprietary anti-metabolite. It is composed of cytarabine covalently bound to asparagine, acting as a pro-drug of cytarabine. Cytarabine serves as the backbone of AML therapy for over 45 years due to its superior efficacy, however, it is associated with severe bone marrow, gastrointestinal, and neurological toxicities, which significantly limit its use, especially in older and medically compromised patients. Due to its unique pharmacokinetics and metabolism, aspacytarabine enables high-dose therapy with lower systemic exposure to free cytarabine and relative sparing of normal tissues. As such, aspacytarabine may serve as a new therapy for AML and other hematological malignancies and disorders, including for older adults who are unfit for intensive therapy.

Aspacytarabine was granted FDA Fast Track Designation for treatment of AML patients unfit for standard chemotherapy, and FDA and EMA Orphan Drug Designations, which entitle Biosight to seven and ten years of market exclusivity in the U.S. and Europe, respectively, upon aspacytarabine marketing approval for the treatment of AML in each territory.

Interim results from an ongoing Phase 2b study evaluating aspacytarabine as a single-agent first-line AML therapy demonstrate safety and single-agent activity, and additional studies are launched to evaluate aspacytarabine as a second line treatment for patients with relapsed or refractory MDS or AML. For more information regarding the Phase 2b clinical study of BST-236, please visit www.clinicaltrials.gov.

Ensysce Biosciences Reports Second Quarter 2021 Financial Results and Recent Corporate Updates

On August 16, 2021 Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ: ENSC, OTC: ENSCW), a clinical-stage biotech company with proprietary technology platforms to reduce the economic and social burden of prescription drug abuse and overdose, reported financial results for the second quarter of 2021 and recent corporate updates (Press release, Ensysce Biosciences, AUG 16, 2021, View Source [SID1234586673]).

"In the second quarter, we successfully closed our merger with Leisure Acquisition Corp., providing us with financial resources to advance our lead clinical programs and focus on expanding our pipeline of products in the pain, opioid use disorder (OUD) and ADHD space as a publicly listed company," said Dr. Lynn Kirkpatrick, CEO of Ensysce Biosciences. "We currently have two technology platforms, TAAP and MPAR, with three clinical-stage product candidates. Our pipeline of candidates provides us with the ability to grow each of these programs. Our focus is on prioritization and resource allocation to maintain an optimal balance between aggressively pursuing our more advanced clinical-stage product candidates, such as PF614, PF614-MPAR, and nafamostat, while ensuring the continued development of additional potential product candidates. We have partnered with contract development and manufacturing organizations (CDMOs) to bolster our team and facilitate multiple parallel development programs. Our view, based on data so far and feedback from experts, is that our lead assets for chronic and severe pain have the potential to be transformational."

Dr. Kirkpatrick concluded, "Over the long-term, it is our vision to develop the next generation of innovative solutions for severe pain relief while the reducing the fear of and the potential for opioid misuse, abuse and overdose."

Program Updates

TAAP – opioid abuse deterrent program:

Ensysce’s lead TAAP candidate, PF614, entered Phase 1b/Bioequivalence clinical development.
Ensysce entered into an agreement for manufacture of PF614 clinical trial material with Recro Pharma.
MPAR – opioid overdose protection program:

PF614-MPAR, our overdose protection program lead product, received an Investigational New Drug (IND) allowance from the U.S. Food and Drug Administration.
Notice of Award for year 3 of a multi-year grant was received from the National Institute on Drug Abuse (NIDA), providing Ensysce with additional resources to continue its work to bring PF614-MPAR into clinical development.
PF614-MPAR entered Phase 1 clinical development utilizing a ‘translational pharmaceutics’ approach.
Other programs:

Ensysce entered into an agreement for manufacture of nafamostat clinical trial material with Recro Pharma for its COVID-19 oral therapy program.
Ensysce received a Notice of Allowance from the United States Patent and Trademark Office for a patent entitled Compositions Comprising Enzyme-Cleavable Amphetamine Prodrugs and Inhibitors Thereof. This issuance provides the Company with additional pipeline candidates for ADHD indications.
Second Quarter 2021 Financial Results

Cash – Cash and cash equivalents were $8.0 million as of June 30, 2021. With the public listing of its common stock following the closing of the merger with Leisure Acquisition Corp. on June 30th, Ensysce now has access to a share subscription facility of up to $60 million which it entered into in December 2020. As such, Ensysce believes it has access to sufficient capital to fund its current planned operations for at least the next twelve months.
Federal Grants – Funding under federal grants was $0.4 million for the second quarter of 2021 compared to $1.8 million for the second quarter of 2020. The decrease is attributable to the timing of research activities eligible for funding.
R&D Expenses – Research and development expenses were $0.5 million for the second quarter of 2021 compared to $1.4 million for the same period in 2020. The decrease was primarily resulted from reduced external research and development costs related to preclinical programs for PF614-MPAR and Phase 1 clinical trial activities of nafamostat.
G&A Expenses – General and administrative expenses were $0.4 million for the second quarter of 2021 compared to $0.3 million for the second quarter of 2020. The increase was primarily a result of higher legal and other professional services expenses related to post-merger corporate matters.
Net Loss – Net loss for the second quarter of 2021 was $1.0 million compared to $0.7 million for the same period in 2020.