On May 28, 2024 Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, and global specialty, generic and consumer healthcare medicines company STADA Arzneimittel AG reported to have have reached an exclusive commercialization and license agreement for BAT2506, a biosimilar candidate to Simponi (golimumab) (Press release, BioThera Solutions, MAY 28, 2024, View Source [SID1234643750]).

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Under the agreement, Bio-Thera Solutions ("Bio-Thera") will maintain responsibility for development, manufacturing, and supply of BAT2506. STADA Arzneimittel AG ("STADA") will have exclusive rights to commercialize the product in the European Union (EU), the UK, Switzerland and selected other countries.

Bio-Thera will receive an upfront payment of US$10 million, as well as further development and commercial milestones of up to US$147.5 million, subject to the fulfillment of certain conditions.

"STADA is one of the premier biosimilar companies in Europe, and we are pleased to establish a partnership with STADA for BAT2506", said Dr. Shengfeng Li, CEO of Bio-Thera. "We look forward to working with STADA to bring BAT2506 to immunology patients in Europe."

"With global sales in 2023 of US$2.2 billion, including more than US$1 billion outside of the US, golimumab represents a compelling opportunity to broaden patient access to biological treatments and build scale in immunology alongside our approved adalimumab and ustekinumab biosimilars. Bio-Thera’s broad expertise in biologic medicines, including with two biosimilars already approved by the US Food and Drug Administration, makes it an attractive partner for STADA," commented STADA’s head of Global Specialty, Bryan Kim.

Golimumab is a human IgG1 monoclonal antibody that targets tumor necrosis factor alpha (TNF- α), a pro-inflammatory molecule. Binding of golimumab to TNF-α results in reductions in C-reactive protein (CRP), Interleukin 6 (IL-6), Intercellular Adhesion Molecule 1 (ICAM-1), Matrix Metalloproteinase 3 (MMP-3), and Vascular Endothelial Growth Factor (VEGF), all inflammatory markers.

On May 28, 2024 Cellectis (the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene editing platform to develop life-saving cell and gene therapies, reported business updates and reported financial results for the three-month period ending March 31, 2024 (Press release, Cellectis, MAY 28, 2024, View Source [SID1234644826]).

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"We are thrilled to have announced the closing of the additional equity investment of $140 million by AstraZeneca. This followed AstraZeneca’s initial payment of $105 million, composed of a $80 million equity investment and a $25 million upfront payment under our research collaboration.

Following AstraZeneca’s additional investment, we expect our cash runway to fund operations into 2026. We will continue to focus our efforts and expenses on advancing its core clinical trials BALLI-01, NATHALI-01 and AMELI-01, which remain wholly owned assets, while building, within our owned preclinical pipeline and in collaboration with AstraZeneca, the next generation of medicines to address areas of high unmet patient needs.

We strongly believe that gene edited cell and gene therapy products are revolutionizing medicine across a number of therapeutic areas and will become a large part of molecular medicine of the future." said André Choulika, Ph.D., Chief Executive Officer at Cellectis.

Pipeline Highlights

UCART Clinical Programs

Cellectis continues to focus on the enrollment of patients in the BALLI-01 study (evaluating UCART22) in relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL), in the NATHALI-01 study (evaluating UCART20x22) in relapsed or refractory B-cell non-Hodgkin lymphoma (r/r B-NHL), and in the AMELI-01 study (evaluating UCART123) in relapsed or refractory acute myeloid leukemia (r/r AML).
We expect to provide updates in the advancements of BALLI-01 and NATHALI-01 by year-end 2024.

Partnerships

Licensed Allogeneic CAR T-cell Development Programs

Anti-CD19 program

Allogene’s investigational oncology products utilize Cellectis technologies. Servier, which has an exclusive license to the anti-CD19 investigational products from Cellectis, has granted Allogene an exclusive sublicense to these products in the U.S., European Union and the United Kingdom.

Allogene announced the execution with Servier of an amendment to the sublicense to expand the licensed territory to the European Union and the United Kingdom.
Allogene announced that it continues to focus on the development of its investigational product cemacabtagene ansegedleucel, or cema-cel (previously known as ALLO-501A), as part of the first line (1L) treatment plan for LBCL patients who are at risk of relapse following 1L chemoimmunotherapy. Allogene announced that start-up activities for the ALPHA3 trial are ongoing with a planned study initiation in mid-2024.
Allogene further announced that enrollment is ongoing in the relapsed/refractory (r/r) CLL cohort of the Phase 1 ALPHA2 trial of cema-cel.

Anti-CD70 program

The anti-CD70 program is licensed exclusively from Cellectis by Allogene and Allogene holds global development and commercial rights to this program.

Allogene announced that a Phase 1 data update of the ongoing TRAVERSE trial with ALLO-316 in RCC from approximately 20 patients with CD70 positive RCC is planned by YE 2024.

Corporate Updates

Collaboration and Investment Agreements with AstraZeneca

On May 6, 2024, Cellectis announced the completion of the subsequent investment of $140M in Cellectis by AstraZeneca (LSE/STO/Nasdaq: AZN).
AstraZeneca subscribed for 10,000,000 "class A" convertible preferred shares and 18,000,000 "class B" convertible preferred shares, in each case at a price of $5.00 per convertible preferred share, issued by the board of directors of Cellectis.
AstraZeneca owns approximately 44% of the share capital and 30% of the voting rights of the Company (based on the number of voting rights currently outstanding).

On May 28, 2024 Exelixis, Inc. (Nasdaq: EXEL) reported that company management will participate in a fireside chat at the William Blair 44th Annual Growth Stock Conference on Tuesday, June 4 at 4:20 p.m. ET / 3:20 p.m. CT / 1:20 p.m. PT in Chicago (Press release, Exelixis, MAY 28, 2024, View Source [SID1234643734]).

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To access the webcast link, log onto www.exelixis.com and proceed to the Event Calendar page under the Investors & News heading. A replay will also be available at the same location for at least 30 days.

On May 28, 2024 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, reported that it has entered into a clinical trial agreement with the Mays Cancer Center at The University of Texas Health Science Center at San Antonio (UT Health San Antonio) and Swedish Orphan Biovitrum AB (Sobi) (STO:SOBI), a specialized international biopharmaceutical company (Press release, BerGenBio, MAY 28, 2024, View Source [SID1234643751]).

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The parties will collaborate to study BerGenBio’s selective AXL inhibitor, bemcentinib, in combination with Sobi’s pacritinib in patients with advanced lung adenocarcinoma. The clinical study is externally funded and is complementary to BerGenBio’s ongoing Ph1b/2a clinical study in first-line Non-Small Cell Lung Cancer patients with mutations in the STK11 gene.

Bemcentinib is a first-in-class, selective, oral once-a-day inhibitor of AXL receptor tyrosine kinase, a promising therapeutic target for serious diseases. Pacritinib (marketed as VONJO) is a JAK2 inhibitor indicated for treatment of myelofibrosis, a bone marrow disorder, and works by blocking certain growth factors and cytokines.

The clinical study will advance the ground-breaking work of Josephine A. Taverna, MD, a thoracic oncologist at the Mays Cancer Center and Assistant Professor in the Division of Hematology and Oncology at UT Health San Antonio. Dr. Taverna’s prior research has demonstrated that AXL and JAK-STAT3 work together to transmit signals that promote tumor growth and metastasis in advanced lung cancer. The study will be performed in collaboration with Sobi and will be led by Dr. Taverna as the principal investigator and is funded by a grant received from the National Cancer Institute (NCI) of the National Institutes of Health (NIH).

Martin Olin, Chief Executive Officer of BerGenBio stated, "We are excited to work with two stellar partners to bring this intriguing area of research to patients. This study will further extend our knowledge of the role of selective AXL inhibition with bemcentinib in lung cancer, our area of highest strategic focus."

Dr. Taverna commented, "Our data suggests that targeting the AXL-STAT3 pathway with bemcentinib and pacritinib can prevent tumor cells from recruiting tumor-associated macrophages and other aggressive host cells into the tumor microenvironment, disrupting tumor growth and metastatic spread. Understanding this discovery could shed light on novel therapeutic strategies for lung cancer."

On May 28, 2024 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported members of its executive team are scheduled to participate in the upcoming conferences, detailed below (Press release, Innate Pharma, MAY 28, 2024, View Source [SID1234643735]). Participants will include Hervé Brailly, Chief Executive Officer, Sonia Quaratino, Executive Vice President (EVP), Chief Medical Officer, Yannis Morel, EVP, Chief Operating Officer and Arvind Sood, EVP, President of US Operations.

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Jefferies Global Healthcare Conference
Event dates: June 5-6, 2024 | New York, United States

Goldman Sachs 45th Annual Global Healthcare Conference
Event dates: June 10-13, 2024 | Miami, United States

H.C. Wainwright 2nd Annual Immune Cell Engager Virtual Conference
Event date: June 25, 2024 | Virtual

Stifel 2nd European Healthcare Summit Lyon
Event dates: June 25-27, 2024 | Lyon, France