On September 26, 2022 Seagen Inc. (Nasdaq: SGEN), a world leader and pioneer in antibody-drug conjugate (ADC) therapies, and LAVA Therapeutics N.V. (Nasdaq: LVTX), a clinical-stage immuno-oncology company focused on developing its proprietary Gammabody platform of bispecific gamma delta T cell engagers, reported an exclusive license agreement in which Seagen will work to develop, manufacture and commercialize LAVA-1223 (Press release, Seagen, SEP 26, 2022, View Source [SID1234621412]). LAVA-1223 is an advanced preclinical asset that utilizes LAVA’s proprietary Gammabody technology to target epidermal growth factor receptor (EGFR)-expressing solid tumors.

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Under the terms of the agreement, Seagen will receive an exclusive global license for LAVA-1223 and pay LAVA $50 million upfront; up to approximately $650 million in potential development, regulatory and commercial milestones; and royalties ranging from the single digits to the mid-teens on future sales. The agreement also provides Seagen with the opportunity to exclusively negotiate rights to apply LAVA’s proprietary Gammabody platform on up to two additional tumor targets.

"Seagen is committed to driving innovation to improve the lives of people with cancer, and this agreement represents the company’s entry into a novel class of therapeutics that are designed to overcome the challenges of standard T cell engagers by leveraging the activity of a distinct T cell subset," said Roger Dansey, M.D., interim CEO and Chief Medical Officer, Seagen. "This exclusive license from LAVA provides Seagen with the opportunity to harness its expertise in developing first-in-class targeted cancer therapies, along with the company’s global development and commercialization capabilities."

LAVA-1223 employs a targeted approach that is designed to amplify natural tumor recognition by directing gamma delta T cells to the EGFR+ tumor to kill target cells and trigger immune activation while minimizing impact to normal antigen-expressing tissue. Activating the adaptive immune system with this approach has the potential to provide durable immune responses with the possibility of enhancing patient survival.

"LAVA is pioneering the development of gamma delta bispecific antibodies to treat cancer, and we are pleased to work with Seagen in this pursuit. The combination of LAVA’s proprietary Gammabody platform and deep bispecific expertise, with Seagen’s leadership in developing targeted therapies for cancer and commercialization infrastructure, makes this an ideal partnership to advance novel therapies for patients," said Stephen Hurly, President and Chief Executive Officer of LAVA Therapeutics. "This agreement enables LAVA to further validate its platform in a second solid tumor product candidate, bringing us closer toward our goal of generating effective Gammabody medicines for cancer patients. We look forward to working with Seagen to develop potential next generation cancer treatments."

About LAVA-1223

LAVA-1223 is a potential first-in-class therapy designed specifically to target and activate Vγ9Vδ2 (gamma delta) T cells in the presence of epidermal growth factor receptor (EGFR)-expressing tumor cells. EGFR is a well-validated target that is over-expressed in multiple solid tumor types including colorectal cancer, lung cancer and head and neck cancer.

On September 26, 2022 BlueSphere Bio, a T-cell receptor (TCR) T-cell therapy company developing a powerful TCR discovery platform and novel therapeutic candidates for patients with hematologic malignancies and solid tumors, reported the presentation of preclinical data supporting the ability of its TCXpress and iTCXpress platforms to rapidly and efficiently identify novel TCR candidates at the 7th annual CAR-TCR Summit from September 19 – 22, 2022 (Press release, BlueSphere Bio, SEP 26, 2022, View Source [SID1234621411]).

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Mark Shlomchik, M.D., Ph.D., co-founder and chief scientific officer of BlueSphere Bio, commented, "The potential of TCRs as a targeting modality is immense, but has been limited by our ability to effectively identify potential candidates from the vast diversity of naturally occurring TCRs. The data from this presentation provides further validation of our multi-platform approach to rapidly screen and identify promising TCRs capable of recognizing any desired target. This is enabling us to identify a series of TCRs useful in allogeneic stem cell transplant and is scalable and rapid enough to enable targeting of patient-specific tumor neoantigens, when used in conjunction with our NEOXpress platform. We are also ready to partner with others to identify panels of specific TCRs for applications in tumor immunology, autoimmunity and infectious disease, using either TCR-based cell therapy or in antibody-like molecules, such as bi-specific T cell engagers."

TCXpress and iTCXpress have enabled the discovery of BlueSphere’s first clinical candidate, a TCR T-cell therapy reactive against the minor histocompatibility antigen (miHA) HA-1. The company anticipates filing its first IND by 1Q2023, which will include its novel anti-HA-1 TCR T-cell therapy, in conjunction with allogeneic stem cell transplantation, in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and acute lymphoblastic leukemia (ALL). The TCXpress platform has also enabled the discovery of several new TCRs reactive against other clinically relevant miHAs, in addition to HA-1. These additional TCRs will become part of a panel that positions BlueSphere with best-in-class population coverage in these indications, as it advances its programs into the clinic. BlueSphere plans to announce details on these other targets in the coming months.

Presentation Highlights

Title: TCXpress and iTCXpress: A Direct, High-throughput Platform Utilizing Parallel Processes for Efficient and Cost-Effective Discovery and Characterization of Novel TCRs.

Presenters: Jennifer Roy, Associate Scientist, BlueSphere Bio and Stephanie Stras, Associate Scientist, BlueSphere Bio

Data Highlights:

The functionality and versatility of TCXpress and iTCXpress provides an elegant, innovative approach to identifying TCR candidates for engineering TCR-T adoptive cell therapy.
By applying both direct and parallel cloning methods, BlueSphere can rapidly produce specific, expressible TCRs from both liquid and solid tumors with efficiencies above 80%.
The TCXpress approach reduces the cost of TCR identification to approximately $5/TCR to create a scenario where screening larger libraries for functional candidates is financially and logistically feasible.
BlueSphere can identify numerous unique clonotypes without expansion and instead can utilize expansion as a potential enhancement in process when necessary.
About TCXpress

TCXpress is a proprietary high-throughput and efficient T-cell receptor (TCR) capture, expression and functional screening platform capable of processing thousands of single T cells directly into functionally expressed TCRs within a matter of days, thereby creating extensive libraries without the need for sequencing or TCR gene synthesis. TCXpress is used in conjunction with iTCXpress, a proprietary bioinformatics platform that helps to quickly analyze and identify a broad range of unique antigen-specific TCRs for downstream processing and functional testing.

On September 26, 2022 Cerus Corporation (Nasdaq:CERS) reported a selection of abstracts and an industry workshop at the 2022 AABB Annual Meeting, taking place in Orlando, FL from October 1 through October 4 (Press release, Cerus, SEP 26, 2022, View Source [SID1234621410]). This year’s AABB Annual Meeting attracts individuals and institutions from around the globe involved in the fields of transfusion medicine and biotherapies. This year marks the first time the conference has taken place in person since 2019, as well as its 75th anniversary.

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The following is a select list of presentations and abstracts of interest for Cerus. All presentation times are listed in Eastern Daylight Time (EDT).

Oral Presentations

Sunday, October 2, 2022 – 4:30 p.m.– Impact of 100% Pathogen Reduction and 7-Day Storage on Platelet Safety and Availability in France – Plenary Abstract Session
Monday, October 3, 2022 – 7:00 a.m. – Cerus Industry Workshop
Poster Presentations

Held between Sunday, October 2 and Monday, October 3, 2022

Impact of Pathogen Reduction (PR) vs. LVDS Testing on Platelet Availability: A Study Based on Real-Life Experience
Comparing Usable Shelf-Life of Pathogen Reduced Platelets vs LVDS Screened Platelets
Pathogen Reduced Cryoprecipitated Fibrinogen Complex Restores Fibrinogen Levels, Clot Firmness and Thrombin Generation in a Hemodilution Model
Survival and Growth of Bacteria during Manufacturing and Storage of Cryo-AHF Compared to Pathogen Reduced Cryoprecipitated Fibrinogen Complex
The full program of Cerus-related abstracts can be found at the following link: View Source

Cerus representatives will be in the exhibition area at booth #1108.

On September 26, 2022 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Filing, 6-K, Novo Nordisk, SEP 26, 2022, View Source [SID1234621409]). This programme is part of the overall share repurchase programme of up to DKK 24 billion to be executed during a 12-month period beginning 2 February 2022.

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Under the programme initiated 3 August 2022, Novo Nordisk will repurchase B shares for an amount up to DKK 4.4 billion in the period from 4 August 2022 to 31 October 2022.

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

With the transactions stated above, Novo Nordisk owns a total of 20,912,478 B shares of DKK 0.20 as treasury shares, corresponding to 0.9% of the share capital. The total amount of A and B shares in the company is 2,280,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 24 billion during a 12-month period beginning 2 February 2022. As of 23 September 2022, Novo Nordisk has since 2 February 2022 repurchased a total of 19,201,699 B shares at an average share price of DKK 768.92 per B share equal to a transaction value of DKK 14,764,625,404.

On September 26, 2022 Theratechnologies Inc. (TSX: TH) (NASDAQ: THTX) (Theratechnologies), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that it will report financial results for its third quarter of fiscal 2022 ended August 31, on Thursday, October 13, 2022 (Press release, Theratechnologies, SEP 26, 2022, View Source [SID1234621408]).

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The conference call will be held at 8:30 a.m. (ET) on October 13, 2022 to discuss the results and recent business updates. The call will be hosted by Paul Lévesque, President and Chief Executive Officer. Joining Mr. Lévesque on the call will be other members of the management team, including Chief Financial Officer Philippe Dubuc and Chief Medical Officer Christian Marsolais, who will be available to answer questions from participants following prepared remarks.