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Bellicum Pharmaceuticals to Participate in the 2022 Cell & Gene Meeting on the Mesa

On October 4, 2022 Bellicum Pharmaceuticals, Inc. (Nasdaq: BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported that Rick Fair, President and CEO, will present at the annual Cell & Gene Meeting on the Mesa to be held October 11-13 in Carlsbad, CA and livestreamed globally (Press release, Bellicum Pharmaceuticals, OCT 4, 2022, View Source [SID1234621659]).

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Details regarding Bellicum’s presentation at the conference are as follows:

Event: 2022 Cell & Gene Meeting on the Mesa
Date: October 11, 2022
Time: 4:30 p.m. PT
Location: Park Hyatt Aviara Resort, 7100 Aviara Resort Dr., Carlsbad, CA 92011

Virtual attendance is available which includes a livestream of Bellicum’s presentation and the ability to view all conference sessions on-demand. Please visit View Source for full information including registration.

Complimentary attendance at this event is available for credentialed investors and members of the media only. Investors should contact Laura Stringham at [email protected] and interested media should contact Stephen Majors at [email protected].

About the Cell & Gene Meeting on the Mesa

Organized by the Alliance for Regenerative Medicine, the Cell & Gene Meeting on the Mesa is a three-day conference featuring more than 90 dedicated company presentations by leading public and private companies, highlighting technical and clinical achievements over the past 12 months in the areas of cell therapy, gene therapy, gene editing, tissue engineering, and broader regenerative medicine technologies, as well as over 100 panelists and featured speakers.

AIVITA Biomedical Announces Publication Detailing 50% Enhanced Survival in Phase 2 GBM Study

On October 4, 2022 AIVITA Biomedical, Inc., a biotech company specializing in innovative cell applications, reported that the Journal of Oncology Research and Therapy has published data from its completed Phase 2 glioblastoma (GBM) study which demonstrates enhanced progression-free survival (PFS) (Press release, AIVITA Biomedical, OCT 4, 2022, View Source [SID1234621657]). The publication, titled "Enhanced Progression-Free Survival in a Phase 2 Trial of Personal Dendritic Cell Vaccines in Patients with Newly Diagnosed Glioblastoma" can be viewed online at: View Source

"The strengths of our approach include its lack of toxicity and the ability to pair it with other treatment modalities such as chemotherapy, inhibitors of angiogenesis and immune checkpoints," said Robert O. Dillman, chief medical officer at AIVITA.

AIVITA completed a multi-center Phase 2 trial of its immunotherapy candidate, AV-GBM-1, which had demonstrated an encouraging 50% improvement in PFS over standard of care in patients with a recent diagnosis of GBM. This publication focuses on PFS resulting from AV-GBM-1 administration and compares the results to those reported in GBM trials of other therapies. The data suggest that continuous treatment could further improve progression-free survival and overall survival.

"AIVITA has developed an inexpensive, pain-free personal immunotherapy that meaningfully increases survival," said Hans S. Keirstead, chairman and chief executive officer of AIVITA. "These data are a significant milestone in our quest to make GBM a non-lethal and manageable disease."

AmplifyBio acquires Pact Pharma assets to enhance cell and gene therapy characterization capabilities

On October 3, 2022 AmplifyBio, a contract research organization (CRO) focused on accelerating innovation across pharmaceutical modalities; reported the acquisition of select assets from PACT Pharma, Inc., a privately held biopharmaceutical company developing neoantigen-specific T cell receptor cell therapies (Press release, AmplifyBio, OCT 3, 2022, View Source [SID1234635613]). The deal will provide AmplifyBio with advanced characterization platforms, bioinformatics capabilities, and 40 drug development experts to enhance their cell and gene therapy service offerings. AmplifyBio will also acquire the South San Francisco advanced laboratory space.

With the acquisition of these assets, AmplifyBio aims to provide an early, consistent characterization of a treatment’s purity, potency, and viability throughout the life cycle of therapeutic development. Unlike small molecules, there is no single, consistent process for cell and gene therapy companies to research, develop, and test their therapeutics. The gap that exists in characterization between the discovery phase and preclinical testing leads to material changes in a therapeutic during development, which can in turn create manufacturing inconsistencies and safety concerns during scale-up.

"Many biologics developers have adopted the phrase ‘the process is the product’ to describe how their therapeutic is differentiated based on a unique development process," said AmplifyBio Chief Executive Officer (CEO) and President J. Kelly Ganjei. "Rather than create our own, individual technique, AmplifyBio aims to replace that saying with a new one: ‘the product is the product. Our acquisition of these assets from PACT Pharma means that cell and gene therapies can now be differentiated based on safety and efficacy profiles and specific product characteristics, not development processes."

"This deal allows PACT to retain its core intellectual property and continue our mission of developing novel, neoantigen-targeted T-Cell Therapies," added Scott Garland, PACT Pharma’s CEO. "At the same time, we’re working with AmplifyBio to leverage our platforms to offer a unique combination of optimization, characterization, safety and efficacy services to a wider range of clients seeking to better understand the immunology of their adoptive cell therapies."

AmplifyBio was spun out in 2021 from Battelle, a not-for-profit organization that advances science and technology to have the greatest impact on our society and economy. Following today’s acquisition of the South San Francisco facility, AmplifyBio plans to add a third site in New Albany, Ohio that consists of 350,000 square feet of multi-function lab spaces. There, AmplifyBio will build on its advanced therapy services by adding capabilities for complex genotypic and phenotypic characterization analysis for late-stage development. The company expects to add additional development platforms and partnerships to become a commercial accelerator delivering safe, effective, reproducible advanced therapies to patients.

Estrella Biopharma, Inc., a biopharmaceutical company to Become a Publicly Traded Company Via Merger with TradeUP Acquisition Corp.

On October 3, 2022 Estrella Biopharma, a preclinical-stage biopharmaceutical company focusing on cancer therapeutics, and TradeUP Acquisition Corp., a publicly traded special purpose acquisition company, reported that they have entered into a definitive business combination agreement on September 30, 2022 that will result in Estrella becoming a publicly listed company (Press release, Estrella Biopharma, OCT 3, 2022, View Source [SID1234628554]).

Upon closing of the transaction, TradeUP will be renamed "Estrella Immunopharma, Inc." (the "Combined Company").

Estrella is a preclinical-stage biopharmaceutical company developing CD19-targeted ARTEMIS️ T-cell therapies under certain license agreements with the capacity to address treatment challenges for patients with blood cancers and solid tumors. Estrella’s lead product candidate, EB103, a CD19-Redirected ARTEMIS️ T-cell therapy, targets CD19, a protein expressed on the surface of almost all B-cell leukemias and lymphomas. Estrella is also developing EB104, a CD19/22 duel-targeting ARTEMIS️ T-cell therapy, which targets both CD19 and CD22, a protein expressed on the surface of mature B lymphocytes. EB103 and EB104 utilize the ARTEMIS Cell Receptor Platform technologies Estrella has in-licensed from Eureka Therapeutics, Inc. ("Eureka") earlier this year. Estrella is also collaborating with Imugene Ltd and its product candidate, CF33-CD19t, an oncolytic virus ("CF33-CD19t"), which forces solid tumor cells to express a CD19 target, to treat solid tumors in a "Mark and Kill" strategy.

Estrella’s President and CEO, Cheng Liu, PhD and the current management team will continue to lead the Combined Company. Dr. Liu will also continue in his role as President and CEO of Eureka.

"Estrella is committed to making a meaningful difference in areas of unmet medical needs by continue advancing our pipeline programs into the clinics. The team is confident that fueled by ARTEMIS technologies, EB103 and EB104 have the potential to address blood cancers while mitigating safety concerns. Meanwhile, we plan to extend the use of our CD19 ARTEMIS️ T-cell therapy into diverse solid tumors by combining with Imugene’s CF33-CD19t in the novel "Mark and Kill" approach," said Dr. Liu, President and CEO of Estrella. "We are delighted to have found such a stellar group of partners and investors as we take the next step in our growth trajectory as a public company."

Weiguang Yang, Co-CEO of TradeUP, commented: "We are truly excited about the merger with Estrella. Estrella represents a rare opportunity to further advance T-cell therapies in minimizing life-threatening side effects such as Cytokine Release Syndrome ("CRS") and has the potential to address blood cancers while mitigating safety concerns. The collaboration with Imugene is expected to tackle the major challenge for current T-cell therapies in solid tumor treatment. We believe this business combination will provide Estrella or the Combined Company the financial resources to continue developing its lead drug candidate and bring its novel therapies to fruition."

Transaction Overview
The pro forma equity valuation (assuming no redemptions) of the Combined Company is expected to be approximately $398.5 million. Estimated cash proceeds to the Combined Company from the transaction are expected to consist of TradeUP’s approximately $45.4 million of cash in trust (assuming no redemptions).

Upon the closing of the transaction, and assuming none of TradeUP’s public stockholders elect to redeem their shares of common stock and no additional shares of common stock are issued upon the closing of the transaction, it is anticipated that TradeUP’s public stockholders would retain an ownership interest of approximately 11.1% in the Combined Company, the sponsors, officers, directors and other holders of TradeUP founder shares will retain an ownership interest of approximately 3.6% of the Combined Company, and the Estrella stockholders will own approximately 81.6% of the Combined Company.

The board of directors of each of TradeUP and Estrella as well as stockholders of Estrella approved the transaction, which is expected to close in the first half of 2023. The transaction will require the approval of the stockholders of TradeUP and is subject to other customary closing conditions including the receipt of certain regulatory approvals.

Additional information about the proposed transaction, including a copy of the business combination, will be provided in a Current Report on Form 8-K to be filed by TradeUP with the SEC and available at www.sec.gov.

Novo Nordisk A/S – Share repurchase programme

On October 3, 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") (Press release, Novo Nordisk, OCT 3, 2022, View Source [SID1234621785]). 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.

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.

Since the announcement 26 September, the following transactions have been made:

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 21,376,688 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 30 September 2022, Novo Nordisk has since 2 February 2022 repurchased a total of 19,665,909 B shares at an average share price of DKK 768.55 per B share equal to a transaction value of DKK 15,114,315,530.