On June 3, 2024 LadRx Corporation (OTCQB: LADX) ("LadRx" or the "Company"), a biopharmaceutical innovator focused on research and development of life-saving cancer therapeutics, is pleased to announce that the Company and NantCell, Inc. ("NantCell"), together with NantCell’s parent company ImmunityBio, Inc. ("ImmunityBio"), have agreed to a mutual termination of the license of aldoxorubicin entered into in 2017 (Press release, ImmunityBio, JUN 3, 2024, View Source [SID1234644163]).

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With the termination of the license agreement between LadRx and NantCell, LadRx regains control of aldoxorubicin. In 2023, LadRx transferred the royalty and milestone rights of arimoclomol and aldoxorubicin to XOMA Corporation (NASDAQ: XOMA) ("XOMA") in exchange for $5 million in upfront gross proceeds, up to an additional $2 million for milestones related to arimoclomol and $5 million for milestones related to aldoxorubicin. XOMA consented to the mutual termination of the LadRx-NantCell agreement in order to facilitate the return of the program to LadRx. In parallel, LadRx and XOMA have amended their 2023 Royalty Purchase Agreement to provide XOMA with a low-single-digit synthetic royalty on aldoxorubicin and a mid-single-digit percentage of any economics derived by LadRx from future out-license agreements related to aldoxorubicin. The agreement between LadRx and XOMA regarding future royalties and milestones associated with arimoclomol is not affected by the termination of the aldoxorubicin license between LadRx and NantCell.

Stephen Snowdy, PhD, CEO of LadRx commented, "We are excited to have aldoxorubicin back in-house. Aldoxorubicin is the first LADR-based drug to reach the clinic and was shown in multiple clinical studies to have lower cardiotoxicity compared to doxorubicin while showing promise of efficacy in a Phase II trial in advanced soft tissue sarcoma. Aldoxorubicin also proved the premise of LADR-based drugs that targeting chemotoxins via the LADR backbone allows for several-fold higher dosing of chemotherapeutic drugs."

Dr. Snowdy continued, "We congratulate ImmunityBio on their recent successes with their immunity-based products and certainly understand their going-forward focus on those modalities. Over the coming months, we will be reviewing the pre-clinical and clinical data for aldoxorubicin and plotting a path forward for its continued clinical development. Meanwhile, we continue to march LADR-7 towards the clinic and remain on track for filing an IND application for LADR-7 in the third or fourth quarter of 2024."

On June 3, 2024, Royalty Pharma plc (the "Issuer") reported to have entered into an underwriting agreement (the "Underwriting Agreement"), by and among the Issuer, Royalty Pharma Holdings Ltd (the "Guarantor"), RP Management, LLC (the "Manager") and BofA Securities, Inc., Citigroup Global Markets Inc., J.P. Morgan Securities LLC, Morgan Stanley & Co. LLC and TD Securities (USA) LLC, as representatives of the several underwriters listed on Schedule I thereto (the "Underwriters"), pursuant to which the Issuer has agreed to issue and sell to the Underwriters $500 million aggregate principal amount of its 5.150% Senior Notes due 2029, $500 million aggregate principal amount of its 5.400% Senior Notes due 2034 and $500 million aggregate principal amount of its 5.900% Senior Notes due 2059 (collectively, the "Notes") in a registered public offering pursuant to an effective shelf registration statement on Form S-3 (Registration File No. 333-279905) (Filing, 8-K, Royalty Pharma , JUN 3, 2024, View Source [SID1234644140]). The Notes will be guaranteed on a senior unsecured basis by Royalty Pharma Holdings Ltd. The offering is expected to close on June 10, 2024, subject to the satisfaction of customary closing conditions. The description of the Underwriting Agreement contained herein is qualified in its entirety by reference to the Underwriting Agreement, a copy of which is included as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.

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On June 3, 2024 BlueSphere Bio, a drug development company focused on the discovery of novel T-Cell receptor (TCR) based therapies, reported that the Food and Drug Administration (FDA) has cleared BlueSphere’s Investigational New Drug application (IND) for a Phase 1/2a trial (TCX-101) of its first-in-human (BSB-1001) product candidate for patients with relapsed or refractory acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and myeloid dysplastic syndrome (MDS), in conjunction with allogeneic hematopoietic stem cell transplantation (alloHSCT) (Press release, BlueSphere Bio, JUN 3, 2024, View Source [SID1234644080]). The Company anticipates enrolling the first patient in this multi-center, open-label study in 4Q2024. Notably, because of the unique product and trial design, the TCX-101 trial will enroll patients with active morphologic disease or cytogenetic features placing them at high risk of relapse. Additionally, patients will receive simultaneous administration of BSB-1001 with alloHSCT to optimally target residual leukemia, without the use of immunosuppressive drugs.

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BSB-1001 targets HA-1, a blood-restricted minor histocompatibility antigen (miHA) and is the first TCR-T cell therapy candidate generated using the Company’s TCXpress platform. TCXpress is an integrated, high-throughput TCR identification and screening platform that enables efficient TCR discovery with a competitive timeline. While BlueSphere is also developing assets for solid tumors and non-oncology indications, it has chosen to prioritize its high-risk leukemia programs in the clinic.

Simultaneously, BlueSphere also announced three additional blood-restricted miHA TCR product candidates that are ready for clinical development – all discovered utilizing the TCXpress platform. Together, these four TCR T-cell therapy candidates comprising the TCX-101 program positions the Company’s miHA portfolio with best-in-class HLA coverage in these hematologic indications.

"We are eager to begin treating patients in our TCX-101 trial," said Keir Loiacono, Esq., Chief Executive Officer of BlueSphere. "Our team is focused on accelerated identification, development and translation of novel products to the clinic. While alloHSCT provides a chance of a cure for patients, a large fraction of patients will still relapse or do not have it as an option because of active leukemia. Deploying a TCR-based approach to blood restricted antigens – like miHAs combined with alloHSCT – could provide new options for these patients. We believe that BlueSphere’s unique approach to product and trial design will, among other things, enable us to treat patients who previously were unable to receive alloHSCT because of the presence of active leukemia."

To further expand the reach of our TCR-based portfolio, BlueSphere has broadened its pipeline to address an additional subset of AML patients having mutated NPM1. Utilizing TCXpress, the Company identified and subsequently nominated a single lead TCR reactive against mutant NPM-1 for the TCX-102 program. As a testament to the power of our TCXpress platform and ability to accelerate translation to the clinic, the Company screened close to 700 million T cells and was able to select three (3) lead candidates in under six months, ultimately nominating a single TCR for clinical development. IND enabling work is underway with an IND filing anticipated in 2Q2025. The TCX-102 trial will be an autologous program and will not be given in combination with alloHSCT.

"The NPM1 mutation is a founder mutation present in approximately 30% of AML patients and is present throughout the duration of the disease, making it an ideal target for TCR-based therapy," said Erkut Bahceci, MD, Chief Medical Officer of BlueSphere. "The advancement of the TCX-102 program in patients with mutant NPM1 demonstrates our commitment to this disease space and underscores the power of our TCR discovery platform to discover rare and potent TCR candidates."

On June 3, 2024 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer reported that the first patient has been enrolled in the Phase II part of the randomized Phase I/II clinical trial of the individualized therapeutic cancer vaccine, TG4050, in the adjuvant treatment of head and neck cancer (Press release, Transgene, JUN 3, 2024, View Source [SID1234644069]). Patient screening and enrollment are active, with the aim of enrolling 80 patients internationally in the overall Phase I/II trial.

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TG4050 is based on Transgene’s myvac viral vector platform and NEC’s cutting-edge AI capabilities for the identification and prediction of the most immunogenic neoantigens for each patient. The therapeutic vaccine, TG4050, is being jointly developed by Transgene and NEC in head and neck cancer.

TG4050 advancing to Phase II part based on Phase I data showing immunogenicity and first signs of clinical benefit.

The promising TG4050 Phase I data presented at AACR (Free AACR Whitepaper) 2024 (see press release distributed on April 9, 2024, here) showed strong immunogenicity, persistent cellular immune response as well as signs of clinical benefit for patients. At the time of the analysis, only patients in the control arm had relapsed, while all patients who received TG4050 were disease-free. Based on these promising data, Transgene and its partner NEC have decided to move forward with an extension of the randomized trial consisting of a Phase II part. This Phase II part will continue investigating single-agent TG4050 in patients with newly diagnosed, locoregionally advanced, HPV-negative, squamous cell carcinoma of the head and neck (SCCHN) in the adjuvant setting following completion of surgery and chemoradiotherapy.

Although some advancements in the treatment of SCCHN have been made, there remains a significant medical need for these patients, including in the adjuvant setting. With the current standard of care, 30% to 40% of patients are expected to relapse within 24 months following surgery and adjuvant therapy. Despite completed Phase III trials, immune checkpoint inhibitors have yet to demonstrate significant benefits for these patients.

TG4050 is the only individualized neoantigen cancer vaccine currently being developed in a randomized trial in the adjuvant treatment of head and neck cancer.

Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene commented, "The inclusion of the first patient in the Phase II part of our Phase I/II trial marks a further milestone for Transgene. In the ongoing trial, TG4050 is targeting patients with head and neck cancer at high-risk of relapse, with the aim of extending disease-free survival. The Phase I data we have generated indicate that TG4050 enables the induction of specific cellular immune responses that persist up to 7 months post treatment initiation, with all treated patients remaining disease-free after a median follow-up of 18.6 months. We are encouraged by these promising clinical outcomes and look forward to generating data from the Phase II part of the trial. Personalized cancer vaccines are an extremely exciting development and, if successful, could also be utilized to treat other forms of cancer to improve and extend the lives of patients."

This international, multicenter, open label, two-arm trial is currently screening patients in France at IUCT-Oncopole (Toulouse) and Institut Curie (Paris). Additional sites in France, Europe and the US will be added in the coming months. Overall, the Phase I/II trial will randomize approximately 80 patients. The inclusion of the last patient in the Phase II part of the study is expected in Q4 2025.

TG4050 is designed based on each patient’s tumor

TG4050 is an individualized immunotherapy derived from Transgene’s myvac platform, combining Transgene’s biotechnology known-how and expertise with NEC’s artificial intelligence (AI) capabilities. Cancer vaccines of this type are individually designed to stimulate and educate the patient’s immune system to fight against their own cancer. This viral-based immunotherapy integrates about thirty tumor neoantigen, identified and selected from tumor sequencing to generate the most effective immune response.

On June 3, 2024 Diakonos Oncology Corp., a clinical-stage immuno-oncology company, reported that Chief Financial Officer and Head Of Business Development Anthony Baldor will give a company presentation at the 2024 BIO International Convention June 3 – 6, 2024 in San Diego (Press release, Diakonos Oncology, JUN 3, 2024, View Source;6-2024 [SID1234644068]). The corporate update will be June 4 at 3 pm PT in Company Presentation Theater 2 at the San Diego Convention Center.

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Mr. Baldor’s presentation will include a review of Diakonos’ highly differentiated double-loaded autologous dendritic cell vaccines for cancer, and an operational update on the company’s plans for growth, including clinical development outlook and expansion of its leadership team.

Diakonos recently completed a Phase 1 trial of DOC1021, its lead vaccine for glioblastoma multiforme (GBM), and is planning a Phase 2 study. The US Food and Drug Administration has granted Fast Track and Orphan Drug status for DOC1021. Two other clinical trials are under way with dendritic cell vaccines targeting pancreatic cancer and angiosarcoma.

"We are very excited about the results of our Phase 1 trial for GBM," Mr. Baldor said. "Data observed to date give us great confidence in our dendritic cell vaccines and their potential to treat a broad range of solid tumor cancers, including the most deadly. Twelve month survival is currently at 90% for evaluable patients, and the therapy is well tolerated."

Diakonos’ dendritic cell vaccines activate robust cytotoxic TH1 cell signaling pathways that better harness a patient’s immune system to target and eliminate cancer cells by initiating a natural immune response. This is achieved without any genetic modification of the patient’s immune cells, which greatly simplifies the manufacturing process and significantly reduces costs when compared to leading cell therapy approaches.