On January 29, 2024 Immunocore Holdings plc (Nasdaq: IMCR), reported its intention to offer, subject to market and other conditions, $300.0 million aggregate principal amount of convertible senior notes due 2030 (the "notes") in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Immunocore, JAN 29, 2024, View Source [SID1234639680]). Immunocore also expects to grant the initial purchasers of the notes an option to purchase, for settlement within a period of 13 days from, and including, the date the notes are first issued, up to an additional $45.0 million aggregate principal amount of the notes.

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The notes will be senior, unsecured obligations of Immunocore, will accrue interest payable semi-annually in arrears and will mature on February 1, 2030, unless earlier converted, redeemed or repurchased. Upon conversion, Immunocore will deliver ordinary shares represented by American Depositary Shares (the "ADSs") (each currently representing one of Immunocore’s ordinary shares), together with, if applicable, a cash payment in lieu of delivering any fractional ADS, at the then-applicable conversion rate. The interest rate, initial conversion rate and other terms of the notes will be determined at the pricing of the offering.

Immunocore intends to use the net proceeds from the offering, together with its existing cash and cash equivalents, to accelerate its clinical pipeline and for ongoing commercial expansion. In addition, Immunocore intends to repay in full loans outstanding under its loan agreement with investment funds managed by Pharmakon Advisors, LP. Immunocore intends to use any remaining proceeds for other working capital and general corporate purposes.

The offer and sale of the notes, the ADSs deliverable upon conversion of the notes and the ordinary shares represented thereby have not been, and will not be, registered under the Securities Act or any other securities laws, and the notes, such ADSs and such shares cannot be offered or sold except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any other applicable securities laws. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, the notes, the ADSs deliverable upon conversion of the notes or the ordinary shares represented thereby, nor will there be any sale of the notes, such ADSs or such shares, in any state or other jurisdiction in which such offer, sale or solicitation would be unlawful.

On January 29, 2024 Eilean Therapeutics LLC, a biopharmaceutical company dedicated to discovering and developing best-in-class and first-in-class small molecule inhibitors to target escape mutations in hematologic and solid malignancies, reported the clearance from the Human Research Ethics Committee in Australia to begin human dosing in the Phase 1 clinical program of eiletoclax, a highly potent and selective BCL2 inhibitor (Press release, Eilean Therapeutics, JAN 29, 2024, View Source [SID1234639696]).

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"The first in human dosing of eiletoclax in Australia represents another important milestone for Eilean Therapeutics, as we progress, with an accelerated development of our portfolio of best-in-class agents targeting hematological malignancies," stated Iain Dukes, Chief Executive Officer of Eilean Therapeutics. "The highly differentiated pre-clinical profile of eiletoclax emphasizes important advantages over venetoclax-like molecules in safety, tolerability and feasibility of outpatient treatment, enabling the molecule to safely target AML and CLL patients alone and in combination with other targeted therapies."

About Eiletoclax

Eiletoclax (ZE50-0134) has earlier reported best-in-class potency and selectivity against BCL2, a key pro-survival protein that is overexpressed in many cancers. This clinical candidate demonstrated equivalent in vivo anti-tumor efficacy as venetoclax in B cell and myeloid malignancy cell lines and in vivo models. Compared to venetoclax, eiletoclax exhibits significantly less suppression of non-malignant immune cell populations, a result that suggests superior selectivity and an improved safety profile.

On January 29, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported favorable early efficacy results from the first patient enrolled in the Phase 1 Deltacel-01 clinical trial with Deltacel for treating stage 4 metastatic non-small cell lung cancer (NSCLC) (Press release, Kiromic, JAN 29, 2024, View Source [SID1234639681]).

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Favorable preliminary evidence demonstrates Deltacel’s efficacy in controlling the growth of NSCLC. Deltacel continues to be well-tolerated, further confirming the early safety assessment reported on January 5th. The first patient was enrolled at the Beverly Hills Cancer Center (BHCC) and was confirmed to suffer from an actively progressing disease three days prior to beginning treatment. The CT scan performed six weeks later confirmed stabilization of the disease, indicating a preliminary progression-free survival of one and one-half months. Kiromic plans to provide updates as more data becomes available from follow-up monitoring activities and as additional subjects are enrolled in the study.

"We are delighted to share these best-case scenario, preliminary efficacy results following recently announced favorable safety and tolerability data in this patient. It is a significant clinical milestone in a deadly cancer that counts more than 2 million new diagnoses globally each year and is almost three times as deadly as breast and ovarian cancers," said Pietro Bersani, Chief Executive Officer of Kiromic. "Our initial results with Deltacel offer a glimpse of hope and are a testament to our dedication to improving patient outcomes with this challenging disease. We look forward to sharing more detailed data as our trial progresses and remain committed to the rigorous investigation of Deltacel’s potential in treating NSCLC."

"The first patient treated in the Deltacel-01 study continues to do well. We remain hopeful regarding the treatment outcome with subsequent patients and look forward to working with Kiromic to advance enrollment in this study," said Afshin Eli Gabayan, M.D., Medical Oncologist, Medical Director, and Principal Investigator at Beverly Hills Cancer Center.

About Deltacel-01

In Kiromic’s open-label Phase 1 clinical trial, titled "Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Stage 4 Metastatic Non-Small Cell Lung Cancer" (NCT06069570), patients with stage 4 NSCLC will receive two intravenous infusions of Deltacel with four courses of low-dose, localized radiation over a 10-day period. The primary objective of the study is to evaluate safety, while secondary measurements include objective response, progression-free survival, overall survival, time to progression, time to treatment response and disease control rates.

About Deltacel

Deltacel (KB-GDT-01) is an investigational gamma delta T-cell (GDT) therapy currently in the Deltacel-01 Phase 1 trial for the treatment of stage 4 metastatic NSCLC. An allogeneic product consisting of unmodified, donor-derived gamma delta T cells, Deltacel is the leading candidate in Kiromic’s GDT platform. Deltacel is designed to exploit the natural potency of GDT cells to target solid cancers, with an initial clinical focus on NSCLC, which represents about 80% to 85% of lung cancer cases. Data from two preclinical studies demonstrated Deltacel’s favorable safety and efficacy profile when it was combined with low-dose radiation.

On January 29, 2024 2seventy bio, Inc. (the "Company") reported to have entered into an asset purchase agreement (the "Purchase Agreement") with Regeneron Pharmaceuticals, Inc. ("Regeneron") (Filing, 2seventy bio, JAN 29, 2024, View Source [SID1234639699]). Subject to the terms and conditions of the Purchase Agreement, the Company has agreed to sell to Regeneron (the "Asset Sale") the Company’s oncology and autoimmune research and development programs, clinical manufacturing capabilities, and related platform technologies (collectively, the "Programs" and such assets, the "Transferred Assets"). Pursuant to the Purchase Agreement, in consideration for the Transferred Assets, at the closing of the Asset Sale (the "Closing"), Regeneron will make an upfront payment to the Company of $5 million in cash and also assume certain liabilities of the Company arising after Closing, including liabilities related to the conduct of the Programs, under transferred contracts and with respect to certain of the Company’s employees (collectively, the "Assumed Liabilities"). Regeneron also agreed to sublease the Company’s facilities in Seattle, Washington and a portion of the Company’s facilities in Cambridge, Massachusetts. In addition to the upfront consideration, Regeneron has agreed to pay the Company a one-time $10 million milestone payment upon receipt of regulatory approval for the first product candidate within the Transferred Assets in certain specified countries and agreed-upon royalty payments based on net sales of the product candidates if commercialized.

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The Purchase Agreement contains customary representations, warranties and covenants of each of the Company and Regeneron. The Purchase Agreement further provides that, subject to certain limitations, the Company and Regeneron will each indemnify the other for certain losses arising from such breaches of representations, warranties and covenants and liabilities allocated to such party pursuant to the terms of the Purchase Agreement. Effective as of the Closing, the existing collaboration agreement between the Company and Regeneron regarding certain of the Programs will terminate.

The Closing is subject to customary closing conditions, including, among others: (a) the absence of laws enjoining, making illegal or otherwise prohibiting the Asset Sale; (b) the accuracy of the other party’s representations and warranties, subject to certain customary materiality standards; (c) compliance in all material respects by the other party with its obligations under the Purchase Agreement; and (d) no Material Adverse Effect (as defined in the Purchase Agreement) having occurred with respect to the Transferred Assets and Assumed Liabilities, taken as a whole, since the date of the Purchase Agreement. Upon the Closing, the parties will enter into certain ancillary agreements, including a transition services agreement, a license agreement and sublease agreements for the Company’s facilities as described above.

The foregoing descriptions of the terms of the Purchase Agreement and the Asset Sale do not purport to be complete and are qualified in their entirety by reference to the terms and conditions of the Purchase Agreement, which the Company intends to file as an exhibit to its Quarterly Report on Form 10-Q for the quarter ending March 31, 2024.

On January 29, 2024 NANOBIOTIX (Euronext : NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported achievement of operational requirements in NANORAY-312, an ongoing pivotal Phase 3 study evaluating potential first-in-class radioenhancer NBTXR3 for elderly patients with head and neck cancer, resulting in a $20M milestone payment from strategic partner Janssen Pharmaceutica NV ("Janssen"), a Johnson & Johnson company (Press release, Nanobiotix, JAN 29, 2024, View Source [SID1234639682]).

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"This first milestone payment related to our ongoing pivotal Phase 3 study evaluating NBTXR3 for patients with head and neck cancer represents another step forward in our pathway to bring NBTXR3 to registration," said Laurent Levy, Nanobiotix co-founder and chairman of the executive board. "We look forward to continued collaboration with Janssen as we work to deliver the potential benefits of NBTXR3 to millions of patients around the world."

This $20M represents the first applicable development milestone from the global licensing agreement executed between Nanobiotix and Janssen (For more details, please consult the press release dated 4 December 2023).

About NBTXR3
NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas for which the product received a European CE mark in 2019. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

Radiotherapy-activated NBTXR3 is being evaluated across multiple solid tumor indications as a single agent or in combination with anti-PD-1 immune checkpoint inhibitors, including in NANORAY-312—a global, randomized phase III study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the phase III study.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several phase I and phase II studies evaluating NBTXR3 across tumor types and therapeutic combinations. In 2023 Nanobiotix announced a license agreement for the global co-development and commercialization of NBTXR3 with Janssen Pharmaceutica NV.