On December 15, 2024 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, and Eli Lilly and Company (NYSE: LLY) today jointly announced a Distribution and Promotion Agreement in Mainland China regarding Lilly’s non-covalent (reversible) Bruton’s tyrosine kinase (BTK) inhibitor, Jaypirca (pirtobrutinib, 100 mg & 50 mg tablets). The agreement highlights the following aspects:

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Innovent will be responsible for the importation, marketing, distribution and promotion of Jaypirca;
Lilly will be responsible for the R&D and post-market medical affairs of Jaypirca.
Jaypirca, a highly selective kinase inhibitor, utilizes a novel non-covalent binding mechanism to re-establish BTK inhibition in mantle cell lymphoma (MCL) patients previously treated with a covalent BTK inhibitor (approved including ibrutinib, acalabrutinib, zanubrutinib, or orelabrutinib) and extend the benefit of targeting the BTK pathway, thus effectively addressing the unmet clinical needs for these patients. Approved by the U.S. FDA in January 2023, Jaypirca (pirtobrutinib) became the first and only approved non-covalent (reversible) BTK inhibitor. In October 2024, Jaypirca (pirtobrutinib) received approval from China’s National Medical Products Administration (NMPA) as monotherapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two types of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor (Link).

Lilly is conducting comprehensive global Phase 3 development programs (including in China), in first-line and relapse or refractory patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), and BTK inhibitor-naïve relapse or refractory MCL, to explore monotherapy or combination therapy.

Under the agreement, Innovent holds the sole commercialization rights for Jaypirca in Mainland China, overseeing importation, marketing, distribution and promotion. Lilly will be responsible for R&D and post-market medical affairs. Leveraging Innovent’s established hematology oncology commercial team and Lilly’s deep expertise in drug development and scientific insights in the therapeutic area, the partnership is committed to broadening access to innovative treatments and improving outcomes for cancer patients in Mainland China.

Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "Building on our long-term strategic collaboration with Lilly, we are proud to expand our collaboration through this agreement. Jaypirca, the world’s first and only approved non-covalent (reversible) BTK inhibitor, represents a breakthrough treatment option for patients who have previously received BTK inhibitors. Innovent has built a robust and leading portfolio in the hematological malignancy field, consisting of TYVYT (sintilimab injection), HALPRYZA (rituximab injection), olverembatinib, FUCASO (Equecabtagene Autoleucel Injection), and Jaypirca. By fully leveraging our commercialization capabilities and extensive coverage in this field, we aim to bring forward innovative medicines to benefit cancer patients and further enhance our leading position in oncology. We remain steadfast in our commitment to advancing the biopharmaceutical industry through collaborative efforts so that first-rate pharmaceutical drugs can become widely accessible."

Huzur Devletsah, President and General Manager of Lilly China, states, "Lilly is thrilled to appoint Innovent for the distribution and promotion of Jaypirca marking a pivotal moment in hematologic cancer treatment for Lilly. This agreement allows to rapidly increase patient access in Mainland China by drawing on Innovent’s robust market presence and our extensive R&D expertise. Together, we are poised to deliver innovative therapies and support the ‘Healthy China 2030’ initiative, continuing our commitment: ‘In China, For China."

About Jaypirca (pirtobrutinib)

Jaypirca (pirtobrutinib, formerly known as LOXO-305) is a highly selective (300 times more selective for BTK versus 98% of other kinases tested in preclinical studies), non-covalent (reversible) inhibitor of the enzyme BTK.[i] BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including mantle cell lymphoma.[ii],[iii]

About Innovent’s strategic cooperation with Lilly

Innovent and Lilly have established a comprehensive level of cooperation, setting an example of partnership between a Chinese innovative pharmaceutical company and a global leading medicine company in the field of R&D, CMC, clinical development and commercialization, aiming to accelerate the access of innovative medicines to benefit more patients worldwide.

In March 2015, Innovent entered into a strategic partnership with Lilly focused on biological medicine. Under the initial agreement, Lilly and Innovent co-developed and co-commercialized oncology medicines, including Tyvyt (sintilimab injection) in China. In October 2015, the two parties announced the extension of collaboration to include the co-development of three additional antibodies in oncology. In August 2019, the cooperation extended with a licensing agreement for the development and commercialization of a potentially global best-in-class investigational GCG/GLP-1 medicine in China. In August 2020, Innovent and Lilly announced a global expansion of their strategic alliance for sintilimab. In March 2022, Lilly and Innovent deepened their engagement in oncology, granting Innovent sole commercialization rights for Cyramza (ramucirumab) and Retsevmo (selpercatinib), and a right of first negotiation for potential future commercialization of Jaypirca (pirtobrutinib) in Mainland China. In December 2024, the agreement of the commercialization of Jaypirca (pirtobrutinib) in Mainland China officially achieved.

On December 13, 2024 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering novel approaches to precision T cell activation, reported that Chief Executive Officer, Zhen Su, M.D., MBA, presented a clinical update highlighting the STARt-001 trial at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2024 taking place in Geneva, Switzerland (Press release, Marengo Therapeutics, DEC 13, 2024, View Source [SID1234649110]).

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The oral presentation highlighted findings from the Phase 1 clinical study of invikafusp alfa (STAR0602), Marengo’s first-in-class Vβ6/10 selective dual T cell agonist as monotherapy in patients with PD-1-resistant cancers. The results, previously showcased during a late-breaking plenary session at the SITC (Free SITC Whitepaper) Annual Meeting, demonstrated initial anti-tumor activity and a favorable safety profile in heavily pre-treated, biomarker-enriched patients who are resistant to prior PD-1 therapy.

"We are honored to share this exciting clinical advancement with the global oncology community at ESMO (Free ESMO Whitepaper) IO," said Dr. Su. "The insights gained from the STARt-001 trial underscore the potential of invikafusp alfa to address the unmet needs of patients with PD-1-resistant tumors. They also validate the precision immunology approach underlying our STAR platform, which drives the design of Marengo’s selective dual T cell agonist antibodies. We look forward to advancing invikafusp alfa into a Phase 2 study in the near term."

Oral presentation details:

Title: Reinvigorating T cell repertoire in vivo: Igniting the TIL Compartment
Session Title: Special Session: Boosting cancer cell immunity
Presentation Date and Time: Friday, December 13, 2024, 10:45 AM – 11:00 PM CET
Presenter: Zhen Su, M.D., MBA, Chief Executive Officer at Marengo

On December 13, 2024 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) ("BioVaxys" or the "Company") reported that it has closed the first tranche (the "First Tranche") of its previously announced non-brokered private placement (the "Private Placement") with the issuance of 2,200,000 units (the "Units") of the Company at a price of $0.05 per Unit for aggregate gross proceeds of $110,000 (Press release, BioVaxys Technology, DEC 13, 2024, View Source [SID1234649111]).

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Each Unit consist of one (1) common share in the capital of the Company (each, a "Share") and one (1) whole Share purchase warrant (each, a "Warrant"), whereby each Warrant is convertible into one additional Share at an exercise price of $0.15 until December 13, 2026, being the date that is 24 months from the date of issue.

The Company intends to use the net proceeds of the First Tranche for working capital. No finder’s fees were paid in connection with the First Tranche. All securities issued pursuant to the First Tranche are subject to a statutory hold period expiring April 14, 2025, being the date that is four months and one day from the date of issuance in accordance with applicable securities legislation

In addition, the Company announces that it has entered into a debt settlement agreement with an arm’s-length consultant of the Company to settle an aggregate of $500,000 in debt owed to the consultant by issuing 5,000,000 Shares at a deemed price of $0.10 per Share (the "Debt Settlement"). The board of directors of the Company has determined that it is in the best interests of the Company to settle the outstanding debt through the issuance of Shares in order to preserve the Company’s cash for working capital purposes.

All securities proposed to be issued pursuant to the Debt Settlement will be subject to a statutory hold period of four months from the date of issuance in accordance with applicable securities legislation. Closing of the Debt Settlement is conditional upon a number of conditions, including receipt of all applicable corporate and regulatory approvals, including the acceptance of the Canadian Securities Exchange.

This news release does not constitute an offer to sell or a solicitation of an offer to buy of any securities in the United States. The securities described herein have not been, and will not be, registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act"), or any state securities laws, and may not be offered or sold within the United States except in compliance with the registration requirements of the U.S. Securities Act and applicable state securities laws or pursuant to available exemptions therefrom.

On December 13, 2024 BrightPath Bio (Tokyo Stock Exchange Growth 4594, "BrightPath"), a pioneer in iPS cell-derived Natural Killer T ("NKT") cell therapy, and Cellistic, a leader in advanced iPS cell therapy manufacturing, reported a process development and manufacturing agreement to advance BrightPath’s novel allogeneic CAR-T cell therapy platform, utilizing iPSC-derived NKT cells for clinical trials (Press release, BrightPath Biotherapeutics, DEC 13, 2024, View Source [SID1234649112]).

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The strategic collaboration includes the use of Cellistic’s innovative 3D bioreactor-based manufacturing platform, Echo, to enable GMP-compliant, clinical-scale manufacturing of iPSC-derived BCMA-targeting CAR-NKT cells for Phase 1 multiple myeloma trial; establishing BrightPath as a first mover in this emerging field.

"The use of NKT cells as effectors in allogeneic CAR-T therapy represents a promising strategy, offering not only direct cytotoxicity but also indirect anti-tumor activity through the priming of host CD8+ T cells—a mechanism expected to evade host immune rejection and to enhance the durability of clinical responses. However, achieving clinical-scale manufacturing of such a rare subset of T cells while preserving their original functionality has conventionally been a significant challenge. Induced pluripotent stem (iPS) cell technology has overcome this barrier, making large-scale production feasible," stated Ken Nagai, CEO of BrightPath.

"While we have established a robust 2D culture-based manufacturing process, we have recognized the importance of anticipating the full scalability potential of the iPS cells from commercial perspective at an early stage. To address this need, we are committed to implement more scalable manufacturing solutions. Cellistic is well-positioned to meet this critical requirement with their unique 3D platform and extensive experiences in iPSC differentiation and scale-up of a variety of cell types," Ken Nagai further noted. "We are delighted to partner with Cellistic, which has the most experience in culturing iPS cells using 3D bioreactors. This collaboration with Cellistic allows us to leverage their state-of-the-art development and manufacturing capabilities to accelerate the development of our BCMA CAR-NKT product."

"We are excited to partner with BrightPath in the development of their revolutionary iPSC derived cell therapy," said Gustavo Mahler, CEO of Cellistic. "Our Echo manufacturing platform is designed to meet the unique challenges of cell therapy production, ensuring scalability, quality, and regulatory compliance. Together, we can advance the therapeutic potential of BCMA CAR-NKT cells and help BrightPath to bring innovative solutions to patients in need."

The agreement marks a significant step forward in the industry’s pursuit of innovative and effective cell therapies, with both companies committed to advancing healthcare solutions that improve patient outcomes.

On December 13, 2024 Oxford Vacmedix (OVM), the UK-based biopharma company developing vaccines to treat cancer, reported the finalisation of a licensing deal for its lead cancer vaccine OVM-200, with its largest shareholder Dx&Vx (Press release, Oxford Vacmedix, DEC 13, 2024, View Source;utm_medium=rss&utm_campaign=oxford-vacmedix-licenses-ovm-200-to-dxvx [SID1234649103]). The sub-license will grant Dx&Vx rights to develop and commercialise OVM-200 in South Korea, China, (including Macau, Hong Kong, and Taiwan) and India. In return OVM will receive substantial milestones and double-digit royalties on sales. Under the agreement Dx&Vx will run clinical trials in South Korea, China, and India. Also, Dx&Vx will manage all regulatory and commercial aspects of OVM-200 development. OVM will co-operate on all aspects of clinical development and have access to the clinical trial data generated.

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In anticipation of the sub-licence, the development team from Dx&Vx has recently visited Oxford for very productive discussions on development and CMC of OVM-200 for clinical trials in S. Korea, China, and India.

OVM-200 targets survivin, a protein overexpressed by cancer cells that allow unregulated growth, which stimulates an immune response. The vaccine is in a Phase 1 trial in the UK which is both the first time OVM-200 has been used in people and also the first time any ROP (Recombinant Overlapping Peptide) based vaccine has been tested in the clinic. The ongoing trial is focused on safety and on establishing an immune response in advanced cancer patients in three cancer indications: non-small-cell lung cancer (NSCLC), prostate cancer, and ovarian cancer. Initial results from Phase 1a, the dose escalation part of the trial, have shown very good safety and a strong immune response. Phase 1b for another 18-20 patients is ongoing with extended dosing approved by the UK MHRA (Medicines and Healthcare products Regulatory Agency).

William Finch, CEO of OVM, said:

We are very pleased that Dx&Vx is licensing OVM-200. This demonstrates real confidence in the technology. Our recent discussions in Oxford showed that Dx&Vx have both expertise and capability. We look forward to working closely with Dx&Vx on this programme. OVM-200 will be used both alone and in combination to help patients with advanced cancers.

Kevin Kwon, CEO of Dx&Vx, added:

We are delighted to be licensing-in OVM-200 and intend to implement Phase 1/ Phase 2a clinical trials in major Asian countries (South Korea, China, and India). We will try to launch OVM-200 through an accelerated approval that will allow patients to benefit from this novel technology as early as possible once clinical trials are completed around 2027.