On January 9, 2025 Boehringer Ingelheim and Synaffix B.V. ("Synaffix"), a Lonza company (SWX:LONN) focused on commercializing its clinical-stage platform technology for the development of best-in-class antibody drug conjugates (ADCs), reported that Boehringer has licensed Synaffix’s ADC technology (Press release, Synaffix, JAN 9, 2025, View Source [SID1234649552]). This new partnership significantly bolsters Boehringer’s ADC portfolio, driven by its subsidiary, NBE Therapeutics, to achieve the company’s aim of transforming the lives of people with cancer.

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ADCs are a cutting-edge class of cancer treatments that combine the targeting ability of antibodies with the potent cancer-killing power of drugs. This allows for the precise delivery of therapeutic agents directly to cancer cells, minimizing damage to healthy tissue and enhancing treatment efficacy.

Peter van de Sande, Head of Synaffix, said: "Boehringer Ingelheim is a leader in oncology treatment development, and the selection of our ADC technologies to further bolster their pipeline portfolio is a strong recognition of the potential of these technologies to maximize the therapeutic index of ADCs. This licensing agreement represents the culmination of a successful preclinical evaluation of our technology."

Lamine Mbow, Global Head of Discovery Research, Boehringer Ingelheim, said: "We are building a broad pipeline of ADCs addressing the novel tumor target space to develop next-generation cancer treatments. By combining our deep expertise in cancer treatment development with Synaffix’s clinical-stage platform technology, we aim to accelerate the delivery of first-in-class cancer treatments to improve cancer patient outcomes."

Synaffix has developed a clinically validated ADC platform technology that utilizes an enzymatic modification of native glycan anchor points on antibodies, enabling the development of best-in-class ADCs or bispecifics. With the access to Synaffix’s technology, NBE Therapeutics broadens its ADC portfolio. This will enable Boehringer Ingelheim to address novel tumor targets from its comprehensive portfolio to develop first-in-class cancer treatments that address high unmet medical needs in oncology.

Under the terms of the agreement, Synaffix will provide access to its proprietary ADC technologies for an agreed but undisclosed number of targets. The first target was nominated upon signature, and additional targets will subsequently be nominated within a predefined timeframe. In addition to the upfront payment, Synaffix is eligible to receive potential additional milestone payments of up to $1.3 billion, plus additional royalty payments on net sales of resulting products.

On January 9, 2025 Synaffix B.V. ("Synaffix"), a Lonza company (SWX:LONN) focused on commercializing its clinical-stage platform technology for the development of antibody-drug conjugates (ADCs) with best-in-class therapeutic index, reported that it has licensed its ADC technology to Mitsubishi Tanabe Pharma Corporation ("MTPC"), the pharma arm of Mitsubishi Chemical Group ("MCG") (Press release, Synaffix, JAN 9, 2025, View Source [SID1234649550]).

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Synaffix is responsible for the manufacturing of the components that are related to its proprietary technologies, and MTPC is responsible for the research, development, manufacturing and commercialization of the ADC.

Peter van de Sande, Head of Synaffix, said: "This latest licensing deal with MTPC highlights the appeal of our industry-leading ADC technology offering. MTPC is a key collaborator for us, expanding our presence in the APAC region, and we are excited to work alongside such a large and reputable corporation with the aim to make a tangible difference for patients in areas of high unmet medical need."

On January 9, 2025 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to R289 for the treatment of myelodysplastic syndromes (MDS) (Press release, Rigel, JAN 9, 2025, View Source [SID1234649549]). R2891, Rigel’s potent and selective dual inhibitor of IRAK1 and IRAK4, is being studied in an ongoing Phase 1b study evaluating the safety, tolerability, pharmacokinetics and preliminary activity in patients with LR-MDS who are relapsed or refractory to prior therapies.

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"Receiving Orphan Drug designation for R289 supports the development of this therapeutic candidate for the treatment of MDS and highlights the significant unmet medical need that exists for these patients," said Raul Rodriguez, Rigel’s president and CEO. "Orphan Drug and Fast Track designations, along with encouraging initial data from our ongoing Phase 1b study in patients with lower-risk MDS, represent significant milestones in the advancement of R289 as a potential new treatment option."

The FDA Office of Orphan Products Development grants orphan drug designation to support the development of medicines for rare disorders that affect fewer than 200,000 people in the U.S. Under the Orphan Drug Act, orphan drug designation qualifies a company for incentives including tax credits, exemptions from certain FDA fees for clinical trials and the potential for seven years of market exclusivity following drug approval.

R289 was previously granted Fast Track designation by the FDA for the treatment of patients with previously-treated transfusion dependent lower-risk MDS.

About R289
R289 is a prodrug of R835, an IRAK1/4 dual inhibitor, which has been shown in preclinical studies to block inflammatory cytokine production in response to toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) family signaling. TLRs and IL-1Rs play a critical role in the innate immune response and dysregulation of these pathways can lead to various inflammatory conditions. Chronic stimulation of both these receptor systems is thought to cause the pro-inflammatory environment in the bone marrow responsible for persistent cytopenias in lower-risk MDS patients.

On January 9, 2025 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients with inflammatory and immunological diseases, reported that Brian Wong, M.D., Ph.D., President and Chief Executive Officer, will present a company overview at the 43rd Annual J.P. Morgan Healthcare Conference on Thursday, January 16, 2025 at 9:00 a.m. Pacific Time (Press release, RAPT Therapeutics, JAN 9, 2025, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-present-43rd-annual-jp-morgan-healthcare [SID1234649547]).

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To access the live webcast or subsequent archived recording of the company presentation, please visit the RAPT Therapeutics website at https://investors.rapt.com/events-and-presentations.

On January 9, 2025 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, reported that the U.S. Food and Drug Administration ("FDA") has granted Fast Track designation to LYT-200, a first-in-class anti-galectin-9 monoclonal antibody, for the treatment of acute myeloid leukemia ("AML") (Press release, PureTech Health, JAN 9, 2025, View Source [SID1234649546]). Fast Track designation is a process designed to streamline the development and accelerate the assessment of drugs that target serious conditions with unmet medical need.

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"Fast Track designation from the FDA reinforces our belief in the potential for LYT-200 to address the urgent needs of AML patients," said Luba Greenwood, J.D., Entrepreneur-in-Residence at PureTech who is leading the Gallop Oncology work. "This milestone builds on the FDA’s recognition of LYT-200’s promise, including Orphan Drug designation for AML and a second Fast Track designation for head and neck cancers, both of which were granted last year. By targeting galectin-9, a key driver of cancer proliferation and immune suppression, LYT-200 represents a novel and promising approach for patients in need, and we look forward to the continued development of this program."

LYT-200 exerts its therapeutic effects in AML by killing cancer cells directly via apoptosis and DNA damage as well as reactivating central anti-cancer effectors of the immune system. LYT-200 is the most advanced clinical program against galectin-9 and is being evaluated in two ongoing clinical trials, including:

1. Phase 1/2 clinical trial evaluating LYT-200 as a monotherapy and in combination with venetoclax and hypomethylating agents in hematological malignancies, including AML and high-risk myelodysplastic syndrome (MDS). In this trial, LYT-200 has demonstrated a favorable safety and tolerability profile as well as early signals of clinical activity as single agent and in combination.

2. Phase 1/2 trial in advanced/metastatic solid tumors, including head and neck

cancers. In this trial, LYT-200 is being evaluated as a monotherapy and in combination with tislelizumab, an anti-PD-1 antibody developed by BeiGene. To date, LYT-200 has demonstrated a favorable safety profile in all cohorts, including the monotherapy and combination arms with BeiGene’s tislelizumab, and shown disease control and suggestions of initial anti-tumor activity.

The FDA has also granted orphan drug designation to LYT-200 for the treatment of AML as well as a separate Fast Track designation for the treatment of recurrent/metastatic head and neck squamous cell carcinomas ("head and neck cancers"), in combination with anti-PD1 therapy. PureTech previously announced that it intends to advance LYT-200 via its Founded Entity, Gallop Oncology.

About LYT-200

LYT-200 is a fully human IgG4 monoclonal antibody targeting a foundational oncogenic and immunosuppressive protein, galectin-9, for the potential treatment of hematological malignancies and locally advanced metastatic solid tumors, including head and neck cancers, with otherwise poor survival rates. A wide variety of preclinical data support the potential clinical efficacy of LYT-200 and the importance of galectin-9 as a target and suggest a potential opportunity for biomarker development. PureTech has presented data demonstrating high expression of galectin-9 across various solid tumor types and blood cancers and has found that, in several cancers, galectin-9 levels correlate with shorter time to disease relapse and poor survival. Preclinical work also demonstrates single mechanistic and anti-tumor efficacy of LYT-200 in multiple animal and patient-derived tumor cell models. For example, LYT-200 outperforms anti-PD-1 in solid tumor models models as a single agent. LYT-200 also synergizes with anti-PD-1 in activating CD4 and CD8 T cells in in vivo cancer models. LYT-200 is currently being evaluated in two ongoing Phase 1/2 adaptive design trials for the potential treatment of AML/MDS and head and neck cancers.