On November 4, 2024 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, and Nobelpharma Co., Ltd. reported that they have entered into an exclusive license and distribution agreement for the development and commercialization in Japan of DANYELZA for the treatment of patients with relapsed/refractory high-risk neuroblastoma and, upon agreement by the parties, potentially relapsed osteosarcoma (Press release, Y-mAbs Therapeutics, NOV 4, 2024, View Source [SID1234647672]).

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Under the terms of the agreement, Nobelpharma will employ its regulatory, marketing, sales and access expertise to carry out development work and to submit DANYELZA for approval by Japanese regulatory authorities, and to market, sell, and distribute DANYELZA in Japan, if approved. Pursuant to the agreement, Y-mAbs will receive an upfront payment of $2.0 million from Nobelpharma in connection with entering into the agreement and is entitled to receive up to $31.0 million in product and commercial milestone payments in addition to royalties in the low double digits on commercial sales on DANYELZA, if successfully approved and commercialized in Japan.

"Our exclusive license and distribution agreement with Nobelpharma in Japan is an important step in our continued global expansion efforts of DANYELZA," said Michael Rossi, President and Chief Executive Officer of Y-mAbs. "If approved in the region, we believe DANYELZA can deliver a meaningful impact to patients in Japan fighting relapsed/refractory high-risk neuroblastoma and improve long-term quality of life for these children."

"We believe that Nobelpharma is the right partner for Y-mAbs in Japan, and we are excited to work with Nobelpharma towards the potential approval and commercial launch of DANYELZA in the region," said Thomas Gad, Founder and Chief Business Officer of Y-mAbs. "DANYELZA, if approved in Japan for relapsed/refractory high-risk neuroblastoma, will provide a new out-patient anti-GD2 therapeutic option for physicians in the treatment of children facing this advanced form of pediatric cancer. We remain steadfast in our commitment to provide access to DANYELZA and improve the lives of children and families around the globe facing advanced cancers."

Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed DANYELZA (naxitamab-gqgk), which is exclusively licensed by MSK to Y-mAbs. MSK has institutional financial interests in the compound and Y-mAbs.

About DANYELZA (naxitamab-gqgk)

DANYELZA (naxitamab-gqgk) is indicated, in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF"), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. DANYELZA includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis. See full Prescribing Information for complete Boxed Warning and other important safety information.

DANYELZA is currently not approved for the treatment of osteosarcoma in any jurisdiction.

On November 4, 2024, Syndax Pharmaceuticals, Inc. ("Syndax") reported to have entered into a Purchase and Sale Agreement (the "Purchase and Sale Agreement") with Royalty Pharma Development Funding, LLC ("Royalty Pharma"), pursuant to which Royalty Pharma purchased rights to certain revenue streams from net sales of products comprising or containing axatilimab (including Niktimvo) (collectively, the "Product") by Syndax, its affiliates and its licensees in the United States and its respective territories, districts, commonwealths and possessions (including Guam and Puerto Rico) (the "Territory") in exchange for $350 million (Press release, Syndax, NOV 4, 2024, View Source [SID1234647671]).

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Pursuant to the Purchase and Sale Agreement, Royalty Pharma purchased the right to receive a percentage of net sales equal to a royalty rate of 13.8% on quarterly net sales of the Product in the Territory; provided that the royalty rate is subject to certain adjustments based on future aggregate net sales of the Product in the Territory (the "Revenue Participation Right"). Aggregate payments made to Royalty Pharma in respect of the Revenue Participation Right will be capped at $822.5 million (the "Royalty Cap").

The Purchase and Sale Agreement contains customary representations, warranties and indemnities of Syndax and Royalty Pharma and customary covenants relating to the royalty payments, including the grant of a back-up security interest in the purchased royalties and certain assets related to the Product and restrictions on the incurrence of additional indebtedness and on the existence of liens on Syndax’s assets related to the Product.

Upon a change of control, Syndax will have the right, but not the obligation, to repurchase the Revenue Participation Right at a repurchase price set forth in the Purchase and Sale Agreement. In addition, the Purchase and Sale Agreement provides that if certain events of default occur, including certain bankruptcy events or certain termination events with respect to Syndax’s license agreement with UCB Biopharma Srl, Royalty Pharma may require Syndax to repurchase Royalty Pharma’s interests in the Revenue Participation Right at a repurchase price equal to the Royalty Cap.

The foregoing description of the terms of the Purchase and Sale Agreement does not purport to be complete and is qualified in its entirety by the full text of the agreement. Syndax intends to file a copy of the Purchase and Sale Agreement with its Annual Report on Form 10-K for the year ending December 31, 2024.

On November 4, 2024 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported that the company will have five presentations at the 15th Annual World ADC Conference, taking place in San Diego, November 4-6, 2024 (Press release, Sutro Biopharma, NOV 4, 2024, View Source;utm_medium=rss&utm_campaign=sutro-biopharma-demonstrates-meaningful-adc-innovation-with-five-presentations-at-the-15th-annual-world-adc-conference [SID1234647670]).

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Presentation Details:
Development of Dual-Payload Antibody Drug Conjugates
Presenter: Daniel Calarese, Ph.D.
Date/Time: November 4, 2024, 2:00pm PT
Showcasing Clinical Update & Learnings for Luvelta Targeting Folate Receptor
Presenter: Hanspeter Gerber, Ph.D.
Date/Time: November 5, 2024, 11:30am PT
Characterizing ADC Safety & Activity in Preclinical Development of STRO-004
Presenter: Alice Yam, Ph.D.
Date/Time: November 5, 2024, 2:00pm PT
Leveraging Cell-Free Protein Synthesis for Site- Specific Conjugation to Enhance ADC Therapeutic Index
Presenter: Gang Yin, Ph.D.
Date/Time: November 5, 2024, 2:30pm PT
Optimizing High DAR & Dual Payload ADCs: Discovery of Hydrophilic β-glu Cleavable Linker Payloads for Superior Efficacy and Safety
Presenter: Krishna Bajjuri, Ph.D.
Date/Time: November 6, 2024, 3:00pm PT

Following the event, the content will be made available in the Clinical/Scientific Presentation and Publication Highlights section of Sutro Biopharma’s website at www.sutrobio.com.

On November 4, 2024 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, reported it will prioritize future development activity for SC291, the company’s CD19-directed allogeneic CAR T cell therapy, in B-cell mediated autoimmune diseases (AID) (Press release, Sana Biotechnology, NOV 4, 2024, View Source [SID1234647669]). The company will suspend development of both SC291 in oncology and of SC379, its glial progenitor cell program, as it seeks partnerships for these programs. Sana will increase its investment in its type 1 diabetes program with the cash savings from these changes.

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"Early clinical data with our hypoimmune platform (HIP) suggest HIP-modified cells evade immune detection, giving us confidence in the potential of the platform across multiple therapeutic areas. At the same time, we need to ensure that we are directing our investments into the areas where we believe we can have the greatest impact for patients," said Steve Harr, Sana’s President and Chief Executive Officer. "Greater focus on type 1 diabetes, SC291 in AID, and SC262 in refractory blood cancers will enhance our ability to present robust clinical data over the next twelve to eighteen months. This modified strategy will also help us reduce our cash burn but comes with the necessity of parting with some talented and valued colleagues. We thank them for their contributions toward building Sana and thank the patients who have been treated in the SC291 oncology study."

With these changes, Sana extends its expected cash runway into 2026. Payments related to ongoing activities combined with the reduction in force may increase the 2024 operating cash burn above prior guidance of less than $200 million.

"Since joining Sana, I have actively engaged with the team to understand both Sana and competitor data and believe it is the right time to prioritize where we believe we have the most differentiated therapeutic candidates and the highest probability of success for patients," said Dhaval Patel, M.D., Ph.D., Chief Scientific Officer of Sana. "Type 1 diabetes is a significant unmet need, and we are optimistic that our program is novel and has the potential to offer patients meaningful benefit. The decision to prioritize SC291 in B-cell mediated autoimmune diseases is based on early clinical data with this drug in both oncology and autoimmune diseases, which show that therapy with SC291 can predictably lead to the deep B cell depletion that appears to drive an immune "reset" and significant clinical benefit in patients with B-cell mediated autoimmune diseases such as lupus. We look forward to generating and sharing more data from across our portfolio."

Select Program Review

UP421 (HIP-modified primary pancreatic islet cells) in type 1 diabetes: The investigator-sponsored trial exploring the potential of HIP modifications to allogeneic primary islet cells to enable immune evasion and overcome transplant rejection in type 1 diabetes is active; Sana expects to share proof of concept data in 2024 and/or 2025.

SC291 (HIP-modified CD19-directed allogeneic CAR T) in autoimmune diseases: Sana continues enrollment in the Phase 1 GLEAM trial for SC291 for the treatment of B-cell mediated autoimmune diseases and expects to share clinical data in 2024 and/or 2025.

SC262 (HIP-modified CD22-directed allogeneic CAR T) in oncology: Sana continues enrollment in the Phase 1 VIVID study for patients with refractory B-cell malignancies who have failed a previous CD19-directed CAR T therapy and expects to share data in 2025.

SC451 (HIP-modified stem cell-derived pancreatic islet cells) in type 1 diabetes: Sana continues preclinical development of this HIP-modified, stem-cell derived therapy for patients with type 1 diabetes.

SG299 (in vivo CAR T with CD8-targeted fusogen delivery of a CD19-directed CAR): Sana is continuing its preclinical development of this program, with potential in both B-cell mediated autoimmune diseases and oncology.

SC291 (HIP-modified CD19-directed allogeneic CAR T) in oncology: Given alternative opportunities within its pipeline as well as increased competition within blood cancers and uncertainty about the best path to regulatory and commercial success, Sana is halting enrollment and further internal investment in the Phase 1 ARDENT trial. It is actively seeking a licensing partner to support advancement.

SC379 (stem-cell derived glial progenitor cells) in various CNS diseases: Sana will actively seek a partner or opportunity to spin out this program into a new company.

On November 4, 2024 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that overcome tumor immune evasion and drug resistance, reported it has identified serum CEACAM1 as an additional new potential blood biomarker that may help determine which metastatic pancreatic ductal adenocarcinoma (PDAC) patients are most likely to benefit from treatment with CM24 (Press release, Purple Biotech, NOV 4, 2024, View Source [SID1234647668]). CM24 is a humanized monoclonal antibody that blocks CEACAM1 binding thereby inhibits its activity. CEACAM1 is overexpressed on certain tumor cells, immune cells, and neutrophils extracellular traps (NETs).

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PDAC patients who had pretreatment serum CEACAM1 levels between 6K and 15K pg/mL demonstrated the best outcomes following treatment with CM24 and nivolumab in combination with irinotecan/fluoropyrimidine based chemotherapy compared to chemotherapy control, with respect to both progression free survival (PFS) (median = 4.6 months, hazard ratio [HR] < 0.1, P = 0.003) and overall survival (OS) with an 79% reduction in risk of death (HR = 0.21, P = 0.04). The median OS improved from 3.6 months with chemotherapy alone to 8.7 months with the combination.

Purple Biotech’s randomized Phase 2 study of CM24 in the second line treatment of PDAC has previously identified multiple potential biomarkers including another serum-based marker, myeloperoxidase (MPO), and tumor markers.

"As we look ahead to topline Phase 2 results before the end of the year and anticipate advancing CM24 into further clinical development, the identification of an additional serum biomarker for patient selection is a critical advantage for our future CM24 study and more importantly, potentially for cancer patients in need of better outcomes, particularly for pancreatic cancer," said Gil Efron, Purple Biotech CEO.