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Candid Therapeutics and EpimAb Biotherapeutics Enter Into Research Collaboration to Discover and Develop Novel T-Cell Engagers for Autoimmune Indications

On December 16, 2024 Candid Therapeutics, Inc. ("Candid"), a clinical-stage biotechnology company focused on becoming the leader in advancing T-cell engagers for autoimmune diseases, and EpimAb Biotherapeutics, Inc. ("EpimAb" or "EpimAb Biotherapeutics") a clinical-stage biopharmaceutical company specializing in the discovery and development of multi-specific antibodies for diseases with high unmet need, reported that the companies have entered a strategic research collaboration to discover and develop novel T-cell Engager program candidates for various autoimmune indications (Press release, Candid Therapeutics, DEC 16, 2024, View Source [SID1234649149]).

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"EpimAb team has impressed us with their scientific expertise and antibody design capabilities. We are excited to partner with EpimAb as we broaden our pipeline of novel TCEs for autoimmune indications," said Dr. Ken Song, Chairman, President and CEO of Candid.

"We are excited to enter this partnership with Candid, a company with the leadership and resources to realize full potential of TCEs in autoimmune indications," said Dr. Chengbin Wu, CEO and founder of EpimAb. "We are proud of the versatility of our proprietary bispecific and TCE platforms and the partnership with Candid provides further validation of our approach."

Under the terms of the agreement, EpimAb is entitled to obtain an upfront payment, and development and sales milestones totaling over $1 billion, assuming multiple drug candidates are advanced through commercialization, as well as royalties on net sales. Candid has exclusive worldwide rights to develop and commercialize programs discovered under the collaboration.

Personalis and Tempus Expand Collaboration to Biopharma

On December 16, 2024 Personalis, Inc. (Nasdaq: PSNL) and Tempus AI, Inc. (Nasdaq: TEM) reported that the companies have expanded their commercial relationship (Press release, Personalis, DEC 16, 2024, View Source [SID1234649148]). The companies agreed in November 2023 to collaborate and bring ultra-sensitive MRD testing to market and launched their efforts at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Tempus is serving as the exclusive commercial diagnostic partner for Personalis’ ultra-sensitive tumor-informed MRD product, NeXT Personal Dx, for broad patient adoption in breast and lung cancers, and for immunotherapy monitoring across all solid tumors.

Following a positive reaction from the diagnostic market, the companies have agreed to expand their relationship to the biopharma industry. Under this expanded relationship, Tempus will be enabled to offer Personalis’ NeXT Personal MRD product to pharmaceutical and biotech customers who wish to bundle MRD testing with other Tempus offerings in a given study.

"While we already offer NeXT Personal through our own biopharma channel, we are pleased to leverage Tempus’ integrated platform as well for these biopharma customers who desire to combine NeXT Personal with other Tempus products," said Chris Hall, CEO of Personalis. "We believe the expansion of the relationship with Tempus will accelerate market penetration of our leading ultra-sensitive MRD platform and allow us to better capitalize on the opportunity."

MAIA Biotechnology Granted FDA Rare Pediatric Disease Designation for THIO as a Treatment for Pediatric High-Grade Gliomas

On December 16, 2024 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported that the FDA has designated THIO for the treatment of pediatric-type diffuse high-grade gliomas (PDHGG) as a drug for a "rare pediatric disease (Press release, MAIA Biotechnology, DEC 16, 2024, View Source [SID1234649147])."

"THIO is a versatile anti-cancer agent that has demonstrated positive results in multiple difficult to treat cancer types, including pediatric high-grade glioma, which is among the most treatment-resistant cancers in children. THIO is shown to activate the immune system while evading tumor immunosuppression, a novel therapeutic approach for this devastating childhood disease," said MAIA Chairman and Chief Executive Officer Vlad Vitoc, M.D. "We are proud to receive the FDA’s Rare Pediatric Disease designation for THIO, which significantly bolsters our plans for continuing research in the PDHGG indication."

MAIA’s Vice President and Head of Regulatory and Quality K. Robinson Lewis added, "Rare pediatric disease designation also offers a highly valuable incentive for MAIA. Upon FDA approval of a future new drug application in PDHGG, MAIA would be eligible to receive a priority review voucher that can be redeemed or sold as an asset at a very high valuation."

Rare pediatric disease priority review vouchers (PRVs) can be redeemed by drug developers for FDA priority review of a different product or transferred or sold to another sponsor. Since 2015, FDA priority review vouchers have sold as assets at an average amount of $100 million.1

Previous research showcased THIO’s potency as a treatment for a PDHGG subtype known as diffuse intrinsic pontine glioma (DIPG). A research collaboration between MAIA and Nationwide Children’s Hospital found that THIO combined with ionizing radiation (IR) resulted in significantly decreased cell proliferation and produced potent anticancer effects in highly aggressive DIPG. The data was presented in April 2024 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

MAIA collaborated with Only Orphans Cote for THIO’s designation request. Only Orphans Cote is a foremost provider of regulatory services and strategies for FDA orphan drug designations and marketing authorization.

In addition to its rare pediatric disease designation in PDHGG, THIO holds orphan drug designations (ODD) in three cancer types: hepatocellular carcinoma (HCC), small cell lung cancer (SCLC) and glioblastoma. MAIA believes that THIO is the only direct telomere-targeting agent currently in clinical development.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

CBTN Partners with Day One to Drive New Therapies for Pediatric Brain Tumors

On December 16, 2024 The Children’s Brain Tumor Network (CBTN), a consortium of leading pediatric brain tumor research institutions, reported that it has formed a groundbreaking partnership with Day One Biopharmaceuticals (Day One), a company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases (Press release, Day One, DEC 16, 2024, View Source [SID1234649146]). This new partnership between CBTN and Day One aims to accelerate the development of new treatments for children with brain tumors. It leverages the robust Pediatric Brain Tumor Atlas (PBTA), a comprehensive resource containing genomic, clinical, and imaging data from over 7,600 pediatric brain tumor patients. Day One will utilize this data set to design clinical trials.

"We are deeply grateful for this partnership, which reflects a shared commitment to advancing therapies for children with brain tumors," said Dr. Angela Waanders, LLG Study Chair for the Children’s Brain Tumor Network. "Uniting CBTN resources with Day One’s innovative approach accelerates the delivery of clinical trials to children worldwide."

Together, CBTN and Day One aim to accelerate the development of new treatments for children with brain tumors.

CBTN’s innovative approach ensures data remains open to the global research community while facilitating collaboration with commercial entities like Day One.

"CBTN’s commitment to open access data, coupled with their world-class expertise in pediatric brain tumors, makes them an ideal partner for Day One," said Elly Barry, M.D., chief medical officer, Day One Biopharmaceuticals. "This collaboration should allow us to better design clinical trials to potentially bring new therapies to children in need."

The partnership between CBTN and Day One also paves the way for developing trial-ready external control arms in pediatric clinical studies.

IDEAYA Announces Development Candidate Nomination of IDE251, a Potential First-in-Class KAT6/7 Dual Inhibitor Targeting 8p11 Amplification Tumors in Breast and Lung Cancers

On December 16, 2024 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported the development candidate nomination of IDE251, a potential first-in-class KAT6/7 dual inhibitor (Press release, Ideaya Biosciences, DEC 16, 2024, View Source [SID1234649145]).

"We are pleased to announce the nomination of IDE251 as our third development candidate this quarter and 8th development candidate in our precision medicine oncology pipeline. IDE251 has a potential first-in-class product profile and selectively inhibits two epigenetic modulators, KAT6 and KAT7, and based on the preclinical profile we believe there is an opportunity for an enriched response in 8p11 amplified cancers, which occur in 15% of breast cancers patients and in up to 17.5% in squamous NSCLC," said Yujiro S. Hata, President and Chief Executive Officer of IDEAYA Biosciences.

"IDE251 is a promising potential first-in-class molecule designed to selectively target both KAT6 and KAT7 while sparing other structurally similar KAT family members. KAT6 and KAT7 are mechanistically intertwined epigenetic modulators of cell identity and lineage commitment programs corrupted by oncogenic transformation. Dual KAT6/7 inhibition with IDE251 delivers robust and durable anti-tumor activity, superior to KAT6 inhibition alone, in preclinical tumor models with 8p11 amplifications as well as in biomarker selected indications dependent upon lineage-specific transcription factor activity. IND-enabling studies are progressing as planned and we are targeting to bring this program to the clinic next year," commented Michael White, Ph.D., Chief Scientific Officer, IDEAYA Biosciences.

IDE251 is an equipotent, highly selective, small molecule dual inhibitor of the lysine acetyltransferase (KAT) 6 and 7, both of which have been shown to support cancer cell survival. IND-enabling studies to support the potential clinical evaluation of IDE251 monotherapy in patients with breast and lung cancers with 8p11 amplification are ongoing, as well as additional opportunities in the setting of lineage addiction. Based on IDEAYA’s biomarker evaluation, 8p11 amplification prevalence is projected to be approximately 15% in breast cancer and 17.5% in squamous NSCLC.

IDEAYA is targeting an Investigational New Drug (IND) submission to the U.S. Food and Drug Administration (FDA) in 2025 for IDE251, subject to satisfactory completion of ongoing preclinical and IND-enabling studies.