OnCusp Therapeutics Raises Oversubscribed $100 Million Series A Financing to Advance Portfolio of Assets for Cancer Patients

On January 4, 2024 OnCusp Therapeutics, Inc., a biopharmaceutical company dedicated to transforming cutting-edge preclinical innovation into clinically validated treatments for cancer patients worldwide, reported an oversubscribed $100 million Series A financing round (Press release, OnCusp Therapeutics, JAN 4, 2024, View Source [SID1234638990]).

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The round was co-led by Novo Holdings, OrbiMed, and F-Prime Capital, alongside Sofinnova Investments, Catalio Capital Management, Marshall Wace, Forge Life Science Partners, Blackbird BioVentures, CJNV BioVenture and others, as well as BioTrack Capital, a co-lead for the Seed Round. OnCusp Therapeutics has raised $139 million since its establishment in April 2021. The proceeds from this financing will be used to advance CUSP06, an ADC targeting CDH6, toward clinical proof-of-concept. Additionally, the capital will aid in expanding the OnCusp portfolio and team.

CUSP06 has strong preclinical data demonstrating the potential for best-in-class activity. Engineered to increase potency, heighten "bystander effect," elevate linker stability, and overcome drug resistance, CUSP06’s differentiating attributes could translate into higher clinical response rates and durability, with an improved safety profile. Having obtained FDA IND clearance in 3Q 2023, CUSP06 will be in a first-in-human Phase I study in the US.

"We are grateful to have the trust and support from some of the most prominent global biotech investors," said Dr. Bing Yuan, Co-Founder and CEO of OnCusp Therapeutics. "I am also thankful to the OnCusp team for their commitment and excellent work. We hold a strong conviction to develop innovative oncology therapies for patients. This significant Series A financing enables OnCusp to accelerate the development of CUSP06 and other game-changing therapeutics in our fight against cancer."

As part of the financing, OnCusp Therapeutics will appoint Dr. Karen Hong, Partner in the Venture Investments team at Novo Holdings US, Inc., a wholly owned subsidiary of Novo Holdings; Diyong Xu, Principal at OrbiMed; and Dr. Chong Xu, Partner at F-Prime Capital, to the company’s Board of Directors.

"We are thrilled to have co-led this round. The remarkable progress that the company has made in such a short time is a testament to its highly efficient business model and the team’s exceptional execution capabilities," said Dr. Karen Hong. "We share OnCusp’s mission in bringing oncology innovations to life and are committed to supporting the company’s continued growth and success."

"ADCs have become one of the most promising modalities for treating cancer, and CDH6 is emerging as a winning ADC target. We believe CUSP06 is well positioned to unlock the full potential of this target, both in high and low CDH6 expressing tumors," said Diyong Xu. "We also look forward to OnCusp expanding its portfolio to fully leverage its translational and clinical development expertise."

"I am excited to join the OnCusp Board at this transformative moment for the company," stated Dr. Chong Xu. "F-Prime is committed to proactively champion breakthrough approaches like CUSP06, which holds immense potential to help patients with ovarian cancer and other advanced solid tumors. I look forward to working with other board members and the executive team to propel OnCusp to its next phase of growth."

"As a major investor since the company’s inception, I am impressed by the entrepreneurship, commitment, and perseverance exemplified by the OnCusp team in the current challenging biotech market." added Dr. Jiacong Guo, one of OnCusp’s current Board Directors and a Principal at BioTrack Capital. "I believe companies who are leading their field will emerge triumphant in their mission. I am confident that OnCusp is one of those companies."

Inspirna Partners with Merck KGaA, Darmstadt, Germany, to Accelerate Global Development of Ompenaclid (RGX-202)

On January 4, 2024 Inspirna, Inc., a clinical stage biopharmaceutical company developing first-in-class cancer therapeutics, reported a licensing agreement with Merck KGaA, Darmstadt, Germany, for ompenaclid (RGX-202), a first-in-class oral inhibitor of the creatine transport channel SLC6A8, currently in development for RAS mutated (RASm) second-line (2L) advanced or metastatic colorectal cancer (mCRC) and SLC6a8 targeting follow-on compounds (Press release, Inspirna, JAN 4, 2024, View Source [SID1234638974]).

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"We are excited to partner with Merck KGaA, Darmstadt, Germany, a leader in the oncology field with global drug development and commercial expertise in colorectal cancer specifically, to help bring our novel therapies to more patients in need," said Dr. Usman "Oz" Azam, M.D., Chief Executive Officer of Inspirna. "The data to date validates our belief in ompenaclid as a potential first-in-class therapy for advanced colorectal cancer and underscores the power of our proprietary target discovery platform RNA-DRIVEr. We look forward to working closely with Merck KGaA, Darmstadt, Germany, as we continue to evaluate ompenaclid in a Phase 2 randomized controlled trial."

"Over the past decade, the treatment paradigm for patients with RAS-mutated CRC, accounting for approximately 45% of second-line population, has not seen major innovation," said Victoria Zazulina, M.D., Head, Development Unit, Oncology for the Healthcare business of Merck KGaA, Darmstadt, Germany. "With our expertise in the treatment of CRC, and based on the encouraging early data for ompenaclid, this agreement with Inspirna offers the opportunity to advance a potential new first-in-class therapy that may improve outcomes for patients."

Under the terms of the license agreement, Merck KGaA, Darmstadt, Germany will receive an exclusive license to ompenaclid outside of the United States and an option to co-develop and co-promote ompenaclid in the US. Furthermore, the parties agreed to collaborate on Inspirna’s SLC6A8 follow-on compounds for which Inspirna will retain US co-development and co-commercialization rights. Inspirna will receive an upfront payment of $45 million. Upon the achievement of certain development and sales milestones for ompenaclid, Inspirna is eligible to receive milestone payments with tiered royalty rates in the low teens on net sales outside of the US. Inspirna is eligible to also receive development, regulatory and sales milestone payments for each follow-on compound targeting SLC6A8 along with up to double-digit royalties on net sales outside of the US.

Inspirna most recently presented clinical data from the Phase 1b/2 study of ompenaclid in combination with FOLFIRI and bevacizumab at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in October 2023. Results as of the September 18, 2023 data cutoff showed encouraging efficacy and safety data, including a median progression-free survival of 10.2 months and median overall survival of 19.1 months across all 41 patients with 2L RASm mCRC. Of the 30 evaluable patients for response, the objective response rate was 37%, with 11 partial responses. Ompenaclid was well-tolerated, with no dose-limiting toxicities observed in the dose-escalation cohort and combination safety profile comparable to FOLFIRI plus bevacizumab backbone treatment.

Inspirna has initiated a Phase 2 double-blind randomized controlled trial in 2L RAS mutant advanced or metastatic mCRC comparing ompenaclid versus placebo plus FOLFIRI and bevacizumab.

Avenzo Therapeutics Announces Global License of AVZO-021 (ARTS-021), a Potentially Best-in-Class Clinical Stage CDK2 Inhibitor from Allorion Therapeutics

On January 4, 2024 Avenzo Therapeutics, Inc. (Avenzo), a clinical-stage biotechnology company developing next generation oncology therapeutics, reported that it has entered into an exclusive licensing agreement with Allorion Therapeutics Inc. (Allorion) to develop and commercialize AVZO-021 (formerly ARTS-021), a potentially best-in-class cyclin-dependent kinase 2 (CDK2) selective inhibitor globally (excluding Greater China) (Press release, Avenzo Therapeutics, JAN 4, 2024, View Source [SID1234638991]). As part of the agreement, Avenzo also receives an exclusive option for an additional preclinical program planned for IND submission in early 2025.

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CDK2 has emerged as a promising target given its role as a resistance mechanism to approved CDK4/6 therapies in hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer, and given its role as an oncogene in many cyclin E1 (CCNE1) amplified cancers. Avenzo will leverage its internal drug development expertise to advance AVZO-021, which is currently being studied in a Phase 1 clinical trial across multiple sites in the U.S. for the treatment of HR+/HER2- metastatic breast cancer and other advanced solid tumors.

"With this agreement, we have laid the foundation for our potentially best-in-class oncology pipeline," said Athena Countouriotis, M.D., co-founder, president and CEO of Avenzo. "Patients with HR+/HER2- metastatic breast cancer continue to have limited therapeutic options, and we believe AVZO-021 may provide patients with a new treatment option both as a single agent and in multiple combinations. We are excited to advance the ongoing Phase 1 clinical study (NCT05867251), and to partner with the Allorion team to advance the program globally."

Under the terms of the license agreement, Allorion will receive an upfront payment of $40 million and be eligible to receive additional payments based on achievement of certain development, regulatory and commercial milestones and tiered royalties on net sales by Avenzo. Potential payments for both programs may total more than $1 billion.

"We developed AVZO-021 as a potential best-in-class CDK2-selective inhibitor to address an area of unmet medical need," said Peter Ding, co-founder and CEO of Allorion. "The Avenzo team has a proven track record and deep expertise in developing and advancing next-generation oncology therapies. We are delighted to partner with Avenzo to drive innovation and transform the treatment landscape for cancer patients."

"AVZO-021 is a highly potent and selective CDK2 inhibitor for the treatment of HR+/HER2- breast cancer and CCNE1-amplified cancers," said Afshin Dowlati, M.D., Professor of Medicine and Oncology at University Hospitals Seidman Cancer Center and Case Western Reserve, and Director of the Early Phase Therapeutics Program. "I look forward to working with Avenzo as they continue to develop this therapy that has the potential to provide a new treatment option to patients fighting cancer."

In preclinical studies, AVZO-021 exhibited nanomolar potency against CDK2 while sparing other CDKs with high selectivity over CDK1, a key driver of toxicity. In addition, AVZO-021 demonstrated efficacy in in vivo xenograft models, both as a single agent and in combination with CDK4/6 inhibitors. Allorion disclosed select data in poster presentations at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in October 2023.

Evotec and Owkin enter an A.I.-powered strategic partnership to accelerate therapeutics pipeline in oncology and I&I

On January 4, 2024 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) and Owkin, a French-American techbio company reported an A.I.-powered integrated multi-target collaboration in oncology, immunology and inflammation ("I&I") (Press release, Evotec, JAN 4, 2024, View Source [SID1234638959]).

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The collaboration brings together highly complementary platforms and expertise to accurately select targets, discover and develop new therapeutics. Harmonising Owkin’s cutting-edge target discovery engine with Evotec’s end-to-end shared R&D platforms and disease biology expertise will accelerate Owkin’s novel programmes from the discovery phase to the clinic.

Owkin will identify indication-relevant targets and subgroups using A.I. applied to multimodal patient data. Evotec will leverage its shared R&D platform to accelerate and de-risk the validation of targets, identification of drug candidates and successful completion of pre-clinical development activities up to IND. An Owkin-Evotec joint Research Strategy Team formed of highly experienced drug hunters will drive the collaboration, designing fully tailored strategic programme plans from target selection to IND and ensuring delivery of the programmes. The partnership also enables Owkin to maximise capital efficiency while reducing risk. Evotec will receive R&D funding from Owkin and is eligible to earn performance milestone payments and royalties on product sales.

Dr Matthias Evers, Chief Business Officer of Evotec, commented: "Owkin and Evotec both feel there is something special brewing by convergence between A.I. and science in drug innovation – hence, we are thrilled to strike this partnership towards accelerating therapeutics in therapeutic areas of highest unmet needs – patients need us, together."

Dr Thomas Clozel, Co-founder and CEO of Owkin, remarked: "The combination of in silico hypothesis generation through A.I. and experimental lab validation is the core of our pipeline strategy. Evotec’s broad capabilities in drug discovery, which range all the way from target validation through to IND-enabling studies, coupled with their understanding of artificial intelligence and its implementation in their workflows make them an ideal partner for us."

Inspirna to Present at the 42nd Annual J.P. Morgan Healthcare Conference

On January 4, 2024 Inspirna, Inc., a clinical stage biopharmaceutical company developing first-in-class cancer therapeutics, reported that Chief Executive Officer Dr. Usman "Oz" Azam, M.D., will participate in a corporate presentation at the 42nd Annual J.P. Morgan Healthcare Conference on Thursday, January 11, 2024 at 8:30am PT / 11:30am ET (Press release, Inspirna, JAN 4, 2024, View Source [SID1234638975]).

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