On June 8, 2022 OnCusp Therapeutics reported a licensing agreement with Multitude Therapeutics for the development and commercialization of AMT-707 (now referred to as CUSP06), a potentially highly differentiated second-in-class CDH6 antibody drug conjugate ("ADC") (Press release, OnCusp Therapeutics, JUN 8, 2022, View Source [SID1234615816]).

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Under the agreement, OnCusp obtains the exclusive global rights to lead development and commercialization of CUSP06 worldwide outside of Greater China. Multitude will receive an upfront payment as well as development, regulatory and sales milestone payments, and tiered royalties.

CDH6 (Cadherin-6 or K-cadherin) is a high-potential ADC target for multiple solid malignancies. CDH6 is highly expressed in ovarian and renal cancers, and data indicate increased CDH6 expression is also found in patients with cholangiocarcinoma, gastric cancer, thyroid cancer, and other malignancies. CDH6 is well suited as an ADC target due to its high expression in tumor tissues, limited expression in non-tumor tissues, and rapid cellular internalization of the complex upon drug binding.

CUSP06, a preclinical-stage CDH6 ADC, is composed of a proprietary antibody with high CDH6 binding affinity, a protease cleavable linker, and an exatecan payload (a potent and clinically validated topoisomerase-1 inhibitor). The linker is specially designed to accommodate the exatecan payload, generating a highly stable and homogenous ADC. The payload is not a substrate for BCRP/P-gp. In preclinical data, this linker/payload has been shown to enable a stronger "bystander effect" than competitor ADCs. CUSP06 has a drug-to-antibody ratio of approximately 8. This asset has demonstrated excellent anti-tumor efficacy across several in vivo cancer models with both high and low CDH6 expression. CUSP06 is currently in Investigational New Drug ("IND") enabling studies. OnCusp and Multitude have engaged WuXi XDC, a global CRDMO company dedicated to end-to-end bioconjugates services, as the CMC partner for CUSP06.

"We are very excited to obtain the ex-China rights for CUSP06 and partner with Multitude, a leading ADC platform company in China," said Dr. Bing Yuan, Chairman and CEO of OnCusp. "CDH6 is emerging as a promising ADC target with exciting preliminary clinical data. CUSP06 is thoughtfully designed with clearly differentiated attributes from the competition and is well positioned to be a leader in this field. We are eager to advance CUSP06 into the clinic and deliver benefits for cancer patients worldwide."

"We are thrilled to join forces with OnCusp and leverage their highly experienced preclinical and global clinical development team to bring AMT-707 (CUSP06) to patients outside of China," said Dr. Xun Meng, Chairman and CEO of Multitude. "OnCusp’s focus on generating global clinical data, management team’s successful track record in clinical development of ADCs, and rich experience in clinical-oriented translational research make them the ideal partner for this asset. We look forward to working with Oncusp to bring AMT-707 (CUSP06) to patients globally."

On June 8, 2022 CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), reported its acquisition of Frame Cancer Therapeutics, a private company focused on advanced genomics and bioinformatics to identify both unique and shared neoantigens across different cancer types (Press release, CureVac, JUN 8, 2022, View Source [SID1234615806]).

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"The addition of Frame’s technology and talent to CureVac’s oncology research complements our ability to identify and validate promising neoantigens for our mRNA cancer vaccine programs," said Franz-Werner Haas, Chief Executive Officer of CureVac. "The bioinformatics platform developed by Frame’s researchers has the potential to identify a broad panel of neoantigens that go beyond conventional neoantigens and could strongly increase the likelihood of developing highly effective cancer vaccines. We are excited to join forces with the innovative Frame Cancer Therapeutics team and combine their bioinformatics capabilities with our own mRNA expertise to potentially deliver a new class of cancer vaccines."

Frame’s FramePro platform identifies structural changes within the cancer genome that give rise to new open reading frames. These new open reading frames result in novel proteins that are absent in healthy tissues and can thereby be recognized as foreign by the immune system. Although these genetic changes are highly specific to individuals, the resulting neoantigenic proteins may be shared among many patients, potentially enabling development of more broadly applicable cancer vaccines.

An additional application of Frame’s technology is the development of personalized cancer vaccines, thereby leveraging the full antigenic potential of a tumor. In December 2021, regulators in the Netherlands approved Frame’s clinical trial protocol to evaluate this approach based on a peptide vaccine in 15 patients with non-small cell lung cancer. CureVac will refocus development of personalized cancer vaccines on an mRNA modality.

"We are very enthusiastic about the great synergies between our content-driven approach in antigen discovery and validation and CureVac’s extensive experience with mRNA vaccine development," said Ronald Plasterk, Founder and CEO of Frame Cancer Therapeutics. "The resulting vaccines could greatly enhance our ability to activate the human immune system against cancer, both in a personalized and off-the-shelf manner."

The total consideration for the acquisition of Frame Therapeutics is valued at €32 million. It will be paid in CureVac shares. Following a 50 percent upfront payment, the residual amount will be split across two project milestone driven steps. CureVac will expand the antigen discovery and validation activities at the Amsterdam Science Park.

On June 8, 2022 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that senior leadership plans to present at the following conferences in June (Press release, Iovance Biotherapeutics, JUN 8, 2022, View Source [SID1234615798]):

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Jefferies Healthcare Conference
Fireside Chat: June 9 at 4 p.m. ET
New York, NY
JMP Global Healthcare Conference
Fireside Chat: June 15 at 2:30 p.m. ET
New York, NY
Goldman Sachs Global Healthcare Conference
Fireside Chat: June 15 at 6:20 p.m. ET
Palos Verdes, CA
Stifel Virtual Cell Therapy Conference
Panel: June 29 at 3:30 p.m. ET
Virtual
The live and archived webcasts, and the most recent corporate presentation, will be available at View Source

On June 8, 2022 EpiAxis Therapeutics has reported the results of its pioneering clinical trial EPI-PRIMED, the first time that an epigenetic inhibitor has been used in combination with chemotherapy to treat metastatic cancer (Press release, EpiAxis Therapeutics, JUN 8, 2022, View Source;utm_medium=rss&utm_campaign=epiaxis-therapeutics-clinical-trial-validates-targeting-lsd1-inhibition [SID1234615797]).

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The purpose of the EPI-PRIMED study was to investigate the safety of the combination, nab-paclitaxel and an irreversible LSD1 inhibitor, in patients with metastatic breast cancer (mBC). Women with inoperable or metastatic breast cancer from three Australian facilities: Canberra Region Cancer Centre, Southern Medical Day Care Centre and Liverpool Hospital participated in the study. The results of this trial have now been published in leading cancer journal Frontiers of Oncology.

CEO Jeremy Chrisp said the results of the clinical trial provide proof of concept for the company’s current drug development program for its first in class therapies to inhibit nuclear LSD1. In particular EpiAxis was pleased to note the biomarker results indicate that inhibition of LSD1 was associated with phenotypic change away from an aggressive phenotype in cancer cells.

"The publication of this study is the culmination of several years’ work and the results are important for both patients and the company, as we have demonstrated that nuclear inhibition of LSD1 is possible and results in cell reprogramming," Dr Chrisp said.

"This indicates that we are on the right track to progress our novel first in class candidates to a new clinical trial. We would like to thank the staff and patients of the three sites that participated, as well as EpiAxis Therapeutics founding scientist Professor Sudha Rao. We look forward to sharing the immune data from the study in the near future."

The findings of the EPI-PRIMED study give EpiAxis a solid foundation for its next clinical trial using its novel peptide inhibitors. The company is currently working with The Sage Group to raise US$12million to advance a candidate into an IND enabled program.

Dr Chrisp will be attending the BIO International Convention with The Sage Group from 13-16 June 2022 at San Diego Convention Center to facilitate discussions with interested parties.

On June 8, 2022 Chimeric Therapeutics Ltd (ASX:CHM) reported that it has formally submitted a pre-Investigational New Drug (IND) meeting request to the US Food and Drug Administration (FDA) for its cancer drug CHM 2101, a novel third-generation CDH17 CAR T cell therapy from the University of Pennsylvania (Press release, Chimeric Therapeutics, JUN 8, 2022, View Source [SID1234615796]).

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The pre-IND meeting request marks a major milestone for the development of CHM 2101 as it is the first formal meeting with the FDA on the development path to IND submission.

What’s more, the pre-IND meeting will provide Chimeric with the opportunity to discuss its IND plans with the FDA to gain feedback and insight prior to IND submission.

Looking ahead, the next step will be the submission of the CHM 2101 IND, enabling Chimeric to initiate the phase 1 clinical trial.

"First critical step"
Chimeric CEO and managing director Jennifer Chow said: "We are very excited to be taking this first critical step on the path to IND submission for CHM 2101,"

"We believe that CHM 2101 offers great promise for patients with gastrointestinal cancers and are very eager to move this asset to the clinic."

About CHM 2101
CHM 2101 (CDH17 CAR T) is a novel, third-generation CDH17 CAR T invented at the world-renowned cell therapy centre, University of Pennsylvania.

Preclinical evidence for CHM 2101 was published in March 2022 in Nature Cancer.

CHM 2101 (CDH17 CAR T) is in preclinical development with a planned phase 1 clinical trial in neuroendocrine tumours, colorectal, gastroesophageal and gastric cancer.