On June 27, 2022 Redx (AIM: REDX), the clinical-stage biotechnology company focused on discovering and developing novel, small molecule, highly targeted therapeutics for the treatment of cancer and fibrotic disease, reported that two presentations were delivered at the inaugural Extracellular Matrix Pharmacology Congress ("ECM 2022") in Copenhagen, 23-25 June (Press release, Redx Pharma, JUN 27, 2022, View Source [SID1234616280]). The presentations highlighted novel preclinical research performed by the Company and academic collaborators including encouraging data supporting Redx’s Porcupine and ROCK inhibitors as potential novel treatments for cancer-associated fibrosis.

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Dr Richard Armer, Chief Scientific Officer, Redx Pharma, commenting on both presentations at the ECM Congress said: "The encouraging data sets presented at the ECM Congress demonstrate the potential of our proprietary molecules to address hard-to-treat cancers and fibrotic diseases, including cancer-associated fibrosis. Redx is uniquely positioned to become a leader in these underserved clinical areas as we continue to leverage our current clinical assets, world-class medicinal chemistry, and drug discovery engine. We look forward to continuing our work with leading academic institutions to research possible future applications of our molecules."

Collaboration partner, Professor Marina Pajic of the prestigious Garvan Institute of Medical Research (the "Garvan") in New South Wales, Australia presented the RXC004 (PORCUPINE) and ROCK2 selective inhibitor data showing that targeting fibrosis associated with pancreatic cancer led to increased survival in mouse models. The collaboration between Redx and the Garvan was announced on 5 April 2022.

Professor Marina Pajic, Associate Professor and Strategic Program Lead for Precision Medicine for Cancer at the Garvan commented: "Highly fibrotic pancreatic cancers are a key research area for us. Our work with Redx’s proprietary, highly selective small molecules allows us to expand our understanding of how targeting different signalling pathways may be used to develop novel treatments which improve patient survival in these difficult-to-treat cancers."

In a second presentation, Head of Inflammation and Fibrosis at Redx, Dr Peter Bunyard, presented data supporting RXC008, a GI-targeted ROCK inhibitor, as a potential first-in-class treatment for fibrostenotic Crohn’s disease. The presented results were from a research collaboration between Redx and scientists at Belgium’s Ghent University and assessed the preclinical efficacy of RXC008 based on the use of magnetic resonance imaging (MRI) texture analysis to determine fibrotic changes in the colon. The data showed that RXC008 could significantly reduce fibrosis in the mouse dextran sulfate sodium (DSS) model measured by both histology and, for the first time, non-invasive MRI. This study therefore highlights that RXC008 has the potential to be the first pharmaceutical treatment for fibrostenotic Crohn’s disease, reducing or replacing the need for repeated and debilitating surgical interventions, currently the only treatment option for patients, and that MRI could be used to monitor the effectiveness of new treatments in the clinic without the need for invasive biopsy.

Debby Laukens, Professor of Gastro-Intestinal Inflammation at Ghent University, commented: "We are proud of our work with Redx and the crucial role it played in profiling a differentiated drug candidate through measuring its anti-fibrotic effects using a novel, non-intrusive technique. We were clearly able to demonstrate the efficacy of Redx’s GI-targeted ROCK inhibitor to specifically target fibrosis in the intestines."

About the Extracellular Matrix Pharmacology Congress The Congress, organised by the Danish Research Foundation, brought together experts in the fields of cancer, fibrosis and immunology to discuss new pharmacological approaches to treat chronic diseases often caused by alterations in the extracellular matrix ("ECM") structure. Redx was one of eight symposium sponsors.

On June 27, 2022 Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, reported the Food and Drug Administration (FDA) has placed a partial clinical hold on the Company’s Phase 1 dose escalation study of NUV-422 in solid tumors, including high grade glioma, HR+/HER2- advanced breast cancer and metastatic castration resistant prostate cancer (Press release, Nuvation Bio, JUN 27, 2022, View Source [SID1234616296]). The Company’s Phase 1 trial began enrolling patients 19 months ago in December 2020 and, in recent months, was exploring higher doses to define a maximum tolerated dose. Following the emergence of uveitis, a form of inflammation in the eye, in certain patients receiving NUV-422, the Company proactively paused enrollment of new patients in order to further assess these adverse events with investigators and uveitis experts, and also reached out to the FDA for guidance around an appropriate path forward. While the partial hold is in place, no new patients will be enrolled in the NUV-422 program, although current study participants may continue to be treated in the Phase 1 study.

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"We are committed to patient safety across all of our studies and to working collaboratively with the FDA to develop, as efficiently as possible, new medicines where existing therapies are inadequate," said David Hung, M.D., founder, president and chief executive officer of Nuvation Bio. "Based upon the recent development of uveitis as a potential safety signal, we will conduct an overall risk/benefit analysis of the NUV-422 program. Our goal is always to ensure that we deploy our resources on programs that have the highest probability of success and of generating value for patients and our investors. With $737.7 million in cash as of March 31, 2022, we are well positioned to continue developing all of our internal product candidates.

The Company will provide updates on the direction of the NUV-422 program after it has completed its internal risk-benefit analysis which will factor in feedback from FDA.

On June 27, 2022-Defence Therapeutics Inc. ("Defence" or the "Company"), a Canadian biopharmaceutical company specialized in the development of immuneoncology vaccines and drug delivery technologies, is pleased to reported potent pre-clinical results on the use of its AccumTM-linked protein vaccine, AccuVAC-PT007, against cervical cancer (Press release, Defence Therapeutics, JUN 27, 2022, View Source [SID1234626250]).

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Cervical cancer is a type of cancer affecting the cervix. Various strains of the human papillomavirus (HPV), a sexually transmitted infection, play a major role in causing cervical cancer. When exposed to HPV, epithelial cells of the cervix undergo a series of transformation events eventually leading to tumor development. Although the risk of developing cervical cancer can be significantly reduced by performing regular screening tests, receiving anti-HPV vaccines such as Gardasil, Gardasil-9 or Cervarix, remain currently the most effective strategy to prevent from cervical cancer caused by HPV 16 and 18. However, there is currently no cure besides standard of care for patients who develop cervical cancer, and the clinical trials conducted with other companies with both the E6 and E7 oncoproteins (derived from the HPV genome) were highly unsuccessful.

Using the AccumTM platform, Defence developed the AccuVAC-PT007, a protein-based vaccine targeting the E7 oncoprotein of the HPV virus. AccuVAC-PT007 was previously shown to provide complete protection against cervical cancer (prophylactic vaccination) as shown in our press release dated on May 18, 2022. These ground-breaking observations led to the testing of AccuVAC-PT007 as a treatment with pre-established cervical cancer (therapeutic vaccination). Pre-clinical studies conducted on rodents show that the co-delivery of AccuVAC-PT007 with several immune-checkpoint blockers (anti-PD-1, anti-CTLA4 or anti-CD47) lead to potent control of tumor growth with a more pronounced effect observed with anti-CD47, one of the latest immune-checkpoint blockers undergoing clinical development.

"Currently available HPV vaccines serve one purpose: protection from the HPV virus. Our vaccine is not only simpler to manufacture as it is based on a single protein, but its dual action makes it highly attractive as it can both protect from-and treat the same tumor type", says Mr. Sebastien Plouffe, the CEO of Defence Therapeutics.

Specifically, the cervical cancer therapeutics market size is expected to reach $7.1 billion by 2027 according to Aritzon Advisory and Intelligence. And further more since the cervical cancer is derived form HPV "human papillomavirus vaccine", this market is anticipated to generate a revenue of $10,823 million and grow at a healthy CAGR of 12.4% over the forecast period from 2022 to 2030 according to Research Dive.

On July 27, 2022 Relay Therapeutics, Inc. (Nasdaq: RLAY) a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, reported the anticipated registrational path for RLY-4008 and three new programs within a growing HR+/HER2- breast cancer franchise at a virtual analyst and investor event from 8:00 a.m. to 9:00 a.m. ET (Press release, Relay Therapeutics, JUN 27, 2022, View Source [SID1234616263]).

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"2022 has proven to be an extremely productive year so far for Relay Therapeutics and we’re looking forward to sharing updates across our portfolio today," said Sanjiv Patel, M.D., Relay Therapeutics’ president and chief executive officer. "We are excited to be announcing the anticipated registrational path for RLY-4008 and the maturation of the data to support that pathway. In addition, building on the foundation of our PI3Kα franchise, we will outline a broad commitment to developing comprehensive treatment options for breast cancer patients. We believe our platform and approach have the potential to address some of the hardest-to-treat diseases and are excited to do just that in the coming years."

RLY-4008 Regulatory and Clinical Data Update

Relay Therapeutics conducted an end-of-phase 1 meeting with the FDA to discuss next steps for the clinical development of RLY-4008. Based on discussions with the FDA, the Company has decided to move forward with a single arm trial design for FGFRi-naïve FGFR2-fusion CCA at 70 mg once daily to potentially support accelerated approval. The Company also intends to add additional supportive CCA cohorts to an NDA submission, including frontline, FGFRi-experienced and FGFR2 mutation and amplification patients that could potentially facilitate a line and alteration agnostic label if the submission is approved.

The interim data shared with the FDA included a data cut-off of April 19, 2022, from the dose escalation portion of the ongoing study. The interim data included a safety database of 115 patients, with 58 patients treated with the once daily (QD) dosing schedule, and 13 of these patients were FGFRi-naïve FGFR2-fusion CCA patients treated with the once daily schedule ranging from 20 mg up to 70 mg. Also, in addition to the 17 patients previously disclosed at a twice daily (BID) schedule, an additional 40 patients were evaluated with an intermittent dosing schedule, both of which have been deprioritized.

The safety analysis as of the April 19, 2022 cut-off date was consistent with the analysis from the initial October 2021 data disclosure. Most treatment emergent adverse events were expected FGFR2 on target, low-grade, monitorable, manageable, and largely reversible. There were no observed Grade 4 or 5 adverse events. Notable off-target toxicities of hyperphosphatemia and diarrhea continued to be clinically insignificant.

The efficacy analysis from this interim data on the once daily dosing schedule presented to the FDA demonstrated confirmed partial responses in eight out of thirteen (62%) FGFRi-naïve FGFR2-fusion CCA patients across the 20 mg to 70 mg QD cohorts. There were four patients treated at the registrational trial dose of 70 mg QD as of the April 19, 2022 cut-off date, all of which had confirmed partial responses.

An update from the FGFRi-naïve FGFR2-fusion CCA patients treated at 70 mg QD across dose escalation and expansion is expected to be presented at a medical meeting in the second half of 2022. The entirety of the dose escalation data is expected to be presented at a medical meeting or published by the end of the first half of 2023. Lastly, initial data from the non-CCA expansion cohorts is expected to be presented in 2023.

Breast Cancer Portfolio and New Targets

Relay Therapeutics today disclosed three new programs from a growing breast cancer franchise including a selective CDK2 inhibitor, a rationally designed ERα degrader, and a chemically distinct pan-mutant selective PI3Kα inhibitor (RLY-5836).

CDK2 is a common cause of resistance to the over 50,000 patients a year in the U.S. on CDK4/6 inhibitors and potentially an important PI3Kα combination partner. Relay Therapeutics progressed from first compound synthesized to an advanced CDK2 lead compound with robust selectivity over other CDK family members in less than a year. This program is expected to enter the clinic in Q4 2023 or Q1 2024.
Leveraging the Dynamo platform, Relay Therapeutics has been able to move from the traditional empirical design of bi-functional degraders to rationally designed molecules. The company expects to nominate an ERα degrader development candidate in 2023.
As a demonstration of Relay Therapeutics’ commitment to PI3Kα mutant inhibition, the Company has designed a selective and chemically distinct pan-mutant PI3Kα inhibitor, RLY-5836. RLY-5836 is expected to be ready to enter the clinic in 2023.
Conference Call Information

Relay Therapeutics will host a live webcast and conference call today beginning at 8:00 am E.T. The virtual analyst and investor event will be webcast live and may be accessed through Relay Therapeutics’ website under Events in the News & Events section through the following link: View Source An archived replay of the webcast will be available following the event.

About RLY-4008

RLY-4008 is a potent, selective and oral small molecule inhibitor of FGFR2, a receptor tyrosine kinase that is frequently altered in certain cancers. FGFR2 is one of four members of the FGFR family, a set of closely related proteins with highly similar protein sequences and properties. Preclinically, RLY-4008 demonstrated FGFR2-dependent killing in cancer cell lines and induced regression in in vivo models, while minimal inhibition of other targets was observed, including other members of the FGFR family. In addition, RLY-4008 demonstrated strong activity against known clinical on-target resistance mutations in cellular and in vivo preclinical models. RLY-4008 is currently being evaluated in a clinical trial in patients with advanced or metastatic FGFR2-altered solid tumors with a single arm, potentially registration-enabling cohort for pan-FGFR ("FGFRi") treatment-naïve FGFR2-fusion CCA. To learn more about the clinical trial of RLY-4008, please visit here.

On June 27, 2022 Philogen reported that it will attend EANO Meeting in Vienna in September 2022 (Presentation, Philogen, JUN 27, 2022, View Source [SID1234616281]).

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