On October 8, 2021 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported the presentation of preliminary Phase 1 monotherapy clinical data from its Phase 1/2 TRESR (Treatment Enabled by SNIPRx) clinical trial of RP-3500, a potent and selective oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase) for the treatment of solid tumors with specific synthetic-lethal genomic alterations including those in the ATM gene (ataxia teleangectasia mutated kinase), at the AACR (Free AACR Whitepaper)-NCI-EORTC Virtual 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) (Press release, Repare Therapeutics, OCT 8, 2021, View Source [SID1234591015]).

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The data are featured today at the AACR (Free AACR Whitepaper)-NCI-EORTC conference in an oral presentation titled, "First-in-Human biomarker-driven Phase I TRESR trial of ATR inhibitor RP-3500 in patients with advanced solid tumors harboring synthetic lethal genomic alterations" (Abstract number 4950). Preliminary data show that monotherapy RP-3500 is safe and well tolerated, with compelling early efficacy signals across multiple genotypes and tumor types in heavily pretreated patients.

The Company will subsequently host a virtual webcast event today, October 8th at 5:00 p.m. Eastern Time to discuss the latest results from the TRESR trial.

"Our initial data for 101 patients treated with RP-3500 in the ongoing TRESR study resulted in a firm recommendation for Phase 2 dose and schedule, suggest a favorable and differentiated safety profile and provide compelling early evidence of broad clinical efficacy across genotypes predicted by our SNIPRX platform," said Maria Koehler, MD, PhD, Chief Medical Officer of Repare. "The evolving nature of the data from this ongoing study and specifically the stable tolerability profile and maturing efficacy data offer a clear direction for further development of RP-3500. Additionally, we are excited to see that even at this early point in our clinical program, the pharmacokinetic and pharmacodynamic biomarker data already confirm proof-of-mechanism for RP-3500 in tumors with diverse molecular backgrounds."

"The TRESR study is the largest ever biomarker-selected trial testing single agent ATR inhibitor. We are very pleased that these data suggest RP-3500 may have a best-in-class profile as a potent and highly selective ATR inhibitor and represent compelling validation for the ability of our SNIPRx platform and our STEP2 process to improve efficacy through molecular selection of tumors," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "We look forward to the imminent expansion of the TRESR study in a range of genotypes and, continuing and broadening our combination therapy studies, including with a range of PARP inhibitors and gemcitabine."

Key Initial Findings from the TRESR Phase 1/2 Study:

TRESR is a first-in-human, multi-center, open-label Phase 1/2 dose-escalation and expansion study, designed to establish the recommended Phase 2 dose and schedule, evaluate safety and pharmacokinetics and identify preliminary anti-tumor activity associated with RP-3500, given alone and in combination with talazoparib. The study also examined biomarker responses and their relationship with response to RP-3500 treatment.

Data presented in the abstract reflect the monotherapy cohort at data cutoff of June 4, 2021 and include 62 patients, while data presented at the conference reflect a data cutoff of August 15, 2021 and include 101 patients. Highlights from the data presented at the AACR (Free AACR Whitepaper)-NCI-EORTC conference include:

RP-3500 appears safe and well tolerated. The most common treatment emergent adverse events (TEAE) in any of the 101 patients treated, expectedly, was grade 1-2 anemia, with only 21.8% of all patients experiencing Grade 3 anemia (no Grade 4), and only 14.5% of those patients treated on the recommended weekly schedule of 3 days on/4 days off.
There were no discontinuations related to RP-3500 emergent adverse events and dose interruptions, reductions or red blood cell transfusions were infrequent on the recommended 3 days on/4 days off regimen.
Recommended Phase 2 dose (RP2D) and schedule for further monotherapy RP-3500 evaluation is 160mg, taken weekly for 3 days on and 4 days off. This schedule assures repeated weekly exposure to RP-3500 at an efficacious dose.
Antitumor activity was observed in patients with tumors harboring SNIPRX predicted genomic alternations at doses >100mg (ATM, CDK12, BRCA1, BRCA2, RAD51B, RAD51C, FZR1), across multiple tumor types and included patients after PARP inhibitor failure.
Meaningful clinical benefit was observed in 49% of 69 patients with available scans. Those include 12 patients with tumor responses per established international efficacy criteria, 14 patients with ongoing stable disease for at least 16 weeks and 8 patients with stable disease who only had two radiological evaluations, but had demonstrated significant decreases in tumor markers and tumor shrinkage of less than 30%.
Promising deep molecular responses in circulating tumor DNA (ctDNA) for tumors with STEP2 genomic alterations were observed in the initial set of patients available for serial ctDNA analysis
Company Virtual Webcast Event:

The Company will host a virtual investor webcast with accompanying slides for analysts and investors today at 5:00 p.m. Eastern Time to further discuss the RP-3500 data presented at the AACR (Free AACR Whitepaper)-NCI-EORTC Virtual 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). Repare’s executive management team will be joined by Timothy Yap, MBBS, PhD, FRCP, Principal Investigator and Medical Director, Institute for Applied Cancer Science, Associate Professor, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, MD Anderson Cancer Center, Houston, Texas. At this event, the Company will provide an update on the status of the unconfirmed partial responses presented at the AACR (Free AACR Whitepaper)-NCI-EORTC conference since the August 15, 2021 data cutoff.

A live video webcast will be available in the Investor section of the Company’s website at View Source A webcast replay will also be archived for at least 30 days.

About Repare Therapeutics’ SNIPRx Platform

Repare’s SNIPRx platform is a genome-wide CRISPR-based screening approach that utilizes proprietary isogenic cell lines to identify novel and known synthetic lethal gene pairs and the corresponding patients who are most likely to benefit from the Company’s therapies based on the genetic profile of their tumors. Repare’s platform enables the development of precision therapeutics in patients whose tumors contain one or more genomic alterations identified by SNIPRx screening, in order to selectively target those tumors in patients most likely to achieve clinical benefit from resulting product candidates.

On October 8, 2021 OncoNano Medicine, Inc. reported positive results from its preclinical study of ONM-501, a novel dual-activating polyvalent STING agonist for immuno-oncology applications (Press release, OncoNano Medicine, OCT 8, 2021, View Source [SID1234591013]). The data, presented at The American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Conference on Tumor Immunology and Immunotherapy, demonstrate strong efficacy in multiple tumor models.

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"We are excited by the positive preclinical results for ONM-501 recently presented at AACR (Free AACR Whitepaper). STING plays a crucial role in mediating our innate immune systems but has consistently been a challenging pathway to target," said Martin Driscoll, Chief Executive Officer of OncoNano Medicine, Inc. "We are encouraged by the constellation of preclinical data that demonstrates ONM-501 could have a clinical profile differentiated from earlier generation cyclic dinucleotide STING agonist compounds. The novel ONM-501 formulation consisting of our STING activating pH-sensitive micelle loaded with an endogenous agonist has demonstrated a capability to produce a dual and prolonged activation of STING while recruiting a robust adaptive immune response to the tumor microenvironment. We look forward to continuing our IND-enabling activities as we advance ONM-501 to first in human trials."

Presentation Overview
TITLE: ONM-501 ― A synthetic polyvalent STING agonist for cancer immunotherapy

PRESENTER: Qingtai Su, Ph.D., Senior Scientist, OncoNano Medicine, Inc.

ONM-501 demonstrated antitumor efficacy in six different syngeneic mouse models from different tissues of origin (MC38, 4T1, TC-1, B16-F10, CT26 and A20). The animals were treated intratumorally with ONM-501 as a monotherapy or in combination with PD-1 blockade. The findings indicate that ONM-501 demonstrated:

Strong antitumor efficacy across all tumor models tested as a mono or combo therapy
Significantly improved efficacy with increased complete response in several modelswhen combined with PD-1 blockade
Successful combination of a novel, proprietary STING activating micelle with theendogenous cGAMP potentially offers a synergistic immunotherapy strategy against cancer

On October 8, 2021 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported that its collaboration with Bristol Myers Squibb (NYSE: BMY) has been expanded to include a new cell type, triggering a payment of $ 9.0 m to Evotec (Press release, Evotec, OCT 8, 2021, View Source;announcements/press-releases/p/evotec-expands-neuroscience-collaboration-with-bristol-myers-squibb-to-include-novel-cell-type-6100 [SID1234591011]).

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The collaboration was initiated in December 2016 with the goal of identifying disease-modifying treatments for a broad range of neurodegenerative diseases. Currently approved drugs only offer short-term management of the patients’ symptoms and there is tremendous unmet medical need for therapeutic options that slow down or reverse disease progression. The collaboration pursues an innovative approach to the discovery and development of novel medicines by leveraging Evotec’s iPSC platform using patient-derived disease models, which is one of the largest and most sophisticated platforms in the industry.

Since 2016, the companies have expanded the collaboration several times. The latest expansion will enable the companies to investigate the root causes of many neurodegenerative diseases in a cell type specific fashion using cells directly derived from patients. In addition, molecular disease signatures will be used to define detailed molecular disease phenotypes using Evotec’s leading panomics platform, EVOpanOmics & EVOpanHunter.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "We are delighted that our important collaboration with Bristol Myers Squibb will now investigate and target mechanisms driving neurodegeneration more comprehensively through the addition of a new cell type. Through our human iPSC-based approach we believe we have the potential to improve clinical outcomes of neurodegeneration programmes. iPSC technology enables us to directly work on human neurons to explore new drug candidates in the pre-clinical setting."

On October 7, 2021 AbClon (174900, CEO Jong-seo Lee) a bio venture company and Ebixgen(CEO Yoo Ji-chang) reported a business agreement(MOU) on joint research and development of antibody new drugs with increased tissue permeability (Press release, AbClon, OCT 7, 2021, View Source;wr_id=148&page=2 [SID1234638670]). It was announced on 07 that the agreement was concluded. The two companies signed an MTA (material transfer agreement >, last 8month)With this MOU, we will continue to promote joint research and development of new antibody drugs.

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An official of AbClon said, "According to this agreement, Antibodies discovered using AbClone’s antibody and epitope discovery technologyNESTplatform are transferred to Ebixgen’s drug delivery platform. We plan to conduct joint research to develop new antibody drugs that increase the cell delivery ability of drugs by applying them to ACP"< /span>. "by developing innovative new antibody drugs with improved pharmacological efficacy and safety. He emphasized, "We expect to be able to expand to areas that existing antibody treatments cannot solve" said

AbClon is a specific epitope of an antigen(binding site) NEST (Novel Epitope), a technology to discover antibodies that bind to Screening Technology) has a platform. Via the NESTplatform Discovered AC101(stomach cancer, breast cancer antibody treatment< a i=13>) is affiliated with Shanghai Henlius Biotech(Shangahi Henlius Biotech) in China. Technology transfer(L/O)year and clinical trial2ahead. . In addition, its own antibody that binds to a new epitope of the disease protein CD19 Developed, applied it CAR-T cell therapy IND< /span>. month6 It was submitted last Phase1 Domestic clinical trial of AT101

Ebixgen possesses ACP (Advanced Cell Penetrating Peptide technology)technology, which is a new drug development platform technology and next-generation cell and tissue penetration delivery technology. Doing. This is a technology that improves the penetration and delivery ability of drugs that act on cells and tissues. In particular, the blood-brain barrier of drugs(BBB) ​​increasing the permeability of drugs, which is the biggest challenge in the development of existing treatments for brain diseases a>BBB It is characterized by being able to solve the transmission problem. Also, several poorly soluble It can dramatically increase the low solubility, which is a limitation of the drug, thereby increasing the usefulness of poorly soluble drugs with limited application. It is a technology that can expand and improve indications. The company currently treats AIDS, age-related macular degeneration, dry eye disease, < /span>. We have a variety of pipelines, including treatments for atopic dermatitis.

Meanwhile, cell and tissue penetration of drugs, etc. Involved’Drug Delivery System(DDS, Drug Delivery System)’ Is As the final stage of new drug development, controlling the speed of drug application and minimizing side effects are the key to technological prowess . Depending on the size or charge of the new drug candidate, the drug There are many cases where it cannot pass through the inside of the cell, and various DDS Technology is being researched.

On October 7, 2021 Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases, reported that it has commenced concurrent but separate underwritten public offerings of its common stock and its Series X Convertible Preferred Stock (Press release, Cidara Therapeutics, OCT 7, 2021, View Source [SID1234636984]). With respect to the common stock offering, Cidara also expects to grant the underwriters a 30-day option to purchase additional shares of its common stock at the public offering price. The closing of each proposed offering is not contingent upon the closing of the other. The offerings are subject to market conditions, and there can be no assurance as to whether or when either or both of the offerings will be completed, or as to the actual size or terms of the offerings.

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Cantor Fitzgerald & Co. is acting as the sole book-running manager for each offering.

The securities described above are being offered by Cidara pursuant to a shelf registration statement, which has been declared effective by the Securities and Exchange Commission (SEC). Preliminary prospectus supplements and the accompanying prospectus relating to the offerings will be filed with the SEC and will be available for free on the SEC’s website at View Source Copies of the preliminary prospectus supplements and accompanying prospectus relating to these offerings, when available, may be obtained from: Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Ave., 4th Floor, New York, New York 10022, or by e-mail at [email protected].

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