On February 9, 2022 Cyclica Inc. ("Cyclica"), a neo-biotech with the vision to advance the most robust and sustainable drug discovery pipeline, reported that launches Perturba Therapeutics Inc. ("Perturba"), a spin out from the Stagljar Lab at the University of Toronto, Donnelly Centre for Cellular and Biomolecular Research (Press release, Cyclica, FEB 9, 2022, View Source [SID1234607940]). Perturba is advancing a rich pipeline of assets from undrugged protein-protein interactions (PPIs) .

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Only a small subset of biologically important drug targets are currently being explored within the pharma industry. Perturba is taking this challenge on by integrating Cyclica’s comprehensive AI-augmented proteome-wide drug design technology with two first-in-class live cell-based assays from the Stagljar Lab. With this integrated AI-augmented drug design and empirical phenotypic approach, Perturba is developing precision therapies that modulate PPIs and PPI-mediated biological processes with a focus on difficult-to-treat cancers. Perturba will initially focus on advancing two EGFR triple mutant inhibitors for non-small cell lung cancer, and four programs targeting small GTPases for various intractable cancers.

Naheed Kurji, Co-Founder, CEO and President of Cyclica indicates that "More than half of all human disease-related proteins are considered undruggable using conventional approaches. As a result, patients suffering from life threatening diseases are left waiting for treatment. What others view as "undruggable", we see as potential. Perturba represents an important franchise in the pursuit of our cancer strategy. We’re so excited to partner with Professor Stagljar and the world class Stagljar Lab in driving forward our shared vision."

Dr. Igor Stagljar, Professor at University of Toronto’s Temerty Faculty of Medicine and Principal Investigator at the Donnelly Centre, shares, "over the past two years, my lab has developed two high impact, live cell-based technologies for studying protein-protein interactions and identifying novel drug molecules – MaMTH-DS and SIMPL. Combining these two technologies with Cyclica’s world-class AI-drug design approach will usher in a new way to conduct drug discovery for highly intractable targets in an unprecedented way at scale. I’ve known Naheed and the team at Cyclica for years and jointly have shown multiple proof points using our platforms with a program targeting an osimertinib resistant EGFR triple mutant that we will be progressing in Perturba, and a program targeting an oncogenic KRAS in a separate collaboration that gave us confidence to target other small GTPases in Perturba."

Seasoned drug developer Rick Panicucci, PhD, SVP at BridgeBio Pharma and a long time advisor at Cyclica has been appointed as non-executive Chairman of Perturba to help oversee the company’s strategy. Su Dharmawardhane Flanagan, PhD, Tony Hunter, PhD and Ming Tsao, MD, have been appointed to Perturba’s Scientific Advisory Board. Cyclica will provide initial funding for Perturba and will seek external funding from strategic partners as required.

"I’ve been involved in drug discovery & development for over 25 years. What I can say with certainty is that the way things will be done going forward is going to be very different from how it was done before. I’ve been an advisor at Cyclica for 6 years and have witnessed first hand the power of AI and data-first approaches to drive drug discovery fast and with quality. Now, with Perturba and integrating AI drug design and phenotypic assays opens a whole new way of design-make-test-analyze at scale for target classes that have been ignored for too long," shares Panicucci.

On February 9, 2022 Imagia Cybernetics, an AI-healthcare company that accelerates oncology solutions generated from real world data, reported its merger with Canexia Health (Press release, Canexia Health, FEB 9, 2022, View Source [SID1234607939]). Canexia is an oncology innovator that streamlines complex cancer genomic information which allows oncologists to identify optimal treatment selection and patient monitoring. The merger includes C$20 million funding with participation from: BDC Capital’s Women in Technology Venture Fund, Desjardins Capital, and PacBridge Capital. Combined, Imagia and Canexia will increase access to precision oncology at the community level. In addition to working with four leading pharmaceutical companies, Imagia and Canexia are integrated with 20 hospital systems and reference labs around the world. Their expertise in genomics, oncology, artificial intelligence, and informatics will enable health systems to bring testing in-house, delivering precision oncology to patients no matter where they live.

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While 85 percent of all cancer treatments in the United States are administered at community cancer centers and local hospitals, only 15 percent of patients are routinely screened for targeted treatment selection that can improve outcomes threefold1. The new company, Imagia Canexia Health, improves accessibility through cost-effective local testing, thereby reducing expenses and generating faster results. This integrated solution leverages AI-based informatics for treatment selection, patient monitoring, and provides clinical laboratories support to bring testing in-house. The result is a new ability to integrate patient clinical and genomic data which achieves more effective treatment decisions by oncologists.

"Combating cancer is what Imagia set out to accomplish through advanced AI technology, and merging with Canexia speeds up our momentum to realize that goal," said Imagia CEO Geralyn Ochab, who will lead the new company. Ochab spent over 20 years on technology’s cutting-edge in healthcare creating durable business partnerships in previous roles at Toshiba, GE Healthcare, and Resonant Medical. During that time, she orchestrated market expansions, built high performance teams, and spearheaded full scale corporate restructures. "Imagia’s EVIDENS platform, with its distributed model providing onco-clinical solutions generated from real world data, is critical to our joint ecosystem’s ability to provide earlier treatment selection and recurrence monitoring."

Aligning resources, the merger now enables expanded access to precision-guided cancer management. Imagia’s robust data insights technology preserves cancer healthcare data privacy via federated learning and Canexia’s end-to-end solution tests, validates, and delivers the analysis directly to the oncologist. Together, they will provide faster and more comprehensive insights.

"Targeted cancer therapies transform access to cancer treatment, patient outcomes, and health system effectiveness. Through Imagia Canexia Health these precision treatments can be available to physicians and patients around the world," said Canexia Health Board Chair Sue Paish, who will also chair the new company. "This merger with Imagia will greatly enhance access to life saving cancer treatments and improve health equity."

"This merger realizes new revenue streams from integrated workflow solutions, and more services that bring therapeutics to where patients need them most," said Michael Ball, Canexia Health CEO.

"Combining two advanced technology companies to bring affordable access to the best cancer treatments closer to the patient is exactly the kind of opportunity that we want to invest in," said Michelle Scarborough, a Managing Partner at BDC’s Women in Technology Venture Fund.

The transaction is expected to close at the end of February, subject to shareholder approval.

On February 9, 2022 Sirnaomics Ltd. (the "Company" or "Sirnaomics", stock code: 2257.HK), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, reported the start of a Phase I clinical trial for evaluation of the safety, tolerability and anti-tumor activity of the Company’s siRNA (small interfering RNA) drug candidate, STP707 with intravenous (IV) administration in the United States (Press release, Sirnaomics, FEB 9, 2022, View Source [SID1234607936]). The first two patients in the clinical trial have received treatment.

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The Phase I clinical trial, a multi-center, open label, dose escalation and dose expansion study, will evaluate the safety, tolerability and anti-tumor activity of STP707. Thirty participants with advanced solid tumors, who have been unresponsive to standard therapies, will be enrolled in dose escalation. Once maximum tolerated dose or recommended Phase II dose has been established, up to 10 additional patients will be enrolled to confirm safety and explore anti-tumor activity. The study encompasses five cohorts who will receive one of five escalating doses of STP707 through IV administration on a 28-day cycle. The primary endpoints are to determine maximum tolerated dose and establish dosage recommendations for future Phase II studies. Additional secondary endpoints are to determine the pharmacokinetics of STP707, and to observe preliminary antitumor activity.

"The first dosing of STP707 in patients with hepatocellular carcinoma and other types of solid tumors through IV administration is a significant milestone as we seek to advance this novel siRNA therapeutic, which has demonstrated promising activity in our preclinical efficacy and safety studies," said Patrick Lu, Ph.D., founder, chairman of the Board, Executive Director, President and CEO of Sirnaomics. "Our goal is to take advantage of polypeptide nanoparticle (PNP) formulated siRNA therapeutics for unmet clinical needs, specifically in the areas of oncology and fibrotic diseases. The Company is inspired to lead the RNAi community in development of novel oncology therapeutics, and initiating this study helps us work towards achieving that."

"Sirnaomics’ mission is to leverage research in RNAi therapeutics to develop drug candidates, which includes STP707, that are able to solve critical unmet needs for patients with a variety of cancers," said Michael Molyneaux, M.D., Executive Director and Chief Medical Officer at Sirnaomics. "With the start of this Phase I clinical trial, we can expand our therapeutic reach using IV administration as a modality. In doing so it opens us up to more opportunities to explore the impact of STP707, including the appropriate dosage and anti-tumor activity that we’ve already seen in previous studies."

STP707 takes advantage of a dual-targeted inhibitory property and a PNP-enhanced targeted delivery to solid tumors and metastatic tumors via intravenous administration. An initial preclinical study has demonstrated that simultaneously knocking down TGF-β1 and COX-2 gene expression in the tumor microenvironment increases active T cell infiltration. A further combination study demonstrated synergistic antitumor activity between STP707 and a PD-L1 antibody using a mouse orthotopic liver cancer model.

For more information about Sirnaomics’ clinical trials please visit ClinicalTrials.gov (Identifier NCT05037149) and the Company’s website at www.sirnaomics.com.

About STP707

STP707 is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA respectively, formulated in nanoparticles with a Histidine-Lysine Co-Polymer (HKP+H) peptide as the carrier. The specific carrier peptide is distinct from the carrier used in Sirnaomics’ STP705 product. Each individual siRNA was demonstrated to inhibit the expression of their target mRNAs, and combining the two siRNA’s produces a synergistic effect that diminishes pro-inflammatory factors. Over-expression of TGF-β1 and COX-2 have been well-characterized in playing key regulatory roles in tumorigenesis. In preclinical studies with STP707, IV administration resulted in knock-down of TGF-β1 and COX-2 gene expressions in various organs including liver and lung. In addition, in preclinical models STP707 had antitumor activity in various solid tumor types.

On February 9, 2022 Secura Bio, Inc. (Secura Bio) – (www.securabio.com), an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, reported that it completed enrollment on February 1, 2022, in the PRIMO study (Press release, Secura Bio, FEB 9, 2022, View Source [SID1234607935]). PRIMO is evaluating COPIKTRA for the treatment of adult patients with relapsed or refractory (r/r) Peripheral T-cell Lymphoma (PTCL) and has enrolled a total of 157 patients .

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COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and gamma pathways, which are involved in the proliferation and sustenance of malignant cells. COPIKTRA monotherapy has received Fast Track status for the treatment of PTCL patients who have received at least one prior therapy. Additionally, COPIKTRA has received an Orphan Drug Designation for use in the treatment of T-cell lymphomas. Treatment of T-cell lymphomas is a disease category for which COPIKTRA is not currently indicated.

The PRIMO study is a global, multi-center, open-label, parallel cohort, Phase 2 study. In the dose optimization portion of the study, 33 patients were randomized to receive COPIKTRA 25mg twice daily (Cohort 1) or COPIKTRA 75mg twice daily continuously (Cohort 2) until progressive disease (PD) or unacceptable toxicity. Based on the dose optimization results, an expansion group of 124 patients was added in which COPIKTRA is dosed at 75mg twice daily for two cycles, followed by 25mg twice daily, until PD or unacceptable toxicity. The primary endpoint of the expansion phase of the study is overall response rate (ORR; complete response [CR] + partial response) as determined by an independent review committee (IRC). Secondary endpoints include additional efficacy measures including duration of response (DOR), progression free survival, pharmacokinetics, and safety.

An interim analysis of the first 78 patients in the expansion phase, with a minimum follow-up of 6 months, was reported in December 2021 at the 63rd Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in Atlanta, Georgia. The study is ongoing and is expected to have enough events for the primary endpoint analysis later in 2022.

Interim results included an ORR by IRC assessment of 50% (39/78 pts) and a CR rate of 32.1% (25/78), with a median DOR of 233 days (range, 1-420+). Patients had a median of 3 (range, 1-7) prior therapeutic regimens and included the following PTCL subtypes: PTCL NOS (53.8%), ALCL (14.1%), AITL (26.0%) and Other (0.5%). Eighteen percent of patients remain on therapy; 47.4% discontinued due to PD, 6.4% discontinued for stem cell transplant, and 19.2% discontinued due to unacceptable toxicity.

Overall, the safety profile was consistent with that seen in previous studies. In this analysis the most frequent > Grade 3 adverse events seen were neutropenia (21.8%), ALT/AST increased (24.4%/ 21.8%), rash (7.7%), lymphocyte count decreased (7.7%), and sepsis (6.4%). ALT and/or AST elevations were the most common treatment-emergent AEs leading to treatment discontinuations (N=12, 15.4%).

Shortly following the presentation of these data at ASH (Free ASH Whitepaper), COPIKTRA was included in the National Comprehensive Cancer Network T-Cell Lymphoma Guidelines (Version 1.2022, 12/22/21) as a Category 2A designated option for the treatment of all subtypes of r/r PTCL.

"Secura Bio is dedicated to the development of COPIKTRA for the treatment of T-cell malignancies because these patients often have limited therapeutic options and generally poor outcomes. In addition to the treatment of r/r PTCL patients, we are exploring a wide range of development options for T-cell malignancies, including earlier line use as a single-agent or in combinations with other mechanisms of action." Said Dr. David Cohan, Chief Medical Officer of Secura Bio.

"Secura Bio in the last few months has sharpened its overall development focus to a very great extent on the potential of COPIKTRA in the treatment of T-cell malignancies. We believe that this patient population has the potential to benefit greatly based on these actions." Said Joseph M. Limber, President and CEO of Secura Bio.

On February 9, 2022 Theseus Pharmaceuticals, Inc. (NASDAQ: THRX) ("Theseus"), a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients through the discovery, development and commercialization of transformative targeted therapies, reported that Tim Clackson, Ph.D., President and Chief Executive Officer of Theseus, will participate in a virtual fireside chat for the 11th Annual SVB Leerink Global Healthcare Conference, taking place February 14-18, 2022 (Press release, Theseus Pharmaceuticals, FEB 9, 2022, View Source [SID1234607934]).

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Presentation Details:
Event: 11th Annual SVB Leerink Global Healthcare Conference
Date / Time: Friday, February 18th at 2:20pm ET
Format: Live Fireside Chat

A live webcast will be available in the Events section of the company’s investor relations website at ir.theseusrx.com and archived for 30 days following the presentation.

Management will also be participating in one-on-one investor meetings throughout the conference. Investors interested in scheduling a meeting with the Theseus management team should contact their SVB Leerink representative.