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.

On February 9, 2022 Sirtex Medical ("Sirtex"), a leading manufacturer of targeted liver cancer therapies, reported with its shareholder, Grand Pharmaceutical Group Limited, that SIR-Spheres Y-90 resin microspheres have been approved by the National Medical Products Administration (NMPA) for the treatment of patients with colorectal cancer liver metastases (Press release, Sirtex Medical, FEB 9, 2022, View Source [SID1234607933]).

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The NDA approval of SIR-Spheres for the Chinese market is the first therapeutic radiopharmaceutical approved by the NMPA in 2022 and is the only radioactive microsphere product approved by the NMPA based on clinical trial data obtained outside of China. The first procedure of selective internal radiation therapy (SIRT) using SIR-Spheres in China was successfully performed for a patient in September 2021, which at that time utilized the pilot implementation policy for commercialized medical devices in Hainan.

"We are proud to expand the reach of SIR-Spheres to China, where thousands of patients will now have access to this treatment option," said Kevin R. Smith, Chief Executive Officer of Sirtex. "We express deep gratitude to our partners at Grand Pharmaceutical Group Limited, Sirtex China and our Global Regulatory, Quality Assurance, Operations and Medical teams for their incredible work and diligence that has allowed us to reach this goal."

According to GLOBOCAN 2020, there were 410,000 new cases of liver cancer with 390,000 deaths in China. Additionally, in 2020, there were over 550,000 new cases of colorectal cancer with more than 280,000 deaths in China. Those morbidity and mortality rates are about twice as high as average global rates.

"The prognosis for patients suffering from liver cancer in China is poor, with the five-year survival rate being roughly 12%," notes Dr. Tang Weikun, Chairman of the Board at Grand Pharmaceutical Group Limited. "The use of SIR-Spheres to downstage liver tumors to the point where they can be surgically removed has been well documented in other countries. Our hope is that by expanding the reach of SIR-Spheres to China, we will have a similar impact, with improved treatment outcomes and survival rates among patients diagnosed with liver tumors."

On February 9, 2022 Aeglea BioTherapeutics, Inc. (Nasdaq:AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare metabolic diseases, reported a proposed underwritten public offering in which it intends to offer and sell shares of its common stock and, in lieu of common stock, to offer and sell to certain investors pre-funded warrants to purchase shares of its common stock (Press release, Aeglea BioTherapeutics, FEB 9, 2022, View Source [SID1234607932]). Aeglea expects to grant the underwriters a 30-day option to purchase additional shares of common stock. All of the securities are being offered by Aeglea. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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JonesTrading Institutional Services LLC and LifeSci Capital LLC are acting as joint book-running managers in the offering.

Aeglea intends to use the net proceeds from the offering, together with its existing cash resources, to fund its ongoing Biologics License Application submission activities for pegzilarginase and its potential commercialization in the United States, complete its ongoing Phase 1/2 clinical trial of AGLE-177 and prepare for a potential pivotal study in Homocystinuria, advance AGLE-325 for Cystinuria through IND-enabling studies, and the remainder to fund continued research and development, manufacturing, working capital and general corporate purposes.

The securities are being offered by Aeglea pursuant to a registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission (SEC). The offering will be made only by means of the written prospectus and prospectus supplement that forms a part of the registration statement. A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying base prospectus may also be obtained, when available, from JonesTrading Institutional Services LLC at [email protected] or LifeSci Capital LLC at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of Aeglea, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.