On January 17, 2023 Eclipse Bioinnovations (Eclipsebio), a leading RNA genomics company developing and commercializing novel, data-driven technologies that interrogate RNA, reported its new research demonstrating the optimization of Eclipsebio’s industry-standard eCLIP technology to improve the study of RNA-binding protein interactomes, which promises to accelerate the study of human diseases caused by failed RNA processing (Press release, Eclipse Bioinnovations, JAN 17, 2023, View Source [SID1234626322]). The study, published in Nature Methods, was led by Eclipsebio’s Associate Director of Research Daniel Lorenz, Ph.D., and co-founder Gene Yeo, Ph.D.

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"Multiplexed transcriptome discovery of RNA-binding protein binding sites by antibody-barcode eCLIP"

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Enhanced cross-linking immunoprecipitation followed by high-throughput sequencing, or eCLIP, is a powerful technique to uncover RNA sequences where RNA-binding proteins (RBPs) bind, known as RBP interactomes. RBPs regulate RNA molecules, controlling the function and quantity of proteins expressed in a cell. RBP mutations have been associated with cancer, amyotrophic lateral sclerosis, and a number of other diseases.

"eCLIP is a powerful technique that scientists utilize to study disease samples with RBP mutations, and this optimized antibody-barcode eCLIP (ABC) technology will allow a faster and more efficient study of RBP interactomes to gain new insights into novel disease targets and therapeutics," said Eclipsebio CEO and cofounder Peter Chu, Ph.D. "ABC is designed to optimize the study of RNA-binding protein interactomes in clinically relevant samples, including disease tissues, where source materials are rare and often scarce."

In this published study, Eclipsebio and UC San Diego scientists developed the ABC methodology that bypasses electrophoresis and membrane transfer and allows the study of interactomes of more than one RBP in the same reaction tube, which will support small sample volumes and sizes.

"We proved that ABC methodology maintains a comparable sensibility and specificity to eCLIP while improving the number of RBP interactomes that can be studied in one reaction tube," explained Dr. Yeo. "We showed that a single ABC library obtained from one reaction tube generates similar data to ten separate eCLIP experiments."

During eCLIP, there is an immunoprecipitation (IP) step, where an antibody against the RBP of interest is used to "grab" the binding RNA. In ABC, the IP step allows using more than one antibody in the same reaction tube, where each antibody is tagged with a different DNA barcode. After the IP step, a multiplex reverse transcriptase (RT) reaction identifies to which one of the RBP antibodies the RNA sequences were bound since the DNA barcode used serves as a primer for the RT reaction.

Dr. Chu concluded, "The Eclipsebio team is committed to developing the leading technologies to accelerate the study of RNA regulation, and this study opens the door to even further scaling. By increasing the number of barcodes used in each reaction tube, more interactomes could be studied simultaneously. We look forward to supporting important RBP research with our current and future eCLIP products that will include the ABC technology."

The publication entitled, "Multiplexed transcriptome discovery of RNA-binding protein binding sites by antibody-barcode eCLIP," is available open access on Nature Methods.

About Eclipsebio’s RNA Genomics Platform and Products

Eclipsebio’s comprehensive RNA genomics platform is poised to build the world’s most detailed multi-dimensional RNA maps through transcriptome-wide views of RNA interactions with RNA binding proteins (RBP-eCLIP), RNA modifications such as m6A (m6A-eCLIP), alternative transcription start site and polyadenylation site usage (EndSeq), and microRNA-mRNA interactions (miR-eCLIP). Upcoming products in development are designed to profile translation (eRibo) and probe RNA structure

On January 17, 2023 Avacta Group plc (AIM: AVCT), a life sciences company developing innovative, targeted oncology drugs and powerful diagnostics reported that AVA6000 continues to show a very favourable safety profile in the fourth dose cohort of the ALS-6000-101 dose escalation phase 1 clinical trial (Press release, Avacta, JAN 17, 2023, View Source [SID1234626321]). Additionally, analysis of tumour biopsies obtained from six patients across several cohorts indicates that doxorubicin is being released within the tumour tissue, confirming the tumour targeting potential of the pre|CISION technology.

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AVA6000 continues to be well tolerated by patients in cohort 4, with a marked reduction in the incidence and severity of the typical toxicities associated with the standard doxorubicin chemotherapy administration. Typical toxicities include alopecia, myelosuppression, nausea, vomiting, mucositis, and cardiotoxicity. Importantly, even at the highest dosing levels in cohort 4, equivalent to more than double the normal dose of doxorubicin, the typical drug-related cardiotoxicity of doxorubicin was not observed.

A number of tumour biopsies obtained from patients in different cohorts have also been analysed in order to confirm the release of the active chemotherapy, doxorubicin, in the tumour tissue. This analysis shows that AVA6000 targets the release of doxorubicin to the tumour tissue at therapeutic levels which are much higher than the levels being detected in the bloodstream at the same timepoint.

Nineteen patients with a range of advanced and/or metastatic solid tumours enrolled across four cohorts, have been administered AVA6000 to date. On the basis of the very favourable safety profile of AVA6000 in the study to date, the Safety Data Monitoring Committee (SDMC) has recommended continuation to higher dose cohorts with the aim of identifying a maximum tolerated dose (MTD) necessary to inform the dosing levels for the phase 1b and future studies. The Company expects that it will complete these additional cohorts during the first half of 2023.

Dr Alastair Smith, Chief Executive Officer of Avacta Group plc commented: "We’re delighted with the very positive data emerging from the dose escalation study of our lead pre|CISION tumour targeted therapy AVA6000. The very significant reduction in the usual toxicities, plus the observed release of doxorubicin at significant levels in the tumour tissue, show that the pre|CISION platform has the potential to significantly improve the safety and tolerability of chemotherapies, and other drugs, by targeting their release to the tumour.

"This is extremely encouraging as we work towards realising our vision of "chemotherapy without side effects" to make a meaningful difference to cancer patients’ lives.

"We are now in a position to proceed beyond the fourth cohort in the dose escalation study to even higher doses than originally anticipated, which is an unexpected and very positive development. The data being generated in the ALS-6000-101 study are providing detailed insights into the pre|CISION platform, which add significant value to the technology and confirm the potential of the pre|CISION platform."

On January 17, 2023 Asher Biotherapeutics, Inc. (Asher Bio), a biotechnology company focused on developing therapies to precisely engage specific immune cells to fight cancer, reported that the first patient has been dosed with AB248 in a Phase 1 first-in-human study, AB248-101. AB248, a CD8-targeted interleukin-2 (IL-2), is Asher Bio’s lead compound and first to enter the clinic for the treatment of patients with solid tumors (Press release, Asher Biotherapeutics, JAN 17, 2023, View Source [SID1234626320]). The Phase 1a/1b study, which consists of a dose escalation and expansion stage, will evaluate AB248 as a monotherapy and in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD1 therapy, in patients with recurrent locally advanced or metastatic solid tumors, including melanoma, renal cell carcinoma (RCC), non-small cell lung cancer (NSCLC) and squamous cell carcinoma of the head and neck (SCCHN). As previously announced, Asher Bio is conducting this Phase 1a/1b trial under a clinical trial collaboration and supply agreement with Merck (known as MSD outside the United States and Canada).

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"We are delighted to begin clinical evaluation of AB248, our most advanced product candidate," said Craig Gibbs, Ph.D., Chief Executive Officer of Asher Bio. "This is a significant milestone for Asher Bio and our efforts to deliver a new class of therapies that address the limitations of existing immune-based medicines by specifically targeting them to, and activating, only the desired immune cell type, thereby avoiding pleiotropic effects that can both hinder efficacy and drive toxicity. I am grateful to our research team, which advanced AB248 from ideation through preclinical development in only three years, and I look forward to working with our clinical partners at sites across the United States to evaluate the potential of AB248 to deliver better outcomes – and restore hope, health and happiness – to patients with difficult-to-treat solid tumors."

High dose IL-2 (aldesleukin, Proleukin) was the first modern immunotherapy to show long lasting, durable, complete responses in a subset of cancer patients, leading to its approval for the treatment of patients with metastatic melanoma and RCC.1 More recently, high dose IL-2 also demonstrated similar responses in melanoma and RCC patients who previously failed checkpoint inhibitor immunotherapy.2 However high dose IL-2 has been associated with significant toxicities limiting its clinical use, and newer second-generation (not α) IL-2 medicines are generally limited by off-target effects that both suppress anti-tumor responses and drive toxicity. In order to overcome these challenges, Asher Bio developed an innovative cis-targeting approach to deliver IL-2 only to a specific immune cell subset. AB248 is an investigational cis-targeted immunotherapy that was engineered to selectively activate CD8+ T cells, which drive anti-tumor efficacy, while avoiding NK cells, which can act as a pharmacological sink and contribute to toxicity, as well as avoiding Tregs, which are immunosuppressive. Preclinical data were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, where AB248 demonstrated an approximately 1000-fold preference for the activation of CD8+ T cells over NK cells and Tregs.

"We are very excited to enter the clinical evaluation of AB248 to assess its therapeutic potential in patients who failed prior standard of care treatments, and are very thankful to Dr. Costantine Albany and staff at Horizon Oncology, Lafayette IN for treating the first patient on January 10th, 2023, as well as Dr. David Spigel at Sarah Cannon Research Institute at Tennessee Oncology, Nashville and Dr. Elizabeth Buchbinder at the Dana Faber Cancer Institute and their respective staff for their collaboration as we start our Phase 1 study," said Andrea Pirzkall, M.D., Chief Medical Officer of Asher Bio. "Our research team designed AB248 to enable improved safety and efficacy by acting only on CD8+ T cells. Preclinical data showed AB248 to have a highly differentiated pharmacodynamic profile relative to other IL-2 therapeutics, suggestive of a potentially best-in-class IL-2 therapy. We expect to know from pharmacodynamic data whether treatment with AB248 is having its desired effect and hope to achieve proof-of-mechanism early in our development effort. We look forward to reporting initial clinical data in the second half of 2023."

About AB248 Phase 1 Trial

AB248-101 is an open-label Phase 1a/b study consisting of a dose escalation and expansion phase to investigate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of AB248 alone and in combination with pembrolizumab in subjects with locally advanced/metastatic solid tumors who failed prior therapies. The dose escalation phase will follow the Bayesian Optimal Interval (BOIN) design and enroll subjects at multiple dose levels and frequencies for the AB248 monotherapy portion and pembrolizumab combination.

Upon determining a recommended dosing regimen, the study will open indication specific expansion cohorts to further evaluate monotherapy AB248 and the combination of AB248 and KEYTRUDA in patients with melanoma, RCC and NSCLC after failure to prior therapies, as well as first-line SCCHN. Please refer to www.clincialtrials.gov (NCT05653882) for additional details related to this Phase 1a/1b clinical trial.

"I am excited to begin administering AB248 to patients as part of this clinical trial," said Elizabeth Buchbinder, M.D., Dana-Farber Cancer Center and investigator in the Phase 1a/1b clinical trial. "Although there has been significant progress made in the treatment of patients with locally advanced and metastatic solid tumors, many patients remain underserved by existing options, particularly once they have failed therapy with immune checkpoint inhibitors. I am encouraged by the preclinical data supporting AB248’s differentiated profile and look forward to working with Asher Bio and fellow clinical investigators to evaluate AB248 in this Phase 1a/1b clinical trial."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA

About AB248
AB248 is a novel CD8+ T cell selective IL-2, generated by fusing a reduced potency IL-2 mutein to an anti-CD8β antibody. It was specifically engineered to selectively and potently activate CD8+ T-cells, while avoiding natural killer (NK) cells, which can act as a pharmacological sink and contribute to toxicity, and regulatory T (Treg) cells, which are immunosuppressive. In preclinical studies, AB248 exhibited an approximately 1,000-fold preference for the activation of CD8+ T cells over NK cells and Tregs. In preclinical murine tumor studies, AB248 demonstrated potent anti-tumor activity both alone and in combination with PD-1 checkpoint blockade in a wide variety of murine tumor models.

On January 17, 2023 MAIA Biotechnology, Inc. (NYSE American: MAIA) reported the advancement of its Telomere-Targeting Molecule Program ("Project T3") (Press release, MAIA Biotechnology, JAN 17, 2023, View Source [SID1234626319]). MAIA is designing and evaluating multiple telomere-targeting compounds designed to modify the telomeric structure through the cancer cell – intrinsic telomerase activity – and thus cause the death of these cells. The studies, conducted in vitro in multiple cancer cell lines and in vivo in several pre-clinical cancer models, demonstrated the intended mechanism of action and high-level anti-cancer activity for these new molecules. The compounds belong to a new chemical class of molecules called telomere targeting divalent dinucleotides.

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MAIA has nominated one lead new molecular entity candidate (designated as MAIA-2021-20) and one back-up new molecular entity candidate (MAIA-2022-12) for further advancement into preclinical GLP-toxicity and other studies, and may advance one of these candidates into human clinical trials upon completion of the required preclinical evaluations. MAIA also has filed a broad provisional patent application covering the composition of matter for the new telomere-targeting molecules in the fourth quarter of 2022.

"The discovery and preclinical advancement of these new telomere-targeting compounds represent the beginning of a significant new chapter for MAIA," said Sergei Gryaznov, Ph.D., MAIA Chief Scientific Officer. "We have generated highly encouraging data in vitro and in vivo in several different tumor models showing impressive single-agent activity for the new compounds, as well as in combination with immune checkpoint inhibitors. The observed anti-cancer activity is quite remarkable, often leading to complete tumor eliminations in in vivo models. We are working diligently to advance these candidates toward clinical development."

"Project T3 is a major step forward as we are generating novel direct telomere-altering compounds," said MAIA Chairman and Chief Executive Officer Vlad Vitoc, M.D. "We are advancing multiple compounds through comprehensive preclinical development as potential follow-on candidates to our lead therapeutic candidate, THIO, which is currently being evaluated in a Phase 2 trial (THIO-101 trial) in patients with Non-Small Cell Lung Cancer. We look forward to announcing further developments of MAIA’s proprietary new molecular entity candidates in 2023 and beyond."

At the XXIV International Round Table on Nucleosides, Nucleotides, and Nucleic Acids in Stockholm in August 2022, MAIA presented an overview of its promising THIO drug discovery platform for generating potential anti-cancer agents. The presentation demonstrated the importance of cancer cell telomeric DNA structural and functional integrity, as well as therapeutically attractive opportunity to induce stress, increase innate sensing and adaptive anti-tumor immunity via "cancer cell self-produced" chemical modification of telomeres.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC), in sequential administration with LIBTAYO (cemiplimab) an anti-PD1 therapy, developed and commercialized by Regeneron. Telomeres play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being developed as a second or higher line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

On January 17, 2023 Shanghai Henlius Biotech, Inc. (2696. HK) reported that its first self-developed innovative anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (generic name: serplulimab injection), in combination with carboplatin and etoposide for the first-line treatment of extensive stage small cell lung cancer (ES-SCLC), has been approved by the National Medical Products Administration (NMPA), making it the world’s first anti-PD-1 mAb for the first-line treatment of small cell lung cancer (SCLC) (Press release, Henlius Biopharmaceuticals, JAN 17, 2023, View Source [SID1234626315]). HANSIZHUANG had already been approved for the treatment of Microsatellite Instability-High (MSI-H) solid tumors and squamous non-small cell lung cancer (sqNSCLC).

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Wenjie Zhang, Chairman, Executive Director, and CEO of Henlius, said, "This is the second approval HANSIZHUANG has received in the first-line treatment of lung cancer, after approval of sqNSCLC, demonstrating its great potential in lung cancer treatment. It is another milestone for HANSIZHUANG as well as a remarkable achievement for anti-PD-1 mAbs to improve survival notably in patients with SCLC. Looking forward, as the representative of China’s innovative drugs, HANSIZHUANG is expected to be approved in overseas markets to benefit more lung cancer patients with its consistent efficacy."

Professor Ying Cheng, the leading principal investigator of the phase 3 clinical study of HANSIZHUANG on ES-SCLC, from Jilin Province Cancer Hospital, said, "SCLC is the most aggressive subtype of lung cancer, patients with SCLC deteriorate rapidly in clinical behavior and the overall prognosis is poor. The success of ASTRUM-005, a multi-center clinical trial of HANSIZHUANG, is a breakthrough in the treatment of ES-SCLC. Apart from providing a better immunotherapy option, this approval will also reshape the first-line treatment of ES-SCLC and promote the treatment of lung cancer around the world."

Innovate to solve the dilemma of SCLC treatment

Lung cancer (LC) is one of the most common malignancies around the world. According to GLOBOCAN 2020, there were 2.2 million new LC cases and 1.8 million new deaths in 2020 worldwide, and LC is still the leading cause of cancer death[1]. SCLC is the most aggressive subtype of lung cancer, accounting for around 15% of all lung cancer cases[2]. The SCLC breaks down into limited stage small cell lung cancer (LS-SCLC) and ES-SCLC. Most patients are in extensive stage when diagnosed[3]. Their clinical condition deteriorates rapidly and the overall prognosis is poor. In the past 20 years, etoposide combined carboplatin/cisplatin was still the standards of care for ES-SCLC, but almost all patients in extensive stage relapse within one year[4], with a median overall survival (OS) of only 10 to 11 months. The advent of immune checkpoint inhibitors has brought new hope to patients with ES-SCLC. At present, anti-PD-L1 mAbs combined with chemotherapy has prolonged the OS of patients with SCLC to 12-13 months compared to chemotherapy, but the improvements were still modest. Meanwhile, a number of anti-PD-1 mAbs have failed in SCLC, and more effective solutions are urgent needed.

The approval was primarily based on ASTRUM-005, a randomized, double-blind, placebo-controlled international multi-center phase 3 clinical study. The study has set up a total of 128 sites in various countries including China, Turkey, Poland, and Georgia, and enrolled 585 subjects who were screened from 114 sites, among whom 31.5% were White. The results of ASTRUM-005 were presented in oral for the first time at the 2022 ASCO (Free ASCO Whitepaper) annual meeting，and the results were updated at the 2022 European Society for Medical Oncology Asia (ESMO Asia) Congress in December 2022. In September 2022, the results of ASTRUM-005 had been published in The Journal of the American Medical Association (JAMA, impact factor of 157.3), one of the top four medical journals in the world, which made ASTRUM-005 the first study published on JAMA in SCLC immunotherapy, demonstrating the high level of academic acclaim on a global scale.

According to the study analysis, the median OS was significantly longer in the serplulimab group (15.8 months) than in the placebo group (11.1 months), and a 38% reduction in risk of death was observed in the serplulimab group compared with the placebo group(HR=0.62, 95%CI:0.50-0.76).The Asians subgroup also showed a 4.8 months longer median OS in the serplulimab group (HR=0.63，95%CI: 0.49-0.81). Median PFS assessed by the independent radiology review committee per RECIST v1.1 was prolonged with the addition of serplulimab (5.8 vs. 4.3 months; HR=0.47, 95%CI:0.38-0.58).The results indicated that HANSIZHUANG (serplulimab injection) in combination with chemotherapy (Carboplatin-Etoposide) could bring significant benefits against chemotherapy (Carboplatin-Etoposide) in the treatment of previously untreated patients with ES-SCLC, met the pre-defined primary endpoint criteria, and had good safety and tolerability. HANSIZHUANG could potentially bring more significant benefits to Asian patients.

Global footprint for more patients

HANSIZHUANG is the first innovative mAb developed by Henlius. Since launched in March 2022, HANSIZHUANG has become one of the pioneering anti-PD-1 mAb for the "pan-cancer" treatment of MSI-H solid tumors in China. Up to date, HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors, sqNSCLC and ES-SCLC, its new drug application(NDA) in combination with chemotherapy for the first-line treatment of locally advanced/metastatic esophageal squamous cell carcinoma(ESCC) has also been accepted by the NMPA. As a backbone, HANSIZHUANG’s synergy with in-house products of the company and innovative therapies are forging ahead. It has successively obtained clinical trial licenses in China, the United States, the European Union and other countries and regions to initiate 12 clinical trials on immuno-oncology combination therapies in a wide variety of indications, such as lung cancer, esophageal carcinoma, head and neck squamous cell carcinoma and gastric cancer, etc.

Guided by unmet clinical needs, Henlius has devoted itself to lung cancer and built a comprehensive layout of the first-line treatment for lung cancer in sqNSCLC, ES-SCLC, nsNSCLC and LS-SCLC, which covers more than 90% of lung cancer patients. In the field of SCLC, multi-regional clinical trials regarding ES-SCLC and LS-SCLC have been conducted and the results will support NDAs in overseas markets. In 2022, HANSIZHUANG was also granted orphan drug designations by the Food and Drug Administration (FDA) and European Commission (EC) for the treatment of SCLC. Based on the positive feedback of FDA Biologics license Application (BLA) submission for HANSIZHUANG for the treatment of ES-SCLC and the discussion results of the FDA’s Class C consultation meeting, Henlius has initiated a bridging head-to-head trial in US patients with ES-SCLC to evaluate the efficacy of HANSIZHUANG, which propels the product towards US market approval further. According to the research progress in SCLC, the company plans to submit new drug applications of the product in the EU and US in the coming years.

In addition, Henlius actively promotes the commercialization of HANSIZHUANG to enhance its accessibility by marketing, channel management, pricing and market access. By the end of 2022, HANSIZHUANG has completed the tendering process on the procurement platform in 28 provinces in Chinese mainland and was included into the commercial medical insurance directory in 5 cities such as Ningbo, Jinhua, etc., benefiting more than 10,000 Chinese patients. As early as 2019, Henlius forged a partnership with PT Kalbe Genexine Biologics (KG Bio) to grant it an exclusive license to develop and commercialize HANSIZHUANG in relation to a monotherapy and two combination therapies in 10 Southeast Asian countries. To accelerate the launch of HANSIZHUANG in the United States, Henlius entered into an exclusive license agreement with Fosun Pharma for the commercialization of HANSIZHUANG in December 2022. By virtual of Fosun Pharma’s advantages and commercial capabilities, HANSIZHUANG will expand its overseas distribution fast to benefit more patients. Going forward, Henlius will continue to expand global commercialization layout of HANSIZHUANG to reach out to more countries and regions, which urges this product to step on to the world PD-1 stage and benefits a broader patient population worldwide with its world-class quality.

With HANSIZHUANG as a model, Henlius will further promote its innovative and differentiated product portfolio and expand the global footprint to establish a prestigious national brand and bring hope to more patients across the world.