On February 13, 2023 Boan Biotech reported that BA1106, a self developed investigational non-IL-2 blocking anti-CD25 antibody has been administered for the first patient in a Phase I clinical trial (Press release, Boan Biotech, FEB 13, 2023, View Source [SID1234627124]). This trial is designed to evaluate the safety, pharmacokinetics and preliminary efficacy of BA1106 in patients with advanced solid tumors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

BA1106 is the first investigational anti-CD25 antibody to start clinical trials in China for treating solid tumors. Focusing on key therapeutic areas including oncology and autoimmunity, Boan Biotech has been speeding up the development of novel antibodies. The company now has multiple investigational antibodies in its pipeline that are protected by international intellectual property rights.

BA1106 is an investigational non-IL-2 blocking anti-CD25 antibody with promising anticancer potential

Anti-CD25 antibodies are broad-spectrum immuno-oncology drugs with the potential to treat multiple cancers where CD25 is highly expressed, including cervical cancer, renal cancer, ovarian cancer, melanoma, pancreatic cancers, hepatocellular carcinoma, gastric cancer, and breast cancer. BA1106 therefore has great potential for treating those cancers. However, developing anti-CD25 antibodies faces two major challenges: first, the function of Fc as a mediator is limited, and as a result, they only work in early-stage tumor models, not in late-stage tumor models; second, the IL-2 signaling pathway is blocked, leading to poor antitumor outcomes. BA1106 is a drug candidate that can successfully overcome these two challenges.

The main mechanism of action of BA1106 is to deplete Treg cells in the tumor microenvironment through the antibody-dependent cellular cytotoxicity (ADCC) and increase the number of effector T cells. Preclinical studies have shown that BA1106 demonstrated a good therapeutic effect on both early-stage and late-stage tumor models as well as a synergy when used in combination with an anti-PD-1 antibody. Moreover, BA1106 does not block the IL-2 signaling pathway, and depletes Treg cells moderately and specifically, with the potential for monotherapy and combination therapy. The results of the study on BA1106 have been published in Scientific Reports, a journal of Nature Portfolio1.

In terms of the development speed, BA1106 is currently faster than most other anti-CD25 antibodies with the same mechanism of action. The competing product against the same target is RG6292, which is a novel anti-CD25 antibody from Roche now under Phase I clinical trials. No other public anti-CD25 antibodies are currently under development as anticancer drugs.

Facilitating the efficient development of innovative antibodies with proprietary platforms

BA1106 was developed by Boan Biotech on its transgenic mouse and phage display platforms for human antibodies. BA-huMab is the company’s proprietary transgenic mouse platform for human antibodies. It is a leading platform in China. This platform can directly generate human antibodies without humanization, to significantly accelerate the antibody discovery process and reduce the immunogenicity risk. In addition, it is able to elicit an immune response quickly and produce a high antibody titer after immunization.

Boan Biotech has successfully identified high-affinity and high-specificity potential candidates with over 10 targets on this platform. In addition to BA1106, there are also the anti-Claudin 18.2 antibody BA1105, the anti-PD-L1/TGF-β bispecific antibody BA1201, the anti-Claudin 18.2 ADC BA1301, and other candidates.

Dr. Dou Changlin, R&D President and Chief Operating Officer of Boan Biotech, said: " As the first innovative anti-CD25 antibody to enter the clinical trial stage in China, BA1106 is a potential immunotherapy with a novel mechanism of action for cancer patients. We will speed up the clinical development of this candidate, to provide patients with a better treatment option as early as possible. Leveraging our efficient in-house innovation capabilities, we are ramping up the development of innovative antibodies. This is part of our commitment to meeting the urgent needs of patients with more differentiated innovative therapies. "

On February 13, 2023 Veracyte, Inc. (Nasdaq: VCYT) reported new data being presented this week at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (ASCO GU) Symposium which demonstrate that a gene expression signature derived from the company’s proprietary Decipher Genomics Resource for Intelligent Discovery (GRID) database may help physicians further personalize treatment for men with prostate cancer, based on their tumor’s molecular subtype. Additional data being presented at the meeting, taking place in San Francisco and online, February 16-18, reinforce the clinical utility of the company’s Decipher Prostate Genomic Classifier.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In the first study (Abstract #241; Poster #J6), researchers analyzed data from Veracyte’s Decipher GRID database and found that classifying prostate cancer tumors by their molecular subtype could potentially inform their response to treatment. The researchers evaluated 1,015 men with either localized or metastatic hormone-sensitive prostate cancer (mHSPC) using a Decipher GRID-derived, 215-gene expression signature that was previously shown to classify prostate cancer into four molecular subtypes: luminal differentiated, luminal proliferating, basal immune, and basal neuroendocrine-like.

The findings demonstrated that, after radical prostatectomy, men with luminal differentiated tumors had the most favorable prognosis and those with basal immune tumors derived the greatest metastasis-free survival benefit from postoperative radiotherapy, while those with other subtypes did not see the same benefit. Additionally, in men with metastatic disease, those with luminal proliferating tumors derived the greatest survival benefit from the addition of docetaxel to androgen deprivation therapy.

"These findings demonstrate that our Decipher GRID database can provide researchers with new insights that may help physicians further apply a precision medicine approach to treatment of their prostate cancer patients," said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. "This and the multiple, additional Decipher-focused abstracts being presented at ASCO (Free ASCO Whitepaper) GU reinforce our commitment to research that aims to help physicians provide their patients with the best care possible and advance our collective understanding of the molecular underpinnings of prostate cancer."

The Decipher GRID database includes more than 100,000 whole-transcriptome profiles from patients with urologic cancers and is used by Veracyte and its research partners to help advance understanding of prostate and other urologic cancers. GRID-derived information is available on a Research Use Only basis to physicians who have ordered the Decipher Prostate Genomic Classifier.

In another study to be shared at ASCO (Free ASCO Whitepaper) GU (Abstract #345; Poster #M3), researchers evaluated the impact of the Decipher Prostate Genomic Classifier on patient-reported, quality-of-life outcomes. Previously presented data from the same trial show that men who received Decipher Prostate testing were more likely to receive adjuvant radiation therapy following radical prostatectomy than men who did not undergo genomic testing. The new analysis shows that, despite receiving more adjuvant radiation therapy, the men who underwent Decipher Prostate testing experienced no significant difference in quality-of-life reported outcomes related to urinary or sexual function as compared to their untested peers. These findings are from the G-MINOR trial, the first, prospective, randomized trial to evaluate the clinical utility of any prostate cancer genomic classifier. The trial enrolled 356 patients from 12 centers through the Michigan Urological Surgery Improvement Collaborative (MUSIC).

"These new findings suggest that there is no adverse quality-of-life impact for men whose tumors undergo Decipher Prostate testing compared to those whose do not," said Udit Singhal, M.D., a urologist at University of Michigan Health. "This finding should give physicians even more confidence in using the Decipher Prostate test to help inform treatment decisions for their patients with prostate cancer."

The Decipher Prostate Genomic Classifier is a 22-gene prognostic biomarker that provides a low, intermediate or high score indicating the aggressiveness of an individual patient’s cancer, to help healthcare professionals more accurately categorize risk and select appropriate treatment.

On February 13, 2023 Scilex Holding Company (Nasdaq: SCLX, "Scilex"),reported a majority-owned subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") and an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, together with Sorrento, issued the following statements (Press release, Sorrento Therapeutics, FEB 13, 2023, View Source [SID1234627122]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Henry Ji, Ph.D., Chairman and Chief Executive Officer of Sorrento, commented:

"Today, Sorrento Therapeutics, Inc. and its wholly-owned direct subsidiary, Scintilla Pharmaceuticals, Inc. ("Scintilla"), commenced voluntary proceedings under Chapter 11 of the United States Bankruptcy Code in the United States Bankruptcy Court for the Southern District of Texas (the "Bankruptcy Court").

While Scilex is majority-owned by Sorrento, Scilex is not a debtor in Sorrento Therapeutics’ voluntary Chapter 11 filing. Scilex will continue to operate its business as usual.

As of its chapter 11 filing, Sorrento had over approximately $1 billion in assets, including a $125 million arbitration award against NantPharma, LLC for a dispute related to Sorrento’s sale of Cynviloq. The company had approximately $235 million in liabilities as of its filing and faced a short-term liquidity crunch, due to insufficient cash or other short-term assets to satisfy certain obligations. Included among those obligations was a $175 million arbitration award against Sorrento, which was reduced to enforceable judgments on February 7, 2023 in favor of NantCell, Inc. and Immunotherapy NANTibody LLC. While $125 million of those judgements was stayed for 70 days, $50 million was not stayed and could be enforced immediately.

Sorrento assessed that enforcement actions with respect to the $50 million unstayed portion of these judgements, such as attachment of Sorrento’s assets and bank accounts, could lead to significant business disruption. As a result, Sorrento sought chapter 11 relief to safeguard business operations and its ability to continue developing life-saving therapeutics, while protecting and maximizing value for stakeholders."

Jaisim Shah, Chief Executive Officer and President of Scilex Holding Company, added:

"Scilex is not a debtor in Sorrento’s chapter 11 filing and will continue to operate business as usual, with a focus on growing revenues, offering innovative, non-opioid pain management products, and developing meaningfully differentiated programs that address significant unmet needs and lead to better health outcomes for the millions of acute and chronic pain patients."

On February 13, 2023 Sermonix Pharmaceuticals Inc. and Quantum Leap Healthcare Collaborative reported that Sermonix’s investigational next-generation targeted endocrine therapy, lasofoxifene, will be evaluated in a new study arm of the ongoing I-SPY endocrine program sponsored by Quantum Leap (Press release, Sermonix Pharmaceuticals, FEB 13, 2023, View Source [SID1234627121]). This portion of the study targets patients with newly diagnosed estrogen receptor-positive (ER+) invasive cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The arm is part of the I-SPY 2 Endocrine Optimization Platform (EOP), which is focused on patients with clinically high risk (stage 2/3) estrogen receptor positive (ER+)/HER2- breast cancer, but molecularly low risk (MammaPrint low risk signature). These patients often have substantial risk for recurrence that occurs later (after five years), and thus are in great need of novel agents that are more tolerable and more effective treatments than the current standard of care.

Quantum Leap opened the EOP program in 2021 to specifically address the need for better options for this subset of patients, and to find an early endpoint to measure success of therapy. I-SPY 2 had previously only focused on women with high clinical and molecular risk where complete pathologic response is highly predictive of treatment efficacy.

"Sermonix is delighted to be a part of the truly groundbreaking I-SPY 2 clinical trial, working alongside such esteemed researchers to investigate an area of unmet medical need," said Dr. David Portman, founder and chief executive officer of Sermonix. "To date, we have successfully identified activity from lasofoxifene, and will soon be initiating a Phase 3 registrational trial. It is exciting to be included in I-SPY and potentially generate additional data that could confirm activity of lasofoxifene in early-stage adjuvant settings as well as support differentiated quality-of-life outcomes."

EOP is a sub-study within the main I-SPY-2 clinical trial utilizing neoadjuvant endocrine therapy in patients whose tumors are predicted to be sensitive to endocrine therapy but for whom chemotherapy is expected to provide little or no benefit. Lasofoxifene will be evaluated along with other investigational agents in separate study arms as part of the platform trial.

"Lasofoxifene is a novel endocrine treatment that has demonstrated activity in patients with heavily pre-treated ER+/HER2- metastatic breast cancer, including patients harboring tumors with ESR1 mutations," said Dr. Laura Esserman of the University of California San Francisco, founder and leader of the I-SPY Program. "This agent is very well tolerated and thus would be a true advancement for the significant percentage of breast cancer patients who struggle or fail to complete the recommended five years of aromatase inhibitor (AI) therapy."

Dr. Jo Chien, the EOP study’s principal investigator, added: "Lasofoxifene is reported to promote vaginal and sexual health benefits, which are known and challenging side effects of AIs. Should lasofoxifene prove more efficacious and better tolerated than AIs in the neoadjuvant setting, this could have broad implications for both the survival and quality of life for women in the metastatic and early-stage adjuvant settings. Using the I-SPY model, we can accelerate the development of new cancer treatments and target new and innovative treatments to the patients who will benefit most, and we are eager to see data from lasofoxifene-treated subjects in this trial."

In two successfully completed Phase 2 studies (ELAINE-1 and ELAINE-2), lasofoxifene was found to be safe and well tolerated and demonstrated compelling anti-tumor activity, both as monotherapy (ELAINE-1) and in combination with abemaciclib (ELAINE-2). Of particular note, Sermonix shared a case study from ELAINE-1 detailing the first ever known finding of a durable complete response that could be characterized as complete clinical remission in a metastatic estrogen receptor-positive (ER+)/HER2- breast cancer patient with an ESR1 mutation after prior CDK4/6 inhibitor treatment upon participation in any single-agent hormonally based therapy. Additionally, lasofoxifene-treated patients in ELAINE-2 demonstrated mean progression-free survival over 13 months. Full results from the ELAINE-1 and ELAINE-2, which provide strong support for a Phase 3 combination study in 2023, were presented at ESMO (Free ESMO Whitepaper) 2022 and ASCO (Free ASCO Whitepaper) 2022, respectively.

Sermonix will supply lasofoxifene and provide financial support to Quantum Leap for this study. Quantum Leap is sponsor of the I-SPY program, which includes 30 open sites and at least 10 more expected to be added in the first quarter of 2023. All I-SPY sites have the EOP program open.

About Lasofoxifene

Lasofoxifene is an investigational novel endocrine therapy in clinical development which has demonstrated robust target engagement as an ESR1 antagonist in the breast particularly in the presence of ESR1 mutations. Lasofoxifene has demonstrated anti-tumor activity as monotherapy and in combination with abemaciclib in phase 2 studies and has unique tissue selectivity distinguishing it from other current and investigational endocrine therapies with beneficial effects seen on vagina and bone in previous clinical studies. Lasofoxifene, which Sermonix licensed globally from Ligand Pharmaceuticals Inc. (NASDAQ:LGND), has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a novel targeted and tissue selective oral endocrine therapy could, if approved, play a critical role in the precision medicine treatment of advanced ER+ breast cancer.

On February 13, 2023 Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it will host an Investor Day for institutional investors and financial analysts in New York City on Thursday, March 16, 2023 at the New York Stock Exchange.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

During the event, Jim Davis, CEO and President, Sam Samad, Executive Vice President & CFO, and other senior executives will provide updated views of the U.S. laboratory market, the company’s business strategy, capital deployment priorities, and long-term outlook.

Advance registration is required. To register for the event, please go to: Quest Diagnostics Investor Day 2023 Registration.

A live webcast of the event will be broadcast on the Quest Diagnostics Investor Relations website.

An archived copy of the webcast will be available on the Quest Diagnostics Investor Relations website following the conclusion of the event