On February 13, 2023 Compugen Ltd. (NASDAQ: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported that the Company will release its fourth quarter and full year 2022 financial results on Monday, February 27, 2023, before the U.S. financial markets open (Press release, Compugen ltd, FEB 13, 2023, View Source [SID1234627126]). Management will host a conference call and webcast to review the results and provide a corporate update at 8:30 AM ET.

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To access the live conference call by telephone, please dial 1-866-744-5399 from the U.S.,
or +972-3-918-0644 internationally. The call will be available via live webcast through Compugen’s website, located at the following link, Following the live webcast, a replay will be available on the Company’s website.

On February 13, 2023 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported that the Company will present in a fireside chat at the SVB Securities Virtual Global Biopharma Conference on Wednesday, February 15, 2023 at 12:00 p.m. ET. Presenting on behalf of Fusion will be Chief Executive Officer John Valliant, Ph.D, Chief Scientific Officer Christopher Leamon, Ph.D., and President and Chief Business Officer Mohit Rawat.

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A live webcast of the event will be available on the "Events and Presentations" page in the "Investors & Media" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following their respective presentation dates.

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.

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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.

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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]).

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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."