On May 11, 2021 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases, reported financial results for the first quarter ended March 31, 2021 (Press release, RAPT Therapeutics, MAY 11, 2021, View Source [SID1234579691]).

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"Our oncology and inflammation programs continue to make excellent progress," said Brian Wong, M.D., Ph.D., President and Chief Executive Officer of RAPT Therapeutics. "We recently reported preclinical data at the AACR (Free AACR Whitepaper) Annual Meeting that show anti-tumor potential of targeting and inhibiting CCR4 in combination with CAR-T therapy, as well as the promise of exciting next-generation immuno-oncology targets, such as HPK1. In March, we completed enrollment in our Phase 1b trial of RPT193, our lead inflammatory disease drug candidate, in patients with atopic dermatitis. We look forward to reporting top line results this quarter."

Financial Results for the First Quarter Ended March 31, 2021

Net loss for the first quarter of 2021 was $16.5 million, compared to $13.1 million for the first quarter of 2020.

Research and development expenses for the first quarter of 2021 were $13.8 million, compared to $10.7 million for the same period in 2020. This increase was primarily due to increased clinical trial costs for FLX475 and RPT193, increased personnel costs and stock-based compensation expense and an increase in facilities costs, offset by a decrease in laboratory supplies spend.

General and administrative expenses for the first quarter of 2021 were $4.0 million, compared to $3.3 million for the same period of 2020. The increase was primarily due to increases in stock-based compensation expense, insurance expense and personnel costs.

As of March 31, 2021, the Company had cash and cash equivalents and marketable securities of $98.4 million.

On May 11, 2021 Avenda Health reported that Breakthrough Device Designation for a male "lumpectomy" product in development designed to treat prostate cancer in-office while preserving quality of life (Press release, Avenda Health, MAY 11, 2021, View Source [SID1234579707]). Breakthrough Device Designation by FDA is reserved for devices that are potentially transformative, offering treatment for serious diseases that may be more effective than currently available treatments. Avenda Health is a California-based software and medical device company aiming to improve cancer outcomes through artificial intelligence (AI) and minimally invasive technologies.

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Prostate cancer is one of the most common cancers, with one in eight men developing it in their lifetime.1 Prostate cancer is traditionally treated by surgery or radiation, which have well-known side effects such as urinary, sexual or bowel dysfunction. The Avenda Health Focal Therapy System, which is designed to spare healthy tissue and minimize side effects, uses patient-specific information and AI to deliver a precise and personalized treatment, targeting only the tumor. This treatment can be performed in a physician’s office with just local anesthesia, minimizing the patient’s downtime and potentially reducing cost to the healthcare system.

"We are working to advance the treatment of prostate cancer by giving patients and their doctors more options. We see our approach as similar to that of a lumpectomy for breast cancer – if the cancerous tumor and appropriate treatment margins can be identified, the standard approach of removing the entire prostate gland and surrounding tissue may not be necessary," said Shyam Natarajan, co-founder and CEO of Avenda Health.

Under the FDA Breakthrough Device Program, the FDA will provide Avenda Health with priority review for clinical trial protocols and commercialization decisions. The designation may also facilitate Medicare reimbursement following FDA approval of the technology.

"The FDA has not approved a new device for the treatment of localized prostate cancer in more than 40 years. We look forward to working closely with the FDA to bring our product to market so that patients no longer need to choose between treating their prostate cancer and preserving their quality of life," said Brit Berry-Pusey, co-founder and COO of Avenda Health.

Avenda Health spun out of UCLA and was founded with support from a National Cancer Institute grant, which helped fund a Phase I study on 10 patients that recently completed enrollment. The study demonstrated safety and no decline in urinary or sexual function in patients over the follow-up period.

"Ten years ago, a group of dedicated clinical scientists at UCLA came together from urology, radiology, pathology and biomedical engineering with the goal of improving treatment for prostate cancer. Where we are today compared to when we started is remarkable," said Leonard S. Marks, M.D., co-founder and chief medical officer of Avenda Health and professor of urology at UCLA. "Avenda Health continues to advance in this mission, and the FDA’s recognition of the incredible impact that this technology could have on the field of urology in treating prostate cancer is encouraging."

About Avenda Health Focal Therapy System

The Avenda Health Focal Therapy System is the only artificial intelligence (AI)-enabled focal therapy system being developed to treat localized prostate cancer in a urologist’s office under local anesthesia. In conjunction with AI-based margin prediction algorithms that rely on a large database of imaging and pathology, it uses a laser and a proprietary optical and thermal sensor to precisely target and treat just the prostate tumor – not the entire prostate. The goal is for this targeted ablation to minimize the impact on healthy tissues, without compromising urinary or sexual function.

The device has 510(k) clearance from the FDA for ablation of soft tissue. It is not yet commercially available while the company is working to advance clinical trials in pursuit of a PMA for the technology and system as a Class III medical device for the treatment of localized prostate cancer.

On May 11, 2021 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, reported that John Climaco, Chief Executive Officer of CNS Pharmaceuticals, will present at the Q2 Virtual Investor Summit on Tuesday, May 18th at 12:30 PM ET (Press release, CNS Pharmaceuticals, MAY 11, 2021, View Source [SID1234579724]).

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In addition to the presentation, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information about the conference, please visit the conference website.

A live video webcast will be accessible on the Events page in the Investors section of the Company’s website (www.cnspharma.com) and will be archived for 90 days following the event.

On May 11, 2021 Cellectis S.A. (NASDAQ: CLLS – Euronext Growth: ALCLS), a clinical-stage biotechnological company employing its core proprietary technologies to develop best-in-class products based on gene-edited allogeneic CAR T-cells ("UCART") in the field of immuno-oncology, and Sanofi (Euronext: SAN – NYSE: SNY), reported that entered into a partnership agreement and a supply agreement regarding alemtuzumab, an anti-CD52 monoclonal antibody, to be used as part of a lymphodepleting regimen in certain Cellectis sponsored UCART clinical trials (Press release, Cellectis, MAY 11, 2021, View Source [SID1234579661]).

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Cellectis is the inventor of the combination of CD52 knockout UCART cells with a lymphodepleting regimen with an anti-CD52 antibody such as alemtuzumab. The CD52 knockout renders its UCART product candidates resistant to alemtuzumab as part of the lymphodepleting regimen. Patients’ lymphodepleting regimens reduce host immune cells and should improve allogeneic CAR T-cell expansion and persistence. In Cellectis sponsored trials, alemtuzumab is currently used as part of the lymphodepleting regimen for UCART22 in the BALLI-01 clinical trial in relapsed/refractory ALL, and for UCART123 in the AMELI-01 clinical trial in relapsed/refractory AML, but not for UCARTCS1 which has a self-lymphodepleting activity. Both Cellectis’ UCART22 and UCART123 candidate products have the CD52 gene inactivated by TALEN gene editing technology.

As part of the agreement, Sanofi will supply alemtuzumab to support Cellectis’ clinical trials and the parties agreed to enter into discussions to execute a commercial supply of alemtuzumab under pre-agreed financial conditions.

On May 11, 2021 Anticancer Bioscience (ACB), pioneers in synthetic lethal approaches to precision oncology, reported that progress in its MYC-synthetic lethal (MYC-SL) program (Press release, Anticancer Bioscience, MAY 11, 2021, View Source [SID1234579676]). The Company has identified three classes of novel small molecule compounds that demonstrate robust anti-cancer activity in preclinical studies, acting through interfering with mitosis and blocking cytokinesis. ACB is progressing through optimization and final candidate selection with the goal of progressing at least one of these MYC-SL compounds into clinical trials by 2022.

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The MYC family oncogene, encoding a transcription factor Myc, is deregulated in over 50% of human cancers, and this deregulation is frequently associated with poor prognosis and unfavorable patient survival. Myc has a central role in almost every aspect of the oncogenic process, orchestrating proliferation, apoptosis, differentiation, and metabolism. Direct targeting of Myc has been a challenge for decades owing to its "undruggable" protein structure, with a lack of a drug binding pocket. The synthetic lethality associated with Myc overexpression is being explored for its potential in the development of novel anti-cancer therapies.

Commenting on the progress and pre-clinical data, Dun Yang PhD, Founder, President, and CEO of ACB said:

"We are excited by our early in vitro and in vivo pre-clinical studies and in our molecular biology work to identify the target that our novel compounds hit. In animal models, data consistent with the in vitro studies has confirmed that the MYC-SL compounds act through interfering mitosis and blocking cytokinesis. We have filed patents on our compounds and are progressing rapidly through optimization to candidate selection and IND enabling studies."

The novel target for ACB’s MYC-SL compounds has been identified and will be subject to peer review publication in due course.

ACB has developed an innovative and proprietary general utility new scaffold-drug fragment (GUNS-DF) library approach to small molecule drug discovery. It is constructing 10 types of pilot GUNS-DF libraries, each of which contains a distinct core scaffold. Twenty compounds with excellent drug-like properties have been identified from three types of GUNS-DF libraries with a potency of less than 20 nM in a cell-based assay for MYC-SL agents. This potency was achieved after synthesizing and screening approximately 350 analogs during lead optimization.

At low nM concentrations, these compounds elicited potent cytotoxicity in a panel of 50 cell lines representing a variety of human malignancies. With adequate bioavailability, many of these compounds also suppressed the growth of various cancer cell lines that grew as xenografts in immunocompromised mice.

Having raised CNY131m (~USD21m) in seed finance to fund its discovery research, ACB is currently pursuing a Series A financing to progress at least one of its MYC-SL compounds into clinical trials.

ACB will be showcasing its innovative drug discovery platforms and pipeline at ChinaBio and BioEquity in May, and at BIO in June.