On May 11, 2021 Ipsen (Euronext: IPN; ADR: IPSEY) reported it has exercised its option to collaborate with Exelixis, Inc. (Exelixis) in the pivotal COSMIC-311 Phase III trial (Press release, Ipsen, MAY 11, 2021, View Source [SID1234579675]). COSMIC-311 is evaluating Cabometyx (cabozantinib) 60 mg versus placebo in people living with radioiodine-refractory differentiated thyroid cancer (DTC) who have progressed after up to two prior vascular endothelial growth factor receptor (VEGFR)-targeted therapies.2 Radioactive iodine (RAI) is a treatment option for DTC when patients are at high risk of disease recurrence, have incompletely resected cancer, or distant metastases.3 Patients who develop RAI-refractory DTC, whereby they are resistant to RAI treatment, typically have a poor prognosis with an estimated survival of three to five years on average.4

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Howard Mayer, Executive Vice President and Head of Research and Development at Ipsen, commented:
"A planned interim analysis of the COSMIC-311 Phase III trial has shown promising and clinically meaningful results in the use of Cabometyx in people living with radioiodine-refractory differentiated thyroid cancer who have progressed after prior therapy. We are delighted to build on our strong foundation and join Exelixis to further evaluate, and to work with regulatory authorities on, the potential of Cabometyx in a patient population who currently have limited treatment options."

Results from the planned Phase III interim analysis of COSMIC-311 showed that the trial met the co-primary endpoint of demonstrating significant improvement in progression-free survival.1 The detailed results from the analysis will be presented at the forthcoming ASCO (Free ASCO Whitepaper) Annual Meeting, taking place virtually from 4 to 8 June 2021.

Ipsen has an exclusive collaboration agreement with Exelixis for the commercialization of Cabometyx outside of the U.S. and Japan. Following the decision to opt-in to the COSMIC-311 trial, Ipsen gains access to the results to support potential future regulatory submissions in its territories.

The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for Cabometyx in February 2021 as a potential treatment for people living with DTC who have progressed following prior therapy and who are RAI-refractory (if RAI is appropriate).

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 Nuvalent, Inc., a biotechnology company creating precisely targeted therapies for clinically proven kinase targets in cancer, reported the completion of a $135 million Series B financing (Press release, Nuvalent, MAY 11, 2021, https://www.nuvalent.com/nuvalent-completes-135-million-series-b-financing-to-advance-portfolio-of-novel-precisely-targeted-kinase-inhibitors-for-treatment-resistant-cancers/ [SID1234580619]). The round was led by Bain Capital Life Sciences with participation from sole founding investor, Deerfield Management, and additional new investors Fidelity Management and Research Company LLC, Wellington Management Company, Viking Global Investors, Janus Henderson Investors, Avoro Capital Advisors, Boxer Capital of Tavistock Group, Venrock Healthcare Capital Partners, Fairmount Funds Management LLC, Driehaus Capital Management LLC, and Logos Capital. Andrew Hack, M.D., Ph.D., a Managing Director of Bain Capital Life Sciences, will join the Nuvalent Board of Directors.

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"We are encouraged by the support of this exceptional group of investors and their shared belief in our mission to develop precisely targeted therapies for patients with cancer," said Alex Balcom, Chief Financial Officer at Nuvalent. "With this financing, we are well positioned to efficiently advance our parallel lead programs into clinical development and to accelerate the discovery of additional novel, selective compounds to meet medical needs in treatment-resistant cancers."

Proceeds from the Series B financing will support the clinical advancement of Nuvalent’s parallel lead programs, NVL-520 (previously NUV-520), a potential best-in-class ROS1-selective kinase inhibitor, and NVL-655 (previously NUV-655), a potential best-in-class ALK-selective kinase inhibitor. The financing is also expected to support further expansion and accelerated development of Nuvalent’s discovery research pipeline of novel, selective small molecule kinase inhibitors.

New preclinical data leading to the selection of NVL-520 and NVL-655 for clinical advancement were recently presented at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting. These parallel lead compounds have been designed to address the identified clinical needs of kinase selectivity, brain penetrance, and activity against drug-resistance mutations in ROS1- and ALK-driven tumors, respectively. The preclinical data support the potential for NVL-520 and NVL-655 to remain active in tumors that have developed resistance mutations and to minimize off-target adverse events, including TRK-related adverse events affecting the central nervous system (CNS), in order to drive more durable responses for patients.

"Nuvalent’s focused approach to drug development has led to a promising pipeline of novel drug candidates with specific, rational designs and opportunity for meaningful clinical impact," said Dr. Hack. "I am pleased to join the company’s Board of Directors and look forward to working with this talented team as they continue to apply their internal expertise in chemistry and structure-based drug design towards addressing real-world medical needs identified in close collaboration with leading clinical advisors."

Nuvalent also recently announced several additions to its leadership and advisory team, including precision oncology expert Christopher Turner, M.D., as Chief Medical Officer, and leading scientific advisors with deep expertise in targeted therapies for oncology.

"We welcome Andrew to our Board of Directors, who draws from a breadth of experience across early- to late-stage companies in the biotechnology and life sciences sectors to bring a valuable, multi-faceted perspective to our growing team of distinguished leaders and advisors," said James Porter, Ph.D., Nuvalent Chief Executive Officer. "The milestones that we announced today support our significant achievements since our public launch in January 2021, and the tremendous potential that we believe Nuvalent has. With the support of this investor syndicate, we confidently move forward to develop therapies that drive deep, durable responses for patients with cancer."