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Carisma Therapeutics Inc. (Nasdaq: CARM) is a pioneering clinical-stage biopharmaceutical company headquartered in Philadelphia, PA. The company's primary focus is on the discovery and development of innovative immunotherapies using its proprietary macrophage and monocyte cell engineering platform. Carisma's mission is to create transformative treatments for cancer and other serious diseases.
One of the company's flagship products is CT-0508, a human epidermal growth factor receptor 2 (HER2) targeted chimeric antigen receptor macrophage (CAR-M). CT-0508 is currently being evaluated in a landmark Phase 1 multi-center clinical trial for patients with recurrent or metastatic HER2-overexpressing solid tumors. These tumors do not respond to existing HER2-targeted therapies, making this trial a critical step forward. The trial represents the first time engineered macrophages are being studied in humans and is conducted across seven clinical sites in the U.S., including prominent institutions like the University of Pennsylvania Abramson Cancer Center and the MD Anderson Cancer Center.
In the second quarter of 2023, Carisma achieved a significant milestone by dosing the first patient in the Phase 1 trial of CT-0508 in combination with KEYTRUDA. This achievement underscores Carisma's commitment to advancing the field of engineered macrophages. The company believes it is well-positioned to drive innovation and deliver value to its stakeholders, thanks to its comprehensive and differentiated cell therapy platform.
Financially, Carisma reported having $117.1 million in cash, cash equivalents, and marketable securities as of June 30, 2023. This financial position is expected to sustain the company's planned operations through the end of 2024, providing a solid runway for its ongoing and upcoming projects.
Additionally, Carisma is engaged in various strategic partnerships, research programs, and academic collaborations to further its mission. The company continues to explore new avenues for innovation within its HER2 franchise and across its broader pipeline, aiming for potential value inflection points in the near future.
For more information, visit Carisma's official website at www.carismatx.com.
Sesen Bio (SESN) announced the grant of a non-statutory stock option for 52,500 shares to a new employee, signaling the company's expansion as it transforms into a commercial-stage entity. The option, granted on June 14, 2021, at an exercise price of $4.25, vests over four years. Sesen Bio's lead product, Vicineum™, is under FDA Priority Review with a target PDUFA date of August 18, 2021, for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The company is also monitoring potential impacts from the COVID-19 pandemic, though no disruptions have been reported.
Sesen Bio (SESN) announced a global supply agreement with Qilu Pharmaceutical for the Vicineum drug, aimed at treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). This agreement enhances their manufacturing capabilities and sets specific terms for capacity and delivery. The FDA has accepted the Biologics License Application for Vicineum with a target PDUFA date of August 18, 2021. Upon completion of a technology transfer, Sesen Bio expects a $2 million milestone payment. Additionally, a $3 million payment was received following IND approval for Vicineum in China, with potential market approval expected in 2023.
Sesen Bio (SESN) has expanded its senior leadership team with four key appointments: Patricia Drake as Chief Commercial Officer, Steve Barbera as VP of Market Access, Julie Hoff as VP of Human Resources, and Dewey McLin as VP of Medical Affairs. This strategic move aims to enhance capabilities in preparation for the anticipated launch of their lead product, Vicineum, for treating BCG-unresponsive non-muscle invasive bladder cancer. The company has also granted stock options totaling up to 1,995,000 shares to the new leaders, vesting over four years.
Sesen Bio (SESN) announced the grant of a non-statutory stock option to a new employee as part of its team expansion ahead of the August 18, 2021 PDUFA date for Vicineum™. The option allows the purchase of up to 5,800 shares over four years, with an exercise price of $2.66 based on the grant date's closing price. Vicineum is intended for treating BCG-unresponsive non-muscle invasive bladder cancer and has received Priority Review from the FDA. The company continues to monitor COVID-19's impact on operations, which remain unaffected so far.
Sesen Bio (NASDAQ: SESN) reported Q1 2021 results, showcasing its progress in cancer therapeutics. The FDA has accepted the Biologics License Application (BLA) for Vicineum, aimed at BCG-unresponsive bladder cancer, with a PDUFA date of August 18, 2021. The company also commenced the Marketing Authorization Application (MAA) in Europe and received approval for Vicineum's IND in China, leading to a $3M milestone payment. Cash reserves totaled $110 million, while Q1 net loss was $55.5 million, significantly down from a net income in Q1 2020.
Sesen Bio (SESN) announced the appointment of Lisa LaMond as Vice President of Sales and Corporate Systems, further strengthening its leadership team. LaMond brings extensive experience from Merck & Co., where she led various successful product launches. Additionally, the company partnered with Syneos Health for field sales support of its lead product, Vicineum, which targets BCG-unresponsive non-muscle invasive bladder cancer, with a PDUFA target date of August 18, 2021. The sales strategy aims to deploy a 35-member sales force targeting 2,000 prescribers.
Sesen Bio (SESN) has announced a conference call on May 10, 2021, at 8:00 am ET to review its Q1 2021 operating results and provide a business update. The company’s lead product, Vicineum, a fusion protein for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), is in the follow-up stage of a Phase 3 trial. The FDA has accepted Vicineum’s BLA for review with a PDUFA date of August 18, 2021. The company retains global rights to Vicineum, except for specific regions where it has partnered for commercialization.
Sesen Bio (SESN) announced the grant of non-statutory stock options to four new employees, marking its transition to a commercial-stage company prior to the PDUFA date of August 18, 2021, for its lead product, Vicineum™, aimed at treating BCG-unresponsive non-muscle invasive bladder cancer. The stock options, totaling up to 143,500 shares, will vest over four years at exercise prices between $2.32 and $2.76 per share. The company remains focused on its late-stage pipeline and potential commercialization strategies, while closely monitoring COVID-19's impact on operations.
Sesen Bio (SESN), a clinical-stage company focused on cancer therapeutics, will present at the Canaccord Genuity “Horizons in Oncology” virtual conference on April 15, 2021. Dr. Thomas Cannell, President and CEO, will discuss regulatory and commercial readiness, while Dr. Michael Jewett will provide insights on Vicineum™, a fusion protein targeting BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Vicineum is currently in a Phase 3 trial and has received FDA Priority Review with a PDUFA date of August 18, 2021.
Sesen Bio (SESN) announced the approval of its IND application for Vicineum to treat BCG-unresponsive non-muscle invasive bladder cancer in China, ahead of the April 2021 timeline. This allows Qilu Pharmaceutical to start clinical trials, with a potential market application submission anticipated in 2022 and approval possibly in 2023. Sesen Bio expects to receive a $3M milestone payment, part of $23M in potential payments. With peak sales estimated between $155M and $418M, this marks a significant milestone for the company.
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