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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 receiving a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) for Vicineum™ intended for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The FDA rejected the BLA in its current form, citing the need for additional clinical data and addressing Chemistry, Manufacturing, and Controls (CMC) concerns. Sesen Bio plans to request a Type A meeting with the FDA to discuss the next steps. As of June 30, 2021, the company has $151.1 million in cash.
Sesen Bio (SESN) has expanded its executive leadership team with John Knighton appointed as Vice President and Chief Compliance Officer, effective August 16, 2021. This change supports the company's transformation into a commercial-stage entity as it anticipates a decision on its Biologics License Application (BLA) for Vicineum, targeting BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), with a PDUFA date of August 18, 2021. Knighton brings over 20 years of compliance experience in the life sciences sector.
Sesen Bio (Nasdaq: SESN) reported Q2 2021 results, highlighting significant regulatory progress for Vicineum, targeted for BCG-unresponsive NMIBC. The FDA's decision on the Biologics License Application (BLA) is expected by August 18, 2021, following a successful Late-Cycle Meeting. The cash position increased to $151.1 million, while R&D and G&A expenses rose significantly, reflecting pre-commercialization efforts. The net loss narrowed to $25.4 million or $0.15 per share, compared to $26.3 million last year. Sesen anticipates potential approvals in Europe and MENA markets in 2022.
Sesen Bio (SESN) has partnered with Eczacibasi Pharmaceuticals to license and commercialize Vicineum for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) in Turkey. The FDA has granted Priority Review for Vicineum's Biologics License Application (BLA), with a target decision date of August 18, 2021. Sesen Bio will receive an upfront payment of $1.5 million and a 30% royalty on net sales in Turkey. With around 75% of bladder cancer patients diagnosed with NMIBC, Vicineum could significantly impact patient care in Turkey, the first treatment for this condition in over 20 years.
Sesen Bio (NASDAQ: SESN) has expanded its leadership team with the appointment of Amy Ponpipom as Vice President, Assistant General Counsel, supporting its transition to a commercial company. This move coincides with the Priority Review status of the Biologics License Application (BLA) for Vicineum, targeting non-muscle invasive bladder cancer (NMIBC), with an FDA decision expected by August 18, 2021. Ponpipom's 17 years in pharmaceutical law, including significant roles at AstraZeneca, is anticipated to bolster Sesen's commercialization efforts.
Sesen Bio (SESN) announced the completion of its commercial build phase for the anticipated launch of Vicineum, which is under FDA Priority Review for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The target PDUFA date is August 18, 2021. The company has hired approximately 25 internal employees and 34 sales representatives to promote Vicineum, targeting 2,000 high-prescribers. Sesen Bio aims to ensure product reimbursement through a focused market access strategy, with Vicineum expected to be available by Q4 2021.
Sesen Bio (NASDAQ: SESN) announced the appointments of Dr. Peter K Honig and Dr. Michael A.S. Jewett to its Board of Directors, enhancing its leadership ahead of the FDA's Priority Review of its Biologics License Application (BLA) for Vicineum, targeting BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The target PDUFA date for Vicineum is August 18, 2021. Dr. Honig brings extensive regulatory experience from Pfizer, while Dr. Jewett is a recognized oncologist with significant expertise in bladder cancer.
Sesen Bio (SESN) announced the enrollment of the first patient in China for the clinical trial assessing Vicineum in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). This milestone follows the IND approval by the China National Medical Products Administration, generating a $3M milestone payment from Qilu Pharmaceutical. The trial aims to evaluate Vicineum's efficacy and safety in about 53 patients, with promising market potential in China expected between $155M-$418M. The FDA's decision on Vicineum in the U.S. is anticipated by August 18, 2021.
Sesen Bio (SESN) held a productive Late-Cycle Meeting with the FDA on July 13, 2021, concerning its Biologics License Application (BLA) for Vicineum to treat BCG-unresponsive non-muscle invasive bladder cancer. The FDA confirmed no significant risks have been identified, and no Advisory Committee meeting is scheduled. The review remains on track for a decision by the target PDUFA date of August 18, 2021. Sesen Bio aims to improve patient outcomes and reduce healthcare costs with Vicineum's targeted therapy.
Sesen Bio (SESN) has granted stock options to four new employees as part of its transition to a commercial-stage company. This move supports the upcoming PDUFA date of August 18, 2021, for its lead product, Vicineum™, aimed at treating BCG-unresponsive non-muscle invasive bladder cancer. A total of 206,000 shares are available for purchase upon vesting over four years. Vicineum targets EpCAM antigens and is believed to minimize toxicity to healthy tissues. The company is also in a Phase 3 trial in the US, with FDA Priority Review status granted.
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