On April 24, 2023 Dyve Biosciences, Inc. ("Dyve"), a clinical-stage platform biotechnology company with assets in immunology and oncology, reported the summary results of a poster presentation from the on-going preclinical partnership with the H. Lee Moffitt Cancer Center & Research Institute ("Moffitt") showing preclinical data from the company’s unique delivery approach that unlocks the powerful effects of neutralizing the TME acidity (Press release, Dyve Biosciences, APR 24, 2023, View Source [SID1234630415]).

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The poster, presented in collaboration with Moffitt, showcased data demonstrating the delivery of intuitive, targeted pH modulation to treat solid tumors. Tumor acidosis plays a major role in tumor aggressiveness, invasion, and resistance and is an important target for novel anticancer strategies. In the presentation, Dyve and Moffitt demonstrated for the first time that the extracellular pH of tumors can be increased upon application of a buffer formulation delivered transdermally, bypassing the GI tract and unlocking a more viable route to TME buffering therapy in oncology.

"Dyve continues to advance research in areas where our pH modulation program can unlock decades of ‘settled science’ using our proprietary delivery technology. Our transdermal alkalinization treatment induced pH changes in a murine melanoma model as measured with MRI-CEST pH imaging and demonstrated for the first time that the extracellular pH of tumors can be increased upon application of a buffer formulation delivered transdermally. We are eager to translate these promising results into the clinic, including through our strategic alliance with Moffitt, and believe the on-going studies will continue to validate our approach and ultimately benefit patients across a number of different tumor types." – Ryan Beal, M.D., CEO, Dyve Biosciences

The research was published in AACR (Free AACR Whitepaper) Journals and is available here: View Source

On April 24, 2023 Cellectis (the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, announced it has implemented the use of alemtuzumab as a Cellectis Investigational Medicinal Product (IMP), coded as CLLS52, as part of the lymphodepletion regimen for UCART22 in the BALLI-01 clinical trial in relapsed/refractory B-cell ALL, for UCART123 in the AMELI-01 clinical trial in relapsed/refractory AML, and for UCART20x22 in the NatHaLi-01 clinical trial in relapsed/refractory B-cell NHL.

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In May 2021, Cellectis entered into partnership and supply agreements with Sanofi regarding alemtuzumab. Under the agreements, Sanofi is supplying 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.

"As previously reported, the importance of alemtuzumab in the lymphodepletion regimen was demonstrated in our BALLI-01 and AMELI-01 studies, where the addition of this lymphodepletion agent to the fludarabine and cyclophosphamide regimen was associated with sustained lymphodepletion and significantly higher UCART cell expansion allowing for greater clinical activity. We believe these encouraging outcomes are a meaningful step forward to a safe, effective, and controllable therapeutic window for our allogeneic CAR T-cell product candidates" said Mark Frattini, M.D., Ph.D., Chief Medical Officer at Cellectis.

Cellectis is the inventor of the combination of CD52 knockout UCART cells with a lymphodepleting regimen containing an anti-CD52 antibody such as alemtuzumab. The CD52 knockout aims to render 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. Cellectis’ UCART22, UCART123 and UCART20x22 product candidates have the CD52 gene inactivated by TALEN gene editing technology.

To access Cellectis’ 2022 ASH (Free ASH Whitepaper) data release and Live Webcast release announcing positive preliminary data from the BALLI-01 and AMELI-01 clinical studies, click here: View Source

On April 24, Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported executive changes to support the Company’s continued success in advancing its pipeline toward commercialization through two pivotal Phase III trials in psoriasis and liver cancer (Press release, Can-Fite BioPharma, APR 24, 2023, View Source [SID1234630413]).

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Dr. Pnina Fishman, the Company’s Scientific Founder, was appointed Executive Chairman of the Board to guide the Company’s strategic direction. She will continue to serve as Chief Scientific Officer (CSO) overseeing the Company’s scientific programs and clinical development pipeline. Motti Farbstein will lead the Company as its new Chief Executive Officer (CEO) while continuing to serve as the Company’s Chief Financial Officer (CFO), a position he has held since 2005. Dr. Ilan Cohn, the Company’s Co-Founder and former Chairman, remains on the Board and will continue to guide the Company’s intellectual property strategy and portfolio. Dr. Cohn is a patent attorney and a Co-Founder and Senior Partner of the IP firm Cohn, De Vries, Stadler & Co. These executive changes go into effect on June 30, 2023.

"Having developed Can-Fite’s platform technology and guided our pipeline into pivotal studies, I am pleased to turn the CEO role over to Motti who has the financial and clinical expertise to lead Can-Fite into the registration stage," Dr. Fishman stated. "I will continue to guide our clinical programs as CSO while also taking part in setting the Company’s strategic direction as Executive Chairman of the Board. I have full confidence in Motti’s ability to execute on substantial opportunities for our late-stage clinical pipeline. I am also thankful to Ilan, my Co-Founder, for his dedication serving as Chairman for the past ten years and look forward to his continued support on the board, particularly with IP matters."

"I’m honored and excited to lead Can-Fite as CEO. Having served the Company for 20 years, I’m dedicated to bringing our oral drugs to market to serve patients in need, especially in our most advanced indications in psoriasis and liver cancer," stated Motti Farbstein. "Pnina, Ilan, and I will continue to work closely along with the rest of our team in a seamless transition. As we advance through two pivotal studies, we anticipate the potential for additional distribution transactions and other commercial opportunities.

On April 24, 2023 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") will report its financial results for the first quarter 2023 on Monday, May 8th, 2023 (Press release, BioNTech, APR 24, 2023, View Source [SID1234630412]). BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. EDT (2.00 p.m. CEST) to report its financial results and provide a corporate update for the first quarter 2023.

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To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a pin will be provided. It is recommended to register at least a day in advance.

The slide presentation and audio of the webcast will be available via this link.

Participants may also access the slides and the webcast of the conference call via the "Events & Presentations" page of the Investor Relations section of the Company’s website at www.BioNTech.com. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

On April 24, 2023 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) reported that it will release financial and operational results for the first quarter of 2023, on Thursday, May 4, 2023, before markets open (Press release, Aurinia Pharmaceuticals, APR 24, 2023, View Source [SID1234630411]). Aurinia’s management team will host a conference call/webcast at 8:30 am ET that day to review these results and provide a general business update. Interested participants can dial (888) 645-4404 / (862) 298-0702 (Toll-free U.S. & Canada). The audio webcast can also be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website.

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