PI3K

Global CD70 Targeting Therapies Market Opportunity & Clinical Trials Insight 2024: Cusatuzumab Emerges as Leading Phase II Candidate for Leukemia Treatment, Paving the Way for CD70 Therapy Evolution - ResearchAndMarkets.com

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Tuesday, May 7, 2024

The "Global CD70 Targeting Therapies Market Opportunity & Clinical Trials Insight 2024" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global CD70 Targeting Therapies Market Opportunity & Clinical Trials Insight 2024" report has been added to ResearchAndMarkets.com's offering.
  • Therefore, numerous pharma and biotech companies planned to develop CD70 therapy and initiated clinical trials.
  • Over the preceding decennium, the sphere of global CD70 therapy market has witnessed the development of several novel, innovative as well as advanced contenders targeting CD70.
  • The combinational study for CD70 therapy represents a novel as well as compelling frontier in the commercial CD70 therapy landscape.

Aadi Bioscience to Present New Non-clinical Data Highlighting Combinability of nab-Sirolimus at the American Association for Cancer Research (AACR) Annual Meeting

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Tuesday, April 9, 2024

LOS ANGELES, April 9, 2024 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI), a commercial-stage precision oncology company focused on developing and commercializing therapies for cancers with alterations in the mTOR pathway, today announced it will present new non-clinical data that highlight the combinability of nab-sirolimus and its potential for synergy to enhance anti-cancer effects and overcome resistance. These data will be presented during poster sessions at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, CA, taking place April 5-10, 2024.

Key Points: 
  • Data further support clinical exploration of nab-sirolimus in combination with endocrine therapy for hormone-driven cancers, as is currently being investigated for patients with endometrioid-type endometrial cancer in a Phase 2 trial
    LOS ANGELES, April 9, 2024 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI), a commercial-stage precision oncology company focused on developing and commercializing therapies for cancers with alterations in the mTOR pathway, today announced it will present new non-clinical data that highlight the combinability of nab-sirolimus and its potential for synergy to enhance anti-cancer effects and overcome resistance.
  • These data will be presented during poster sessions at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, CA, taking place April 5-10, 2024.
  • Poster presentation details and abstract highlights include:
    Fulvestrant, the selective estrogen receptor degrader and PI3K inhibitors, such as alpelisib, have demonstrated efficacy in patients with HR+ PI3K-mutated breast cancer; however, resistance still occurs
    These data further support the combination of nab-sirolimus with endocrine therapy for hormone-driven cancers, as is currently being investigated in patients with advanced or recurrent endometrioid endometrial cancer in a Phase 2 study (NCT05997017)
    Corresponding with greater antitumor activity, nab-sirolimus was associated with higher intratumoral drug concentration and stronger mTOR target suppression than everolimus when the agents were combined with KRAS G12C inhibitors

Kazia Therapeutics licenses paxalisib to Sovargen for intractable seizures in rare central nervous system diseases

Retrieved on: 
Thursday, March 21, 2024

Paxalisib is an oral dual inhibitor targeting both PI3K and mTOR within this pathway, and it is distinguished by its ability to penetrate the brain.

Key Points: 
  • Paxalisib is an oral dual inhibitor targeting both PI3K and mTOR within this pathway, and it is distinguished by its ability to penetrate the brain.
  • Although FCD T2 and TSC are rare orphan diseases, they represent a high medical unmet need with significant market opportunity.
  • The licensing agreement includes all countries worldwide, excluding mainland China, Hong Kong, Macao and Taiwan, which Kazia retains.
  • Our license with Sovargen provides us the ability to explore the impact of paxalisib outside of our area of expertise where there is substantial patient need and market opportunity.

Kazia Therapeutics Reports Early Conclusion of Clinical Trial After Reaching Primary Endpoint

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Wednesday, February 21, 2024

SYDNEY, Feb. 21, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), a biotechnology company specializing in oncology, today announced the early conclusion based on positive safety and promising clinical response findings observed to date of an important two-part Phase I trial. This investigator-initiated trial evaluated the use of paxalisib (an oral PI3K/mTOR dual inhibitor) with radiation therapy for the treatment of patients with PI3K pathway mutation brain metastases from solid tumors.

Key Points: 
  • SYDNEY, Feb. 21, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), a biotechnology company specializing in oncology, today announced the early conclusion based on positive safety and promising clinical response findings observed to date of an important two-part Phase I trial.
  • After reviewing the Part II patient data generated to date, the three lead investigators have determined that the primary endpoint of the study has been reached.
  • In addition, the investigators continued to observe encouraging signs of clinical response in patients in the expansion cohort.
  • The increasing incidence of brain metastasis and the low response rates to existing treatments underscores the need for new treatment options.

ENSEM Expands its Leadership Team with the Appointment of Jeff Kutok, M.D., Ph.D. as Chief Scientific Officer

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Wednesday, January 3, 2024

WALTHAM, Mass., Jan. 3, 2024 /PRNewswire/ -- Ensem Therapeutics Inc., a biotechnology company focusing on high value and difficult-to-drug oncology targets, today announced the appointment of Dr. Jeff Kutok as Chief Scientific Officer, effectively immediately.

Key Points: 
  • WALTHAM, Mass., Jan. 3, 2024 /PRNewswire/ -- Ensem Therapeutics Inc., a biotechnology company focusing on high value and difficult-to-drug oncology targets, today announced the appointment of Dr. Jeff Kutok as Chief Scientific Officer, effectively immediately.
  • "Dr. Kutok is a seasoned executive with the right credentials to guide ENSEM's science into the future," stated Shengfang Jin, Ph.D., President & Chief Executive Officer of ENSEM.
  • Dr. Kutok previously served as Executive Vice President and Chief Scientific Officer at Infinity Pharmaceuticals, Inc. where he was responsible for the company's scientific strategy, preclinical development, and translational science.
  • "I am thrilled to join the ENSEM team at this exciting time," stated Dr. Jeff Kutok, Chief Scientific Officer at ENSEM.

Cogent Biosciences Presents New Preclinical Data Highlighting Potential Best-in-Class Potency and Selectivity of ErbB2 and PI3Kα inhibitor programs at the San Antonio Breast Cancer Symposium

Retrieved on: 
Thursday, December 7, 2023

WALTHAM, Mass. and BOULDER, Colo., Dec. 07, 2023 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today presented updated preclinical data from its potent, selective and brain penetrant ErbB2 inhibitor program along with initial preclinical data from its newly disclosed H1047R mutant-selective PI3Kα inhibitor discovery program at the 2023 San Antonio Breast Cancer Symposium (SABCS), taking place December 5-9, 2023 at the Henry B. González Convention Center in San Antonio, Texas. The posters can be found in the ‘Posters and Publications’ portion of the Cogent website.

Key Points: 
  • “In addition, we are pleased to present initial data on our effort to design a potent H1047R mutant-selective PI3Kα inhibitor.
  • The poster presented today shows that CGT4255 demonstrated low nM potency against ErbB2 wild-type and oncogenic ErbB2 mutations with 100-fold selectivity over wild-type-EGFR.
  • PI3Kα mutations are highly prevalent in many solid tumors and are present in 36% of all breast cancer patients.
  • Additional lead series analogs were also described, highlighting our more recent advances toward increasing selectivity and potency against H1047R mutants.

Celcuity to Present Preclinical Data for Gedatolisib at the 2023 San Antonio Breast Cancer Symposium

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Friday, December 1, 2023

MINNEAPOLIS, Dec. 01, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that an abstract accepted for a poster presentation at the 2023 San Antonio Breast Cancer Symposium (SABCS) is now available on the SABCS website.

Key Points: 
  • MINNEAPOLIS, Dec. 01, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that an abstract accepted for a poster presentation at the 2023 San Antonio Breast Cancer Symposium (SABCS) is now available on the SABCS website.
  • The 2023 San Antonio Breast Cancer Symposium (SABCS) is being held virtually and in-person from December 5-9, 2023.
  • The presentation will include potency and efficacy data evaluating the effects of gedatolisib, a pan-PI3K/mTOR (PAM) inhibitor, and approved PAM inhibitors (PAMi) on breast cancer cell lines with mutated or non-mutated PAM pathway genes.
  • A Phase 3 VIKTORIA-1 trial evaluating gedatolisib plus fulvestrant with and without palbociclib is underway in in adults with HR+, HER2- advanced breast cancer.

Adlai Nortye Announces Completion of Patient Enrollment in Global Phase III Clinical Trial of Buparlisib (AN2025) in Combination with Paclitaxel for the Treatment of Recurrent or Metastatic HNSCC

Retrieved on: 
Friday, November 17, 2023

This clinical study evaluates buparlisib (AN2025), an oral pan-PI3K inhibitor, in combination with paclitaxel for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

Key Points: 
  • This clinical study evaluates buparlisib (AN2025), an oral pan-PI3K inhibitor, in combination with paclitaxel for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
  • This represents the first global multicenter phase III trial for HNSCC in the class of PI3K inhibitors.
  • "There is a high unmet medical need for patients with recurrent or metastatic HNSCC after anti-PD-1/anti-PD-L1 therapy.
  • As the trial is now fully enrolled, we eagerly look forward to the results which may change the paradigm of second-line treatment for HNSCC and provide a new treatment option for patients worldwide," said Lars Birgerson, President and Chief Medical Officer of Adlai Nortye Ltd.

KAZIA PROVIDES OVERVIEW OF PAXALISIB RELATED PRESENTATIONS FROM THE SOCIETY OF NEURO-ONCOLOGY 2023 ANNUAL MEETING

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Tuesday, November 21, 2023

SYDNEY, Nov. 21, 2023 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, is pleased to provide key highlights of the clinical and preclinical paxalisib related presentations given by key thought leaders at the Society of Neuro-Oncology 2023 Annual Meeting.

Key Points: 
  • SYDNEY, Nov. 21, 2023 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, is pleased to provide key highlights of the clinical and preclinical paxalisib related presentations given by key thought leaders at the Society of Neuro-Oncology 2023 Annual Meeting.
  • "The 2023 SNO Annual Meeting was another successful event with the latest advances in clinical trials, diagnosis and treatment of pediatric and adult patients with CNS malignancies," stated Dr. John Friend, CEO Kazia.
  • "We are highly encouraged with the preliminary overall survival data from the PNOC022 clinical study that we believe will provide an alternative to the current therapies considered as standard of care."
  • Key paxalisib highlights from the meeting:
    Specifically, the authors observed how ONC201 over activates the PI3K-AKT pathway, which is the target pathway for paxalisib
    Two patient case studies were discussed; each receiving the combination of paxalisib and ONC201 through compassionate access
    Six-year old female with DIPG who received the combination of paxalisib and ONC201 after upfront radiation therapy.

Totus Medicines Appoints John Maraganore to Scientific Advisory Board

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Thursday, October 19, 2023

EMERYVILLE, Calif., Oct. 19, 2023 /PRNewswire/ -- Totus Medicines , the drug discovery and development company revolutionizing small molecule drugs to end the era of untreatable disease, is pleased to announce the appointment of John Maraganore, Ph.D., to the company's Scientific Advisory Board (SAB).

Key Points: 
  • EMERYVILLE, Calif., Oct. 19, 2023 /PRNewswire/ -- Totus Medicines , the drug discovery and development company revolutionizing small molecule drugs to end the era of untreatable disease, is pleased to announce the appointment of John Maraganore, Ph.D., to the company's Scientific Advisory Board (SAB).
  • Maraganore brings over three decades of experience and most recently served as the founding CEO and director of Alnylam Pharmaceuticals.
  • Maraganore remains a member of the Alnylam Scientific Advisory Board.
  • "It's an honor to have John Maraganore join as the newest member of our Scientific Advisory Board," said Totus CEO and co-founder Neil Dhawan, Ph.D. "John brings valuable experience in advancing therapeutics from discovery to commercialization at a time when our first program is rapidly advancing through clinical trials.