On August 30, 2021 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for its CAR-T (Chimeric Antigen Receptor-T cell) therapy, which is being developed in partnership with Moffitt Cancer Center (Moffitt) (Press release, Anixa Biosciences, AUG 30, 2021, View Source [SID1234586994]).

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Dr. Robert Wenham, Chair of Gynecological Oncology at Moffitt will lead the clinical trial.
This CAR-T therapy was developed by Dr. Jose Conejo-Garcia and his research team, when he was at the Wistar Institute. Dr. Conejo-Garcia is currently the Chairman of Immunology at Moffitt.
Anixa Biosciences has an exclusive worldwide license to the technology.
This technology is an autologous cell therapy. The therapeutic product is comprised of engineered T-cells that target the follicle stimulating hormone receptor (FSHR). FSHR is found at immunologically relevant levels exclusively on the granulosa cells of the ovaries. Since the target is a hormone receptor, and the target-binding domain is derived from its natural ligand, this technology is also known as CER-T (Chimeric Endocrine Receptor T-cell) therapy, a new type of CAR-T.
Dr. Amit Kumar, President and CEO of Anixa stated, "We are pleased that the FDA has authorized us to commence human clinical trials of our potentially paradigm-shifting therapy. Outcomes for women with late-stage ovarian cancer are poor, so if this approach demonstrates efficacy, it would have a dramatic impact on patients for whom there are no other options."

"This is a major milestone for our program. CAR-T therapy has had major successes in B-cell malignancies, but no clinical success in other types of tumors. We feel that our technology could be the first CAR-T approach that will demonstrate efficacy in a solid tumor indication, and we are looking forward to testing and verifying that assertion in human trials," said Dr. Wenham.

In addition to Drs. Wenham and Conejo-Garcia, other key members of the team at Moffitt include:

Dr. Marco Davila, Clinician and Director of the Cell Therapy Facility at Moffitt
Dr. Daniel Abate Daga, Assistant Director of the Cell Therapy Facility at Moffitt
Dr. Ana Marie Landin, Experimental Cell Therapy Manager at Moffitt
Dr. Theresa Boyle, Department of Pathology at Moffitt
Carrie Thomas, FDA Regulatory Liaison at Moffitt
Tam Jackson, Project Management Consultant
Scientists and Members of the Moffitt Cell Therapy Facility
Members of the Moffitt Alliance Relations Team

On August 30, 2021 Ziopharm Oncology, Inc. ("Ziopharm" or the "Company") (Nasdaq: ZIOP), reported the appointment of Kevin S. Boyle, Sr. as its new Chief Executive Officer, effective today (Press release, Ziopharm, AUG 30, 2021, View Source [SID1234586993]). As previously planned, Heidi Hagen, Interim CEO, is returning to her position as a member of the Board of Directors (the "Board"). Mr. Boyle has also been named to the Board. In addition, today the Company has announced promotions within its senior leadership.

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Mr. Boyle has over 20 years of experience in leading businesses in competitive and transformative situations and has a strong track record of delivering shareholder value. He is also an accomplished capital markets professional with strong banking relationships cultivated by raising over $2.0 billion in equity and debt capital over his career. Most recently, Mr. Boyle was CEO of Kuur Therapeutics (formerly known as Cell Medica Ltd.), leading the company through a successful transformation, culminating in a $185 million acquisition in May 2021 by Athenex, a global biopharma company focusing on the development and commercialization of cancer therapies.

The appointment of Mr. Boyle and the elevation of roles and responsibilities for select executives continue the Board’s actions to solidify the senior leadership team, move the Company forward and execute on its distinctive cell therapy platform and potentially groundbreaking cancer therapies.

"On behalf of the entire Board of Directors, we welcome Kevin to the Company," said James Huang, Executive Chairman. "During the robust search process, the Board was pleased to interview a number of very strong candidates. The Board was deliberative, and considered candidates from big pharma to small biotechs, and Kevin rose to the top of the list during the process. Kevin brings tremendous business experience with his operational expertise, strong financial acumen, and an ability to drive disciplined capital allocation. He has a strong track record of successfully guiding companies, both in and out of the biotech sector, through critical periods in their growth trajectories. In particular, his work at Kuur demonstrated his operational expertise in effectively managing a business with capital constraints and demanding timelines. We have the right science and scientific team to deliver, and we are confident that we now have the right person to successfully lead the Company forward towards clinical and business success."

Mr. Huang continued, "We also sincerely thank Heidi for her commitment to the Company and the outstanding job she has done over the past six months. We look forward to her continued contributions as a dedicated and valued Board member."

Mr. Boyle said, "I am excited to join the Ziopharm team and am impressed by the extraordinary opportunity that lies ahead. Heidi, the management team and the Board have laid the foundation for Ziopharm to succeed based on its best-in-class science. I understand the challenges ahead and I look forward to working diligently with our dedicated and talented team to unlock our incredible potential as an innovative, world-class oncology company. My priorities will be to deliver shareholder value and to ensure the success of the organization by driving the TCR-T program forward, while seeking and executing validating partnerships across our entire portfolio of scientific assets."

The Board’s selection of Mr. Boyle was unanimous. The CEO search committee was comprised of Robert Postma, Heidi Hagen and Mary Thistle, with support and guidance from the entire Board.

About Kevin S. Boyle, Sr.

During Mr. Boyle’s tenure as CEO of Kuur Therapeutics, he successfully led the company through a $185 million acquisition of Kuur by Athenex. After the acquisition, he supported the integration of Kuur’s CAR-NKT cell platform into Athenex’s Cell Therapy Division. Mr. Boyle joined Kuur Therapeutics in 2018 as CFO, playing a lead role in corporate strategy and financial planning as the company progressed with a pipeline of cell therapy products in both the US and Europe. He successfully led fundraising efforts while executing a restructuring of the company and he was promoted to CEO by the Kuur Board as an endorsement of his leadership abilities during this time.

Kevin previously served as CFO of multiple companies including FloWorks International, Sigma3, RecoverCare, and SPT. He was also previously an officer at two public companies, American Commercial Lines and Seabulk International. He started his career in investment banking.

Mr. Boyle received a law degree from the University of Pennsylvania and a Bachelor of Science degree in Industrial Management & Economics from Carnegie Mellon University. Houston is home to Mr. Boyle and his family. He was recently honored by the Houston Business Journal with the 2021 Most Admired CEO Award.

Executive Team Promotions

The Company also announced today that it has promoted Dr. Raffaele Baffa MD, Ph.D., to Head of Research and Development, adding to his role as Chief Medical Officer. Dr. Baffa joined the Company in November 2020 and has been instrumental in refocusing the Company’s development pipeline. In his expanded role, in addition to directing the development and implementation of Ziopharm’s clinical strategy and plans, Dr. Baffa will oversee and direct research and preclinical development activities in alignment with Ziopharm’s strategy for the development of innovative cell therapies. As the Head of Research and Development, he will also be responsible for ensuring the quality of science and expansion of its therapeutic application.

Ziopharm also announced the promotion of Dr. Adam Levy Ph.D., MBA to Executive Vice President, Corporate Development and Investor Relations. Dr. Levy joined Ziopharm in November 2020 as Executive Vice President of Investor Relations and Corporate Communications. Previously, Dr. Levy held the position of Executive Director and Head, Corporate Strategy and Investor Relations for Gilead Sciences. Prior to Gilead, Dr. Levy served in corporate strategy roles at Alexion and Bristol Myers Squibb. In his newly expanded role, Dr. Levy will lead the Company’s corporate development strategy, including executing licensing and business development deals across the Company’s portfolio, which is an increasingly critical priority for the Company. Dr. Levy will continue to direct investor-related activities and communications.

Mr. Huang added, "It is with great pleasure we announce the promotions of Raffaele and Adam. They each bring tremendous experience and we have benefitted from their contributions since they joined the company in 2020. We look forward to their continued efforts in their expanded roles."

Conference Call and Webcast

Ziopharm will host a conference call and webcast for the investment community today, August 30, 2021, at 4:30 p.m. EDT. The conference call can be accessed by dialing 877-451-6152 (U.S. and Canada) or 201-389-0879 (International). The passcode for the conference call is 13722687. A live webcast may be accessed using the link here, or by visiting the "Investors" section of the Ziopharm website at www.ziopharm.com. The call will be recorded and available for replay on the Company’s website for approximately 90 days after the call.

On August 30, 2021 Portage Biotech Inc. (NASDAQ: PRTG) ("Portage" or the "Company") a clinical-stage immuno-oncology company focused on the development of therapies and treatments targeting cancer treatment resistance, reported financial results for the quarter ended June 30, 2021 (Press release, Portage Biotech, AUG 30, 2021, View Source [SID1234586992]).

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"With the transformation of Portage now complete, our focus for the coming year is to significantly accelerate our clinical pipeline of novel immuno-oncology therapeutics designed to overcome cancer treatment resistance," said Dr. Ian Walters, chief executive officer of Portage Biotech. "Our recent financings provide us with the resources to complete Phase 1 and Phase 2 clinical trials for our lead invariant natural killer T cell (iNKT) agonists, PORT-2 and PORT-3, which we believe have the potential to synergize with PD-1 agents and overcome PD-1 resistance. These attributes represent a substantial opportunity to expand the already significant PD-1 cancer treatment market. Recent increased interest and transactional activity from big pharma in the iNKT space has served as further validation of the role of iNKT cells in cancer. With sufficient resources now in place, we plan to also advance our broader pipeline and to other value-driving catalysts in the coming fiscal year."

First Quarter FY 2022 Financial & Business Highlights

Increased financial resources with over $29 million raised since fiscal year-end:
Successful public offering of 1,150,000 shares with gross proceeds of $26.5 million, securing a cash runway sufficient to advance programs and enable achievement of numerous milestones.
Generation of an additional $2.6 million proceeds through the sale of approximately 91,000 shares via the Company’s At-the-Market offering.
Improved stock liquidity:
Inclusion in the Russell 2000 Index, bringing added visibility to the Company’s robust immuno-oncology pipeline.
Broad-based investor outreach planned for Fall 2021 through participation and/or presentation at the following conferences:
H.C. Wainwright 23rd Annual Global Investment Conference (Sept. 13-15, 2021)
Oppenheimer & Co. Fall Healthcare Life Sciences and MedTech Summit (Sept. 20-23, 2021)
Cantor Fitzgerald Virtual Global Healthcare Conference (Sept. 27-30, 2021)
First Quarter FY 2022 Clinical Highlights

Acceleration of development programs from the Company’s first-in-class immuno-oncology asset portfolio, including milestones related to lead iNKT agonists PORT-2 and PORT-3 and intratumoral amphiphilic therapy PORT-1. Key milestones included:
PORT-2: The first patient was dosed in the IMP-MEL randomized Phase 1/2 study of PORT-2, a liposomal formulation of Portage’s IMM60 iNKT agonist. In the trial, PORT-2 will be tested both as a monotherapy and in combination with standard of care (Keytruda) in melanoma and NSCLC. The PORT-2 study has 6 arms and is expected to enroll up to 100 patients.
PORT-3:
The first patient dosed in the PRECIOUS Phase 1 study of PORT-3, a nanoparticle coformulation of Portage’s iNKT agonist (IMM60) and NY-ESO-1 in patients with NY-ESO-1 expressing tumors. The Phase 1 portion of the trial is expected to enroll 15 patients while the randomized Phase 2 portion is expected to enroll an additional 42 patients.
This platform is designed to demonstrate proof of concept with NY-ESO-1 as an enrichment factor for patient accrual. Portage’s patent position extends to other known tumor antigens, and the Company is prepared to rapidly launch other assets into the clinic if we see strong activity of this formulation.
Notably, Portage received additional grant support from the Horizon 2020 program to explore next-generation targeted nanoparticles.
PORT-1: Presentation of interim data at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) conference from the IT-01 Phase 2 trial conducted by Intensity Therapeutics demonstrated strong safety and survival data for INT230-6 (PORT-1) both as a monotherapy and in combination with pembrolizumab or ipilimumab in solid tumors.
First Quarter FY 2022 Financial Results

The Company generated a net loss and comprehensive loss of approximately $3.2 million in the three months ended June 30, 2021 ("Fiscal 2022 Quarter"), compared to a net loss of approximately $0.7 million and a comprehensive loss of approximately $0.6 million in the three months ended June 30, 2020 ("Fiscal 2021 Quarter"), an increase in loss of $2.5 million and $2.6 million, respectively, year over year. Operating expenses, which include research and development and general and administrative expenses, were $3.6 million in the Fiscal 2022 Quarter, compared to $1.0 million in the Fiscal 2021 Quarter, an increase of $2.6 million, which is discussed more fully below. Operating expenses included $2.2 million of non-cash stock-based compensation expense in the Fiscal 2022 Quarter, compared to $0.3 million in the Fiscal 2021 Quarter.

The Company’s other items of income and expense were substantially non-cash in nature and were approximately $0.3 million net other income in each of the Fiscal 2022 Quarter and the Fiscal 2021 Quarter. Non-cash items included in other income and expenses in the Fiscal 2022 Quarter were:

A gain of $0.4 million representing the change in the fair value of the warrants issued with respect to the SalvaRx settlement; and
A small loss of $0.04 million generated by Stimunity, which operates our STING platform, accounted for under the equity method in the Fiscal 2022 Quarter, compared to a $0.4 million gain in the Fiscal 2021 Quarter.
Additionally, the Company reflected a net income tax benefit of approximately $0.1 million in the Fiscal 2022 Quarter, attributable to recoverable research and development tax credits generated in the U.K., partially offset by the foreign currency exchange rate effect on deferred tax liability.

Research & Development ("R&D") costs increased by approximately $1.0 million, from approximately $0.5 million during the three months ended June 30, 2020, to approximately $1.5 million during the three months ended June 30, 2021. The increase was primarily attributable to non-cash stock-based compensation expense associated with grants made under the 2021 Equity Incentive Plan in connection with our R&D efforts of $1.0 million.

General and administrative ("G&A") expenses increased by approximately $1.5 million, from approximately $0.5 million during the three months ended June 30, 2020, to approximately $2.0 million during the three months ended June 30, 2021. The principal reason for the increase in the Fiscal 2022 Quarter was the $1.1 million of non-cash stock-based compensation expense associated with the Company’s 2021 Equity Incentive Plan. No stock-based compensation expense under the 2021 Equity Incentive Plan was incurred during the three months ended June 30, 2020. Additionally, the Company incurred an increase of $0.3 million in professional fees relating to initiatives associated with a corporate restructuring and public relations/business development. Finally, D&O insurance premiums increased by $0.4 million in the current year period due to market rate increases in the cost of coverage.

As of June 30, 2021, the Company had cash and cash equivalents of approximately $28.6 million and total current liabilities of approximately $2.5 million (inclusive of approximately $0.7 million warrant liability settleable on a non-cash basis). For the three months ended June 30, 2021, the Company is reporting a net loss of approximately ($3.2) million and cash used in operating activities of approximately $1.6 million. As of July 31, 2021, the Company had approximately $28.0 million of cash on hand.

On August 30, 2021 Novartis will present new data from its robust portfolio and pipeline of advanced therapeutic platforms in solid tumors, with more than 55 abstracts from Novartis-sponsored and investigator-initiated trials accepted at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 (Press release, Novartis, AUG 30, 2021, View Source [SID1234586991]). The ESMO (Free ESMO Whitepaper) Congress will be held virtually September 16-21, 2021.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"At Novartis, we boldly push science further to make a meaningful difference to patients," said Susanne Schaffert, PhD, President, Novartis Oncology. "With deeper analyses in overall survival and quality of life in breast and prostate cancer, as well as exciting research in other solid tumors, our data at ESMO (Free ESMO Whitepaper) demonstrates our ambition to transform lives and renew patients’ hope for the future."

Key abstracts accepted by ESMO (Free ESMO Whitepaper) include:

Overall survival (OS) results from the phase III MONALEESA-2 (ML-2) trial of postmenopausal patients with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2−) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib [Kisqali (ribociclib)*; Late-breaker abstract presentation # LBA17; Proffered paper session: Sunday, Sept. 19, 2:10 PM CEST]

Association of quality of life (QoL) with OS in patients with HR+/HER2− ABC treated with ribociblib + ET in the ML-3 ML-7 trials [Kisqali; Abstract presentation # 233P; poster available: Monday, Sept. 13, 12:05 AM CEST]

Health-related QoL, pain and safety outcomes in the phase 3 VISION study of 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer (mCRPR) [Abstract presentation # 576MO; mini oral presentation: Sunday, Sept. 19, 5:50 PM CEST]

EPIK-P1: Retrospective chart review study of patients with PIK3CA-related overgrowth spectrum (PROS) who have received alpelisib as part of a compassionate use programme [Late-breaker abstract presentation # LBA23; Proffered paper session: Friday, Sept. 17, 1:30 PM CEST]

RATIONALE 304: Tislelizumab plus chemotherapy (chemo) vs chemo alone as first-line (1L) treatment for non-squamous (non-sq) non-small cell lung cancer (NSCLC) in patients who are smokers vs non-smokers [Abstract presentation # 1290P; poster available: Monday, Sept. 13, 12:05 AM CEST]

RATIONALE 307: Tislelizumab plus chemo vs chemo alone as 1L treatment for advanced sqNSCLC in patients who were smokers vs non-smokers [Abstract presentation # 1297P; poster available: Monday, Sept. 13, 12:05 AM CEST]
Additional data presentations highlight the breadth of our pipeline and our ongoing commitment to discover and develop innovations that address unmet medical needs for patients with cancer:

Medicine Abstract Title Abstract Number
Prostate Cancer
177Lu-PSMA-617 PSMAddition: a phase 3 trial to compare treatment with 177Lu-PSMA-617 plus standard of care (SOC) versus SOC alone in patients with metastatic hormone-sensitive prostate cancer Abstract presentation # 647TiP
Poster available: Thursday, Sept. 16, 08:30 AM CEST
177Lu-PSMA-617 PSMAfore: a phase 3 study to compare 177Lu-PSMA-617 treatment with a change in androgen receptor pathway inhibitor in taxane-naïve patients with mCRPC Abstract presentation #648TiP
Poster available: Thursday, Sept. 16, 08:30 AM CEST

Breast Cancer
Piqray (alpelisib) Antineoplastic therapies after alpelisib or placebo + fulvestrant in patients with HR+/HER2-, PIK3CA-mutated ABC: an analysis from SOLAR-1 Abstract presentation # 309P
Poster available: Monday, Sept. 13, 12:05 AM CEST

Neuroendocrine Tumors (NET)
Lutathera (lutetium Lu 177 dotatate)** The phase 3 NETTER-1 study of 177Lu-DOTATATE in patients with midgut neuroendocrine tumours: further survival analyses Abstract presentation # 1102P
Poster available: Friday, Sept. 17, 09:00 AM CEST
Lutathera A phase II trial to evaluate the safety and dosimetry of 177Lu-DOTA-TATE in adolescent patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours, pheochromocytomas and paragangliomas Abstract presentation # 1122TiP
Poster available: Friday, Sept. 17, 09:00 AM CEST
With the unique opportunity to engage a variety of cancer care stakeholders in Europe, Novartis will also host an ESMO (Free ESMO Whitepaper) Industry Connect virtual panel on Monday, September 20, 8:00 AM CEST, under the #EUnite initiative, to discuss opportunities presented by the European Commission ‘Europe’s Beating Cancer Plan,’ and practical steps to address inequalities in cancer care in the region. Featured panelists include:

Bettina Ryll – Board Member of the European Commission’s Cancer Mission, Physician and Founder of Melanoma Patient Network Europe
Fatima Cardoso – Director Breast Unit, Champalimaud Clinical Centre; President, Advanced Breast Cancer Global Alliance
John Ryan – EU Commission, Deputy Director General for Health
More information and access to the event will be available to all registered congress participants.

Additional details on Novartis-sponsored abstracts and activities, and access to the presentations will be available on View Source, starting on September 16.

Product Information
Approved indications for products vary by country and not all indications are available in every country. The product safety and efficacy profiles have not yet been established outside the approved indications. Because of the uncertainty of clinical trials, there is no guarantee that compounds will become commercially available with additional indications.

On August 30, 2021 Novartis will present new data from its robust portfolio and pipeline of advanced therapeutic platforms in solid tumors, with more than 55 abstracts from Novartis-sponsored and investigator-initiated trials accepted at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 (Press release, Novartis, AUG 30, 2021, View Source [SID1234586991]). The ESMO (Free ESMO Whitepaper) Congress will be held virtually September 16-21, 2021.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"At Novartis, we boldly push science further to make a meaningful difference to patients," said Susanne Schaffert, PhD, President, Novartis Oncology. "With deeper analyses in overall survival and quality of life in breast and prostate cancer, as well as exciting research in other solid tumors, our data at ESMO (Free ESMO Whitepaper) demonstrates our ambition to transform lives and renew patients’ hope for the future."

Key abstracts accepted by ESMO (Free ESMO Whitepaper) include:

Overall survival (OS) results from the phase III MONALEESA-2 (ML-2) trial of postmenopausal patients with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2−) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib [Kisqali (ribociclib)*; Late-breaker abstract presentation # LBA17; Proffered paper session: Sunday, Sept. 19, 2:10 PM CEST]

Association of quality of life (QoL) with OS in patients with HR+/HER2− ABC treated with ribociblib + ET in the ML-3 ML-7 trials [Kisqali; Abstract presentation # 233P; poster available: Monday, Sept. 13, 12:05 AM CEST]

Health-related QoL, pain and safety outcomes in the phase 3 VISION study of 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer (mCRPR) [Abstract presentation # 576MO; mini oral presentation: Sunday, Sept. 19, 5:50 PM CEST]

EPIK-P1: Retrospective chart review study of patients with PIK3CA-related overgrowth spectrum (PROS) who have received alpelisib as part of a compassionate use programme [Late-breaker abstract presentation # LBA23; Proffered paper session: Friday, Sept. 17, 1:30 PM CEST]

RATIONALE 304: Tislelizumab plus chemotherapy (chemo) vs chemo alone as first-line (1L) treatment for non-squamous (non-sq) non-small cell lung cancer (NSCLC) in patients who are smokers vs non-smokers [Abstract presentation # 1290P; poster available: Monday, Sept. 13, 12:05 AM CEST]

RATIONALE 307: Tislelizumab plus chemo vs chemo alone as 1L treatment for advanced sqNSCLC in patients who were smokers vs non-smokers [Abstract presentation # 1297P; poster available: Monday, Sept. 13, 12:05 AM CEST]
Additional data presentations highlight the breadth of our pipeline and our ongoing commitment to discover and develop innovations that address unmet medical needs for patients with cancer:

Medicine Abstract Title Abstract Number
Prostate Cancer
177Lu-PSMA-617 PSMAddition: a phase 3 trial to compare treatment with 177Lu-PSMA-617 plus standard of care (SOC) versus SOC alone in patients with metastatic hormone-sensitive prostate cancer Abstract presentation # 647TiP
Poster available: Thursday, Sept. 16, 08:30 AM CEST
177Lu-PSMA-617 PSMAfore: a phase 3 study to compare 177Lu-PSMA-617 treatment with a change in androgen receptor pathway inhibitor in taxane-naïve patients with mCRPC Abstract presentation #648TiP
Poster available: Thursday, Sept. 16, 08:30 AM CEST

Breast Cancer
Piqray (alpelisib) Antineoplastic therapies after alpelisib or placebo + fulvestrant in patients with HR+/HER2-, PIK3CA-mutated ABC: an analysis from SOLAR-1 Abstract presentation # 309P
Poster available: Monday, Sept. 13, 12:05 AM CEST

Neuroendocrine Tumors (NET)
Lutathera (lutetium Lu 177 dotatate)** The phase 3 NETTER-1 study of 177Lu-DOTATATE in patients with midgut neuroendocrine tumours: further survival analyses Abstract presentation # 1102P
Poster available: Friday, Sept. 17, 09:00 AM CEST
Lutathera A phase II trial to evaluate the safety and dosimetry of 177Lu-DOTA-TATE in adolescent patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours, pheochromocytomas and paragangliomas Abstract presentation # 1122TiP
Poster available: Friday, Sept. 17, 09:00 AM CEST
With the unique opportunity to engage a variety of cancer care stakeholders in Europe, Novartis will also host an ESMO (Free ESMO Whitepaper) Industry Connect virtual panel on Monday, September 20, 8:00 AM CEST, under the #EUnite initiative, to discuss opportunities presented by the European Commission ‘Europe’s Beating Cancer Plan,’ and practical steps to address inequalities in cancer care in the region. Featured panelists include:

Bettina Ryll – Board Member of the European Commission’s Cancer Mission, Physician and Founder of Melanoma Patient Network Europe
Fatima Cardoso – Director Breast Unit, Champalimaud Clinical Centre; President, Advanced Breast Cancer Global Alliance
John Ryan – EU Commission, Deputy Director General for Health
More information and access to the event will be available to all registered congress participants.

Additional details on Novartis-sponsored abstracts and activities, and access to the presentations will be available on View Source, starting on September 16.

Product Information
Approved indications for products vary by country and not all indications are available in every country. The product safety and efficacy profiles have not yet been established outside the approved indications. Because of the uncertainty of clinical trials, there is no guarantee that compounds will become commercially available with additional indications.