On September 15, 2021 Photocure ASA (OSE: PHO), the Bladder Cancer Company, reported a clinical data presentation and highlights from the 2021 American Urological Association Annual Congress (AUA2021), which was held virtually September 10-13, 2021 (Press release, PhotoCure, SEP 15, 2021, View Source [SID1234587785]). During the program, new results from a study using Blue Light Cystoscopy (BLC) with Cysview in the surveillance setting were reported in a podium presentation, and separately, BLC with Cysview was discussed in an Expert Presentation on Surgical Techniques.

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The American Urological Association (AUA) meeting is one of largest international meetings in the urology calendar. This year’s event included an innovative, evidence-based, quality program for urologists and urologic health care professionals worldwide.

Podium Presentation

Title: UTILITY OF BLUE LIGHT FLEXIBLE CYSTOSCOPY FOR BLADDER CANCER SURVEILLANCE AFTER INTRAVESICAL THERAPY

Presenter: Sanam Ladi Seyedian, M.D., University of Southern California

Session and Date: PD-63: Bladder: Cancer Non-Invasive III: Sept. 13, 2021

Results were provided by two high-volume treatment facilities that perform Blue Light Flexible Cystoscopy (BLFC) and are participants in the Blue Light Cystoscopy with Cysview Registry. In this study, data was captured from 277 office based BLFC examinations in 136 patients who received intravesical BCG or chemotherapy, as part of standard of care treatment for non-muscle invasive bladder cancer (NMIBC).

From these examinations, a total of 52 office-based biopsies were taken, of which 23 (44%) were confirmed as malignant. BLFC identified all 23 malignancies, demonstrating 100% sensitivity for cancer detection in this cohort, whereas analysis by cytology identified only 3 of the 23 confirmed malignancies. Additionally, from the 277 total examinations, 23 (8%) were White Light Cystoscopy (WLC) normal and BLFC abnormal. Of these 23 discordant results, 16 had office-based biopsies and cancer was confirmed in 9 cases (56%), which would have been missed by WLC alone.

The study authors concluded that office-based BLFC helps improve early detection of recurrence in cases with normal WLC and can aid in surveillance of patients receiving intravesical therapy, enhance performance of office-based biopsy and increase early detection of BCG unresponsive disease.

"The results from this study show that use of Blue Light Cystoscopy with Cysview for patient surveillance improved the ability to detect recurrent disease in this high-risk, recently-treated patient cohort, which can significantly impact future treatment decisions," said Dr. Sia Daneshmand, one of the study authors. "Early detection of recurrent or residual cancer during initial treatment is essential for properly risk-stratifying all bladder cancer patients, and confirming response to treatment on follow-up and can have a major impact on subsequent treatment pathways and patient outcomes. As a result, Blue Light Cystoscopy can be an important tool throughout the continuum of care for patients diagnosed with bladder cancer."

Dr. Sia Daneshmand, M.D., is a Professor of Urology with Clinical Scholar designation and serves as director of clinical research as well as the urologic oncology (SUO) fellowship director at the University of Southern California (USC) in Los Angeles.

Abstract Link: View Source

Expert Presentation

Title: ADVANCES IN ENDOSCOPIC TREATMENT OF BLADDER TUMORS

Presenter: Yair Lotan, M.D., UT Southwestern Medical Center

Session and Date: Plenary Session: Surgical Techniques: Sept. 10, 2021

In this presentation, Dr. Lotan emphasized the importance of BLC with Cysview in accurately detecting NMIBC, stratifying bladder tumors, and helping to perform a complete TURBT in the operating room. He also provided an expert perspective on how biopsy and fulguration in the surveillance setting can positively impact patient outcomes using BLC with Cysview in the office-based setting.

Dr. Lotan is a Professor of the Department of Urology at UT Southwestern and Jane and John Justin Distinguished Chair in Urology, In Honor of Claus G. Roehrborn, M.D. He is Vice chair of Clinical Affairs and chief of urologic oncology.

"The study results presented at this year’s AUA meeting as well as the discussion on BLC in the Surgical Techniques presentation underscores how critically important it is for patients to receive the proper bladder cancer care whether they are having tumor resection in the hospital or follow-up procedures" said Geoffrey Coy, Vice President and General Manager of North American Operations at Photocure. "These new study results also highlight the range of opportunities made possible by Blue Light Cystoscopy for urologists, and the benefits to patients, especially when including flexible Blue Light Cystoscopy in the office setting as part of the continuum of care. We remain focused on expanding the availability of the procedure so that more physicians and patients have access to this important solution."

Note to editors: All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA

About Bladder Cancer

Bladder cancer ranks as the seventh most common cancer worldwide with 1 720 000 prevalent cases (5-year prevalence rate)1a, 573 000 new cases and more than 200 000 deaths annually in 2020.1b

Approx. 75% of all bladder cancer cases occur in men.1 It has a high recurrence rate with an average of 61% in year one and 78% over five years.2 Bladder cancer has the highest lifetime treatment costs per patient of all cancers.3

Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike.

Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (75%) of all BC cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. In MIBC the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3, and T4, are more likely to spread and are harder to treat.4

1 Globocan. a) 5-year prevalence / b) incidence/mortality by population.
Available at: View Source, accessed [April 2021].
2 Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657
3 Sievert KD et al. World J Urol 2009;27:295–300
4 Bladder Cancer. American Cancer Society. View Source

About Hexvix/Cysview (hexaminolevulinate HCl)

Hexvix/Cysview is a drug that preferentially accumulates in cancer cells in the bladder making them glow bright pink during Blue Light Cystoscopy (BLC). BLC with Hexvix/Cysview improves the detection of tumors and leads to more complete resection, fewer residual tumors and better management decisions.

Cysview is the tradename in the U.S. and Canada, Hexvix is the tradename in all other markets. Photocure is commercializing Cysview/Hexvix directly in the U.S. and Europe and has strategic partnerships for the commercialization of Hexvix/Cysview in China, Canada, Chile, Australia, and New Zealand. Please refer to View Source for further information on our commercial partners.

On September 15, 2021 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that it will hire and train a 15-person oncology sales force to supplement the Boehringer Ingelheim oncology commercial team (Press release, G1 Therapeutics, SEP 15, 2021, View Source [SID1234587808]). The expansion will allow G1 to target top tier accounts in order to accelerate sales activities and help maximize the adoption of COSELA (trilaciclib).

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The new G1 sales representatives will supplement the existing Boehringer Ingelheim oncology commercial team. G1 entered into a three-year co-promotion agreement with Boehringer Ingelheim to collaborate on the commercialization of COSELA for its first indication in ES-SCLC. (press release)

"This additional sales force will allow us to expand the reach into our top tier accounts, who treat up to 50 percent of patients diagnosed with small cell lung cancer," said Andrew Perry, G1’s Chief Commercial Officer. "COSELA is the only multilineage myeloprotection therapy developed to proactively reduce the risk of some of the dangerous side effects of chemotherapy in certain patients. We envision working closely with our partners at BI to maximize demand and adoption of this important medicine among these top accounts, as we seek to ensure the availability of COSELA to as many appropriate patients living with ES-SCLC as possible."

On September 9, 2021, the G1 Board of Directors adopted the G1 Therapeutics, Inc. 2021 Sales Force Inducement Equity Incentive Plan (the "Plan"). There are 500,000 shares of common stock reserved under the Plan to be used exclusively for grants of awards to sales force individuals and support staff that were not previously employees or directors of G1, as an inducement material to the individuals’ entry into employment with G1 within the meaning of Rule 5635(c)(4) of the Nasdaq Listing Rules. The Plan was approved by the Board of Directors without stockholder approval pursuant to Rule 5635(c)(4), and the terms and conditions of the Plan are substantially similar to G1’s stockholder-approved 2017 Equity Incentive Plan, as amended.

About COSELA (trilaciclib) for Injection

COSELA (trilaciclib) was approved by the U.S. Food and Drug Administration on February 12, 2021.

Indication
COSELA (trilaciclib) is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer.

Important Safety Information
COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.

Warnings and precautions include injection-site reactions (including phlebitis and thrombophlebitis), acute drug hypersensitivity reactions, interstitial lung disease (pneumonitis), and embryo-fetal toxicity.

The most common adverse reactions (>10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.

This information is not comprehensive. Please click here for full Prescribing Information. View Source

To report suspected adverse reactions, contact G1 Therapeutics at 1-800-790-G1TX or call FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

On September 15, 2021 The board of directors of Abbott (NYSE: ABT) reported a quarterly common dividend of 45 cents per share (Press release, Abbott, SEP 15, 2021, View Source [SID1234587729]).

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This marks the 391st consecutive quarterly dividend to be paid by Abbott since 1924. The cash dividend is payable Nov. 15, 2021, to shareholders of record at the close of business on Oct. 15, 2021.

Abbott has increased its dividend payout for 49 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have increased dividends annually for at least 25 consecutive years.

On September 15, 2021 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage precision oncology company focused on developing targeted drugs to inhibit frontier targets that drive and sustain RAS-addicted cancers, reported that the company will participate in the upcoming 3rd Annual RAS-Targeted Drug Development Summit being held September 21-23, 2021 (Press release, Revolution Medicines, SEP 15, 2021, View Source [SID1234587745]). Steve Kelsey, M.D., president, research and development, will serve as chairperson for one of the conference’s scientific tracks and moderate a panel discussion during the virtual event. In addition, Jan Smith, Ph.D., senior vice president, biology and Bob Nichols, Ph.D., project lead for RMC-6291, the company’s development-stage KRASG12C(ON) inhibitor, will each deliver a scientific presentation as part of the conference.

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Details of Revolution Medicines’ participation in the 3rd Annual RAS-Targeted Drug Development Summit are as follows:

Presentations:

Title: Targeting KRASG12C(ON) & Potential Application to Overcoming Drug Resistance in RAS-Addicted Tumors
Presenter: Bob Nichols, Ph.D., project lead for RMC-6291
Date: Wednesday, September 22, 2021
Time: 11:55 a.m. Eastern

Title: Combination Strategies to Defeat RAS-Addicted Cancers
Presenter: Jan Smith, Ph.D., senior vice president, biology
Date: Wednesday, September 22, 2021
Time: 2:00 p.m. Eastern

Panel Discussion:

Title: On the Horizon – Discussing the Post-Approval Landscape for Successful RAS Drugs Beyond AMG510
Moderator: Steve Kelsey, M.D., president, research and development
Date: Thursday, September 23, 2021
Time: 4:15 p.m. Eastern

Scientific Track:

Title: Validating Robust Combination Strategies
Chairperson: Steve Kelsey, M.D., president, research and development
Date/Time: Wednesday, September 22, 2021; 11:30 a.m. – 5:00 p.m. Eastern
Thursday, September 23, 2021; 11:00 a.m. – 12:30 p.m. Eastern

Additional information on the Digital RAS-Targeted Drug Discovery Summit is available through the conference website at https://ras-drugdevelopment.com/

On September 15, 2021 GammaDelta Therapeutics Ltd. (GDT), a biotechnology company pioneering the discovery and development of allogeneic gamma delta T cell therapies for cancer, reported that it has initiated a first-in-human Phase I clinical trial evaluating GDX012 for the treatment of acute myeloid leukaemia (AML) (Press release, GammaDelta Therapeutics, SEP 15, 2021, View Source [SID1234587763]). GDX012 is an allogeneic, non-engineered, variable delta 1 (Vδ1) gamma-delta (γδ) T cell therapy manufactured from healthy donor blood.

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AML is the most common form of acute leukaemia in adults with an estimated 20.000 new cases per year in the US. Despite progress in the development of targeted therapies over the recent years the prognosis for patients with AML remains poor, with an average overall 5‐year survival rate of approximately 30%1.

"The unique biological characteristics of non-engineered Vδ1 γδ T cells potentially open a new modality for innate cell therapy. Vδ1 γδ T cells provide a basis for ‘off-the-shelf use’ and the platforms developed by our team further support gene engineering of these cells to enable the foundations of our allogeneic cell therapy pipeline for haematological malignancies and solid tumours", said Dr. Paolo Paoletti, CEO of GDT.

GDT’s Phase I trial, conducted in the U.S., is an open-label, multi-centre study of GDX012 enrolling adults diagnosed with AML and presenting with measurable residual disease (MRD) after standard of care (SOC) treatment. The objectives of the trial are to evaluate the safety, tolerability, pharmacokinetics, anti-leukaemic activity and maximum tolerated dose of GDX012

Dr. Michael Koslowski, Head of R&D and Chief Medical Officer of GDT added: "This is an important milestone in the development of our lead product candidate, GDX012, for patients with AML that present with MRD after SOC treatment. Supported by encouraging preclinical data we believe that GDX012 can provide an attractive treatment option for these AML patients that are at high risk of relapse. We are very excited to bring GDX012 into clinical development and we look forward to advancing our growing pipeline of allogeneic, ‘off-the-shelf’ Vδ1 γδ T cell products for solid and haematological tumours."

GDT is advancing its novel T cell platforms under an ongoing collaboration with Takeda Pharmaceutical Company Limited formed in 2017. GDT’s technology platforms are based on pioneering world-class research funded in part by Cancer Research UK, conducted by Professor Adrian Hayday and Dr Oliver Nussbaumer, at King’s College London and the Francis Crick Institute and Professor Bruno Silva-Santos at the University of Lisbon. GDT was formed in 2016 by Abingworth with support from Cancer Research UK’s commercial partnership team.

Vδ1 γδ T cells are a unique subset of T cells that specifically recognise and are activated by molecular patterns of dysregulation on cancer cells. The non-MHC-restricted activity of Vδ1 γδ T cells makes them a unique cell type for the development of fully allogeneic, ‘off-the-shelf’ cell therapies.

GDT has developed proprietary technologies to generate both blood-and tissue-derived allogeneic immunotherapies based on Vδ1 γδ T cells for the treatment of haematological malignancies and solid tumours. Both platforms have enabled the creation of non-engineered and genetically engineered allogeneic cell therapies, which demonstrate cellular activity and tumour cell killing capacity in pre-clinical models.