On June 29, 2022 GSK plc reported the first recipient of the Target the Future Think Tank Challenge £70,000 (equivalent to approximately $100,000) grant to the HealthTree Foundation, a non-profit organisation helping patients learn more about their health and become their own best advocates (Press release, GlaxoSmithKline, JUN 29, 2022, View Source [SID1234616368]). Their proposal, the "HealthTree Equity and Diversity for Multiple Myeloma Program," will improve access, education and support for underserved communities and minority patients.

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Tania Small, Vice President, Global Head of Oncology Medical Affairs and Head of R&D Diversity, Equity and Inclusion at GSK, said: "The response to this challenge showcased an abundance of innovation, creativity and ingenuity, which we need to address patients’ unmet needs. We see great potential in the HealthTree Foundation’s proposal, which goes beyond the science to improve access, equitable care and quality of life for the multiple myeloma community."

GSK’s grant will help support the HealthTree Foundation as it develops digital delivery tools to distribute information on treatments and trials, facilitate digital communities and expand outreach efforts to support, educate and provide more equitable care to multiple myeloma patients.

Jenny Ahlstrom, Founder and CEO of the HealthTree Foundation, said: "I am alive today because I had the right information and treatments, and we must extend that access to communities of colour. GSK saw problems and created a programme to target a better future. Because of GSK’s support, we can implement a strategy to help our community by providing necessary tools to broaden awareness. We’re ready to make a difference in this underserved population suffering from multiple myeloma."

Specifically, the Target the Future grant from GSK will aid in the expansion of two of the following initiatives at the HealthTree Foundation:

"Black Myeloma Health": Outreach from the HealthTree Foundation will expand to spotlight Black patients with multiple myeloma and their experiences through video journaling and distribution of new educational brochures with information about relevant treatments and resources. It will also create distinct communities online for Black patients and caregivers to come together and support each other.
"HealthTree for Mieloma Multiple": The organisation’s efforts to support multiple myeloma patients will increase through deployment of Spanish-speaking patient navigators who will help people get answers along their treatment journey in their native language. It will also create referral forms in Spanish at clinics and translate existing HealthTree Foundation materials so more patients can access and understand information relevant to their care.
About the Target the Future Think Tank Challenge

Target the Future is an international, multi-year initiative dedicated to advancing innovation and addressing key needs in the multiple myeloma community. The Think Tank Challenge issued a clarion call for innovative ideas to support patients. GSK assembled a multidisciplinary advisory group of people personally and professionally connected to the multiple myeloma community and evaluated the top 20 submissions from around the world.

Entries came in from patients, caregivers, healthcare professionals, developers, researchers, advocates and non-profits. Following finalist presentations, the panel evaluated ideas on novelty, feasibility to execute and ability to address unmet needs. The panel unanimously voted in favour of the inaugural winner. GSK will share detailed updates as the HealthTree Foundation’s idea comes to life and report on results of this effort within the community.

The Think Tank Challenge will issue the next call for submissions in the second half of 2022. To learn more about GSK’s Target the Future programme and ways GSK is collaborating with the community to get ahead of this disease together, please visit View Source

GSK in Oncology

GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, tumour cell targeting therapies and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody-drug conjugates and cell therapy, either alone or in combination.

On June 29, 2022 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported results from the open-label Phase 1 stage of the GRECO-1 trial of rucosopasem in combination with stereotactic body radiation therapy (SBRT) in patients with centrally located or large non-small cell lung cancer (NSCLC) (Press release, Galera Therapeutics, JUN 29, 2022, View Source [SID1234616367]). Enrollment is ongoing in the randomized, double-blinded, placebo-controlled Phase 2 stage of the trial, with completion of enrollment anticipated in the second half of 2023.

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"The initial results from the Phase 1 stage of GRECO-1 demonstrate a promising safety profile for the rucosopasem and SBRT combination in patients with NSCLC," said Mel Sorensen, M.D., Galera’s President and CEO. "We are also encouraged by the initial signs of anti-tumor activity observed and the preliminary evidence for preservation of pulmonary function compared to historical literature evaluating pulmonary function in a similar patient population with SBRT alone. We look forward to seeing how the combination performs compared to SBRT alone in the ongoing Phase 2 stage of this trial."

Key findings in this group of seven patients (median age = 72) include:

Rucosopasem in combination with SBRT appeared well tolerated. The most frequent adverse events were fatigue, cough, and nausea, which are common in patients with lung cancer receiving radiotherapy.
In-field partial responses or stable disease were seen in six of the seven patients at six months follow-up, including target tumor reductions in five patients of 61%, 58%, 33%, 29% and 27% from baseline.
All seven patients are alive through a minimum of nine months of follow-up.
Early evidence of protection of pulmonary function was observed compared to the literature. No Grade 2-4 (RTOG scale) declines in DLCO1 were seen in any of the seven patients receiving rucosopasem compared to a prospective trial (n=127) evaluating pulmonary function after four to five fractions of lung SBRT, in which 7-12% of patients had Grade 2-4 decline in DLCO.2
GRECO-1 consists of two stages. The primary endpoint of this open-label Phase 1 stage was safety of 100 mg of rucosopasem administered intravenously over 15 minutes in combination with each of five SBRT treatments. Secondary endpoints include late toxicities through 12 months and anti-cancer efficacy through 24 months. Anti-cancer endpoints include overall and progression-free survival, as well as local tumor and distant metastasis control.

The Phase 2 stage of GRECO-1 is a randomized, double-blinded, placebo-controlled evaluation in up to 66 patients with large and/or central NSCLC tumors. Patients are being randomized in a 1:1 ratio to receive either 100 mg of rucosopasem or placebo before each fraction of SBRT. The primary endpoint of the Phase 2 stage of the trial is in-field (i.e., SBRT target) tumor response at six months post SBRT. Patients are also being followed for long-term anti-cancer endpoints and safety similar to the Phase 1 stage of the trial.

About Rucosopasem
Rucosopasem manganese (rucosopasem, or GC4711) is a selective dismutase mimetic in development to augment the anti-cancer efficacy of stereotactic body radiation therapy (SBRT). The molecule is currently being studied in a Phase 1/2 trial in combination with SBRT in patients with non-small cell lung cancer (NCT04476797) and a Phase 2b trial in combination with SBRT in patients with locally advanced pancreatic cancer (NCT04698915).

On June 29, 2022 Fusion Antibodies reported that it is delighted to be attending Discovery on Target 2022 (Press release, Fusion Antibodies, JUN 29, 2022, View Source [SID1234616366]).

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This event will be delivered in Boston from 17-20th October 2022.

Discovery on Target (DOT) highlights advances in current and emerging "hot" targets and technologies, as well as target validation strategies for the discovery and development of novel therapeutic agents ranging from biologics to small molecules.

Get in touch below to organise a meeting with one of the Fusion Antibodies team.

On June 29, 2022 EVERSANA, the pioneer of next-generation commercial services to the global life sciences industry, and Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., reported a partnership to support the recent launch of CAMCEVI (leuprolide) 42mg injection emulsion for the treatment of advanced prostate cancer in adults (Press release, EVERSANA, JUN 29, 2022, View Source [SID1234616365]). Accord BioPharma is heading distribution in the United States. The U.S. Food and Drug Administration approved the New Drug Application (NDA) for CAMCEVI from Foresee Pharmaceuticals on May 25, 2021.

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CAMCEVI is the first-ever ready-to-inject sterile formulation of leuprolide for subcutaneous injection that comes in a pre-filled syringe with no mixing required. In an open-label, single-arm study of 137 adults who received 42mg of CAMCEVI on Day 0 and Week 24, CAMCEVI offered consistent testosterone suppression to castrate levels after the initial injection, from Week 4 to Week 48.1 CAMCEVI should not be used in patients with hypersensitivity to GnRH or GnRH analogs due to possible anaphylactic reactions.1 CAMCEVI, like other GnRH agonists, causes a transient increase in serum levels of testosterone during the first week of treatment, which can cause transient worsening of symptoms. As with other GnRH agonists, cases of ureteral obstruction, spinal cord compression, have been observed, which may contribute to paralysis with or without fatal complications. 1 Click here for full Prescribing Information.

Leveraging the power of the company’s integrated solutions, EVERSANA will provide multiple services to Accord BioPharma for CAMCEVI, including field deployment solutions, training, and the company’s comprehensive data and analytics platform. Together, EVERSANA and Accord BioPharma will empower specialized pharmaceutical sales teams with the resources they need to connect with clinicians across the country to drive adoption of this therapy.

"Accord Healthcare has been offering quality pharmaceutical products in the U.S. and globally since the early 2000s. Through this strategic partnership with EVERSANA for the launch of CAMCEVI, we are excited to sharpen Accord BioPharma’s focus on specialty pharmaceuticals. This will help us enable better access to therapy for advanced prostate cancer patients across the U.S.," said Binish Chudgar, Managing Director – Accord Healthcare and Accord BioPharma.

"The commercialization of therapies, especially in oncology, requires deep knowledge of the industry and rich data on point-of-care options to help the treatment get to those patients in need," said Jim Lang, CEO, EVERSANA. "It’s why we built EVERSANA, to support the needs of clients like Accord BioPharma and help bring innovative drugs like CAMCEVI to market."

EVERSANA will also provide additional services to Accord BioPharma as part of the commercialization agreement. EVERSANA brings extensive experience in the oncology sector, including patient services, channel management, medical information, pharmacovigilance and more.

"Accord BioPharma is committed to going beyond biology when it comes to drug development. Creating therapies that people will use is not just about following the science, but about pursuing innovative thinking in healthcare," said Chrys Kokino, U.S. president of Accord BioPharma. "EVERSANA’s services, experience, and depth of commercial solutions make them the ideal partner for us in pursuing that commitment."

IMPORTANT SAFETY INFORMATION

Do not use CAMCEVI in patients with hypersensitivity to GnRH, GnRH agonist analogs, or any of the components of CAMCEVI as anaphylactic reactions to these drugs have been reported in the medical literature. CAMCEVI, like other GnRH agonists, causes a transient increase in serum levels of testosterone during the first week of treatment which can cause transient worsening of symptoms. As with other GnRH agonists, cases of ureteral obstruction, spinal cord compression, have been observed, which may contribute to paralysis with or without fatal complications. Patients with metastatic vertebral lesions and/or with urinary tract obstruction should be closely observed during the first few weeks of therapy. Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists. Blood glucose levels should be monitored and managed according to current clinical practice. Increased risk of myocardial infarction, sudden cardiac death, and stroke has been reported in association with the use of GnRH agonists. The risk appears low based on the reported odds ratios and should be evaluated carefully along with cardiovascular risk factors when determining a treatment for patients with prostate cancer. Patients should be monitored for cardiovascular disease and according to current clinical practice. Androgen deprivation therapy may prolong the QT interval. Consider periodic monitoring of electrocardiograms and electrolytes. Convulsions have been reported in patients receiving GnRH agonists, like CAMCEVI. Patients experiencing convulsions should be managed according to the current clinical practice. Monitor serum levels of testosterone following injection of CAMCEVI. Based on findings in animal studies and mechanism of action, CAMCEVI may cause fetal harm when administered to pregnant women. The most common (≥10%) adverse reactions during a median follow-up of 336 days were hot flush, hypertension, injection site reactions, upper respiratory tract infections, musculoskeletal pain, fatigue, and pain in extremities.

On June 29, 2022 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrine, oncologic, metabolic and neurological disorders by modulating the effects of the hormone cortisol, reported that it has initiated ROSELLA, a pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer (Press release, Corcept Therapeutics, JUN 29, 2022, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-initiates-rosella-pivotal-phase-3-trial [SID1234616364]).

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"We are excited that our ROSELLA study is now open," said Bill Guyer, PharmD, Corcept’s Chief Development Officer. "The 20,000 women in the United States and an equal number in Europe with platinum-resistant ovarian cancer have few good treatment options. Our Phase 2 study demonstrated improvements in progression free survival, duration of response and overall survival without increased side effect burden. Our goal in Phase 3 is to replicate these positive results, which would be of unprecedented benefit to women with platinum-resistant ovarian cancer, for whom relacorilant plus nab-paclitaxel has the potential to become a new standard of care."

ROSELLA has a planned enrollment of 360 women with recurrent, platinum-resistant ovarian cancer, randomized 1:1 to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel monotherapy. The primary endpoint will be progression-free survival, with overall survival as a key secondary endpoint. The ROSELLA trial design closely tracks the design of Corcept’s successful Phase 2 study. Additional information about ROSELLA and Corcept’s Phase 2 trial results can be found at the publications and press releases tabs of www.corcept.com.

About Platinum-Resistant Ovarian Cancer

Ovarian cancer is the fifth most common cause of cancer death in women.1 Patients whose disease returns less than six months after receiving platinum-containing therapy are described as having "platinum-resistant" disease. In the United States, approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year.2 There are few treatment options and median overall survival following recurrence of disease is 12 months or less with single-agent chemotherapy.3 No approved therapy has been shown to significantly extend overall survival in patients with recurrent, platinum-resistant ovarian cancer compared to standard chemotherapy.4

About Corcept’s Oncology Programs

There is substantial evidence that cortisol activity at the glucocorticoid receptor ("GR") reduces the efficacy of certain anti-cancer therapies and that modulating cortisol’s activity may help anti-cancer treatments achieve their intended effect.

Many types of solid tumors express the GR and are potential targets for cortisol modulation therapy. In some cancers, cortisol inhibits cellular apoptosis – the tumor-killing effect many treatments are meant to stimulate. In other cancers, cortisol activity promotes tumor growth. Cortisol also suppresses the body’s immune response; activating – not suppressing – the immune system is beneficial in fighting certain cancers.

Corcept is conducting clinical trials of its proprietary selective cortisol modulators in combination with three different anti-cancer treatments in patients with ovarian, adrenal and prostate cancers. Corcept’s first controlled study in oncology – relacorilant plus nab-paclitaxel for the treatment of patients with ovarian cancer – has demonstrated statistically significant and clinically meaningful results.

About Relacorilant

Relacorilant is a non-steroidal, selective glucocorticoid receptor modulator that does not bind to the body’s other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders, including ovarian and adrenal cancer and Cushing’s syndrome. Relacorilant is proprietary to Corcept and is protected by composition of matter and method of use patents, as well as orphan drug designation in the United States for the treatment of pancreatic cancer and both the United States and the European Union for the treatment of Cushing’s syndrome.