On June 29, 2022 Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of therapeutics designed to activate the immune response to cancers and infections, reported expanded data from the Phase 1b study of botensilimab (Fc-enhanced anti-CTLA-4) and balstilimab (anti-PD-1) in patients with microsatellite stable colorectal cancer (MSS CRC) (Press release, Agenus, JUN 29, 2022, View Source [SID1234616374]). The data demonstrate that the combination offers strong durability and superior efficacy than what has been reported in separate trials for standard of care and other investigational therapies in 2L+ MSS CRC.

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"These data reinforce the strong therapeutic potential of botensilimab, when used in combination with balstilimab, in cold tumors such as MSS CRC," said Steven O’Day, MD, Chief Medical Officer at Agenus. "Thus far, botensilimab has demonstrated activity in nine cold and treatment-resistant cancers, and we plan to initiate a robust, global Phase 2 program, including in MSS CRC, later this year."

Study Highlights

A total of 41 evaluable patients with metastatic MSS CRC received either 1 or 2 mg/kg botensilimab Q6W, and 3 mg/kg balstilimab Q2W. Patients were heavily pre-treated, with a median of 4 prior lines of therapy, and 34% had received prior immunotherapy. The botensilimab/balstilimab combination produced superior responses and strong durability, relative to what has been reported in separate trials for standard of care and other combinations currently in development.

Objective responses:

24% overall response rate
73% disease control rate (partial response + stable disease)
50% objective responses with greater than 50% tumor reduction
Durability:

80% objective responses ongoing at data cut-off
30% objective responses exceeding 1 year
Patient Sub-Populations:

Objective responses in 5 patients with RAS mutations for a 24% overall response rate and 81% disease control rate in this population; other PD-1 combinations in separate trials have reported only rare responses in this population (≤1% response rate)
Responses observed in patients with metastases historically resistant to immunotherapy, including patients with malignant pleural effusions, soft tissue, peritoneal, retroperitoneal, and bone metastases
Tolerability:

Botensilimab was well tolerated, with no grade 4/5 treatment-related adverse events
Rates of gastrointestinal and skin toxicities were comparable to those reported with first-generation CTLA-4 inhibitors
"Colorectal cancer is the second leading cause of cancer-related death worldwide, with roughly 95% classified as microsatellite stable and historically unresponsive to immunotherapy. Treatment resistant MSS CRC patients lack effective options, with standard of care offering only a 1-2% response rate and a median expected survival ranging from 6 to 7 months," said Anthony El-Khoueiry, MD, Phase I Program Director at the USC Norris Comprehensive Cancer Center, Keck Medicine of USC. "The combination of robust response rate, durability, and tolerability demonstrated by botensilimab and balstilimab supports further development of the combination in MSS CRC, as well as more broadly, in other cold and treatment-resistant tumors."

Presentation Details

The data were presented today at 7:05 AM EDT in a late-breaking oral presentation at the ESMO (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer in Barcelona, Spain.

Abstract Title: Botensilimab, a Novel Innate/Adaptive Immune Activator, Plus Balstilimab (Anti-PD-1) for Metastatic Heavily Pretreated Microsatellite Stable Colorectal Cancer

Abstract Number: LBA-09

Presenting Author: Dr. Anthony El-Khoueiry, M.D., Associate Director of Clinical Research at the USC Norris Comprehensive Cancer Center, Keck School of Medicine

Investor Webcast

The Company will host an investor webcast today at 10:00 AM EDT to review these data. Participants may register here, or on the Investors section of the Agenus website at investor.agenusbio.com. The webcast will include presentations by the below speakers and will be followed by a Q&A session:

Steven O’Day, M.D., Agenus’ Chief Medical Officer
Dr. Anthony El-Khoueiry, M.D., Associate Director of Clinical Research at the USC Norris Comprehensive Cancer Center, Keck School of Medicine
Dr. Manuel Hidalgo, Chief of the Division of Hematology and Medical Oncology at Weill Cornell Medicine/NewYork-Presbyterian Hospital, and
Dr. Heinz-Josef Lenz, M.D., Professor of Medicine and J. Terrence Lanni Chair in Gastrointestinal Cancer Research, Keck School of Medicine
Following the webcast, an archived version will be available on the Agenus website.

On June 29, 2022 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that it will hold its second-quarter 2022 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. ET on Thursday, July 28 (Press release, Merck & Co, JUN 29, 2022, View Source [SID1234616373]). During the call, company executives will provide an overview of Merck’s performance for the quarter and outlook.

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Investors, journalists and the general public may access a live audio webcast of the call via this weblink. A replay of the webcast, along with the sales and earnings news release, supplemental financial disclosures, and slides highlighting the results, will be available at www.merck.com.

Participants may join the call by dialing 877-692-8955 (USA Toll-Free) or 234-720-6979. If you are calling from other countries, visit this weblink. All dial-in participants can use the access code 1857604. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team.

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.