On June 29, 2022 Chimeric Therapeutics Ltd (ASX:CHM) reported that it has expanded its licensing agreement with the University of Pennsylvania to include non-exclusive access to its lentiviral vector plasmid system, a viral vector technology critical for the manufacture of chimeric antigen receptor (CAR) T cells (Press release, Chimeric Therapeutics, JUN 29, 2022, View Source [SID1234616350]).

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Licensing of this technology will support Chimeric’s efforts to develop and commercialise its CHM 2101 CDH17 CAR T technology, offering improved safety as a third-generation technology.

The amended licence agreement with Pennsylvania University will allow CHM to manufacture clinical-grade lentiviral vector for use in its planned Phase 1 study of CHM2101 for gastrointestinal cancers.

Chimeric will also be able to cross-reference regulatory information on file with the US Food and Drug Administration (FDA) to support the filing of an investigational new drug (IND) designation for CHM 2101.

CDH17 CAR T technology
CHM 2101 (CDH17 CAR T) is based on a novel third-generation iteration of the CDH17 CAR T technology invented by the University of Pennsylvania.

The treatment is at a pre-clinical development stage, with plans for a Phase 1 clinical trial assessing neuroendocrine tumours, colorectal, gastroesophageal and gastric cancer already in the works.

Preclinical data has indicated a particular efficacy in solid tumours, having demonstrated the complete eradication of tumour cells with no relapse and no toxicity to normal tissue.

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 CanariaBio Inc. (developing its biotechnology assets through its subsidiaries, MH C&C and OncoQuest Pharma US Inc.) reported that it has reached 50% of target enrollment of 602 patients for its pivotal Phase III clinical study of its lead product oregovomab, in combination with standard of care chemotherapy (carboplatin and paclitaxel) for the treatment of front-line advanced ovarian cancer patients (Press release, CanariaBio, JUN 29, 2022, View Source [SID1234616385]).

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This double blind and placebo controlled multinational trial (FLORA-5, GOG-3035, NCT04498117) is currently accruing patients at over 137 centers in Argentina, Belgium, Brazil, Canada, Chile, Czech Republic, Hungary, Italy, Korea, Mexico, Poland, Spain, Taiwan and US; with additional sites in India and Romania being activated. This study seeks to confirm the observations of Brewer et al (Gynecology Oncology 2020 156:523-529) that demonstrated oregovomab in combination with carboplatin and paclitaxel improved both progression free and overall survival relative to chemotherapy which was statistically significant and clinically meaningful in the absence of incremental toxicity.

For this ongoing Phase-III study, the last Independent Data Safety Monitoring Board (IDSMB) meeting held in March 2022 identified no safety concerns and IDSMB recommended to continue the study without modifications.

"We are excited about reaching this important milestone, which is a testament of the hard work that all our investigators, GOG leadership, team members and collaborators has put in, and are grateful to the patients that have participated in the study," said Dr. Sunil Gupta MBBS, FRCPC, Chief Medical Officer of OncoQuest Pharma US, Inc. (a subsidiary of CanariaBio Inc.) "We remain on track with our projected enrollment, and we are excited about the potential benefits that our drug may bring to patients with ovarian cancer."

About Oregovomab.
Oregovomab is a murine IgG against CA 125. Indirect immunization with oregovomab interacts with immune modulating properties of infused paclitaxel and carboplatin resulting in synergistic clinical benefit as observed in a phase 2 trial. In a randomized Phase 2 clinical trial of 97 patients, treatment with Oregovomab in combination with chemotherapy had demonstrated a highly statistically significant and clinically meaningful outcome for both progression-free and overall survival compared to standard of care chemotherapy (carboplatin and paclitaxel). The risk of progression and of death was reduced by more than 50% when compared to control arm, and safety data showed that oregovomab did not add incremental toxicity to the chemotherapy regimen. Clinical and translational results were published in Gynecology Oncology 2020 156:523-529) and Cancer Immunology and Immunotherapy 2020 69: 383-397, respectively. To learn more, visit www.FLORA-5.com.

On June 29, 2022 ReCode Therapeutics, a genetic medicines company using superior delivery to power the next wave of messenger RNA (mRNA) and gene correction therapeutics, reported the close of a Series B extension financing round, co-led by new investors, Leaps by Bayer, the impact investment unit of Bayer AG, AyurMaya, an affiliate of Matrix Capital Management, and with participation from Amgen Ventures (Press release, ReCode Therapeutics, JUN 29, 2022, View Source;utm_medium=rss&utm_campaign=recode-therapeutics-to-expand-next-generation-delivery-platform-and-diversify-genetic-medicines-pipeline-with-oversubscribed-series-b-financing-totaling-200m [SID1234619533]). With the additional $120M in new financing, the company has secured a total of $200M in Series B funding. In connection with the financing, Alan Colowick, M.D., M.P.H., managing director of Matrix, and Rakhshita Dhar, senior director of Venture investments Health at Leaps by Bayer, will join ReCode’s Board of Directors.

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"At AyurMaya, we help build companies that have the potential to transform the therapeutic landscape for patients. ReCode has an impressive combination of groundbreaking science, a highly accomplished leadership team and investor base, and the opportunity to have an immense impact on accelerating precision genetic medicines through delivery to disease-relevant cells," said Alan Colowick, M.D., M.P.H, Matrix Capital Management. "I am delighted to join ReCode’s Board during this important growth trajectory for the company and am eager to work with the leadership team to expand ReCode’s next generation genetic medicines delivery platform and diversify its pipeline."

The initial Series B financing announced in October 2021 was co-led by Pfizer Ventures and EcoR1 Capital and included Sanofi Ventures, Orbimed, Vida Ventures, MPM Capital, Colt Ventures, Hunt Technology Ventures L.P., Osage University Partners, Tekla Capital Management LLC, Superstring Capital, and NS Investment. Proceeds from the financing will be used to fund the diversification of ReCode’s pipeline into central nervous system (CNS), liver, and oncology indications, while continuing to advance ReCode’s lead mRNA programs for primary ciliary dyskinesia (PCD) and cystic fibrosis (CF) into the clinic. The funds also will be used to advance development of ReCode’s platform to deliver a wider range of genetic medicine cargoes, including additional gene correction modalities and small interfering RNA (siRNA) therapies, to a wider range of target cell types in a predictable and programmable fashion.

"The successful administration of billions of doses of mRNA COVID-19 vaccines, and continued progress with novel RNA and gene correction therapeutics, have catapulted us into a new era of possibility for genetic medicines. We are harnessing that potential with our novel selective organ targeting (SORT) lipid nanoparticle (LNP) delivery platform which is engineered with unique properties to enable delivery of genetic therapeutics directly to the organs and cells most impacted by disease, offering improved efficacy and potency. This potentially game-changing precision medicine technology creates vast possibilities for genetic medicines which have been limited by current technologies," said Shehnaaz Suliman, M.D., MBA, M.Phil., chief executive officer and board member, ReCode Therapeutics. "With the infusion of new capital and the addition of AyurMaya, an affiliate of Matrix Capital Management, and Leaps by Bayer to our high-caliber board, we are confident that our team will successfully drive ReCode’s mission to develop new precision genetic medicines enabled by superior delivery."

The capability to precisely target specific organs and cell types is important for maximizing the efficacy of genetic medicines and limiting potential adverse effects. Additionally, as evidenced with the mRNA COVID vaccines and novel RNA and gene correction therapeutics, LNP packaging enables redosing. For people with genetic diseases such as CF that require potentially lifelong therapy, this means LNP delivered therapeutics can be administered repeatedly over time, potentially without significant immunogenicity.

"The ability to directly target specific organs and cells beyond the liver remains a key challenge for genetic medicines," said Juergen Eckhardt, head of Leaps by Bayer. "At Leaps by Bayer, we strongly focus on finding breakthrough solutions that have the potential to make a meaningful difference for people with rare genetic diseases, and we believe ReCode is a unique company in our industry whose innovations have the potential to fundamentally shift an entire area of genetic medicine."

In May 2022, ReCode presented preclinical data from its two lead programs in PCD and CF at the American Thoracic Society (ATS) 2022 International Conference. These data demonstrated that selective organ targeting (SORT) LNP-formulated therapeutic candidates for PCD and CF can be precisely delivered directly to disease-relevant cells without significant exposure to other tissue, effectively releasing the encapsulated genetic cargo, and expressing the correct proteins at relevant levels. The company plans to advance to investigational new drug (IND) filings for PCD and CF in late 2022 and mid-2023, respectively.

About the SORT LNP Platform

ReCode is differentiated by its first-in-class modular genetic medicines delivery platform. The company’s selective organ targeting (SORT) lipid nanoparticle technology (LNP) platform is the foundation for its pipeline. Pioneered by co-founder Professor Daniel J. Siegwart, Ph.D., of the University of Texas, and described by Nature as one of the "Seven Technologies to Watch in 2022," ReCode’s SORT LNP platform is an innovation beyond the lipid delivery system used by the mRNA COVID vaccines and novel RNA and gene correction therapeutics.

LNPs are used to package and deliver genetic cargo such as mRNA. When delivered into the blood, first-generation LNPs primarily are taken up by the liver, which limits their utility for broad therapeutic applications. ReCode’s SORT LNPs are engineered with a biochemically distinct fifth lipid to help the body "sort" and direct the LNPs to other targeted organs such as the lung and spleen, with the ability to bypass the liver, if desired.

Beyond its highly selective targeting capability, ReCode’s SORT LNP platform is further distinguished by its versatility in both mode of administration (including IV, inhaled, subcutaneous, intramuscular, and intrathecal), and the diversity of genetic cargo that can be delivered (including mRNA, siRNA, DNA, gene correction components and mixed cargoes). Together, these qualities offer vast opportunities to address a wide range of unmet medical needs through a precision medicine approach that delivers the right medicine to the right organs and cells using the optimal mode of administration.

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.