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Samsung Pharm & GemVax present pancreatic cancer immunotherapeutic drug, RIAVAX™, phase III results at ASCO 2021

On June 5, 2021 Samsung Pharm Co., Ltd. reported that the company presented the results of a phase III clinical trial of its pancreatic cancer immunotherapeutic drug candidate called ‘RIAVAX (GV1001)’ conducted in Korea at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual meeting (Press release, GemVax, JUN 5, 2021, View Source;gemvax-present-pancreatic-cancer-immunotherapeutic-drug-riavax-phase-iii-results-at-asco-2021-301306066.html [SID1234583623]).

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ASCO 2021, which celebrates its 57th anniversary this year, runs from June 4th to June 8th and will be held virtually due to COVID-19. Some 4500 experts in the field gather every year to share and discuss the results of leading clinical research and advance cancer research and development.

‘RIAVAX ( GV1001)’ is a peptide drug derived from human telomerase consisting of 16 amino acids. It has been developed as an immunotherapeutic drug for pancreatic cancer which works to activate immune cells to attack the cancer cells. It is known to extend survival in pancreatic cancer patients with high serum eotaxin levels when administered in combination with the current chemotherapy, Gemcitabine/Capecitabine.

The RIAVAX Phase III clinical trial was conducted to investigate safety and efficacy when given in combination with Gemcitabine/Capecitabine in 148 patients with locally advanced and metastatic pancreatic cancer at 16 hospitals across Korea, including the Severance Hospital.

The results of the clinical trial showed median overall survival (OS) of 11.3 months in the treatment group compared to 7.5 months in the control group, with statistically significant improvement (p=0.021). Another key endpoint which is time to tumor progression (TTP) also showed a statistical significance with 7.3 months in the treatment group compared with 4.5 months in the control group (p=0.021). No specific safety issues were reported. These results indicate that RIAVAX should be considered as one of the treatment options for patients with locally advanced and metastatic pancreatic cancer with high serum eotaxin levels.

Samsung Pharm in-licensed domestic rights to RIAVAX from its affiliate, GemVax & KAEL Co., Ltd. in 2014. GemVax & KAEL conducted a large-scale Phase III clinical trial of RIAVAX (‘TeloVac’) in the United Kingdom from 2007 to 2011, with 1,062 locally advanced and metastatic pancreatic cancer patients. The results of the TeloVac study were presented at 2013 ASCO (Free ASCO Whitepaper) followed by the presentation an analysis of the correlation between the high eotaxin level and improved survivals in pancreatic cancer patients administered with GV1001 at 2014 ASCO (Free ASCO Whitepaper).

Analysis of MINDACT Study Confirms MammaPrint Accurately Identifies Extremely Indolent Ultra Low Risk Breast Cancers

On June 5, 2021 Agendia, Inc., a world leader in precision oncology for breast cancer, reported that data from the landmark MINDACT study will be shared at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in an oral presentation (Press release, Agendia, JUN 5, 2021, View Source [SID1234583617]). The presentation will detail an additional risk threshold previously established within the MammaPrint Low Risk category, identifying patients with an Ultra Low Risk of distant recurrence, essentially meaning the patient’s tumor is very unlikely to recur or metastasize over at least 20 years of follow-up, according to prior studies. This information could be helpful in further tailoring adjuvant treatment for patients with early stage breast cancer.

In the oral presentation, titled "Outcome of patients with an ultralow risk 70-gene signature in the MINDACT trial," Josephine Lopes Cardozo, MD, first author of the abstract, PhD Candidate at the Netherlands Cancer Institute and fellow at the EORTC, will outline that in the MINDACT study, patients with an UltraLow Risk signature have an excellent prognosis, with 8-year breast cancer specific survival above 99% regardless of clinical risk status, and an 8-year distant metastasis free interval of 97%. The presentation, part of ASCO (Free ASCO Whitepaper) 2021’s Breast Cancer track, can be accessed here.

"The Ultra Low threshold identifies patients who may be candidates for further de-escalation of treatment," said Dr. Lopes Cardozo. "To give the patient’s care team this kind of prognostic insight at the time of diagnosis will hopefully allow for many patients to avoid over treatment and further reduce the risk of side effects while maintaining excellent survival."

The MINDACT trial, an independent, phase III, prospective, randomized clinical trial sponsored by the European Organization for Research and Treatment of Cancer (EORTC), was conducted with the primary goal of determining whether Agendia’s 70-gene MammaPrint test could be used to de-escalate clinically high risk patients with early stage breast cancer from chemotherapy treatment. The study enrolled nearly 7,000 patients with newly-diagnosed breast cancer, and at median long-term follow-up of 8.7 years, 46% of clinically high risk patients with a MammaPrint Low Risk result could forgo chemotherapy without negatively affecting their outcomes. These data were recently published in The Lancet Oncology.

The current study to be presented at ASCO (Free ASCO Whitepaper) focuses on the clinical characteristics and outcomes of the 1,000 women with a MammaPrint Ultra Low risk status enrolled in MINDACT. Consistent with three prior studies presented since 2017, these data show a nearly 100% breast cancer specific survival at 8 years, with 5 years of anti-estrogen therapy, and excellent outcomes (97.8% DMFI) for the 157 Ultra Low Risk women who received no systemic therapy.

"The confirmation of the clinical importance and excellent prognosis of the MammaPrint Ultra Low Risk category provides further support for the inclusion of this information in the management of endocrine therapy, particularly for those women experiencing severe side effects, and struggling to remain on their prescribed treatment," said William Audeh, MD, Chief Medical Officer at Agendia. "We are extremely proud to have contributed to the EORTC’s MINDACT study, which has influenced the clinical treatment of patients and will inspire ongoing translational research that will contribute to the library of data we need to personalize the treatment of breast cancer."

Beyond answering the traditional adjuvant chemotherapy question, the MINDACT study continues to produce a wealth of insights with immediately meaningful clinical implications and access to an unprecedented full genome dataset for further research, resulting in widespread health system cost savings.

At ASCO (Free ASCO Whitepaper) 2021, Agendia also presented a larger suite of data from the company’s groundbreaking FLEX registry, a large-scale, prospective, observational breast cancer study using whole transcriptome sequencing, recruiting patients from various ethnicities, ages and genders representative of the total breast cancer population as part of an ongoing effort to increase representation of diverse populations and data in clinical trials.

Auransa and POLARISqb enter research collaboration finding treatments for neglected women’s diseases

On June 04, 2021 Auransa, Inc., an artificial intelligence (AI) company developing precision medicines in areas of unmet medical needs, and Polaris Quantum Biotech (POLARISqb), a quantum drug design company, reported a research collaboration addressing therapeutics for neglected diseases disproportionately affecting women (Press release, Auransa, JUN 4, 2021, View Source [SID1234635628]).

The partnership seeks to discover treatments that may tackle many such diseases, and their complementary expertise promises to seek solutions that elude medical research. Auransa is an AI-driven biotech company, with a pipeline of novel compounds for various diseases. Auransa’s proprietary predictive computational platform, SMarTR Engine, uses computational approaches to tackle disease heterogeneity to predict targets and compounds, generating insights from molecular data. POLARISqb built the first drug discovery platform using quantum computing, making the process ten times faster. POLARISqb’s TachyonTM platform scans billions of molecules from a massive chemical space, finding novel molecular drugs.

"We are excited about collaborating with Polaris to undertake a neglected area in the pharmaceutical industry. As women CEOs, we’ve joined forces to tackle female diseases like endometriosis, polycystic ovary syndrome, triple negative breast cancer or ovarian cancer. Together, I believe that we will be able to combine our expertise in biology and chemistry to generate quality solutions for hard to tackle or neglected diseases affecting women’s health." stated Pek Lum, Ph.D., CEO of Auransa.

"Quantum Computing technology is coming of age, allowing us to shorten the time to discover new drugs and scale up to multiple targets. We are thrilled to be able to combine our technology with Auransa’s and tackle neglected diseases affecting women. Together, we have unique perspectives on the industry and of unmet needs the pharmaceutical industry can and should tackle, utilizing the best technology available." said Dr. Shahar Keinan, POLARISqb CEO.

Bolt Biotherapeutics Presents Preliminary Results from Phase 1/2 Trial of Lead HER2-targeting Boltbody™ ISAC BDC-1001 at ASCO 2021

On June 4, 2021 Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, reported that a poster presentation discussing preliminary data from the Phase 1/2 clinical trial of BDC-1001, Bolt’s lead candidate, was presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held virtually from June 4-8, 2021 (Press release, Bolt Biotherapeutics, JUN 4, 2021, View Source [SID1234618696]). The poster is titled "Preliminary results from a phase 1/2 study of BDC-1001, a novel HER2 targeting TLR7/8 immune-stimulating antibody conjugate (ISAC), in patients (pts) with advanced HER2-expressing solid tumors."

BDC-1001 is a human epidermal growth factor receptor 2, or HER2, ISAC comprised of a HER2-targeting biosimilar of trastuzumab conjugated to one of Bolt’s proprietary TLR7/8 agonists, for the treatment of patients with HER2-expressing solid tumors, including HER2-low tumors. As of January 29, 2021, Bolt had treated 20 patients and BDC-1001 appeared to be well tolerated with mild to moderate adverse events; no dose-limiting toxicities or drug-related serious adverse events were observed. Clinical activity was seen in the form of stable disease, reductions in tumor volume including a confirmed partial response and increases in pharmacodynamic markers that Bolt believes are consistent with its proposed mechanism of action.

"This poster reinforces the favorable safety and tolerability demonstrated in the first 20 patients treated with BDC-1001 in this first-in-human study in patients with HER2-expressing cancers," said Manish R. Sharma, M.D., of START Midwest, a principal investigator in Bolt’s ongoing BDC-1001 Phase 1/2 trial. "We have seen signs of activity, including a patient with a confirmed partial response and others with stable disease, in a population with diverse tumor types and a median of four prior lines of therapy."

The BDC-1001 Phase 1/2 trial is expected to enroll up to a total of 390 patients and is being conducted in four parts, with dose-escalation dose-expansion parts exploring both monotherapy and combination with a PD-1 checkpoint inhibitor. The monotherapy dose-escalation part of the trial continues to proceed according to plan, and full results are expected to be presented in the second half of 2021. Bolt plans to advance to the monotherapy Phase 2 dose-expansion cohorts and the dose-escalation combining BDC-1001 with an anti-PD-1 antibody later this year.

"I am grateful to everyone on the team for their hard work throughout this trial, especially during the pandemic," said Ecaterina Dumbrava, M.D., of The University of Texas MD Anderson Cancer Center, a principal investigator of the BDC-1001 Phase 1/2 trial. "These initial data provide additional support for the ISAC targeted approach that stimulates both the innate and adaptive immune systems in the treatment of cancer patients."

The abstract and poster from the ASCO (Free ASCO Whitepaper) presentation can be found on the ASCO (Free ASCO Whitepaper) website, as well as on the Bolt website.

About Bolt Biotherapeutics’ Immune-stimulating Antibody Conjugate (ISAC) Platform Technology
The Boltbody ISAC platform technology harnesses the ability of innate immune agonists to convert cold tumors into immunologically hot tumors, thereby illuminating tumors to the immune system and allowing them to be invaded by tumor-killing cells. Boltbody ISACs have demonstrated the ability to eliminate tumors following systemic administration as monotherapy in preclinical models and have also led to the development of immunological memory, which is predicted to translate into more durable clinical responses for patients.

About the Ongoing BDC-1001 Phase 1/2 Study in Patients with HER2-Expressing Solid Tumors
The Phase 1/2, multi-center, open-label study is evaluating the safety, pharmacokinetics, pharmacodynamics and proof of mechanism of BDC-1001 in patients with HER2-expressing solid tumors. The first portion of the study includes a monotherapy dose-escalation phase in which cohorts of patients will receive ascending intravenous doses of BDC-1001 to determine the maximum tolerated dose and/or the recommended dose to advance into expansion cohorts and Phase 2 based on safety and tolerability. The second portion of the study is a dose expansion phase in which patients will receive BDC-1001 monotherapy to further evaluate the safety, tolerability and clinical antitumor activity of the recommended Phase 2 dose. The study also includes similar dose escalation and expansion portions evaluating the combination of BDC-1001 with an anti-PD1 checkpoint inhibitor. Please refer to www.clinicaltrials.gov NCT04278144 for additional clinical trial information.

Sorrento and Researchers at Karolinska Institutet Have Signed a Research Collaboration Agreement on iPSC-Derived Dimeric Antigen Receptor-Modified Natural Killer (DAR-NK) Cells With The Vision To Bring “Off-The-Shelf" NK Cell-Based Cancer Treatments Rapidly To Patients

On June 4, 2021 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported that the Company has entered into an additional collaborative agreement with NextGenNK Competence Center-associated research groups at the Department of Medicine, Huddinge, Karolinska Institutet ("KI") in Stockholm, Sweden, aimed at producing novel cell-based therapeutics using natural killer ("NK") cells derived from induced pluripotent stem cells ("iPSCs") (Press release, Sorrento Therapeutics, JUN 4, 2021, View Source [SID1234583901]). Sorrento and KI are collaborative partners in the Competence Center for the development of next-generation NK cell-based cancer immunotherapies ("NextGenNK") coordinated by KI.

Under the agreement, Sorrento will provide know-how in the core chimeric antigen receptor ("CAR") and dimeric antigen receptor ("DAR") technologies and support the collaborative effort to develop new CAR-NK and DAR-NK candidates, as well as fund the translational validation of the technologies. Multiple product candidates will be developed and tested in the initial phase of the planned work, with the goal that the candidate products will qualify for further human clinical trials.

The foundational Sorrento research assets critical to this program are novel proprietary CAR and DAR constructs identified through Sorrento’s proprietary G-MAB fully human antibody library and previously validated as determinants of cell-based therapy potency against hematologic and solid tumors.

"It is a privilege to continue and extend our collaborative work with the distinguished KI faculty. We are proud to contribute our technologies to produce new optimized off-the-shelf adoptive NK cell immunotherapies", said Dr. Henry Ji, Chairman and CEO of Sorrento. "Our partnership with KI combines our know-how with the expertise of a world-renowned institution in the field of NK cell therapy. These types of partnerships are essential in advancing medicine and bringing new solutions to cancer patients in need."

KI scientists within NextGenNK will establish iPSC-derived NK-based therapeutic candidates utilizing Sorrento’s constructs and DAR technology. Work within KI has contributed to the development of methodologies that consistently generate robust and potent NK cell lineages following iPSC differentiation. Clinical trials of NK cell-based therapies for treatment of multiple myeloma led by researchers at KI have yielded promising preliminary results with long-lasting remissions. In a very cross-knit collaboration between Sorrento and KI, the team will aim to establish novel allogeneic, off-the-shelf, retargeted NK cell-based therapies.

Utilizing iPSCs enables mass production of off-the-shelf NK cell therapies that leverage Sorrento’s existing manufacturing infrastructure and know-how. Sorrento expects these validated re-engineered NK cell-based therapeutic candidates could potentially become a new generation in off-the-shelf treatments for cancer and infectious diseases. The core research will be performed at Karolinska Institutet with active involvement of the Sorrento R&D team in San Diego.

"The present collaboration brings together key competence from Sorrento and KI in an important area of cancer immunotherapy research. Sorrento’s intellectual contribution to the research at the Competence Center is a critical piece in enabling retargeted off-the-shelf NK cell products", said Evren Alici, Principal Investigator at KI.

"This is an important step in further enabling academic and industrial partnerships in the mission of achieving common goals for advancement of novel cancer immunotherapies," said Hans-Gustaf Ljunggren, Director of the NextGenNK Competence Center.