On September 29, 2021 EpicentRx Inc., a leading-edge drug and device company with cancer and inflammatory disease-targeted platforms, reported the completion of patient enrollment in the first cohort of a Phase 1 trial called BETA PRIME for its TGF-beta (TGFß) trap-enhanced cancer targeting adenovirus (Press release, EpicentRx, SEP 29, 2021, https://www.prnewswire.com/news-releases/epicentrx-announces-completion-of-first-cohort-in-phase-1-beta-prime-trial-with-adapt-001-301387822.html [SID1234590491]).

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AdAPT-001 Mechanism of Action
The study, which has successfully enrolled three patients in the first cohort, is evaluating the safety, tolerability, optimal dose level and immunogenicity for single and multiple doses of AdAPT-001 both alone and in combination with a checkpoint inhibitor when administered to advanced cancer patients.

TGFß, a protein that inhibits the activity of the immune system as a safeguard against severe inflammation and autoimmunity, is hijacked by cancer cells to escape immune elimination. Therapeutically resistant cancer is an area of high unmet medical need, which this triple combination strategy involving the AdAPT-001 cancer targeting virus armed with a TGFß trap and a checkpoint inhibitor intends to address.

The AdAPT-001 Phase 1 multi-center clinical trial is conducted in three parts starting with a single dose escalation that is followed by an expansion cohort at the highest tolerable dose prior to combination with a checkpoint inhibitor.

EpicentRx’s proprietary platform of next-generation oncolytic viruses that preferentially infect and kill cancer cells has been developed with over two decades of oncolytic virus research by EpicentRx’s CEO, Dr. Tony Reid, MD, PhD and VP of Viral Therapy, Dr. Christopher Larson, MD, PhD. EpicentRx’s discovery pipeline of multiple differentiated oncolytic virus candidates are potent and tumor-selective.

"The completion of enrollment in cohort 1 of the BETA PRIME trial is the first step for EpicentRx on its journey to bring a first-in-class treatment to the millions of patients in America and ultimately around the world that are afflicted with resistant cancer," said Dr. Tony R. Reid, Chief Executive Officer of EpicentRx. "To date, we have seen no serious adverse events in the trial. To defeat cancer what is needed are therapeutic agents like AdAPT-001 that are not only as genetically sophisticated as the tumor itself but also that are minimally toxic."

The trial is titled "A First in Human Study of AdAPT-001 in Subjects With Refractory Solid Tumors." Trial design details can be found at View Source

On September 29, 2021 Synaffix B.V., a biotechnology company focused on commercializing its clinical-stage platform technology for the development of antibody-drug conjugates (ADCs) with best-in-class therapeutic index, reported that its partner Shanghai Miracogen has commenced a Phase I trial in the US with MRG004A, an ADC designed to treat solid tumors (Press release, Synaffix, SEP 29, 2021, View Source [SID1234590466]). This is the 3rd ADC built with GlycoConnect ADC technology to enter the clinic.

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Synaffix signed a licensing agreement with Shanghai Miracogen (now fully owned by LEPU BIOPHARMA CO., LTD), a Chinese biotechnology company with a clinical-stage pipeline of ADCs, in 2019. This major development has triggered a milestone payment to Synaffix.

MRG004A is an ADC targeting human Tissue Factor (TF), conjugated using GlycoConnect site specific conjugation technology. In preclinical studies, MRG004A exhibited significantly improved stability in circulation, enhanced efficacy and tolerability compared to the conventional ADC technology.

Mary Hu, CEO of Miracogen and Co-CEO of Lepu Biopharma said:

"We have been very pleased with our collaboration with Synaffix and the data that we generated with ADCs built with its outstanding ADC technology. MRG004A has demonstrated the potential to become a best-in-class TF-targeted ADC and to address high unmet medical need for patients."

Peter van de Sande, CEO of Synaffix, said:

"This is an important milestone in our collaboration and we look forward to continuing our successful partnership as Miracogen develops multiple best-in-class ADC product candidates using our technology.

There are now 3 ADCs that were built with Synaffix’s ADC technology in clinical development. We have now announced 6 collaborations that we have established with biotech and pharma partners around the world and more than 10 ADCs are being developed under those license agreements. We look forward to announcing further progress and additional partnerships in the coming months."

In the last few months, Synaffix has signed significant agreements with Kyowa Kirin, a global specialty pharmaceutical company; ProfoundBio, an emerging oncology biotherapeutics company; and Innovent Biologics, a leading biopharmaceutical company developing innovative medicines for the treatment of major diseases. These come in addition to preexisting collaborations with ADC Therapeutics, Mersana Therapeutics and Shanghai Miracogen.

On September 29, 2021 Freenome, a privately-held biotech company, reported that new research today at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Pancreatic Cancer (Press release, Freenome, SEP 29, 2021, View Source [SID1234590493]). The data demonstrated the potential of extending Freenome’s multiomics approach into other cancers, such as pancreatic cancer, with biomarkers already embedded in the existing platform.

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Freenome’s platform uses a routine blood test to detect cancer.

"An accurate blood-based test like this could be a powerful tool for early diagnosis and treatment, impacting so many patients," said Randall Brand, M.D., professor of Medicine and Human Genetics at the University of Pittsburgh School of Medicine, and co-author of the study. "We are hoping to further validate the findings through additional studies, which are already underway."

Pancreatic cancer is one of the deadliest cancers, with an overall five-year survival rate of 11%. If detected at an early stage, the five-year survival rate increases to 42%.[1] The only FDA-authorized test for pancreatic cancer is the carbohydrate antigen 19-9 (CA19-9), which is only cleared for monitoring response to therapy.

This retrospective study of 75 participants evaluated whether Freenome’s multiomics approach of combining methylation and CA19-9 signals together (as a subset of existing analytes in the platform) detected pancreatic cancer in stages II, III and IV with higher sensitivity than either alone.

Across all stages studied, Freenome’s approach achieved a sensitivity of 93% at a nominal specificity of 96%. At an identical specificity, the sensitivity of methylation or CA19-9 alone was 74% and 87%, respectively. In stages II, III and IV, the multiomics approach achieved a sensitivity of 82%, 89%, and 100%, respectively.

This new study demonstrates that Freenome’s platform can be used to detect pancreatic cancer in addition to colorectal cancer (CRC). Last year, Freenome presented data showing a sensitivity of 94% at a specificity of 94% for early-stage (I/II) CRC using their multiomics platform.[2] Freenome’s CRC test is currently undergoing analytical and clinical validation.

"We’re demonstrating success in detecting CRC and advanced adenomas in blood. We’re now expanding our platform to detect additional cancers," said Mike Nolan, chief executive officer, Freenome. "Our goal is to transform the way cancer of all types is managed by enabling early detection, and this data on pancreatic cancer is an important step in that direction."

On September 28, 2021 MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, reported that it will be participating at the Lytham Partners Fall 2021 Investor Conference on Tuesday, October 5, 2021 at 11:45 am (ET) (Press release, Mannkind, SEP 28, 2021, View Source [SID1234590369]). Presenting from the Company will be its Chief Executive Officer, Michael Castagna, PharmD.

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Interested parties can access a link to the live webcast of the presentations from the Events & Presentations section of the Company’s website at View Source The webcast replay may be accessed at the same location for 14 days following the live presentation.

On September 28, 2021 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company"), a leader in the development of targeted radiotherapies for patients with unmet needs, reported that it will present at the Cantor Fitzgerald Virtual Global Healthcare Conference, which is being held from September 27th to 30th (Press release, Actinium Pharmaceuticals, SEP 28, 2021, View Source [SID1234590397]).

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Presentation Details:

Event:

Cantor Fitzgerald Virtual Global Healthcare Conference

Date:

Wednesday, September 29th

Time:

3:20 p.m. ET

Webcast:

The presentation will be accessible on the investor relations section of Actinium Pharmaceuticals website at www.actiniumpharma.com.

In addition, members of the executive team will be available for one-on-one meetings with conference attendees. Those interested in scheduling a meeting may do so by contacting their Cantor Fitzgerald representative.