On July 5, 2021 Prescient Therapeutics Ltd (ASX: PTX) reported the back of news its cancer treatment drug, OmniCAR, has been substantially de-risked (Press release, Prescient Therapeutics, JUL 5, 2021, View Source;utm_medium=rss&utm_campaign=the-prescient-asxptx-share-price-rocketed-10-higher-today-heres-why [SID1234584590]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

After reaching a multi-year high of 26.5 cents this morning, the Prescient share price has retreated slightly and is currently trading at 25 cents apiece, up 8.7%.

Today, Prescient announced positive results from in silico immunogenicity testing of SpyTag and SpyCatcher, OmniCAR’s key binding components.

Let’s take a look at today’s news from the cancer treatment development company.

Positive immunogenicity results
According to Prescient’s release, the results have de-risked the entire OmniCAR platform.

The in silico tests found SpyTag and SpyCatcher don’t inspire a negative response from human antibodies – meaning, the human body won’t attack the treatment itself.

In silico tests are done on a computer using algorithms. In this case, the tests mimicked the human body’s response to introduced medication.

OmniCAR combines controllable CAR T-cell therapy and multi-antigen targeting. According to Prescient, high levels of immunogenicity – a negative response from antibodies – can negatively impact CAR-T cell expansion and persistence, which can affect the safety and clinical response of the treatment.

OmniCAR is currently being developed to treat acute myeloid leukemia, Her2+ solid tumours (including breast, ovarian and gastric cancers), and the most common form of brain cancer, glioblastoma.

Today’s development follows the successful completion of manufacturing and delivery of critical components of the OmniCAR platform.

Commentary from management
Prescient CEO and managing director Steven Yatomi-Clarke commented on the results, saying:

The immunogenicity results could not have been better. In short, it gives us confidence that if these therapies are ultimately delivered to patients, that their immune systems will not impair the therapy itself.

This is essential not only for Prescient’s three in-house OmniCAR programs, but also for potential external collaborators, who consider immunogenicity very stringently.

On July 5, 2021 Prescient Therapeutics (PTX) reported that it recent results from testing show its entire platform has been substantially de-risked (Press release, Prescient Therapeutics, JUL 5, 2021, View Source;utm_medium=rss&utm_campaign=prescient-therapeutics-asxptx-returns-successful-immunogenicity-results [SID1234584589]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In silico immunogenicity testing of the company’s OmniCAR key binding components, SpyTag and SpyCatcher, evaluated the immune response against a new therapy, affecting safety and efficacy.

OmniCAR is a universal immune receptor platform enabling controllable T-cell activity and multi-antigen targeting with a single cell product. Prescient is developing OmniCAR programs for acute myeloid leukemia, solid tumours like breast, ovarian and gastric cancers, and glioblastoma multiforme, the most common form of brain cancer.

The immunogenicity of SpyTag and SpyCatcher was tested in silico by an independent US research provider to determine if either component has the potential to cause adverse immune responses that could compromise the therapy.

The results demonstrated both SpyTag and SpyCatcher have very low immunogenicity — significantly lower than a panel of humanised therapeutic antibodies already approved for human use.

In the case of CAR-T cell therapies, high levels of immunogenicity can impact CAR-T cell expansion and persistence, which can impact the overall safety and response to the treatment.

The company says the positive results re-risk the entire OmniCAR platform and trigger the next steps for development.

Prescient’s CEO and Managing Director, Steven Yatomi-Clarke, said the immunogenicity results could not have been better.

"In short, it gives us confidence that if these therapies are ultimately delivered to patients, that their immune systems will not impair the therapy itself. This is essential not only for Prescient’s three in-house OmniCAR programs, but also for potential external collaborators, who consider immunogenicity very stringently."

The new development follows Prescient finishing manufacturing and delivering critical components of the OmniCAR platform for several cancer targets and lentiviral vectors used to produce CAR-T cells.

The company says its development plans are on schedule to deliver the next important milestones.

"Together with our talented research team at Peter Mac, we are excited to progress our inhouse next generation cell therapies for cancer patients," said Mr Yatomi-Clarke.

On July 2, 2021 Aptamer Science reported that the company preparing to apply for a phase 1 clinical trial plan for ‘AST-201’, a liver cancer treatment candidate, in Korea and China in the second half of 2021 (Press release, Aptamer Sciences, JUL 2, 2021, View Source;idx=132 [SID1234641529]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Aptamer Science has been implementing a business strategy of promoting technology export of candidate substances after completing preclinical (animal testing) testing or conducting phase 1 clinical trials and then exporting technology.

Aptamer Science plans to complete preclinical trials of AST-201 within this year and begin global phase 1 clinical trials in Korea and China.

Aptamer Science explained that AST-201 is an aptamer anticancer treatment that binds gemcitabine, a cytotoxic substance, to liver cancer cells.

Currently, Aptamer Science is known to have signed a confidentiality agreement (CDA) regarding AST-201 with a Chinese pharmaceutical company and is discussing technology export.

In the securities industry, there is a view that Aptamer Science is planning to enter phase 1 clinical trials within 2021 and achieve results in order to speed up discussions on technology export.

Aptamer Science is the only company in Asia that possesses aptamer discovery technology. It was founded in 2011 by CEO Dong-il Han and professors at Pohang University of Science and Technology.

An aptamer is an oligonucleotide that forms a three-dimensional shape and binds to a target substance. It is known to have high material stability because it recognizes its three-dimensional shape and is produced through chemical synthesis.

In general, antibodies bind only to a single site and have immunogenic side effects, but aptamers can bind to multiple sites and there is no case of immune rejection in humans. Low manufacturing costs and the ability to expand to various application fields are also considered strengths.

The liver cancer treatment candidate is also the only one in Asia made with aptamer technology.

In an interview with a media outlet, CEO Han said, "Aptamer technology binds as if surrounding the target with a three-dimensional structure, showing even better binding power," and added, "We will widely promote aptamer technology, which is easier to chemically synthesize and has superior efficacy than existing antibodies." "He said.

In the pharmaceutical bio industry, the aptamer anti-cancer treatment AST-201 is evaluated as a substance that can overcome the limitations of existing targeted anti-cancer treatments as it shows high tissue permeability (the degree to which the drug is absorbed into the tissue) and the characteristics of overcoming anti-cancer drug resistance.

In 2005, the global pharmaceutical company Pfizer developed Macugen, a macular degeneration treatment, the first new drug made with aptamer technology, and the possibility of developing new drugs was already proven.

Aptamer Science also developed the world’s first lung cancer early diagnosis kit based on Aptamer technology. It received Class 3 medical device certification from the Ministry of Food and Drug Safety in 2017 and European CE (European Standards and Standards System) certification in 2018, and is preparing for commercialization in the second half of 2021.

At the ‘Bio Korea 2021’ event held in June, Aptamer Science conducted joint research discussions with global pharmaceutical companies to develop blood-brain barrier (BBB)-penetrating shuttle aptamer technology, which expanded the application areas of aptamer technology.

It is reported that global pharmaceutical companies have shown particular interest because the blood-brain barrier penetration technology can be used for all brain disease drugs.

An Aptamer Science official said, "We cannot disclose the current discussions on AST-201 and blood-brain barrier penetration technology as they are business secrets."

According to U.S. market research firm Transparency Market Research, the global aptamer market is expected to grow from $1.3 billion in 2017 to $5.9 billion in 2025. It grows by 20.9% every year.

On July 2, 2021 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX:13) reported that it will be announcing its interim results for the six months ended June 30, 2021 on Wednesday, July 28, 2021 at 12:00 noon British Summer Time (BST) (7:00 pm Hong Kong Time (HKT); 7:00 am Eastern Daylight Time (EDT)) (Press release, Hutchison China MediTech, JUL 2, 2021, View Source [SID1234586915]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Analysts and investors are invited to join a conference call and audio webcast presentation with Q&A, conducted by HUTCHMED management.

The conference call and audio webcast will take place at 1:00 pm BST / 8:00 pm HKT / 8:00 am EDT on Wednesday, July 28, 2021 and will be webcast live via the company website at www.hutch-med.com/investors/event-information/. The presentation will be available for downloading before the conference call begins. Details of the conference call dial-in will be provided in the financial results announcement and on the company website. A replay will also be available on the website shortly after the event.

On July 2, 2021 Philogen S.p.A. (BIT:PHIL), a clinical-stage biotechnology company focused on the development of innovative medicines based on tumor targeting antibodies and small molecule ligands, reported to provide an update on three R&D programs: Fibromun, OncoFAP and ABBV-022 (Press release, Philogen, JUL 2, 2021, View Source [SID1234584934]). A full pipeline update will be made to the market on 28 September, 2021, in the Company’s Half Year results announcement.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Prof. Dr. Dario Neri, Co-Founder, Chief Executive Officer and Chief Scientific Officer of Philogen S.p.A., said: "We are extremely pleased to see that our technology has been delivering exciting product candidates of diverse nature, both by our partners such as AbbVie and under our ownership, across a variety of clinical trials. The early signs of activity support our ambition to bring innovative treatment options to patients with serious unmet medical need."

Fibromun

Fibromun (L19TNF), wholly-owned by Philogen, is a fully-human immunomodulatory product consisting of the L19 antibody and TNF (a strong pro-inflammatory cytokine). Recombinant TNF has so far been approved only for certain loco-regional clinical applications.

Promising interim survival benefits have been demonstrated in the European Phase I/II trial, investigating Fibromun as a monotherapy for the treatment of IDH wildtype WHO Grade III-IV High-Grade Glioma at first recurrence/relapse. Data on progression free survival at six months are being finalized, while the overall survival data will be consolidated by the end of 2021, with expected publication in a peer-reviewed scientific journal in 2022.
In the European Phase I/II trial, in which Fibromun is combined with lomustine for the treatment of Glioblastoma at first recurrence/relapse, a partial response has been observed already in the first patient treated in the study. The historical overall response rate for this patient population is 4.3% (Wick et al., J Clin Oncol 2010, 28,1168)
A Parallel Scientific Advice (PSA) with the European Medicines Agency and the US Food and Drug Administration has been completed in June 2021. The development plan for the treatment of glioblastoma and the proposed strategy for marketing authorization have been discussed and agreed with competent authorities. Philogen will follow the recommendations that were provided during the PSA.
In the European Phase II trial, in which Fibromun is combined with dacarbazine for the treatment of pretreated advanced/metastatic Soft Tissue Sarcoma (3rd line), the second patient treated in the study enjoyed a partial response. The historical overall response rate for this patient population is 4.0% (Garcia-del-Muro et al., J Clin Oncol 2011, 29,2528). After the run-in part of the trial, the trial progresses to a randomized part.
Fibromun is investigated in six clinical trials, of which five have a pivotal potential. In Soft Tissue Sarcoma, the European Phase III trial in 1st line and the Phase II trial in 3rd line are expected to read out by the end of 2023.

OncoFAP

OncoFAP is a small molecule radiotracer, wholly-owned by Philogen, with ultra-high affinity for Fibroblast Activation Protein (FAP). The product is suitable for the non-invasive detection of a variety of metastatic solid tumors, as FAP is overexpressed in more than 90% of epithelial cancers (e.g., malignant breast, colorectal, ovarian, lung, skin, prostate, and pancreatic cancers, as well as in some soft tissue and bone sarcomas)

Clinicians from the Department of Nuclear Medicine at the University Hospital of Münster have employed a OncoFAP-based radionuclide conjugate (OncoFAP-68Ga) in clinical scanning of patients with various FAP-positive cancer types and have shown excellent tumor uptake in both primary and metastatic lesions with low uptake in healthy organs (including kidneys) after intravenous injection.
These clinical results also support the investigation of OncoFAP-177Lu for Radionuclide Ligand Therapy (RLT).
Philogen is currently planning international, exploratory, clinical trials to investigate OncoFAP in a variety of cancer indications. The results from these studies will provide the basis for a pivotal clinical program in selected cancer types.

ABBV-022

ABBV-022, a product out-licensed by Philogen to AbbVie, consists of an IL-22 payload fused to a targeting antibody. The cytokine, selectively delivered to the epithelial surface of damaged gut mucosa, promotes survival of intestinal stem cells, improves goblet cell function and epithelial barrier, thereby reducing inflammation.

ABBV-022 has started a Phase I clinical trial for the treatment of Ulcerative Colitis. The original collaboration between Philogen and AbbVie began in 2014.