On August 18, 2021 Astellas Venture Management LLC (President: Kazunori Maruyama, Ph.D., "AVM"), a wholly-owned venture capital subsidiary of Astellas Pharma Inc., and LabCentral, a launchpad for early-stage life-sciences startups, reported their collaboration on the "Future Innovator Prize" formerly known as the Astellas Golden Ticket Competition (Press release, Astellas, AUG 18, 2021, View Source [SID1234586737]). The Future Innovator Prize offers entrepreneurial scientists or emerging biotechnology start-ups one-year usage of LabCentral’s state-of-the-art lab facility in Cambridge, Massachusetts, as well as access to Astellas’ research and development (R&D) capabilities and business leaders.

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!

Astellas’ sponsorship of the Future Innovator Prize follows AVM obtaining Gold Sponsorship of LabCentral in October of 2019. With a shared commitment to discovering and advancing innovative science for the potential future benefit of patients worldwide, Astellas and LabCentral are proud to support scientists and early stage companies to accelerate their novel therapeutic programs, modalities or platforms.

"External innovation is critically important in helping us achieve our VISION of turning innovative science into VALUE for patients," said Maruyama, President, AVM. "Combining our R&D capabilities and expertise with LabCentral’s established network and launchpad in the Boston area, we look to bring hope to patients worldwide by partnering with emerging biotechnology companies and transforming their ideas into reality."

"We are extremely pleased to be working with Astellas to foster life-science innovation in the Boston area," said Johannes Fruehauf, LabCentral Co-founder and President. "Our labs offer a fertile environment in which biotechnology visionaries can thrive by providing them with the space and resources they need to test out, challenge, and nurture early ideas. We are excited that Astellas has chosen to create the Future Innovator Prize program to supplement their external innovation initiatives."

About the Future Innovator Prize at LabCentral
Astellas is offering up to two Future Innovator Prizes for pioneering scientists with innovative research that complements Astellas’ areas of interest that fit with the Astellas Focus Area Approach and pipeline, including oncology, immunology, neuroscience including neuromuscular and sensory disorders.

Companies awarded an Astellas Future Innovator Prize will gain one year’s priority admission or renewal to LabCentral’s state-of-the-art laboratory as well as access to Astellas’ R&D scientists and leaders. Time for submitting applications for the competition is from Wednesday August 18, 2021 to Monday September 20, 2021. Entrepreneurial scientists, emerging life-science or biotech start-ups are encouraged to apply and can learn more about the opportunity at View Source The decision to award any Future Innovator Prize, and the assessments underlying such decision, are solely the judgment of Astellas and LabCentral, and are not subject to objection or appeal.

On August 18, 2021 Illumina, Inc. (NASDAQ: ILMN) reported that it has acquired GRAIL, a healthcare company focused on life-saving early detection of multiple cancers, but will hold GRAIL as a separate company during the European Commission’s ongoing regulatory review (Press release, Illumina, AUG 18, 2021, View Source [SID1234586722]).

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!

Illumina, the global leader in DNA sequencing, first announced its intention to acquire GRAIL nearly a year ago, reuniting Illumina with GRAIL four years after it was spun off. GRAIL’s Galleri blood test detects 50 different cancers before they are symptomatic. Illumina’s acquisition of GRAIL will accelerate access and adoption of this life-saving test worldwide.

Regulators in the EU are reviewing the transaction, but a decision is projected after the deal expires. GRAIL has no business in the EU, and the company believes that the European Commission does not have jurisdiction to review the merger as the EU merger thresholds are not met, nor are they met in any EU member state. The General Court of the European Union will hear Illumina’s jurisdictional challenge later this year. By holding GRAIL separate while proceedings are ongoing, Illumina is positioned to abide by whatever final decision is reached in these legal processes.

There is no legal impediment to acquiring GRAIL in the US. Illumina is committed to working through the ongoing FTC administrative process, and as always, will abide by whatever outcome is ultimately reached in the US courts.

The reasons to reunite the two companies are compelling:

The deal will save lives. Cancer kills around 10 million people annually worldwide and 600,000 people in the US alone. Cancers responsible for nearly 71% of cancer deaths have no recommended early detection screening, and most cancers are detected when chances of survival are lower. Illumina feels there is a moral obligation to have the deal decided by a thoughtful and full review by the EU regulators and the US courts. This can only be done if Illumina acquires GRAIL now. Otherwise, the company is locked into a situation where the deal terms will expire before there is a chance for full review; the clock will just run out.

Right now, the Galleri test is available but costs $950 because it is not covered by insurance. Reuniting the two companies is the fastest way to make the test broadly available and affordable. Illumina’s expertise in market development and access has resulted in coverage of genomic testing for over 1 billion people around the world already. This experience will help lead to coverage and reimbursement for the Galleri test.

GRAIL and Illumina have a long history. Illumina formed GRAIL and spun it out in 2016. GRAIL’s first employees were part of Illumina, which still owns 12 percent of the company. GRAIL and Illumina are not competitors—this is a vertical acquisition.

Based on past experience, when Illumina enters a market, the market expands. When Illumina entered the non-invasive prenatal testing space, prices dropped, reimbursement expanded, the number of providers increased, and more expectant parents had access to testing.

Illumina’s acquisition of GRAIL is driven by the belief that this test should be available to as many people as possible as quickly as possible. From fighting the COVID-19 pandemic to matching cancer patients to therapies, Illumina’s mandate is to save lives and transform healthcare. The first COVID-19 viral sequence was on an Illumina machine and now genomic surveillance has emerged as a critical tool in the global fight against the pandemic, with over 70 countries now using Illumina platforms for COVID-19 variant tracking.
"Just as we are now able to screen for early-stage diabetes and high cholesterol, we will soon be able to conduct multi-cancer early detection with a simple blood test in your doctor’s office," said Francis deSouza, Chief Executive Officer of Illumina. "Since early detection of cancer saves lives, this new genomic test will be nothing short of transformational for human health and the economics of healthcare."

"The merger with Illumina will get the Galleri test to people far faster. We aim to accelerate this process so the test will be available in doctors’ offices everywhere, fully reimbursed," said Hans Bishop, Chief Executive Officer of GRAIL. "A one-year acceleration of access to the Galleri test for the US population has the potential to save 10,000 lives over a 9-year period."

"The decision to make the acquisition and hold the companies separate permits the regulatory processes to proceed while safeguarding the life-saving, pro-competitive benefits of this vertical transaction without the deal expiring. We will abide by any outcome ultimately reached by the courts," said Charles Dadswell, General Counsel of Illumina.

On August 18, 2021 Prescient Therapeutics and University of Pennsylvania (Penn) reported that thay are developing a new way for cancer-fighting CAR-T cells to overcome the resistance present in some types of B-cell driven cancers (Press release, Prescient Therapeutics, AUG 18, 2021, View Source;utm_medium=rss&utm_campaign=university-of-pennsylvania-finds-solution-for-war-weary-car-t-cells [SID1234586723]).

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!

Although CAR-T treatments have proven effective against numerous cancer types, chronic lymphocytic leukemia (CLL) has so far proven difficult to treat.

But new research from researchers at Penn – who pioneered CAR-T technology – could provide a solution.

Penn researchers found that by inhibiting ‘bromodomain and extra terminal’ (BET) proteins, they could improve CAR-T cell function by fighting ‘T-cell exhaustion’ – a phenomenon that hinders genetically-engineered T-cells from fully fighting certain cancers.

It’s a significant finding, as many CLL patients undergo aggressive chemotherapy before receiving CAR-T treatments, and this chemotherapy process can leave many T cells exhausted.

Using a small-molecule drug called JQ1 to inhibit BET proteins during the cell engineering process, Penn researchers were able to lessen T-cell exhaustion and increase the production of CAR-T cells.

"Treating these ‘war weary’ T cells during the CAR T cell engineering process has the potential to boost responses, we’ve shown here," senior author and assistant professor of microbiology at Penn Joseph A. Fraietta said.

"It’s setting the stage for a very promising set of next steps that rationalize further studies, including clinical trials, to prove this approach is safe and feasible."

Prescient Therapeutics advances separate Penn technology
While the Penn research team have been fighting T-cell exhaustion, ASX-listed biotechnology company Prescient Therapeutics has partnered with the Peter MacCallum Cancer Centre to advance OmniCAR – a next generation CAR-T platform built using technology licensed from Penn.

OmniCAR is designed to give medical practitioners greater control over traditional CAR-T treatments – which genetically re-engineer a patients’ own immune system to identify and attack cancerous cells.

The platform is also designed to make treatment safer for patients and to be able to direct the CAR-T cells against a variety of cancer targets.

In July, immunogenicity testing on OmniCAR provided positive safety results. The in-silico tests (meaning they were conducted by complex computer algorithms) found two binding components used in OmniCAR treatments, SpyTag and SpyCatcher, are unlikely to trigger adverse immune responses in patients.

Join Prescient Therapeutics CEO Steven Yatomi-Clarke for a special investor briefing next Wednesday, 25th August at 11am (AEST), where he will discuss the encouraging progress through clinical trials of Prescient’s foundational assets PTX-100 and PTX-200, provide an introduction into the amazing field of CAR-T, and how Prescient’s next gen CAR-T platform, OmniCAR, is seeking to take this burgeoning cancer field to the next level. Click here to book in.

Reach Markets have been engaged by PTX to help manage their investor communications

Sources:

Fierce Biotech: Novartis-backed Penn study proposes boosting CAR-T responses in CLL by waking up ‘war weary’ T cells
Penn Medicine: Existing Drug May Help Improve Responses to Cellular Therapies in Advanced Leukemias
ASX: PTX announcement 5 July 2021
PTX: Technology

On August 18, 2021 Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences", HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported positive interim results from the pivotal study "CHOICE-01" (NCT03856411), a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab plus chemotherapy as first-line treatment of advanced squamous or non-squamous non-small cell lung cancer (NSCLC) (Press release, Coherus Biosciences, AUG 18, 2021, View Source [SID1234586739]). The interim analysis met the primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression free survival (PFS) per RECIST v1.1 compared to chemotherapy alone.

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!

The results will be summarized September 13 in an oral presentation by Professor Jie Wang, MD, PhD, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, during the Mini Oral Session at the 2021 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer (IASLC). The abstract is now available on the WCLC website.

"The CHOICE-01 study in patients with advanced non-small cell lung cancer has demonstrated the clinical benefit of toripalimab in yet another first-line setting, building on the evidence of efficacy in first-line studies in nasopharyngeal carcinoma and esophageal squamous cell carcinoma," said Dr. Patricia Keegan, Chief Medical Officer at Junshi Biosciences. "With an excellent clinical profile being established across multiple tumor types, we expect to pursue registration for toripalimab for a broad array of indications in China, the United States and other markets."

"The CHOICE-01 efficacy and safety data are compelling and demonstrate the potential for toripalimab to deliver the significant benefits of the PD-1 class of checkpoint inhibitor drugs to patients with non-small cell lung cancer," said Ildiko Csiki, MD, PhD, Chair of the Coherus Scientific Advisory Board and Chief Commercial Research and Development Officer at City of Hope, a comprehensive cancer center. "As data accumulate in the pivotal studies in the broad clinical development program, toripalimab is showing itself to be an excellent checkpoint inhibitor. We eagerly anticipate results from additional Phase 3 studies in esophageal, lung, liver, breast, kidney, bladder, stomach, and skin cancers."

About CHOICE-01
A total of 465 treatment-naive advanced NSCLC patients (220 squamous and 245 non-squamous) were randomized (2:1): 309 to the toripalimab plus chemotherapy arm and 156 to the placebo plus chemotherapy arm. The primary endpoint of PFS was assessed by the investigator. Secondary endpoints included PFS assessed by a blinded independent review committee (BIRC), overall survival (OS), objective response rate (ORR) and duration of response (DoR). Crossover to toripalimab was allowed for patients from the placebo plus chemotherapy arm upon disease progression.

As of November 17, 2020 (the data cut-off date of the interim analysis), 218 PFS events were observed, with a median follow-up of 7.1 and 7.0 months in the toripalimab arm and the placebo arm, respectively.
At the interim analysis, a significant improvement in PFS was detected for toripalimab over placebo [hazard ratio (HR)=0.58,95% confidence interval (CI): 0.44-0.77, P=0.0001] with median PFS of 8.3 vs. 5.6 months. The 1-year PFS rates for toripalimab and placebo arms were 32.6% and 13.1%, respectively.
This improvement in PFS was observed in both squamous [HR = 0.55 (95% CI: 0.38-0.83)] and non-squamous [HR=0.59 (95% CI: 0.40-0.87)] NSCLC and regardless of PD-L1 expression.
PFS assessed by BIRC showed similar results as PFS assessed by the investigator.
Toripalimab in combination with chemotherapy, as compared with chemotherapy alone, resulted in better ORR (squamous NSCLC: 68.7% vs. 58.9%; non-squamous NSCLC: 58.6% versus 26.5%) and median DoR (squamous NSCLC: 6.9 months vs. 4.2 months; non-squamous NSCLC: 8.6 months vs. 5.1 months).
Patients in the placebo plus chemotherapy arm were actively crossed over to toripalimab treatment at the time of disease progression.
Overall survival data were not yet mature as of March 7, 2021. There was a trend favoring the toripalimab arm [median OS of 21.0 vs. 16.0 months, HR = 0.81 (95% CI: 0.57-1.17)].
The addition of toripalimab to standard first-line chemotherapy in patients with advanced NSCLC showed a manageable safety profile with no new safety signal observed. The incidence of Grade ≥3 adverse events (AEs) was 76.3% in the toripalimab arm vs. 80.1% in the control arm. AEs leading to discontinuation of toripalimab or placebo were 12.3% vs. 1.9%, respectively.
Junshi Biosciences and Coherus plan to meet with the United States Food and Drug Administration to discuss a potential submission of a biologics license application for toripalimab for first line treatment of advanced NSCLC.

About toripalimab

Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 is thought to recharge the immune system’s ability to attack and kill tumor cells.

More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. Pivotal clinical trials are ongoing or completed evaluating the safety and efficacy of toripalimab for a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI). On December 17, 2018, toripalimab was granted a conditional approval from the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. In December 2020, toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the supplemental NDA for toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic nasopharyngeal carcinoma was accepted by the NMPA. In the same month, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. In April, NMPA granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

In the United States, a rolling submission of the first toripalimab Biologics License Application (BLA) is underway for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the 1st line treatment of recurrent or metastatic nasopharyngeal carcinoma ("NPC") and also for toripalimab monotherapy in second or third line treatment of recurrent or metastatic NPC. There are currently no PD-1 blocking antibodies indicated for use in NPC in the United States. Additionally, FDA has granted Fast Track status for the development of toripalimab for the treatment of mucosal melanoma and orphan drug designation for NPC, mucosal melanoma and soft tissue sarcoma. Earlier in 2021 Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare cancers and highly prevalent cancers.

-+

On August 18, 2021 ProMIS Neurosciences Inc. ("ProMIS" or the "Company") (TSX: PMN), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported it has upsized its public offering (the "Offering") of units ("Units") to US$17.5M from US$15M at a price of US$0.16 per Unit. If the Agent’s Option (as defined below) is exercised in full, the aggregate gross proceeds of the Offering will be approximately US$20.1M (Press release, ProMIS Neurosciences, AUG 18, 2021, View Source [SID1234586724]).

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!

Each Unit consists of one common share of the Company (a "Common Share") and one quarter of one Common Share purchase warrant (each whole purchase warrant, a "Warrant"). Each Warrant will entitle the holder thereof to purchase one Common Share (each, a "Warrant Share") at a price of US$0.21 per Warrant Share at any time up to 60 months following the issuance date thereof, subject to acceleration.

The Offering will be conducted on a commercially reasonable efforts basis pursuant to the terms and conditions of an agency agreement to be entered into between the Company and Leede Jones Gable Inc. (the "Agent"). The Company will also grant the Agent an option (the "Agent’s Option"), exercisable, in whole or in part, at the sole discretion of the Agent, to increase the size of the Offering by up to 15%. The Agent’s Option is exercisable, in whole or in part, at any time until the date that is two business days prior to the Closing Date (as defined herein).

The Offering is expected to close on or about August 24, 2021, or such other date as may be mutually agreed to by the Company and the Agent (the "Closing Date"), subject to satisfaction of customary closing conditions, including the approval of the Toronto Stock Exchange (the "TSX").

The Offering is being made pursuant to a prospectus supplement to the Company’s short form base shelf prospectus dated June 30, 2021 (the "Base Prospectus"), which the Company will file with the securities commissions or other security regulatory authorities in each of the provinces and territories of Canada (other than Québec). Additionally, the Offering is expected to be conducted by way of private placement in other jurisdictions where the Offering can lawfully be made.

The Company intends to use the net proceeds from the Offering (including additional proceeds from the possible exercise of the Agent’s Option) to advance its lead Alzheimer’s therapy PMN310 to the filing of an Investigational New Drug application to enable a first clinical trial, expanding the ProMIS portfolio of antibodies and patents, and general corporate purposes, as more fully described in the preliminary prospectus supplement of the Company dated August 17, 2021 (the "Preliminary Prospectus Supplement").

The securities referred to in this news release have not been, nor will they be, registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act"), or applicable state securities laws, and such securities may not be offered or sold to, or for the account or benefit of, persons in the United States or U.S. persons (as such terms are defined in Regulation S under the U.S. Securities Act) absent registration or an applicable exemption from such registration requirements. This news release does not constitute an offer for sale of securities nor a solicitation for offers to buy any securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.