Junshi Biosciences and Coherus Announce Publication of Positive Results from CHOICE-01, a Phase 3 Clinical Trial Evaluating Toripalimab in Combination with Chemotherapy as First-Line Treatment for Non-Small Cell Lung Cancer, in the Journal of Clinical Oncology

Toripalimab in combination with chemotherapy was associated with significant improvements in PFS and OS compared with chemotherapy alone in patients with advanced NSCLC without EGFR/ALK mutations, regardless of PD-L1 expression

SHANGHAI, China and REDWOOD CITY, Calif., Oct. 12, 2022 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”) today announced the publication of toripalimab plus chemotherapy for patients with treatment-naïve advanced non-small cell lung cancer: a multi-center randomized phase 3 trial (CHOICE-01) in the Journal of Clinical Oncology.

Toripalimab in combination with chemotherapy was associated with significant improvements in progression-free survival (PFS) (primary endpoint) and overall survival (OS) (secondary endpoint) compared with chemotherapy alone in patients with advanced non-small cell lung cancer (“NSCLC”) without epidermal growth factor receptor (EGFR)/anaplastic lymphoma kinase (ALK) mutations, regardless of PD-L1 expression. No new safety signals were observed with toripalimab in this study.

“These data support our strategy for toripalimab in non-small cell lung cancer where we plan to evaluate toripalimab in combination with other immuno-oncology agents, including our TIGIT-targeted antibody, CHS-006/JS006, in patients with NSCLC as well as for other indications in the U.S.,” said Rosh Dias, MD, MRCP, Chief Medical Officer at Coherus.

A total of 465 patients with treatment-naïve, advanced NSCLC without EGFR/ALK mutations were randomized 2:1 to receive toripalimab 240 mg (n=309, “the toripalimab arm”) or placebo (n=156, “the placebo arm”) in combination with chemotherapy for 4-6 cycles, followed by the maintenance of toripalimab or placebo plus standard care. PFS was the primary endpoint.

Statistically significant improvements in both PFS and OS were detected in the toripalimab arm compared with the placebo arm, with similar rates of adverse events (AEs). At the final analysis, PFS was significantly longer in the toripalimab arm than in the placebo arm (median PFS 8.4 vs 5.6 months; 1-year PFS rates 36.7% vs 17.2%). At the interim OS analysis, the toripalimab arm had a significantly longer OS than the placebo arm (median OS not reached vs 17.1 months). OS rates at 2 years were 51.2% vs 33.9%, in the two arms. The incidence of Grade > 3 AEs was similar between the two arms (78.6% vs 82.1%).

About CHOICE-01
The CHOICE-01 study was a multi-center, randomized double-blind, placebo-controlled phase 3 study conducted in 59 centers across China. 465 treatment-naïve advanced NSCLC patients without EGFR/ALK mutations were randomized to receive either toripalimab plus chemotherapy (n=309) or placebo plus chemotherapy (n=156). The primary endpoint was PFS assessed by the investigator. Secondary endpoints included PFS assessed by a blinded independent review committee (BIRC), OS, and safety. Patients from the placebo arm were actively crossed over to toripalimab treatment upon disease progression. The trial was conducted in full conformance with the ICH E6 guidelines for Good Clinical Practice and the principles of the Declaration of Helsinki.

As of October 31, 2021:

  • At the final analysis, a significant improvement in PFS was detected in the toripalimab arm over the placebo arm (hazard ratio (HR)=0.49; 95% confidence interval (CI): 0.39-0.61, P<0.0001) with median PFS of 8.4 vs. 5.6 months. The 1-year PFS rates for the toripalimab and placebo arms were 36.7% and 17.2%, respectively.
  • PFS as assessed by BIRC was also significantly longer in the toripalimab arm.
  • A prespecified interim analysis demonstrated a statistically significant improvement in OS for the toripalimab arm over the placebo arm (median OS not reached vs. 17.1 months, HR = 0.69 (95% CI: 0.53-0.92)).
  • The PFS benefits were observed in patients treated with toripalimab plus chemotherapy across key subgroups, including histologic subtype and tumor PD-L1 expression.
  • The addition of toripalimab to standard first-line chemotherapy in patients with advanced NSCLC showed a manageable safety profile with no new safety signals observed. The incidence of Grade ≥3 AEs was 78.6% in the toripalimab arm vs. 82.1% in the placebo arm. AEs leading to discontinuation rates of toripalimab or placebo were 14.3% vs. 3.2%, respectively.
  • An exploratory genomic analysis showed that high tumor mutational burden was associated with significantly better PFS in the toripalimab plus chemotherapy arm and that mutations in the FA-PI3K-Akt pathway were associated with significantly better PFS and OS in the toripalimab plus chemotherapy arm

In China, the National Medical Products Administration (“NMPA”) approved the supplemental new drug application for toripalimab in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous 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 promotes 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 by Junshi Biosciences, including in China, the United States, Southeast Asia, and European countries. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover 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®). Currently, there are six approved indications for toripalimab in China:

  1. unresectable or metastatic melanoma after failure of standard systemic therapy;
  2. in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic nasopharyngeal carcinoma (“NPC”).
  3. recurrent or metastatic NPC after failure of at least two lines of prior systemic therapy;
  4. locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;
  5. in combination with paclitaxel and cisplatin in first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (“ESCC”);
  6. in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous NSCLC.

The first three indications have been included in the National Reimbursement Drug List (“NRDL”) (2021 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for melanoma and NPC.

In the United States, the FDA is reviewing the Biologics License Application (“BLA”) resubmission for toripalimab in combination with gemcitabine and cisplatin as first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma (“NPC”) and for toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy. The FDA has set a Prescription Drug User Fee Act (“PDUFA”) action date for December 23, 2022. The FDA has granted Breakthrough Therapy designations for toripalimab in combination with chemotherapy for the first-line treatment of recurrent or metastatic NPC as well as for toripalimab monotherapy in the second or third-line treatment of recurrent or metastatic NPC. Additionally, the FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and Orphan Drug designations for the treatment of esophageal cancer, NPC, mucosal melanoma, soft tissue sarcoma, and small cell lung cancer (“SCLC”).

In the European Union, toripalimab was also designated as an orphan medicinal product by the European Commission for the treatment of NPC.

About Junshi Biosciences
Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for the treatment of various cancers was the first in the world to be approved for clinical trials by the FDA and NMPA and has since entered Phase Ib/II trials in both China and the US. Its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA.

In the face of the pandemic, Junshi Biosciences’ response was strong and immediate, joining forces with Chinese and international scientific research institutions and enterprises to develop an arsenal of drug candidates to combat COVID-19, taking the initiative to shoulder the social responsibility of Chinese pharmaceutical companies by prioritizing and accelerating COVID-19 R&D. Among the many drug candidates is JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2 and the result of the combined efforts of Junshi Biosciences, the Institute of Microbiology of the Chinese Academy of Science and Lilly. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations (EUA) in over 15 countries and regions worldwide. As of December 3 2021, over 700,000 patients have been treated with bamlanivimab or bamlanivimab and etesevimab, potentially preventing more than 35,000 hospitalizations and at least 14,000 deaths. Meanwhile, VV116, a new oral nucleoside analog anti-SARS-CoV-2 drug designed to hinder virus replication, is in global Phase III clinical trials. A Phase III clinical study (NCT05341609) comparing the efficacy and safety of VV116 versus nirmatrelvir/ritonavir (“PAXLOVID”) for patients with mild to moderate COVID-19 who are at high risk for progression to severe COVID-19, has reached its pre-specified primary endpoint and secondary efficacy endpoint. The study results show that compared to PAXLOVID, VV116 provided patients with a shorter median time to sustained clinical recovery, while achieving statistical superiority. The JS016 and VV116 programs are a part of the company’s continuous innovation for disease control and prevention of the global pandemic.

Junshi Biosciences has more than 3,100 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc). For more information, please visit: http://junshipharma.com.

About Coherus BioSciences
Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer. Coherus’ strategy is to build a leading immuno-oncology franchise funded with cash generated through net sales of its diversified portfolio of FDA-approved therapeutics.

In 2021, Coherus in-licensed toripalimab, an anti-PD-1 antibody, in the United States and Canada. A BLA for toripalimab for the treatment of nasopharyngeal carcinoma is under review by the FDA with a target action date of December 23, 2022. Toripalimab is also being evaluated in pivotal clinical trials for the treatment of cancers of the lung, breast, liver, skin, kidney, stomach, esophagus, and bladder.

Coherus markets UDENYCA® (pegfilgrastim-cbqv), a biosimilar of Neulasta®, and CIMERLI™ (ranibizumab-eqrn), a biosimilar of Lucentis®, in the U.S., and expects to launch the FDA-approved Humira® biosimilar YUSIMRY™ (adalimumab-aqvh) in the U.S. in 2023.

Forward-Looking Statements
Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Coherus’ ability to build its immuno-oncology franchise to achieve a leading market position; Coherus’ ability to generate cash; Coherus’ investment plans; Coherus’ expectations for the launch date of YUSIMRY™ and Coherus’ plans to evaluate toripalimab in combination with other immune-oncology agents. Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus’ actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, risks and uncertainties inherent in the clinical drug development process; risks relating to the COVID-19 pandemic; risks related to our existing and potential collaboration partners; risks of the drug development position of Coherus’ competitors; the risks and uncertainties of the regulatory approval process, including the speed of regulatory review, international aspects of Coherus’ business, the need to schedule inspections in China and the timing of Coherus’ regulatory filings; the risk of FDA review issues; the risk of Coherus’ execution of its change in strategy from a focus on biosimilars to a strategy using cash from its portfolio to fund an oncology franchise; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus’ drug candidates; and the risks and uncertainties of possible litigation. All forward-looking statements contained in this press release speak only as of the date of this press release. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the significant risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see Coherus’ Annual Report on Form 10-Q for the quarter ended June 30, 2022, filed with the Securities and Exchange Commission on August 4, 2022, including the section therein captioned “Risk Factors” and in other documents that Coherus files with the Securities and Exchange Commission.

UDENYCA®, CIMERLI™, and YUSIMRY™, whether or not appearing in large print or with the trademark symbol, are trademarks of Coherus, its affiliates, related companies or its licensors or joint venture partners, unless otherwise noted.

Junshi Biosciences Contact Information
IR Team:
info@junshipharma.com
+ 86 021-6105 8800
PR Team:
Zhi Li
zhi_li@junshipharma.com
+ 86 021-6105 8800

Coherus Contact Information
Investors:
Marek Ciszewski, SVP Investor Relations
IR@coherus.com
Media:
Jodi Sievers, VP Corporate Communications
media@coherus.com

TMC and Allseas Achieve Historic Milestone: Nodules Collected from the Seafloor and Lifted to the Production Vessel Using 4 km Riser During Pilot Trials in the Clarion Clipperton Zone for First Time Since the 1970s

Engineers inspect first batch of nodules

Allseas engineers inspect the first batch of polymetallic nodules collected from the seafloor as they travel on a conveyor aboard the Hidden Gem.

  • During a 60-minute pilot collection run across ~150 meters of the seafloor, ~14 tonnes of nodules were collected by the pilot collector vehicle, transported to the surface using a 4.3-km riser system and placed into the hold of the surface production vessel Hidden Gem
  • In the first such test in the Clarion Clipperton Zone (CCZ) since the 1970s, the pilot trials show that the Allseas-designed nodule collection system can withstand the pressures and temperatures of its deep-sea operating environment
  • Conducted in a small test area in NORI-D, the ongoing collection system trials and concurrent environmental impact monitoring campaign are part of the International Seabed Authority’s regulatory and permitting process and will provide critical environmental data to inform TMC subsidiary NORI’s application to the ISA for an exploitation contract

NEW YORK, Oct. 12, 2022 (GLOBE NEWSWIRE) — TMC the metals company Inc. (Nasdaq: TMC) (“TMC” or the “Company”), an explorer of the world’s largest estimated undeveloped source of critical battery metals, today announced that it has successfully collected an initial batch of seafloor polymetallic nodules, and transported them up a 4km-long riser system to the surface, in what represents the first integrated system test conducted in the Clarion Clipperton Zone of the Pacific Ocean since the 1970s.

Nodules on the conveyor

Following their 12-minute trip from the seafloor to the Hidden Gem, nodules will be dewatered and sent along a conveyor to the vessel’s hold for storage.

Having successfully completed at-sea construction of the riser system and its integration with the flexible jumper hose and pilot nodule collector vehicle, the dedicated team of 130 crew and engineers aboard the Hidden Gem commenced initial nodule collection runs, driving the pilot collector 147 meters in one hour on a pre-determined path and collecting 14 tonnes of nodules. From inside the collector nodules were channeled to the jumper hose and into the riser where they were lifted on compressed air in a 12-minute-trip from seafloor to the Hidden Gem, where the return water was discharged to the midwater column at depth. To date on the current campaign the collector vehicle has successfully been test-driven approximately 18.1km within NORI-D.

Meanwhile, aboard a dedicated 103-meter-long monitoring vessel, expert industry contractors and independent scientists from leading research institutions from around the world are conducting a complex monitoring program to assess the environmental impacts of the collector system trials using an array of over 50 subsea sensors and monitoring stations. The assets are designed to record any changes in the marine environment that may occur during testing of the collector system. The state-of the-art technology that TMC subsidiary NORI has applied to this monitoring effort includes over 20 strategically positioned sediment collection stations; acoustic moorings and landers to measure sound propagation; two Autonomous Underwater Vehicles (AUVs) conducting underwater mapping; two Remotely Operated Vehicles (ROVs) collecting water samples in the plume; optical backscatter and laser diffraction sensors to measure sediment particle settling velocity; trace metal samplers; seven fixed landers equipped with Acoustic Doppler Current Profilers (ADCPs) and conductivity, temperature, and depth (CTD) sensors. NORI expects the findings from the data being collected will be published in scientific literature next year.

The company’s most complex offshore campaign

The pilot nodule collection system trials and environmental monitoring program together represent the most complex offshore campaign the Company has ever undertaken, requiring the coordination of 250 people across three vessels.

Gerard Barron, CEO & Chairman of The Metals Company said: “With the first nodules making their way from seafloor to surface using an integrated pilot collection system, we find ourselves at a historic moment in the development of this industry. Once again, our strategic partner Allseas have shown why they’re the best in the business when it comes to pioneering offshore engineering and operations. This is just the beginning, and we look forward to sharing more news as the trials and impact monitoring continue this quarter.”

Upon completion of the trials, which require the coordination of 250 people across three vessels, the research teams will undertake post-collection surveys to compare the status of the environment before and after the test. The data collected, together with many terabytes of existing baseline data collected by NORI throughout 16 offshore campaigns, will form the basis of NORI’s application to the International Seabed Authority for an exploitation contract, which the Company expects to submit in the second half of 2023.

Engineers inspect 4km riser system

Allseas engineers inspect the above surface portion of the 4km-long riser system that is being used to uplift nodules from seafloor to surface.

In September 2022, NORI announced that it received the ISA’s recommendation to commence its pilot nodule collection system trials in the CCZ after its review of the Collector Test Environmental Impact Statement (EIS) and Collector Test Environmental Monitoring and Management Plan (EMMP). While several ISA contractors including BGR and GSR have successfully conducted trials of prototype nodule collectors in recent years, NORI’s tests will mark the first time an integrated nodule collection system — including nodule riser — has been tested in the Clarion Clipperton Zone since the 1970s, when oil, gas, mining and industrial majors including Shell, BP, Rio Tinto (Kennecott), US Steel, INCO (Vale) and Sumitomo successfully conducted pilot test work, collecting over 1,500 tons of nodules.

In May 2022, TMC and Allseas announced successful trials of the nodule collector vehicle in deep-water in the Atlantic as well as harbor wet-test commissioning and shallow-water drive tests in the North Sea.

Launching the pilot nodule collector vehicle

The Allseas-designed pilot nodule collector awaits deployment from the Launch and Recovery System (LARS) installed aboard the Hidden Gem.

A video accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/453aa06e-2539-4e43-a8f9-36c837e78cd0

About The Metals Company
The Metals Company is an explorer of lower-impact battery metals from seafloor polymetallic nodules, on a dual mission: (1) supply metals for the clean energy transition with the least possible negative environmental and social impact and (2) accelerate the transition to a circular metal economy. The Company through its subsidiaries holds exploration and commercial rights to three polymetallic nodule contract areas in the Clarion Clipperton Zone of the Pacific Ocean regulated by the International Seabed Authority and sponsored by the governments of Nauru, Kiribati and the Kingdom of Tonga.

More Info
Media | media@metals.co
Investors | investors@metals.co

Forward Looking Statements

Certain statements made in this press release are not historical facts but are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. The forward-looking statements contained in this press release include, without limitation, statements regarding the publication of data from monitoring of the pilot collection system testing in the CCZ, TMC’s pilot collection testing in the CCZ, and the timing and content of an application to the ISA for an exploitation contract as well as the design, use and accuracy of any technology developed by TMC and its partners, agents and/or service providers to support its operations. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from those discussed in the forward-looking statements. Most of these factors are outside TMC’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the successful and timely completion of the ongoing pilot testing of TMC’s collection system in the CCZ; regulatory uncertainties and the impact of government regulation and political instability on TMC’s resource activities; changes to any of the laws, rules, regulations or policies to which TMC is subject; the impact of extensive and costly environmental requirements on TMC’s operations; environmental liabilities; the impact of polymetallic nodule collection on biodiversity in the CCZ and recovery rates of impacted ecosystems; TMC’s ability to develop minerals in sufficient grade or quantities to justify commercial operations; the lack of development of seafloor polymetallic nodule deposit; uncertainty in the estimates for mineral resource calculations from certain contract areas and for the grade and quality of polymetallic nodule deposits; risks associated with natural hazards; uncertainty with respect to the specialized treatment and processing of polymetallic nodules that TMC may recover; risks associated with collection, development and processing polymetallic nodules; risks associated with TMC’s limited operating history; the impact of the COVID-19 pandemic; risks associated with TMC’s intellectual property and the validity, use and ownership of any new technology or intellectual property subsisting therein; TMC’s ability to raise additional funds; and other risks and uncertainties indicated from time to time in the Company’s Form 10-K, dated and filed with the U.S. Securities and Exchange Commission (SEC) on March 25, 2022 as well as the Company’s Form 10-Q filed with the SEC on August 15, 2022, including those under “Risk Factors” therein, and in TMC’s other future filings with the SEC. TMC cautions that the foregoing list of factors is not exclusive. TMC cautions readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. TMC does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based except as required by law.

Photos accompanying this announcement are available at:

https://www.globenewswire.com/NewsRoom/AttachmentNg/23557e1b-e22c-43a3-8f9e-0db3d71bdcd6

https://www.globenewswire.com/NewsRoom/AttachmentNg/8c4fc19a-7c78-42e7-b3b7-2be0be1579f5

https://www.globenewswire.com/NewsRoom/AttachmentNg/3045ee04-ac14-41ee-8076-e559688a6d71

https://www.globenewswire.com/NewsRoom/AttachmentNg/16ab0260-77be-457c-9e45-8cdf4924458c

https://www.globenewswire.com/NewsRoom/AttachmentNg/db487784-f0a0-46c7-bc54-4bb2aa333dfa

A video accompanying this announcement is available at:

https://www.globenewswire.com/NewsRoom/AttachmentNg/453aa06e-2539-4e43-a8f9-36c837e78cd0

Scientists Grow Human Brain Cells in Rats to Study Diseases

Scientists have transplanted human brain cells into the brains of baby rats, where the cells grew and formed connections.
It’s part of an effort to better study human brain development and diseases affecting this most complex of organs, which makes us who we are but has long been shrouded in mystery.
“Many disorders such as autism and schizophrenia are likely uniquely human” but “the human brain certainly has not been very accessible,” said said Dr. Sergiu Pasca, senior author of a study describing the work, published Wednesday in the journal Nature.
Approaches that don’t involve taking tissue out of the human brain are “promising avenues in trying to tackle these conditions.”
The research builds upon the team’s previous work creating brain “organoids,” tiny structures resembling human organs that have also been made to represent others such as livers, kidneys, prostates, or key parts of them.
To make the brain organoids, Stanford University scientists transformed human skin cells into stem cells and then coaxed them to become several types of brain cells. Those cells then multiplied to form organoids resembling the cerebral cortex, the human brain’s outermost layer, which plays a key role in things like memory, thinking, learning, reasoning and emotions.
Scientists transplanted those organoids into rat pups 2 to 3 days old, a stage when brain connections are still forming. The organoids grew so that they eventually occupied a third of the hemisphere of the rat’s brain where they were implanted. Neurons from the organoids formed working connections with circuits in the brain.
Human neurons have been transplanted in rodents before, but generally in adult animals, usually mice. Pasca, a psychiatry professor at the Stanford School of Medicine, said this is the first time these organoids have been placed into early rat brains, creating “the most advanced human brain circuitry ever built from human skin cells and a demonstration that implanted human neurons can influence an animal’s behavior.”
To examine a practical use of this approach, scientists transplanted organoids into both sides of a rat’s brain: one generated from a healthy person’s cells and another from the cells of a person with Timothy syndrome, a rare genetic condition associated with heart problems and autism spectrum disorder.
Five to six months later, they saw effects of the disease related to the activity of the neurons. There were differences in the two sides’ electrical activity, and the neurons from the person with Timothy syndrome were much smaller and didn’t sprout as many extensions that pick up input from nearby neurons.
Researchers, whose study was funded partly by the National Institutes of Health, said they could do the same sorts of experiments using organoids made from the cells of people with disorders such as autism or schizophrenia — and potentially learn new things about how these conditions affect the brain, too.
Dr. Flora Vaccarino of Yale University – who previously grew lumps containing cerebral cortex that were made with DNA from people with autism – said the study moves the field forward.
“It’s extremely impressive what they do here in terms of what these cells can actually show us in terms of their advanced development … in the rat,” said Vaccarino, who wasn’t involved with the study.
Such experiments in animals raise ethical concerns. For example, Pasca said he and his team are cognizant of the rats’ well-being and whether they still behave normally with the organoids inside them, which he says they do. Still, Pasca does not believe this should be tried in primates. Ethicists also wonder about the possibility of brain organoids in the future attaining something like human consciousness, which experts say is extremely unlikely now.
Some scientists are studying human brain organoids outside of animals. For example, researchers at ETH Zurich in Switzerland published a study in Nature earlier this month describing how they are growing brain-like tissue from stem cells in the lab and then mapping the cell types in various brain regions and genes regulating their development. Some are using these structures to study autism.
Pasca said brain organoids could also be used to test new treatments for neuropsychiatric disorders, the largest cause of disability worldwide. Such research, he said, should help scientists make strides that have been extremely difficult until now because it’s so hard to get at the human brain – which is “the reason why we’re so much more behind in psychiatry compared to any other branch of medicine in terms of therapeutics.”

Source: Voice of America

FDA Clears Updated COVID Boosters for Kids as Young as 5

The U.S. on Wednesday authorized updated COVID-19 boosters for children as young as 5, seeking to expand protection ahead of an expected winter wave.

Tweaked boosters rolled out for Americans 12 and older last month, doses modified to target today’s most common and contagious omicron relative. While there wasn’t a big rush, federal health officials are urging that people seek the extra protection ahead of holiday gatherings.

Now the Food and Drug Administration has given a green light for elementary school-age kids to get the updated booster doses, too — one made by Pfizer for 5- to 11-year-olds, and a version from rival Moderna for those as young as 6.

There’s one more step before parents can bring their kids in for the new shot: The Centers for Disease Control and Prevention, which recommends how vaccines are used, must sign off.

Americans may be tired of repeated calls to get boosted against COVID-19 but experts say the updated shots have an advantage: They contain half the recipe that targeted the original coronavirus strain and half protection against the dominant BA.4 and BA.5 omicron versions.

These combination or “bivalent” boosters are designed to broaden immune defenses so that people are better protected against serious illness whether they encounter an omicron relative in the coming months — or a different mutant that’s more like the original virus.

“We want to have the best of both worlds,” Pfizer’s Dr. Bill Gruber, a pediatrician, told The Associated Press. He hopes the updated shots will “re-energize interest in protecting children for the winter.”

The updated boosters are “extremely important” for keeping kids healthy and in school, said Dr. Jason Newland, a pediatric infectious disease specialist at Washington University in St. Louis.

Parents should know “there is no concern from the safety perspective with the bivalent vaccines, whether Moderna or Pfizer,” Newland added.

Only people who’ve gotten their initial vaccinations with any of the original-formula versions — qualify for an updated booster. That means about three-fourths of Americans 12 and older are eligible. As of last weekend, only at least 13 million had gotten an updated booster, White House COVID-19 coordinator Dr. Ashish Jha estimated Tuesday.

To pediatricians’ chagrin, getting children their first vaccinations has been tougher. Less than a third of 5- to 11-year-olds have had their two primary doses and thus would qualify for the new booster.

This age group will get kid-size doses of the updated booster — and they can receive it at least two months after their last dose, whether that was a primary vaccination or an earlier booster, the FDA said.

Pfizer said it could ship up to 6 million kid-sized doses within a week of authorization, in addition to ongoing adult-dose shipments.

Until now, Moderna’s updated booster was cleared only for adults. Wednesday’s FDA action authorized the booster for teens as well as children as young as age 6.
As for even younger tots, first vaccinations didn’t open for the under-5 age group until mid-June — and it will be several more months before regulators decide if they’ll also need a booster using the updated recipe.

Exactly how much protection does an updated COVID-19 booster shot offer? That’s hard to know. Pfizer and Moderna are starting studies in young children.

But the FDA cleared the COVID-19 booster tweaks without requiring human test results — just like it approves yearly changes to flu vaccines. That’s partly because both companies already had studied experimental shots tweaked to target prior COVID-19 variants, including an earlier omicron version, and found they safely revved up virus-fighting antibodies.

“It’s clearly a better vaccine, an important upgrade from what we had before,” Jha said earlier this week.

ha urged adults to get their updated shot in October — like they get flu vaccinations — or at least well before holiday gatherings with high-risk family and friends. People who’ve recently had COVID-19 still need the booster but can wait about three months, he added.

Source: Voice of America

19th CPC Central Committee concludes 7th plenary session

The 19th Central Committee of the Communist Party of China (CPC) concluded its seventh plenary session in Beijing, China on Wednesday with a communique issued.
Xi Jinping, general secretary of the CPC Central Committee, made an important speech at the four-day session, which was presided over by the Political Bureau of the CPC Central Committee.
It was decided at the plenary session that the 20th CPC National Congress will open on Oct. 16 in Beijing, according to the communique.
Entrusted by the Political Bureau of the CPC Central Committee, Xi delivered a work report to the plenum.
The plenary session also discussed and adopted a report to be made by the 19th CPC Central Committee to the 20th CPC National Congress, a work report of the 19th CPC Central Commission for Discipline Inspection (CCDI) to the congress, and an amendment to the CPC Constitution.
The three documents will be submitted to the upcoming congress for examination and deliberation, read the communique.
During the session, Xi delivered explanatory remarks on the draft report by the 19th CPC Central Committee to the 20th CPC National Congress. Wang Huning made explanations on the draft amendment to the CPC Constitution.
The seventh plenary session of the 19th CPC Central Committee opened in Beijing on Oct. 9, with 199 full members and 159 alternate members present. Members of the CCDI and leading officials of related departments were also present in a non-voting capacity.

Source: Lao News Agency

Cellebrite Enhances its Investigations & Evidence Management Solution with New Features Centered Around the Ethical Treatment of Digital Evidence

The Cellebrite Guardian solution provides additional features to address the challenges around the ethical treatment of digital evidence, especially child sexual abuse material

PETAH TIKVA, Israel and TYSONS CORNER, Va., Oct. 12, 2022 (GLOBE NEWSWIRE) — Cellebrite DI Ltd. (Nasdaq: CLBT), a global leader in Digital Intelligence (DI) solutions for the public and private sectors, today announced the release of the next generation of Cellebrite Guardian, which provides critical features aiding law enforcement in handling digital evidence in an ethical way, including storing, managing, and sharing evidence, with unmatched instant review of digital evidence.

Cellebrite Guardian is an immediately deployable and highly secure SaaS-based solution that streamlines management of investigations and evidence, removes silos, and connects all stakeholders. Cellebrite Guardian provides unlimited evidence storage and access, as well as immediate sharing and review of evidence for real-time collaboration, inter- and intra-agency.

Cellebrite Guardian marks the cornerstone of Cellebrite’s approach to the importance of ethical values in the conduct of law enforcement investigations, including by eliminating the number of physical copies, controlling access per role to sensitive evidence, providing accurate audit trails of all activity, and ensuring adherence through streamlined workflow management.

Investigators of suspected child sexual abuse material (CSAM) can prevent unintentional sharing with access, review, and tagging functionality for each upload so that only the submitter, case owner, and administrator can access the file(s). The enhanced Investigator Activity Report shows all details, creating and maintaining a full chain of custody. Cellebrite Guardian is built to Security First and Zero Trust principles, is hosted on AWS GovCloud in the U.S., aligns to UK Cloud Security Principles, and is SOC2 compliant.

Detective Duane Jacques, of the Portsmouth Police Department, NH ICAC unit commented, “As a regional task force county lead working in the field of child exploitation material, requests from affiliate agencies are often submitted for me to coordinate a review between the case agent and the county prosecutor. Cellebrite Guardian simplifies this process while treating the evidence in an ethical manner, retaining a chain of custody and an audit trail without requiring the case agent and the attorney to travel. Cellebrite Guardian allows for virtual evidence review and collaboration, which creates court material all while in a secure cloud environment.”

Detective Jacques added, “With the new feature of the added level of the visual cue, Cellebrite Guardian ensures all content is treated with the utmost protection. We can rest assured that the sensitive material is being treated with the care that it demands.”

To learn more about Cellebrite Guardian, visit here.

Cellebrite Media
Victor Cooper
Public Relations and Corporate Communications Director
Victor.Cooper@cellebrite.com
+1 404.804.5910