Japan’s Ispace Launches World’s First Commercial Moon Lander

A Japanese space startup launched a spacecraft to the moon Sunday after several delays, a step toward what would be a first for the nation and for a private company.
Ispace Inc’s HAKUTO-R mission took off without incident from Cape Canaveral, Florida, after two postponements caused by inspections of its SpaceX Falcon 9 rocket.
More than a hundred people at a viewing party in Tokyo roared in applause when the rocket fired and lifted into the dark skies.
“I’m so happy. After repeated delays, it’s good that we had a proper launch today,” said Yuriko Takeda, a 28-year-old worker at an electronics company who joined the gathering.
“I have this image of the American flag from the Apollo landing, so while this is just the launch, the fact that it’s a private company going there with a rover is a really meaningful step.”
The national space agencies of the United States, Russia and China have achieved soft landings on Earth’s nearest neighbor in the past half century, but no companies have.
Mission success would also be a milestone in space cooperation between Japan and the United States at a time when China is becoming increasingly competitive and rides on Russian rockets are no longer available in the wake of Russia’s invasion of Ukraine.
It would also cap a space-filled few days for Japan, after billionaire Yusaku Maezawa revealed on Friday the eight crew members he hopes to take on a SpaceX flyby of the moon as soon as next year.
The name HAKUTO refers to the white rabbit that lives on the moon in Japanese folklore, in contrast to the Western idea of a man in the moon. The project was a finalist in the Google Lunar XPRIZE before being revived as a commercial venture.
Next year is the Year of the Rabbit in the Asian calendar.
The craft, assembled in Germany, is expected to land on the moon in late April.
The company hopes this will be the first of many deliveries of government and commercial payloads. The ispace craft aims to put a small NASA satellite into lunar orbit to search for water deposits before touching down in the Atlas Crater.
The M1 lander will deploy two robotic rovers, a two-wheeled, baseball-sized device from Japan’s JAXA space agency and the four-wheeled Rashid explorer made by the United Arab Emirates.
It will also be carrying an experimental solid-state battery made by NGK Spark Plug Co.
“The Rashid rover is part of the United Arab Emirates ambitious space program,” said Dubai ruler Sheikh Mohammed bin Rashid al-Maktoum, who is also vice president of the United Arab Emirates and who watched the launch at the Mohammed bin Rashid Space Centre.
“Our aim is knowledge transfer and developing our capabilities and to add a scientific imprint in the history of humanity,” he tweeted.
Privately funded ispace has a contract with NASA to ferry payloads to the moon from 2025 and is aiming to build a permanently staffed lunar colony by 2040.

Source: Voice of America

NASA Moon Capsule Orion Due to Splash Down After Record-Setting Voyage

After making a close pass at the moon and venturing further into space than any previous habitable spacecraft, NASA’s Orion capsule is due to splash down Sunday in the final test of a high-stakes mission called Artemis.
As it hurtles into Earth’s atmosphere at a speed of 40,000 kph, the gumdrop-shaped traveler will have to withstand a temperature of 2,800 degrees Celsius — about half that of the surface of the sun.
Splashdown in the Pacific off the Mexican island of Guadalupe is scheduled for 1739 GMT (9:39 am local time).
Achieving success in this mission of just over 25 days is key for NASA, which has invested tens of billions of dollars in the Artemis program due to take people back to the moon and prepare for an onward trip, someday, to Mars.
So far, the first test of this uncrewed spacecraft has gone very well.
But it is only in the final minutes of this voyage that the true challenge comes: seeing if Orion’s heat shield, the biggest ever built, actually holds up.
“It is a safety-critical piece of equipment. It is designed to protect the spacecraft and the passengers, the astronauts on board. So the heat shield needs to work,” said Artemis mission manager Mike Sarafin.
A first test of the capsule was carried out in 2014 but that time the capsule stayed in Earth’s orbit, so it came back into the atmosphere at a slower speed of around 32,000 kph.
Choppers, divers and boats
A U.S. Navy ship, the USS Portland, has been positioned in the Pacific to recover the Orion capsule in an exercise that NASA has been rehearsing for years. Helicopters and inflatable boats will also be deployed for this task.
The falling spacecraft will be slowed first by the Earth’s atmosphere and then a web of 11 parachutes until it eases to a speed of 30 kph when it finally hits the Pacific.
Once it is there, NASA will let Orion float for two hours — a lot longer than if astronauts were inside — to collect data.
“We’ll see how the heat soaks back into the crew module and how that affects the temperature inside,” said Jim Geffre, NASA’s Orion vehicle integration manager.
Divers will then attach cables to Orion to hoist it onto the USS Portland, which is an amphibious transport dock vessel, the rear of which will be partly submerged. This water will be pumped out slowly so the spacecraft can rest on a platform designed to hold it.
This should all take about four to six hours from the time the vessel first splashes down.
The Navy ship will then head for San Diego, California, where the spacecraft will be unloaded a few days later.
When it returns to Earth, the spacecraft will have traveled more than 2 million kilometers since it took off Nov. 16 with the help of a monstrous rocket called SLS.
At its nearest point to the moon, it flew less than 130 kilometers from the surface. And it broke the distance record for a habitable capsule, venturing 432,000 kilometers from our planet.
Artemis 2 and 3
Recovering the spacecraft will allow NASA to gather data that is crucial for future missions.
This includes information on the condition of the vessel after its flight, data from monitors that measure acceleration and vibration, and the performance of a special vest put on a mannequin in the capsule to test how to protect people from radiation while flying through space.
Some components of the capsule should be good for reuse in the Artemis 2 mission, which is already in advanced stages of planning.
This next mission planned for 2024 will take a crew toward the moon but still without landing on it. NASA is expected to name the astronauts selected for this trip soon.
Artemis 3, scheduled for 2025, will see a spacecraft land for the first time on the south pole of the moon, which features water in the form of ice.
Only 12 people — all of them white men — have set foot on the moon. They did this during the Apollo missions, the last of which was in 1972.
Artemis is scheduled to send a woman and a person of color to the moon for the first time.
NASA’s goal is to establish a lasting human presence on the moon, through a base on its surface and a space station circling around it. Having people learn to live on the moon should help engineers develop technologies for a years-long trip to Mars, maybe in the late 2030s.

Source: Voice of America

Junshi Biosciences Announces Updated Clinical data from Phase I study of anti-BTLA antibody Tifcemalimab in Treatment of Relapsed/Refractory Lymphomas at 64th ASH Annual Meeting

— Preliminary study results show that tifcemalimab is well-tolerated at all administered doses. The observed clinical activity of tifcemalimab in combination with toripalimab in lymphoma patients refractory to checkpoint inhibitors warrants further evaluation. Combination dose expansion is under way.

— Among the 28 evaluable patients who received the combination regimen, while 85.7% of the patients progressed upon prior anti-PD-1, 39.3% achieved ORR, and median DoR has not yet been reached.

SHANGHAI, China, Dec. 10, 2022 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced today that the updated preliminary data from a Phase I study of tifcemalimab as a single agent or in combination with toripalimab in relapsed/refractory lymphomas in a poster at the 64th American Society of Hematology (ASH) Annual Meeting. Tifcemalimab is the world’s first-in-human anti-tumor anti-BTLA monoclonal antibody independently developed by the company.

“Nowadays, PD-1 inhibitors are widely used in the treatment of lymphomas, particularly relapsed or refractory classical Hodgkin’s lymphoma (R/R cHL),” said Dr. Yuqin Song of Peking University Cancer Hospital and Institute. “However, if PD-1 inhibitors fail, there is no standard treatment to resort to, thus new treatment methods are urgently needed in clinical practice. Through research, we have discovered that these types of patients can expect to benefit once again when treated with tifcemalimab and toripalimab combined. We’ve also observed a similar advantage in this treatment method as well as other immune checkpoint inhibitors—both may bring long-term survival benefits to patients. As the clinical trials continue, we look forward to observing tifcemalimab’s performance and the new treatment options it can bring to more lymphoma patients.”

“The first of its kind in the entire world, tifcemalimab exhibits promising safety and efficacy in early clinical trials,” said Dr. Jianjun Zou, Global Research and Development President at Junshi Biosciences. “In particular, the updated research data released at the ASH Annual Meeting highlights that the tifcemalimab-toripalimab dual immunotherapy is promising for patients with relapsed/refractory lymphoma resistant to anti-PD-1 monoclonal antibodies, and is worth further evaluation. Apart from that, we’ve also seen its outstanding safety and efficacy in patients with solid tumors, and are eager for further verification in subsequent research.”

The study is a single-arm, open-label, multicenter, dose-escalation phase I study (NCT0447772) evaluating the safety and efficacy of tifcemalimab as a single agent or in combination with toripalimab in relapsed/refractory lymphomas. This is the very first time an anti-BTLA antibody was evaluated for safety and efficacy in the treatment of lymphomas. Earlier this year in June, tifcemalimab made its debut with preliminary data from the clinical trials at the American Society of Clinical Oncology (ASCO) annual meeting, creating a milestone for all BTLA-targeting drugs in the field of cancer. Now, updated results from the clinical trial for lymphomas have been presented at the ASH annual meeting. The leading PI of this study include Dr. Jun Ma from Harbin Institute of Hematology and Oncology and Dr. Jun Zhu from Peking University Cancer Hospital and Institute, with Dr. Yuqin Song as the presenting author.

By the cutoff date of October 26, 2022, a total of 63 patients with relapsed/refractory lymphoma were enrolled in the study, including 43 patients with Hodgkin’s lymphoma (HL) and 20 with non-Hodgkin’s lymphoma (NHL). Among the 25 evaluable patients who received monotherapy, 9 received monotherapy dose escalation and 16 received monotherapy dose expansion; among the 38 patients who received combination treatment, 6 received combination dose escalation and 32 received combination dose expansion. Patients were heavily treated with median 4 prior lines of therapy. 46 patients (73.0%) received prior anti-PD-1/L1 therapy.

In terms of safety and tolerability, as of October 26, 2022, no dose-limiting toxicity (DLT) was observed in either monotherapy or combination dose escalation. Additionally, the immune related adverse event (irAE) profile of the combination was consistent with toripalimab monotherapy, and no novel safety signals were identified in the combination cohorts.

Regarding clinical anti-tumor activity, as of October 26, 2022, the median follow-up was 29.1 weeks, 1 case of partial remission (PR) and 7 cases of stable disease (SD) were observed among the 25 evaluable patients receiving monotherapy. Among the 28 evaluable patients receiving the combination regimen, 24 (85.7%) patients progressed upon prior anti-PD-1, and 1 complete response (CR), 10 PR, and 13 SD were observed. The objective response rate (ORR) reached 39.3% and the disease control rate (DCR) reached 85.7%. All patients with CR/PR responses in the combination groups are ongoing by the cutoff date and the median duration of response (DoR) is not yet reached.

About Tifcemalimab (JS004/TAB004)
Tifcemalimab is the world’s first-in-human recombinant humanized anti-BTLA (B- and T-lymphocyte attenuator) monoclonal antibody independently developed by Junshi Biosciences. So far, tifcemalimab has entered phase Ib/II study, and several trials of tifcemalimab in combination with toripalimab in patients with different types of tumors are ongoing in China and the United States.

In 2003, B and T lymphocyte attenuator (BTLA), the target of tifcemalimab was discovered. It is a member of the CD28 receptor family. It has a single IgSF V extracellular domain; its sequence is similar to other molecules of the CD28 family (such as PD-1 and CTLA-4).

BTLA is expressed in the T lymphocyte, B lymphocyte and dendritic cell subpopulations. In 2005, the interaction between BTLA and its ligand, Herpes virus entry mediator (HVEM) was discovered. HVEM is a TNF receptor extensively expressed in the hematopoietic system and is confirmed as the ligand of BTLA.

BTLA is an immunoglobulin associated membrane protein; its protein structure is similar to that of the transmembrane receptors (CTLA-4 and PD-1). Under normal physiological conditions, after BTLA binds with its ligand HVEM, the over-activation of lymphocytes in the human body is inhibited, thus avoiding autoimmune injuries.

By binding with BTLA, tifcemalimab blocks the HVEM-BTLA interaction, thereby obstructing the BTLA-mediated inhibitory signal pathways and activating the tumor specific lymphocytes.

Tifcemalimab interferes with the HVEM-BTLA interaction by binding to BTLA, thus blocking the inhibitory signal pathway mediated by BTLA and resulting in the activation of tumor-specific lymphocytes.

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 monoclonal 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. Meanwhile, VV116, a new oral nucleoside analog anti-SARS-CoV-2 drug designed to hinder virus replication, is in global Phase III clinical trials. 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 and Guangzhou). For more information, please visit: http://junshipharma.com.

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

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

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