Hanwha Corp.

Photo Credit: Vertical Aerospace Vertical Aerospace (London, U.K.) has provide an update on its overall program including a flight test update, addressing the unexpected fault that occurred earlier in August and where the company is at in regard to its program timeline. Vertical concluded its remote thrustborne flight test campaign in July 2023, as the first full-scale VX4 electic vertical takeoff and landing (eVTOL) aircraft prototype reached its target speed of 70 kilometers per hour, demonstrating exceptional overall stability and control. Performance targets were generally exceeded by 10-30% during hover and low-speed flights. The company says the prototype performed especially well in sustained hover, typically the most challenging regime for a VTOL aircraft, where it maintained level flight for longer than anticipated. The aim of these thrustborne flight tests was to verify acceptable stability, battery efficiency and control characteristics, aerodynamics, structural loads, performance and vibration throughout this speed range — all of which were achieved. Vertical continued further uncrewed flight tests following the completion of the remote thrustborne flight test campaign. The purpose of these was to understand how the aircraft performed outside of its expected operating conditions before the aircraft’s planned retirement. During one of these test flights, an unexpected fault occurred causing the aircraft to enter a stable descent, before being damaged on impact with the ground. Vertical completed a swift and thorough investigation and submitted a report to the Air Accidents Investigation Branch (AAIB). The company’s investigation identified the root cause to be a fault with a propeller. This early generation propeller had already been redesigned prior to the incident, with the issue fully resolved ahead of the next phase of testing. Further recommendations by the investigation are being implemented by Vertical. Vertical believes transparency and openness is fundamental to the safety of aerospace. It therefore intends to provide a further full update to the industry on the incident once the AAIB’s investigation has concluded. Supported by the learnings from the completed thrustborne campaign, the VX4 and its certification program remains on track with no changes to timelines. The assembly of a second significantly more advanced full-scale VX4 prototype is underway at GKN Aerospace’s Global Technology Centre in Bristol., U.K. This demonstrator is expected to be ready to fly in early 2024. Its components will include technology from most of Vertical’s certification partners: Honeywell, GKN Aerospace, Hanwha, Solvay, Leonardo and Molicel. An additional, identical full-scale aircraft has also now been approved and is expected to be flying in the second half of 2024. These upgraded full-scale aircrafts’ structures and subsystems will be tested in line with certification standards. Both will require rigorous regulatory oversight, including a Permit to Fly from the UK Civil Aviation Authority, to progress to piloted flying. “We are pleased with our flight test progress to date and the data, insights and invaluable learnings we have collected,” Stephen Fitzpatrick, Vertical founder and CEO, says. “While a fault of any sort is disappointing, it is not wholly unexpected at this stage of testing a novel aircraft. I am pleased that as a result of our expert team we have isolated the cause of the fault and been able to provide the AAIB with our report within 14 days of the incident. Our planned second upgraded prototype, which will include most of our top Tier partners’ technology, will have us in the air early next year and we remain on track for our certification timelines.”

ADI-001 demonstrated 75% overall response rate (ORR) and 69% complete response (CR) across all dose levels with favorable safety and tolerability profile in patients with relapsed/refractory high-grade aggressive NHL, as of December 5, 2022 data-cut date 100% ORR and CR rate in 5/5 anti-CD19 autologous chimeric antigen receptor T cells (CAR-T) relapsed large B-cell lymphoma (LBCL) patients 86% CR rate in LBCL patients across dose level three (DL3) and above (75% CR rate in LBCL patients across all dose levels) Both dose level 2 (DL2) and DL3 demonstrated a six-month CR rate of 33%; Patient follow up continues in dose level 4 (DL4) to assess six-month durability Circulating ADI-001 cells visible through day 28 in peripheral blood at DL4 Company expects to initiate a potentially pivotal study in post-CAR T LBCL patients in the second quarter of 2023; Evaluating potential second pivotal study in earlier-line LBCL patients Company to host investor webcast Sunday, December 11 at 9:00 am ET Figure 1: ADI-001: Preliminary Efficacy Data (Graphic: Adicet Bio) REDWOOD CITY, CA & BOSTON, MA, USA I December 10, 2022 I Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, today announced positive safety and efficacy data from the Company’s ongoing Phase 1 study of ADI-001 for the potential treatment of relapsed or refractory B-cell NHL. The Company believes these data continue to support the potential of Adicet’s investigational gamma delta CAR T cell therapy to provide significant benefit both in terms of anti-tumor activity and safety. Based on the study findings as of a December 5, 2022 data-cut date, Adicet plans to transition ADI-001 into a potentially pivotal program in the second quarter of 2023. “It is very encouraging to see durability of response at six months and beyond along with a continued favorable safety profile in patients with aggressive lymphomas,” said Francesco Galimi, M.D., Ph.D., Senior Vice President and Chief Medical Officer of Adicet Bio. “Notably, a 100% complete response rate with ADI-001 in post-autologous CAR T-relapsed LBCL patients may offer a potential treatment option to those patients, who do not currently have effective therapies.” “These data are exciting and support our belief that ADI-001 has the potential to generate meaningful clinical responses for patients,” said Chen Schor, President and Chief Executive Officer of Adicet Bio. “Based on the positive data reported today, we plan to transition ADI-001 into a potential pivotal program with a potentially best-in-class ORR, CR and durability profile in the second quarter of 2023.” “As these data mature, it is impressive to see continued complete responses across all dose levels including six-month durable responses and a 100% ORR and CR rate in LBCL patients previously treated with autologous CAR T therapy,” said Sattva Neelapu, M.D., Professor in the Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center. “Achieving these results in such high-risk patients with aggressive disease suggests that an allogeneic gamma delta CAR T cell therapy like ADI-001 could provide a significant advance for NHL patients.” Data highlights as of the December 5, 2022 data-cut date were as follows: Table 2: Summary of Phase 1 ADI-001 Preliminary Safety Data in Efficacy-Evaluable Patients as of the December 5, 2022 data-cut date: + + Safety assessment was performed using the Common Terminology Criteria for Adverse Events (v5) and the American Society for Transplantation and Cellular Therapy criteria. Enrollment in the Phase 1 clinical study of ADI-001 is currently ongoing to provide additional durability data and further support the recommended Phase 2 dose. The Company expects to discuss with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) a potential path to support a Biologics License Application (BLA) and Marketing Authorization Application (MAA) for ADI-001, including potential pivotal studies in post-CAR-T LBCL patients and in earlier line LBCL patients, respectively. Webcast / Conference Call information Adicet will host a webcast presentation on Sunday, December 11, 2022 at 9:00 a.m. EST to discuss the most recent data-cut from its ongoing Phase 1 study evaluating the safety and tolerability of ADI-001 for the potential treatment of relapsed or refractory B-cell NHL. The event will feature Sattva Neelapu, M.D., Professor in the Department of Lymphoma-Myeloma, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, alongside members of the Adicet management team. The live webcast of the presentation can be accessed by registering under “Presentations & Events” in the investors section of the Company’s website at https://www.adicetbio.com . Upon registration, all participants will receive a confirmation email with a unique passcode to provide access to the webcast event. To participate via telephone, please join by dialing 1-833-548-0276 (domestic) or 1-646-876-9923 (international) and referencing the conference ID 98173615816. An archived replay will be available for 30 days following the presentation. The archived webcast will be available on the Company's website beginning approximately two hours after the event. About ADI-001 ADI-001 is an investigational allogeneic gamma delta CAR T cell therapy being developed as a potential treatment for relapsed or refractory B-cell NHL. ADI-001 targets malignant B-cells via an anti-CD20 CAR and via the gamma delta innate and T cell endogenous cytotoxicity receptors. Gamma delta T cells engineered with an anti-CD20 CAR have demonstrated potent anti-tumor activity in preclinical models, leading to long-term control of tumor growth. In April 2022, ADI-001 was granted Fast Track Designation by the FDA for the potential treatment of relapsed or refractory B-cell NHL. About the GLEAN Study This Phase 1 study is an open-label, multi-center study of ADI-001 enrolling adults diagnosed with B-cell malignancies who have either relapsed, or are refractory to, at least two prior regimens. The primary objectives of the study are to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ADI-001, and to determine optimal dosing as a monotherapy. The study is expected to enroll approximately 75 patients. For more information about the clinical study design, please visit www.clinicaltrials.gov ( NCT04735471 ). About Adicet Bio, Inc. Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs) and adaptors (CAds), to enhance selective tumor targeting and facilitate innate and adaptive anti-tumor immune response for durable activity in patients. For more information, please visit our website at https://www.adicetbio.com . SOURCE: Adicet Bio

Users breathe into the Lumen device in order to get a reading on their metabolism. Based on the results, the connected app will give users a recommendation to follow a low-carb diet that day, a high-carb diet or somewhere in-between. Wellness and fitness company Lumen announced Thursday that it aims to bring its metabolism tracking platform to more consumers in the U.S. and globally after raking in $62 million in Series B funding. The Tel Aviv, Israel-based startup was founded in 2014 by twin sisters Michal and Merav Mor when they were training for the Ironman, a triathlon consisting of swimming, biking and running. They created a peer-reviewed handheld device that measures users’ metabolism through breath and connects to an app that helps track goals and provides nutrition coaching. The product is sold directly to consumers through the company’s website. “Lumen understands the impact of each person’s nutrition, exercise, sleep, and stress on their metabolism by simply breathing into the device,” Michal Mor, co-founder and head of science for product for Lumen, wrote in an email. “Up until now, this was a process that was only available in hospitals or clinics and consisted of a 45-minute lab test.” Users breath into the device each morning, which measures CO2 to determine the body’s source for energy that day: fats or carbs. It gives a score from one to five, with one meaning the user is almost entirely burning fat and five meaning the user is almost entirely burning carbs. Lumen will then give a recommendation for the user’s food intake, which could be a low-carb day, a high-carb day or somewhere in between. The $62 million funding round was led by Pitango Venture Capital, and included participation from Hanwha Group and Resolute Ventures. In total, the wellness company has raised $77 million. With the financing, Lumen hopes to reach more consumers, expand its personalized nutrition and lifestyle coaching services and gain more research partnerships with academic institutions. In the past year, the company has conducted several studies with universities, including Purdue University’s Whistler Center for Carbohydrate Research, University of Toronto’s Faculty of Kinesiology and Physical Education and ARU Cambridge, Mor said. Additionally, an October study done with Tel Aviv Sourasky Medical Center found that 12-week prediabetic Lumen users lowered their Hb1c levels, and achieved an average weight loss of 13 pounds and a 3% body fat reduction. Lumen offers three pricing options for its product: $249 for six months, $399 for 12 months or $699 for 12 months with personalized support from nutritionists. There’s a need for the company’s services. The metabolic health crisis is responsible for $464 billion in annual healthcare costs and affects eight out of 10 American adults, according to ScienceDaily. “Our goal has always been to make metabolism measurement accessible to global communities because it’s the starting point to unlock your health and prevent major illnesses,” Mor said. “Lumen’s tracker helps users to improve their metabolic health, by optimizing nutrition, sleep, fitness regimes and more. Taking specific health conditions into account, like menopause and diabetes, helps us target our prime metabolic health.” Lumen is the only company measuring metabolism through breath with a handheld device, Mor declared. However, for people diagnosed with a metabolic disease like diabetes, companies such as Dexcom, Medtronic and Abbott offer continuous glucose monitoring devices available by prescription.