Talaris Phase 3 Clinical Update

 Talaris Therapeutics, Inc. (Nasdaq: TALS), a late-clinical stage cell therapy company developing therapies with the potential to transform the standard of care in solid organ transplantation and severe immune and blood disorders, today provided a clinical update on its ongoing Phase 3 FREEDOM-1 study in living donor kidney transplant (LDKT) recipients.

To date, Talaris has enrolled 22 donor-recipient pairs in the Phase 3 FREEDOM-1 study (NCT# 03995901) of FCR001. Seven patients have been successfully dosed at five different trial sites. All three patients who were dosed more than 12 months prior to the data cutoff date have been successfully weaned off all chronic anti-rejection drugs without evidence of rejection and with stable kidney function. All of these patients, including the first patient who is now 24 months post-transplant, continue to remain off all anti-rejection drugs. Furthermore, all patients treated with FCR001 at least three months prior to the data cutoff date have achieved and maintained T-cell chimerism levels >50% at each of the 3-, 6- and 12-month timepoints post-transplant. The safety profile observed was generally consistent with that expected in patients receiving a kidney transplant and an allo-HSCT. Three cases of low-grade acute graft-versus-host disease (aGvHD) were reported, all of which were treatment-responsive and have since resolved. One of these patients is more than 12 months post-transplant and has been successfully weaned off all anti-rejection drugs. As a result of an internal review triggered by the GvHD cases, Talaris has modified its mobilization protocol and added a second post-transplant dose of cyclophosphamide for GvHD prophylaxis. Trial enrollment continues.

Conference Call & Webcast Information
Talaris will host an investor webcast and conference call today at 8:00 a.m. ET to discuss its presentations at the American Transplant Congress (ATC) and provide a data update from its ongoing Phase 3 FREEDOM-1 study in living donor kidney transplant (LDKT) recipients. To access the conference call, the dial-in numbers are 1-855-605-1739 for domestic callers and 1-914-987-7955 for international callers. The conference ID number for the live call will be 6249115. A live webcast and replay of the conference call will also be available under "Events & Presentations" in the Investors section of the Company's website at www.talaristx.com.

https://finance.yahoo.com/news/talaris-therapeutics-provides-freedom-1-110000609.html

Cyclacel To Test Higher Doses Of Fadraciclib In Solid Tumor Patients

 

• Cyclacel Pharmaceuticals Inc (NASDAQ: CYCC) is adding two dose levels in a protocol amendment to test higher doses of oral fadraciclib before determining the recommended Phase 2 dose anticipated in 2H of 2022, citing the absence of dose-limiting toxicities.

• Fifteen patients with advanced solid tumors and lymphomas were treated with oral fadraciclib at all five doses.

• In the first oral treatment cycle with fadraciclib, a cutaneous T cell lymphoma patient achieved partial response (PR).

• A patient with a peripheral T cell lymphoma achieved a 38% reduction in target lesions.

• An endometrial cancer patient achieved stable disease with a 15% reduction of target lesions after the first oral treatment cycle. In an earlier study of intravenous fadraciclib as monotherapy, a patient with MCL1 amplified endometrial cancer achieved confirmed complete response (CR) and remains on study after 2.5 years of treatment.

• A pancreatic cancer patient achieved stable disease by the confirmatory scan for five oral treatment cycles.

• For CYC140, no dose-limiting toxicities were observed to date in the Phase 1/2 study of oral CYC140.

• An ovarian cancer patient in 140-101 achieved stable disease with tumor shrinkage after the first cycle.

https://finance.yahoo.com/news/cyclacel-test-higher-doses-fadraciclib-164648552.html

Rapid Micro Confirms Unsolicited, Non-Binding Proposal from Kennedy Lewis

 Rapid Micro Biosystems, Inc. (Nasdaq: RPID) (the “Company”), an innovative life sciences technology company providing mission critical automation solutions to facilitate the efficient manufacturing and fast, safe release of healthcare products, today confirmed that it has received an unsolicited, non-binding proposal from Kennedy Lewis Investment Management LLC to acquire all of the outstanding shares of the Company for $5.00 per share in cash.

Consistent with its fiduciary duties and in consultation with its independent advisors, the Rapid Micro Biosystems Board of Directors will carefully review the unsolicited proposal to determine the course of action that it believes is in the best interest of the Company and all Rapid Micro Biosystems shareholders. Rapid Micro Biosystems shareholders do not need to take any action at this time.

https://finance.yahoo.com/news/rapid-micro-biosystems-confirms-receipt-183300893.html

ADP to pause, retool employment report

 ADP Research Institute (ADPRI) and the Stanford Digital Economy Lab (the "Lab") announced they will retool the ADP National Employment Report (NER) methodology to provide a more robust, high-frequency view of the labor market and trajectory of economic growth. In preparation for the changeover to the new report and methodology, ADPRI will pause issuing the current report and has targeted August 31, 2022, to reintroduce the ADP National Employment Report in collaboration with the Stanford Digital Economy Lab (the "Lab"). We look forward to providing an even more comprehensive labor market analysis and will be in touch with additional details closer to the re-launch, later this summer. For more information on this announcement, please visit here.

https://adpemploymentreport.com/2022/May/NER/Report

BeiGene: Overall Survival Benefit for Tislelizumab Plus Chemo in First-Line Esophageal Cancer

 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, today announced new data from RATIONALE 306, a global Phase 3 trial evaluating tislelizumab plus chemotherapy in adult patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) without prior systemic treatment for advanced disease. Study results presented today as a late-breaking oral presentation at the 2022 European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer (Abstract #LBA-1) showed a statistically significant and clinically meaningful improvement in overall survival (OS) for patients receiving tislelizumab in combination with chemotherapy with a median OS of 17.2 months [95% CI: 15.8,20.1] versus 10.6 months [95% CI: 9.3,12.1] for those receiving chemotherapy plus placebo. The combination of tislelizumab with chemotherapy reduced the risk of death by 34% (HR=0.66 [95% CI: 0.54,0.80, p<0.0001]) compared to chemotherapy plus placebo.

https://www.biospace.com/article/releases/beigene-announces-late-breaking-data-at-esmo-gi-showing-overall-survival-benefit-for-tislelizumab-plus-chemotherapy-in-first-line-advanced-or-metastatic-esophageal-squamous-cell-carcinoma/

MediciNova Announces Extension of BARDA Contract

 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ: MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced a modification to its contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, to repurpose MN-166 (ibudilast) as a potential medical countermeasure (MCM) against chlorine gas-induced lung damage such as acute respiratory distress syndrome (ARDS) and acute lung injury (ALI). The contract was amended to extend the period of performance until March 2023.

Under the Division of Research, Innovation, and Ventures (DRIVe) Repurposing Drugs in Response to Chemical Threats (ReDIRECT) program, BARDA has previously provided funding for proof-of-concept studies of MN-166 in preclinical models of chlorine gas-induced ALI. MN-166 was the first compound to receive BARDA’s development support through the DRIVe ReDIRECT program, a collaboration between BARDA’s DRIVe and Chemical Medical Countermeasures Program within BARDA’s Division of Chemical, Biological, Radiological and Nuclear Medical Countermeasures.

This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50121C00022.

https://finance.yahoo.com/news/medicinova-announces-extension-barda-contract-230000388.html

AstraZeneca says Imfinzi combo shows promise in late-stage lung cancer trial

 AstraZeneca said on Thursday a combination of its cancer drug, Imfinzi, and chemotherapy showed promise in a late-stage trial in patients with an aggressive form of lung cancer, when given before surgery.

Data showed the combination was more effective in removing cancer cells in tissue samples taken during surgery when compared with just chemotherapy in patients with non-small cell lung cancer, the Anglo-Swedish drugmaker said.

The interim result is a boost to the company's oncology efforts - a major area of focus - following disappointing data for Imfinzi earlier in the year in another area of therapy. (https://reut.rs/3nq1chi)

AstraZeneca added the trial would continue as planned to assess the additional main goal of event-free survival, and the interim data would be shared with health authorities globally.

Imfinzi belongs to the immunotherapy class of treatments, which boost the body's defences to fight cancer by using antibodies that block or bind to foreign substances in the body. The treatment generated $2.41 billion in 2021 sales.

"Engaging the immune response with Imfinzi both before and after surgery is an exciting new strategy," said Susan Galbraith, executive vice president of oncology R&D at AstraZeneca.

Non-small cell lung cancer is the most common form of lung cancer, accounting for about 85% of the estimated 2.2 million new cases of the disease diagnosed each year worldwide, according to the World Health Organization. 

https://finance.yahoo.com/news/1-astrazeneca-says-imfinzi-combo-072029536.html