IN8bio: Complete Remission in 100% of Evaluable Patients in Phase 1 Trial of INB-100 in Leukemia

 

• Durable complete remission (CR) achieved in 100% of treated patients, including high-risk and relapsed acute myeloid leukemia (AML) patients and those who had failed multiple prior lines of therapy, including CAR-T.
  
  
• All trial participants remain alive and relapse free as of last assessment, and six patients have been relapse free for over one year.
  
  
• New data shows long-term in-vivo expansion and persistence of allogeneic gamma-delta T cells 365 days following a single administration of INB-100, demonstrating the first-ever durable persistence of an allogeneic cellular therapy.
  
  
• Data to be presented today (abstract: 4853) at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition.
  
  
• The Company will host a conference call at 8:30 am ET tomorrow to discuss these updates. Please use this link to participate in the live call; a listen-only version of the webcast is available here.

https://www.globenewswire.com/news-release/2023/12/11/2794257/0/en/IN8bio-Announces-Positive-Clinical-Update-Demonstrating-Continued-Durable-Complete-Remission-in-100-of-Evaluable-Patients-in-Phase-1-Trial-of-INB-100-in-Leukemia.html

Aditxt to Acquire Evofem

 

Definitive Agreement to Acquire Evofem Biosciences, Inc., Creator of Phexxi®, the First and Only FDA-Approved Hormone-Free Contraceptive Gel, to Address Diverse Reproductive Health Needs of Women Globally

Evofem posted $13.4 million in net sales of Phexxi for the first nine months of 2023;

Aditxt looks to accelerate Evofem into the global non-hormonal birth control market valued at $27.7 billion in 2022 and is projected to grow to $52.2 billion by 2031

https://www.businesswire.com/news/home/20231212529968/en/

C4, Merck to Discover and Develop Degrader-Antibody Conjugates (DACs)

 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science to develop a new generation of small-molecule medicines and transform how disease is treated, today announced that it has entered into an exclusive license and collaboration agreement with Merck (known as MSD outside of the U.S. and Canada) to develop degrader-antibody conjugates (DACs), an emerging modality designed to selectively target and neutralize disease-causing proteins in cancer cells.

Under the terms of the agreement, C4T will receive a $10 million upfront payment. C4T and Merck will collaborate to develop DACs directed to an initial undisclosed oncology target that is exclusive to the collaboration. For DACs directed to this initial target, C4T is eligible to receive milestone payments totaling approximately $600 million, as well as tiered royalties on future sales. The agreement also provides Merck with the option to extend the collaboration to include three additional targets that would be exclusive to the collaboration, which could yield option exercise payments as well as potential milestones and royalties. If Merck exercises all of its options to extend the collaboration, C4T would be eligible to receive up to approximately $2.5 billion in potential payments across the entire collaboration.

As part of the collaboration, C4T will be responsible for using its proprietary TORPEDO® platform to develop degrader payloads in the discovery phase. Merck will be responsible for antibody conjugation to create DACs in the discovery phase and for advancing these DAC candidates through preclinical and clinical development as well as commercialization.

https://www.globenewswire.com/news-release/2023/12/12/2794588/0/en/C4-Therapeutics-Announces-License-and-Research-Collaboration-with-Merck-to-Discover-and-Develop-Degrader-Antibody-Conjugates-DACs.html

ADC Initial Results from Investigator-Initiated Phase 2 Lymphoma Trial

 Combination demonstrated clinically meaningful benefit in r/r FL patients with 96% overall response rate and 85% complete response rate

https://www.globenewswire.com/news-release/2023/12/12/2794525/0/en/ADC-Therapeutics-Announces-Initial-Results-from-Investigator-Initiated-Phase-2-Clinical-Trial-Evaluating-ZYNLONTA-in-Combination-with-Rituximab-in-Patients-with-Relapsed-Refractory.html

US consumer group seeks stronger warnings on Botox, similar treatments

 Consumer advocacy group Public Citizen on Tuesday filed a petition with the U.S. Food and Drug Administration seeking to require makers of Botox and several similar injections to include stronger warnings about the risk of a potentially fatal muscle-paralyzing disease.

These injections, which use various versions of botulinum toxins to contract specific muscles by blocking certain nerve signals to erase wrinkles, already have a 'black box' warning in their labels about the risks of the intended effect spreading to other areas. The consumer group asked the FDA to make it clear that these adverse effects could happen even at recommended dosages.

The new petition seeks a stronger warning on the label of six toxin-based injections including market leader Botox from AbbVie, Revance Therapeutics' Daxxify, Evolus' Jeuveau, Supernus Pharmaceuticals' Myobloc, Galderma's Dysport and Xeomin from Merz Therapeutics.

Public Citizen also asked the FDA to remove promotional statements that claim there are no definitive serious side-effects of distant spread of toxin effect associated with the toxins.

The request comes after the advocacy group analyzed over 5,400 reports of deaths, life-threatening events and other serious side effect related to Botox and rival toxin-based wrinkle treatments between January 1989 and March 2021 that were recorded in FDA's adverse events database.

The FDA maintains the database to help it identify unusual or emerging side effect trends that may require further investigation or actions, such as adding warnings to a product.

The group is asking the FDA to add clear warnings about systemic iatrogenic botulism, a condition that can cause progressive muscle paralysis if the toxin used in these products spreads beyond the intended treatment site.

The FDA said it will review the petition and respond directly to Public Citizen. Merz said it closely tracks the FDA adverse event database, and submits safety reports to the agency on a regular basis, while Revance and Evolus declined to comment. The other companies did not respond to requests for comment.

https://finance.yahoo.com/news/us-consumer-group-seeks-stronger-050100638.html

AstraZeneca to buy vaccine developer Icosavax for up to $1.1 bln

  AstraZeneca on Tuesday agreed to buy vaccine developer Icosavax in a deal valued at up to $1.1 billion to bolster its respiratory syncytial virus (RSV) vaccine portfolio.

The deal values Icosavax at $15 per share in cash at closing, plus a non-tradable contingent value right for up to $5 per share in cash if certain milestones are met.

The upfront payment of $15 apiece represents a premium of about 43% to U.S.-listed Icosavax's last close.

https://finance.yahoo.com/news/1-astrazeneca-buy-rsv-vaccine-071944311.html

ASH: Vertex Positive Results from Pivotal Trials of CASGEVY

 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced two oral presentations at the American Society of Hematology (ASH) Annual Meeting and Exposition from the global pivotal trials of CASGEVY™ (exagamglogene autotemcel [exa-cel]).

Data from 96 patients (44 sickle cell disease [SCD], 52 transfusion-dependent beta thalassemia [TDT]) treated with CASGEVY in pivotal studies, with the longest follow-up of more than four years, continue to reinforce the consistent and durable response to treatment. In addition, new data illustrating improvements in patient-reported outcomes after treatment with CASGEVY were featured in poster presentations at ASH.

https://www.biospace.com/article/releases/positive-results-from-pivotal-trials-of-casgevy-exagamglogene-autotemcel-highlighted-in-oral-presentations-at-the-american-society-of-hematology-ash-annual-meeting-and-exposition/