Takeda Adds Potential First-in-Class Celiac Treatment to Repertoire

 Takeda, Zedira and Dr. Falk Pharma will collaborate to develop ZED1227/TAK-227, a potential first-in-class investigational therapy for the treatment of celiac disease, Takeda announced Thursday. 

The collaboration will provide Takeda with an exclusive license to develop and commercialize ZED1227/TAK-227 in the United States and other countries outside of Australia, Europe, Canada and China, according to a press release.

Under the terms of the agreement, Zedira and Dr. Falk Pharma will receive upfront payment and eligibility to receive potential development, regulatory and commercial milestones and royalties on net sales.

The Phase IIb investigational therapy trial will involve global clinical studies of the treatment.

TAK-227 works by inhibiting the tissue transglutaminase (TG2), which is an enzyme that generates immunogenic gluten peptide fragments upon the breakdown of gluten in the stomach and intestinal tissues. It was proven to be safe and well tolerated in a Phase IIA proof-of-concept study published in the New England Journal of Medicine. 

ZED1227, originally discovered by Zedira, had its European rights licensed to Dr. Falk Pharma in 2011. Dr. Falk Pharma has been in charge of preclinical and clinical development of the treatment since then. This license agreement guaranteed Zedira an upfront payment and milestone payments and royalties in the European market.

In 2015, Dr. Falk Pharma and Zedira collaborated on ZED1227 for a Phase I clinical trial. The trial offered additional safety when applied in the midst of a "mostly gluten-free diet," which stood to improve quality-of-life for millions of patients.

TAK-227 isn't Takeda's only celiac treatment in development. The company is currently developing two other investigational celiac therapies, both of which recently entered Phase II clinical trials.

TAK-062 is a highly-potent glutenase that was computationally engineered to treat celiac disease. TAK-101, a potential first-in-class treatment, is an immune-modifying nanoparticle that contains gliadin proteins designed to promote immune tolerance to gluten by preventing gliadin-specific T-cell activation.

Takeda acquired a global license to develop and commercialize TAK-101 in 2019 following a successful Phase IIa proof-of-concept study.

https://www.biospace.com/article/takeda-announces-first-in-class-celiac-therapy/

Suspected fentanyl pills hidden in candy boxes seized at Los Angeles airport

 Law enforcement agents on Wednesday said they seized 12,000 fentanyl pills hidden inside candy boxes in a major drug bust at Los Angeles International Airport.

A suspect attempted to move through a Transportation Security Administration checkpoint with the drugs, which were packed inside Skittles and Whoppers boxes, according to a release from the L.A. County Sheriff’s Narcotics Bureau and the Drug Enforcement Agency (DEA).

The county did not say where the boxes were hidden. At the checkpoint, the suspect was stopped by an official who discovered the candy boxes were loaded with rainbow-colored fentanyl pills.

The suspect fled before agents could seize him, although the individual has been identified and the investigation is ongoing, according to the county.

The seizure is the latest drug bust with rainbow fentanyl pills, which are brightly colored and designed to look like candy. Fentanyl is a synthetic opioid that is 50 to 100 times stronger than morphine.

Last weekend, federal agents seized 300,000 rainbow fentanyl pills and 20 pounds of fentanyl in white and blue powder from an apartment in New York.

The DEA has warned the cheaply made narcotics are being shipped into the U.S. by Mexican drug cartels for huge profit.

https://thehill.com/policy/transportation/3696918-suspected-fentanyl-pills-hidden-in-candy-boxes-seized-at-los-angeles-airport/

Biden backs federal fund for abortion support

 President Biden said he would support a federal fund to help women pay for abortion procedures while calling on companies to also help their employees pay for reproductive care.

“The answer is absolutely,” Biden told NowThis News when asked in a recent interview if he supports a federal fund for individuals who need to take time off work or obtain child care for an abortion.

“I do support that, and I’ve publicly urged companies to do that. I’ve urged them publicly as president of the United States saying, ‘This is what you should be doing … I urge you to do it because there’s so many, and imagine the women who need that kind of assistance, but have no money at all to be able to do this. None … what do they do? They don’t have the option,” the president said.

Biden was interviewed alongside Danielle Mathisen, a medical resident pursuing a career in obstetrics and gynecology, for NowThis. It was recorded on Tuesday and will air on Sunday at 7 p.m. ET.

The president’s comments mark a reaffirming of his stance against the Hyde amendment, which prohibits federal funds from being used to pay for abortions.

The Hyde amendment first passed Congress in 1976 and allows exceptions given for cases of rape, incest and when the life of the pregnant person is endangered.

Biden supported the Hyde amendment throughout his long political career, but during the Democratic presidential primary, he said he could no longer support it. He was then hailed by reproductive rights groups when he didn’t include it in his 2022 budget.

The president signed an executive order in August, in response to the Supreme Court’s June ruling striking down Roe v. Wade, to direct the Department of Health and Human Services to consider working with states to use Medicaid waivers to pay for expenses for people who cross state lines to receive abortions. 

Just days after the Supreme Court’s ruling, several of the nation’s largest companies said they would be willing to reimburse employees who travel out of state to legally access abortion services. Those companies included Disney, Meta, Zillow, BuzzFeed and Amazon, among others.

https://thehill.com/homenews/administration/3696875-biden-backs-federal-fund-for-abortion-support/

AbbVie Acquires DJS Antibodies, Further Strengthening Immunology Pipeline

-- DJS Antibodies' DJS-002 is a potential first-in-class antibody directed to LPAR1, currently in investigational preclinical studies for the treatment of Idiopathic Pulmonary Fibrosis and other fibrotic diseases

-- The company's proprietary HEPTAD platform will extend AbbVie's current discovery research capabilities by generating potential novel antibodies against difficult-to-drug protein targets in immunology and beyond

AbbVie (NYSE: ABBV) today announced the acquisition of DJS Antibodies Ltd ("DJS"), a privately-held UK-based biotechnology company dedicated to discovering and developing antibody medicines that target difficult-to-drug disease-causing proteins, such as G protein-coupled receptors (GPCRs). DJS's lead program is DJS-002, a potential first-in-class lysophosphatidic acid (LPA) receptor 1 (LPAR1) antagonist antibody currently in investigational preclinical studies for the treatment of Idiopathic Pulmonary Fibrosis (IPF) and other fibrotic diseases. IPF is an aggressive, high mortality disease caused by fibrotic scarring in the lungs and remains an area of high unmet medical need.

https://finance.yahoo.com/news/abbvie-acquires-djs-antibodies-further-130000344.html

Kite, Refuge in Agreement for Investigational Gene Expression Platform for Blood Cancers

 Kite, a Gilead Company (Nasdaq: GILD) and Refuge Biotechnologies, Inc. ("Refuge"), today announced that Kite has entered into an exclusive, worldwide license agreement with Refuge, a synthetic biology company for cancer immunotherapy, for exclusive rights to utilize Refuge’s proprietary gene expression platform to develop potential treatments for blood cancers.

Refuge’s proprietary platform is a synthetic biology system that utilizes an expression modulation strategy to repress or activate transcription of target genes. Early pre-clinical data suggest a potential for this highly modular platform to regulate target antigen-dependent gene expression as a means to improve upon both the efficacy and safety of first-generation CAR T-cell therapies. Kite will have an exclusive license to Refuge’s intellectual property portfolio for use in blood cancers, as well as a library of synthetic gene expression programs for these indications. Refuge will retain all rights and programs related to solid tumor indications.

https://finance.yahoo.com/news/kite-refuge-biotechnologies-announce-exclusive-130000163.html

hookipa, Roche to develop novel arenaviral immunotherapy for KRAS-mutated cancers

 

• Roche to receive license for HOOKIPA’s HB-700 program and option to license a second undisclosed novel arenaviral immunotherapy
  
  

• HOOKIPA to receive $25 million in upfront cash as well as potential future success-based milestone payments up to approximately $930 million for both programs, plus tiered royalties

 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapies based on its proprietary arenavirus platform, announced today a strategic collaboration and license agreement with Roche to develop HB-700 for KRAS-mutated cancers and a second undisclosed novel arenaviral immunotherapy. This represents HOOKIPA’s first oncology licensing collaboration.

Through the collaboration, HOOKIPA will conduct research and early clinical development through Phase 1b for HB-700, a novel investigational arenaviral immunotherapy for the treatment of KRAS-mutated cancers. Upon the completion of the Phase 1b trial, Roche has the right to assume development responsibility and to commercialize licensed products across multiple indications upon approval. The agreement also includes an option for Roche to license a second arenaviral cancer immunotherapy.

https://finance.yahoo.com/news/hookipa-announces-strategic-collaboration-license-110000974.html

ResMed upped to Buy from Neutral by B of A

 Target to $260 from $245

https://finviz.com/quote.ashx?t=RMD&p=d