Zenas BioPharma Obtains IND Approval in China for Phase 1/2 Study of ZB001 for the Treatment of Thyroid Eye Disease  

WALTHAM, Mass and SHANGHAI, China, July 31, 2022 (GLOBE NEWSWIRE) — Zenas BioPharma, a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients in need around the world, announced that it has received approval of its Investigational New Drug (IND) application from the National Medical Products Administration (NMPA) of China for the initiation of a Phase 1/2 clinical study of ZB001 for the treatment of Thyroid Eye Disease (TED). The main objective of the Phase 1/2 is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZB001.

TED is a debilitating vison-threatening autoimmune disease that causes inflammation and fibrosis within the orbit of the eye. With no approved therapies for TED patients in China, treatment options are limited and often involve high doses of steroids associated with serious side effects or surgical intervention. ZB001 is a differentiated humanized monoclonal antibody targeting insulin-like growth factor 1 receptor (IGF-1R) intended for the treatment of TED.

“We are proud that the IND application for ZB001 was approved by the NMPA about two months following its submission, highlighting our team’s unique ability to efficiently execute on our development programs,” said Hua Mu, MD, PhD, Chief Executive Officer at Zenas. “We are excited to work with leading clinical experts in China to accelerate the development of ZB001 to address the significant unmet clinical need in thyroid eye disease.”

Zenas BioPharma licensed the exclusive rights to develop, manufacture and commercialize ZB001 (Viridian VRDN-001) and other compounds targeting IGF-1R in non-oncology indications in the greater China area from Viridian Therapeutics, Inc. (Viridian) in October 2020. After submitting an IND for VRDN-001 to the U.S. Food and Drug Administration in October 2021, Viridian initiated a Phase 1/2 clinical trial in December 2021 to evaluate proof of concept in TED patients in North America and released encouraging interim healthy volunteer data suggesting robust activity with excellent safety and tolerability of the candidate product.

About Zenas BioPharma

Zenas BioPharma is a global biopharmaceutical company based in the USA and China committed to becoming a leader in the development and commercialization of immune-based therapies for patients in the US, China and around the world. Zenas is rapidly advancing a deep pipeline of innovative therapeutics that continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those facing autoimmune and rare diseases. For more information about Zenas BioPharma, please visit www.zenasbio.com and follow us on Twitter at @ZenasBioPharma and LinkedIn.

Investor and Media Contact:
Joe Farmer
Zenas BioPharma
IR@zenasbio.com

Pat Carroll, Emmy Winner and Voice of Ursula, Dies at 95

Pat Carroll, a comedic television mainstay for decades, an Emmy-winner for “Caesar’s Hour” and the voice Ursula in “The Little Mermaid,” has died. She was 95.

Her daughter Kerry Karsian, a casting agent, said Carroll died at her home in Cape Cod, Massachusetts, on Saturday. Her other daughter Tara Karsian wrote on Instagram that they want everyone to “honor her by having a raucous laugh at absolutely anything today (and everyday forward) because besides her brilliant talent and love, she leaves my sister Kerry and I with the greatest gift of all, imbuing us with humor and the ability to laugh…even in the saddest of times.”

Carroll was born in Shreveport, Louisiana, in 1927. Her family relocated to Los Angeles when she was 5 years old. Her first film role came in 1948 in “Hometown Girl,” but she found her stride in television.

She won an Emmy for her work on the sketch comedy series “Caesar’s Hour” in 1956, was a regular on “Make Room for Daddy” with Danny Thomas, a guest star on “The DuPont Show with June Allyson” and a variety show regular stopping by “The Danny Kaye Show,” “The Red Skelton Show” and “The Carol Burnett Show.”

Carroll also played one of the wicked stepsisters in the 1965 television production of “Rodgers and Hammerstein’s Cinderella” with Lesley Ann Warren.

In addition, she also played one of the wicked stepsisters in the 1965 television production of “Rodgers and Hammerstein’s Cinderella” with Lesley Ann Warren. Plus, she won a Grammy in 1980 for the recording of her one-woman show “Gertrude Stein, Gertrude Stein, Gertrude Stein.”

A new generation would come to know and love Carroll’s voice thanks to Disney’s “The Little Mermaid,” which came out in 1989. She was not the first choice of directors Ron Clements and John Musker or the musical team of Howard Ashman and Alan Menken, who reportedly wanted Joan Collins or Bea Arthur to voice the sea witch. Elaine Stritch was even cast originally before Carroll got to audition. And her throaty rendition of “Poor Unfortunate Souls” would make her one of Disney’s most memorable villains.

Carroll would often say that Ursula was one of her favorite roles. She said she saw her as an “Ex-Shakespearean actress who now sold cars.”

“She’s a mean old thing! I think people are fascinated by mean characters,” Carroll said in an interview. “There’s a fatal kind of distraction about the horrible mean characters of the world because we don’t meet too many of them in real life. So when we have a chance, theatrically, to see one and this one, she’s a biggie, it’s kind of fascinating for us.”

She got the chance to reprise the role in several “Little Mermaid” sequels, spinoffs and even theme park rides.

Carroll was also the voice of Granny in the English-language dub of Hayao Miyazaki’s “My Neighbor Totoro.”

Source: Voice of America

Spanish Government’s Body Positivity Campaign Goes Awry

The Spanish government maybe had a good idea, but the execution of the body positivity campaign has gone horribly wrong.

The idea was to encourage women to come out and enjoy the beaches – without any worries about how they looked in their swimsuits.

But three of the five women whose photographs were used in the campaign said they had not given permission for the images to be used.

Arte Mapache the campaign’s creator, has apologized for failing to obtain permission to use the images.

“Given the – justified – controversy over the image rights in the illustration, I have decided that the best way to make amends for the damages that may have resulted from my actions is to share out the money I received for the work and give equal parts to the people in the poster,” the artist said.

Two of the women in the campaign’s artwork are professional models. One has a prosthetic leg that was airbrushed out of the campaign artwork.

Sian Green-Lord told The Guardian, “It’s one thing using my image without my permission, but it’s another thing editing my body, my body with my prosthetic leg … I don’t even know what to say but it’s beyond wrong.”

Juliet FitzPatrick, a cancer survivor, told the BBC that the face of a woman who had a mastectomy may be based on a photograph of her. However, while the woman in the Spanish government photo has had a single mastectomy, FitzPatrick had a double mastectomy.

She told the BBC that using her likeness without her permission “seems to be totally against” the theme of the campaign. “For me it is about how my body has been used and represented without my permission.”

British photographer Ami Barwell who had taken photos of Fitzpatrick told the BBC that she believes Fitzpatrick’s photo was a composite of photos that she had taken of Fitzpatrick and another woman.

Barwell told the BBC, “I think that the person who created the art has gone through my gallery and pieced them together.”

Another model, Nyome Nicholas-Williams, who wears a gold bikini in the photo, said her image was taken from her Instagram account without her permission.

Source: Voice of America