On October 23, 2025 Circle Pharma, Inc., a clinical-stage biopharmaceutical company pioneering next-generation targeted macrocycle therapeutics for cancer, reported preclinical data related to the company’s cyclin D1 development program at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). The data highlight the therapeutic potential of Circle Pharma’s first-in-class oral macrocyclic inhibitors to preserve retinoblastoma protein (Rb) tumor-suppressor activity by selectively blocking its interaction with cyclin D1, a key driver of cell cycle progression and proliferation in multiple hematological and solid tumor cancer types.

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"Cyclin D1 has long been recognized as a key driver in many cancers, but it has remained an elusive direct therapeutic target," said Marie Evangelista, Ph.D., senior vice president and head of cancer biology at Circle Pharma. "Using our MXMO platform, we have engineered orally bioavailable, cell-permeable macrocycles that selectively inhibit cyclin D1-Rb binding while sparing related isoforms such as cyclin D3—an approach aimed at reducing hematologic toxicities commonly observed with dual CDK4/6 inhibitors. These data mark a significant step forward in developing novel, macrocycle-based therapies for patients with cyclin D1-driven cancers."

"We are excited by the strong selectivity and anti-tumor activity we’re seeing across multiple cyclin D1-driven cancer models including mantle cell lymphoma and ER-positive breast cancer," said David J. Earp, J.D., Ph.D., president and chief executive officer of Circle Pharma. "Our approach has the potential to open a new class of therapeutics for patients, including for use in combination with other therapies, and we are on track to declare a development candidate for our cyclin D1 program by end of 2025."

Presentation Highlights:

In cyclin D1-dependent preclinical tumor models, Circle’s oral macrocyclic cyclin D1 RxL inhibitors:

Potently and selectively disrupt the cyclin D1–Rb interaction with >2,000-fold selectivity over cyclin D3–Rb binding, leading to phospho-Rb suppression and G1 cell cycle arrest in cyclin D1-dependant tumor cells.
Demonstrate robust anti-tumor activity in mantle cell lymphoma (MCL) and ER-positive breast cancer models, including enhanced efficacy in combination with CDK4-selective, CDK4/6-dual, and endocrine therapies.
Show a substantially improved in-vitro hematopoietic safety profile compared to dual CDK4/6 inhibition.
The poster presentation will be made available on the Circle Pharma website at View Source

About Circle Pharma’s Oral Cyclin D1 RxL Inhibitor Program

Cyclin D1 is a regulatory protein that plays a crucial role in cell cycle progression and is overexpressed in many solid tumors and hematologic malignancies. In these cancers, the cyclin D1/CDK4 complex drives cell proliferation by binding to the tumor suppressor retinoblastoma protein (Rb) and promoting its phosphorylation and inactivation. Using its MXMO platform, Circle Pharma has developed oral macrocyclic inhibitors that potently and selectively disrupt the cyclin D1-Rb interaction, demonstrating robust anti-tumor activity in cyclin D1-driven cancers.

(Press release, Circle Pharma, OCT 23, 2025, View Source [SID1234656939])

On October 23, 2025 Orion Corporation ("Orion") and Abzena, the leading end-to-end integrated CDMO for complex biologics and bioconjugates, reported that Orion has obtained an exclusive, focused commercial license to one of Abzena’s monoclonal antibodies (mAbs) that targets a cancer of high clinical unmet need. The antibody will strengthen Orion’s broad oncology-focused drug Research and Development pipeline.

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The antibody was designed and developed at Abzena’s Cambridge, UK, early phase R&D facility using their proprietary Composite Human Antibody (CHAb) technology as part of an integrated developability platform approach to select a superior lead candidate. Abzena’s scientists screened antibodies against a number of parameters including functionality, safety, and manufacturability to identify a lead candidate devoid of risks that could impact downstream development processes and ultimately affect the clinical outcome of the antibody. Leveraging the AbZelectPRO cell line development (CLD) platform a highly stable and productive manufacturing cell line for this antibody was generated for manufacture.

Campbell Bunce, Chief Scientific Officer of Abzena, said, "We are delighted to have partnered with Orion on the design and development of our CHAb-designed mAb to support their extensive oncology-focused Research and Development pipeline. Using our uniquely integrated developability approach along with our streamlined AbZelectPRO CLD platform, we were able to design a de-risked lead antibody that offers Orion’s program the best chances of success in the clinic."

Antti Haapalinna, Vice President, External Science and Partnering, R&D, Orion Corporation, said, "We are very satisfied with the excellent and transparent collaboration and the results it has delivered in our common antibody program."

Abzena has over 20 years of experience designing, developing, and manufacturing monoclonal antibody programs. The organization can support antibody programs at its Cambridge, UK, and San Diego, USA facilities, with downstream process development and GMP manufacturing activities taking place in the US up to 2,000 litre in scale.

(Press release, Orion, OCT 23, 2025, View Source [SID1234656956])

On October 23, 2025 Coherus Oncology, Inc. (NASDAQ: CHRS) reported that the company will be webcasting its presentations at the following upcoming conferences:

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UBS Global Healthcare Conference in Palm Beach Gardens, FL on Monday, November 10, 2025, at 1:15 p.m. Eastern Time / 10:15 a.m. Pacific Time
Jefferies Global Healthcare Conference in London, England on Tuesday, November 18, 2025, at 10:30 a.m. Greenwich Mean Time / 5:30 a.m. Eastern Time
Baird Biotech Discovery Series takes place virtually on Wednesday, December 17, 2025, at 1:30 p.m. Eastern Time / 10:30 a.m. Pacific Time
The presentations will be accessible via webcast links on the Investor Events section of the Coherus website: View Source Replays of the presentations will be available for 30 days.

If you would like to request a one-on-one meeting with company management during the conferences, please reach out to your respective bank representative.

(Press release, Coherus Oncology, OCT 23, 2025, View Source [SID1234656940])

On October 23, 2025 MIT reported the pills are by far the most convenient form of cancer treatment, but most oral cancer drugs quickly dissolve in the stomach, delivering a burst of chemicals into the bloodstream all at once (Press release, Enzian Pharmaceutics, OCT 23, 2025, View Source [SID1234656957]). That can cause side effects. It also may limit the drug’s effectiveness because its concentration in the blood may become too low after the initial burst.

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Now, the startup Enzian Pharmaceutics, founded by Aron Blaesi PhD ’14 and former principal research scientist Nannaji Saka ScD ’74, is developing an oral tablet that delivers drugs into the gastric fluid and the blood steadily over time. The company’s tablets use tiny 3D-printed fibers that turn into a gel-like substance when exposed to water. The tablets have been shown to stay in the stomach of animals for up to a day, slowly degrading while releasing the drug in controlled quantities.

The company is currently validating its tablets’ ability to stay in place in a small number of healthy human volunteers. In about a year, it plans to begin testing the technology’s ability to improve the effectiveness and safety of cancer drugs in patients.

"A lot of orally delivered cancer drugs could benefit from this," says Blaesi, who incorporated the company in 2016. "Right now, soon after someone has taken a cancer drug, its concentration in the blood can be up to 50 times greater than when they are supposed to take the next pill. During the peak, the drug goes into the heart, it goes into the liver, the brain, and it can cause a lot of problems, while at the end of the dosing interval the concentration in the blood may be too low. By taking out that peak and increasing the time the drug is released, we could improve the effectiveness of treatments and mitigate certain side effects."

In search of innovation
When Blaesi came to MIT, he knew he wanted his mechanical engineering PhD work to form the basis of a company. Early on, as part of the Novartis-MIT Center for Continuous Manufacturing, he worked on manufacturing pills with an injection molding machine that melted and solidified the material, in contrast to the traditional process of compacting powder. He noticed injection molding made the pills far less porous.

"If you put a typical pill into a fluid or into the stomach, the fluid percolates the pores and quickly dissolves it," Blaesi explains. "That’s not the case when you have an injection molded product. That’s when Dr. Saka, who I met almost daily to discuss my research with, and I started to realize that microstructure is very important."

The researchers began exploring how different tablet microstructures changed the rate at which drugs are released. For more precision, they moved from injection molding to 3D printing.

Using MIT machine shops, Blaesi built a 3D printer and produced tightly wound microstructures that could carry the drugs. He focused on fibrous structures with space between the fibers, because they would allow gastrointestinal fluid to percolate the pill and dissolve rapidly. He tested the structures in both his Cambridge, Massachusetts, apartment and at MIT’s shared facilities.

Blaesi then experimented with different carrier materials, finding that the higher the molecular weight, the longer it took the pill to dissolve because the material would absorb water and expand before degrading.

"Initially I thought, ‘Oh no, the drug isn’t being dissolved fast enough anymore,’" Blaesi recalls. "Then we thought, ‘Everything has its place.’ This could stay in the stomach for longer because of the expansion. Then it could release the drug over time. We realized this wouldn’t just improve manufacturing, it would improve the product."

In 2019, Blaesi and Saka published the first paper on their expandable fibrous tablets for prolonged drug delivery. It received a mixed reception.

"Some reviewers said, ‘Research on similar gastroretentive dosage forms has been done for 40 years and no one’s really succeeded,’" Blaesi recalls. "People said, ‘It will never work. Do experiments in animals and then we’ll talk.’"

Blaesi moved back to Switzerland during the Covid-19 pandemic and ran his animal experiments there.

"The reviewers were right: What we had didn’t work," Blaesi says. "But we adjusted the design and showed we could make the pill stay in the stomach for longer."

Inside Enzian’s final tablet design, tiny fibers are arranged in a grid. When water flows into the spaces between the fibers, they expand to form a strong gel-like substance that slowly erodes in the stomach, steadily releasing the drug. In animal studies, Enzian’s team showed its technology allowed tablets to remain in the stomach for 12 to 24 hours before being safely excreted.

The team soon found cancer drugs would be a good fit for their technology.

"A lot of cancer drugs are only soluble in acidic solutions, so they can only be absorbed while the drug is in the stomach," Blaesi explains. "But on an empty stomach, the drug may be in the stomach for just 30 or 40 minutes at present. For a full stomach, it’s a few hours. And because you have a short time to deliver the drug, you need to release a high dose immediately. That shoots up the blood concentration, and if you dose every 12 hours, the concentration is going down during the other 10 hours."

From the lab to patients
In upcoming human trials, Enzian plans to use its tablets to deliver a drug for prostate cancer that Blaesi says is currently dosed at several hundred milligrams a day. He hopes to get down to about a tenth of that with a better therapeutic effect.

Enzian also believes its technology could improve treatments for blood, skin, and breast cancers.

"This could really be used to improve treatment for a variety of cancers," Blaesi says. "We believe this is a more efficient and effective way to deliver drugs."

Maximizing effectiveness and minimizing side effects is also important in clinical trials, where a new drug’s superiority over existing treatments must be shown, and a single adverse event can end its development.

The upcoming move into patients is the culmination of more than a decade of work for Blaesi, who is confident Enzian can deliver on its promise of improving treatments.

"The opportunity is enormous," Blaesi says. "So many oral cancer drugs have this delivery problem. We still have to do the efficacy and safety studies on patients, but we expect this to be a game changer."

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