AstraZeneca Targets Obesity Market with Potential $2B Deal for Early GLP-1 Candidate

 AstraZeneca has signed an exclusive license agreement with Shanghai-based biotech Eccogene for ECC5004, an early-stage investigational oral glucagon-like peptide 1 receptor agonist that is being developed for obesity, type 2 diabetes and other cardiometabolic diseases.

Under the terms of the deal announced on Thursday, AstraZeneca will make an upfront payment of $185 million with the potential for nearly $1.83 billion in future clinical, regulatory and commercial milestones. Eccogene will also be eligible for tiered royalties on net product sales.

In exchange for its investment, AstraZeneca will have the exclusive global rights to develop and commercialize ECC5004—except in China, where the pharma will share these rights with Eccogene.

“We believe this oral GLP-1RA molecule could offer alternatives to current injectable therapies both as a potential monotherapy as well as in combination for cardiometabolic diseases such as type-2 diabetes, as well as for obesity,” Sharon Barr, AstraZeneca’s executive vice president of biopharmaceuticals R&D, said in a statement.

Designed to be taken orally once a day, ECC5004 is a small molecule agonist of the GLP-1 receptor, the activation of which stimulates the secretion of insulin in response to increasing blood glucose levels. The candidate is currently being assessed in a Phase I study in the U.S., data from which are “promising,” according to Barr.

Preliminary data from this early-stage study point to a “differentiating clinical profile” for ECC5004, highlighting its good tolerability alongside its promising performance in terms of glucose and weight reductions, according to AstraZeneca’s announcement.

Thursday’s deal puts AstraZeneca in the hunt to target the lucrative weight-loss market, though it still lags far behind its main competitors. On Wednesday, Eli Lilly won the FDA’s approval for Zepbound (tirzepatide), the first-ever authorized treatment targeting two incretin hormone receptors—GIP and GLP-1—for chronic weight management.

Tirzepatide is also being sold under the brand name Mounjaro, which was first approved in May 2022 and is indicated for type 2 diabetes, but has been used off-label for obesity.

Another front-runner in the weight loss market is Novo Nordisk, which during its third-quarter earnings report last week revealed that sales for its obesity treatment Wegovy skyrocketed more than 700% from the same quarter in 2022. Since its approval in June 2021, Wegovy has generated strong market demand that has consistently outpaced Novo’s production capacity.

The weight loss market is expected to grow even further in the coming years, with some analysts expecting figures to reach $100 billion, while others post forecasts of $150 billion to $200 billion.

https://www.biospace.com/article/astrazeneca-targets-obesity-market-with-potential-2b-deal-for-early-glp-1-candidate/

Ikena stock falls after data for lead asset, Q3 results

 

Ikena Oncology (IKNA) shares plunged 63% after reporting Phase 1 data for its lead drug IK-930, against a rare connective tissue cancer.

https://seekingalpha.com/news/4034252-ikena-stock-falls-data-lead-asset-q3-results

Lantern Financial Results and Operational Updates

 

• Lantern Pharma Inc (NASDAQ:LTRN) progresses with clinical trials for cancer therapies and advances in AI-driven drug development.

• Financial discipline emphasized with a cash runway into at least Q3 of 2025, backed by approximately $45 million in cash and securities.

• Operational highlights include IND clearance for LP-284, dosing of initial patient in LP-184 Phase 1 trial, and progression of LP-300 Harmonic clinical trial.

• Company's RADR AI platform continues to evolve, enhancing the prediction of drug-cancer interactions and development of ADCs.

https://finance.yahoo.com/news/lantern-pharma-inc-ltrn-reports-234355963.html

Ginkgo sinks on earnings miss

Ginkgo Bioworks (DNA) shares fall 13% as the biotech company revises its annual outlook for cell engineering segment, while Q3 revenue falls

https://seekingalpha.com/news/4033867-ginkgo-bioworks-stock-sinks-after-q3-earnings-miss

Ironwood: Growth in LINZESS Sales and Maintains Full Year Guidance

 

• Ironwood Pharmaceuticals Inc (NASDAQ:IRWD) sees an 8% year-over-year increase in LINZESS prescription demand.

• U.S. net sales of LINZESS reach $279 million, marking a 7% increase compared to the previous year.

• Positive final data from STARS Nutrition Phase II study of apraglutide, with topline data for CNP-104 Phase II study expected in Q3 2024.

• Full Year 2023 Guidance reaffirmed by Ironwood Pharmaceuticals Inc (NASDAQ:IRWD).

https://finance.yahoo.com/news/ironwood-pharmaceuticals-inc-irwd-reports-133912960.html

Adaptimmune, Monte Rosa and Intellia discontinue programs

 Many hoped the end of 2023 would bring some solace for biotech after nearly two years of challenging market conditions. As the year nears its end, that relief remains largely out of reach, as cuts to both teams and pipelines continue to climb. Today, at least three more biotechs have tossed candidates into the ever-growing pile of discontinued programs.

First up is Adaptimmune Therapeutics, a biotech terminating two programs dubbed Gavo-cel and TC-510. After a review of safety and efficacy data for both candidates, the T-cell therapy company didn’t “see a path forward” for further development of either programs, according to a third-quarter earnings release.

Gavo-vel was a phase 2 autologous cell therapy that had an overall response rate (ORR) of 11% across patients with ovarian cancer or mesothelioma. Meanwhile, cell therapy TC-510 was tied to one partial response in mesothelioma out of five patients with varying cancers but a high incidence of cytokine release syndrome and pneumonitis.

The blow comes after GSK paid Adaptimmune 30 million pounds ($37.3 million) to wipe its hands of two programs this spring. One of the programs was lete-cel, an asset Adaptimmune had at one point touted as its leading cell therapy but has now been removed from the pipeline.

As the biotech awaits an FDA approval decision for its investigational therapy targeting MAGE-A4 in solid tumors, dubbed Afami-cel, discovery work will continue with Roche’s Genentech on two allogeneic programs.   

The second biotech cutting programs is Monte Rosa Therapeutics, a Boston-based biotech with a molecular glue platform. In a move to prioritize resources, the company is discontinuing an early-stage sickle cell program. Not much is known beyond that, as little was publicly revealed about the discovery program. The company will focus on other programs, such as its clinical-stage GSPT1-directed candidate called MRT-2359 and work with Roche, who inked a deal last month for the use of Monte Rosa’s QuEEN platform to target cancer and neurological diseases previously considered out of reach.

Last but not least is Intellia Therapeutics, a Cambridge, Mass.-based company using CRISPR-based tech to build in vivo and ex vivo therapies. The biotech is halting all further preclinical activities for NTLA-2003, an asset designed to treat a rare, inherited disorder called AATD-associated liver disease.

Instead, Intellia intends to advance a different AATD research-stage program that uses the company’s DNA writing technology. Intellia, which reported earnings this morning, saw its stock tumble 12% from $28.45 at market open this morning to $25.03 at 11 a.m. ET. 

Less than a month ago, Intellia received the FDA green light to study NTLA-2001, an in vivo CRISPR-based gene editing therapy in the U.S. The company worked with sites in Europe and New Zealand to study the therapy in a phase 1 trial and showed NTLA-2001 may safely reduce levels of misfolded TTR, a protein that drives the rare, life-threatening disease ATTR amyloidosis. The new FDA allowance positions the company to start a phase 3 trial of the Regeneron-partnered candidate by the end of the year.

https://www.fiercebiotech.com/biotech/adaptimmune-monte-rosa-and-intellia-discontinue-programs

Amylyx Crashes 26% As New ALS Drug Faces A Barrage Of Troubles

 Amylyx Pharmaceuticals (AMLX) meaningfully missed Wall Street's expectations on Thursday amid struggles with its amyotrophic lateral sclerosis drug. AMLX stock crashed in morning trades.

It's been over a year since the Food and Drug Administration approved its drug, Relyvrio, to treat amyotrophic lateral sclerosis, or ALS. Also known as Lou Gehrig's disease, it causes progressive degeneration of nerve cells in the spinal cord and brain.

Amylyx noted patients are dropping off Relyvrio treatment after six months, Evercore ISI analyst Michael DiFiore said in a report. But Amylyx said the number of new patients starting treatment was "steady." DiFiore says his math suggests otherwise.

He also noted Amylyx blocked analysts from seeing Relyvrio prescription data this summer.

https://www.investors.com/news/technology/amlx-stock-crashes-as-patients-drop-off-als-drug-relyvrio/