BioNTech, DualityBio Move ADC into Phase III for HER2-Low Breast Cancer

BioNTech’s licensed antibody-drug conjugate is moving on to Phase III testing in a potential effort to challenge AstraZeneca and Daiichi Sankyo’s blockbuster Enherto in a heavily treated breast cancer subpopulation. DualityBio, BioNTech’s partner and the ADC’s creator, posted the trial plans Wednesday. 

BioNTech added the ADC, DB-1303, to its portfolio in April 2023 when it paid China’s DualityBio $170 million upfront for rights to it plus a second preclinical asset. Another $1.5 billion is on the line in milestone payments, plus tiered royalties. 

DB-1303 will be pitted against chemotherapy in the open-label Phase III for patients with HER2-low, HR+ metastatic breast cancer patients whose disease has progressed despite endocrine therapy.  

ADC therapy is like a targeted missile for cancer, with an antibody targeted to deliver the cancer killing payload. DB-1303 is a topoisomerase-1 inhibitor. Phase I/II trial results showed the treatment to be well tolerated with encouraging antitumor activity in the already heavily pretreated patient population. 

If approved, BioNTech and DualityBio’s drug could be a strong competitor for AstraZeneca and Daiichi Sankyo’s HER2-directed antibody and topoisomerase inhibitor conjugate. Enhertu has already reached blockbuster status and is projected by to reach annual sales of $2.4 billion for the fiscal year ending March 2024. 

The ADC market continues to be hot. BioNTech’s pandemic partner Pfizer closed the biggest M&A deal of the year with its $43 billion buy of Seagen and its four already-approved cancer ADCs in March 2023. 

In August, BioNTech and DualityBio added another ADC to their collaboration to include a Trop2 antibody-drug conjugate. The third-generation ADC has demonstrated efficacy in non-small cell lung cancer (NSCLC) and other solid tumors. The deals grant BioNTech rights to market the three drugs globally except in mainland China, Hong Kong and Macau, where DualityBio retains commercial rights. 

Gilead’s Trodelvy is currently the only Trop-2 directed ADC approved by the FDA across multiple indications. Sales of the drug, primarily driven by breast cancer, were up to $260 million for the second quarter of 2023, with analysts projecting sales of $2.8 billion by 2028. 

BioNTech has been looking for new revenue streams, returning to its initial focus of cancer therapeutics in the face of sharp COVID-related product sales declines. Revenue for the first half of 2023 fell to $1.5 billion, compared to $10.4 billion during the same time period last year. 

DB-1303 is slated for primary completion of its Phase III by August 2025. 

https://www.biospace.com/article/biontech-dualitybio-move-adc-into-phase-iii-for-her2-low-breast-cancer-/

EU regulator recommends pregnant women not use epilepsy drug topiramate

 The European Medicines Agency's safety committee, on Friday, recommended pregnant women not use topiramate-containing medicines to prevent migraine or manage their body weight as their newborns could have a higher risk of neurodevelopmental disorders.

Topiramate‑containing medicines are currently used in the EU to treat epilepsy and prevent migraines, and in some EU countries, the medicine is also used in combination with phentermine to reduce weight.

The recommendations by the Pharmacovigilance Risk Assessment Committee (PRAC), including one that said women should avoid becoming pregnant while taking the drug, follow a review of three recent observational studies.

Two of those suggested that children born to women who took topiramate-containing medicines while pregnant may have a two- to three-fold higher risk of neurodevelopmental disorders than children born to women with epilepsy, but not taking antiepileptic medication.

These disorders include autism spectrum disorders, intellectual disability and attention deficit hyperactivity disorder (ADHD).

PRAC recommends that those using topiramate to treat epilepsy avoid doing so during pregnancy unless there is no other suitable treatment available.

https://news.yahoo.com/emas-safety-committee-warns-pregnant-114201003.html

Centogene shares climb after study confirms biomarker for Gaucher disease

 Shares of Centogene NV (CNTG) gained 7% premarket on Friday after the company announced data confirming the utility of its proprietary biomarker lyso-Gb1 in indicating the severity of Gaucher disease, a rare inherited disorder that affects the body's ability to break down a certain type of fat. The study results also indicate that lyso-Gb1 could help predict the clinical course of patients and personalize care for the disease, Centogene said in a release. "The progressive increase in lyso-Gb1 levels in untreated Gaucher patients suggests that these patients could benefit from treatment, such as enzyme replacement therapy," Dr. Tobias Bottcher, Centogene's director of clinical neurogenetics, said in a statement. Centogene shares have gained 28% in the year to date, while the S&P 500 has gained 17.4%.

https://www.morningstar.com/news/marketwatch/20230901357/centogene-shares-climb-after-study-confirms-biomarker-for-gaucher-disease

Abcam’s Founder Threatens to Reignite Board Battle

 Abcam Plc founder Jonathan Milner is threatening to resume a boardroom battle at the biotechnology supplier he started 25 years ago, weeks after the company said it would explore a sale.

Milner, who owns about 6.1% of Abcam, has been agitating for change at the company, asking to be named executive chairman alongside the removal of three directors. Milner argued in an open letter to shareholders on May 30 that Abcam’s incumbents lacked a “shareholder mindset” — and urged them to seek a buyer. 

Milner paused his campaign in June after the company said it would explore “all options” including a potential sale of the company after receiving inquiries from “multiple parties.”

Read More: Life Sciences Firm Abcam Gets Approaches While Battling Founder

However, in an open letter due to be sent to the Abcam board on Wednesday, and reviewed by Bloomberg News, Milner said he was “disappointed” that his offer to rejoin the board hadn’t been acted upon. Since then, he said he had been provided with “one unsatisfactory call” with management. 

“Should you continue to refuse my offer, and continue to under-deliver, I will call the board accountable again and will resume my campaign in the autumn,” Milner said in his letter. He’s given the board a deadline of Aug. 31 to provide an update, when Abcam is due to report interim results. “I have been contacted by many shareholders who are similarly supportive of a sale of the company at a full and fair value.”

A spokesperson for Abcam responded by pointing to the company’s statement on June 23, in which it said it didn’t intend to comment further on its strategic review. It said in that statement it would “make further announcements in accordance with its ongoing disclosure obligations and pursuant to applicable laws and regulations.”

Abcam first listed on London’s junior market, Aim, and has been trading on the Nasdaq since 2020, dropping its UK listing last year. It runs an online store selling protein research tools to scientists and has been called the “Amazon of antibodies.” 

Milner, 58, started the company in 1998 and remained chief executive officer until 2014. He then became deputy chairman, before stepping down from the board in October 2020.

Bloomberg reported in June that Abcam had attracted initial interest from US life sciences companies Danaher Corp. and Agilent Technologies Inc.

https://www.bnnbloomberg.ca/biotech-supplier-abcam-s-founder-threatens-to-reignite-board-battle-1.1959518

Amgen, Horizon Resolve FTC Lawsuit, Clearing Path to Close Acquisition

 Amgen (NASDAQ:AMGN) and Horizon Therapeutics plc (NASDAQ:HZNP) today announced the entry into a consent order agreement with the Federal Trade Commission (FTC) that resolves the pending FTC administrative lawsuit. This clears the path to take the final steps to close Amgen’s acquisition of Horizon.

As a result of the consent order agreement, Amgen and Horizon expect that the parties will jointly file stipulated proposed orders to dismiss the preliminary injunction motion and dissolve the temporary restraining order (TRO) in the U.S. District Court for the Northern District of Illinois, and that Amgen and Horizon will quickly seek the final approvals required under Irish law to close the acquisition.

Amgen has consistently stated to the FTC, the courts and the public that it has no reason, ability or intention to bundle Horizon’s TEPEZZA® (teprotumumab-trbw) or KRYSTEXXA® (pegloticase injection) with any of its products. This narrow assurance, formalized in the consent order with the FTC, will have no impact on Amgen’s business.

The companies anticipate being able to close the acquisition in early fourth-quarter 2023 and look forward to the opportunity to serve patients around the world suffering from rare diseases.

https://finance.yahoo.com/news/amgen-horizon-therapeutics-plc-resolve-132000619.html

Renovaro: GEDiCube Joins NVIDIA Inception for Early Cancer Detection in Clinical Trials

 

• GEDiCube, an AI/ML platform that combines differential molecular capabilities with multi-omic analysis to detect cancer early, to join NVIDIA Inception
• Initial focus is on pancreatic cancer: upcoming clinical trials will be an innovative multi-modal approach to building a predictive model

https://www.businesswire.com/news/home/20230830575428/en/GEDiCube-Joins-NVIDIA-Inception-to-Advance-Unique-Platform-for-Early-Cancer-Detection-in-Clinical-Trials

TRxADE Health 'Gearing Up for Big Splashes In $151 B Snacks Industry'

 TRxADE Health, Inc. 

MEDS+57.5%+ Free Alerts

, known for its pharmaceutical exchange platform, has recently merged with Superlatus, Inc., a leading food technology and distribution company. The combined entity has now announced a binding agreement to acquire The Urgent Company Inc. along with its portfolio of popular consumer brands Coolhaus, Brave Robot, Modern Kitchen, and California Performance Co. These brands are currently owned by Perfect Day, Inc.

This company expects the acquisition to significantly enhance its position in the development of sustainable and fair food products. The transaction should also enable the combined company to easily enter new markets and increase its market share. This is especially true because many of the acquired Superlatus brands are innovators in the industry.

Superlatus has announced plans to introduce a new type of snack called pulse-based twisted protein snacks through its Brave Robot brand. This innovation is made possible by the advanced food extrusion technology developed by Sapientia Technology, LLC, a subsidiary of Superlatus. Superlatus is committed to capitalizing on the synergies between its subsidiaries to drive growth, enhance competitiveness and generate returns. By combining the unique food technology of Dr. Gino Bortone with the distribution power of the Brave Robot brand, the company hopes to succeed in the snack food market, which is projected to grow to $736 billion by 2026.

"Over 100,000 schools and institutions serve school lunches to 29.6 million students daily. We know soft drinks and traditional chips are the most frequent items sold in vending machines at school," said Superlatus interim CEO Tim Alford. "By dominating and leading the better-for-you (BFY) snack category in the schools, colleges, and universities across the continental United States, we have the unique opportunity to grow rapidly as our products have a long shelf-life, no chemicals, and there are no freezing costs."

https://www.benzinga.com/general/biotech/23/08/34112362/trxade-health-nasdaq-meds-newly-merged-with-superlatus-is-gearing-up-to-make-big-splashes-in-the-