A readout of phase III data of buntanetap in Parkinson’s disease is up next as Annovis Bio Inc. tries to recover from the market’s reaction to mixed phase II/III data results in Alzheimer’s disease. Data for the translational inhibitor of amyloid precursor protein in treating mild to moderate Alzheimer's disease (AD), released April 29, showed a significantly higher rate of improvement in ADAS-Cog 11 scores relative to placebo in those with mild AD, along with improved cognition at three months. However, the data also showed no statistical significance in ADCS-CGIC, which measures patient performance from a trial’s beginning, or in ADCS-ADL, a measure of a patient’s performance with tasks. Annovis said it now plans to move ahead to a pivotal phase III study of buntanetap in biomarker-positive early AD patients. The company’s stock (NYSE:ANVS) dropped 60% when the data were released and continued downward at midday April 30, with shares 18% lower at $5.95.

Covalent proteins? Enlaza views opportunity with $100M series A

Covalent drugs, which are designed to form a bond with the target, allowing for increased potency, greater selectivity and prolonged duration of action, have been on the drug development radar for a century and have seen a resurgence in recent years thanks for the success of BTK inhibitors and therapies targeting KRAS. But all approved covalent drugs to date are small molecules. Enlaza Therapeutics Inc. is hoping to change that. The company, which disclosed a $100 million series A round, is looking to develop the first covalent protein therapeutics, in what CEO Sergio Duron calls a “white space opportunity.”

Two more challenges to US Rx price negotiations dismissed

The U.S. government chalked up another win yesterday against the constitutional challenges to the Inflation Reduction Act’s provision mandating direct Medicare price negotiations for selected prescription drugs. Like the other U.S. district judges that have ruled on similar cases, Judge Zahid Quraishi dismissed the challenges brought by Bristol Myers Squibb Co. (BMS) and Johnson & Johnson’s (J&J) Janssen Pharmaceuticals Inc. BMS immediately appealed to the Third Circuit. Although Quraishi heard challenges from Novo Nordisk A/S and Novartis AG last month in conjunction with the BMS and J&J suits, he has yet to rule on them.

BioWorld Cancer Index ends Q1 up on pipeline progress, despite restructurings

The BioWorld Cancer Index (BCI) closed out the first quarter of 2024 with a 4.66% increase, slightly down from its 11.07% rise at the end of February. This comes after an outstanding performance in 2023, when it finished the year up by 76.26%. Despite outperforming the Nasdaq Biotechnology Index, which rose by 1.36% in Q1, BCI lagged behind the Dow Jones Industrial Average, which saw a 5.62% in the first three months of the year. In contrast, BCI experienced a decline of 41.98% in 2022 and a 36.34% decrease in 1021.

Newron hails ‘groundbreaking’ evenamide data in schizophrenia

Newron Pharmaceuticals SpA added heft to the data supporting evenamide, reporting positive top-line results from a phase II/III placebo-controlled trial of the glutamate inhibitor in patients with chronic schizophrenia who were receiving a second-generation antipsychotic, but having an inadequate response to that treatment. The addition of 30 mg of evenamide to a second-generation antipsychotic was associated with a highly statistically significant reduction in the Positive and Negative Syndrome Scale of 10.2 points, compared to 7.6 points in patients receiving placebo at day 29.

Full US approval for Pfizer/Genmab cervical cancer drug Tivdak

Ten days early, the U.S. FDA granted full approval under priority review to Pfizer Inc. and Genmab A/S’s antibody-drug conjugate Tivdak (tisotumab vedotin) to treat cervical cancer. Copenhagen, Denmark-based Genmab and Bothell, Wash.-based Seagen Inc., which was acquired by New York-based Pfizer Inc. last December, received accelerated approval for the ADC in September 2021 based on tumor response and durability of response from the InnovaTV 204 pivotal phase II single-arm trial in previously treated patients. The FDA accepted the supplemental BLA seeking full approval for Tivdak in January, issuing a May 9 PDUFA date. Tivdak is the first ADC to show overall survival in patients with recurrent or metastatic cervical cancer with disease progression on or after therapy.

Korea-US biotech Orum plans Kosdaq IPO following $100M+ BMS deal

Orum Therapeutics Inc., of Boston and Daejeon, South Korea, is planning for an IPO on the Korea Exchange by the end of 2024, having passed a technology evaluation required for listing on the Kosdaq, a company spokesperson confirmed to BioWorld. Orum garnered “A” and “BBB” marks from two independent evaluators designated by the KRX, allowing the biotech to pursue an eligibility review to list on the tech-heavy trading board. Kosdaq’s special listing track places greater emphasis on technological capabilities, rather than financial ones, for up-and-coming innovative companies.

UK industry prepping for fallout of US Biosecure Act

The industry in the U.K. is starting to get concerned about the U.S. Biosecure Act and the possible impact on its ability to use Chinese service providers, and the implications for future dealmaking with U.S.-based companies. The scope of the legislation as it stands would prevent companies that have federal government contracts, loans or grant funding from having any contracts with a “biotechnology company of concern.”

WHO pandemic deal doesn’t protect developing countries, groups say

The latest World Health Organization’s (WHO) Pandemic Agreement falls short of protecting all countries in future pandemics, said international patient groups and public health organizations. As the final Intergovernmental Negotiating Body (INB) meeting of the WHO Pandemic Agreement gets closer, international organizations such as the AIDS Healthcare Foundation and the AHF Global Public Health Institute are voicing concerns that the latest proposal has been significantly watered down through the negotiation process and lacks the requisite power to operationalize equity and achieve its intended objectives.

US FDA to listen, not just talk, about adcom reforms

It’s been a year since U.S. FDA Commissioner Robert Califf first started talking about reforming the agency’s advisory committee process. Now the FDA is moving beyond talking about it to listening. The agency has scheduled an all-day listening session June 13 to get feedback on optimizing the use of adcoms and the processes involved. The virtual public meeting will focus on the composition of the committees, as well as ways to improve the experience for panelists and to ensure public awareness and understanding of the role of the committees.

China’s CAR T market comes of age

BioWorld’s three-part series takes a deep dive into CAR T therapy development and investment in mainland China. The report examines the growing interest in CAR T therapy, an approach to cancer treatment designed to harness the power of the body’s immune system, looking at the rapid pipeline growth, investments and dealmaking, clinical trials and challenges surrounding patient access.

BioWorld Insider Podcast: Mark McKenna storms back with Mirador and eyes the development landscape

In one of the biggest financings of the year so far, former Prometheus Biosciences Inc. CEO Mark McKenna helped raise $400 million to launch a new company, Mirador Therapeutics Inc. He didn’t sit on the sidelines for long after Merck & Co. Inc. bought Prometheus for $10.8 billion in 2023. He recruited key Prometheus executives to focus on Mirador’s genetic approach to drug discovery and precision medicine. McKenna said there was too much left undone to just hang back. In this BioWorld Insider episode, he talks about the new company and the multi-billion-dollar drugs that he believes provide sub-optimal efficacy compared to the tailor-made therapies he wants to develop. He also has deep insights into drug pricing and why the investment market is so tough on companies that don’t have A-plus science and teams.

Also in the news

Accord, Addex, Aim Immunotech, Akero, Aquestive, Aribio, Astrazeneca, Bavarian Nordic, Bitterroot, Carsgen, Charm, Cognition, Cyclacel, Daré, Dermavant, Ena Respiratory, Enanta, Generate, Immix, Inflammasome, Inmune, Intellia, Kamari, Mannkind, Merck, Mustang, Nkgen, Octapharma, Prime Medicine, Processa, Qlaris, Regeneron, Selection, Sellas, Soleno, Synox, TFF, Vertex, X4