// Biotech and Pharma Therapeutics
Novartis takes preclinical cancer program off MorphoSys’ hands for $23M cash
MorphoSys subsidiary Constellation Pharmaceuticals signed the deal with the Big Pharma to research, develop and commercialize its preclinical inhibitors of a novel cancer target, according to a Tuesday release. The program was added to MorphoSys’ early-stage pipeline after the $1.7 billion acquisition of the epigenetics biotech last year. Under the agreement terms, Novartis will head up all activities for the program.
Lilly aims Verzenio at broader post-surgery breast cancer nod as Novartis’ rival draws near. Will FDA bite?
When Eli Lilly’s Verzenio snagged an FDA go-ahead to treat certain breast cancer patients after surgery, the first-in-class nod was weakened by an unexpected limitation. Now, the company hopes longer-term follow-up data will convince U.S. regulators to remove the restriction. Lilly has filed an FDA application to expand Verzenio’s use in HR-positive, HER2-negative early breast cancer at high risk of recurrence after surgery to include patients with low levels of the cellular proliferation marker Ki-67.
Apogee emerges with $169M and plans to carry Paragon’s programs to clinic
Apogee, which means the highest point in the development of something, was founded by Fairmount Funds Management and Venrock Healthcare Capital Partners this year. To date, the company has raised $169 million, including an oversubscribed $149 million series B financing round led by Deep Track Capital and RTW Investments.
GSK, Sanofi, Pfizer and Boehringer Ingelheim free from federal Zantac litigation with new ruling
Pfizer, GSK, Sanofi and Boehringer Ingelheim are now able to wash their hands of thousands of Zantac-related lawsuits after a federal judge in Florida ruled that the claims against the companies weren’t sound. U.S. District Judge Robin Rosenberg’s ruling in the federal multidistrict litigation took about 50,000 claims off the drugmakers’ plates. While the decision does not impact the thousands of cases in state courts, it chalks up a major win for the companies in the litigation, which has been looming since 2020. That’s when the FDA first asked all Zantac and its generic manufacturers to voluntarily recall their products. That followed a 2019 recall spree, after online pharmacy Valisure discovered high levels of a likely carcinogen in the drug and its generics.
AbbVie offers up to $335M for connection with HotSpot’s preclinical small-molecule program
HotSpot will use its drug discovery platform, dubbed Smart Allostery, to develop one of the first small-molecule IRF5 (interferon regulatory factor 5) inhibitors aimed at treating cancer and autoimmune diseases, according to the terms of the deal. AbbVie will pay HotSpot $40 million upfront and provide the Boston biotech the chance to make up to $295 million in option fees and R&D milestones, with the potential to make further milestones and royalties.
// 4th Industrial Revolution
How AI and machine learning can predict illness and boost health equity
Artificial intelligence and machine learning are key to unlocking patient data and solving some of healthcare’s most complex problems. Even as the U.S. seeks to put the COVID-19 pandemic in the rearview mirror, many who survive the initial illness suffer debilitating long-term health impacts, especially those with underlying health conditions.
Ekso Takes Its Robotic Exoskeletons Into Outpatient and Home Settings With $10M Acquisition
Ekso Bionics — a San Rafael, California-based company that makes exoskeleton bionic devices — on Monday acquired Parker Hannifin’s business unit for human motion and control for $10 million. Parker is an Ohio-based manufacturer specializing in motion and control technologies. It received $5 million from Ekso at the deal’s closing, and it will receive the remaining $5 million over the next five years.
Natus Medical eyes Micromed buyout to build brain monitoring portfolio
The two companies did not disclose the financial terms of the deal in their announcement, with the transaction slated to close early next year. The goal is to provide a single portfolio of neurodiagnostic and neuromonitoring products. Micromed’s catalog spans a range of brain EEG devices and other sensors, including monitors designed for intensive care units and other clinical research settings.
Owkin open sources biotech AI bundle
France/US-headquartered AI biotech company Owkin is open sourcing the Artificial Intelligence (AI) software behind Melloddy and Substra. Big fans of ‘open science’, Owkin hopes to help universities, hospitals and pharmaceutical companies to benefit from its privacy-preserving, secure and collaborative AI technologies. Owkin is open sourcing Substra, its Federated Learning (FL) software, to allow researchers and developers to collaboratively train ML models without the data leaving its source.
GE Healthcare looks to bring MediView’s AR headsets to X-ray-guided surgeries
The company has begun working with MediView to help surgeons see patients’ anatomies more as they are with the help of augmented reality goggles. The upcoming OmnifyXR system is being designed to provide holographic 3D images and also a heads-up display of interventional X-ray imaging using Microsoft’s HoloLens hardware. The goal is to offer views of 3D anatomy in a more ergonomic position and with a line of sight that’s better aligned with the patient, instead of having clinicians repeatedly turn to face different physical monitors during a procedure. At the same time, OmnifyXR’s connectivity will allow others to collaborate remotely via a surgeon’s-eye view.
// Business & Markets
Lysogene, looking for saving grace after trial flop, suspends stock trading and seeks partners
The gene therapy company focused on central nervous system diseases has requested the opening of a safeguard proceeding, which is a legal option French companies can take in an attempt to stay alive. Safeguard proceedings allow struggling companies to be restructured at a preventive stage under supervision of the court. In anticipation of the safeguard proceedings, in which a decision is expected during the week of Dec. 12, Lysogene has requested that the trading of its shares be suspended until the court rules.
With a new No. 1, Avrobio hopes to get investors back on gene therapy bandwagon
Avrobio will preview its new course Wednesday morning, showcasing data from five patients with Gaucher disease two years after receiving the gene therapy AVR-RD-02 in the phase 1/2 Guard1 trial. It’s a small interim data set, but, for the first time, Avrobio is presenting evidence of improvement in a patient with the more severe type 3 form of the disease. The five patients, four with type 1 and one pediatric case with type 3, saw stabilization of multiple clinically relevant measures for the lysosomal disorder. For the type 3 patient, Avrobio said the data show a complete biochemical correction, meaning both enzyme activity and substrate levels normalized after treatment with AVR-RD-02.
Vertex invests in a rare disease drug and its developer
Founded in 2016, Entrada and its technology have attracted interest from a variety of investors. The company raised $59 million in late 2018 through a Series A financing round that was led by 5 AM Ventures and MPM Capital and saw participation from the Roche Venture Fund. Nearly three years later, Entrada raked in another $182 million via an initial public offering. Now Vertex is investing. Along with its upfront payment, the big biotech has agreed to pay its new partner as much as $485 million if certain milestones are hit. Entrada may also receive tiered royalties from any products that result from the collaboration.
Vaxxas raises $23M to fund needle-free COVID-19 vaccine trial
Vaxxas has secured funding to support clinical development of its needle-free COVID-19 vaccine, stuffing its coffers with $23 million from investors including OneVentures and UniQuest. The biotech is built around a patch-based delivery technology, HD-MAP, that uses an array of thousands of projections to get vaccines to immune cells below the surface of the skin. Using dry-coating technology, Vaxxas applies vaccines onto the projections under sterile conditions, resulting in a delivery system that could improve immune responses, lower doses, eliminate the cold chain and enable self-administration.
Re-Vana reels in $12M to develop sustained-release eye implants
Investors have boosted Re-Vana Therapeutics’ ambition to develop sustained-release eye disease drugs, putting up $11.9 million in series A funding on the back of nonclinical ocular safety and efficacy studies. Re-Vana spun out of Queen’s University in Northern Ireland in 2016 to build on Raj Thakur’s work on photocrosslinked technologies. UV light encapsulates drugs through the photocrosslinking of polymers. The approach could enable the creation of implants that release drugs over long periods of time, such as biodegradable devices that provide sustained release of molecules in the back of the eye.
// Legal & Regulatory
In fresh blow to floundering PI3K space, FDA feedback drives MEI, Kyowa to halt blood cancer program
Emerging evidence that PI3K inhibitors may shorten life expectancy has driven the FDA to harden its stance on the class of blood cancer drugs. At the start of the year, Gilead Sciences pulled an accelerated approval for Zydelig after finding enrollment in a confirmatory study “an ongoing challenge” and Incyte withdrew a submission for its rival PI3K inhibitor parsaclisib because it would be impossible to complete confirmatory trials “within a time period that would support the investment.”
Merck escapes nearly 1,200 Zostavax shingles vaccine lawsuits as plaintiffs’ testimony falls short
Following a court judgment in its favor last year, Merck & Co. is formally bidding adieu to more than 1,000 lawsuits alleging its shingles vaccine Zostavax caused patients to develop the disease. Tuesday, a Pennsylvania federal judge threw out exactly 1,189 cases against Merck in the four-year-long group of cases. The plaintiffs in the now-dismissed clutch of lawsuits argued Zostavax caused their shingles. But the medical expert attempting to back up that claim failed to consider whether the plaintiffs’ disease occurred naturally because they’d had chickenpox as kids, according to court filings published this week.
Merck escapes nearly 1,200 Zostavax shingles vaccine lawsuits as plaintiffs’ testimony falls short
December 8, 2022 / Merck & Co. / Zostavax / Lawsuits / Drug Safety
Following a court judgment in its favor last year, Merck & Co. is formally bidding adieu to more than 1,000 lawsuits alleging its shingles vaccine Zostavax caused patients to develop the disease.Tuesday, a Pennsylvania federal judge threw out exactly 1,189 cases against Merck in the four-year-long group of cases.
AstraZeneca partner FibroGen slaps former employees with trade secret theft lawsuit
FibroGen is cracking down on former employees accused of trade secret theft. The company filed a lawsuit in the U.S. District Court in the Northern District of California. The company slapped former employees Dong Liu, Ph.D., and Shaojiang Deng, Ph.D., with the suit to ask that the defendants stop their use of the propriety information and correct their patents to list the true owner, which is FibroGen, the company alleges. The company is also seeking compensation and wants the former employees to give up profits made from the patents they “wrongfully” claim.
Pfizer, BioNTech strike back at Moderna with mRNA vaccine patent lawsuit
As the salad days of pandemic vaccine sales wane, two mRNA camps are taking a legal stand on the global stage—and duking it out in the name of drug delivery.In response to an August lawsuit from Moderna alleging patent infringement related to its COVID-19 vaccine technology, Pfizer and BioNTech have hit back with a countersuit, demanding a jury trial and refuting Moderna’s claims of infringement.
// Research & Development
Summit bets $5B that Akeso’s bispecific antibody will ascend clinical peaks in cancer
The deal is one of the largest deals in 2022 and in recent memory, reminiscent of AstraZeneca’s potential $6 billion licensing pact for Daichii Sankyo’s TROP2 antibody-drug conjugate disclosed in 2020. The asset at the center of the deal announced Tuesday was ivonescimab, a bispecific antibody that acts as both a PD-1 blocker and blood vessel growth inhibitor.
AstraZeneca focuses on breast cancer care transformation
Twelve AZ breast cancer medicines and potential new treatments will be highlighted across 55 presentations – including five oral presentations. The company will also showcase the company’s growing leadership throughout different subtypes and stages of the disease. Two presentations will focus on the DESTINY-Breast clinical programme, demonstrating the efficacy of Enhertu – also known as trastuzumab deruxtecan.
FDA authorizes updated Covid-19 boosters for youngest children
“More children now have the opportunity to update their protection against Covid-19 with a bivalent Covid-19 vaccine, and we encourage parents and caregivers of those eligible to consider doing so — especially as we head into the holidays and winter months where more time will be spent indoors,” FDA Commissioner Robert Califf said in a statement.
ITakeda’s dengue shot scores crucial EU nod, opening the door to wider global use
Just a few months after Takeda’s dengue fever vaccine, Qdenga, scored its first global approval in Indonesia, the vaccine has been cleared for use in Europe. Importantly, the latest regulatory endorsement paves the way for more approvals across the world. Thursday, the European Commission endorsed Takeda’s Qdenga to protect against dengue in people aged 4 and older as a two-dose series.
Gossamer touts phase 2 win but analysts aren’t breaking out the champagne
Patients with pulmonary arterial hypertension, or PAH, who received the therapy had a 14.3% improvement in pulmonary vascular resistance, or PVR, a measure of blood flow across the heart with a p-value of 0.031, according to results posted Tuesday. The company said the therapy met the trial’s main goal. The drug also improved patients’ six-minute walk test by 6.5 meters, the secondary endpoint of the phase 2 TORREY trial.
Following Biden’s cancer pledge, European orgs launch a moonshot of their own focused on rare diseases
Now, European stakeholders are rallying for a moonshot program of their own, this time focused on rare diseases. The new coalition, announced Tuesday evening as part of the European Health Summit, unites seven European organizations involved in drug development to pool resources and direct attention toward advancing rare disease therapies.
Dems plot their own government funding plan as talks stall
As bipartisan negotiations on a sprawling year-end package to fund the government remain mired in gridlock, Democrats have a new negotiation plan: publicly releasing their own partisan proposal on Monday. Democratic appropriators want that plan, which they’ve been drafting behind the scenes while bipartisan negotiations flounder, to come up for a vote in the House and Senate next week, according to a Senate Democratic aide, despite its certain failure in the upper chamber.