Akseli Hemminki. TILT Biotherapeutics CEO

On­colyt­ic virus start­up TILT rais­es €22M to ad­vance can­cer ther­a­pies

Fin­land-based TILT Bio­ther­a­peu­tics an­nounced to­day it raised €22 mil­lion in the fi­nal close of a sec­ond round of fi­nanc­ing to push its on­colyt­ic virus pipeline in­to Phase II tri­als. The com­pa­ny raised €10 mil­lion in the first round in June of last year.

A chunk of the sec­ond round, €5.9 mil­lion, comes from the Eu­ro­pean In­no­va­tion Coun­cil Fund with an­oth­er €2.1 mil­lion grant from EIC’s Ac­cel­er­a­tor pro­gram.

The mon­ey will go to­ward its ear­ly-stage pipeline, in­clud­ing its lead as­set, TILT-123, which the biotech de­scribes as an on­colyt­ic virus ther­a­py “armed” with two hu­man cy­tokines. The com­pa­ny’s TILT can­di­dates, which can be in­ject­ed lo­cal­ly or sys­tem­at­i­cal­ly, are de­signed to en­hance T cell ther­a­pies by break­ing down the tu­mor mi­croen­vi­ron­ment and elim­i­nat­ing its abil­i­ty to sup­press im­mune re­spons­es to can­cer.

TILT-123 is still in Phase I tri­als and is be­ing in­ves­ti­gat­ed in sol­id tu­mors, melanoma, ovar­i­an can­cer, head and neck can­cer and lung can­cer.

The com­pa­ny was found­ed in 2013 as a spin­out of the Uni­ver­si­ty of Helsin­ki, but has since snagged some big-name phar­mas to test out TILT-123, like the Mer­ck KGaA and Pfiz­er Al­liance. They’re test­ing out TILT-123 in com­bi­na­tion with the PD-L1 in­hibitor, Baven­cio, in head and neck can­cer. For ovar­i­an and re­frac­to­ry non-small cell lung can­cer, TILT is teamed up with MSD (Mer­ck) to com­bine it with Keytru­da.

“Our tri­als are pro­gress­ing well through Phase I, and this new fund­ing will sup­port us in pro­gress­ing them in­to Phase II, an­oth­er key step for these new ther­a­pies to reach pa­tients in a range of can­cers,” said founder and CEO Ak­seli Hem­min­ki.

In 2019, the com­pa­ny al­so ex­pand­ed in­to Chi­na with a col­lab­o­ra­tion with pri­vate­ly-owned Bio­theus to de­vel­op and com­mer­cial­ize TILT-123 in the coun­try.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Af­ter safe­ty re­view, EMA mir­rors FDA with up­dat­ed rec­om­men­da­tions for JAK in­hibitors

The EMA released updated recommendations today for the use of JAK inhibitors (JAKi) after reviewing data from several clinical trials that showed increased incidents of issues in certain patients who have rheumatoid arthritis and other risk factors.

The EMA noted malignancy, major adverse cardiovascular events (MACE), serious infections, venous thromboembolism (VTE) and mortality in some patients.

Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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Man­u­fac­tur­ing roundup: Catal­ent to pro­duce low-cost ver­sion of nalox­one; CSL opens R&D site

Catalent will be manufacturing a low-cost version of the opioid overdose treatment naloxone as part of a contract with Harm Reduction Therapeutics.

Catalent plans to manufacture the treatment at its facility in Morrisville, NC. No financial details on the deal were disclosed.

Harm Reduction was granted priority review status for the NDA on its spray last year. The company has been working on a naloxone product since 2017. It is anticipating approval in July of this year and a US launch in early 2024.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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As­pen looks to re­bound in pro­duc­tion and rev­enue af­ter Covid-19

Last year, South African-based vaccine manufacturer Aspen Pharmacare was facing reports that it had not received a single order for its manufactured Covid-19 shots and that manufacturing lines were sitting idle. But now the vaccine producer is looking to turn things around.

Aspen’s disclosure of its financial results in March unveiled that manufacturing revenue had decreased by 12% to R 603 million ($33.8 million), which Lorraine Hill, Aspen Group’s COO, said is attributable to lower Covid vaccine sales.

Ribbon cutting ceremony for Thermo Fisher's new cell therapy manufacturing site in San Francisco

Ther­mo Fish­er moves on cam­pus with new cell man­u­fac­tur­ing site in San Fran­cis­co

Thermo Fisher Scientific is putting down more roots in the Bay Area.

The manufacturer opened the doors to a new cell therapy manufacturing facility next to the University of California-San Francisco Medical Center’s Mission Bay campus and on the university’s campus.

UCSF and Thermo Fisher have had a partnership since 2021, with the new site focusing on manufacturing cell therapeutics for certain cancers, including glioblastoma and multiple myeloma. The new site plans to use Thermo Fisher’s expertise in manufacturing services to help UCSF accelerate the development of cell therapies and eventually get them into the clinic, said Dan Herring, the general manager of cell therapy services at Thermo Fisher, in an interview with Endpoints News.