Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Deci­bel Ther­a­peu­tics has large­ly piv­ot­ed to­ward gene ther­a­pies for the in­ner ear, its lead clin­i­cal can­di­date sim­ply aims to pro­tect can­cer pa­tients from chemother­a­py-in­duced hear­ing loss. On Tues­day, the biotech pre­sent­ed its first ef­fi­ca­cy da­ta for the pro­gram, and ex­ecs like what they see.

Deci­bel re­port­ed in­ter­im re­sults from a Phase Ib study show­ing the ex­per­i­men­tal drug, dubbed DB-020, large­ly pro­tect­ed a small group of pa­tients from los­ing their hear­ing. Re­searchers used a par­tic­u­lar­ly unique study de­sign, ad­min­is­ter­ing the com­pound in one of each pa­tients’ ears be­fore they re­ceived cis­platin chemother­a­py and place­bo in the oth­er.

The biotech had 17 evalu­able pa­tients as of the Feb. 4 cut­off date who had nev­er be­fore re­ceived cis­platin. Fol­low­ing the most re­cent chemo cy­cle, 15 of the 17 pa­tients ex­pe­ri­enced on av­er­age a 30 deci­bel-loss from base­line in the place­bo ear. Of those 15, eight pa­tients did not lose their hear­ing in the DB-020-treat­ed ear, and an­oth­er five were par­tial­ly pro­tect­ed from hear­ing loss.

All ears treat­ed with DB-020 lost ap­prox­i­mate­ly eight deci­bels on av­er­age from base­line, Deci­bel said.

DB-020 is a for­mu­la­tion of sodi­um thio­sul­fate in­ject­ed through the eardrum be­fore pa­tients re­ceive cis­platin-based chemother­a­py. The pro­ce­dure can be done in an ENT’s of­fice with­out the need for in­va­sive meth­ods, the com­pa­ny touts.

A Phase Ia study in healthy vol­un­teers had been com­plet­ed in 2019 and the com­pa­ny sub­se­quent­ly moved for­ward with the Phase Ib tri­al. The re­sults had been de­layed due to the Covid-19 pan­dem­ic, Deci­bel said in a press re­lease ear­ly last year. Af­ter kick­ing off the Phase Ib tri­al in Feb­ru­ary 2020, the com­pa­ny an­tic­i­pat­ed col­lect­ing fi­nal pri­ma­ry out­come mea­sures in April 2021 and com­plet­ing the study that Oc­to­ber. The biotech re­vised those time­lines dur­ing the pan­dem­ic, with the tar­get dates now De­cem­ber 2022 and De­cem­ber 2023, ac­cord­ing to changes to the tri­al’s reg­istry on clin­i­cal­tri­

Deci­bel’s gene ther­a­py pro­grams still re­main in the pre­clin­i­cal phase, but the com­pa­ny is hop­ing to have an IND for its first such can­di­date sub­mit­ted by the end of the year. The fo­cus on gene ther­a­pies for re­gen­er­a­tion and bal­ance came af­ter a piv­ot away from ear-re­lat­ed con­di­tions such as tin­ni­tus and hear­ing loss a few years ago. Deci­bel is part­nered with Re­gen­eron on some of the pro­grams, and se­cured an ex­ten­sion to its re­search col­lab­o­ra­tion with the bio­phar­ma last No­vem­ber.

The shift was enough to gar­ner a Se­ries D in No­vem­ber 2020 and a quick jump to Nas­daq a few months lat­er. Like many com­pa­nies, Deci­bel has seen its stock price $DBTX sink in this year’s bear mar­ket, as it’s down 55% since the start of the year as of Mon­day’s close.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance Chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

Ab­bott pumps $450M+ in­to new Ire­land-based man­u­fac­tur­ing site project and hir­ing spree

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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