Martin Silverstein

Mana joins the hec­tic fight against sol­id tu­mors with an ‘off-the-shelf’ can­di­date an­gling for an IND this year

The hunt for ef­fec­tive ther­a­pies for sol­id tu­mors has heat­ed up in ear­ly 2021 with a string of biotechs tout­ing big in­vestor checks and name-brand col­lab­o­ra­tions to chase those hard-to-treat lumps. Now, with one of its can­di­dates al­ready in the clin­ic for leukemia, Mana Ther­a­peu­tics is tak­ing a new round of fund­ing to join the fray.

On Fri­day, Mana un­veiled a $35 mil­lion Se­ries A fi­nanc­ing round that will help push the Boston-area biotech’s lead can­di­date through a Phase I tri­al and could help the com­pa­ny se­cure an IND for an off-the-shelf al­lo­gene­ic mol­e­cule tar­get­ing trans­plant-in­el­i­gi­ble AML and sol­id tu­mors with­in the year.

Marc Co­hen

The biotech’s lead­ing mol­e­cule, dubbed MANA-312, is al­ready en­gaged in the Phase I study of pa­tients with acute myeloid leukemia, myelodys­plas­tic syn­drome af­ter un­der­go­ing an al­lo­genic hematopoi­et­ic stem cell trans­plan­ta­tion. Mana’s goal is to use its tech­nol­o­gy to cre­ate an in­ven­to­ry of off-the-shelf al­lo­gene­ic prod­ucts that can treat the ma­jor­i­ty of pa­tients with cer­tain tar­get­ed can­cer in­di­ca­tions us­ing what’s called a hu­man leuko­cyte anti­gen match­ing sys­tem.

It’s a dif­fer­ent take on a sim­i­lar line of at­tack for sol­id tu­mors: us­ing the body’s nat­ur­al im­mune sys­tem to ed­u­cate healthy cells al­ready in the body to tar­get anti­gens on the sur­face of the tu­mor’s can­cer cells with­out dam­ag­ing the oth­er­wise healthy cells. To do this, Mana us­es an in-house plat­form called ED­I­FY, which it says lever­ages nat­ur­al im­mune sys­tem path­ways to ed­u­cate T cells to tar­get mul­ti­ple cell sur­faces and in­tra­cel­lu­lar tu­mor-as­so­ci­at­ed anti­gens.

Through mul­ti­ple anti­gen tar­get­ing process­es, the com­pa­ny’s tech­nol­o­gy is de­signed to pre­vent the tu­mor’s im­mune es­cape, and it says the al­lo­gene­ic method — which us­es healthy donor cells to cre­ate a mas­ter cell bank and is then used for spe­cif­ic ther­a­pies — of at­tack­ing the sol­id can­cer tu­mors could pro­vide su­pe­ri­or ef­fi­ca­cy to sin­gle anti­gen and oth­er cell ther­a­py ap­proach­es.

MANA-312 al­so isn’t the biotech’s on­ly can­di­date in the works. MANA-412 is a pre­clin­i­cal off-the-shelf al­lo­gene­ic cell ther­a­py for treat­ing trans­plant-in­el­i­gi­ble acute myeloid leukemia and sol­id tu­mors and could be ready for an IND fil­ing by the end of the year, Mana said. The Se­ries A round will help fund pre­clin­i­cal de­vel­op­ment for that can­di­date as well.

Mana was found­ed based on re­search and hu­man proof-of-con­cept clin­i­cal tri­als con­duct­ed by Cather­ine Bol­lard of Chil­dren’s Na­tion­al Hos­pi­tal and her col­leagues at Johns Hop­kins Med­ical Cen­ter. Those tri­als, in both sol­id and hema­to­log­ic tu­mors, “sup­port­ed a strong safe­ty pro­file, showed im­muno­log­i­cal an­ti-tu­mor ac­tiv­i­ty and val­i­dat­ed MANA’s ini­tial set of tu­mor anti­gens,” the com­pa­ny said. Then Bol­lard co-found­ed the com­pa­ny with in­dus­try vet Marc Co­hen. Ex-Gilead ex­ec Mar­tin Sil­ver­stein is the CEO.

Cather­ine Bol­lard

“The hu­man proof-of-con­cept tri­als con­duct­ed by my team and col­leagues showed po­ten­tial for a nonengi­neered ap­proach to ed­u­cat­ing T-cells to at­tack mul­ti­ple tu­mor anti­gens, which MANA is ex­pand­ing even fur­ther through re­fine­ment of the man­u­fac­tur­ing process for an al­lo­gene­ic prod­uct and ap­pli­ca­tion to a broad­er set of anti­gens in a va­ri­ety of clin­i­cal in­di­ca­tions and set­tings,” Bol­lard said in a state­ment.

MANA’s $35 mil­lion fi­nanc­ing round was led by Co­bro Ven­tures and Lightchain Cap­i­tal and joined by LifeSci Ven­ture Part­ners with oth­er undis­closed in­vestors.

BY­OD Best Prac­tices: How Mo­bile De­vice Strat­e­gy Leads to More Pa­tient-Cen­tric Clin­i­cal Tri­als

Some of the most time- and cost-consuming components of clinical research center on gathering, analyzing, and reporting data. To improve efficiency, many clinical trial sponsors have shifted to electronic clinical outcome assessments (eCOA), including electronic patient-reported outcome (ePRO) tools.

In most cases, patients enter data using apps installed on provisioned devices. At a time when 81% of Americans own a smartphone, why not use the device they rely on every day?

Image: Shutterstock

Eli Lil­ly asks FDA to re­voke EUA for Covid-19 treat­ment

Eli Lilly on Friday requested that the FDA revoke the emergency authorization for its Covid-19 drug bamlanivimab, which is no longer as effective as a combo therapy because of a rise in coronavirus variants across the US.

“With the growing prevalence of variants in the U.S. that bamlanivimab alone may not fully neutralize, and with sufficient supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralizing antibodies together,” Daniel Skovronsky, Lilly’s CSO, said in a statement.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 107,000+ biopharma pros reading Endpoints daily — and it's free.

Osman Kibar (Samumed, now Biosplice)

Os­man Kibar lays down his hand at Sa­mumed, step­ping away from CEO role as his once-her­ald­ed an­ti-ag­ing biotech re­brands

Samumed made quite the entrance back in 2016, when it launched with some anti-aging programs and a whopping $12 billion valuation. That level of fanfare was nowhere to be found on Thursday, when the company added another $120 million to its coffers and quietly changed its name to Biosplice Therapeutics.

Why the sudden rebrand?

“We did that for obvious reasons,” CFO and CBO Erich Horsley told Endpoints News. “The name Biosplice echoes our science much more than Samumed does.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 107,000+ biopharma pros reading Endpoints daily — and it's free.

Near­ly a year af­ter Au­den­tes' gene ther­a­py deaths, the tri­al con­tin­ues. What hap­pened re­mains a mys­tery

Natalie Holles was five months into her tenure as Audentes CEO and working to smooth out a $3 billion merger when the world crashed in.

Holles and her team received word on the morning of May 5 that, hours before, a patient died in a trial for their lead gene therapy. They went into triage mode, alerting the FDA, calling trial investigators to begin to understand what happened, and, the next day, writing a letter to alert the patient community so they would be the first to know. “We wanted to be as forthright and transparent as possible,” Holles told me late last month.

The brief letter noted two other patients also suffered severe reactions after receiving a high dose of the therapy and were undergoing treatment. One died a month and a half later, at which point news of the deaths became public, jolting an emergent gene therapy field and raising questions about the safety of the high doses Audentes and others were now using. The third patient died in August.

“It was deeply saddening,” Holles said. “But I was — we were — resolute and determined to understand what happened and learn from it and get back on track.”

Eleven months have now passed since the first death and the therapy, a potential cure for a rare and fatal muscle-wasting disease called X-linked myotubular myopathy, is back on track, the FDA having cleared the company to resume dosing at a lower level. Audentes itself is no more; last month, Japanese pharma giant Astellas announced it had completed working out the kinks of the $3 billion merger and had restructured and rebranded the subsidiary as Astellas Gene Therapies. Holles, having successfully steered both efforts, departed.

Still, questions about precisely what led to the deaths of the 3 boys still linger. Trial investigators released key details about the case last August and December, pointing to a biological landmine that Audentes could not have seen coming — a moment of profound medical misfortune. In an emerging field that’s promised cures for devastating diseases but also seen its share of safety setbacks, the cases provided a cautionary tale.

Audentes “contributed in a positive way by giving a painful but important example for others to look at and learn from,” Terry Flotte, dean of the UMass School of Medicine and editor of the journal Human Gene Therapy, told me. “I can’t see anything they did wrong.”

Yet some researchers say they’re still waiting on Astellas to release more data. The company has yet to publish a full paper detailing what happened, nor have they indicated that they will. In the meantime, it remains unclear what triggered the events and how to prevent them in the future.

“Since Audentes was the first one and we don’t have additional information, we’re kind of in a holding pattern, flying around, waiting to figure out how to land our vehicles,” said Jude Samulski, professor of pharmacology at UNC’s Gene Therapy Center and CSO of the gene therapy biotech AskBio, now a subsidiary of Bayer.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

J&J faces CDC ad­vi­so­ry com­mit­tee again next week to weigh Covid-19 vac­cine risks

The CDC’s Advisory Committee on Immunization Practices punted earlier this week on deciding whether or not to recommend lifting a pause on the administration of J&J’s Covid-19 vaccine, but the committee will meet again in an emergency session next Friday to discuss the safety issues further.

The timing of the meeting likely means that the J&J vaccine will not return to the US market before the end of next week as the FDA looks to work hand-in-hand with the CDC to ensure the benefits of the vaccine still outweigh the risks for all age groups.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 107,000+ biopharma pros reading Endpoints daily — and it's free.

Ex­clu­sive in­ter­view: Pe­ter Marks on why full Covid-19 vac­cine ap­provals could be just months away

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, took time out of his busy schedule last Friday to discuss with Endpoints News all things related to his work regulating vaccines and the pandemic.

Marks, who quietly coined the name “Operation Warp Speed” before deciding to stick with his work regulating vaccines at the FDA rather than join the Trump-era program, has been the face of vaccine regulation for the FDA throughout the pandemic, and is usually spotted in Zoom meetings seated in front of his wife’s paintings.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Pascal Soriot (AstraZeneca via YouTube)

Af­ter be­ing goad­ed to sell the com­pa­ny, Alex­ion's CEO set some am­bi­tious new goals for in­vestors. Then Pas­cal So­ri­ot came call­ing

Back in the spring of 2020, Alexion $ALXN CEO Ludwig Hantson was under considerable pressure to perform and had been for months. Elliott Advisers had been applying some high public heat on the biotech’s numbers. And in reaching out to some major stockholders, one thread of advice came through loud and clear: Sell the company or do something dramatic to change the narrative.

In the words of the rather dry SEC filing that offers a detailed backgrounder on the buyout deal, Alexion stated: ‘During the summer and fall of 2020, Alexion also continued to engage with its stockholders, and in these interactions, several stockholders encouraged the company to explore strategic alternatives.’

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 107,000+ biopharma pros reading Endpoints daily — and it's free.

Alex Leech, Alchemab CEO (SV Health Investors)

Alchemab bags fresh round of in­vestor for tar­get-ag­nos­tic an­ti­body de­vel­op­ment for Hunt­ing­ton's, Covid-19

With a “target-agnostic” approach to antibody development, the UK’s Alchemab has used lessons learned from patients with resistance to certain diseases to chase after conditions as far apart as Huntington’s and Covid-19. Now, investors are jumping on board the concept with an $86 million Series A.

The proceeds will go toward advancing the company’s target-agnostic drug discovery program, a release said. That approach looks at the antibody repertoires of patients who show resistance to typically destructive diseases regardless of genetic disposition.

Craig Parker, Surrozen CEO

The world of Wnt heads to Nas­daq as Sur­rozen an­nounces a $212M SPAC deal

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

Another day, another SPAC merger in the world of biotech.

Less than 24 hours after Tango Therapeutics announced its own leap to Nasdaq through the blank check route, Surrozen has decided to take a similar step. The Wnt pathway-focused biotech is reverse-merging with Consonance Capital Management’s SPAC in a $212 million deal, which includes $92 million from the shell company and $120 million in PIPE financing.