Den­mark's Gubra to col­lab­o­rate with Bay­er on pep­tides; Sam­sung and Bio­gen re­ceive FDA ap­proval for Lu­cen­tis biosim­i­lar

Dan­ish biotech Gubra an­nounced a re­search col­lab­o­ra­tion and li­cense agree­ment with Bay­er to de­vel­op pep­tide ther­a­peu­tics to treat car­diore­nal dis­eases. The col­lab­o­ra­tion will uti­lize Gubra’s pep­tide drug dis­cov­ery plat­form to iden­ti­fy po­ten­tial can­di­dates.

This is not the first time Gubra has part­nered with a com­pa­ny on pep­tide ther­a­peu­tics — they part­nered with Boehringer In­gel­heim back in 2017 to cre­ate pep­tide ther­a­peu­tics to treat obe­si­ty.

“We are very pleased to en­ter this re­search col­lab­o­ra­tion and li­cense agree­ment with Bay­er,” said Gubra CEO Hen­rik Blou in a state­ment. “We are pleased that the po­ten­tial of our tech­nol­o­gy is be­ing rec­og­nized by such a qual­i­fied part­ner ca­pa­ble of ad­vanc­ing in­no­v­a­tive med­i­cines in­to the clin­ic.”

As part of the agree­ment, Gubra will re­ceive an undis­closed pay­ment up­front, as well as up to $253 mil­lion for reach­ing de­vel­op­ment and com­mer­cial­iza­tion mile­stones.

Sam­sung and Bio­gen re­ceive FDA ap­proval for Lu­cen­tis biosim­i­lar

Sam­sung Bioepis and Bio­gen an­nounced to­day that the FDA has ap­proved Lu­cen­tis biosim­i­lar By­ooviz for three in­di­ca­tions:

  • Neo­vas­cu­lar (wet) age-re­lat­ed mac­u­lar de­gen­er­a­tion (AMD)
  • Mac­u­lar ede­ma fol­low­ing reti­nal vein oc­clu­sion (RVO)
  • My­opic choroidal neo­vas­cu­lar­iza­tion (mC­NV)

While By­ooviz is the first oph­thal­mol­o­gy biosim­i­lar ap­proved in the Unit­ed States, this ap­proval was like­ly a mat­ter of time as CHMP had rec­om­mend­ed the drug’s ap­proval back in June.

By­ooviz was ap­proved in Eu­rope on Au­gust 18 and in the UK on Au­gust 31.

“We are very ex­cit­ed to be able to open a new chap­ter with the ap­proval of By­ooviz in the US,” said Bio­gen SVP and glob­al head of biosim­i­lars Ian Hen­shaw in a state­ment.

How much will BY­OOVIZ cost? Bio­gen spokesper­son Al­li­son Parks de­clined to say.

“Be­cause we’re not launch­ing un­til June, it’s too pre­lim­i­nary to an­nounce pric­ing,” Parks told End­points News. “We will work in part­ner­ship with ex­ter­nal stake­hold­ers, in­clud­ing pay­ers and providers to en­sure a pre­dictable and sus­tain­able ac­cess po­si­tion is de­vel­oped for BY­OOVIZ.”

Syn­log­ic un­veils da­ta from mul­ti­ple clin­i­cal stud­ies on PKU

Mass­a­chu­setts biotech Syn­log­ic an­nounced pos­i­tive da­ta from clin­i­cal stud­ies look­ing at two en­gi­neered mi­crobes to treat phenylke­tonuria, or PKU — SYNB1618 and SYNB1934.

SYNB1618 showed re­duc­tions of pheny­lala­nine (Phe) at dif­fer­ent dose lev­els, across mul­ti­ple time points, in an in­ter­im analy­sis of a Phase II Syn­Phe­ny-1 study. SYNB1934, an op­ti­mized strain evolved from SYNB1618, showed two-fold high­er ac­tiv­i­ty than SYNB1618 in a head-to-head Phase I study in healthy vol­un­teers, as mea­sured by bio­mark­ers of Phe me­tab­o­lism.

Based on these clin­i­cal da­ta, Syn­log­ic will start plan­ning a piv­otal Phase III study.

“These events mark a ma­jor mile­stone for Syn­log­ic’s Syn­thet­ic Bi­ot­ic plat­form. We look for­ward to com­plet­ing our Phase 2 Syn­Phe­ny-1 study and ad­vanc­ing the PKU pro­gram in­to a piv­otal study,” said Syn­log­ic pres­i­dent and CEO Aoife Bren­nan in a state­ment.

Glax­o­SmithK­line to em­bark on clean en­er­gy in­vest­ment

As GSK CEO Em­ma Walm­s­ley par­tic­i­pat­ed at the open­ing event for New York Cli­mate Week, GSK an­nounced ma­jor up­dates on ef­forts to achieve cer­tain en­vi­ron­men­tal goals, in­clud­ing ma­jor new in­vest­ment in re­new­able elec­tric­i­ty at man­u­fac­tur­ing sites in the UK and US.

There is al­so a new ini­tia­tive to re­duce green­house gas emis­sions from its me­tered dose asth­ma in­halers, which ac­count for al­most half of the com­pa­ny’s car­bon emis­sions.

“For GSK, our sus­tain­abil­i­ty com­mit­ments are an in­te­gral part of our strat­e­gy, mak­ing our busi­ness more re­silient, pro­tect­ing our op­er­a­tions and ul­ti­mate­ly help­ing us to achieve health im­pact on a glob­al scale while de­liv­er­ing re­turns for our share­hold­ers,” said Walm­s­ley.

GSK said these in­vest­ments al­so co­in­cid­ed with con­fir­ma­tion of the glob­al phar­ma­ceu­ti­cal and med­ical tech­nol­o­gy sec­tor reach­ing the Race to Ze­ro ‘break­through’ tar­get of 20% of ma­jor com­pa­nies (by rev­enue) com­mit­ting to net ze­ro car­bon emis­sions by 2050.

FDA ac­cepts Mar­i­nus’s NDA on epilep­sy seizure treat­ment

Mar­i­nus Phar­ma­ceu­ti­cals an­nounced to­day that the FDA ac­cept­ed Mar­i­nus’ NDA for the use of ganax­olone in the treat­ment of seizures as­so­ci­at­ed with rare ge­net­ic epilep­sy CD­KL5 de­fi­cien­cy dis­or­der.

The NDA was grant­ed pri­or­i­ty re­view and the FDA as­signed a PDU­FA ac­tion date of March 20, 2022. In its ac­cep­tance let­ter, the FDA in­di­cat­ed that it is not cur­rent­ly plan­ning to hold an ad­vi­so­ry com­mit­tee meet­ing to dis­cuss the ap­pli­ca­tion.

“We be­lieve that ganax­olone has the po­ten­tial to pro­vide mean­ing­ful clin­i­cal ben­e­fit for pa­tients and we look for­ward to work­ing close­ly with the FDA dur­ing the re­view process,” said Mar­i­nus CEO Scott Braun­stein in a state­ment.

Ganax­olone re­ceived or­phan drug des­ig­na­tion and Rare Pe­di­atric Dis­ease (RPD) des­ig­na­tion for CDD in June 2017 and Ju­ly 2020, re­spec­tive­ly.

The ac­cep­tance of the NDA for fil­ing en­ables the biotech to draw $30 mil­lion un­der its May 2021 fi­nanc­ing agree­ment with in­vest­ment firm Oak­tree Cap­i­tal Man­age­ment, based on cer­tain con­di­tions de­scribed in the cred­it agree­ment. If the NDA is ap­proved by the end of next year, an ad­di­tion­al $30 mil­lion is avail­able un­der the agree­ment.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Spe­cial re­port 2022: Meet 20 women blaz­ing trails in bio­phar­ma R&D

When you run a special report for a fourth year, it can start feeling a little bit like a ritual. You go through the motions — in our case opening up nominations for top women in biopharma R&D and reviewing more than 500 entries — you make your choices of inclusion and exclusion. You host a ceremony.

But then things happen that remind you why you do it in the first place. Perhaps a Supreme Court rules to overturn the constitutional right to abortion and a group of women biotech leaders makes it clear they strongly dissent; perhaps new data on gender diversity in the industry come out that look all too similar to the old ones, suggesting women are still dramatically underrepresented at the top; perhaps protests and conflicts around the world put in stark terms the struggles that many women still face in earning the most basic recognition.

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Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Prometheus moves to raise cash hours af­ter PhII da­ta leads to stock surge

After releasing better-than-anticipated data on two mid-stage studies Wednesday morning, Prometheus Biosciences’ CEO said the company would “take some time to assess” its next financing options.

It only needed about seven hours. Wednesday afternoon after the market closed, the biotech announced it would seek $250 million through an equity offering as the company looks to edge out anti-TL1A competitor Pfizer and its new partner Roivant.

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Piper Trelstad, head of CMC, Bill & Melinda Gates Medical Research Institute

Q&A with Gates leader: Women tak­ing on more roles in phar­ma man­u­fac­tur­ing, but still work to do

More and more women are driving innovation and taking leadership roles in biotech – as evidenced today in the release of Endpoints News’ list of the top 20 women in the R&D world – but those gains are beginning to extend across pharma sectors.

In pharma manufacturing in the US today, around 46% of all roles are occupied by women, according to the US Bureau of Labor Statistics for 2021. And according to a Bloomberg report, women’s roles across manufacturing roles had a massive boost after the start of the pandemic.

Phar­ma rep­u­ta­tion re­tains 'halo' even as pan­dem­ic me­dia cov­er­age re­cedes — sur­vey

The Covid-19 halo effect on the pharma industry is continuing, according to a new global study from Ipsos. The annual survey for the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) finds considerable goodwill from consumers across measures of trust, cooperation with governments, and advancing research and drug development.

“Despite the pandemic in many countries no longer being the top of mind concern generally – although it does remain the top concern as a health issue – the industry’s reputation has remained positive,” said Ipsos research director Thomas Fife-Schaw.

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FDA commissioner Robert Califf (Jose Luis Magana/AP Images)

FDA pulls On­copep­tides' Pepax­to in­di­ca­tion, open­ing the door for dan­gling ac­cel­er­at­ed ap­proval en­force­ment

In a move all but ensured after an overwhelmingly negative adcomm vote this September, the FDA is yanking Oncopeptides’ dangling accelerated approval. And there may be more to come.

In recent months, US regulators have honed in on reforming the accelerated approval pathway and preventing drugmakers from continuing to sell their medicines in the event of a confirmatory study flop. The moves come after commissioner Rob Califf has called for companies to do more to produce post-marketing evidence quickly earlier this year.

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Mark McKenna, Prometheus Biosciences chairman & CEO

With clear PhII win in IBD, Prometheus thwarts Pfiz­er com­par­isons as it fol­lows Hu­mi­ra 'play­book'

Prometheus Biosciences reported a clear Phase II win in two inflammatory bowel disease conditions in a clinical development race with Pfizer, planting the biotech’s flag in a field of antibodies attempting to go against black box-cornered JAK inhibitors and AbbVie’s Humira.

Shares $RXDX have soared since the summer — a small dip last week notwithstanding when rival Pfizer teamed up with Roivant on a new company for their competing anti-TL1A monoclonal antibody. And they skyrocketed once again Wednesday morning, climbing from $36 apiece to more than $100 on the back of two Phase II studies: one placebo-controlled in ulcerative colitis and the other an open-label trial in patients with Crohn’s disease.

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