Sec­ond dose of Sophiris' prostate can­cer drug proves fu­tile, shares crash

Fol­low­ing a pa­tient death that was ruled un­re­lat­ed to the study drug, Sophiris Bio con­tin­ued test­ing a sec­ond ad­min­is­tra­tion of its ex­per­i­men­tal drug in pa­tients with prostate can­cer who re­spond­ed well to the first round of dos­ing. That faith was in vain, as re-treat­ment with the drug, top­salysin, failed to con­fer ad­di­tion­al ben­e­fit in the Phase IIb study, oblit­er­at­ing the San-Diego-based com­pa­ny’s shares $SPHS af­ter the bell on Mon­day.

Pre­vi­ous­ly, the biotech had re­port­ed that 10 out of 37 pa­tients with lo­cal­ized prostate can­cer in the tri­al demon­strat­ed a clin­i­cal re­sponse six months fol­low­ing a sin­gle ad­min­is­tra­tion of top­salysin — and that 6 of those 10 re­spon­ders ex­pe­ri­enced com­plete ab­la­tion of their tu­mor. On Mon­day, the com­pa­ny up­dat­ed its re­sults from the mid-stage tri­al say­ing that the 10 re­spon­ders who re­ceived a sec­ondary ad­min­is­tra­tion of the drug did not de­rive ad­di­tion­al ben­e­fit, ac­cord­ing to a tar­get­ed biop­sy con­duct­ed on them six months af­ter re-treat­ment.

Shares of the com­pa­ny, which said it was for­mu­lat­ing a de­sign for a Phase III study for sub­mis­sion to US and EU reg­u­la­tors, cratered about 40% af­ter-mar­ket.

In June, the com­pa­ny tem­porar­i­ly halt­ed sec­ondary dos­ing in pa­tients who had re­spond­ed well to the first ad­min­is­tra­tion of the drug, af­ter a pa­tient sud­den­ly died. By Au­gust, Sophiris said it would re­sume dos­ing af­ter re­searchers con­clud­ed the drug had not caused the death.

Mark Em­ber­ton

On Mon­day, lead study in­ves­ti­ga­tor Mark Em­ber­ton said that “tak­ing in­to ac­count the ob­served ef­fi­ca­cy and safe­ty pro­file to date fol­low­ing a sin­gle ad­min­is­tra­tion, we be­lieve urol­o­gists would wel­come a treat­ment like top­salysin for men with clin­i­cal­ly-sig­nif­i­cant lo­cal­ized prostate can­cer.” Mean­while, the com­pa­ny did not pro­vide any de­tails on re­ac­tion to the sec­ond dose, oth­er than to say it had not in­tro­duced any ad­di­tion­al ben­e­fit.

Top­salysin is de­signed to be ac­ti­vat­ed on­ly by en­zy­mat­i­cal­ly-ac­tive prostate spe­cif­ic anti­gen (PSA), which is over­pro­duced in pa­tients with prostate can­cer. The drug is be­ing de­vel­oped as an op­tion for pa­tients to de­lay or even pre­vent ag­gres­sive surg­eries such as rad­i­cal prosta­te­c­to­my, which comes with sex­u­al side-ef­fects and uri­nary in­con­ti­nence. The drug’s safe­ty pro­file could po­ten­tial­ly al­low it to po­si­tion it­self be­tween non-in­va­sive ther­a­peu­tic op­tions and in­va­sive sur­gi­cal pro­ce­dure, while al­so re­duc­ing or pre­vent­ing the off-tar­get ef­fects, HC Wain­wright’s Joseph Pant­gi­nis wrote in a note last month.

Oth­er than skin can­cer, prostate can­cer is the most com­mon can­cer in Amer­i­can men, ac­cord­ing to the Amer­i­can Can­cer So­ci­ety.

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.

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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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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Eisai and METAvivor plan to debut the latest 'This is MBC' campaign at the San Antonio Breast Cancer Symposium (SABCS).

Ei­sai re-ups metasta­t­ic breast can­cer aware­ness cam­paign with strik­ing pa­tient pho­tographs

Eisai is debuting the newest ads in its long-running “This is MBC” campaign this week. In what’s become an annual tradition, Eisai and metastatic breast cancer advocacy partner METAvivor will show the striking photographs of people living with metastatic breast cancer first at the San Antonio Breast Cancer Symposium (SABCS).

The new “Imagine” campaign features 12 patients photographed around waterfalls to symbolize that same kind of sudden drop into a pool that MBC causes in a person’s life, said Beth Fairchild, co-founder of #CancerCulture who was the president of METAvivor six years ago when the campaign began. Fairchild, who is living with MBC, has helped create all of the annual “This is MBC” campaigns.

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Pfiz­er and BioN­Tech look to toss Mod­er­na patent suit, call­ing claims 'unen­force­able'

Pfizer and BioNTech took a swing at Moderna’s Covid-19 patent claims in Massachusetts federal court on Monday, calling them “invalid,” “overbroad” and “unenforceable.”

The defendants also filed counterclaims against the Cambridge, MA-based biotech, seeking a dismissal of the case, recovery of court fees and an official judgment invalidating Moderna’s claims.

Moderna sued Pfizer and BioNTech back in August, alleging that the partners’ Covid-19 vaccine Comirnaty copied parts of Moderna’s vaccine technology patented before the pandemic, when it was developing an mRNA vaccine for MERS, another respiratory illness.

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US sup­ports ex­ten­sion for Covid-19 IP waiv­er de­ci­sion

After much debate, the US government is now calling for a deadline extension to discuss a controversial potential IP waiver for Covid-19 diagnostics and therapeutics.

Over the last five months, the Office of the United States Trade Representative said it has consulted with members of Congress, public health advocates, organized labor groups, academics, think tanks, companies and trade associations on the WTO’s recent TRIPS agreement, which established a 5-year waiver of certain patent requirements on Covid-19 vaccines.

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Glen­mark hit with warn­ing let­ter over pro­ce­dures, qual­i­ty con­trol is­sues at In­dia man­u­fac­tur­ing plant

The generics producer Glenmark Pharmaceuticals has been handed a warning letter by US regulators.

The letter, which was sent to the manufacturer on Nov. 22, noted issues from an inspection over the summer at Glenmark’s facility in the town of Colvale, India, in the state of Goa.

According to the letter, the FDA found that Glenmark’s investigation of rejected batches of drugs “failed to extend to other batches, dosage strengths, and drug products.” The warning letter also noted that the site had failed to establish “adequate written procedures” for production and process control to ensure drugs have the correct strength, quality and purity.

Klick Health is lighting the way, literally, this holiday season to encourage connection for lonely seniors in long-term care facilities.

Klick Health an­nu­al hol­i­day spot­light se­nior lone­li­ness and the pow­er of con­nec­tion

Every year Klick Health leans into a cause for the holidays, and this year it’s highlighting the sometimes lonely season for seniors. So Klicksters, as employees call themselves, decided to brighten one nursing home community in hopes of inspiring others to do the same.

Klick literally lit up the Tony Stacey Centre for Veterans Care, a long-term care home in Toronto where 75% of residents receive no visitors during the holiday season. The agency brought staff and family along with lighting crews and musicians for a “Light the Way” event, creating a video of the experience debuting on Tuesday.

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Sum­i­to­vant sub­sidiaries En­zy­vant and Al­ta­vant merge in­to com­bined com­pa­ny

Two Sumitovant Biopharma entities are merging under one name, effective immediately.

Enzyvant Therapeutics and Altavant Sciences announced they have merged to form a singular entity focused on developing therapies for patients with rare diseases. The combined company will keep the name Enzyvant and along with clinical development will eventually include in-house manufacturing.

Bill Symonds, the current CEO of both Altavant and Enzyvant, is now CEO of the merged company.