An ear­ly SITC los­er: Five Prime shares crushed as an­a­lysts fret over a snap­shot on lead drug da­ta

Shares of Five Prime Ther­a­peu­tics $FPRX were crushed on Tues­day as word spread about their ab­stract re­leased ahead of the So­ci­ety for Im­munother­a­py of Can­cer meet­ing this week­end de­tail­ing the first snap­shot of da­ta on a small group of pan­cre­at­ic can­cer pa­tients treat­ed with cabi­ral­izum­ab and Op­di­vo.

In what turned out to be a nasty sur­prise for an­a­lysts, the ab­stract de­tailed an ob­jec­tive re­sponse rate of 10%, with three par­tial re­spons­es and a 6-month dis­ease con­trol rate of 13%. But the back­lash al­so cen­tered on the trou­bling safe­ty da­ta among 205 pa­tients with sol­id tu­mors, with a 43% rate of Grade 3 to 5 (death) ad­verse events in the study which trig­gered a dis­con­tin­u­a­tion rate of 13%.

Michael Schmidt, Leerink

That pro­file pushed the stock over the cliff and down 41% by the end of the day. And Five Prime is host­ing an in­vestor call this morn­ing to see if it can re­verse the tide.

The re­ac­tion is bad news for Bris­tol-My­ers Squibb, which paid Five Prime $350 mil­lion up­front two years ago to part­ner on Five Prime’s colony stim­u­lat­ing fac­tor 1 re­cep­tor (CSF1R) an­ti­body pro­gram, which in­clud­ed cabi­ral­izum­ab (FPA008) as the lead in the clin­ic. The deal over­all was worth up to $1.74 bil­lion.

The ear­ly-stage tri­al num­bers were worse than ex­pect­ed, said Jef­feries’ Eun Yang, with a weak­er ef­fi­ca­cy pro­file and a dam­ag­ing set of safe­ty fig­ures. “While the da­ta is not as strong as we like to see,” Yang added, “this com­pares rea­son­ably to chemo com­bo in 2L PC.”

Leerink’s Michael Schmidt, on the oth­er hand, rather liked the re­sponse da­ta but fret­ted about safe­ty. He not­ed:

That said, we think the safe­ty pro­file dis­closed in the ab­stract, in­clud­ing Grade 3-5 treat­ment-emer­gent ad­verse events (TEAE) seen in 43% of pa­tients needs to be bet­ter un­der­stood and could raise some in­vestor ques­tions un­til the full dataset is pro­vid­ed at SITC next week­end.

We’ll be at SITC over the week­end for an up­date on the da­ta from Five Prime.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

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.

Up­dat­ed: Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The subbleases are “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” Biogen spokesperson Ashleigh Koss wrote in a statement to Endpoints News, adding that the company has had subleases across several buildings for years.

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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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Who are the women blaz­ing trails in bio­phar­ma R&D? Nom­i­nate them for End­points' 2022 spe­cial re­port

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

Pfiz­er launch­es re­bate pro­gram for rare dis­ease pa­tients who have to stop tak­ing Panzy­ga

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.

Horizon's back-to-school campaign for children with cystinosis includes an all about me poster as part of a care package box.

Hori­zon read­ies kids and fam­i­lies for back to school with week­long ac­tiv­i­ties around rare dis­ease cysti­nosis

Going back to school is usually a bumpy readjustment from summer freedom for all kids, but especially for kids with chronic health conditions. Horizon Therapeutics is hoping to help smooth the way for some who have the rare disease cystinosis. Cystinosis is a genetic disease that causes the amino acid cystine to build up in different tissues and organs.

The “Gear Up” for school campaign is running all week with different online and at-home events and activities for families and children with cystinosis. Each family who signed up receives a care package mailed to their home including an activity coloring book “Michael’s Show-and-Tell.” The book tells Michael’s story about living with cystinosis while offering kids matching, coloring and finding object games along with information.

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Phar­mas spend mil­lions on di­a­betes ad­ver­tis­ing, but few pa­tients can re­call brand names — sur­vey

While many Big Pharma diabetes brands spend millions of dollars on TV ads every year, most people with type 2 diabetes don’t recognize specific drug brand names, according to a new study.

No brand garnered more than 30% recognition in Phreesia Life Science’s latest in-office patient survey of more than 4,000 adults with type 2 diabetes. Eli Lilly’s Trulicity topped the list as the most recognized brand with 29% of those surveyed recalling it, followed by Boehringer Ingelheim and Lilly’s Jardiance at 27% and Merck’s Januvia and Novo Nordisk tying for the third spot with 24%. Meanwhile, 76% of the patients surveyed were familiar with the generic treatment metformin.

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Faced with thou­sands of opi­oid law­suits, En­do says it will like­ly file for bank­rupt­cy 'im­mi­nent­ly'

Endo International will likely be the next pharma company to file for bankruptcy under a mountain of opioid lawsuits.

The Dublin, Ireland-based company revealed in its Q2 results on Tuesday that it’s in talks with first lien creditors, and that “these negotiations will likely result in a pre-arranged filing under Chapter 11 of the U.S. Bankruptcy Code by Endo International plc and substantially all of its subsidiaries, which could occur imminently.”

Feud be­tween two biotechs left near­ly 12M dos­es of mon­key­pox an­tivi­ral on the ta­ble

As the US embarks on a new delivery strategy to stretch out its thinning supply of monkeypox vaccines, the need for treatments could pick up as cases of the virus rise. And the amount of courses of one potential antiviral, soon to be clinically tested for efficacy in humans, was almost 12 million more than it is today, according to SEC filings.

While not greenlit for treating monkeypox, SIGA’s FDA-approved smallpox antiviral, Tpoxx, can be requested by physicians under an expanded use program. As of Monday, HHS tells Endpoints News it had tapped into more than 15,000 of the 1.7 million courses of Tpoxx that have been stockpiled, but with cases climbing over the past few weeks, demand will likely not peter out in the near future, especially if the vaccine supply runs dry.

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