Ken Song, Ablaze chairman and RayzeBio CEO

Af­ter Big Phar­ma sparked in­ter­est in the US, Ablaze looks to bring ra­dio­phar­ma­ceu­ti­cals over­seas

Thanks in part to in­ter­est from Big Phar­ma play­ers like Bay­er and No­var­tis over the last decade, there’s been no short­age in cash for new com­pa­nies look­ing to slay tu­mor cells with tar­get­ed ra­dioiso­topes. Now a transpa­cif­ic up­start has hooked $75 mil­lion to bring the in­creas­ing­ly pop­u­lar drugs to Chi­na.

Ablaze Phar­ma­ceu­ti­cals emerged from stealth on Mon­day with a Vi­vo Cap­i­tal and Ad­van­Tech Cap­i­tal-led Se­ries A round and a li­cens­ing pact with Ver­sant-backed Rayze­Bio. The goal? In­tro­duce tar­get­ed ra­dio­phar­ma­ceu­ti­cal ther­a­pies (TRTs) to the Chi­nese mar­ket.

“Tar­get­ed ra­dio­phar­ma­ceu­ti­cal ther­a­pies rep­re­sent the next foun­da­tion­al modal­i­ty to treat can­cer,” Ken Song, Rayze­Bio CEO and chair­man of the board at Ablaze, said in a state­ment. “In form­ing Ablaze, we re­al­ized to be suc­cess­ful, it was crit­i­cal to have a com­pa­ny fo­cused on the Chi­na mar­ket and fo­cused on ra­dio­phar­ma­ceu­ti­cals.”

Un­like ra­di­a­tion ther­a­py, which is ad­min­is­tered by an ex­ter­nal beam of high-en­er­gy rays, ra­dio­phar­ma­ceu­ti­cals de­liv­er ra­dioiso­topes to tu­mors via the blood­stream. Song told End­points News back in June that the over­all con­cept is sim­i­lar to that of an an­ti­body-drug con­ju­gate. You start with a binder, a link­er and a pay­load — ex­cept in­stead of an an­ti­body, there are small­er pep­tides, and in­stead of a chemother­a­peu­tic pay­load, there’s a ra­dioac­tive par­ti­cle which is “many or­ders of mag­ni­tude” more po­tent. By switch­ing ra­dioiso­topes, sci­en­tists can al­so per­form imag­ing di­ag­no­sis, Ablaze says.

Bay­er was one of the ear­ly en­trants in this space, with an Al­ge­ta-part­nered ra­dionu­clide ther­a­py that was shown to boost the over­all sur­vival of cas­tra­tion-re­sis­tant prostate can­cer pa­tients with symp­to­matic bone metas­tases. Bay­er snapped up Al­ge­ta just be­fore the drug, Xofi­go, was ap­proved by the FDA. Mean­while, No­var­tis se­cured its place in the race through multi­bil­lion-dol­lar buy­outs of Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions and En­do­cyte, giv­ing it FDA-ap­proved Lu­tathera among oth­er pro­grams.

Alex Qiao

Then there are the small­er play­ers, like San Diego-based Rayze­Bio, MPM-found­ed Ak­tis On­col­o­gy, and now Ablaze, which has lo­ca­tions in both Shang­hai and San Diego. CEO Alex Qiao says Ablaze is al­ready in the clin­ic, though he of­fered few de­tails on the com­pa­ny’s pro­grams. In ad­di­tion to the Rayze­Bio pro­grams, the com­pa­ny has one part­nered pro­gram with an aca­d­e­m­ic in­sti­tu­tion, he said.

The Se­ries A — which al­so saw par­tic­i­pa­tion from RAYZ In­vest­ments, Nan Fung Life Sci­ences, Piv­otal bioVen­ture Part­ners Chi­na, ven­Bio Part­ners, Sam­sara Bio­Cap­i­tal and Ven­rock Health­care Cap­i­tal Part­ners — will be used to es­tab­lish a pipeline of TRTs for the treat­ment of sol­id tu­mors, ex­pand the team, and build up in­fra­struc­ture, ac­cord­ing to Qiao.

It’s al­so ex­plor­ing oth­er part­ner­ships, the CEO said. But for now, in­vestors are con­fi­dent the com­pa­ny will be able to break in­to the mar­ket over­seas.

“TRT is an emerg­ing field that has al­ready demon­strat­ed tremen­dous clin­i­cal ef­fi­ca­cy in treat­ing can­cer world­wide,” Hong­bo Lu, man­ag­ing part­ner of Vi­vo Cap­i­tal, said in a state­ment.

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.

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.

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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Lorenz Mayr, Vector BioPharma CEO (PhoreMost)

Up­dat­ed: 'Close to the mid­dle': Ver­sant launch­es Vec­tor with 'gut­less ade­n­ovirus' de­liv­ery method

Most of the gene therapy world centers around viral vectors, but a few biotechs have sprung up in recent years to try and avoid the safety issues that can come with adeno-associated viruses.

A new biotech has emerged to straddle somewhere “close to the middle,” in the words of Alex Mayweg, Versant managing director and board member of the incubator’s latest startup, Vector BioPharma.

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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Alessandro Maselli, Catalent CEO

Catal­ent ac­quires North Car­oli­na CD­MO for $475M, boost­ing oral solids work

As Catalent has been expanding its reach in the US this year, as well as recently completing a C-suite shuffle, the company announced last night that it has acquired the CDMO Metrics Contract Services for $475 million from Mayne Pharma Group.

The acquisition will increase Catalent’s capabilities in oral solid formulation development, manufacturing and packaging as well as expand its capacity to handle more highly potent compounds.

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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.”