Fate sees pos­i­tive B-cell lym­phoma da­ta at #AS­CO21; Imag­inAb se­cures fund­ing for CD8 imag­ing tri­als

Fate Ther­a­peu­tics re­vealed some new da­ta at #AS­CO21 for their R/R B-cell lym­phoma pro­gram on Fri­day.

The San Diego biotech said in­ter­im Phase I da­ta for FT516 re­vealed eight of 11 pa­tients as of the March cut­off date had achieved an ob­jec­tive re­sponse, in­clud­ing six who hit lev­els of com­plete re­sponse. Four of the pa­tients came from the sec­ond dose co­hort, while the oth­er sev­en came from the third dose co­hort.

“Based on the fa­vor­able ther­a­peu­tic pro­file of FT516 that con­tin­ues to emerge and the po­ten­tial to treat pa­tients on-de­mand with­out de­lay, we plan to ini­ti­ate mul­ti­ple in­di­ca­tion-spe­cif­ic, dose-ex­pan­sion co­horts for pa­tients with B-cell lym­phomas to broad­ly as­sess FT516 in com­bi­na­tion with CD20-tar­get­ed mon­o­clon­al an­ti­body reg­i­mens,” Wayne Chu, VP of clin­i­cal de­vel­op­ment, said in a state­ment.

Pa­tients had re­ceived a me­di­an of three pri­or lines of treat­ment, and a me­di­an of two pri­or lines con­tain­ing CD20-tar­get­ed ther­a­pies. Of the 11 pa­tients, eight had ag­gres­sive B-cell lym­phoma, five were re­frac­to­ry to their most re­cent pri­or ther­a­py and four had pre­vi­ous­ly been treat­ed with au­tol­o­gous CD19 CAR-T cell ther­a­py.

The biotech added that no dose-lim­it­ing tox­i­c­i­ties nor treat­ment-re­lat­ed se­ri­ous side ef­fects above Grade 3 were ob­served. — Max Gel­man

Imag­inAb se­cures fund­ing for CD8 imag­ing tri­als

A Los An­ge­les-based biotech fo­cused on ra­dio­phar­ma­ceu­ti­cal imag­ing and ther­a­py agents an­nounced that it has se­cured $12.8 mil­lion to ex­pand its clin­i­cal tri­als.

Imag­inAb se­cured the mon­ey from ex­ist­ing in­vestors Adage Cap­i­tal and Cy­cad Group, and were joined by new in­vestors Norgine Ven­tures and Ther­a­vance Res­pi­ra­to­ry Com­pa­ny. Pro­ceeds will help the com­pa­ny ex­pand its CD8 Im­munoPET clin­i­cal tri­als that are be­ing ad­min­is­tered in more than 20 hos­pi­tals in North Amer­i­ca, Eu­rope and Aus­tralia, the com­pa­ny said in a re­lease.

“We are pleased to se­cure this fi­nanc­ing to sup­port our imag­ing and RPT ini­tia­tives. Imag­inAb is an in­no­v­a­tive leader with­in the Im­munoPET imag­ing field and have ex­pe­ri­enced strong rev­enue growth over the last 12 months as our tech­nol­o­gy con­tin­ues to be em­braced by our phar­ma and biotech part­ners,” chair­man K. Leonard Jud­son said in a state­ment.

It will al­so aid R&D. CD8 is a mini­body that binds the CD8 re­cep­tor on hu­man T cells, which are the main ef­fec­tor cells in­volved in an­ti-tu­mor re­spons­es. Im­ages of these cells can be used to di­ag­nose pa­tients, mea­sure the ef­fi­ca­cy of ther­a­pies and pre­dict out­comes.

“Imag­inAb’s vi­sion is to be the lead in di­ag­nos­tic and treat­ment choic­es, help­ing pa­tients live bet­ter and health­i­er lives,” CEO Ian Wil­son said in a press re­lease. — Josh Sul­li­van

Mag­ne­ta re­veals stem cell col­lec­tion and mo­bi­liza­tion da­ta

Ahead of the ex­pect­ed ex­it from Mag­nen­ta’s CMO and R&D chief, the biotech re­vealed new da­ta at #AS­CO21 on Fri­day.

The Cam­bridge, MA-based stem cell play­er re­vealed the Phase II re­sults for their MG­TA-145 and pler­ix­afor com­bo in pa­tients with mul­ti­ple myelo­ma. Ma­gen­ta’s goal of the study was “to mo­bi­lize and col­lect hematopoi­et­ic stem cells for au­tol­o­gous stem cell trans­plant” in such pa­tients, the com­pa­ny said in a state­ment.

Cu­mu­la­tive da­ta as of the May 12 cut­off date show that all 15 pa­tients treat­ed with the com­bo met the pri­ma­ry end­point of suf­fi­cient stem cell mo­bi­liza­tion and col­lec­tion. Ad­di­tion­al­ly, 12 of the 15 pa­tients hit the goal in a sin­gle day of treat­ment.

Re­searchers had been aim­ing for pa­tients to col­lect 2 mil­lion CD34+ stem cells per kg in up to two days. The me­di­an num­ber of stem cells col­lect­ed was 6.3 mil­lion per kg, and all 12 pa­tients that have re­ceived trans­plants saw suc­cess­ful en­graft­ment. — Max Gel­man

Sur­face teams up with Roche to add drug duo to HCC treat­ment

Af­ter col­lab­o­rat­ing with a di­vi­sion of Mer­ck in March, Sur­face On­col­o­gy will join forces with Roche on an on­col­o­gy study of SRF388, the com­pa­ny an­nounced Fri­day.

The in­ves­ti­ga­tion­al IL-27 an­ti­body will be used in com­bi­na­tion with Roche’s ate­zolizum­ab and be­va­cizum­ab in pa­tients with treat­ment-naïve he­pa­to­cel­lu­lar car­ci­no­ma. The com­bi­na­tion of ate­zolizum­ab and be­va­cizum­ab has proven to im­prove over­all sur­vival.

In March, the com­pa­ny un­veiled a col­lab­o­ra­tion deal with Mer­ck’s Keytru­da, as a part of a Phase I study of the use of SRF388 to tar­get IL-27 in pa­tients with liv­er and kid­ney sol­id tu­mors. Sur­face has iden­ti­fied the tu­mor types that it be­lieves IL-27 has a role in pro­vid­ing re­sis­tance, and it got its first Phase I re­sults back in No­vem­ber 2020.

Sur­face CMO Al­i­son O’Neill said in a state­ment:

At Sur­face, we are com­mit­ted to iden­ti­fy­ing and ac­cel­er­at­ing the de­liv­ery to pa­tients of life-chang­ing treat­ments, whether as a sin­gle agent or in sci­en­tif­i­cal­ly and clin­i­cal­ly ap­pro­pri­ate com­bi­na­tions. This col­lab­o­ra­tion lever­ages Roche’s deep ex­pe­ri­ence in he­pa­to­cel­lu­lar car­ci­no­ma and Sur­face’s com­mit­ment to ra­tio­nal­ly and rapid­ly de­vel­op SRF388, a first-in-class an­ti­body against IL-27, to pro­vide mean­ing­ful ben­e­fit to pa­tients with liv­er can­cer.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

Credit: Shutterstock

How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.

Peter Nell, Mammoth Biosciences CBO

UP­DAT­ED: Jen­nifer Doud­na spin­out inks a Mam­moth CRISPR deal with Ver­tex worth near­ly $700M

When a company gets its start in gene editing pioneer Jennifer Doudna’s lab, it’s bound to make headlines. But three years in, the fanfare still hasn’t died down for Mammoth Biosciences. Now, the Brisbane, CA-based company is cheering on its first major R&D pact.

Mammoth unveiled a nearly $700 million deal with Vertex on Tuesday morning, good for the development of in vivo gene therapies for two mystery diseases. The stars of the show are Mammoth’s ultra-small CRISPR systems, including two Cas enzymes licensed from Doudna’s lab over the past couple years, Cas14 and Casɸ.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.

An­gion's or­gan dam­age drug strikes out again, this time in high-risk kid­ney trans­plant pa­tients

After flopping a test in Covid-19 earlier this year, Angion’s lead organ damage drug has now hit the skids again in kidney transplant patients.

Angion and partner Vifor Pharma’s ANG-3777 failed to beat out placebo in terms of improving eGFR, a measure of kidney function, in patients who had received a deceased donor kidney transplant and were at high risk of developing what is known as delayed graft function, according to Phase III results released Tuesday.

(Photo courtesy Pfizer)

FDA's vac­cine ad­comm votes al­most unan­i­mous­ly in fa­vor of Pfiz­er's Covid-19 vac­cine for younger chil­dren

The FDA’s Vaccines and Related Biological Products Advisory Committee on Tuesday voted 17-0, with one panelist abstaining, that the benefits of the Pfizer-BioNTech Covid-19 vaccine outweigh the risks for children between the ages of five and 12.

The vote will likely trigger a process that could allow the shots to begin rolling out as early as next week.

The vaccine, which is one-third of the adult Pfizer dose, proved to be about 90% effective in a placebo-controlled trial in which about 1,500 kids in this age range received the vaccine, and only about 12% of those receiving the vaccine had any adverse event. All serious adverse events in the trial were unrelated to the vaccine.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na chips in fur­ther on African vac­cine sup­ply — but ad­vo­cates are call­ing for even more

In a sign of its growing commitment to the continent, Moderna will supply up to 110 million doses of its Covid-19 vaccine to the African Union, the company announced Tuesday. And CEO Stéphane Bancel said it’s just the first step.

“We believe our vaccine can play an important role in addressing the needs of low-income countries given its combination of high Phase 3 efficacy against COVID-19, strong durability in the real-world evidence, and superior storage and handling conditions. We recognize that access to COVID-19 vaccines continues to be a challenge in many parts of the world and we remain committed to helping to protect as many people as possible around the globe,” Bancel said in a statement.

An image of Alzheimer's brain tissue. The red show gingipains, a protein from P. gingivalis, intermixing with neurons (yellow) and glial cells (green)

An Alzheimer's dark­horse fails its first big tri­al, but of­fers hope for a long-over­looked hy­poth­e­sis

Three years ago, Cortexyme emerged out of obscurity with some big-name backers and an unorthodox approach to treating Alzheimer’s.

They moved their drug into a pivotal study the next year, offering one of the first major tests for a hypothesis that has fluttered on the outskirts of Alzheimer’s research for decades: that, in many cases, the disease is driven by infectious agents — the havoc they wreak in the brain and the inflammation the body uses to try to fend them off. And that quashing the infection could slow patients’ cognitive decline.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.

ARCH-backed SciNeu­ro kicks off search for CNS au­toan­ti­bod­ies with new deal; Mer­ck + Gilead an­nounce PhII tri­al for HIV com­bo

From the very beginning at SciNeuro, CEO Min Li has envisioned a mix of licensing deals and scientific efforts to replicate the breakout success of China’s oncology companies in neuroscience.

The GlaxoSmithKline vet has now inked a deal that somewhat straddles the line between the two strategies.

Teaming up with Mabylon out of Zurich, SciNeuro is now looking to test the hypothesis that the human immune system can play a role in fighting neurodegenerative diseases by discovering and developing human autoantibodies against neurological “targets of mutual interests.” The new partners offered TAR DNA binding protein-43 (TDP-43) and apolipoprotein E (APOE), which are linked to ALS and Alzheimer’s, as examples.