LLS backs 5 new cancer drug projects with up to $50M; Trodelvy continues to impress with more TNBC data
The Leukemia and Lymphoma Society has tapped 5 new early-stage projects to back with up to $10 million each in fresh investments. The 5 biotechs are:
— Caribou, headed by Rachel Haurwitz and co-founded by Jennifer Doudna, is working on next-gen, off-the-shelf CAR-Ts to replace the patient-derived cells now in use.
— The LLS supported NexImmune’s IPO, helping fund its work on nanoparticles that can gin up an immune response directed at cancer cells. The biotech has 2 projects now in Phase I trials.
— Immune-Onc Therapeutics is getting help with their early work on IO-202, “a first-in-class antibody targeting the immune inhibitory receptor Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB) member 4 (LILRB4, also knowns ILT3).”
— Saar Gill’s Carisma, spun out of Penn, is getting help with its CAR-engineered macrophages.
— Abintus Bio is getting financial support for its in vivo-generated CARs that avoid extracting cells, engineering them and then transfusing them, back into patients.
Haurwitz had this to say:
“We’re particularly excited to be working with LLS TAP because it gives us access to their deep knowledge of blood cancer and their network of patients and drug development experts.” — John Carroll
Trodelvy continues to impress with more TNBC data
The drug behind Gilead’s $21 billion acquisition of Immunomedics last September continues to post good data results from its confirmatory Phase III study.
In a paper published in the New England Journal of Medicine on Thursday, the drug Trodelvy secured a statistically significant progression-free survival and overall survival in patients with relapsed or refractory metastatic triple-negative breast cancer. Median PFS was 5.6 months compared to 1.7 months on chemo, and median OS was 12.1 months versus chemo’s 6.7 months.
Trodelvy also recorded an objective response rate of 35%, compared to just 5% on chemotherapy.
“For a patient population whose cancer is particularly difficult to treat, these results are extremely encouraging and reinforce the significant treatment advance that Trodelvy represents for patients with previously treated unresectable locally advanced or metastatic TNBC,” Gilead CMO Merdad Parsey said in a statement.
Just a few weeks ago, Trodelvy secured a full FDA approval with a broader label than its accelerated OK indication, expanding the patient population to include those with unresectable locally advanced TNBC rather than just metastatic cases. Patients must have received two or more prior systemic therapies, at least one of them for metastatic disease.
The heart of Gilead’s Immunomedics buyout, Trodelvy came to fruition after Immunomedics worked on developing the drug for about 37 years. The drug’s data were so impressive at last summer’s ESMO that Gilead CEO Dan O’Day angled to get a deal done before the conference. — Max Gelman
China-based mRNA spinoff raises $10M as Covid-19 vaccine IND looms
Sirnaomics’ mRNA spinoff RNAimmune has gathered a $10 million seed round to continue building out its platform, with a focus on infectious diseases, cancer and rare diseases.
Smooth River and Hong Kong Hongrun led the investment, with participation from Shanghai Walga Biotechnology, High Forest Investment and Terra Magnum Sigma.
Founded in early 2020, the lead program is for another mRNA vaccine pointed against Covid-19. As J&J and AstraZeneca run into increased flak over safety fears for their vaccines, analysts have begun wondering how the rest of the market will play out as Pfizer/BioNTech and Moderna dominate the field. That still may leave opportunities ahead, and the fledgling startup sees a shot at getting into the second wave.
The biotech has an R&D center in China and raised $2.35 million in its original funding round. An IND for Covid is planned later in the year with another program in the works for a RAS tumor vaccine.
Patrick Lu, chairman of the board of RNAimmune, said:
“The recent success of Moderna’s and BioNTech’s mRNA vaccines has demonstrated that mRNA technologies for development of novel therapeutics and vaccines are dramatically changing the landscape of the global pharmaceutical industry. RNAimmune has tremendous opportunities as a global mRNA innovating company.” — John Carroll
Acne treatment from Bausch’s spinout Ortho hits all 3 endpoints
In a second Phase III trial, Ortho Dermatologics’ latest acne treatment showed a benefit of patients as early as 2 weeks into usage, the Bausch Health spinout announced Thursday.
The trial tested IDP-126, a combination retinoid, anti-bacterial and antibiotic topical to treat acne vulgaris in patients. If the treatment is approved, it would be the first to use this triple combination, the release said.
The study achieved all 3 of its endpoints at week 12, including a change in inflammatory and noninflammatory lesion counts with a p-value of less than 0.001. Treatment success was 50.5% and 20.5% for IDP-126 and its placebo, respectively.
For 12 weeks, the 193 patients ages 9 and up applied either IDP-126 or a placebo to their face once a day in 13 locations in the US.
Ortho hopes to submit a new drug application with the FDA in the latter half of 2022, president Scott Hirsch said in the statement. — Josh Sullivan