Arch Oncology scores USD 105 Million for anti-CD47 med in solid tumors, multiple myeloma

Arch Oncology scored USD 105 million from new and old backers to expand the drug’s journey through the clinic and into new trials, having moved its anti-CD47 antibody into a phase 1/2 study. 

Arch tests the drug alone in patients with multiple myeloma and alone and in combination with the chemotherapy drug paclitaxel in patients with select solid tumors. Next up, Arch intends to evaluate AO-176 alongside Merck’s PD-1 drug Keytruda in solid tumors and combination with other drugs for multiple myeloma, namely Velcade (bortezomib) and dexamethasone. Moreover, the company does not plan to stop there. 

Arch CEO Laurence Blumberg, M.D., informed that they would also explore other indications and combinations consistent with their novel mechanisms of action. 

The drug’s mechanism is by inhibiting CD47; a cell surface receptor expressed at high levels in multiple cancers. One of the most sought-after targets in immuno-oncology, CD47, gives a signal to stop immune cells from detecting, engulfing, and destroying tumor cells. 

Arch believes that AO-176 could improve other CD47-targeting antibodies in development because it is designed to bind better to the CD47 receptor in acidic conditions, similar to those found in the tumor microenvironment, attaching less to the CD47 found on normal cells, including red blood cells. 

Abbott launches AI-powered coronary imaging platform in Europe

Abbott announced that it launched its new coronary imaging platform in Europe with CE marked.

The platform, powered by Ultreon 1.0 software, merges optical coherence tomography (OCT) with AI to improve visualisation and identify the severity of calcium-based blockages and gauge vessel diameter. The goal is to bolster decision-making during coronary stenting procedures.

Abbott Park, Ill.–based Abbott’s OCT technology utilises near-infrared light to proffer high-definition, precise imaging from within a blood vessel, aiding to improve the assessment of blockages the vessels and optimise decisions related to stent selection, placement, and deployment.

Ultreon software, when integrated with Abbott’s new Dragonfly OpStar imaging catheter, then enables physicians to capture information from even more intricate patient anatomy.

Abbott intends to showcase the new Ultron software for the first time at the EuroPCR from May 18 to May 21 during the company’s “Tools and Technique Sessions.” The company also schedules to continue regulatory approval for the software in the U.S. and Japan.

Abbott CMO & divisional VP of global medical affairs at Abbott’s vascular business Dr Nick West said that increased adoption of OCT imaging, combined with advanced technology like AI, allows cardiologists to have a more precise and measurable way of supporting patients undergoing coronary stent procedures. Ultreon software can potentially enhance physician and patient experience by utilising a systematic process, reducing variability, and increasing the accuracy of diagnosis and application of therapies. 

Lilly scraps IL-23 psoriasis program despite phase 3 success

Eli Lilly has dismissed plans to seek approval for mirikizumab in psoriasis. Lilly chose not to enter the market despite the anti-IL-23p19 antibody surpassing Novartis’ Cosentyx in a phase 3 trial last year.

AbbVie’s anti-IL-23 antibody Skyrizi and Johnson & Johnson’s Tremfya and Stelara, which hits IL-12 and IL-23, are already authorised in plaque psoriasis. Despite trailing other anti-IL-23 drugs, Lilly moved mirikizumab into a broad phase 3 program that comprised three psoriasis studies, including a long-term evaluation of its safety and maintenance of treatment effect.

In July, Lilly pledged to submit data from the first two phases 3 trials to regulatory authorities worldwide after seeing mirikizumab surpassing placebo and Novartis’ IL-17 drug Cosentyx. However, nine months later, Lilly has discarded the psoriasis submission plan.

As part of its first-quarter financial results, Lilly informed it would no longer submit mirikizumab for approval in psoriasis in any geography. Mirikizumab performed comparably to other IL-23p19 drugs, as per Lilly, but management has opted against competing in the competitive space. 

The decision leaves Lilly’s mirikizumab strategy focused on ulcerative colitis and Crohn’s disease. Last month, Lilly displayed mirikizumab enhanced clinical remission in patients with moderately to severely active ulcerative colitis whom conventional or biologic therapies had flunked.  

Biogen to offer early access to experimental ALS med

Biogen is laying out a plan after months of holding its ground on not proffering an experimental ALS drug to patients outside of clinical trials

The treatment, tofersen, is in a phase 3 study in 178 patients with amyotrophic lateral sclerosis (ALS) emanating from mutations in the SOD1 gene. After talking it over with regulators, clinical trial investigators, ethicists, and patient advocates, the company will now proffer tofersen to patients with this form of ALS starting in mid-July.  

In the two-part program, Biogen will commence with the patients whose disease is exacerbating the fastest in mid-July, after the study participants now on placebo shift to tofersen but before the drug is displayed to be safe and effective. 

Later, if the drug proves safe and effective when the study reads out, the company will provide the drug to the broader population of patients with SOD1-ALS under an Early Access Program. The company plans to roll out the latter part of the program in the fall. 

In March, the company reiterated its decision not to provide the drug, tofersen, to patients requesting it under compassionate use. Doing so would not be fair to patients still getting a placebo in its phase 3 study, Biogen R&D chief Al Sandrock, M.D., Ph.D., informed. 

The company would give early access to the drug only after study participants switched from placebo to tofersen. He said that if the study turned out a success, Biogen would immediately open an Early Access Program for patients with SOD1-ALS. 

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