DF-4101

Plus, news about Cybin, Incyte, Roche, Merck, Eisai, Neuphoria Therapeutics, Aldeyra Therapeutics and X4 Pharmaceuticals: 🏭 FDA issues CRL to Regeneron: The drugmaker has officially been handed a complete response letter for its pre-filled syringe for Eylea HD. The company had warned in August that it expected regulatory delays after issues were found at a Catalent site in Bloomington, IN, that’s now owned by Novo Nordisk. The plant has since been issued an “official action indicated” classification. Another customer of the Indiana site, Scholar Rock, also received a CRL related to the plant. — Anna Brown 🧪 AbbVie scraps asset licensed from Dragonfly Therapeutics: The Chicago-area pharma giant terminated a Phase 1 test of the first asset that it licensed from Dragonfly . AbbVie started testing ABBV-303/DF4101 in 2024 in solid tumors. Dragonfly CEO Bill Haney told Endpoints News that the company’s other programs with AbbVie are ongoing. Dragonfly has multiple internal candidates in clinical testing as well as Phase 1 programs with Bristol Myers Squibb and Merck. It also has a preclinical pact with Gilead. — Kyle LaHucik 💵 Cybin’s $175M direct offering: The company is selling about 22.3 million shares at $6.51 apiece from several blue-chip investors, including Venrock Healthcare Capital Partners, OrbiMed and Point72. It’s developing a psychedelic called CYB003 as a treatment for major depressive disorder. — Jaimy Lee 🛠️ Incyte halts work on two drugs: Under new CEO Bill Meury, the drugmaker has paused development of its anti-CD122 candidate, called INCA034460, and its BET inhibitor, called INCB57643. The biotech also ended povorcitinib’s development in chronic spontaneous urticaria and hinted that more pipeline adjustments are in the works. “We are taking a deliberate approach to pipeline prioritization. We are actively reviewing our R&D efforts and focusing on high-value programs that are scientifically differentiated, address unmet medical needs, and have the potential to significantly drive Incyte’s next phase of growth,” Meury said in a release.  Incyte also raised its revenue guidance for the year. It’s now in the range of $4.23 billion to $4.32 billion. — Kyle LaHucik 🔬 Roche’s Gazyva succeeds in kidney disorder: The drug met its primary endpoint in a Phase 3 study for idiopathic nephrotic syndrome, a rare autoimmune disease that affects the kidneys. Roche will head to the FDA to discuss next steps for the drug, but the timing is not yet clear. Gazyva was approved earlier this month for the treatment of active lupus nephritis. — Max Gelman 💊 Merck, Eisai tout kidney cancer data: The combination of Merck’s Welireg and Eisai’s Lenvima achieved a statistically significant improvement in progression-free survival over Exelixis’ Cabometyx in advanced renal cell carcinoma. Overall survival did not reach statistical significance, though Merck and Eisai noted this was an interim analysis. There was also a “trend toward improvement” on OS. — Max Gelman 📈 Neuphoria Therapeutics adopts poison pill after Phase 3 fail: The biotech’s board selected the shareholder rights plan to “protect the interest of the company and its stockholders.” The move lowers the chances that a person or group will accumulate enough shares to control Neuphoria. The biotech’s social anxiety drug failed a Phase 3 trial last week, and the company decided to drop the asset, named BNC210. The biotech’s stock price $NEUP was up almost 6% in premarket trading on Tuesday. — Kyle LaHucik 💼 Aldeyra Therapeutics updates its pipeline: The biotech discontinued work on ADX-629 in patients with Sjögren-Larsson Syndrome. It also said it expects to file INDs for a pair of RASP modulators sometime next year. — Jaimy Lee 💰 X4 Pharmaceuticals ended up raising $155.3 million in its public offering, up from the $135 million it set out to raise. — Jaimy Lee

This is the eighth drug using Dragonfly's platform technology, and the sixth TriNKET ® to enter into clinical trials. WALTHAM, Mass., March 5, 2024 /PRNewswire/ -- Dragonfly Therapeutics, Inc., a clinical stage biotechnology company developing novel immunotherapies, today announced receipt of a milestone payment following dosing of the first patient in a clinical trial conducted by AbbVie (NYSE: ABBV) to evaluate ABBV-303, a solid tumor targeting TriNKET ®. ABBV-303, an investigational drug being developed for the treatment of solid tumors, is the eighth drug using Dragonfly's platform technology to enter the clinic, and the first AbbVie-licensed TriNKET ® drug candidate to enter into the clinic. The Phase 1 clinical trial, conducted by AbbVie, is evaluating ABBV-303 alone and in combination with AbbVie's budigalimab (ABBV-181), in solid tumors. "We are delighted that AbbVie has advanced ABBV-303 into the clinic," said Bill Haney, CEO and Dragonfly co-founder. "AbbVie is a global leader in advancing novel treatments for some of the most complex diseases and a terrific partner. We look forward to continued success and rapid progress with the AbbVie team to advance potential new treatment options for patients." Additional information about the M24-122 Phase 1 trial, can be found at: (ClinicalTrials.gov Identifier: NCT06158958). About Dragonfly Dragonfly Therapeutics is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing novel therapies that harness the body's immune system to bring breakthrough treatments to patients. In addition to a set of advanced programs in the clinic, Dragonfly has a deep pipeline of wholly owned preclinical candidates discovered using its proprietary platforms that are progressing toward the clinic, as well as productive collaborations with Merck, AbbVie, Gilead and Bristol Myers Squibb in a broad range of disease areas. For more information visit: DRAGONFLY MEDIA CONTACT: Anne E. Deconinck | [email protected] SOURCE Dragonfly Therapeutics, Inc.