The Daily Biotech Pulse: MorphoSys-Incyte Snag European Nod, Immutep Granted Chinese Patent, Bolt Biotherapeutics Strike Oncology Collaboration

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Aug. 26)

  • Agenus Inc. AGEN
  • Alkermes plc ALKS
  • BeyondSpring Inc. BYSI ( moved on a co-development and commercialization agreement for chemotherapy-induced neutropenia treatment candidate)
  • BioLife Solutions, Inc. BLFS
  • Celldex Therapeutics, Inc. CLDX
  • Day One Biopharmaceuticals, Inc. DAWN
  • DexCom, Inc. DXCM
  • Dynavax Technologies Corporation DVAX
  • Erasca, Inc. ERAS
  • Fulcrum Therapeutics, Inc. FULC
  • Imago BioSciences, Inc. IMGO
  • MiMedx Group, Inc. MDXG
  • Monte Rosa Therapeutics, Inc. GLUE
  • Nuvalent, Inc. NUVL (IPOed July 29)
  • PDS Biotechnology Corporation PDSB
  • Prothena Corporation plc PRTA
  • Regeneron Pharmaceuticals, Inc. REGN
  • Repligen Corporation RGEN
  • ShockWave Medical, Inc. SWAV
  • Zentalis Pharmaceuticals, Inc. ZNTL

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Aug. 26)

  • Alzamend Neuro, Inc. ALZN
  • Edgewise Therapeutics, Inc. EWTX
  • FibroGen, Inc. FGEN
  • MaxCyte, Inc. MXCT
  • Reneo Pharmaceuticals, Inc. RPHM
  • Theravance Biopharma, Inc. TBPH
  • TScan Therapeutics, Inc. TCRX

Stocks In Focus

Immutep Announces Award of Chinese Patent For Out-licensed Antibody Treatment Candidate For Cancer and Infectious Disease

Immutep Limited IMMP announced the grant of a patent entitled "Antibody molecules to LAG-3 and uses thereof" by the Chinese Patent Office.

This new Chinese patent follows the grant of the corresponding Australian, U.S., European, and Japanese patents announced in 2018 through 2020. The claims of the patent are directed to LAG525, pharmaceutical compositions comprising LAG525, nucleic acid molecules that code for the LAG525 antibody, an expression vector or host cell that comprises the nucleic acid molecules, and to the use of LAG525 in the manufacture of a preparation for the treatment of cancer or infectious disease.

LAG525 is a humanised form of Immutep's IMP701 antibody which is out-licensed to Novartis AG NVS. The patent is co-owned by Novartis AG and Immutep and will expire on March 13, 2035.

Immutep shares were up 1.11% at $3.65 in premarket trading.

See Benzinga's FDA Calendar Here

MorphoSys-Incyte Announce European Regulatory Nod For Minjuvi Combo Therapy In Lymphoma Patients

Incyte Corporation INCY and MorphoSys AG MOR announced that the European Commission has granted conditional marketing authorization for Minjuvi (tafasitamab) in combination with Bristol-Myers Squibb Company BMY's Revlimid, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, who are not eligible for autologous stem cell transplant.

MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. XNCR.

The EC decision follows the positive opinion received from the European Medicines Agency's Committee for Medicinal Products for Human Use in June 2021 recommending the conditional marketing authorization of Minjuvi.

MorphoSys shares were up 3.68% at $14.65 in premarket trading.

Bolt Strikes Oncology R&D Partnership With Hong Kong's Innovent Biologics

Bolt Biotherapeutics, Inc. BOLT and Hong Kong-based biopharma Innovent Biologics announced a drug research and development collaboration to develop three new anti-cancer therapeutic immune-stimulating antibody conjugate candidates.

The parties will leverage Innovent's proprietary therapeutic antibody portfolio and discovery capability against undisclosed oncology targets in combination with Bolt's advanced ISAC technology and myeloid biology expertise to create three new cancer treatments with the potential to provide significant benefit to patients.

Bolt will receive an upfront payment of $5 million in cash from Innovent at signing and a possible future equity investment of up to $10 million. Furthermore, both Bolt and Innovent are eligible to receive additional milestone payments and royalties associated with the development and commercialization of products in each other's territories.

Neoleukin Rises On Insider Buying

Neoleukin Therapeutics, Inc. NLTX gained ground after an SEC filing revealed that the company's CEO Jonathan Drachman purchased 150,000 shares in the company at a price range of $6.111-$6.449.

The stock was adding 4.42% to $6.61 in premarket trading.

Hikma Announces Licensing Agreement For J&J's Stelara Biosimilar

China's Bio-Thera Solutions, and Hikma Pharmaceuticals announced that they have entered into a commercialization and license agreement to commercialize BAT2206, a monoclonal antibody that is a proposed biosimilar referencing Johnson & Johnson, Inc. JNJ Janssen unit's Stelara in the U.S.

BAT2206 is currently in a global Phase 3 clinical trial.

Under the agreement, Bio-Thera will maintain responsibility for development, manufacturing, and supply of BAT2206. Hikma will have exclusive rights to commercialize the product in the U.S. The agreement also provides Hikma with a first-right-to-negotiate to add Europe, excluding CIS countries. Bio-Thera is eligible for an upfront payment of $20 million as well as further development and commercial milestones of up to $130 million.

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