• Memo Therapeutics, a late-stage biotech company translating unique immune responses into superior medicines to treat viral infections and cancer, announces that the last patient has been enrolled in its 22-site U.S. Phase II trial for its BK polyomavirus (“BKV”)-neutralizing antibody, potravitug.

• With topline data expected in mid-2025, the randomized, double-blind, placebo-controlled study assesses the safety, tolerability and efficacy of potravitug in kidney transplant patients. 

• Ventus Therapeutics, a clinical-stage biopharmaceutical company utilizing its proprietary ReSOLVE™ platform to discover and develop differentiated small-molecule therapeutics, announced results from its Phase 1 clinical trial of VENT-03, the first cyclic GMP-AMP synthase (cGAS) inhibitor to successfully complete a first-in-human study.
• The Phase 1 trial evaluated the pharmacokinetics (PK), target engagement, safety, and tolerability of VENT-03 across a broad range of single and multiple ascending doses in 72 healthy adult volunteers.

• TikkunLev Therapeutics, a biotechnology company developing precision therapies targeting the causal disease biology of failing heart muscle, officially announced the company’s launch, lead program for non-ischemic DCM, seed financing from undisclosed investors, and the establishment of its Scientific Advisory Board.
• The proceeds from the seed financing have been supporting ongoing IND-enabling development and product manufacturing, in anticipation of the company’s first IND filing in 2025.

• AbbVie and Aliada Therapeutics today announced a definitive agreement under which AbbVie will acquire Aliada, a biotechnology company advancing therapies using a novel blood-brain barrier (BBB)-crossing technology to address challenging central nervous system (CNS) diseases.
• Aliada's lead investigational asset utilizing this delivery technology, ALIA-1758, is an anti-pyroglutamate amyloid beta (3pE-Aβ) antibody in development for the treatment of Alzheimer's disease.

• Dewpoint Therapeutics, the leading biotechnology company that develops therapeutics by targeting biomolecular condensates, announced the nomination of its first development candidate, DPTX3186, an orally administered small molecule condensate modulator (c-mod) inhibiting the oncogenic function of beta catenin, as a potential therapeutic agent for treatment of Wnt-driven cancers.
• The development candidate was discovered using Dewpoint’s fully automated, AI/ML-enabled state-of-the-art platform and proprietary chemical library. 

• DELFI Diagnostics, a developer of accessible blood-based tests that deliver a new way to enhance cancer detection, announced that Incendia Therapeutics will use the DELFI-TF Monitoring assay as part of their suite of assays for evaluation of treatment response and disease progression in patients enrolled in their Phase I clinical trial (NCT05753722).

•  Monte Rosa Therapeutics, a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today announced a global exclusive development and commercialization license agreement with Novartis to advance VAV1 MGDs, including MRT-6160. MRT-6160 is currently in an ongoing Phase 1, single ascending dose (SAD)/multiple ascending dose (MAD) healthy volunteer study for immune-mediated conditions.
• Under the terms of the agreement, Novartis will obtain exclusive worldwide rights to develop, manufacture and commercialize MRT-6160 and other VAV1 MGDs and will be responsible for all clinical development and commercialization, starting with Phase 2 clinical studies. Monte Rosa remains responsible for completion of the ongoing Phase 1 clinical study of MRT-6160.

• Odyssey Therapeutics, a clinical-stage biopharmaceutical company seeking to transform the standard of care for patients suffering from autoimmune and inflammatory diseases by developing medicines that are designed to precisely target disease pathology, and Terray Therapeutics, a biotechnology company focused on improving human health by transforming the speed, cost, and success rate of small molecule drug development using computation integrated with novel data at scale, announced that they have entered into a strategic collaboration to jointly discover and develop small molecule medicines against transcription factor targets of interest.
• The collaboration combines Odyssey’s expertise in immunology and transcription factor biology with Terray’s complementary expertise in immunology and integrated AI platform, tNova, which leverages proprietary experimental data at scale to power its AI capabilities.

• Lyell Immunopharma, announced that it has entered into a definitive agreement to acquire ImmPACT Bio USA Inc., a privately-owned clinical-stage biotechnology company.
• ImmPACT’s lead program, IMPT-314, is a CD19/20-targeting chimeric antigen receptor (CAR) T-cell product candidate that Lyell will continue to develop for hematologic malignancies, including large B-cell lymphoma. IMPT-314 was designed to outperform the efficacy of approved CD19 CAR T-cell therapies via a dual-targeting CAR T-cell design and to improve CAR T-cell persistence by enriching for naïve and central memory T cells during manufacturing.
• The acquisition of ImmPACT is expected to significantly strengthen Lyell’s clinical-stage pipeline of next- generation CAR T-cell therapies and complement its suite of proprietary technologies designed to generate longer-lasting, functional T cells to achieve more durable outcomes for patients with solid tumors and hematologic malignancies.

• Modalis Therapeutics has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for MDL-101, which Modalis is developing for the treatment of congenital muscular dystrophy type 1A (LAMA2-CMD)

• Accent Therapeutics, a biopharmaceutical company pioneering novel small molecule targeted cancer therapeutics, announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ATX-559, a first-in-class DHX9 inhibitor.

• Dyno Therapeutics, Inc., a genetic technologies company applying artificial intelligence (AI) to enable in vivo gene delivery, announced its second research collaboration with Roche to develop next-generation adeno-associated virus (AAV) vectors for gene therapies targeting neurological diseases.
• Dyno and Roche previously announced a research collaboration and license agreement for neurological diseases and liver-directed therapies in October 2020.
• Under the terms of this new collaboration, Dyno Therapeutics provides Roche further access to the company’s field-leading platform and sequence design technologies enabling in vivo gene delivery.

• Rakovina Therapeutics, a biopharmaceutical company committed to advancing new cancer therapies based on novel DNA-damage response (DDR) technologies, announced that it has received initial results from the proprietary Deep Docking AI platform.
• Rakovina employed the Deep Docking algorithm to evaluate billions of molecular structures to develop a short-list of drug candidates that have been optimized to a specific target-product profile. A screening effort of this magnitude would not be possible with traditional medicinal chemistry approaches.

• Maze Therapeutics, a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with common diseases, announced positive results from the Phase 1 clinical trial of MZE829 in healthy volunteers.
• MZE829 is an oral, small molecule inhibitor of APOL1 that Maze is advancing as a potential treatment for people living with APOL1 kidney disease (AKD), a subset of chronic kidney disease estimated to affect over one million patients in the United States alone. APOL1 is a protein encoded by the APOL1 gene in humans.
• Genetic variants of the gene (G1 and G2) are associated with increased risk for a spectrum of progressive kidney diseases in people of West African ancestry. MZE829 was identified through insights generated from Maze’s proprietary, purpose-built platform, Maze Compass™.

• Acasti Pharma, a late-stage, biopharma company advancing GTx-104, its novel injectable formulation of nimodipine that addresses high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), announced that it is changing its name to Grace Therapeutics, Inc. (Grace Therapeutics).
• Grace Therapeutics was the name of the company developing GTx-104 prior to its merger with Acasti in 2021. Grace Therapeutics will begin trading on Nasdaq under the trading symbol “GRCE” at the open of the market on October 28, 2024 and all company branding including corporate website will be updated accordingly.

• Jubilant Therapeutics Inc., a biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, announced the dosing of first patients in global clinical trials involving two pipeline programs: Phase I/II clinical trial of JBI-802 in heme-oncology and Phase I clinical trial for JBI-778 in solid tumors.

• CareDx, Inc a leading precision medicine company focused on the discovery, development, and commercialization of healthcare solutions for transplant patients and caregivers, and Dovetail Genomics, a leader in the field of genomic solutions — announced a strategic partnership to drive the next wave of innovation in HLA genotyping for organ and stem cell transplant matching.

• Coeptis Therapeutics Holdings, a biopharmaceutical company developing innovative cell therapy platforms for cancer, autoimmune, and infectious diseases, announced the expansion of its license agreement with Deverra Therapeutics , broadening the potential applications of its allogeneic natural killer (NK) cell technology.
• This expansion includes the use of unmodified NK cells in treating viral infections, pandemic-related illnesses, and emergency stockpiling for future health crises.

• Aquestive Therapeutics, a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, announced positive topline results from its Oral Allergy Syndrome (OAS) challenge study for Anaphylm™ (epinephrine) Sublingual Film.
• This marks the completion of the final supportive adult study in the Anaphylm development program prior to meeting with the U.S. Food and Drug Administration (FDA).

• Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO ® (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.
• ABRYSVO now offers the broadest RSV vaccine indication for adults, which previously included those 60 years and older. Additionally, it remains the only RSV immunization approved for pregnant individuals at 32 through 36 weeks of gestation to protect infants from birth up to 6 months of age.

• Jasper Therapeutics, a clinical stage biotechnology company focused on development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) to address mast cell driven diseases such as chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU) and asthma, announced that it is commencing an open-label extension study in chronic urticarias that will roll over patients from the BEACON and SPOTLIGHT studies upon completion of their initial follow up period.
• Additionally, Jasper also announced it has obtained regulatory clearance in the US and in the EU to further expand the BEACON study in CSU by adding a 360mg single-dose cohort (n=4), and that enrollment in this cohort has commenced. 

• Autobahn Therapeutics, a biotechnology company developing restorative treatments for people affected by neuropsychiatric and neuroimmunologic disorders, announced the clearance of an investigational new drug (IND) application by the U.S. Food and Drug Administration (FDA) to support initiation of a Phase 2 trial of ABX-002 as an adjunctive treatment for patients with bipolar depression.
• ABX-002 is a highly potent, oral, thyroid hormone beta receptor (TRβ) selective agonist designed to enhance the CNS benefits of thyroid hormone biology and drug concentrations directly in the brain.

• Oncternal Therapeutics, announced updated data from its Phase 1/2 Study of ONCT-534 for the treatment of patients with relapsed or refractory metastatic Castration-Resistant Prostate Cancer (mCRPC).
• Based on initial pharmacokinetic results, two additional dosing cohorts with twice daily (BID) oral dosing of ONCT-534 had been incorporated in the Phase 1/2 study ONCT-534-101 (NCT05917470). Overall, fifteen patients received ONCT-534 once daily (QD) in six dosing cohorts and six patients received ONCT-534 BID in two dosing cohorts.

• Indaptus Therapeutics, a clinical-stage biotechnology company pioneering innovative cancer and viral infection treatments, announced a clinical supply agreement with BeiGene.
• Building on Indaptus’ preclinical observation that Decoy20, when combined with a PD-1 inhibitor, induced complete cancer regressions and immunological memory in animal models, Indaptus plans to advance human clinical evaluation of the combination of BeiGene's anti-PD-1 antibody, tislelizumab, with Indaptus’ Decoy20, a novel treatment designed to induce a broad immune response to fight cancer.

• Sangamo Therapeutics, a genomic medicine company, announced the outcome of a recent successful interaction with the U.S. FDA, providing a clear regulatory pathway to Accelerated Approval for isaralgagene civaparvovec, or ST-920, its wholly owned gene therapy product candidate for the treatment of Fabry disease.

• RELIEF THERAPEUTICS Holding SA, a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, reported that the European Patent Office (EPO) has issued a Notice of Allowance under Rule 71(3) EPC for Relief’s patent application No. 20737588.2, titled “Therapeutic Uses of Oxidizing Hypotonic Acid Solutions.”
• This Notice of Allowance signifies the EPO’s intention to grant a patent covering Relief’s proprietary, highly pure hypochlorous acid solutions, including its investigational drug RLF‑TD011 intended for the treatment of wounds caused by epidermolysis bullosa (EB).

• LENZ Therapeutics, a pre-commercial biopharmaceutical company focused on the development and commercialization of the first and only aceclidine-based eye drop to improve near vision in people with presbyopia, announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for LNZ100 for the treatment of presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million people in the United States.
• The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025 for LNZ100.

• Seaport Therapeutics, a clinical-stage biopharmaceutical company that is advancing novel neuropsychiatric medicines with a proven strategy and team, announced the closing of an oversubscribed $225 million Series B financing round.
• The financing brings the total capital raised by Seaport to $325 million since the Company’s launch in April 2024.
• Seaport will use the proceeds to advance its clinical-stage pipeline of first and best-in-class medicines through important clinical milestones as well as further advance the capabilities of the Glyph™ technology platform, which has demonstrated clinical proof-of-concept.  

• Adcentrx Therapeutics, a clinical-stage biotechnology company advancing innovative protein conjugates for cancer and other life-threatening diseases, announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application of ADRX-0405 for the treatment of select advanced solid tumors.
• ADRX-0405 is a next-generation antibody-drug conjugate (ADC) composed of a humanized IgG1 antibody targeting six-transmembrane epithelial antigen of the prostate 1 (STEAP1), a cell surface protein that is upregulated in prostate cancer and certain other cancers, yet has limited expression in healthy tissue.

• Trevi Therapeutics, a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), announced that it has completed enrollment in its Phase 2a trial for the treatment of RCC ("RIVER").

• Regeneron Pharmaceuticals, announced positive three-year (156-week) data for EYLEA HD® (aflibercept) Injection 8 mg from an extension study of the Phase 3 PHOTON trial in patients with diabetic macular edema (DME).
• At three years, the longer-term data showed the vast majority of EYLEA HD patients who entered the extension study sustained the visual gains and anatomic improvements achieved by the end of the second year, while achieving substantially longer treatment intervals than have been previously demonstrated.
• Notably, patients switched to EYLEA HD experienced substantially slower fluid reaccumulation following their first EYLEA HD dose. 

• Phenomix Sciences, a precision medicine biotechnology company that brings data intelligence to the treatment of obesity, announces a new partnership to advance precision medicine in obesity with InformedDNA, the nation’s leading applied genomics solutions company.
• The collaboration integrates Phenomix’s MyPhenomeTM genetic obesity test with InformedDNA’s DNAimpactTM precision health platform, broadening access to genetics-based weight management care for InformedDNA’s extensive network of payers, health systems, employers, and life sciences organizations.

• Alnylam Pharmaceuticals, the leading RNA interference (RNAi) therapeutics company, announced the submission of a Type II Variation to the European Medicines Agency (EMA) for vutrisiran, an investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM).
• Vutrisiran is the generic name for AMVUTTRA®, which is currently approved in the European Union (EU) for the treatment of hereditary transthyretin-mediated (hATTR) amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy.

Element Biosciences, a developer of pioneering technologies to empower science, introduced Trinity™ - an innovative solution that simplifies target capture sequencing by eliminating or moving traditionally time-consuming steps to the AVITI™ System and providing customers with the option to dramatically reduce hybridization time, without sacrificing cost or quality.

• 10x Genomics, a leader in single cell and spatial biology, announced the launch of two new Chromium products intended to democratize access to single cell analysis.
• The new offerings – GEM-X Flex and GEM-X Universal Multiplex – introduce significant improvements in performance, workflow and cost effectiveness, enabling more researchers to pursue single cell analysis for more applications. 

• Repare Therapeutics Inc., a leading clinical-stage precision oncology company, announced the first patient has been dosed in the Company’s Phase 1 (POLAR) clinical trial evaluating RP-3467, a Polθ ATPase inhibitor, alone and in combination with the poly-ADP ribose polymerase (PARP) inhibitor, olaparib. RP-3467 is Repare’s fourth clinical program.