Partnology

Please join us in recognizing Chief Scientific Officer of SOFIE, Sherly Mosessian in this weeks Biotech Leader Spotlight Series! Check out our interview with Sherly to learn from her biomedical research and executive leadership expertise. Dr. Mosessian earned her bachelor’s degree in Biochemistry, followed by her Ph.D. from UCLA Department of Molecular and Medical Pharmacology, with publications in tumor signaling, molecular imaging targets and clinical trials of Positron Emission Tomography (PET) probes. She joined the SOFIE team in 2021 as the Vice President of Clinical and Regulatory Affairs leading the clinical development of FAPI diagnostic. She was promoted to Chief Scientific Officer in 2022. Prior to joining SOFIE, she served as a Chief Administrative Officer at UCLA and oversaw the establishment of a current Good Manufacturing Process (cGMP) facility in support of PET radiopharmaceutical production for research and clinical service. She successfully established a pathway at the UCLA Department of Pharmacology to translate PET imaging agents from bench to the clinic in a time and cost-efficient manner. In addition to her expertise in biomedical research, she has served in an executive leadership capacity in technology, having co-led the establishment of DGIT, the integrated information technology organization in support of the research and education mission of the UCLA School of Medicine. Dr. Mosessian is Armenian and having immigrated to the United States at a young age, values the importance of diversity/inclusion, seeking opportunities and having a strong work ethic. #biotechleaders #womeninbio #womeninscience #biotech #biotechnology

Recent Funding: Autobahn Therapeutics, Inc. (San Diego) raises $100 million Series C. The San Diego-based biotech is developing restorative treatments for people affected by #neuropsychiatric and #neuroimmunologic disorders. Proceeds from the Series C will be used to commence two Phase 2 clinical trials for the company’s lead program, ABX-002, a potent and selective thyroid hormone beta receptor. Financing was led by Newpath Partners, with new investors Canaan Partners, Monograph Capital, and Insight Partners. Montara Therapeutics, Inc. (San Francisco), a biotech company aiming to revolutionize the discovery and development of brain-targeting drugs, announced the closing of an oversubscribed $8 million seed financing led by SV Health Investors’ Dementia Discovery Fund and co-lead Two Bear Capital. Dolby Family Ventures and KdT Ventures also participated in the round. Previous Founder and CSO of Mitokinin, Nicholas Hertz, Ph.D, is the President and CEO of Montara, bringing along nine of his former Mitokinin employees. Therapeutics for #neurological diseases must penetrate the blood-brain barrier and be active against the target at the disease site. However, many promising drug candidates fail to advance due to dose-limiting on-target off-tissue peripheral side effects or toxicities that compromise both safety and efficacy. To address this challenge, Montara is pioneering BrainOnly, a platform designed to prevent on-target off-tissue peripheral side effects or toxicities of existing and novel drugs to make best-in-class and first-in-class therapies. FDA Approvals: US FDA approves BioMarin Pharmaceutical Inc. (San Rafael)’s supplemental Biologics License Application (sBLA) for BRINEURA® (cerliponase alfa) to slow the loss of ambulation in children of all ages with neuronal ceroid lipofuscinosis type 2 (CLN2 disease), also known as tripeptidyl peptidase 1 (TPP1) deficiency. Previously, BRINEURA was indicated in symptomatic children 3 years of age and older with late infantile CLN2 disease. This expanded indication now includes children of all ages with CLN2 disease, regardless of whether they are symptomatic or presymptomatic. Recent Layoffs:  Merck & Co: The big pharma has implemented a team reduction of 75 to 80 workers in its early research division this week, people familiar with the move told STAT. The layoffs account for a small percentage of Merck’s overall workforce and are part of a routine re-evaluation of the pharma's structure and resources, according to a source. Other Interesting News: Ventyx Biosciences (San Diego) will stop funding trials of an experimental TYK2 drug after it missed the main goal of a Phase 2 study in people with Crohn’s disease. Treatment with the oral drug didn’t result in a statistically significant difference in Crohn’s symptoms.

Please join us in recognizing Chief Executive Officer of Sustained Therapeutics, William Annett in this weeks Biotech Leader Spotlight Series! William is a highly experienced leader with a successful track record in the life sciences industry. He has been #CEO of four early stage companies, taking two of them public and exiting a third via acquisition. He was also a Partner at Accenture, where he led the West Coast Life Sciences practice. In addition he spent eight years at Genentech where he led the Launch Office, directed the Project Finance function supporting all Development pipeline products, and led numerous large operational transformation projects. He received his MBA from the Harvard Business School. Check out our interview with William Annett to learn from his years of experience and in-depth #biotech industry insights:

Recent Funding: NGM Biopharmaceuticals (South SF), now private, raises $122M for redrawn research plans. Led by longtime backer The Column Group, the Series A round will help NGM take its liver disease drug in a new direction. This will fund a registrational trial for the company’s drug aldafermin in primary sclerosing cholangitis, or PSC, and a Phase 2 study for another candidate called NGM120 in hyperemesis gravidarum, a rare condition of pregnancy that leads to frequent vomiting. Recent Layoffs:  Caribou Biosciences (Berkeley) is laying off staff one month after a clinical setback sent its shares tumbling. In a regulatory filing, the company said it has reduced its workforce by 12%, or by 21 positions. Caribou also has discontinued preclinical research on its allogeneic CAR-NK platform. Together, the moves will extend the company’s cash runway and focus resources on its CAR-T therapies, data for one of which it presented last month. MEI Pharma (San Diego), after failed Infinity merger last year, is evaluating strategic alternatives including potential transactions or a potential wind-down of the company to maximize the value of assets for its shareholders. RAPT Therapeutics (South SF) is slashing its headcount by 40% to extend its cash runway, just months after it ended Phase 2 studies of its lead immunology candidate, zelnecirnon. The biotech plans to lay off 47 employees, according to a Friday SEC filing. The workforce cuts should be complete by the end of the third quarter and will incur just short of $1 million in charges. M&A, Deals, Partnerships: Private biotech M&A surges amid difficult IPO market. #Pharmaceutical companies are finding bargains in mature #biotechs that aren’t yet public, driving up the pace of private M&A. As of mid-July, 13 of the 26 acquisitions worth at least $50 million in upfront value this year were of private biotechs, surpassing the pace set in each of the previous six years, according to Biopharma Dive data. In a research note last month, analysts at the investment bank Jefferies noted how the share of buyouts involving #startups is by far the highest of any year since 2015. IPOs: Artiva Biotherapeutics (San Diego) announced Thursday that it is upsizing its initial public offering, placing 13.9 million shares on the market at $12 per share. This offering will bring an estimated $167 million to the San Diego–based biotech. Other Interesting News: Biogen passed on Ionis Pharmaceuticals, Inc. plans to push one of its rare disease drugs into late-stage testing now that a smaller trial found its drug offered “robust and consistent” benefits on communication, cognition and motor function. The trial focused on Angelman syndrome, an uncommon genetic disorder that causes severe functional and learning disabilities.

Recent Funding: NGM Biopharmaceuticals (South SF), now private, raises $122M for redrawn research plans. Led by longtime backer The Column Group, the Series A round will help NGM take its liver disease drug in a new direction. This will fund a registrational trial for the company’s drug aldafermin in primary sclerosing cholangitis, or PSC, and a Phase 2 study for another candidate called NGM120 in hyperemesis gravidarum, a rare condition of pregnancy that leads to frequent vomiting. Recent Layoffs:  Caribou Biosciences (Berkeley) is laying off staff one month after a clinical setback sent its shares tumbling. In a regulatory filing, the company said it has reduced its workforce by 12%, or by 21 positions. Caribou also has discontinued preclinical research on its allogeneic CAR-NK platform. Together, the moves will extend the company’s cash runway and focus resources on its CAR-T therapies, data for one of which it presented last month. MEI Pharma (San Diego), after failed Infinity merger last year, is evaluating strategic alternatives including potential transactions or a potential wind-down of the company to maximize the value of assets for its shareholders. RAPT Therapeutics (South SF) is slashing its headcount by 40% to extend its cash runway, just months after it ended Phase 2 studies of its lead immunology candidate, zelnecirnon. The biotech plans to lay off 47 employees, according to a Friday SEC filing. The workforce cuts should be complete by the end of the third quarter and will incur just short of $1 million in charges. M&A, Deals, Partnerships: Private biotech M&A surges amid difficult IPO market. #Pharmaceutical companies are finding bargains in mature #biotechs that aren’t yet public, driving up the pace of private M&A. As of mid-July, 13 of the 26 acquisitions worth at least $50 million in upfront value this year were of private biotechs, surpassing the pace set in each of the previous six years, according to Biopharma Dive data. In a research note last month, analysts at the investment bank Jefferies noted how the share of buyouts involving #startups is by far the highest of any year since 2015. IPOs: Artiva Biotherapeutics (San Diego) announced Thursday that it is upsizing its initial public offering, placing 13.9 million shares on the market at $12 per share. This offering will bring an estimated $167 million to the San Diego–based biotech. Other Interesting News: Biogen passed on Ionis Pharmaceuticals, Inc. plans to push one of its rare disease drugs into late-stage testing now that a smaller trial found its drug offered “robust and consistent” benefits on communication, cognition and motor function. The trial focused on Angelman syndrome, an uncommon genetic disorder that causes severe functional and learning disabilities.

Recent Funding: Resolute Science (San Diego) is pleased to announce the National #Cancer Institute (#NCI) has issued a Notice of Award for the Phase 2 portion of its Fast Track Small Business Innovation Research (#SBIR) grant. This $2.1 million grant supports the advancement of Resolute's lead asset, RS-5, a novel synthetic, pan-cancer drug conjugate for treating soft tissue sarcomas (STS) and other aggressive, hard-to-treat solid tumors. This NCI grant will enable Resolute to accelerate its IND-enabling activities as it advances RS-5 toward clinical trials. Novo Holdings led a $100M raise for Asceneuron SA’s Alzheimer’s asset. Asceneuron, which develops small molecules targeting tau protein aggregation, plans to use the funds to advance its #Alzheimer’s disease asset into Phase II. Recent Layoffs:  Novartis has let go of 29 employees in San Diego and will eliminate approximately 100 more jobs as it winds down its research site there. IPOs:  Artiva Biotherapeutics (San Diego) provided more details on its #IPO push, outlining plans to offer 8.7 million shares and raise approximately $116 million to advance its early-stage #celltherapy candidates. Artiva plans to use the funds raised to support the development of its AlloNK therapy for systemic #lupus erythematosus. FDA Approvals: Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT)(Westlake Village) received FDA approval for its atopic #dermatitis cream Zoryve in adults and children 6 years and older. Zoryve is a once-daily, steroid-free cream and the third formulation of Arcutis’ drug ingredient roflumilast to secure FDA approval. Other Interesting News: Amgen axes development of their early-stage bispecific T-Cell engager for solid tumors. The company had been studying AMG 794 in a Phase I trial for several solid tumors including non-small cell lung cancer and epithelial ovarian cancer. It is not clear what exactly led to the termination of the AMG 794 program. Revolution Medicines (Redwood City) firms up Phase 3 trial plans with latest cancer drug data. Updated results show the biotech’s therapy shrank #pancreatic tumors in 20% to 25% of study participants, but with high rates of side effects like rash and nausea. Sionna Therapeutics has licensed a group of experimental cystic fibrosis drugs from AbbVie, planning to test them in combination regimens that could challenge Vertex Pharmaceuticals’ market-leading medicines. Vertex Pharmaceuticals (Boston/San Diego) sues US over limits on providing fertility services to Casgevy patients. Vertex Pharmaceuticals’ new treatment for sickle cell disease can eliminate the damaging pain crises people with the blood condition frequently experience, however, drugs used to prepare patients for the treatment, called Casgevy, carry a high risk of infertility. Vertex has said it will help patients insured on the commercial market access fertility preservation services, but federal rules bar it from doing the same for people covered by Medicaid.

M&A, Deals, Partnerships: TuHURA Biosciences, Inc., a Phase 3 registration-stage immune-oncology company, and Kintara Therapeutics, Inc. NASDAQ: KTRA, a biopharma focused on the development of new solid tumor cancer therapies, today announced TuHURA has entered into an Exclusivity and Right of First Offer Agreement with Kineta, Inc. for the potential acquisition of Kineta's KVA12123 anti-VISTA #antibody and related rights and assets associated with and derived from the asset. KVA12123 is a rationally targeted, anti-VISTA antibody checkpoint inhibitor to reverse VISTA immune suppression and remodel the tumor microenvironment (TME) to overcome acquired resistance to immunotherapies. Recent Layoffs:  Oncology biopharma Apollomics (Foster City) is letting go of two members of its leadership team as well as an unspecified number of staff. "As a result of the updated strategic focus and resource needs going forward, Sanjeev Redkar, Ph.D., Company co-founder and President, and Peony Yu, M.D., Chief Medical Officer, are expected to transition to consulting roles in August,” the announcement stated. The reductions are linked to the company’s narrowing of the target patient population for its candidate vebreltinib, currently in a Phase II clinical trial for certain tumors. FDA Approvals: Adicet Bio, Inc (Menlo Park) announced the U.S. FDA has granted Fast Track Designation to ADI-270 for the potential treatment of patients with #metastatic/advanced clear cell renal cell #carcinoma (ccRCC) who have been treated with an immune checkpoint inhibitor and a vascular endothelial growth factor inhibitor. Biostar Pharmaceuticals Inc, the U.S. subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd., which is a synthetic biology-driven #biopharma company focusing on the development and commercialization of innovative #oncology drugs, announced that their core pipeline product Utidelone Injection had been granted to conduct a phase 2 study for HER2- breast cancer brain metastasis by the US FDA. Other Interesting News: Eli Lilly and Company has agreed to buy Morphic Therapeutic for $3.2 billion, giving the Big Pharma control of an oral, midphase challenger to Takeda’s injectable inflammatory bowel disease blockbuster #Entyvio. Morphic’s pipeline is led by MORF-057. The oral small molecule inhibits α4β7, an integrin expressed on some white blood cells. Takeda showed targeting the integrin can control intestinal inflammation and improve outcomes in ulcerative colitis and Crohn’s disease. Eli Lilly and Company has opened its first-ever Lilly Gateway Labs location in San Diego, CA. Gateway Labs is Lilly's shared innovation accelerator that provides participating companies with state-of-the-art lab space and unique access to Lilly scientists, researchers and executives, as well as exposure to Lilly's functional and scientific expertise. This is the company's third Gateway Labs location, with additional sites located in San Francisco and Boston.

Recent Funding: Holoclara Inc (Los Angeles) raises $16 million Series A to develop therapeutics—with worms. Financing led by BOLD Capital Partners and will support clinical development of first-in-class, worm-derived medicines for allergies and autoimmune disorders and advancement of discovery engine. Frontier Medicines (San Francisco) announced the appointment of Gerardo Ubaghs Carrión as Chief Financial Officer and the additional close of $20 million extension to its Series C, bringing the total amount raised to $100 million, with the financing slated to accelerate multiple pipeline programs. M&A, Deals, Partnerships: Radionetics Oncology (San Diego) announced today the formation of a strategic relationship with Eli Lilly and Company to take forward Radionetics’ proprietary GPCR targeting small molecule #radiopharmaceuticals. Codexis, Inc. (Redwood City, CA) a leading enzyme engineering company, today announced it has entered into an asset purchase agreement with Crosswalk Therapeutics for the Company’s investigational Fabry and Pompe disease compounds. IPOs:  Alumis (San Francisco) announced the pricing of its IPO of 13,125,000 shares of common stock at an initial public offering price of $16.00 per share. FDA Approvals: Neurocrine Biosciences (San Diego) announced the U.S. FDA has accepted its two New Drug Applications (NDA) with Priority Review designations for crinecerfont in the treatment of children, adolescents and adults with classic congenital adrenal hyperplasia (CAH). Longboard Pharmaceuticals (La Jolla) receives Breakthrough Therapy Designation for Bexicaserin (LP352) for the treatment of seizures associated with Developmental and Epileptic Encephalopathies (DEEs). Circle Pharma, Inc. (San Francisco),a leader in macrocycle drug discovery and development, announced the submission of its first Investigational New Drug (IND) application to the U.S. FDA for CID-078, a first-and-only-in-class cyclin A/B RxL inhibitor. Soleno Therapeutics, Inc. (Redwood City) announced the submission of a NDA to the U.S. FDA for approval of DCCR (diazoxide choline) extended-release tablets for the treatment of Prader-Willi syndrome (PWS) in individuals four years and older who have hyperphagia. ReCode Therapeutics (Menlo Park), a clinical-stage genetic medicines company using tissue-specific delivery to power the next wave of mRNA and gene correction therapeutics, announced that the U.S. FDA has granted Orphan Drug Designation for RCT1100 for the treatment of primary ciliary dyskinesia (PCD). Abdera Therapeutics (Menlo Park) announced that the U.S. FDA has granted Fast Track designation to ABD-147 for the treatment of patients with extensive stage small cell lung cancer (ES-SCLC) who have progressed on or after platinum-based chemotherapy. Vir Biotechnology, Inc. (San Francisco) receives FDA IND clearance and Fast Track Designation for Tobevibart and Elebsiran for the Treatment of Chronic Hepatitis Delta Infection.

Recent Funding: Marea Therapeutics (SF) has emerged with $190 million and a mid-stage #cardiometabolic clinical program. Incubated by Third Rock Ventures, the #biotech will use the money to fund phase 2 activities for lead program MAR001, a monoclonal antibody (#mAb) designed to inhibit ANGPTL4, a protein highly expressed in body fat. Preclinical models found that MAR001 reduced triglycerides, remnant cholesterol and ectopic fat, while improving insulin sensitivity. The biotech plans to launch a phase 2b trial assessing MAR001 for #metabolic dysfunction in the beginning of next year. Iambic Therapeutics (San Diego) has now raised an oversubscribed $50 million extension round led by new investors Mubadala Capital and Exor Ventures. The new cash will be used to advance the biotech's #clinical and #preclinical pipeline. This includes IAM1363, a small molecule inhibitor designed to treat both wild-type and oncogenic HER2 mutants currently in phase 1/1b testing, as well as a preclinical dual CDK2/4 inhibitor designed to tackle treatment resistance in solid tumors. āshibio, Inc (Brisbane) exited stealth mode today with $40 million in seed and Series A financing to advance therapies for bone and connective tissue disorders. MPM BioImpact led the Series A round, with contributing funds from Agent Capital, YK Bioventures, and Mirae Asset Capital Life Science. Recent Layoffs:  eFFECTOR Therapeutics, Inc. (Solana Beach): The #oncology biotech has laid off staff as it plans to wind down. This includes eFFECTOR CEO Stephen Worland, Ph.D.; CFO Michael Byrnes; and CMO Douglas Warner, M.D., who all stopped serving in their positions at the end of last week. M&A, Deals, Partnerships: Belharra Therapeutics (San Mateo & San Diego), a next-generation #chemoproteomics company transforming small molecule drug discovery by illuminating binding pockets on elusive, high-value drug targets across the proteome, announced a strategic collaboration with Sanofi to advance the discovery of novel small molecule therapeutics for #immunological diseases. FDA Approvals: Halozyme, Inc. (San Diego) announced that argenx received U.S. FDA approval for VYVGART® Hytrulo co-formulated with ENHANZE®, Halozyme's proprietary recombinant human hyaluronidase enzyme, rHuPH20, for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (#CIDP). Adicet Bio, Inc (Redwood City) announced that the U.S. FDA has cleared the Company’s IND application to evaluate ADI-270, an armored allogeneic “off-the-shelf” gamma delta chimeric antigen receptor (CAR) T cell therapy candidate targeting CD70+ #cancers, for the treatment of relapsed/refractory renal cell #carcinoma (RCC). 4D Molecular Therapeutics (SF) announced U.S. FDA clearance of the IND for 4D-175, an R100 vector-based intravitreal #genetic medicine, for the treatment of patients with geographic atrophy.

Versant Ventures debuts Santa Ana Bio, Inc. (Alameda) with $168 million and a trio of programs that riff in new ways on existing ideas like targeting mast cells and stimulating the PD-1 pathway. One of Santa Ana’s drugs, dubbed SAB01, is a so-called bispecific #antibody. It is designed to mute the mast cells that drive allergic disease by blocking a protein called c-Kit. But the drug will only do so when it detects another target that’s found on those cells. Foresite Capital (Larkspur) an investment firm that backs life sciences and healthcare companies, has raised a $900 million fund. The fund, Foresite’s sixth, will invest in companies focused on precision medicine, healthcare delivery and life sciences infrastructure. In drug developers, specifically, the firm is looking for those using #genetics and #machinelearning to identify potential therapies. Actio Biosciences, Inc. (San Diego) announces $55 Million Series A financing to deploy a suite of proprietary tools and deep #genetics expertise to develop #therapeutics against targets shared between rare and more prevalent diseases. They have a lead small molecule program targeting TRPV4 mutations advancing toward clinic for treatment of Charcot-Marie-Tooth disease type 2C and other serious bone diseases. Actio also announced an innovative partnership with The Jackson Laboratory to develop and implement new transgenic models of rare disease pathways. M&A, Deals, Partnerships: Johnson & Johnson is handing back a bispecific T cell engager program designed to target both CD20 and CD3 to its partner Xencor, ending a significant piece of an agreement between the companies that started in 2021. Xencor completed enrollment for a Phase 1 trial of plamotamab last year. The biotech said the drug is now Phase 2-ready, adding it will review its potential to address unmet needs. The original collaboration and license deal saw Xencor get $100 million upfront for global development and commercialization rights to plamotamab. Other Interesting News: The failure of a Pfizer medicine for #Duchenne muscular dystrophy adds new uncertainty around the effectiveness of #genetherapy for the muscle-wasting condition. Pfizer said the treatment missed its mark in a definitive Phase 3 study of boys between 4 and 7 years of age with DMD. Pfizer said the therapy didn’t lead to a significant difference versus placebo on a measure of motor function, or on key secondary measures such as timed tests for how quickly study participants could stand or walk. Avidity Biosciences, Inc. (San Diego) drug for muscular dystrophy shows promise. Shares in Avidity rose by nearly one-third as the company revealed new clinical trial data for its drug del-brax in a form of #musculardystrophy.  Among eight patients treated with del-brax, Avidity reported greater than 50% average reduction in a panel of genes regulated by another gene called DUX4. Avidity also said participants showed signs of increased strength.