Nick Galli

MassBioDrive harnesses the power of MassBio’s global life sciences network to help new founders launch their biotech startups. We announced our #MassBioDrive Spring 2024 Cohort back in March, and as we near the end of the eight-week program, we are highlighting our five emerging biotech companies chosen to participate. Today, please meet Nucyrna Therapeutics! Q: Tell us about your company and what you’re developing. What are you most excited about? A: Nucyrna Therapeutics aims to redefine RNA-targeting therapeutics by co-targeting nuclear and cytoplasmic RNAs. Nucyrna’s oligonucleotide platform enables a superior therapeutics index for single RNA silencing and can serve as a dual-RNA targeting platform. With our lead programs targeting ALS, we are working to address the huge unmet medical needs in CNS disorders in our rapid aging society. I’m most excited about developing disease-modifying therapies for these patients. Q: What advice do you have for other biotech companies just getting started? A: It’s never too early to talk to advisors such as serial entrepreneurs for advice. MassBioDrive is an amazing mentorship program helping entrepreneurs figure out challenges at the early stage. Q: What has been most impactful or surprising to you since joining the MassBioDrive program? A: The most impactful thing is we have decided our leading two programs based on our oligonucleotide platform technology with the guidance from MassBioDrive program mentors. Learn more about Nucyrna Therapeutics: https://www.nucyrnatx.com/ Learn more about MassBioDrive: https://lnkd.in/eAEMRZ-b Damon (Feng) Wang, PhD

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MassBioDrive harnesses the power of MassBio’s global life sciences network to help new founders launch their biotech startups. We announced our #MassBioDrive Spring 2024 Cohort back in March, and as we near the end of the eight-week program, we are highlighting our five emerging biotech companies chosen to participate. Today, please meet Anita Scheuber and Hestia Therapeutics! Q: Tell us about your company and what you’re developing. What are you most excited about? A: At Hestia, we are developing the aNKor platform of tri-specific, tri-funtional immunocytokines that engage the adaptive AND innate immune system to very effectively attack cancer cells. Our approach is a targeted delivery of potent cytokines into the tumor microenvironment that is safer for patients compared to naked cytokines. Q: What advice do you have for other biotech companies just getting started? A: Surround yourself with a diverse group of people that bring industry relevant expertise to complement your own. Q: What has been most impactful or surprising to you since joining the MassBioDrive program? A: The Biotech hub in the Boston area remains strong, innovative and daring - it is just fantastic to learn through the MassBioDrive program that the immense resources, support and entrepreneurship still exists. It is truly inspiring and humbling to receive all that encouragement. Learn more about Hestia Therapeutics: https://hestiatx.com/ Learn more about MassBioDrive: https://lnkd.in/eAEMRZ-b

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MassBioDrive harnesses the power of MassBio’s global life sciences network to help new founders launch their biotech startups. We announced our #MassBioDrive Spring 2024 Cohort back in March, and as we near the end of the eight-week program, we are highlighting our five emerging biotech companies chosen to participate. Today, please meet DoriNano! Q: Tell us about your company and what you’re developing. What are you most excited about? A: DoriNano, a Harvard spinoff, pioneers the use of DNA origami nanoparticles as a transformative delivery platform for combination immunotherapies, offering precise cellular targeting and minimal effective doses of cargo for treating serious diseases. Our mission is to develop safe, effective, and affordable combination nanomedicines that overcome past limitations in nanoparticle-based therapeutics. We are particularly excited about the multifaceted potential of DNA origami nanoparticles, which have the potential to revolutionize the nanotechnology delivery landscape. Q: What advice do you have for other biotech companies just getting started? A: Starting a biotech company requires resilience, a willingness to learn, and openness to suggestions. Every challenge presents an opportunity for growth. Embrace the journey, endure sacrifice, minimize complaints, learn from setbacks, and move forward. Building the right team is the key and most challenging sector. Surround yourself with dedicated individuals who share your vision.  Q: What has been most impactful or surprising to you since joining the MassBioDrive program? A: The MassBioDrive program's structured approach, coupled with the dedication of organizers and mentors, has been very impactful. The informative working sessions cover vital aspects of company launch, regulatory compliance, legal considerations, CMC considerations, investment strategies and pharma partnering. As a scientist-turned-entrepreneur, these resources have been invaluable, providing comprehensive guidance tailored to our needs. The interactive Q&A sessions during both mentor sessions and working sessions have deepened our comprehension and helped address questions regarding the company’s development. Learn more about DoriNano: https://lnkd.in/eXJ7PQ_X Learn more about MassBioDrive: https://lnkd.in/eAEMRZ-b Yang (Claire) Zeng

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🔥 Some very exciting investments over the last week or so! 🧬 Some really innovative companies and advancements! City Therapeutics ($135M): A Cambridge, MA-based biopharmaceutical company, raised $135 million in Series A funding to advance its RNAi-based medicine. Maven Clinic ($125M): A New York-based virtual clinic for women's and family health, Maven Clinic raised $125 million in Series F funding to enhance its partnerships in maternity care. Purespring Therapeutics ($105M): A London-based gene therapy company, they raised $105 million in Series B funding to support its pipeline, including initiating a Phase I/II clinical trial for IgAN. Glooko ($100M): Digital health company, Glooko raised $100 million in Series F funding to accelerate the global expansion of its digital healthcare platform for diabetes management. Cytovale ($100M): A SF-based company founded secured a $100 million Series D funding to develop rapid tests for early detection of sepsis. This accelerate bringing their innovative tools to market. Orasis Pharmaceuticals: Raised $78 million to launch Qlosi™, a new eye drop for the treatment of presbyopia. ShiraTronics, Inc.: Raised $66 million to support its FDA-approved pivotal trial, RELIEV-CM2, and seek premarket approval for its migraine therapy system. Basecamp Research: Raised $60 million to expand its data collection, strengthen its AI capabilities, and invest in computing to tackle more complex tasks in the life sciences. Arda Therapeutics Raised $43 million to expand its operations and development efforts in targeted cell depletion therapies for chronic diseases. Eleanor Health: Raised $30 million to expand its outpatient addiction treatment services. MARAbio Raised $19 million to support the commercial launch of its autism test in 2025 and the development of therapeutic interventions. Lymphatica Medtech: Raised €17.9 million to accelerate the clinical development and validation of LymphoDrain, an implantable device designed to treat lymphedema. Centaur Labs: Raised over $16 million to expand its operations and development efforts in health data annotation. Somagenetix: Raised CHF10 million to advance its leading gene therapy candidate, SGX-001, for phagocyte disorders. MiLaboratories: Raised an undisclosed amount to create software solutions that enhance biological research and development. Amprion Raised $6 million to expand its commercial reach and invest in research and development to improve brain disease diagnosis. Booster Therapeutics: Raised $15 million in seed funding. clock.bio: Raised $5.3 million to build its "Atlas of Rejuvenation Factors" by identifying genes influencing aging. LEVY Health Raised $4.5 million to integrate its virtual care pathways with electronic medical record software and expand its offerings to women's health and reproductive care. ALPHA FUSION INC. Raised ¥1.02 billion to expand its research and development efforts in targeted alpha therapy using Astatine-211 for cancer treatment.

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University of Pennsylvania spinout Interius BioTherapeutics raises $67M in a private equity round. The Philadelphia company is seeking to raise a total of $82.5 million from its Series B round. July 9, 2024 Interius was granted Human Research Ethics Committee (HREC) approval and Clinical Trial Notification (CTN) clearance by the Australian Therapeutic Goods Administration (TGA) to commence a first-in-human Phase 1 clinical trial of INT2104, its lead in vivo CAR candidate for treatment of B-cell malignancies. #funding #financing #genetherapy #invivo #CARtherapy #therapeutics #Bcellmalignancies #celltherapy #genetherapy #advancedtherapies #regenerativemedicine #lifescience #lifesciences #biotech #biotechnology #clinicaltrials #seriesfinancing #equityfinancing

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MassBioDrive harnesses the power of MassBio’s global life sciences network to help new founders launch their biotech startups. We announced our #MassBioDrive Fall 2024 Cohort last month, and are highlighting our five emerging biotech companies chosen to participate. Today, please meet RedPoint Oncology, Inc! Q: Tell us about your company and what you’re developing. What are you most excited about? A: At RedPoint, we are committed to overcoming therapy-resistant cancers by developing next-generation payloads for targeted therapies. Therapy resistance is responsible for more than 90% of cancer-related deaths, and our payloads are specifically designed to induce a form of cell death that these difficult-to-treat cancer cells are particularly vulnerable to. We are particularly excited about our potential to overcome therapy resistance, which remains one of the biggest challenges in cancer care. In addition, we are very excited about the modular nature of our payloads, which allows them to be compatible with various targeted delivery methods, enabling the generation of numerous new medicines. Q: What advice do you have for other biotech companies just getting started? A: My advice is simple: don’t be afraid to ask for help. Building a biotech startup involves navigating so many complex challenges, especially for first-time founders, and it can feel overwhelming. When I first started, I wasn’t sure where to begin or if my idea was even feasible. But by reaching out for help, even through cold outreach, I met incredible mentors who shared their knowledge and opened doors to great opportunities. Their support has been instrumental in getting RedPoint off the ground. I think we often hesitate to ask for help because we fear rejection, but I’ve found there are so many people willing to help, even if you’ve never met them before—you just have to ask. Q: What has been most impactful or surprising to you since joining the MassBioDrive program? A: The most impactful part would be the tremendous support system and mentorship I received from the MassBioDrive (MBD) program. I think MBD is different from many other accelerator programs as it is tailored to each of our specific needs. From building the mentor team to covering biotech-specific topics, the program offers personalized guidance. Our mentors are incredibly knowledgeable and have been so supportive throughout the process. Each week, we engage in open discussions and receive constructive feedback on our progress. I’m truly grateful for the experience! Learn more about RedPoint Oncology: https://lnkd.in/eeQTDCh6 Learn more about MassBioDrive: https://lnkd.in/eAztxEdd Mengdie Wang, PhD

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Appreciate John Glasspool’s op/ed in the Boston Business Journal. He brings the perspective of a CEO of a Cambridge-based #biotech, MassBio member Anthos Therapeutics, to the debate over the White House’s plans to use Bayh-Dole as a blunt instrument to force price controls. The reality is that any effort to use “march in” rights like this would hurt innovation, chill the collaborative relationship between research institutes and small biotechs (which are the lion’s share of Massachusetts’ industry) when it comes to advancing early science, and do nothing to address the price of drugs. You can’t argue with Bayh-Dole’s success: 6 million jobs, $2 trillion in economic output, thousands of startups, and 200+ drugs and vaccines. As John points out, we can’t go back to a time when science sat on shelves instead of getting into medicine cabinets. https://lnkd.in/ezkNndKA cc: The Bayh-Dole Coalition

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Jonathan Montagu, CEO of MassBio member HotSpot Therapeutics, Inc., writes on the #LifeSCiVC blog about hopes around an immuno-oncology spring this year, aligning with the emergence of #biotech from its own long winter. Jonathan points out that after the #lifesciences industry dove headfirst into I-O “to address the substantial need that still persists for many cancer patients with a range of tumor types,” much of the second-generation agents fell short. He writes about why he’s optimistic that new approaches have started to turn the tide. What are your thoughts on the I-O space right now? https://lnkd.in/eMh62Z8j #immunooncology #oncology #patientdriven

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Interested in the latest developments at the FDA's Office of Therapeutic Products (#OTP)? Join a free, public webinar on June 14th featuring Dr. Nicole Verdun, OTP's Super Office Director, and Rachael Anatol, Ph.D., Deputy Super Office Director. What you'll learn: The new "Super Office" structure of the OTP Progress on hiring new staff An overview of the OTP's organization Brought to you by Alliance for Regenerative Medicine. Please use the link in the post below. #celltherapy #genetherapy #cellandgenetherapy #advancedtherapies #lifescience #lifesciences #regulatory #structure #biotech #biotechnology #webinar #productupdate #regulatorystructure

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Why are Americans paying so much for #prescription medicines? According to the FTC, it’s because the biggest #PBMs -- all owned by health insurers -- are using their market power to drive up costs, pocket #rebate dollars, and force patients to use pharmacies that the PBMs own. At the same time, they’re providing independent pharmacists with “untenably low” reimbursement, undermining the care ecosystem even as costs increase. The scathing new #PBM report from the FTC makes clear that PBMs are often a shell game, using vertical integration and convoluted corporate structures to hide the fact that PBM "benefits" are often just a way to steer dollars to the PBM's other businesses. Patients suffer the most, first paying higher prices than they should be paying at the pharmacy, and later as they will have access to fewer new treatments because #biotech innovation suffers due to PBM greed, unless we call attention to this egregious behavior. #patientsfirst #innovation #biotech Biotechnology Innovation Organization https://lnkd.in/gK2A2zFh

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In a notable prelude to #JPM2025, Tune Therapeutics has announced a $175M Series B funding round to advance its epigenetic editing platform. Epigenetic editing represents a compelling alternative to traditional gene-editing technologies, focusing on controlling gene expression without altering the underlying DNA. This approach offers the potential for safer, reversible therapies and could play a major role in tackling diseases like cancer, rare genetic disorders, and neurological conditions. The last few years haven’t been easy for genetic medicine. Challenges like delivery limitations, scalability, and concerns over off-target effects have underscored how complex translating genomic innovation into real-world treatments can be. Tune’s focus on fine-tuning gene activity rather than permanently rewriting the genome offers an alternative to overcoming some of these barriers. Let's hope that after such a significant investment, the interest in editing as a transformative technology will grow . As JPM 2025 kicks off, many of us will watch out for where exciting conversations about genetic medicines will go. Read the full article in the Endpoints News: https://lnkd.in/e8CFVEHW #JPM2025 #Epigenetics #Biotech #GenomicMedicine #HealthcareInnovation

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How do we minimize the number of protocol amendments and increase the operational feasibility of our clinical trials? This article below points out the benefits of using data, conversations and real world data to enhance the feasibility of the protocol design and inclusion/exclusion criteria: 1) Are we being too strict on our criteria in order to "control" for data variability? 2) Do are criteria allow for the intended patient population in the real world (if not, they need to) 3) How realistic is your design in how the study sites actually work? How they see and treat patients? How is your company ensuring the design meets these requirements? https://lnkd.in/gzJzFd-3

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The #biosecure act is bad legislation and anti-competitive and will force US #biotech companies to abandon strong and honest #CDMO partners without making us more secure. Longstanding, productive drug-discovery collaborations will inevitably be compromised by an ill-conceived initiative — all for short-term political gain. Patients in need of innovative medicines are the ones that will lose out; I urge leaders in the #biotech industry to stand up and be counted in opposition to this proposed legislation.

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MassBioDrive harnesses the power of MassBio’s global life sciences network to help new founders launch their biotech startups. We announced our #MassBioDrive Fall 2024 Cohort earlier this fall, and are highlighting our five emerging biotech companies chosen to participate. Today, please meet HarborSite! Q: Tell us about your company and what you’re developing. What are you most excited about? A: HarborSite is pioneering a transformative approach to treating genetic diseases by leveraging proprietary recombinase-based gene insertion technology. Through precise and efficient targeting of large DNA sequences into safe regions of the human genome, HarborSite’s platform achieves durable and robust expression of therapeutic genes, leading to curative, one-and-done treatments. Q: What advice do you have for other biotech companies just getting started? A: Surround yourself with people who have successfully gone through the challenges you are currently facing. If it is licensing — talk to academic startup founders; if it is a partnership opportunity — reach out to BDs at mid-stage biotechs, if it is fundraising — connect with CEOs who recently closed a round. The biotech field is extremely complex, requiring unique knowledge that can only be acquired with experience. Luckily, the community is very generous and willing to help new generations of entrepreneurs. Q: What has been most impactful or surprising to you since joining the MassBioDrive program? A: One of the biggest upsides of the program is the opportunity to interact with fellow co-founders, learn about their bottlenecks, realize that all of us are experiencing similar hurdles, and help each other overcome them. These are long-lasting relationships we look forward to continue building upon. Learn more about HarborSite: https://lnkd.in/ecws_Pnx Learn more about MassBioDrive: https://lnkd.in/eAztxEdd Erik Aznauryan | Ben W.

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MassBio CEO & President Kendalle Burlin O'Connell, Esq. recently spoke with Adil Ali, MD and Onyx about representing the world's most consequential life sciences ecosystem, MassBio's Vision 2030 strategic roadmap, programs like #MassBioDrive and BioversityMA, and more. Onyx's in-depth report, Vital Signs: Future of Healthcare, will appear in Fortune magazine in December ahead of JPM Week. 🔗: https://lnkd.in/eVkggiwv

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MassBioDrive harnesses the power of MassBio’s global life sciences network to help new founders launch their biotech startups. We announced our #MassBioDrive Spring 2024 Cohort back in March, and as we near the end of the eight-week program, we are highlighting our five emerging biotech companies chosen to participate. Today, please meet Sphinxion Therapeutics! Q: Tell us about your company and what you’re developing. What are you most excited about? A: We are developing adeno-associated virus mediated SGPL1 gene therapy as a lifesaving cure for sphingosine phosphate lyase insufficiency syndrome, a rare but devastating inborn error of lipid metabolism that leads to fibrotic kidney disease, kidney failure and other serious consequences. We believe our gene therapy will additionally have broad utility in the treatment of other fibrotic conditions. Q: What advice do you have for other biotech companies just getting started? A: Picking the right team to start your journey is as important as the science fueling the company. Have the end game in mind with your team to avoid irrevocable mistakes at the outset. Build a team with complementary, but different skill sets and lean on industry mentors to pressure test your work and make it better. Everything is amplified in a startup environment, so choosing the right people to learn and grow from is as important as progressing your company. Q: What has been most impactful or surprising to you since joining the MassBioDrive program? A: We expected a diversity of talent within our mentor group since the MassBioDrive program is staffed with seasoned experts across functions. We were pleasantly surprised by how quickly our group clicked and supported each other as well as our ambition for our company. Interacting with our mentors gave us tremendous insight about how our scientific knowledge, preclinical findings and key assumptions inform the strategy and tactics to propel our company forward. Learn more about Sphinxion Therapeutics: https://sphinxion.com/ Learn more about MassBioDrive: https://lnkd.in/eJrjF72Y

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In 2022 when Illumina and GRAIL leadership where touting how many lives would be saved if only the antitrust authorities got out of the way, here's what was really happening. Please read carefully, shows how this "life saving" test doesn't work: "[With the] San Francisco firefighters, the test did not identify the statistically expected number of cancers, provided false positives for half the cancers it did identify, and missed at least three cases of confirmed cancer. In other words, the exercise showed Galleri to be a disaster." "In this example prominently featured on GRAIL’s website and in marketing materials as an example of how “multi-cancer early detection screening can be critical for those at elevated cancer risk”—GRAIL provided 1,786 screenings to a group of San Francisco firefighters and their family members, a “high risk” group for certain kinds of cancer. During that testing round, which was conducted on December 6, 2022—Galleri generated six false positives and identified only five instances of cancer." "...such a result is alarming in light of the fact that, based on statistical experience, cancer should have been detected in about 29 (not five) of the 1,786 tests. Moreover, of the five instances of where cancer signals were identified, two individuals already knew they had cancer to begin with. Further, all of the instances of detected cancer were at a “late stage,” and where the cancer was too advanced to make a difference for the patients. One firefighter was diagnosed with stage 3 pancreatic cancer and is now in hospice, while another firefighter was diagnosed with lung cancer, which has now metastasized to the brain." "Galleri also missed at least six instances in which the San Francisco firefighters actually had cancer—failing to identify instances of melanoma, prostate cancer, and lymphoma that were identified by private doctors just months after the Galleri test indicated “no cancer signal.” "Further, in one instance in the San Francisco firefighters screening where Galleri generated a false positive, the patient underwent a painful bone marrow biopsy procedure to determine whether the patient did have cancer. In that case, the patient’s bone marrow biopsy procedure, clinically shown to involve “unbearable pain” to the “worst possible pain” a patient can experience, revealed that there was, in fact, no cancer." "The screenings provided to the San Francisco firefighters were an expensive “disappointment.” According to Tony Stefani, the organization’s founder, the screenings demonstrated that the probability of catching an early-stage cancer through the Galleri test was “negligible,” and the screenings only caught “some serious cancers at a later stage,” which likely would have been detected within one or two months without the test. Given the test’s high costs and useless real-world performance, Stefani stated that Galleri was a total “disappointment” and that the foundation had been sold a “bill of goods.” 🤯🤯🤯

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I've been spending a lot of time thinking about the productivity problem in life sciences R&D - which, in my opinion, seems to be the single biggest problem to solve in all of life sciences.   Inefficiency takes on an entirely new meaning in biopharma vs. other industries where it simply amounts to sunk cost. In biopharma - particularly for the long tail of smaller biopharmas - it can be the difference between missing and meeting milestones, securing and not securing funding, life and death. Being efficient is increasingly a requirement for survival. Tech certainly isn't a golden bullet, but we see a lot of opportunity for it to help move the needle, especially if it's in combination with behavioral/cultural change.   Over the last month or so I've been sharing our high-level thoughts on this topic through a series of blog posts, the last of which was published today (see comments for links to the prior two posts). This really only begins to scratch the surface on our thinking here and we're eager to chat with folks in greater detail. If you’re working in this space or have insights to share, I'd love to hear from you! https://lnkd.in/g9EsD5b3

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Our CEO Michael Nally spoke at MassBio's State of Possible Conference with Barry Greene of Sage Therapeutics, Sharon Cunningham of Shorla Oncology, and Daphne Zohar of Seaport Therapeutics, moderated by Douglas Banks of Boston Business Journal. The panel explored Massachusetts' success in the life science industry—a story of innovation and resilience. These leaders discussed how they have survived and thrived through significant challenges. In a blog entry for MassBio, Mike notes: "By spearheading the transition from trial-and-error to programable, precision-based drug development, Massachusetts is reshaping the future of healthcare to better serve patients, the ecosystem, and the economy." Learn more about the panel, including a replay: https://lnkd.in/eHanbnQF #GenerativeAI I #ProteinEngineering 

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