Shoreline Biosciences To Present At Two Upcoming Investor Conferences

SAN DIEGO, Nov. 23, 2021 /PRNewswire/ — Shoreline Biosciences, Inc. (Shoreline), a biotechnology company developing intelligently designed allogeneic off-the-shelf, standardized, and targeted induced pluripotent stem cells (iPSC) derived natural killer (NK) and Macrophage cellular immunotherapies, today announced that company management will present and conduct one-on-one meetings at the Piper Sandler 33rd Annual Healthcare Conference and the 4th Annual Evercore ISI HealthCONx Conference:

Piper Sandler 33rd Annual Healthcare Conference

  • Monday, November 29, 2021, Private Company Day
  • Pre-recorded presentation will be available on Monday, November 22, 2021 at 10 AM ET to conference attendees

4th Annual Evercore ISI HealthCONx Conference

  • Tuesday, November 30, 2021, fireside chat at 12:10 PM ET

About Shoreline Biosciences

Shoreline is dedicated to creating next-generation cellular immunotherapies for cancer that overcome the limitations of current cell therapy products.  Shoreline is advancing a pipeline of natural killer cell and macrophage-cell therapies into the clinic. Shoreline’s clinical candidates are derived from the company’s deep expertise in iPSC differentiation methods and genetic reprogramming of disease relevant pathways.  Shoreline has strategic partnerships with Kite, a Gilead Company, and BeiGene, a global biotechnology company, Contract Development and Manufacturing Organization partnerships with well-established organizations, and is supported by high-quality investors.  Shoreline Biosciences is headquartered in San Diego, CA. 

For more information, please visit https://shorelinebio.com/ and engage with us on LinkedIn.

 

 CONTACT: Amy Conrad, Juniper Point, amy@juniper-point.com, 858-366-3243

Intelligent Cells: Shoreline Builds Immunotherapy Platform, Pipeline with $140M Financing

 

CEO Kleanthis Xanthopoulos touts the San Diego biotech’s engineering prowess in developing iPSC-derived NK cells and macrophages against cancer

Shoreline Biosciences has developed induced pluripotent stem cell (iPSC)-derived natural killer (NK) cells and macrophages that are optimized by applying gene editing to target specific genes with properties sought by the company. San Diego-based Shoreline says its “intelligently engineered” NK cells can target and kill tumors more effectively and efficiently.

Shoreline Biosciences has nearly doubled its total capital by completing a $140-million financing that will help it further build its platform and pipeline, focused on developing natural killer (NK) and macrophage cellular immunotherapies derived from induced pluripotent stem cells (iPSCs).

The financing also gives Shoreline capital toward creating potent and persistent NK cell-specific Chimeric Antigen Receptors (CARs) as well as switchable CAR-NK cell engagers and macrophage-specific CARs to treat blood cancers, solid tumors, and other disorders.

Shoreline has developed iPSC-derived NK cells and macrophages that are optimized by applying gene editing to target specific genes with properties sought by the company. Shoreline says its “intelligently engineered” NK cells can target and kill tumors more effectively and efficiently.

“It is natural to think that we can take advantage of the biology of natural killer cells, and if we can make them more persistent, arm them with specific target missiles that we call chimeric antigen receptors and direct them towards the site of the tumor cell, it will have an effect,” Kleanthis G. Xanthopoulos, PhD, Shoreline’s chairman and CEO, told GEN Edge.

Shoreline reasons it can produce NK cells faster, less expensively, and with potential for re-dosing compared with CAR T cell therapies. Despite their effectiveness fighting blood tumors, CAR-T therapies have shown significant side effects, notably cytokine release syndrome and graft versus host disease. And while T cells require activation before they can be sicced on cancer cells, being part of the adaptive immune system, NK cells do not since they are within the innate immune system.

“We found out that you can engineer the cells to be a better athlete, metabolically better fitted. They can persist longer. They can withstand the tumor micro-environment, which is a hostile environment typically for any cell therapy approaches,” he added. “Armed with these additional properties, we’re hoping that we can have a huge impact on the tumor cells.”

In NK cells, for example, Shoreline has removed the cytokine-inducible SH2 (CIS) protein encoded by the CISH protein coding gene and known to block the interleukin (IL)-2 and IL15 signaling that is critically important for activating cell proliferation.

“If we can intelligently remove that CIS protein, we see an NK cell that responds better to cytokines and at much lower concentrations, is metabolically more active, is a metabolically better fitted cell. It kills better because it produces many more different cytokines and it also withstands the tumor micro-environment better,” Xanthopoulos explained. “That’s the whole idea of intelligent-designed allogeneic cells.”

Looking beyond cancer

Shoreline has chosen to focus on cancer given the huge unmet medical need and the innate ability of NK cells to fight tumors. Long-term, however, the company envisions fighting cancer as well as chronic and infectious diseases through cell therapies based on macrophages.

“We know that there are chronic diseases that eventually can be addressed with macrophage cell therapies that have the innate ability to repair damaged tissue, and you can think of a number of diseases down the road that potentially macrophages can have the ability to do that,” Xanthopoulos said.

“What stands between our goals and moving non-oncology clinical programs forward is the need to understand better the so-called immunodepletion and conditioning of these patients, which we’re doing in the oncology setting, but you can’t necessarily consider doing that for chronic disease,” he added. “We can address that in in the future but the immediate focus is on oncology.”

Could Shoreline someday create cell therapies that combine NKs and macrophages?

“The short answer is yes, they indeed can complement each other,” Xanthopoulos replied. “Down the road we can potentially consider combining those two, but obviously we need to study them in the clinic individually and understand how they behave before we take that step.”

Shoreline’s core cell therapy platform is already designed to produce a homogenous population of optimized, fully functional immune cells. By cloning a select master iPSC-derived NK cell with its new optimized genetic signature, the company said, it can amplify that superior NK cell to create an unlimited number of homogenous quantities of the living cell therapy. The cells are then cryopreserved and stored, ready to treat any number of patients within hours.

“The clonal expansion capabilities of pluripotent stem cells give us the ability to do all the engineering we want at the pluripotent stem cell level, then select the clones or the clone that has the phenotype and the genotype that we are interested in,” Xanthopoulos said.

“From that clone, we can engineer trillions of cells. The process is relatively straightforward. It’s a clonal expansion of the clone that we have identified, and it gives us the ability to then create from a single run currently up to 500 doses, and it the yield will certainly increase as we optimize and we move into what we call smart manufacturing, which we plan to bring online in a couple of years from now.”

To satisfy its initial manufacturing need to get its candidates into the clinic for Phase I studies, Shoreline has partnered with UC San Diego’s Advanced Cell Therapy Laboratory (ACTL). The company says its partnership with ACTL allows it to bring in-house GMP grade iPSCs to bank and rapidly initiate preclinical development and IND-enabling studies. [Shoreline Biosciences]To satisfy its initial manufacturing need to get its candidates into the clinic for Phase I studies, Shoreline has partnered with UC San Diego’s (UCSD) Advanced Cell Therapy Laboratory (ACTL). The company says its partnership with ACTL allows it to bring in-house GMP grade iPSCs to bank and rapidly initiate preclinical development and IND-enabling studies.

$300M in capitalization

Shoreline said the financing, announced Tuesday, brings its total capitalization to more than $300 million. Roughly half of that capital consists of upfront cash that Shoreline received when it signed a pair of cell therapy collaborations in June with big-name partners Kite, a Gilead Company, and BeiGene—collaborations that could generate more than 10 times Shoreline’s current capitalization.

Kite is also partnering with oNKo-innate to develop NK cells. Numerous other companies have expanded into NK cell drug development; Artiva Biotherapeutics, for example, is building a pipeline of NK cell products that include antibody-dependent cellular cytotoxicity (ADCC) enhancers and targeted NK cells engineered to express proprietary CARs. Artiva, Catamaran Bio, Dragonfly Therapeutics, Fate Therapeutics, Kiadis, and Nkarta are among other companies focused on NK cell development.

“These transformative corporate partnerships with Kite and BeiGene have tripled the size of our aspirations and clinical trials,” and thus the number of treatment candidates in Shoreline’s pipeline, Xanthopoulos said. “As such, we are expanding our capabilities in manufacturing.” Shoreline is already building a “smart” manufacturing facility in San Diego designed to enable full automation. Xanthopoulos said the facility will enable the company to keep costs low. “We will announce in the near future some additional collaborations to secure additional manufacturing capabilities,” Xanthopoulos added.

Kite and Shoreline are partnering to develop novel allogeneic candidates for several blood cancers. The companies’ collaboration is initially focusing on CAR NK targets, with Kite having an option to expand the collaboration to include an iPSC CAR macrophage program for an undisclosed target.

“We already have constructs that we received from Kite. They’re now engineered in the backbone of our NK cells that have the CISH knockout. And we’re putting them together, and advancing with the aim to be in the clinic with the KITE collaborations programs in the next couple of years,” Xanthopoulos said.

Kite—which participated in Shoreline’s $43-million Series A round completed last April—selected Shoreline as its strategic partner for a strategic expansion into allogeneic iPSC therapies based around NK cells, in due to the expertise of the laboratory of Dan S. Kaufman, MD, PhD, a UCSD investigator and Shoreline co-founder, who serves as the company’s Chief Scientific Officer.

Last year, Kaufman and Xanthopoulos joined 30-year biotech veteran Steven Holtzman, the former CEO of Decibel Therapeutics, and William Sandborn, MD, in co-founding Shoreline to commercialize research and tech developed in the labs of Kaufman and Sandborn, who is Director of the Inflammatory Bowel Disease Center at UCSD and Shoreline’s Chief Medical Officer. Shoreline is also developing and commercializing additional technologies from Scripps Research’s Calibr division.

NK Cell Partnership

With BeiGene, Shoreline agreed to develop and commercialize NK-based cell therapeutics by combining its research and clinical development capabilities with Shoreline’s iPSC NK cell technology. BeiGene will retain worldwide development and commercialization rights for up to four targets—two solid tumors two blood tumors—with Shoreline holding an option to retain exclusive U.S. and Canadian rights for two of those four, as well as royalties.

BeiGene paid $45 million upfront to launch their collaboration, which could generate more than $1.3 billion for Shoreline in additional R&D funding, milestone payments, plus royalties. Shoreline is overseeing clinical manufacturing, while clinical development will be led by BeiGene globally.

“What we show in partnering with BeiGene is their amazing global clinical development and protein engineering capabilities as we plan to potentially combine our cells with antibodies, or so-called engagers that further enhance the activity of our NK cells,” Xanthopoulos said. “Those are core strategic capabilities—not just from the financial and validation perspective, but importantly from the clinical focus perspective—therefore amplifying Shoreline’s capabilities.”

BeiGene received an option to acquire an equity stake in a subsequent Shoreline financing—an option BeiGene exercised when it joined Kite as an investor in the $140-million financing. The round was led by Aly Bridge Group—whose founder, CEO and CIO Frank Yu joined Shoreline’s board in connection with the financing.

Yu stated that Ally Bridge Group, which focuses its investments on what it deems best-in-class cell therapy companies from oncology to autoimmune diseases, “expects Shoreline to be a new category leader.”

Other new investors in the $140-million round included Eventide Asset Management, Irving Investors, Kingdon, NS Investment, Piper Heartland Healthcare Capital, and Superstring. They were joined by previous investors including Boxer Capital, BVF Partners, Commodore Capital, Cormorant Asset Management, Janus Henderson Investors, Stork Capital, and Wedbush Healthcare Partners.

The latest financing will help Shoreline fund an ongoing expansion: The company plans to double its workforce, now close to 50 full-time equivalents, and anticipates moving in the second quarter of 2022 into a new 60,000-square-foot headquarters in San Diego.

Shoreline has mostly completed its executive suite with the appointment of Scott Forrest, PhD as Chief Business Officer; he was previously CFO of Autobahn Therapeutics. Further expansion will focus on R&D, clinical operations, and Chemistry, Manufacturing and Controls (CMC).

https://www.genengnews.com/topics/drug-discovery/intelligent-cells-shoreline-builds-immunotherapy-platform-pipeline-with-140m-financing/

California Life Sciences awarded Kite Pharma, a Gilead company, and Shoreline Biosciences the 2021 Strategic Partnership of the Year Award

Shoreline Biosciences, Inc. is thrilled and honored to be recognized by the California Life Sciences (CLS) as the #Pantheon2021 award winner for the Strategic Partnership of the Year Award. Thank you, Kite Pharma, a Gilead company; we are incredibly grateful for your continued partnership as we develop safe, effective, and affordable iPSC-derived cell therapies. 

Developing Allogeneic Induced Pluripotent Stem Cell Based Therapies to Kill Cancer Cells with Kleanthis Xanthopoulos Shoreline Biosciences

Nov 4, 2021

Kleanthis Xanthopoulos is Co-Founder and CEO of Shoreline Biosciences. He talks about the Shoreline cell therapy platform that uses standardized manufacturing of allogeneic induced pluripotent stem cells to create an effective treatment to kill tumor cells with multiple advantages over autologous T-cell therapies.

Kleanthis explains, “We are focusing specifically on two different effector cells, Natural Killers and Macrophages, and we derive them from a platform which is induced pluripotent stem cells. This gives us the ability to really engineer the NK cells and Macrophages that we derive from iPSC, so they become allogeneic standardized, meaning they can be introduced to any patient and then are targeted and specific.”

“Initial clinical results are showing us that iPSC derived NK cells don’t appear to have the kind of side effects that you see with T-cells. So we are very, very excited about that. And we are seeing that there’s a different dimension in cell therapies that can be served very, very nicely through these allogeneic pluripotent stem cell based therapies.”

After the interview, Shoreline announced it has raised $140 million in its latest fundraising round.

#ShorelineBio #ShoreBiosciences #Oncology #Immunotherapy #NKCells #iPSC #Macrophages #SanDiego

Download the transcript here

Dendreon Pharmaceuticals and Shoreline Biosciences Announce CMC and Manufacturing Alliance to Advance the Future of iPSC Cellular Therapy

– Partnership Focuses on Next Generation Allogeneic Cell Therapies –

SEAL BEACH, Calif. & SAN DIEGO, November 4th , 2021 – Dendreon Pharmaceuticals, a commercial-stage biopharmaceutical company and pioneer in the development of cellular immunotherapy, and Shoreline Biosciences, a biotechnology company developing allogeneic off-the-shelf, standardized, and targeted natural killer (NK) and macrophage cellular immunotherapies derived from induced pluripotent stem cells (iPSC) for cancer, today announced an alliance to advance the future of iPSC-derived cellular therapies.

The alliance leverages Dendreon’s extensive manufacturing, process development and end-to-end logistics expertise for the advancement of Shoreline’s pipeline of iPSC-derived cellular therapies. Dendreon is providing scalable cGMP manufacturing support for certain programs through clinical development and launch, enabling Shoreline to rapidly advance multiple products in parallel.

“With more than a decade of proven expertise in cell therapy manufacturing and an established supply chain and logistics infrastructure, Dendreon is well positioned to support Shoreline in manufacturing from Phase I clinical trials through commercialization,” said Maria Cho, Vice President of Business Development and Corporate Strategy. “We are thrilled to partner with Shoreline to enable the future of cell therapy and change the way serious diseases are treated.”

“We are excited to partner with Dendreon, a leader in cell therapy, to manufacture cost-efficient, highly-scalable product candidates,” said Mohammad El-Kalay, Ph.D., Senior VP & Head of CMC for Shoreline.  “Through our partnership with Dendreon, we are accelerating the commercialization of our next generation NK cell and macrophage products to bring scalable, allogeneic, “off the shelf” therapies to more patients in need.”

###

About Dendreon

Dendreon is a commercial-stage biopharmaceutical company and end-to-end provider of manufacturing services for the cell therapy market. Dendreon’s flagship product, PROVENGE® (sipuleucel-T), was the first FDA-approved immunotherapy made from a patient’s own immune cells and has been prescribed to over 40,000 men in the U.S. since 2010. Dendreon is headquartered in Seal Beach, Calif. For more information about Dendreon’s contract manufacturing services division, please visit https://www.dendreon.com/Partner-With-Us.

About Shoreline’s iPSC NK cell technology

Shoreline has developed a proprietary platform focused on iPSC-derived natural killer (NK) cells and macrophages that are optimized with precise and rational genetic reprogramming. The Shoreline NK cell and macrophage-based cell therapies are designed to provide an effective and efficient means for targeting and killing tumors as well as repairing tissue homeostasis. Shoreline’s approach, based on the advantage of its iPSC cell engineering and expansion, is being used to create a streamlined, affordable, and scalable manufacturing process that can deliver cell therapy treatments to patients in a more cost-effective, time-saving manner. Shoreline’s technology is at the forefront of regenerative medicine and is being used to develop potential therapies to treat a wide range of oncology indications.

About Shoreline Biosciences

Shoreline is dedicated to creating next-generation cellular immunotherapies for cancer that overcome the current limitations of first-generation cell therapy products.  Shoreline is building a pipeline of natural killer (NK) cell and macrophage-cell therapy candidates derived from its deep expertise in iPSC differentiation methods and genetic reprogramming of disease relevant pathways.  Shoreline has strategic partnerships with Kite, a Gilead Company, and BeiGene, a global biotechnology company, and is supported by high-quality institutional investors.  Shoreline Biosciences is headquartered in San Diego, CA.

For more information, please visit https://shorelinebio.com/ and engage with us on LinkedIn.

Shoreline Biosciences Investor and Media Contact:
Amy Conrad
Juniper Point
amy@juniper-point.com
858-366-3243

Shoreline Biosciences – (iPSC)-Derived Allogeneic Natural Killer (NK) and Macrophage Products

Dr. Kleanthis Xanthopoulos, co-founder,  Chairman  and CEO of Shoreline Biosciences, discusses the development of genetically engineered induced pluripotent stem cell (iPSC)-derived allogeneic natural killer (NK) and macrophage products that are intelligently designed for greater  specificity, potency and persistence, overcoming the limitations of early cell therapies, for use in oncology and regenerative medicine. 

Kleanthis is a serial biotechnology entrepreneur with over two decades of experience in the biotechnology and pharmaceutical research industries as an executive, company founder, chief executive officer, investor and board member.

Dr. Xanthopoulos has founded five companies, introduced three life science companies to NASDAQ and financed and brokered numerous creative strategic alliance and partnership deals with large pharmaceutical partners.In addition to his role at Shoreline Biosciences, Dr. Xanthopoulos is the Chairman of Stork Capital Life Sciences which focuses on building and investing in innovative biotechnology companies. Dr. Xanthopoulos is a member of the board of directors of IRRAS AB, Connect Biopharma, (NASDAQ: CNTB), Zosano Pharma, Inc., (NASDAQ: ZSAN), and is the co-founder and a member of the board of directors of privately held Sente Inc.

Previously, he served on the boards of LDO sp.a. (Milan, Italy), Odyssey Therapeutics, Anadys Pharmaceuticals and Regulus Therapeutics.

Dr. Xanthopoulos participated in The Human Genome Project as a Section Head of the National Human Genome Research Institute from 1995 to 1997. Prior to this, he was an Associate Professor at the Karolinska Institute, Stockholm, Sweden. An Onassis Foundation scholar, Dr. Xanthopoulos received his B.Sc. in Biology with honors from Aristotle University of Thessaloniki, Greece, and received both his M.Sc. in Microbiology and Ph.D. in Molecular Biology from the University of Stockholm, Sweden.

https://healthprofessionalradio.com.au/shoreline-biosciences-ipsc-derived-allogeneic-natural-killer-nk-and-macrophage-products/ 

Shoreline Biosciences Announces $140M Financing To Advance Pipeline Of Next Generation Cell Immunotherapies

Financing accelerates the growth of Shoreline’s pipeline of iPSC-based cell immunotherapies for the treatment of seriously ill patients and enables the buildout of smart manufacturing capabilities

SAN DIEGO, Nov. 2, 2021 /PRNewswire/ — Shoreline Biosciences, Inc. (Shoreline), a biotechnology company developing intelligently designed allogeneic off-the-shelf, standardized, and targeted induced pluripotent stem cells (iPSC) derived natural killer (NK) and macrophage cellular immunotherapies, today announced the completion of a $140M financing, led by Ally Bridge Group, with participation from new investors Eventide Asset Management, BeiGene, Irving Investors, Kingdon, NS Investment, Piper Heartland Healthcare Capital, and Superstring.  Existing investors Boxer Capital, BVF Partners, L.P., Commodore Capital, Cormorant Asset Management, Janus Henderson Investors, Kite, a Gilead Company, Stork Capital, Wedbush Healthcare Partners and an undisclosed leading global investment firm, also participated.  In connection with the financing, Frank Yu, Founder, CEO and CIO of Ally Bridge Group, joined the Shoreline Board of Directors.   

“We are proud of Shoreline’s tremendous progress over the past year, including next generation, more persistent and more effective iPSC-derived NK cells, enhancing our core technologies, advancing our preclinical programs, establishing transformative and validating partnerships with Kite and BeiGene, creating smart manufacturing methods, and attracting exceptional talent to support our next phase of development and growth,” said Kleanthis G. Xanthopoulos, Ph.D., Shoreline’s co-founder, Chairman and Chief Executive Officer. “With this financing and our corporate partnerships, Shoreline has now more than $300 million to continue building our pipeline of safe, effective and affordable cellular immunotherapies for both solid tumors and hematologic malignancies.”

“Having invested in – and followed closely for several years — the iPSC-derived NK cells-based therapeutics field which has made highly encouraging progress in the clinic, we are convinced of the true differentiation demonstrated by the Shoreline technology platform. Ally Bridge Group, a leading investor in best-in-class cell therapy companies from oncology to autoimmune diseases, expects Shoreline to be a new category leader,” said Frank Yu, Founder, CEO and CIO of Ally Bridge Group.   

The proceeds from the financing will allow Shoreline to continue the advancement of its proprietary iPSC platform focused on developing next generation natural killer (NK) cell and macrophage-cell therapies, create potent and persistent NK cell-specific Chimeric Antigen Receptors (CARs) as well as switchable CAR-NK cell engagers and macrophage-specific CARs to treat blood cancers, solid tumors, and other health conditions.   With the close of this financing, Shoreline is well-capitalized with greater than $300 million, including committed partnership R&D funding, to execute on its goals and advance its pipeline.

About Shoreline Biosciences

Shoreline is dedicated to creating next-generation cellular immunotherapies for cancer that overcome the current limitations of first-generation cell therapy products.  Shoreline is building a pipeline of natural killer cell and macrophage-cell therapy candidates derived from its deep expertise in iPSC differentiation methods and genetic reprogramming of disease relevant pathways.  Shoreline has strategic partnerships with Kite, a Gilead Company, and BeiGene, a global biotechnology company, Contract Development and Manufacturing Organization partnerships with well-established organizations, and is supported by high-quality investors.  Shoreline Biosciences is headquartered in San Diego, CA. 

For more information, please visit https://shorelinebio.com/ and engage with us on LinkedIn.

Shoreline Biosciences Investor and Media Contact:
Amy Conrad
Juniper Point
amy@juniper-point.com
858-366-3243

San Diego biotech raises $140M in quest for ‘one-size-fits-all’ cancer treatments

JONATHAN WOSEN BIOTECH REPORTER 

San Diego biotech Shoreline Biosciences announced Tuesday that it has raised $140 million to fund a one-size-fits-all strategy that would use genetically modified immune cells to kill cancer cells.

That’s a popular goal these days. The Food and Drug Administration has approved a growing list of so-called CAR-T therapies, which take a patient’s own immune cells, equip them to recognize and attack a certain cancer, and reinfuse those modified cells back into the patient.

This approach has proven life-changing for some people, but it’s got drawbacks. In some cases, CAR-T therapy triggers overwhelming inflammation that can be debilitating — even deadly. And making tailored treatments is expensive and time-consuming, sometimes taking several weeks. That’s time the sickest patients don’t have.

To avoid these issues, Shoreline’s taking a different tack, developing “off-the-shelf” immune cell therapies that could work across patients. To do so, the company is coaxing stem cells to grow into two types of immune cells in the lab. These are natural killer cells, which target cancerous and infected cells, and macrophages, which clear out dead cells, alert other immune cells and regulate wound healing and tissue repair.

CAR-T therapies use T cells, which can trigger strong immune responses but will also attack healthy tissue if used in a different patient. That’s why CAR-T is currently a bespoke treatment.

Shoreline’s idea is to equip natural killer cells and macrophages with proteins they’ll need to recognize and fight against different cancer types, including leukemias and lymphomas. The company plans to eventually target some inflammatory diseases, too.

“We want to ultimately use cell therapy in a community setting exactly like the way you take a pill for any chronic disease,” said CEO Kleanthis Xanthopoulos.

The company, founded in the spring of 2020, has raised more than $300 million. The latest

Imagining the future of medicine and healthcare is one thing, evolving those ideas from science fiction to science reality is quite another. But that’s exactly what the Bristol Myers Squibb (BMS) Research & Development site in San Diego is…

“We have tons of money,” Xanthopoulos said. “If we cannot prove that we can do what our vision states, then we’re not worth, obviously, that investment.”

The company expects to begin clinical trials on at least one of its experimental treatments by the end of 2022 and hopes to have a steady stream of one to two drugs entering clinical trials each year that follows.

Shoreline struck deals in June with two other biotechs, Kite and BeiGene, to help turn its basic science into biomedical breakthroughs. The deal with California firm Kite, a Gilead subsidiary, has Shoreline conducting early-stage research on three blood cancer treatments for Kite, which will take over once the drugs are cleared to enter clinical trials. That deal could be worth $2.3 billion-plus royalties if all goes well.

The biotech is also working with China-based BeiGene on four cancer-immune cell therapies. Shoreline will have the option to retain the rights to develop and sell two of these products in the U.S. and Canada, and Xanthopoulos says the collaboration could bring the company up to $1.3 billion.

Shoreline has close ties with UC San Diego, and has licensed much of its technology from stem cell expert Dr. Dan Kaufman, UCSD’s director of cell therapy, who is one of the company’s co-founders, serves as chief scientific officer and sits on the firm’s board.

Other local companies are also developing off-the-shelf immune cell therapies against various cancers, including Fate Therapeutics, Poseida Therapeutics and Artiva Biotherapeutics.

Xanthopoulos says there’s plenty of space for everyone, likening this wide-open field to antibodies, which countless biotechs use in different ways for different diseases. The veteran biotech entrepreneur has been the founding CEO of four other San Diego life science firms: Regulus Therapeutics, Anadys Pharmaceuticals, Senté Labs and IRRAS. Regulus, Anadys and IRRAS all went public, with Roche later acquiring Anadys for $230 million.

Shoreline, headquarted in Sorrento Valley, has about 50 employees, though the company will double in size within the next year and has already signed a lease to expand its presence in the Sorrento area.

https://www.sandiegouniontribune.com/business/story/2021-11-02/sorrento-valley-biotech-raises-140m-for-cancer-immunotherapy  

 

Fresh off Kite and BeiGene deals, Shoreline ups the ante with a hefty crossover

Editor: Max Gelman

Though it may seem like Shoreline Biosciences is rapidly gaining momentum with a flurry of deals — and, now, a new funding round — Kleanthis Xanthopoulos doesn’t feel he’s in a rush.

The biotech’s chief executive put the bow on a $140 million Series B on Tuesday, as Shoreline continues a streak of wheeling and dealing that’s seen it partner with Gilead’s Kite and BeiGene these last few months. And despite the new raise technically being a crossover round with Ally Bridge Group leading the way, Xanthopoulos is taking his time in prepping a public offering.

“It’s only smart for us to be ready for an IPO, but we have so much capital we can pick the right timing,” Xanthopoulos told Endpoints News. “Practically, we’re going to be ready to become a public company. When the time comes, we’ll be set, but it’s good to have that luxury.”

Driving all the interest are Shoreline’s off-the-shelf cancer therapies, including a particular focus on iPSC NK cells and macrophages for various tumors. Partnered with Dan Kaufman’s lab out of UC-San Diego, Shoreline has built a war chest of $300 million to advance such treatments, build out its manufacturing capabilities and sign its high-profile collaborations.

Manufacturing specifically has a special place in Shoreline’s plans, as Xanthopoulos eventually hopes the company will be able to create NK cell therapies that will be used in the community setting. It’s a pitch that’s driven significant investment toward the field as a whole, with companies like Artiva gaining backing from blue-chip investors and Merck.

But Shoreline’s focus on pluripotent stem cells — compared to Artiva’s donor cell approach — gives it a key differentiating factor, Xanthopoulos said. The two have very different manufacturing processes and the CEO believes iPSC NK cells will prove safer and more cost-effective in the long run.

“We incorporated AI, automation to completely rethink how we’re going to create the manufacturing,” he said. “We’ve recruited people from the electronic chip manufacturing industry to see how it worked there. A large portion of the raise is earmarked to build that facility.”

The company is now sitting on 10 pipeline programs largely aimed at a variety of hematological and solid tumors. Xanthopoulos said there are nine candidates involving NK cells, including two in house, three from the Kite partnership and four being co-developed with BeiGene. The last is Shoreline’s in-house macrophage program, which is slightly behind the rest, the CEO said.

Xanthopoulos likes to think of it as not just Shoreline’s pipeline, however, but the pipelines of three different companies coming together. Moving forward, Shoreline is getting ready to send its first IND for the lead in-house NK cell therapy by the end of 2022, with plans to submit “one or two” INDs every year after that, Xanthopoulos said.

And once that’s accomplished, maybe the IPO will come. But Xanthopoulos isn’t counting his cell therapies before they come home to roost.

“We want to see [our therapies] as broadly available as antibodies,” he said. “It should be that simple given how safe the NK cells have proven to be in the clinic.”

https://endpts.com/fresh-off-kite-and-beigene-deals-shoreline-ups-the-ante-with-a-hefty-crossover-but-the-biotech-insists-its-in-no-rush/ 

Shoreline Biosciences Announces $140M Financing To Advance Pipeline Of Next Generation Cell Immunotherapies

Financing accelerates the growth of Shoreline’s pipeline of iPSC-based cell immunotherapies for the treatment of seriously ill patients and enables the buildout of smart manufacturing capabilities

SAN DIEGO, Nov. 2, 2021 /PRNewswire/ — Shoreline Biosciences, Inc. (Shoreline), a biotechnology company developing intelligently designed allogeneic off-the-shelf, standardized, and targeted induced pluripotent stem cells (iPSC) derived natural killer (NK) and macrophage cellular immunotherapies, today announced the completion of a $140M financing, led by Ally Bridge Group, with participation from new investors Eventide Asset Management, BeiGene, Irving Investors, Kingdon, NS Investment, Piper Heartland Healthcare Capital, and Superstring.  Existing investors Boxer Capital, BVF Partners, L.P., Commodore Capital, Cormorant Asset Management, Janus Henderson Investors, Kite, a Gilead Company, Stork Capital, Wedbush Healthcare Partners and an undisclosed leading global investment firm, also participated.  In connection with the financing, Frank Yu, Founder, CEO and CIO of Ally Bridge Group, joined the Shoreline Board of Directors.   

“We are proud of Shoreline’s tremendous progress over the past year, including next generation, more persistent and more effective iPSC-derived NK cells, enhancing our core technologies, advancing our preclinical programs, establishing transformative and validating partnerships with Kite and BeiGene, creating smart manufacturing methods, and attracting exceptional talent to support our next phase of development and growth,” said Kleanthis G. Xanthopoulos, Ph.D., Shoreline’s co-founder, Chairman and Chief Executive Officer. “With this financing and our corporate partnerships, Shoreline has now more than $300 million to continue building our pipeline of safe, effective and affordable cellular immunotherapies for both solid tumors and hematologic malignancies.”

“Having invested in – and followed closely for several years — the iPSC-derived NK cells-based therapeutics field which has made highly encouraging progress in the clinic, we are convinced of the true differentiation demonstrated by the Shoreline technology platform. Ally Bridge Group, a leading investor in best-in-class cell therapy companies from oncology to autoimmune diseases, expects Shoreline to be a new category leader,” said Frank Yu, Founder, CEO and CIO of Ally Bridge Group.   

The proceeds from the financing will allow Shoreline to continue the advancement of its proprietary iPSC platform focused on developing next generation natural killer (NK) cell and macrophage-cell therapies, create potent and persistent NK cell-specific Chimeric Antigen Receptors (CARs) as well as switchable CAR-NK cell engagers and macrophage-specific CARs to treat blood cancers, solid tumors, and other health conditions.   With the close of this financing, Shoreline is well-capitalized with greater than $300 million, including committed partnership R&D funding, to execute on its goals and advance its pipeline.

About Shoreline Biosciences

Shoreline is dedicated to creating next-generation cellular immunotherapies for cancer that overcome the current limitations of first-generation cell therapy products.  Shoreline is building a pipeline of natural killer cell and macrophage-cell therapy candidates derived from its deep expertise in iPSC differentiation methods and genetic reprogramming of disease relevant pathways.  Shoreline has strategic partnerships with Kite, a Gilead Company, and BeiGene, a global biotechnology company, Contract Development and Manufacturing Organization partnerships with well-established organizations, and is supported by high-quality investors.  Shoreline Biosciences is headquartered in San Diego, CA. 

For more information, please visit https://shorelinebio.com/ and engage with us on LinkedIn.

Shoreline Biosciences Investor and Media Contact:
Amy Conrad
Juniper Point
amy@juniper-point.com
858-366-3243