Inbio ventures

Our Portfolio Company, Jounce Therapeutics, Signed a Major Collaboration Deal with Celgene to Develop Next-Generation Immuno-oncology Therapies

Jounce to receive upfront payment of $225 million, a $36 million equity investment and up to an additional $2.3 billion in future milestone payments across all programs included in the collaboration
Celgene to receive options to jointly develop and commercialize Jounce’s lead product candidate, JTX-2011, and additional innovative immunotherapies targeting B cells, T regulatory cells and tumor-associated macrophages

Moscow, Russia, July 19, 2016 – A portfolio company of Pharmstandard International, S.A., Jounce Therapeutics, Inc., that is focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers for patient enrichment, today announced a global strategic collaboration with Celgene Corporation (NASDAQ: CELG) focused on developing and commercializing innovative immuno-oncology treatments for patients with cancer. The collaboration includes options on Jounce’s lead product candidate, JTX-2011, targeting ICOS, and up to four early-stage programs to be selected from a defined pool of B cell, T regulatory cell and tumor-associated macrophage targets emerging from the Jounce Translational Science Platform and an additional option to equally share a checkpoint immuno-oncology program. Post option exercise, Jounce will lead global development and U.S. commercialization for JTX-2011 and one additional collaboration program.

“Jounce has built a unique immuno-oncology platform and pipeline with a focus on the development of novel cancer therapies matched to patient populations most likely to respond,” said Robert Hershberg, M.D., Ph.D., chief scientific officer, Celgene. “This collaboration allows both companies to leverage broad capabilities in immuno-oncology to bring forward a new generation of product candidates for cancer patients.”

“Celgene is the ideal partner to collaborate with Jounce to bring potentially transformational treatments to patients with cancer,” said Richard Murray, Ph.D., chief executive officer, Jounce Therapeutics. “This partnership is of significant strategic value for Jounce. With Celgene as our partner, we can broaden our platform, advance our discovery programs and execute comprehensive clinical strategies, all in the context of our approach to bring the right immunotherapies to the right patient populations.”

“Pharmstandard International, represented by Inbio Ventures in this deal, has initially supported Jounce in 2015 with a strong group of investors. Since then Jounce has significantly advanced its immuno-oncology programs and acquired a major partner for further clinical development and commercialization. With this outstanding progress made thus far and a solid partnership, the company is incredibly well positioned to realize its strategic goals,” said Dr. Andrey Petrov, Founder and CEO of Inbio Ventures.

Under the terms of the collaboration, Jounce will receive an upfront payment of $225 million and a $36 million equity investment from Celgene. Jounce will also receive regulatory, development, and net sales milestone payments and tiered royalties on ex-U.S. sales. Aggregate payments for development, regulatory and commercial milestones could potentially be $2.3 billion in total across all programs reaching commercialization.
Celgene has the option to opt-in at defined stages of development across the programs. Following any opt-in, Celgene and Jounce will share U.S. profits and losses on all programs, as follows:

  • Jounce will retain a 60 percent U.S. profit share of JTX-2011, with 40 percent allocated to Celgene;
  • Jounce will retain a 25 percent U.S. profit share on the first additional program, with 75 percent allocated to Celgene;
  • Jounce and Celgene will equally share U.S. profits on up to three additional programs;
  • After opt-in, all development costs will be shared in a manner that is commensurate with product rights; and
  • Celgene will also receive exclusive ex-U.S. commercialization rights for each of the above programs, and Jounce is eligible to receive a royalty on any resulting ex-U.S. sales. Celgene and Jounce will equally share profits globally for the checkpoint program.

About JTX-2011
Jounce’s lead product candidate, JTX-2011, is a monoclonal antibody that binds to and activates ICOS, the Inducible T cell CO-Stimulator, a protein on the surface of certain T cells that is believed to stimulate an immune response against a patient’s cancer. We are developing JTX-2011 to treat solid tumors as a single agent and in combination with other therapies. JTX-2011 is expected to enter the clinic in the second half of 2016.

About the Jounce Translational Science Platform
Jounce’s Translational Science Platform applies an unbiased bioinformatics-based approach to interrogate particular cell types within the human tumor microenvironment (the cellular environment that makes up a tumor). The platform is designed to prioritize targets and identify related biomarkers to match the right therapy to the right patients.

About Jounce Therapeutics
Jounce Therapeutics is an immuno-oncology company dedicated to transforming the treatment of cancer. The company is discovering and developing novel cancer immunotherapies designed to harness the immune system to attack tumors and provide long-lasting benefits to patients. Jounce integrates translational science insights, including identification of related biomarkers designed to match the right immunotherapy to the right patients. The company is advancing programs that leverage contributions from its world-class founders, as well as knowledge acquired from Jounce’s Translational Science Platform, to create a sustainable “discovery to human proof-of-concept” product engine with the potential to drive significantly more durable responses to treatment. Founded by world leaders in tumor immunology, cancer biology and clinical and translational medicine, Jounce Therapeutics was launched in 2013 with funding from leading life sciences investor, Third Rock Ventures. For more information, please visit www.jouncetx.com.
Follow Jounce on social media: @JounceTx, Facebook, LinkedIn
Contacts
Pure Communications, Inc.
Dan Budwick, 973-271-6085
dan@purecommunicationsinc.com

About Pharmstandard International S.A. / Inbio Ventures
Pharmstandard International S.A. – is a company with the main focus on venture investments in innovative medicines/therapies with strong potential both globally and in Russia. Pharmstandard International S.A. is a fully owned subsidiary of PJSC Pharmstandard (LSE:PHST) – Russia’s leading pharmaceutical producer. For more information, please visit: www.pharmstd.lu
Inbio Ventures JSC – is a management company representing Pharmstandard International S.A., and providing professional support in venture transactions. For more information, please visit: http://www.inbio-ventures.com/

Pharmstandard International S.A. Represented by Inbio Ventures Participated in Growth Financing of TransMedics, Inc. from a Strong Investor Syndicate to Transform Organ Transplant Therapy

Moscow, Russia, May 26, 2016  – Pharmstandard International, S.A., has joined the $51.2 million growth equity financing round for TransMedics, Inc., a medical technology company dedicated to improving quality, assessing viability and increasing the utilization of donor organs for transplantation.

 

The financing was co-led by new global life science investors Loreda Investments, Pharmstandard International S.A. represented by Inbio Ventures, Millhouse Capital and included BioStar Ventures.  In addition, existing investors Abrams Capital, United Therapeutics, Flagship Ventures and KPCB participated in this financing.

 

“We are thankful and excited to be supported by a world-class syndicate of new and existing life science investors. This financing best positions TransMedics to capitalize on the significant market opportunity in front of us,” said Dr. Waleed Hassanein, President and CEO of TransMedics.

 

“We are delighted to be able to support the revolutionizing technology in organ transplant which has potential to replace cold storage with Organ Care System (OCS™) in multiple organ transpant practices. Despite the main investment focus of Pharmstandard International / Inbio which is aimed at pharmaceuticals, we are flexible enough to accommodate investment into medical care device space, while still striving to support development of best therapeutic options to help patients suffering from the diseases with yet unmet meecial needs,” said Dr. Andrey Petrov, Founder and CEO of Inbio Ventures.

 

TransMedics has developed the Organ Care System (OCS™), a revolutionary first-in-class technology and multi-organ platform with the potential to improve outcomes for transplant patients and to dramatically increase the number of transplantable organs worldwide. The OCS™ is the only fully portable technology that maintains donor organs in a near-physiologic state outside of the human body and addresses the current limitations of cold storage.  The OCS™ Heart and OCS™ Lung systems are CE Marked and used by leading transplant centers in Europe, Australia and Canada.  The OCS™ Heart, OCS™ Lung, and OCS™ Liver are currently in clinical trials in the United States. The results of the OCS™ Lung INSPIRE trial were recently presented at the 2016 annual meeting of The International Society for Heart and Lung Transplantation (ISHLT) in Washington, D.C.

 

About TransMedics, Inc.

TransMedics, Inc. is the world’s leader in portable ex-vivo warm perfusion and assessment of donor organs for transplantation. Headquartered in Andover, Massachusetts, the company was founded to address the unmet need for more and better organs for transplantation, and has developed technologies to improve organ quality, validate organ viability, and increase the utilization of transplant organs for the treatment of end-stage heart, lung, liver and kidney failure. For more information, please visit: www.transmedics.com

Contact:

TransMedics, Inc.

Stephen Gordon, CFO

sgordon@transmedics.com

Tel: +19785525071

www.transmedics.com

 

About Pharmstandard International S.A. / Inbio Ventures

Pharmstandard International S.A. – is a company with the main focus on venture investments in innovative drugs/therapies with strong potential both globally and in Russia. Pharmstandard International S.A. is a fully owned subsidiary of PJSC Pharmstandard (LSE:PHST) – Russia’s leading pharmaceutical producer. For more information, please visit: www.pharmstd.lu

Inbio Ventures JSC – is a management company representing Pharmstandard International S.A., and providing professional support in venture transactions. For more information, please visit: http://www.inbio-ventures.com/

Pharmstandard International, S.A., leads the new financing of up to $60 Million in Argos Therapeutics

Moscow, March 15, 2016 – Pharmstandard International, S.A., actively led and successfully closed a private placement financing (PIPE) of Argos Therapeutics, Inc. (Nasdaq: ARGS) (“Argos”), an immuno-oncology company focused on the development and commercialization of truly individualized immunotherapies for the treatment of cancer based on the Arcelis® technology platform. The securities purchase agreement anticipates the total investment up to $60 million in Argos’ common stock and warrants to fund the Company operations into the second half of 2017, when the final data from its pivotal Phase 3 ADAPT trial is expected.

 

The financing will take place in up to three tranches, with second and third closings being subject to positive output of interim data analysis from the phase 3 ADAPT trial by the Independent Data Monitoring Committee, scheduled in June and December 2016, correspondingly. Other participants in this financing include Forbion Capital Partners, Tianyi Lummy International Holdings Group Ltd., China BioPharma Capital I, L.P., TVM Capital GmbH and Wasatch Advisors, Inc. For more information, please visit www.argostherapeutics.com.

 

About Pharmstandard International S.A./ Inbio Ventures

Pharmstandard International S.A. – is a company with the main focus on venture investments in innovative drugs/therapies with strong potential at global markets and in Russia. Pharmstandard International S.A. is a fully owned subsidiary of PJSC Pharmstandard (LSE:PHST) – Russia’s leading pharmaceutical producer.

Inbio Ventures is a management company representing Pharmstandard International, S.A., and providing professional support in venture transactions.

Allena Pharmaceuticals, Inc. raises $53M from a strong syndicate of investors, including Pharmstandard International S.A.

Moscow, Russia. – Dec. 10th, 2015 – Allena Pharmaceuticals, Inc., a specialty biopharmaceutical company focused on developing and commercializing innovative nonsystemic oral protein therapeutics to treat metabolic and orphan diseases, today announced the successful completion of a $53 million Series C financing. Allena intends to use the proceeds from the financing to advance its lead product candidate, ALLN-177 for the treatment of secondary hyperoxaluria in patients with a history of calcium oxalate kidney stones, into Phase 3 clinical trials. The proceeds will also be used to explore additional indications for ALLN-177, including oxalate nephropathy and primary hyperoxaluria, and to develop new product candidates utilizing Allena’s non-systemic oral protein therapeutic platform.

The Series C financing was led by Partner Fund Management and included additional new investors Fidelity Management & Research Company and Wellington Management Company. Allena’s existing investors, Frazier Healthcare, HBM BioCapital, and Pharmstandard International, S.A. also participated in the financing. Allena has raised a total of $96 million in private equity financing to date.

“We are very happy with the strong interest and support we received from top-tier healthcare investors,” said Alexey Margolin, co-founder, president and chief executive officer of Allena Pharmaceuticals. “The broadening of our investor base provides a strong vote of confidence in the quality of Allena’s development programs, pipeline and team. It also gives us the resources needed to achieve our ultimate goal – bringing the first hyperoxaluria treatment to patients.”

Building upon the prior successful completion of Phase 1 and Phase 2a trials, Allena is presently conducting two additional Phase 2 trials of ALLN-177 in the United States for calcium oxalate kidney stone patients with hyperoxaluria. The first trial (NCT02503345) is a double-blind, placebo-controlled crossover dose-ranging study. The second trial (NCT02547805) is a double-blind, placebo-controlled parallel design study of 28 days duration.

“We have made important progress since our Series B financing late last year, with the completion of a Phase 2a clinical trial and the evolution of our company,” said Louis Brenner, MD, chief operating officer of Allena. “Hyperoxaluria is a significant metabolic disorder with no approved pharmacological treatment. We can now accelerate the development of our novel therapy to address an unmet need for patients with hyperoxaluria.”

About Hyperoxaluria and ALLN-177

Hyperoxaluria is a condition resulting from high oxalate levels in the urine due to either hyper-absorption of oxalate from the diet (secondary) or from overproduction of oxalate by the liver (primary) due to a genetic defect. Oxalate is a terminal metabolite that cannot be further degraded by humans and is primarily excreted by the kidneys. Hyperoxaluria can initially cause the development of kidney stones, and may also lead to kidney damage (nephrocalcinosis), chronic kidney disease, end-stage renal disease and dialysis. Calcium oxalate is the most common constituent of kidney stones. There are currently no approved pharmacologic treatments for hyperoxaluria.

ALLN-177 is an orally-administered, recombinant oxalate-degrading enzyme in development for the chronic management of hyperoxaluria and kidney stones (nephrolithiasis). ALLN-177 targets oxalate in the gastrointestinal tract in an effort to reduce the burden of both dietary and endogenously produced oxalate. ALLN-177 has the potential to decrease the oxalate available systemically for deposition as calcium oxalate crystals or stones in the kidneys, as well as reduce the incidence of calcium oxalate related complications. Effective management of hyperoxaluria could reduce long-term kidney complications, as well as the number of interventions required for the management of kidney stones.

About Allena Pharmaceuticals

Allena Pharmaceuticals, Inc. is a specialty biopharmaceutical company focused on developing and commercializing non-systemic protein therapeutics to treat metabolic and orphan diseases. Allena is currently conducting two additional Phase 2 clinical trials of its lead product candidate, ALLN-177, in patients with hyperoxaluria. The company’s technological approach enables the design and development of oral protein therapies that remain in the gastrointestinal (GI) tract, where the protein exerts its therapeutic effect by degrading metabolites, without being absorbed into the bloodstream. Led by a proven management team with deep expertise in protein therapeutic design and development, Allena is committed to bringing breakthrough new treatments to patients with unmet medical needs. Based in Newton, Mass., the company is supported by a top-tier investor syndicate including Frazier Healthcare, Third Rock Ventures, Bessemer Venture Partners, HBM Partners, Pharmstandard International, S.A , Partner Fund Management, Fidelity Management & Research Company, and other investors. For more information, please visit www.allenapharma.com.

Company Contact:

Janet Giroux

Manager of Corporate Operations

(617) 467-4577

jgiroux@allenapharma.com

About Pharmstandard International S.A./ Inbio Ventures

Pharmstandard International S.A. – a holding company fully committed by OJSC Pharmstandard (LSE:PHST) – is a venture investments fund focused on innovative drugs/therapies with strong potential at global markets and in Russia. Inbio Ventures is a management company representing Pharmstandard International, S.A., and providing professional support in venture transactions.