On January 10, 2020 PACT Pharma, in pursuit of its vision to eradicate solid tumors using transformational, first-in-class fully personalized NeoTCR-T cell therapies, reported that it has closed an oversubscribed $75 million Series C financing (Press release, PACT Pharma, JAN 10, 2020, View Source [SID1234552981]). This round, led by Vida Ventures, a next generation life science venture firm with industry-leading experience in the cell and gene therapy, also included current investors of PACT.

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Combined with proceeds from previous financings, PACT will use the Series C proceeds to expand the scope of its clinical plan to investigate NeoTCR-T cell products targeting multiple neoantigens for a spectrum of solid tumor types. In addition to clinical expansion, PACT will open in 2020 a next-gen GMP manufacturing facility in South San Francisco to support the end-to-end production and supply chain for the engineering of personalized neoantigen-targeted autologous T cells. Under the direction of industry veteran Tim Moore, President and Chief Technology Officer, PACT will leverage the new in-house manufacturing facility to automate manufacturing and analytic processes to reduce cycle time and manufacturing costs.

"PACT has grown from company launch to opening its first-in-kind clinical trial in two years. Our progress has been exhilarating and the support from our existing investors has made that progress possible," said Alex Franzusoff, PhD, Chief Executive Officer of PACT Pharma. "As we look to the next stage of our development and expansion of our clinical programs, we are excited to have interest from a new group of prominent investors who both understand the potential of NeoTCR-T cell therapy and have direct experience in the space. Vida Ventures stood out as a partner of choice, given their depth of operational experience in research, clinical development and manufacturing in cell therapy as well as their proven ability to guide companies like Kite and Allogene across key stages of development.

As part of the Series C financing, Helen S. Kim, Managing Director at Vida Ventures, will join the Company’s Board of Directors. Ms. Kim brings over 25 years of biotechnology leadership experience and serves on the boards of Assembly Biosciences, Applied Molecular Transport, A2 Biotherapeutics and Exicure, Inc.

"Our investment in PACT Pharma represents our goal to fund scientific advances by embracing cutting edge innovation with the potential to make a meaningful difference in the lives of patients," said Kim. "PACT has developed a pioneering platform of personalized designer T cells with the potential to target some of the most elusive solid cancers facing society today."

On January 10, 2020 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported a strategic outlook for 2020 outlining key priorities for its broad pipeline (Press release, Syndax, JAN 10, 2020, View Source [SID1234552980]).

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"We expect 2020 to be an exciting and transformative year for the Company, with significant data read outs anticipated for all three of our innovative pipeline programs, each addressing an unmet need for some of today’s most underserved patient populations," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "Notably, this includes the final overall survival readout for E2112, our Phase 3 registration trial of entinostat plus exemestane in HR+, HER2- breast cancer, which we expect in the second quarter of 2020. Based on compelling survival data from the Phase 2b ENCORE 301 trial, we believe that the combination of entinostat and exemestane has strong potential to serve as an effective therapeutic option for the substantial number of patients who have progressed on first line hormone treatment. We are on track to file for regulatory approval in 2020 and to become a fully-integrated oncology company with the launch of entinostat in HR+ breast cancer expected in 2021."

Dr. Morrison added, "In 2020, we also expect meaningful data readouts from the Phase 1/2 AUGMENT-101 trial of SNDX-5613, our potent, highly selective, oral Menin inhibitor, in adults with relapsed/refractory acute leukemias and the Phase 1 dose escalation trial of SNDX-6352, our anti-CSF-1R monoclonal antibody, in patients with cGVHD."

Anticipated Key Milestones for 2020

Entinostat

The Company continues to anticipate that the E2112 trial will reach 410 death events in the second quarter of 2020, triggering the final overall survival (OS) analysis. E2112 is Syndax’s NCI-sponsored, ECOG-ACRIN-led Phase 3 registration trial of entinostat, a Class I selective HDAC inhibitor, plus exemestane in advanced hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer.

A positive OS assessment would enable the Company to file for full regulatory approval in the U.S. The E2112 trial design was informed by the Phase 2b ENCORE 301 trial, the results of which led to entinostat’s Breakthrough Therapy designation in HR+ breast cancer, in which patients receiving the entinostat/exemestane combination demonstrated a clinically meaningful OS benefit over treatment with exemestane alone. The Company continues to actively engage in expanding its commercial and medical affairs activities, to support the planned launch of entinostat in the U.S.

SNDX-5613

Syndax anticipates presenting initial clinical data from its Phase 1/2 open-label AUGMENT-101 trial of SNDX-5613, the Company’s potent, highly selective oral Menin inhibitor, at a medical conference in the fourth quarter of 2020. Given that the AUGMENT-101 trial is open-label, meaningful interim data including pharmacokinetic, pharmacodynamic and efficacy data may be available earlier in the year.

The Phase 1 dose escalation portion of AUGMENT-101 is enrolling adults with relapsed/refractory acute leukemias, including patients with MLL-rearrangements and NPM1c mutations, to establish a recommended Phase 2 dose. The Phase 2 portion will evaluate efficacy, as defined by Complete Response rate (per International Working Group response criteria), across three expansion cohorts: MLL-rearranged (MLL-r) acute lymphoblastic leukemia, MLL-r acute myeloid leukemia (AML), and NPM1 mutant AML.

SNDX-6352

The Company has also initiated a Phase 2 expansion cohort for SNDX-6352, its anti-CSF-1R monoclonal antibody, for the treatment of chronic graft versus host disease (cGVHD). The decision to move to the Phase 2 expansion was driven by recently announced encouraging proof of concept results from the ongoing Phase 1 dose escalation trial in which the Company observed responses in all evaluable patients as of the data cutoff date, with no dose limiting toxicities reported.

The Phase 2 expansion cohort is expected to enroll up to 22 patients to further characterize the safety and efficacy at an initial dosing schedule of 1.0 mg/kg of SNDX-6352 administered every two weeks. The Company expects to present results from the Phase 1 trial, for which dose escalation remains ongoing, in the second half of 2020.

On January 10, 2020 OptiKira, LLC, a privately-held biotechnology company developing drugs that inhibit the unfolded protein response (UPR), reported that it has scheduled a company presentation at the upcoming Biotech Showcase being held in San Francisco from January 13-15, 2020, during the most important week in healthcare (Press release, OptiKira, JAN 10, 2020, View Source [SID1234552979]).

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Dr. Tim Pelura, President and Chief Executive Officer of OptiKira, will be presenting at the Biotech Showcase as follows:

Date: Monday, January 13, 2020
Time: 2:45 p.m. PST (5:45 p.m. EST)
Room: Franciscan B (Ballroom Level)
Venue: Hilton San Francisco Union Square, 333 O’Farrell Street, San Francisco, CA 94102 USA

About Biotech Showcase

Biotech Showcase, produced by Demy-Colton and EBD Group, is an investor conference focused on driving advances in therapeutic development by providing a sophisticated networking platform for executives and investors that fosters investment and partnership opportunities. The conference takes place each year during one of the industry’s largest gatherings and busiest weeks.

On January 10, 2020 Rakuten Medical, Inc. (RMI) a clinical-stage, global biotechnology company developing precision-targeted cancer therapies based on its proprietary, anti-cancer treatment platform, Illuminox, reported that will present at the 38th Annual J.P. Morgan Healthcare Conference being held January 13-16, 2020, in San Francisco (Press release, Rakuten Medical, JAN 10, 2020, View Source [SID1234552977]).

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Rakuten Medical’s Chairman and CEO, Hiroshi "Mickey" Mikitani, will present at 4:30 p.m. PST, Monday, Jan. 13 at the Westin St. Francis Hotel, Elizabethan Room C/D.

The annual J.P. Morgan Healthcare Conference is the largest and most informative healthcare investment symposium in the industry, bringing together industry leaders, emerging fast-growth companies, innovative technology creators and members of the investment community.

On January 10, 2020 Tyra Biosciences reported a Series A financing of $50M to discover and develop new small molecule therapies targeting acquired resistance in oncology (Press release, Tyra Biosciences, JAN 10, 2020, View Source [SID1234552976]). Patients are devastated by the emergence of drug resistance after initially responding to targeted therapies, often leaving them and their physicians scrambling for options. Tyra Biosciences is a purpose-built company – with a founding team optimized for tackling this high-impact problem – aiming to develop very specific compounds targeting drug resistant cancer cells and populations.

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The financing round was co-led by Alta Partners, RA Capital, Boxer Capital of Tavistock Group, and Canaan. The funds raised will be used to advance next-generation compounds targeting acquired resistance to current therapies towards clinical trials.

"We are thrilled to have the backing of a strong syndicate, which includes early-stage and crossover firms representing tremendous experience and expertise in the industry," said Todd Harris, co-founder and CEO of Tyra Biosciences. "We are eager to deliver solutions for patients who desperately need additional treatment options. The financing round provides sufficient funding to reach a clinical inflection point, maximizing options for the company."

Targeted oncology – and tyrosine kinase inhibitors (TKIs), specifically – have made significant advancements for cancer patients over the last 20 years. These therapies are able to target discrete proteins involved in signaling pathways that drive tumor growth. In that time, over 40 TKIs have been approved, driving value for patients and investors alike. But as compounds have become more selective and potent, resistance has become a major limitation. Tyra Biosciences is combining insights from structure-based drug design (SBDD), kinase biology, computational chemistry and smart clinical development to discover and develop next-gen small molecule therapies that are active against both wild type and mutant targets.

"The need from patients and the demand from the market for therapies that address acquired resistance has never been stronger," said Isan Chen, Board Member of Tyra Biosciences. "Not only can these medicines be used as the immediate response when resistance emerges but they can also move to front-line treatments with the promise of better efficacy and much longer duration of response than first-generation agents."

"Our approach to drug discovery and development is highly focused and disciplined" said Daniel Bensen, co-founder and COO of Tyra Biosciences. "Leveraging key insights into the molecular basis of acquired resistance, we generate validating translational toolkits and rapidly iterate with SBDD to advance next-generation compounds."

Co-Founders Todd Harris & Daniel Bensen

Co-Founded by Todd Harris, Chief Executive Officer, and Daniel Bensen, Chief Operating Officer, and incubated by Alta Partners, Tyra Biosciences has formed a small cross-functional team, aiming to outpace others in the market by being focused, creative, fast and iterative. Key drug development professionals and scientific advisors include:

— Ronald V. Swanson, Ph.D., Chief Scientific Officer;

— Robert L. Hudkins, Ph.D., Vice President, Chemistry;

— Jane Arboleda, Associate Director of Cell Biology;

— Esther van den Boom. Chief Financial Officer;

— Jeffrey Hager, Ph.D., Scientific Advisor;

— William Hahn, M.D. Ph.D., Scientific Advisor; and

— Jason Sheltzer, Ph.D, Scientific Advisor.

The company’s board members have an extensive history of successful drug development in oncology and life sciences company-building:

— Bob More, Chairman and Managing Director, Alta Partners;

— Isan Chen, M.D., Chief Medical Officer, Mirati Therapeutics;

— Gilla Kaplan, Ph.D., formerly at Gates Foundation, Rockefeller University, and Celgene;

— Jake Simson, Ph.D., Principal, RA Capital Management

— Sid Subramony, Ph.D., Vice President, Boxer Capital of Tavistock Group; and

— Nina Kjellson, General Partner, Canaan.

"As a nimble company with a singular focus on acquired resistance in oncology, Tyra Biosciences is well positioned to deliver solutions for patients," said Gilla Kaplan, Board Member of Tyra Biosciences and pioneering scientist who re-invented thalidomide as an immune modulator, thereby spurning the Celgene success story. "The company has the benefit of a world-class team of drug developers and advisors to help them efficiently and effectively advance new therapies into the clinic."