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."

On January 10, 2020 Fusion Pharmaceuticals Inc., a privately-held, clinical-stage precision oncology company developing next-generation radiopharmaceuticals, reported that Chief Executive Officer John Valliant, Ph.D., will present an overview of the Company at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco, California (Press release, Fusion Pharmaceuticals, JAN 10, 2020, View Source [SID1234552975]). The presentation will take place on Thursday, January 16, 2020 at 11:00am PST.

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On January 10, 2020 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing for product authenticity, traceability solutions, nucleic acid-based biotherapeutic development, and liquid biopsies for cancer diagnostics, reported that CEO Dr. James A. Hayward and leadership of the Company’s majority-owned subsidiary, LineaRx, Inc., will be meeting with members of the global investment community from January 13 to 15, 2020 in San Francisco concurrent with the JP Morgan 38th Annual Healthcare Conference, the world’s largest healthcare investment symposium (Press release, Applied DNA Sciences, JAN 10, 2020, https://adnas.com/applied-dna-to-hold-investment-community-meetings-during-the-jp-morgan-38th-annual-healthcare-conference-and-present-at-the-biotech-showcase-2020/ [SID1234552974]).

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In addition, Dr. Hayward will present an overview of the Company, including its supply chain platform, its diagnostic platform for the blood-based capture of metastatic cells, and review the linear DNA platforms in nucleic acid delivery, gene expression, non-integrated DNA replication, and its robust pipeline of more than 15 contract research opportunities with top cancer, gene therapy, vaccine and RNA partners at the Biotech Showcase 2020 at 3:00 pm PT on Tuesday, January 14, 2020. Dr. Hayward’s presentation will be webcast live at: View Source;tp_key=6924765b8a

On January 10, 2020 Forty Seven, Inc. (Nasdaq:FTSV), a clinical-stage, immuno-oncology company focused on developing therapies to activate macrophages in the fight against cancer, reported its strategic plan and expected milestones for 2020 (Press release, Forty Seven, JAN 10, 2020, View Source [SID1234552973]).

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"Our vision is to deliver groundbreaking therapies to patients by harnessing the potential of the innate immune system in the fight against disease," said Mark McCamish, M.D., Ph.D., President and Chief Executive Officer of Forty Seven. "As we enter the new year, we are executing against this strategy with full force. Our potential-registration enabling programs for magrolimab in MDS and DLBCL are underway, and we are pleased to have recently received FDA Orphan Drug designation for magrolimab in MDS. In parallel, we are preparing to advance FSI-174 and FSI-189 into the clinic, where we believe we can leverage our deep understanding of the CD47/SIRPα pathway to engage previously unexploited phagocytic pathways."

Dr. McCamish continued, "Following our successful follow-on offering in December 2019, we are well financed, with sufficient resources to advance our pipeline through key milestones, including the potential submission of our first biologics license application for magrolimab, while scaling our CMC activities to support future product launches. We expect 2020 to be a year of notable progress across our portfolio, as we read out data for each of our magrolimab programs and accelerate ongoing efforts to offer magrolimab to genomically-defined patient populations, like TP53-mutant AML, where we believe our approach can offer targeted benefit. We will simultaneously progress our earlier-stage assets, FSI-174 and FSI-189, in hopes of delivering on the full potential of macrophage biology for people living with cancer and other serious diseases."

Magrolimab – Registration-Enabling Programs

Forty Seven is focused on advancing magrolimab in registration-enabling programs for the treatment of patients with untreated, higher-risk myelodysplastic syndrome (MDS) and heavily-pretreated, relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Magrolimab has previously been granted Fast Track designation by the FDA for the treatment of MDS and acute myeloid leukemia (AML), and for the treatment of relapsed or refractory DLBCL and follicular lymphoma, as well as Orphan Drug designation by the U.S. Food and Drug Administration (FDA) and European Medicines Agency for the treatment of AML. In December 2019, the FDA granted Orphan Drug designation to magrolimab for the treatment of MDS.

The company expects to achieve the following milestones in 2020:

Myelodysplastic Syndrome:

Initiate Phase 3 ENHANCE trial evaluating the combination of magrolimab and azacitidine compared to azacitidine alone in patients with untreated, higher risk-MDS in the second quarter;

Present updated data from the ongoing Phase 1b clinical trial evaluating the combination of magrolimab and azacitidine in untreated patients with higher risk MDS mid-year;

Complete enrollment in the ongoing Phase 1b clinical trial in the third quarter.

Diffuse Large B-Cell Lymphoma:

Initiate single-arm, registration-enabling trial evaluating the combination of magrolimab and rituximab in heavily pre-treated relapsed or refractory DLBCL patients who have failed at least two prior lines of therapy in the first quarter;

Present initial data from the registration-enabling trial in the fourth quarter.

Magrolimab – Other Programs

Forty Seven will expand enrollment in its ongoing Phase 1b clinical trial evaluating the combination of magrolimab and azacitidine to include additional untreated TP53 mutant AML patients who are ineligible for induction chemotherapy to inform a potential registrational path. Updated data from this trial will be presented mid-year.

Additionally, Forty Seven is evaluating magrolimab for the treatment of colorectal (CRC) and ovarian cancer. Clinical data in patients with CRC and ovarian cancer will be presented at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO-GI), held January 23-25, 2020 in San Francisco, and the ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium, held February 6-8, 2020 in Orlando, respectively. While data from these studies do not support a path to registration, Forty Seven intends to use these results and learnings to identify its next steps in solid tumors.

Additional Pipeline Programs

Forty Seven is developing a broad pipeline of additional programs, which take advantage of the CD47/SIRPα pathway as a rich target for engaging macrophages. FSI-174, an anti-cKIT antibody, is being developed in combination with magrolimab as a novel, all-antibody conditioning regimen to address the limitations of current stem cell transplantation conditioning regimens. FSI-189, an anti-SIRPα antibody, is being developed for the treatment of cancer, as well as certain non-oncology conditions including transplantation conditioning.

The company expects to achieve the following milestones in 2020:

Initiate a Phase 1 clinical trial evaluating the safety and tolerability of FSI-174 in healthy volunteers in the first quarter;

File an investigational new drug application with the FDA for FSI-189 in the first quarter; and

Initiate a Phase 1 clinical trial evaluating the safety and tolerability of FSI-189 for the treatment of cancer in the second quarter.

Cash Position and Financial Guidance:

Based on preliminary estimates, Forty Seven had cash, cash equivalents and short-term investments of $329.1 million at December 31, 2019. Based on its current operating plans, Forty Seven expects that its cash, cash equivalents and short-term investments will fund operating expenses and capital expenditure requirements into the first quarter of 2022.