On March 15, 2018 Investors are betting $94 million that Ideaya Biosciences Inc.reported that it can build on a promising new approach to cancer therapy known as synthetic lethality (Press release, Ideaya Biosciences, MAR 15, 2018, View Source [SID1234525380]).

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Recently approved medications from AstraZeneca PLC and Clovis Oncology Inc. have established the market for drugs based on synthetic lethality, the notion that tumors harbor certain pairs of genes that make them vulnerable. These cells can survive if one of the genes in the pair is mutated or inhibited. If both are mutated or inhibited, they die.

AstraZeneca’s Lynparza and Clovis’s Rubraca can treat certain cancer patients with mutated BRCA genes, which are involved in repairing damaged DNA. Because BRCA is mutated, the cancer cells rely on another enzyme to repair DNA, called Parp. Lynparza and Rubraca inhibit that enzyme.

Rubraca, approved in 2016, treats certain ovarian cancer patients. Lynparza won initial approved in 2014 in ovarian cancer and gained another approval in January, for certain breast cancer patients with mutated BRCA genes.

Last year, U.S. regulators also approved the Parp inhibitor Zejula, from Tesaro Inc., to delay cancer growth in certain patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, a rare cancer.

Ideaya aims to extend the synthetic lethality field. Its programs include a drug targeting PARG, a molecular cousin of Parp, according to co-founder and Chief Executive Yujiro Hata. The drug would treat patients who also have a loss of expression of the protein produced by the gene XRCC1, which also is involved in DNA repair. Breast cancer is the likely initial indication, Mr. Hata said.

South San Francisco, Calif.-based Ideaya intends to move two synthetic-lethality drugs and a smallmolecule immuno-oncology agent into clinical trials over this calendar year and into 2019. Other startups pursuing a synthetic-lethality approach to cancer therapy include Repare Therapeutics Inc., which gathered $68 million in Series A financing last year.

Ideaya, which disclosed a $46 million Series A round in 2016, raised this Series B round from new investors 6 Dimensions Capital, Boxer Capital of the Tavistock Group, BVF Partners, Driehaus Capital Management, GV, Nextech Invest, Perceptive Advisors and Roche Venture Fund. Prior investors 5AM Ventures, Alexandria Venture Investments, Canaan Partners, Celgene Corp. and WuXi Healthcare Ventures also participated.

Nextech Partner Thilo Schroeder and Edward Hu, founding partner of 6 Dimensions, are joining the Ideaya
board. Kanishka Pothula, managing director of BVF, GV Venture Partner Vineeta Agarwala, and Nisha Marathe, investment manager at Roche Venture Fund, are joining the board as observers.

On March 15, 2018 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies, reported that it will be presenting a poster with new and encouraging preclinical data on a novel viral vector (pseudocowpox, PCPV) at the AACR (Free AACR Whitepaper) (American Association for Cancer Research) Annual Meeting 2018, Chicago, IL, USA, April 14 – 18 (Press release, Transgene, MAR 15, 2018, View Source [SID1234621827]).

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The abstract was accepted for a late-breaking session of the congress and will be made available on the AACR (Free AACR Whitepaper) Online Itinerary Planner and Meeting App on April 13, 2018.

Poster title: Pseudocowpox: A next generation viral vector for cancer immunotherapy. A poxviral vector selected for its remarkable ability to induce IFN-alpha.

Adamis Pharmaceuticals has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Adamis Pharmaceuticals, 2018, MAR 15, 2018, View Source [SID1234524831]).

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On March 15, 2018 MabVax Therapeutics Holdings, Inc. (NASDAQ: MBVX), a clinical-stage oncology drug development company, reported that it will present three posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held April 14-18, 2018 in Chicago, Illinois at McCormick Place (Press release, MabVax, MAR 15, 2018, View Source [SID1234524812]). The first poster session features MVT-1075 (177Lu-CHX-A″-DTPA-HuMab5B1), the Company’s novel fully human antibody-based radioimmunotherapy (RIT) currently being evaluated in clinical development for the treatment of pancreatic cancer and other CA19-9 positive malignancies. The second presentation will feature preclinical investigations on the novel fully human antibody targeting the Thomsen-nouveau (Tn) and the sialyl Tn (sTn) cancer antigens which are highly overexpressed on ovarian and breast cancer tissues. The third poster features the Company’s immunoPET imaging agent MVT-2163 (89Zr-DFO-HuMab5B1), as a companion diagnostic for use in pancreatic cancer and CA19-9 positive malignancies.

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MabVax Therapeutics Logo (PRNewsfoto/MabVax Therapeutics Holdings, I)

Paul Maffuid, Ph.D., Executive Vice President of Research and Development of MabVax, stated, "We look forward to sharing the significant progress we have made through these clinical and preclinical studies that continue to establish our growing body of data supporting the development of MVT-1075 for the treatment of pancreatic cancer and other CA19-9 cancers, and our most advanced research program focused on the Tn and sTn cancer antigens."

Dr. Maffuid continued, "MVT-1075 potentially represents a more potent analog of our fully human HuMab-5B1 therapeutic antibody and establishing these safety and early response data bring us an important step closer in providing a much-needed treatment option for patients who have these devastating cancers. Equally important, our anti-Tn/sTn antibody program has made significant progress over the last few months and these data are the subject of partnering interest."

MabVax Abstracts and Poster Presentations

Sunday April 15, 2018 from 1:00 PM – 5:00 PM CDT:
Title: A fully human antibody binds Tn and sTn carbohydrate antigens specifically on serine residues, without need for polypeptide interaction
Session Location: Poster Section 43
Abstract Number: LB-002, Poster Board Number 2
Presenting Author: Jonah Rainey, Ph.D., Executive Director, Antibody Research MabVax Therapeutics

Tuesday April 17, 2018 from 8:00 AM – 12:00 PM CDT:
Title: Phase I dose escalation study of 177Lu-HuMab-5B1 (MVT-1075) in combination with MVT-5873 as radioimmunotherapy (RIT) in subjects with relapsed / refractory pancreatic cancer or other CA19-9+ malignancies
Session Location: McCormick Place South, Hall A, Poster Section 42
Abstract Number: CT140, Poster Board Number 23
Presenting Author: Paul Maffuid, Ph.D., Executive Vice President, Research & Development MabVax Therapeutics

Tuesday April 17, 2018 from 8:00 AM – 12:00 PM CDT:
Title: PEGylated Hyaluronidase Increases Tumor Uptake of 89Zr-DFO-HuMab-5B1 (MVT-2163) in a CA19-9 Positive Hyaluronan-Accumulating Pancreatic Cancer Model
Session Location: McCormick Place South, Hall A, Poster Section 1
Abstract Number: 3036, Poster Board Number 9
Co-presenting Authors: Paul Maffuid, Ph.D., Executive Vice President, Research & Development and Jonah Rainey, MabVax Therapeutics Executive Director, Antibody Research MabVax Therapeutics

About MVT-1075

MVT-1075 is a radioimmunotherapy product that combines established efficacy of radiation therapy with tumor specific targeting. It has the potential to deliver a more potent HuMab-5B1 based product. MVT-1075 uses small doses of the Company’s MVT-5873 antibody, coupled to a radioisotope to target pancreatic cancer cells and kill them.

About the HuMab-Tn Antibody Targeting Tn and sTn

HuMab-Tn is a fully human antibody derived from a patient vaccinated with a pool of cancer glycans, including Tn. The antibody has been affinity-matured and demonstrates highly selective Tn/sTn glycan binding. Further, the antibody recognizes a wide array of cancers, particularly ovarian and breast including approximately 90% of triple negative breast cancers tested.

About MVT-2163

MVT-1075 is an immunoPET imaging agent product that combines the established PET imaging capabilities of 89Zr with 5B1 tumor specific targeting. It has the potential to aid in identifying the best surgical treatment options for patients with pancreatic cancer and as a potential companion diagnostic with treatment options.

On March 15, 2018 Molecular Templates, Inc., (Nasdaq:MTEM) a clinical stage biopharmaceutical company focused on the discovery and development of Engineered Toxin Bodies, a new class of targeted biologic therapies that possess unique mechanisms of action in oncology, reported that new data on two of its pipeline programs will be presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018, to be held April 14-18 at McCormick Place North/South in Chicago, Illinois (Press release, Molecular Templates, MAR 15, 2018, View Source [SID1234524813]).

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Molecular Templates has utilized the ability of its Engineered Toxin Bodies (ETBs) to route to the endoplasmic reticulum and cytoplasm to deliver cytomegalovirus (CMV) foreign antigen for presentation in the context of MHC class I molecules on tumor cells. This Antigen Seeding Technology (AST) allows for the targeted delivery, intracellular processing, and surface MHC-I presentation of CMV antigen and subsequent destruction of tumors via a CMV-specific T lymphocyte response.

Preclinical data on the company’s PD-L1 targeted ETB incorporating AST will be presented at the AACR (Free AACR Whitepaper) meeting. This molecule has been engineered to both destroy PD-L1-expressing tumor cells via ribosomal destruction and to deliver the immunodominant HLA:A02 restricted cytomegalovirus (CMV) protein-pp65 for MHC-I presentation on these cells. The dual mechanisms of action against the PD-L1 target allow for a more potent and complete destruction of tumor cells. Molecular Templates expects this program to enter the clinic in the first half of 2019.

"We are excited by this wholly novel approach to immuno-oncology," said Eric Poma, Ph.D., CEO and CSO of Molecular Templates. "Antigen seeding is a way to target an immense, activated T-cell repertoire to the tumor without having to overcome T-cell exhaustion or stimulate antigen presentation from APCs. We are looking forward moving to this approach into the clinic."

Date: Monday, April 16
Time: 1:00pm – 5:00pm Central Time
Session: PO.IMO2.11 – Therapeutic Antibodies, Including Engineered Antibodies 2
Location: Section 34
Poster Title: Antigen Seeding Technology by Engineered Toxin Bodies Provides a Targeted Immuno-Oncology Approach for Treatment of Cancers
Authors: Brigitte Brieschke, Sangeetha Rajagopalan, Garrett L. Robinson, Erin K. Willert, Hilario J. Ramos

Molecular Templates will also present on its HER2 engineered toxin body program. MT-5111, a HER2-targeted ETB with picomolar potency against HER2 expressing cells, was designed to overcome mechanisms of resistance to current HER2 targeting modalities such as escape from antibody dependent cell-mediated cytotoxicity (ADCC), alterations in signal transduction, epitope masking, and enhanced small molecule efflux. Additionally, MT-5111 was genetically engineered to reduce the anti-drug antibody response and signaling through innate receptors, allowing for repeat dosing.

In vitro and in vivo data will be presented at the AACR (Free AACR Whitepaper) meeting, highlighting the potential for MT-5111 as a novel agent in development for treatment of breast carcinomas and other malignancies overexpressing the HER2 receptor. Molecular Templates intends to file an IND with MT-5111 in 2018.

"Antibody, small molecule, and ADC approaches to HER2 have all shown meaningful benefit in patients with HER2+ cancers but ultimately cease to work in most patients even though HER2 expression persists," said Eric Poma, Ph.D., CEO and CSO of Molecular Templates. "We believe the unique mechanism of action of our HER2 ETB may circumvent mechanisms of resistance to the other HER2 modalities."

Date: Wednesday, April 18
Time: 8:00am – 12:00pm Central Time
Session: PO.ET01.02 – Antibodies, Fusion Proteins, and Related Biologics
Location: Section 35
Poster Title: Targeted Engineered Toxin Bodies Provide a Novel Mechanism of Action Against HER2 Positive Cancers
Authors: Brigitte Brieschke, Garrett L. Robinson, Sangeetha Rajagopalan, Hilario J. Ramos, Jensing Liu, Jack P. Higgins, Erin K. Willert