May 2018 – Page 33 – 1stOncology™: Cancer Intelligence Service

Lupagen & Humanigen to explore point-of-care CAR-T therapy

On May 22, 2018 Lupagen, Inc. (www.lupagen.com), a medical device company developing first-in-class cell and gene therapy delivery technologies for CAR-T, gene editing and immunotherapy products, reported the intent to explore the development of a bedside, point-of-care delivered CAR-T therapy with Humanigen, Inc. (OTCQB: HGEN), a biopharmaceutical company developing cutting-edge CAR-T optimization and oncology treatments (Press release, Lupagen, MAY 22, 2018, View Source;humanigen-to-explore-point-of-care-car-t-therapy-300652016.html [SID1234573190]).

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Lupagen and Humanigen are planning work to investigate the potential of a bedside CAR-T therapy created from Humanigen’s Ifabotuzumab, a first-in-class, monoclonal antibody targeting the EphA3 receptor tyrosine kinase.

"We are excited to support Humanigen’s strategic objectives to deliver safer, more effective and more routine CAR-T treatments, including one with the novel EphA3 target," said Nipon Das, M.D., chief executive officer and co-founder of Lupagen. "A bedside, closed-loop, point-of-care patient-connected system allows patient cells to be harvested, reprogrammed or modified, then reinfused at the bedside. The potential positive impact on CAR-T and other ex-vivo autologous cell and gene therapies is enormous through lower treatment costs, increased patient access and enhanced safety and control of these powerful new therapies."

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Burzynski Research Institute 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 .

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Burzynski Research Institute 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, Burzynski Research Institute, 2018, MAY 22, 2018, View Source [SID1234526849]).

GamaMabs Pharma to present at 2018 ASCO annual meeting results from the First-In-Human clinical study of GM102 in advanced gynecological cancers

On May 22, 2018 GamaMabs Pharma, a biotechnology company developing optimized therapeutic antibodies targeting the Anti-Müllerian Hormone Receptor II (AMHRII) for the treatment of cancer, reported the upcoming presentation of clinical data from the First-In-Human C101 phase Ia/Ib study of its GM102 antibody during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, on June 4 in Chicago, USA (Press release, GamaMabs Pharma, MAY 22, 2018, View Source [SID1234527257]).

Data will be reported on 27 patients with advanced or recurrent AMHRII-positive epithelial ovarian (EOC), granulosa ovarian (GCT), cervical and endometrial cancers, treated with GM102 monotherapy in eight successive escalation cohorts at five major European cancer centers.

No safety signal was reported at all doses tested. Two clinical objective partial responses according to RECIST criteria were observed among four GCT patients. Peripheral blood pharmacodynamic changes observed under GM102 treatment suggested an immune cell recruitment to the tumor site. In paired tumor biopsies before and under GM102 treatment, enhanced CD16 and Granzyme B biomarker expression was observed in the tumor micro-environment, suggesting GM102-induced cellular cytotoxicity or phagocytosis.

Expansion cohorts in EOC and GCT at the recommended GM102 dose are currently ongoing, with first results anticipated early 2019.

GM102 is a first-in-class glyco-engineered (low-fucose) monoclonal antibody selectively targeting AMHRII-expressing tumors. AMHRII, an embryonic receptor involved in the regression of the Müllerian ducts in the male embryo, is constitutively expressed in ovarian granulosa tumors (GCT) and re-expressed in approximately 70% of gynecological tumors. GM102 exerts its anti-tumor activity through NK cell and macrophage engagement in the tumor microenvironment, resulting in enhanced tumor phagocytosis and ADCC (Antibody Dependent Cell Cytotoxicity).

"These first results are really encouraging, especially for patients with granulosa ovarian cancers who do not have therapeutic alternatives at this stage," said Pr. Alexandra Leary, Gustave Roussy Institute (France), principal investigator of the study. "We are gathering experience with additional patients in the expansion part of the study; should these first results be confirmed, we will move forward with a larger phase 2 study in this indication with great enthusiasm, given the unmet medical need."

"We are happy to share such exciting data with the medical community, which confirm the unique immunological mode of action of GM102 and shows its translation into clinical activity," said Stéphane Degove, CEO at GamaMabs Pharma. "We are expanding our GM102 clinical development program beyond the field of gynecological cancers in other tumor types that also express AMHRII," he added.

Results will be presented at the ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago, during the Gynecologic Cancer session, on June 4, 2018, 1:15 PM-4:45 PM.
Abstract #5542; Poster ID 214461, ‘A first-in-human study of monoclonal antibody GM102 in patients with Anti-Mullerian-Hormone-Receptor II (AMHRII) positive gynecological cancers’ by A Leary and co-authors.
Following the presentation, the poster will be available on the Publication page of GamaMabs’ website1.

CytomX Therapeutics Announces FDA Clearance of Investigational New Drug Application for CX-2029, a CD71-Directed Probody Therapeutic

On May 22, 2018 CytomX Therapeutics, Inc. (Nasdaq:CTMX) a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported that the U.S. Food and Drug Administration has cleared its Investigational New Drug (IND) application for CX-2029, a first-in-class CD71-directed Probody drug conjugate being co-developed by CytomX and its partner AbbVie (Press release, CytomX Therapeutics, MAY 22, 2018, View Source [SID1234527069]). CD71, also known as the transferrin receptor 1, is a highly expressed protein present in a number of solid and hematologic cancers that possess attractive molecular properties for the efficient delivery of cytotoxic payloads to tumor cells. The achievement of this milestone triggers a $25 million payment to CytomX from AbbVie.

"CD71 has long been considered a high potential but challenging target for antibody drug conjugates given its high expression in tumors but ubiquitous expression in normal tissues. However, we see CD71 is an attractive candidate for a Probody drug conjugate approach, since our technology can potentially localize treatment directly to tumor tissue," said Sean McCarthy, D.Phil., president and chief executive officer of CytomX Therapeutics. "With CX-2029 now clear to advance into Phase 1, CytomX and our partners now have four clinical-stage Probody programs with anticipated initial data readouts later this year from our two wholly-owned programs, CX-072 and CX-2009. It is also noteworthy that this milestone comes just two years following the signing of our agreements with AbbVie, reflecting the efficiency of this collaboration."

"The IND clearance of CX-2029 marks an important step in our partnership with CytomX," said Steve Davidsen, Ph.D., vice president, oncology drug discovery, AbbVie. "Our partnership has the potential to advance emerging areas of science with the hope of providing additional options for people living with cancer."

About the Collaboration
AbbVie and CytomX are co-developing CX-2029, a Probody drug conjugate against CD71, with CytomX leading pre-clinical and early clinical development. AbbVie will lead later development and commercialization, with global late-stage development costs shared between the two companies. CytomX is eligible to receive up to $470 million in development, regulatory and commercial milestones, pending the achievement of pre-determined outcomes. AbbVie will lead global commercial activities with CytomX eligible to receive a profit share in the U.S. and tiered double-digit royalties on net product sales outside of the U.S. CytomX retains an option to co-promote in the U.S.

AbbVie also received exclusive worldwide rights to develop and commercialize Probody drug conjugates against up to two additional, undisclosed targets. Should AbbVie ultimately pursue these targets, CytomX is eligible to receive additional milestone and royalty payments per target on any resulting products.

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Month: May 2018

Lupagen & Humanigen to explore point-of-care CAR-T therapy

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

GamaMabs Pharma to present at 2018 ASCO annual meeting results from the First-In-Human clinical study of GM102 in advanced gynecological cancers

CytomX Therapeutics Announces FDA Clearance of Investigational New Drug Application for CX-2029, a CD71-Directed Probody Therapeutic