On May 6, 2021, Coeptis Pharmaceuticals, Inc. ("Coeptis"), our wholly-owned subsidiary, reported that initial payments under two agreements described below, making those agreement definitive agreements (Filing, 8-K, Vinings Holdings, MAY 6, 2021, View Source [SID1234583919]). The two definitive option purchase agreements are with VyGen-Bio, Inc. ("Vy-Gen"), pursuant to which Coeptis has the exclusive option to acquire co-development rights with respect to two Vy-Gen product candidates. Coeptis paid a total of $750,000 to acquire the two exclusive options.

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The first option purchase agreement relates to Vy-Gen’s diagnostic product candidate CD38-SNP-DIAG, which is an early stage development platform technology targeted for a novel use of single nucleotide polymorphism (SNP) genotyping for determining optimal treatment decisions in B cell malignancies. Coeptis paid $250,000 to secure this exclusive option, and the option is exercisable at any time until December 31, 2021, with the option exercise payment being an additional $1,250,000-$1,750,000 depending on the timing of the exercise. Details of the intended co-development arrangement are summarized in the option agreement attached at Exhibit 4.1 to this Current Report on Form 8-K, and will be further developed when and if the long-form definitive co-development agreement is negotiated and finalized.

The second option purchase agreement relates to a product candidate based on VyGen’s early stage of development platform technology referred to as Gene-Edited Antibody Resistant (GEAR), which is targeted to potentially support numerous cell-therapy products with potential for co-administration with targeted monoclonal antibodies. The product candidate that is subject to the option is Vy-Gen’s CD38-GEAR-NK(Auto), which is a product candidate being developed to protect CD38+NK cells from destruction by CD38-mAbs. Coeptis paid $500,000 to secure this exclusive option, and the option is exercisable at any time until December 31, 2021, with the option exercise payment being an additional $3,000,000-$4,000,000 depending on the timing of the exercise. Details of the intended co-development arrangement are summarized in the option agreement attached at Exhibit 4.2 to this Current Report on Form 8-K, and will be further developed when and if the long-form definitive co-development agreement is negotiated and finalized. Vy-Gen has an option, after August 31, 2021 but before a formal exercise of the option by Coeptis, to buy-out this option for a one-time payment of $1,000,000. This option purchased agreement also grants to Coeptis the right to acquire an additional to-be-identified product candidate in the GEAR space for $3,500,000, provide that the initial option under this agreement is timely exercised.

On May 6, 2021 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that the research collaboration by Chugai (Forerunner Pharma Research), Department of Allergy and Rheumatology at the University of Tokyo Hospital, and RIKEN on a functional genome database was published online in the U.S. scientific journal Cell on April 29, 2021 (Press release, Chugai, MAY 6, 2021, View Source [SID1234579314]).

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"Dynamic landscape of immune cell-specific gene regulation in immune-mediated diseases"

"Chugai’s innovation is generated by its own scientific and technological capabilities. For the maintenance and improvement of state-of-the-art sciences, open innovation including collaboration with academia is essential. I am very proud that one of these efforts to understand disease biology has obtained the world’s highest level of scientific appraisal through the publication in Cell," said Dr. Osamu Okuda, Chugai’s President and CEO. "TOP I 2030, our growth strategy announced in February, places open innovation as one of its key drivers. We will continue expanding our collaboration with external networks to create innovative new drugs."

This study constructed a large-scale functional genome database "ImmuNexUT" (Immune cell gene expression atlas from the University of Tokyo) that significantly outperforms previous reports in the number of cases of immune-mediated diseases, the variety of clinical cases, and the types of immune cells, and clarified the relationship between gene polymorphisms and gene expression levels in each cell type involved in the onset of various immune-mediated diseases. A total of 9,852 samples of 28 immune cells were obtained from 416 peripheral blood samples from 10 representative patients with immunological diseases and healthy individuals, and these samples were used to quantify gene expression and to analyze the association between gene expression and gene polymorphisms. As valuable data showing the genomic functions of Asians, this database is expected to be applied to genomic studies of various disease states involving immunity, leading to the elucidation of disease states and the identification of therapeutic target molecules and biomarkers for pharmaceuticals.

Chugai participated in this collaborative study with the purpose of elucidating the disease state of autoimmune and autoinflammatory diseases and creating therapies through an integrated understanding of immunology and functional genomics. In promoting research, Chugai’s research subsidiary Forerunner Pharma Research which terminated its operation in March 2021 made significant contributions to building ImmuNexUT through acquisition by utilizing its strong immunology research infrastructure with clinical samples.

Chugai, which aims at becoming a top innovator in the healthcare industry, will promote open innovation including collaboration with academia to contribute to patients around the world through innovative drugs.

On May 6, 2021 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, reported presentations featuring TransCon PTH at two upcoming medical conferences: the 48th annual meeting of the European Calcified Tissue Society (ECTS), taking place virtually May 6-8, 2021 and the 23rd European Congress of Endocrinology taking place virtually May 22-26, 2021 (Press release, Ascendis Pharma, MAY 6, 2021, View Source [SID1234579344]).

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"We are excited to share the 26-week open-label extension (OLE) data from our phase 2 PaTH Forward Trial in adult patients with hypoparathyroidism with the European medical community," said Mark Bach, M.D., Ph.D., Senior Vice President of Endocrine Medical Sciences at Ascendis Pharma.

"These data provide evidence indicating that TransCon PTH has the potential to be a first line therapy as a hormone replacement in patients with hypoparathyroidism. The study was selected for oral presentations by both ECTS and ECE meeting organizers which we think underscores the significance of these results," continued Dr. Bach.

ECTS 2021: Presentation Details

Oral Presentation
Title Date/Time
Week 26 Results from the PaTH Forward Open-Label Extension Trial Support TransCon PTH as a Potential Hormone Replacement Therapy for Patients with Hypoparathyroidism Plenary Oral Presentations 2: Novel Aspects of Osteoporosis and Treatments
May 7, 2021
16:30 – 17:30 CEST
e-ECE 2021: Presentation Details

Oral Presentation
Title Date/Time
TransCon PTH as a Potential Hormone Replacement Therapy for Patients with Hypoparathyroidism: PaTH Forward Open-Label Extension Trial Week 26 Results Oral Communications 6: Calcium and Bone
May 25, 2021
14:30 – 15:30 CEST
The posters will be available on the Ascendis website under Selected Publications in the Pipeline section: View Source If you are a healthcare provider who would like more information, please contact: [email protected].

About TransCon Technology

TransCon refers to "transient conjugation." The proprietary TransCon platform is an innovative technology to create new therapies that are designed to optimize therapeutic effect, including efficacy, safety and dosing frequency. TransCon molecules have three components: an unmodified parent drug, an inert carrier that protects it, and a linker that temporarily binds the two. When bound, the carrier inactivates and shields the parent drug from clearance. When injected into the body, physiologic conditions (e.g., pH and temperature) initiate the release of the active, unmodified parent drug in a predictable manner. Because the parent drug is unmodified, its original mode of action is expected to be maintained. TransCon technology can be applied broadly to a protein, peptide or small molecule in multiple therapeutic areas, and can be used systemically or locally.

On May 6, 2021 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational conditionally activated therapeutics based on its Probody technology platform, reported first quarter 2021 financial results and provided a business update (Press release, CytomX Therapeutics, MAY 6, 2021, View Source [SID1234579360]).

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"Building on the sustained and focused performance by the CytomX team throughout 2020, we made excellent progress in the first quarter of 2021 with an ongoing emphasis on our two lead clinical product candidates, praluzatamab ravtansine (CX-2009) and CX-2029, both of which are in key Phase 2 studies addressing late-stage cancers with substantial unmet need," said Sean McCarthy, D.Phil., president, chief executive officer and chairman of CytomX Therapeutics. "We also continued to innovate with the unveiling of our work on conditionally activated cytokines that leverages the depth of our expertise in protein engineering, protease biology, and our understanding of the tumor microenvironment. Our leadership in the field of conditional activation and the versatility of our Probody technology platform position us for success in realizing our vision of transforming lives with safer, more effective therapies," added Dr. McCarthy.

Business Highlights and Recent Developments

Hosted a virtual investor event and webcast with industry experts John Lambert Ph.D., former chief scientific officer, ImmunoGen; Sara M. Tolaney, M.D., Dana-Farber Cancer Institute, Harvard Medical School; and Melissa L. Johnson, M.D., Sarah Cannon Research Institute, as well as company executives, to discuss CytomX’s Probody technology platform and the two lead product candidates, praluzatamab ravtansine (CX-2009) and CX-2029. An archived replay of the webcast can be accessed on the Events and Presentations section of CytomX’s website.
Began enrolling patients with human epidermal growth factor receptor 2 (HER2)-non-amplified breast cancer into a Phase 2 multi-cohort study evaluating our anti-CD166 conditionally activated antibody-drug conjugate (ADC), praluzatamab ravtansine (CX-2009) as monotherapy and, in patients with triple-negative breast cancer (TNBC), in combination with pacmilimab (CX-072), our conditionally activated anti-PD-L1 antibody.
Patient enrollment continued in the Phase 2 expansion study evaluating CX-2029, the anti-CD71 conditionally activated ADC in co-development with our partner AbbVie, as a single agent in four cohorts: squamous non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal and gastro-esophageal junction cancers, and diffuse large B-cell lymphoma.
Featured presentation at the Triple Negative Breast Cancer (TNBC) Drug Development Digital Summit 2021, by Alison L. Hannah, M.D., CytomX’s chief medical officer, titled "Clinical Development of Praluzatamab Ravtansine (CX-2009), a Conditionally Activated Probody Drug Conjugate (PDC) Targeted Against CD166 (ALCAM) in Patients with Advanced Breast Cancer." The oral presentation can be downloaded using this link.
Presented preclinical data highlighting an improved therapeutic window and potent anti-cancer activity for a conditionally activated interferon alpha-2b at the Cytokine-Based Cancer Immunotherapies Summit, demonstrating successful broadening of the Probody technology platform to cytokine modalities. The oral presentation can be downloaded using this link.
Our partner, Bristol Myers Squibb, expanded the scope of the Part 2b evaluation of BMS-986249, a Probody version of the CTLA-4-targeting antibody, ipilimumab, in combination with the anti-PD-1 antibody, nivolumab, with three new indications, advanced hepatocellular carcinoma, metastatic castration-resistant prostate cancer, and advanced TNBC. This combination is also being evaluated by Bristol Myers Squibb in a randomized study in patients with metastatic melanoma. Bristol Myers Squibb also continued to evaluate BMS-986288, a Probody version of non-fucosylated ipilimumab, as monotherapy or in combination with nivolumab in a Phase 1 clinical trial.
In collaboration with Amgen, investigational new drug application (IND)-enabling studies continued for CX-904, our conditional T-cell engaging bispecific antibody targeting the epidermal growth factor receptor (EGFR) on tumor cells and CD3 on T cells.
IND-enabling studies for CX-2043, our third conditionally activated ADC directed against the epithelial cell adhesion molecule (EpCAM/Trop-1), were delayed as a result of recent supply chain interruptions. We no longer expect to submit an IND for CX-2043 in 2021.
Raised approximately $108 million from a follow-on public equity offering to support clinical and preclinical pipeline advancement and operations.
Anticipated 2021 Events

Initial data from the praluzatamab ravtansine (CX-2009) Phase 2 study in the fourth quarter of 2021.
Initial data from the CX-2029 Phase 2 expansion study in the fourth quarter of 2021.
IND submission for CX-904 in late 2021.
First Quarter 2021 Financial Results
Cash, cash equivalents and short-term investments totaled $393.8 million as of March 31, 2021, compared to $316.1 million as of December 31, 2020.

Revenue was $16.0 million for the three months ended March 31, 2021 compared to $49.6 million for the corresponding period in 2020. The decrease of $33.6 million was due to a $28.9 million decrease in revenue from AbbVie primarily related to the $40.0 million milestone payment earned in March 2020 associated with the CX-2029 project, a $10.0 million decrease in revenue from Bristol Myers Squibb for a milestone payment earned from the CTLA-4 program in February 2020, offset by an increase in revenue of $4.4 million from Astellas mainly driven by the full quarter recognition of the $80.0 million upfront payment related to the Collaboration and License Agreement with Astellas entered into in March 2020.

Research and development expenses decreased by $20.4 million during the three months ended March 31, 2021 to $22.4 million compared to $42.8 million for the corresponding period in 2020. The decrease was largely attributed to a decrease of $11.2 million in licensing expenses and a decrease of $8.5 million in laboratory contracts and services, decreased clinical trial spend and timing of manufacturing activities.

General and administrative expenses were essentially flat during the three months ended March 31, 2021 amounting to $9.2 million compared to $9.6 million for the corresponding period in 2020.

Conference Call & Webcast Information
CytomX management will host a conference call today at 5:00 p.m. ET (2:00 p.m. PT). Interested parties may access the live webcast of the conference call from the Events and Presentations page of CytomX’s website at www.cytomx.com or by dialing 1-877-809-6037 (U.S. and Canada) or 1-615-247-0221 (International) using the passcode 5397530. An archived replay of the webcast will be available on the Company’s website until May 13, 2021.

On May 6, 2021 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported it will host a conference call to discuss the first quarter 2021 financial results and provide a corporate update on Thursday, May 13, 2021 at 4:30 p.m. Eastern/1:30 p.m. Pacific (Press release, Spectrum Pharmaceuticals, MAY 6, 2021, View Source [SID1234579377]).

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Conference Call and Webcast:

The conference call will also be available from the Investor Relations section of the company’s website at View Source and will be archived there shortly after the live event.