On October 9, 2020 Exelixis, Inc. (Nasdaq: EXEL) and Aurigene Discovery Technologies Limited (Aurigene) reported disclosed new preclinical data showing that AUR102 has potent anti-tumor activity in a large panel of cancer cell lines (Press release, Aurigene Discovery, OCT 9, 2020, View Source [SID1234568259]). AUR102 is a potent, selective, and orally bioavailable covalent inhibitor of cyclin-dependent kinase 7 (CDK7), which is an important regulator of the cellular transcriptional and cell cycle machinery . Exelixis has an exclusive option for AUR102 under its July 2019 exclusive collaboration, option and license agreement with Aurigene. The new data will be presented in a poster (Abstract 170) at the 32nd EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Symposium, which is being held virtually on October 24-25, 2020.

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"CDK7 plays a critical role in regulating cellular transcription and cell cycle machinery, making it an exciting target for cancer therapy"

"CDK7 plays a critical role in regulating cellular transcription and cell cycle machinery, making it an exciting target for cancer therapy," said Murali Ramachandra, Ph.D., Chief Executive Officer of Aurigene. "The data to be presented at ENA 2020 demonstrate that AUR102 effectively engages CDK7 and inhibits a key mediator of the cell cycle and transcription. The ability to inhibit CDK7 activity with an orally available therapeutic such as AUR102 holds great potential to improve care and outcomes for patients with diverse cancer indications, including breast cancer, prostate cancer, leukemia and lymphoma."

The abstract provides a summary of results from a detailed characterization of AUR102 in cancer cell lines and animal tumor models. Additional data will be presented in the poster. Key findings included in the abstract are:
• AUR102 exhibited potent anti-proliferative activity in a large panel of cell lines with induction of cell death in cell lines derived from multiple cancer types.
• The observed anti-proliferative activity correlated with cellular CDK7 target engagement and decreased levels of P-Ser5 RNAPII, a key mediator of transcription.
• AUR102 studies showed synergy when used in combination with multiple chemotherapies.
• Oral dosing with AUR102 resulted in dose-dependent anti-tumor activity, including complete tumor regression in diffuse large B-cell lymphoma, acute myeloid leukemia, and triple-negative breast cancer xenograft models.
• Inhibition of tumor growth was accompanied by complete target engagement as demonstrated in a parallel PK-PD study.
• AUR102 significantly impacts several pathways and key cancer driver and immune-response genes.

The study authors conclude that the data support clinical evaluation of AUR102 as a single agent and in combination with chemotherapies for the treatment of cancer.

"The exciting AUR102 data to be presented at ENA 2020 provide further validation of our partnering strategy, which gives us multiple opportunities to build a pipeline of best-in-class cancer therapies," said Peter Lamb, Ph.D., Executive Vice President of Scientific Strategy and Chief Scientific Officer of Exelixis. "AUR102 could be the subject of an Investigational New Drug filing later this year, which would be an important value driver for the program itself and for our collaboration with Aurigene. We commend the Aurigene team on their ongoing success in building a robust body of data supporting the broad clinical potential of AUR102."

Under the terms of the July 2019 agreement, Exelixis made an upfront payment of $10 million for exclusive options to license three preexisting programs from Aurigene. In addition, Exelixis and Aurigene initiated three Aurigene-led drug discovery programs on mutually agreed upon targets, in exchange for additional upfront option payments of $2.5 million per program. Exelixis is also contributing research funding to Aurigene to facilitate discovery and preclinical development work on all six programs. As the programs mature, Exelixis will have the opportunity to exercise an exclusive option for each program up until the time of Investigational New Drug (IND) filing acceptance. If Exelixis decides to exercise an option, it will make an option exercise payment to Aurigene and assume responsibility for that program’s future clinical development and commercialization including global manufacturing. Aurigene will be eligible for clinical development, regulatory, and sales milestones, as well as royalties on sales. Under the terms of the agreement, Aurigene retains limited development and commercial rights for India and Russia.

On October 9, 2020 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and Eli Lilly and Company ("Lilly",NYSE: LLY), reported that HALPRYZA (rituximab injection), a recombinant human/murine chimeric monoclonal antibody drug co-developed by Innovent and Lilly, has been officially approved by the National Medical Products Administration (NMPA) of China for patients with diffuse large b cell lymphoma (DLBCL), follicular lymphoma (FL), and chronic lymphocytic leukemia (CLL) in China (Press release, Innovent Biologics, OCT 9, 2020, View Source [SID1234568276]). HALPRYZA (rituximab injection) is Innovent’s fourth monoclonal antibody drug approved by the NMPA following TYVYT (sintilimab injection), BYVASDA (bevacizumab injection) and SULINNO (adalimumab injection). It is also the second monoclonal antibody approved by NMPA that was co-developed by Innovent and Lilly after the approval of TYVYT.

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The clinical efficacy and safety of rituximab in CD20-positive non-Hodgkin’s lymphoma have been confirmed in several large-scale clinical trials. Rituximab injection, approved by FDA in 1997, is approved for the treatment of non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA)，granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA) and moderate to severe pemphigus vulgaris (PV). The efficacy and safety of rituximab have been well recognized worldwide. HALPRYZA (rituximab injection) is a recombinant human/murine chimeric monoclonal antibody drug co-developed by Innovent and Eli Lilly. The launch of HALPRYZA (rituximab injection) will provide Chinese patients with high-quality and relatively more affordable rituximab injection.

Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent, stated: "HALPRYZA (rituximab injection) is another example of our success with the National Major New Drug Innovation and Development Projects and the fourth monoclonal antibody drug approved by the NMPA following TYVYT (sintilimab injection)，BYVASDA (bevacizumab injection), and SULINNO (adalimumab injection). We hope to bring this high-quality drugs to more patients in need in China as soon as possible."

Dr. Li WANG, Senior VP of Lilly China and Head of Lilly China Drug Development and Medical Affairs Center, stated: "We’re excited that Lilly and Innovent strategic collaboration has reached another success. Lymphoma is one of the malignant tumors with rapid growing incidence. However, the survival rate is also relatively higher than other tumor types when having appropriate treatment. The approval of HALPRYZA (rituximab injection) will bring a new option to Chinese Lymphoma patients, help them to improve quality of life & prolong their survivals."

About Malignant Lymphoma

Malignant lymphoma is one of the most common hematological malignancies in China. It is one of the top ten malignant tumors with high morbidity and mortality. In recent years, the incidence of malignant lymphoma has been rising. According to histopathology, lymphoma can be divided into Hodgkin’s lymphoma (HL) and non-Hodgkin’s lymphoma (NHL), of which NHL accounts for the majority. NHL is a general term for a series of related but different lymphoid malignant tumors. Most (80-85%) originates from B cells. The rest originate from T cells or NK cells. More than 95% of B-cell non-Hodgkin’s lymphoma cells express CD20. The incidence of NHL increases with age. The most common type of NHL in China is diffuse large B-cell lymphoma (DLBCL), accounting for 40-50% (about 30-40% in Western countries). DLBCL is a moderately malignant to highly malignant invasive lymphoma that progresses rapidly and leads to the death of patients within a few months without treatment.

About HALPRYZA (rituximab injection)

HALPRYZA is rituximab injection and a recombinant human/murine chimeric monoclonal antibody drug. Rituximab binds to the CD20 antigen on the surface of B lymphocytes and mediates complement-dependent cytotoxicity (CDC) and antibody-dependent cellular cytotoxicity (ADCC). Normal and malignant B cells are targeted for destruction by the antibody, thereby achieving anti-tumor and immunosuppressive therapeutic effects.

On October 9, 2020 Allarity Therapeutics A/S ("Allarity" or the "Company") reported that following the Company’s name change from Oncology Venture A/S to Allarity Therapeutics A/S, the Company will be trading under its new short name ALLR from Monday, 12 October 2020 (Press release, Allarity Therapeutics, OCT 9, 2020, View Source [SID1234569150]). The share’s ISIN code, DK0060732477, will remain unchanged.

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Concurrently, the Company’s listed equity rights (warrants), TO 2, will change short name from OV TO 2 to ALLR TO 2. The ISIN code of this instrument, DK0061153657, will also remain unchanged.

On October 9, 2020 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported that leading science and technology company and existing shareholder Merck KGaA, Darmstadt, Germany, through its wholly owned subsidiary, Ares Trading S.A., has elected to voluntarily convert a convertible note with an outstanding principal balance of $25 million to increase its stake in Precigen from approximately 11.6% to 14.8% of outstanding shares, remaining as Precigen’s second largest shareholder (Press release, Precigen, OCT 9, 2020, View Source [SID1234568260]). As previously announced in December 2018, Merck KGaA, Darmstadt, Germany, reassigned to Precigen exclusive chimeric antigen receptor T-cell (CAR-T) development rights that were part of an earlier transaction between the companies. This reassignment allowed Precigen to regain full autonomous development of its proprietary CAR-T technology platform in exchange for $150 million in stock and a $25 million convertible note, allowing Merck KGaA, Darmstadt, Germany, to maintain an investment in the future potential of Precigen’s next-generation CAR-T development. The convertible note, which would have otherwise converted in December of 2020, is being exercised ahead of its designated maturity.

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"In line with Merck KGaA, Darmstadt, Germany’s mission to discover innovative therapies with transformative results, we are pleased to continue our relationship with Dr. Sabzevari and her team as they advance Precigen’s pipeline of next generation CAR-T therapies," said Belén Garijo, Vice Chair of the Executive Board and Deputy CEO of Merck KGaA, Darmstadt, Germany, and CEO of Healthcare. "We look forward to continuing a productive relationship with Precigen leading to better health outcomes for patients with a broad range of cancers."

The relationship between Precigen and Merck KGaA, Darmstadt, Germany is longstanding, dating back to 2015 when the two companies signed an agreement to develop and commercialize CAR-T cancer therapies utilizing Precigen’s proprietary Sleeping Beauty non-viral gene integration technology. This technology has evolved into Precigen’s UltraCAR-T next generation CAR-T therapies, which have demonstrated superior efficacy in preclinical studies and combine rapid manufacturing to improve time to treatment. Two UltraCAR-T therapies are currently being evaluated in Phase 1 clinical trials, including PRGN-3005 in ovarian cancer and PRGN-3006 in acute myeloid leukemia (AML).

"We welcome a strengthened relationship with Merck KGaA, Darmstadt, Germany, a recognized leader in oncology and patient care, as it increases its ownership position in Precigen," said Helen Sabzevari, PhD, President and CEO of Precigen. "We look forward to building value for all of our stakeholders through the clinical milestones we have planned over the next year and beyond."

On October 9, 2020 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that it will present initial data from the ongoing dose escalation portion of its Phase 1 clinical trial of SY-5609, its highly selective and potent oral cyclin-dependent kinase 7 (CDK7) inhibitor, in patients with select solid tumors (Press release, Syros Pharmaceuticals, OCT 9, 2020, View Source [SID1234568261]). The data will be presented in a poster session at the 32nd EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium, taking place virtually October 24-25, 2020, and will include data on safety, pharmacokinetics and pharmacodynamics.

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The abstract is now available on the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) conference website at View Source The presentation will be available for on-demand viewing on the ENA website starting Saturday, Oct. 24, 2020.

Details of the poster presentation are as follows:

Presentation Title: Early evidence of dose-dependent pharmacodynamic activity following treatment with SY-5609, a highly selective and potent oral CDK7 inhibitor, in patients with advanced solid tumors
Session Title: New Drugs
Presenter: Kyriakos P. Papadopoulos, M.D., South Texas Accelerated Research Therapeutics
Abstract Number: 180