On May 7, 2021 Luye Pharma Group announced that its biopharmaceutical drug 博优诺 (Bevacizumab Injection), developed by the Group’s holding subsidiary Boan Biotech, has received marketing authorization from China’s National Medical Products Administration (NMPA), for the treatment of advanced, metastatic or recurrent non-small-cell lung cancer (NSCLC), and metastatic colorectal cancer (Press release, Luye Pharma, MAY 7, 2021, View Source [SID1234597708]). 博优诺 is the third biosimilar of Avastin to enter the market in China, as well as the first product from Boan Biotech’s pipeline to receive marketing authorization.

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博优诺 and Avastin are Equivalent in Efficacy – Bevacizumab is a Standard Therapy for the Treatment of Multiple Cancers

The marketing approval for 博优诺 is based on the Guidelines on Similarity Evaluation and Indication Extrapolation of Biosimilars issued by the NMPA’s China Center for Drug Evaluation in February 2021. 博优诺 and Avastin were compared head-to-head in two pivotal clinical studies – the first was a pharmacokinetic(PK) study among healthy subjects, and the second was a comparative study of efficacy and safety in metastatic or recurrent non-squamous NSCLC patients. Both studies met primary endpoints, demonstrating that 博优诺 and Avastin are equivalent in efficacy and highly similar in terms of PK characteristics, safety, and immunogenicity.

As a classic anti-angiogenic oncology drug, Bevacizumab is considered standard therapy and is recommended by a number of guidelines worldwide for treating multiple malignant tumors. The drug is indicated for the treatment of NSCLC, metastatic colorectal cancer, glioblastoma, renal cell carcinoma, cervical cancer, ovarian cancer, and other solid tumors worldwide, with its efficacy and safety widely recognized by physicians and patients through its long-term clinical use. According to the Guidelines on Similarity Evaluation and Indication Extrapolation of Biosimilars, all indications for Avastin approved in China can also be gradually applied to 博优诺.

In addition, the combination of Bevacizumab and paclitaxel provides unique advantages in treatment. 博优诺 can be used with Luye Pharma’s core product paclitaxel liposome injection (Lipusu) to achieve a good synergy effect.

Preparing to Market 博优诺 – Meeting Patient Needs

According to data from the World Health Organization’s International Agency for Research on Cancer, the number of new cancer cases reported in 2020 in China was 4.57 million, the highest in the year and accounting for 23.7% of the total in the world. Lung cancer and colorectal cancer are the two cancers with the highest incidence rate in China, with 820 thousand and 560 thousand new cases each, respectively. Based on the high and ever-increasing number of patients in these two disease areas, the approval of 博优诺 is expected to help patients gain access to high-quality medication and address unmet needs.

Meanwhile, Bevacizumab Injection has been included in China’s National Reimbursement Drug List, further increasing accessibility. As the third biosimilar of Avastin to enter Chinese market, 博优诺 is expected to have optimistic prospects. According to the data from IQVIA, global sales of Bevacizumab Injection totaled USD 6.09 billion, with sales in China accounting for RMB 3.63 billion in 2020.

Through comprehensive leverage of its expertise along the whole industry value chain, Boan Biotech has been active in the preparation for 博优诺 entering the market, in manufacturing, sales team building, market access channels, and other areas. In addition, Luye Pharma Group’s long-term accumulated resources and expansive networks in the field of oncology are also expected to bring synergetic effects to enable the success of 博优诺.

Boan Biotech’s Rapid R&D Pipeline Development – Efficiency in Innovation

Boan Biotech’s antibody discovery research is based on three technology platforms: Human Antibody Transgenic Mouse and Phage Display Technology, Bispecific T-cell Engager Technology, and ADC Technology. By leveraging its efficient and innovative capabilities, the company has developed more than 10 innovative antibody product candidates with international intellectual property protection, and 8 biosimilar products including 博优诺 .

"We are delighted to see 博优诺 become the first product from Boan Biotech’s pipeline approved for marketing, and hope it will bring benefit to patients in need of high-quality and affordable anti-angiogenic treatment." said Jiang Hua, Chief Executive Officer of Boan Biotech, "The approval of 博优诺 is an important milestone for us and validates our efforts in the field with a tangible and substantial payoff. Focusing on the development of biopharmaceuticals, we hope to further accelerate R&D progress with more innovative products, serving more patients in China and around the globe."

In addition to 博优诺, Boan Biotech has a series of biopharmaceutical products in various stages of clinical development, including LY-CovMab, an innovative antibody for the treatment of COVID-19, which has completed phase I clinical trial in China and is soon to start the phase II clinical trials in China, the U.S. and Europe. Other Boan Biotech biosimilar products are expected to bear fruit in the near future. Phase III clinical trials in China for LY06006 (a biosimilar of Prolia) are nearing completion, with final administration of the drug completed for all the subjects, and the drug already receiving approval for clinical trials in Europe and the U.S. LY01011 (A biosimilar of Xgeva) is undergoing phase III clinical trials in China and phase I clinical trials in Europe and the U.S., and LY09004, a biosimilar of Eylea is also undergoing phase III clinical trials in China.

On May 7, 2021 Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, reported that its President and Chief Executive Officer, Christopher U. Missling, PhD, will give a presentation titled, "Clinical Trials for Rare Diseases: Challenges and Opportunities", at the Precision in Clinical Trials Virtual Summit (East Coast) on Monday, May 10that 9:35 a.m. EDT (Press release, Anavex Life Sciences, MAY 7, 2021, View Source [SID1234579429]). The Precision in Clinical Trials Virtual Summit (East Coast) takes place May 10th – 11th 2021.

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On May 7, 2021 Celyad Oncology SA (Euronext & Nasdaq: CYAD) (the "Company"), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, reported an update on its financial results and recent business developments for the fiscal quarter ended March 31, 2021 (Press release, Celyad, MAY 7, 2021, View Source [SID1234579455]).

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"We have entered 2021 with ever-increasing enthusiasm around the progress of our programs," commented Filippo Petti, Chief Executive Officer of Celyad Oncology. "Our lead shRNA-based allogeneic candidate, CYAD-211, which is currently being evaluated in the Phase 1 IMMUNICY-1 trial for the treatment of multiple myeloma, has shown no safety concerns nor evidence of Graft-versus-Host Disease (GvHD) at dose level 1. We look forward to announcing additional proof-of-concept data from this trial by the end of second quarter of 2021. In addition, we have continued to enroll patients in the alloSHRINK expansion trial for CYAD-101 and will turn our attention to the KEYNOTE-B79 trial. Lastly, we are planning an R&D day for this summer that will provide an opportunity for our broader team to offer an in-depth overview of our clinical programs and strategy for advancing our next-generation shRNA platform and allogeneic pipeline."

Recent Highlights

Appointment of Dr. Charles Morris as Chief Medical Officer to lead and provide strategic direction for Celyad Oncology’s medical, regulatory, and clinical development activities.
Appointment of Marina Udier, Ph.D. to Board of Directors
Announced a committed equity purchase agreement for up to $40 million in American Depositary Shares (ADSs) with Lincoln Park Capital Fund, LLC ("LPC")
First Quarter 2021 Financial Review

As of March 31, 2021, the Company had cash and cash equivalents of €12.2 million ($14.3 million). Net cash burn during the first quarter of 2021 amounted to €5.1 million ($5.9 million), in line with expectations. In April 2021, the Company raised proceeds of €3.3 million ($4.0 million) from the sale of ADSs to LPC. The Company confirms its previous guidance that its existing cash and cash equivalents combined with the remaining access to the equity purchase agreement established with LPC should be sufficient, based on the current scope of activities, to fund operating expenses and capital expenditure requirements until mid-2022.

Update on Clinical Programs

CYAD-211 – Allogeneic shRNA-based, anti-BCMA CAR T for r/r MM

CYAD-211 is an investigational, shRNA-based allogeneic CAR T candidate engineered to co-express a BCMA-targeting chimeric antigen receptor and a single shRNA, which interferes with the expression of the CD3ζ component of the T-cell receptor (TCR) complex. The Company is currently conducting the first-in-human, open-label, dose-escalation Phase 1 IMMUNICY-1 trial to evaluate the safety and efficacy of a single infusion of CYAD-211 following preconditioning chemotherapy cyclophosphamide and fludarabine in patients with r/r MM. The trial seeks to determine the recommended dose of CYAD-211 for the treatment of patients with r/r MM for further development as well as to establish proof-of-concept that single shRNA-mediated knockdown can generate allogeneic CAR T cells in humans without inducing GvHD. In March, the Company announced that no safety concerns nor evidence of GvHD had been reported in the first three patients treated at dose level 1 (30×106 cells per infusion) of CYAD-211 in the IMMUNICY-1 trial. In first quarter 2021, the Company initiated enrollment in dose level 2 (100×106 cells per infusion). The Company expects to announce additional proof-of-concept data from the IMMUNICY-1 trial by the end of the second quarter of 2021.

CYAD-101 – Allogeneic TIM-based NKG2D CAR T for mCRC

The Company’s first-in-class, non-gene edited clinical candidate, CYAD-101, which co-expresses the NKG2D receptor and the novel inhibitory peptide TCR Inhibitory Molecule (TIM), is currently in the expansion segment of the alloSHRINK Phase 1 trial for the treatment of advanced mCRC. To the Company’s knowledge, CYAD-101 is the first investigational allogeneic CAR T candidate to generate evidence of clinical activity for the treatment of a solid tumor indication.

Phase 1 alloSHRINK trial is ongoing, in which the Company is evaluating CYAD-101 following FOLFIRI (combination of 5-fluorouracil, leucovorin and irinotecan) preconditioning chemotherapy in refractory mCRC patients, at the recommended dose of one billion cells per infusion. The Company expects to announce preliminary data from the expansion cohort of the trial in mid-2021.
Celyad Oncology will also conduct the Phase 1b KEYNOTE-B79 clinical trial, which will evaluate Celyad Oncology’s investigational non-gene edited allogeneic CAR T candidate, CYAD-101, following FOLFIRI chemotherapy, with MSD’s anti-PD­1 therapy, KEYTRUDA (pembrolizumab) in refractory metastatic colorectal cancer (mCRC) patients with microsatellite stable (MSS) / mismatch-repair proficient (pMMR) disease. The Phase 1b KEYNOTE-B79 trial is expected to be initiated during first half of 2021.
CYAD-02 – Autologous NKG2D receptor-based CAR T for relapsed/refractory acute myeloid leukemia (r/r AML) and myelodysplastic syndromes (MDS)

Enrollment is ongoing in dose level 3 of the Phase 1 CYCLE-1 trial for the next-generation, autologous NKG2D receptor-based CAR T candidate CYAD-02. The dose-escalation Phase 1 CYCLE-1 trial is evaluating the safety and clinical activity of CYAD-02 following preconditioning chemotherapy in patients with r/r AML and MDS. To date, treatment with CYAD-02 has been generally well-tolerated. Of seven patients evaluable for clinical activity, five patients demonstrated anti-leukemic activity (at least 50% bone marrow blasts decrease), including a very-high risk MDS patient treated at dose level 3 who achieved a marrow complete response.

Next-generation shRNA Multiplex Platform

In 2020, the Company began developing a proprietary shRNA platform utilizing a novel framework to optimize and expand the expression of multiple shRNAs with our All-in-One vector approach. The Company’s novel framework has the capability to knockdown or silence up to six genes simultaneously, while providing several key advantages beyond the Company’s first-generation approach. The Company believes its next-generation shRNA multiplex platform will form the backbone for future allogeneic CAR T candidates, including several programs which are in the discovery phase of development. Our next-generation shRNA platform does not incorporate any of the Horizon Discovery technology.

Upcoming Milestones

Additional proof-of-concept data from the initial dose cohorts of the Phase 1 IMMUNICY-1 trial of CYAD-211 for r/r MM are expected by the end of second quarter of 2021.
Preliminary data from the expansion segment of the alloSHRINK trial evaluating CYAD-101 following FOLFIRI preconditioning chemotherapy in refractory mCRC patients are expected in mid-2021.
Initiation of the Phase 1b KEYNOTE-B79 trial evaluating CYAD-101 with KEYTRUDA in mCRC patients with MSS/pMMR disease is anticipated in the first half of 2021.
Additional data from dose level 3 of Phase 1 CYCLE-1 trial of CYAD-02 for r/r AML and MDS are anticipated in the first half of 2021.
Financial Calendar

First Half 2021 Financial Results …………………… August 4, 2021
Third Quarter 2021 Financial Results ……………… November 10, 2021

On May 7, 2021 iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of highly differentiated immuno-oncology therapeutics for patients, reported that it will host a conference call and live webcast at 4:30 p.m. ET on Thursday, May 13th, 2021 to report its first quarter 2021 financial results and provide a corporate update (Press release, iTeos Therapeutics, MAY 7, 2021, View Source [SID1234579475]).

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Conference Call

Dial-in numbers: (833) 607-1661 (US/Canada) or (914) 987-7874 (International); Conference ID: 6160559

Webcast

A live audio webcast will be accessible from the Events page of the Company’s IR website at View Source A replay will be available on the Company’s website approximately two hours after completion of the event and for 30 days following the call

On May 6, 2021 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported first quarter 2021 financial results and provided a corporate update (Press release, Kura Oncology, MAY 6, 2021, View Source [SID1234579342]).

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"We believe KO-539 is well-positioned as a potentially best-in-class and first-in-class menin inhibitor," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "This confidence is supported by a growing body of clinical data, including compelling activity, a favorable safety and tolerability profile and a wide therapeutic window. As such, we intend to conduct a comprehensive clinical development strategy for KO-539, both as a monotherapy and in combination, aimed at providing the greatest benefit to patients with acute leukemia, and we are well funded to execute on this strategy."

"A critical component of our KO-539 development plan is the determination of an optimal Phase 2 dose," continued Dr Wilson. "Given the wide therapeutic window of KO-539, we have amended our KOMET-001 trial to include two genetically enriched Phase 1b expansion cohorts. This should enable us to maximize the benefit-risk for KO-539 in our target patient populations and better inform an optimal dose for Phase 2 and beyond. Enrollment in these Phase 1b expansion cohorts is expected to begin mid-year, and we look forward to sharing our progress as we work to bring this important therapeutic option to patients."

Recent Highlights

Enrollment in KOMET-001 Phase 1b expansion cohorts to begin shortly – KO-539 continues to demonstrate a wide therapeutic window and compelling single-agent activity in an all-comer population of patients with relapsed or refractory acute myeloid leukemia (AML), including patients with NPM1 mutations and KMT2A rearrangements. In order to better inform an optimal Phase 2 dose, Kura has amended its KOMET-001 trial of KO-539 to include two Phase 1b expansion cohorts. Both cohorts will be enriched with NPM1-mutant and KMT2A-rearranged relapsed/refractory AML patients. The Company expects to enroll at least 12 patients in each of the Phase 1b expansion cohorts and assess those patients for safety and tolerability, pharmacokinetics/pharmacodynamics and efficacy in order to determine the recommended Phase 2 dose. In addition, the amended Phase 1b protocol gives the Company flexibility to enroll up to 18 additional patients per cohort, as appropriate. Kura believes the patients enrolled in the cohort selected as the recommended Phase 2 dose have the potential to be included in the subsequent, registration-directed portion of the KOMET-001 trial. Patient enrollment in the genetically enriched Phase 1b expansion cohorts is expected to begin at existing and new clinical sites in mid-2021.

Multiple expansion opportunities in acute leukemias – Pending determination of an optimal Phase 2 dose, Kura is preparing to conduct a comprehensive clinical development plan for KO-539, both as a monotherapy and in combination, aimed at broadening the opportunity in acute leukemias. Additional opportunities include front line combination studies, additional genetic subtypes, a pediatric development strategy and other indications, such as acute lymphocytic leukemia and myelodysplastic syndrome.

Publication of tipifarnib Phase 2 data in Journal of Clinical Oncology – Data from Kura’s Phase 2 clinical trial (RUN-HN) of tipifarnib were recently published in the Journal of Clinical Oncology. These data formed the basis of the Breakthrough Therapy Designation granted by the U.S. Food and Drug Administration (FDA) earlier this year for the treatment of patients with recurrent or metastatic HRAS mutant head and neck squamous cell carcinoma (HNSCC). Tipifarnib is currently being evaluated in an ongoing registration-directed clinical trial (AIM-HN) in this indication of high unmet need.

Breakthrough Device Designation for HRAS companion diagnostic – The FDA has granted Breakthrough Device Designation (BDD) to Illumina for a companion diagnostic to detect HRAS mutations in HNSCC in support of Kura’s tipifarnib program, as the device provides for more effective treatment of a life-threatening disease. The next-generation sequencing-based companion diagnostic is being developed in collaboration with Illumina leveraging the content of TruSight Oncology 500. The BDD enables frequent interactions with the FDA and prioritized review on regulatory submissions.
Financial Results

Research and development expenses for the first quarter of 2021 were $20.3 million, compared to $12.6 million for the first quarter of 2020.

General and administrative expenses for the first quarter of 2021 were $10.6 million, compared to $7.6 million for the first quarter of 2020.

Net loss for the first quarter of 2021 was $30.7 million, compared to a net loss of $19.2 million for the first quarter of 2020. This included non-cash share-based compensation expense of $5.1 million, compared to $3.2 million for the same period in 2020.

Cash, cash equivalents and short-term investments totaled $603.9 million as of March 31, 2021, compared with $633.3 million as of December 31, 2020. Management expects that current cash, cash equivalents and short-term investments will be sufficient to fund current operations into 2024.
Upcoming Milestones

Initiation of genetically enriched Phase 1b expansion cohorts in KOMET-001 in mid-2021

Additional Phase 1 data from KOMET-001 in the second half of 2021

Initiation of a Phase 1/2 proof-of-concept study of tipifarnib in combination with a PI3Kα inhibitor in the second half of 2021

Nomination of a next-generation farnesyl transferase inhibitor Development Candidate in mid-2021
Conference Call and Webcast

Kura’s management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT today, May 6, 2021, to discuss the financial results for the first quarter 2021 and provide a corporate update. The live call may be accessed by dialing (888) 771-4371 for domestic callers and (847) 585-4405 for international callers and entering the conference code: 50156205. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.kuraoncology.com.