APLM | Jotup

Apollomics Announces Private Placement Financing and Addition to Board of Directors

Retrieved on:

Wednesday, May 8, 2024

Sale, Genomics, Canaccord Genuity, Proteomics, Security (finance), PIPE, Lawrence Berkeley National Laboratory, APLM

The PIPE financing is expected to close on May 8, 2024, subject to satisfaction of customary closing conditions.

Key Points:

The PIPE financing is expected to close on May 8, 2024, subject to satisfaction of customary closing conditions.
Apollomics also announced today the appointment of Dr. Robert (Bob) Lin, M.D., Ph.D. to the board of directors of Apollomics.
In addition, Jonathan Wang, Ph.D. has resigned from the board of directors, due to personal reasons.
He brings valuable medical and biotech experience to our Board,” said Dr. Guo-Liang Yu, Ph.D., Chairman and Chief Executive Officer of Apollomics.

Apollomics Announces Approval of Vebreltinib in China as a First-in-Class Treatment for Gliomas with MET Fusion Gene

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Thursday, April 25, 2024

FOSTER CITY, Calif., April 25, 2024 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM), a clinical-stage biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, today announced that its partner in China, Avistone Biotechnology Co. Ltd. (Avistone), received approval from the National Medical Products Administration (NMPA) of China for vebreltinib (APL-101) for the treatment of adult patients with isocitrate dehydrogenase (IDH) mutant astrocytoma (WHO Grade 4) or glioblastoma with a history of low-grade disease who have the PTPRZ1-MET fusion (ZM fusion) gene and have failed previous treatments. This supplemental New Drug Application (sNDA) approval makes vebreltinib the world’s first c-Met inhibitor approved for treatment of Central Nervous System (CNS) tumor with c-Met alteration, and follows the NMPA’s November 2023 approval of vebreltinib for the treatment of patients with Met Exon 14 skipping non-small cell lung cancer (NSCLC).

Key Points:

"The NMPA’s approval of vebreltinib in gliomas is an important, first-in-class approval as it demonstrates vebreltinib’s CNS penetration ability and c-Met inhibitory activity in the tumors there," said Guo-Liang Yu, Ph.D., Chairman and Chief Executive Officer of Apollomics.
Surgery, radiation treatment, and chemotherapy are current standard treatment strategies for gliomas with poor prognoses.
These preliminary data support cross-region similarity of patient response to treatment with vebreltinib.
This collaboration enables both companies to leverage their strengths and maximize the benefit of vebreltinib worldwide.

Apollomics Highlights Clinical Progress and Reports Full Year 2023 Financial Results

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Thursday, March 28, 2024

APLM, NSCLC, New Drug Application, Patient, NDA, Lung cancer, MET, GCN, FDA, Met, Food, Pharmaceutical industry

ET

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FOSTER CITY, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM) (“Apollomics” or the “Company”), a late- stage clinical biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, today announced financial results for the full year ended December 31, 2023, and highlighted progress of its pipeline.
As a result, Apollomics believes that its current capital resources will fund planned operations through the first quarter of 2025.
Dr. Plunkett brings to Apollomics over 25 years of strategic and financial experience within the biopharmaceutical sector, including extensive fundraising and corporate development expertise.
In March 2023, the Company raised $23.7 million in a private placement in public equity (PIPE) financing, before transaction expenses.

Apollomics Receives Nasdaq Notification Regarding Minimum Bid Price Deficiency

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Friday, January 19, 2024

Notice, Common stock, BID, APLM, Cancer, Calendar, Auction

The Notice provided that, in accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has a period of 180 calendar days from the date of the Notice, or until July 15, 2024, to regain compliance with the Bid Price Requirement.

Key Points:

The Notice provided that, in accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has a period of 180 calendar days from the date of the Notice, or until July 15, 2024, to regain compliance with the Bid Price Requirement.
If at any time before July 15, 2024 the bid price of the Ordinary Shares closes at or above $1.00 per share for a minimum of ten consecutive trading days, Nasdaq will provide written notification that the Company has achieved compliance with the Bid Price Requirement and the matter will be closed.
The Company intends to actively monitor the closing bid price of its Ordinary Shares and will evaluate available options to regain compliance with the Bid Price Requirement.
However, there can be no assurance that the Company will be able to regain compliance with the Bid Price Requirement or maintain compliance with any of the other Nasdaq continued listing requirements.

Apollomics Completes Enrollment in Phase 3 Bridging Study of Uproleselan in Chinese Patients with Relapsed/Refractory Acute Myeloid Leukemia

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Wednesday, January 3, 2024

APLM, Survival, Medicine, Prognosis, Greater, Disease, Incidence, Peking Union Medical College, Cancer, Acute myeloid leukemia, Patient, AML

This Phase 3 bridging study is being performed in China with Chinese r/r AML patients.

Key Points:

This Phase 3 bridging study is being performed in China with Chinese r/r AML patients.
Apollomics licensed uproleselan from GlycoMimetics (Nasdaq: GLYC), including the rights to clinical development, production and commercial sales in the Greater China market (Mainland China, Hong Kong, Macau and Taiwan).
“AML is a highly aggressive hematological cancer, and the prognosis of patients with relapsed or refractory disease is extremely poor.
AML remains a major unmet medical need in China with an incidence of close to 40,000 patients every year.

Apollomics Presents Interim Data from Two Ongoing Phase 2 Clinical Trials with Vebreltinib in NSCLC Patients with MetExon14 Skipping Mutation

Retrieved on:

Monday, December 4, 2023

MET, Conference, APLM, Lung cancer, NACLC, GCN, Patient, Safety, NSCLC, Antibiotics

FOSTER CITY, Calif., Dec. 04, 2023 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM) (the “Company”), a late-stage clinical biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, today announced the presentation of vebreltinib efficacy and safety data from the ongoing multi-cohort Phase 2 KUNPENG trial (NCT04258033) and the ongoing global multi-cohort Phase 2 SPARTA trial (NCT03175224) at the 2023 IASLC North America Conference on Lung Cancer (NACLC), that was held December 1-3, 2023, in Chicago, Illinois.

Key Points:

Vebreltinib appears efficacious in non-small cell lung cancer (NSCLC) patients with MetExon14 skipping mutation with or without co-occurring MET amplification.
Of the 83 NSCLC patients with MetExon14 skipping mutation with available gene copy number (GCN) data from the Phase 2 KUNPENG and SPARTA trials, 91.6% did not have co-occurring MET amplifications, reflecting the real-world distribution of the NSCLC patients with MetExon14 skipping mutation from two large public databases (83.6% and 91.9%)1.
“For the first time, we report the ORR of vebreltinib by GCN in NSCLC patients with MetExon14 skipping mutation.
Of NSCLC patients with MetExon14 skipping mutation with available GCN data included in this analysis, 91.6% had no co-occurring MET amplification (GCN

Apollomics Announces Presentation of Vebreltinib Data at the 2023 IASLC North America Conference on Lung Cancer (NACLC)

Retrieved on:

Tuesday, November 28, 2023

MET, Conference, APLM, NACLC, Mutation, Lung cancer, NSCLC, Concurrency

FOSTER CITY, Calif., Nov. 28, 2023 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM ) (the “Company”), a late-stage clinical biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, today announced a poster presentation of clinical results for vebreltinib in the treatment of NSCLC with MET exon 14 skipping mutation with or without concurrent MET amplification at the 2023 IASLC North America Conference on Lung Cancer (NACLC), being held on December 1 through 3, 2023 in Chicago, Illinois.

Key Points:

FOSTER CITY, Calif., Nov. 28, 2023 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM ) (the “Company”), a late-stage clinical biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, today announced a poster presentation of clinical results for vebreltinib in the treatment of NSCLC with MET exon 14 skipping mutation with or without concurrent MET amplification at the 2023 IASLC North America Conference on Lung Cancer (NACLC), being held on December 1 through 3, 2023 in Chicago, Illinois.
Vebreltinib Efficacy In METex14 Mutant NSCLC With or Without Concurrent MET Amplification, MET GCN Status Distributions Compared With Public Databases

Apollomics Announces the First Approval of Vebreltinib for MET Exon 14 Skip Non-Small Cell Lung Cancer

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Thursday, November 16, 2023

NDA, National Medical Products Administration, Food, Aviston, Illinois, NMPA, APLM, Patient, FDA, Lung cancer, MET, NSCLC, Partnership, Cancer, Pharmaceutical industry, Hong Kong

FOSTER CITY, Calif., Nov. 16, 2023 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM), a late-stage clinical biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, today announced that its partner in China, Avistone Biotechnology Co. Ltd., received conditional approval from the National Medical Products Administration (NMPA) of China for the commercialization of vebreltinib to treat patients with MET exon 14 skipping non-small cell lung cancer (NSCLC).

Key Points:

"The NMPA approval of vebreltinib is an important milestone toward providing a new treatment option for patients with MET exon 14 skipping NSCLC in China.
Apollomics extends its full support and congratulations to Avistone on this significant achievement," said Guo-Liang Yu, Ph.D., Chairman and Chief Executive Officer of Apollomics.
By targeting c-Met dysregulation, vebreltinib offers a potential breakthrough for patients with MET exon 14 skipping NSCLC and other cancers driven by c-Met alterations, i.e.
Patients with MET exon 14 skipping mutations, comprise approximately 3% to 4% of all NSCLC cases, face significant challenges due to limited treatment options.

Apollomics Announces Two New Cohorts in Global Phase 2 SPARTA Study of Vebreltinib in Non-Small Cell Lung Cancer and Other Solid Tumors with MET Dysregulation

Retrieved on:

Tuesday, October 31, 2023

The second new cohort, labeled F, will evaluate vebreltinib monotherapy in histology-agnostic solid tumors with wild type MET gene that have high expression of c-MET and hepatocyte growth factor (HGF).

Key Points:

The second new cohort, labeled F, will evaluate vebreltinib monotherapy in histology-agnostic solid tumors with wild type MET gene that have high expression of c-MET and hepatocyte growth factor (HGF).
Dr. Bindiya Patel and Dr. Siddhartha Devarakonda presented this study during a poster session on September 11, 2023, at the World Conference on Lung Cancer (WCLC) in Singapore.
A link to the WCLC poster is available under the Investors tab of the Apollomics website at https://www.apollomicsinc.com .
It works by inhibiting the aberrant activation of the HGF/c-MET axis, a key pathway involved in tumor growth, proliferation, and the development of resistance to certain targeted therapies such as osimertinib.

Apollomics Announces Report of Activity of Vebreltinib in Glioblastoma Multiforme (GBM) with PTPRZ-MET Fusion

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Thursday, October 26, 2023

APLM, National Medical Products Administration, GBM, Temozolomide, NMPA, ESMO, SPARTA, Radiation, Cancer, Partial-response maximum-likelihood, New Drug Application, NDA, European Society for Medical Oncology, Patient, MET, Communication, Aviston, Illinois, Pharmaceutical industry

The patient with GBM with PTPRZ-MET fusion who had previously received radiotherapy and temozolomide, was reported to have an impressive Partial Response (PR) after 8 weeks of treatment with vebreltinib monotherapy during participation in the SPARTA study ( NCT03175224 ) .

Key Points:

The patient with GBM with PTPRZ-MET fusion who had previously received radiotherapy and temozolomide, was reported to have an impressive Partial Response (PR) after 8 weeks of treatment with vebreltinib monotherapy during participation in the SPARTA study ( NCT03175224 ) .
“PTPRZ-MET fusions are known to cause aggressive forms of GBM and are associated with poor prognosis.
We are pleased to achieve positive clinical results in patients with this deadly disease, further demonstrating the potential of vebreltinib as a new treatment for patients with cancers driven by MET alterations,” said Guo-Liang Yu, Ph.D., co-founder, Chairman and Chief Executive Officer of Apollomics.
GBM with MET fusion is an indication pursued by Apollomics and its China partner, Avistone Biotechnology.