On December 27, 2021 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported that Dr. Neal Walker, President and CEO of Aclaris, will participate in a fireside chat at the H.C. Wainwright BioConnect Virtual Conference, which will be available beginning on Monday, January 10, 2022 at 7:00 a.m. ET (Press release, Aclaris Therapeutics, DEC 27, 2021, View Source [SID1234597758]).

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A webcast of the fireside chat may be accessed through the "Events" page of the "Investors" section of Aclaris’ website, www.aclaristx.com. The webcast will be archived for at least 30 days on the Aclaris website.

On December 27, 2021 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of next generation antibody therapeutics, reported it has dosed the first patient in its Phase II clinical trial evaluating the combination of olinvacimab, PharmAbcine’s anti-VEGFR2 (Vascular Endothelial Growth Factor Receptors) antibody, and KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 molecule, for the treatment of mTNBC (metastatic Triple-Negative Breast Cancer) in Australia (Press release, PharmAbcine, DEC 27, 2021, View Source [SID1234597774]).

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The Phase II clinical trial is currently open and actively recruiting patients. It is an open-label and multicenter trial that will enroll 36 immuno-oncology drug naïve mTNBC patients regardless of their PD-L1 expression level. The study is designed to evaluate the clinical efficacy, safety, pharmacodynamics, and the expression level of VEGFR2. The enrolled patients will be treated with 16mg/kg of olinvacimab every week and 200mg of pembrolizumab every 3 weeks for up to 35 cycles (approximately 2 years).

Both companies decided to initiate this study based on the promising clinical data obtained from the Phase Ib olinvacimab and pembrolizumab study in mTNBC which is still ongoing in Australia. According to the interim result presented at SABCS (San Antonio Breast Cancer Symposium) 2020, olinvacimab in combination with pembrolizumab showed a clear safety profile and encouraging efficacy data, including 50% ORR (Overall Response Rate) and 67% DCR (Disease Control Rate) in the high-dose olinvacimab (16mg/kg) cohort (n=6pts). In addition, one patient in PR (Partial Response) showed CR (Complete Response) in the target lesion and another PR patient showed CR in a non-target lesion.

mTNBC is a highly malignant type of cancer that shows a high recurrence rate within the first five years after diagnosis. mTNBC accounts for 15-20% of all breast cancers and shows a 5-year survival rate of approximately 11%. Unlike other breast cancers, mTNBC does not express estrogen or progesterone receptors or HER2 (human epidermal growth factor receptor 2), and it does not respond to existing cancer drugs designed to target these markers. mTNBC is very difficult to treat, and there are very few FDA approved treatment options for these patients.

Olinvacimab is the Company’s leading pipeline and is undergoing multiple global clinical trials. Other than the ongoing Phase II olinvacimab and pembrolizumab combo trial in mTNBC, a Phase II olinvacimab mono study for bevacizumab-nonresponding rGBM (recurrent glioblastoma multiforme) patients is ongoing at multiple sites in both US and Australia. Also, two Phase Ib olinvacimab and pembrolizumab combo trials in mTNBC and rGBM in Australia are still ongoing.

"We are pleased to have commenced the first enrollment and dosing in this important study," said Professor. Arlene Chan, the principal investigator of this study and a medical oncologist at Hollywood Private Hospital in Western Australia. "The encouraging clinical results and the excellent safety profile from the previous Phase Ib trial gave us huge confidence in the Phase II study. We hope to see this combination therapy rise up as a promising treatment option for mTNBC patients in which current treatment options are limited."

"It is thrilling to have reached this important milestone as this study is critical towards offering a potential new treatment for the mTNBC patients," said Dr. Jin-San Yoo, CEO of PharmAbcine. "PharmAbcine is grateful for the collaborative work with MSD, and we are glad that the recruitment process remains on track. We all look forward to generating another encouraging data in a larger population setting."

For more information about the Phase II olinvacimab and pembrolizumab combo study for the treatment of mTNBC, please visit clinicaltrials.gov and search for the reference identifier NCT04986852

On December 27, 2021 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported that CEO and Co-founder Ugur Sahin, M.D., will present a corporate overview and update at the virtual 40th Annual J.P. Morgan Healthcare Conference on Tuesday, January 11, 2022, at 9:45 am ET (Press release, BioNTech, DEC 27, 2021, View Source [SID1234597759]).

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A live webcast of the presentation will be available via the "Events & Presentations" page in the Investor Relations section on the Company’s website at View Source The replay of the webcast will be archived on the Company’s website for 30 days following the conference.

On December 27, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, reported that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved I-Mab’s IND submission for the initiation of a phase 2 trial in China for enoblituzumab (also known as TJ271) in combination with pembrolizumab (Keytruda) in patients with solid tumors, including non-small cell lung cancer (NSCLC), urothelial carcinoma (UC), and other selected cancers (Press release, I-Mab Biopharma, DEC 27, 2021, View Source [SID1234597775]). I-Mab has acquired exclusive rights to develop and commercialize enoblituzumab in Greater China from MacroGenics (Nasdaq: MGNX).

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Enoblituzumab is a highly differentiated humanized monoclonal antibody directed against the immune regulator B7-H3, which plays a key role in regulating immune response against cancers and is widely expressed in multiple cancers. The presence of B7-H3 in tumors is associated with the poor efficacy of neoadjuvant therapies. Enoblituzumab enhances the antibody-dependent killing of cancer cells and has demonstrated strong anti-tumor activity in preclinical studies. Additional preclinical data generated by I-Mab and preliminary clinical evidence from MacroGenics support increased efficacy for the combination of enoblituzumab and a PD-1 antibody against cancers.

The phase 2 clinical trial in China will evaluate the efficacy of the combination of enoblituzumab and pembrolizumab. The trial is designed as a "basket" clinical trial in patients with NSCLC, UC, and other selected cancer types based on previous studies conducted by MacroGenics. These previous studies have indicated that combination therapy resulted in anti-tumor activity in recurrent or metastatic NSCLC and squamous cell carcinoma of the head and neck (SCCHN).

"The initiation of the phase 2 clinical trial will accelerate the clinical development of enoblituzumab in China," said Dr. Andrew Zhu, President of I-Mab. "Enoblituzumab has become a key player against various advanced cancers and one of the Company’s core clinical assets. We are excited about the initiation of this clinical study and expect to bring this valuable compound to cancer patients with critical unmet medical needs."

Currently, MacroGenics is conducting a phase 2 study of enoblituzumab in combination with retifanlimab (PD-1 antibody) or tebotelimab (PD-1 & LAG-3 bispecific DART molecule) for first-line treatment of patients with recurrent or metastatic SCCHN.

About Enoblituzumab

Enoblituzumab is an investigational Fc-optimized monoclonal antibody that targets B7-H3, a member of the B7 family of immune regulator proteins. B7-H3 is widely expressed by many different tumor types and may play a key role in regulating the immune response to various types of cancer. Enoblituzumab has been or is currently being evaluated in clinical trials as a monotherapy or in combination with anti-PD-1-based therapies in patients with B7-H3-expressing cancers. I-Mab acquired the development and commercial rights from MacroGenics for Greater China.

On December 27, 2021 Celularity Inc. (Nasdaq: CELU) ("Celularity"), a clinical-stage biotechnology company developing placental-derived allogeneic cell therapies, reported the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its non-genetically modified cryopreserved human placental hematopoietic stem cell-derived natural killer (NK) cell therapy, CYNK-001, in development for the treatment of acute myeloid leukemia (AML) (Press release, Celularity, DEC 27, 2021, View Source [SID1234597760]).

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"The majority of patients with AML continue to have poor long-term outcomes, particularly those who suffer relapse or have measurable residual disease, necessitating development of novel therapies, including CYNK-001," said Andrew Pecora, M.D., President of Celularity. Robert Hariri, M.D., Ph.D., Founder, Chairperson and Chief Executive Officer of Celularity added, "We believe that the unique properties of our cell source, including the ability to proliferate and maintain activity, could be the key to improving response rates and durability for patients. We are pleased to receive this fast-track designation from the FDA for AML supporting continued development of our placental-derived NK cell platform. CYNK-001 previously received orphan drug designation for malignant gliomas and fast track designation for glioblastoma multiforme."

About Fast Track Designation

Fast Track Designation is an FDA process designed to facilitate the development and expedite the review of new drugs that are intended to treat a serious condition and have the potential to address unmet medical needs. The purpose of Fast Track designation is to expedite the process of getting important new drugs to patients. The designation may offer frequent interactions with the FDA review team on the product’s development and the product may be eligible for rolling review and priority review if certain criteria are met.

About CYNK-001

Celularity’s lead therapeutic program based on its placental-derived unmodified NK cell type is CYNK-001, an allogeneic unmodified NK cell being developed as a treatment for hematologic malignancies, solid tumors, and infectious diseases. CYNK-001 is a cryopreserved allogeneic off-the-shelf cell therapy enriched for CD56+/CD3- NK cells expanded from human placental CD34+ cells. The safety and efficacy of CYNK-001 have not been established, and CYNK-001 has not been approved for any use by the U.S. Food and Drug Administration or any other analogous regulatory authority.