On September 30, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported multiple clinical advancements of its anti-CD47 monoclonal antibody lemzoparlimab (also known as TJC4) (Press release, I-Mab Biopharma, SEP 30, 2021, View Source [SID1234590606]).

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I-Mab has initiated a phase 2 expansion trial (NCT03934814) of lemzoparlimab in combination with rituximab (Rituxan) in non-Hodgkin’s lymphoma (NHL) patients in China. The expanded trial is part of the ongoing international multi-center trial (IMCT) that is being conducted in the U.S. and now also in China. The study is designed to evaluate the safety, pharmacokinetics (PK), pharmacodynamic (PD) and determine the recommended phase 2 dose (RP2D) of lemzoparlimab in combination with rituximab in patients with lymphomas. On September 28, 2021, the first patient in the expanded trial was dosed. Patient enrollment for the trial is expected to be completed in a few months.

Progress in clinical trials of lemzoparlimab in NHL and AML/MDS:

In the U.S. clinical trial of lemzoparlimab in combination with rituximab for NHL patients, the preliminary efficacy and safety data have been summarized and submitted for presentation at the 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. The expanded clinical trial is on track and expected, pending approval by the NMPA, to lead to a registrational trial in patients with NHL in 2022 in China.
In the China clinical trial of lemzoparlimab in combination with azacitidine (AZA) in patients with myelodysplastic syndrome (MDS), preliminary clinical response data is being evaluated, and patient enrollment is on track for completion in Q4 2021, the complete data set will be analyzed and reported at a later time. The Company plans to initiate another registrational trial in patients with MDS in 2022 in China based on the efficacy and safety data from this study, pending approval by the NMPA.
Progress in clinical trials of lemzoparlimab in patients with solid tumors:

I-Mab is currently investigating lemzoparlimab in combination with pembrolizumab (Keytruda) in advanced solid tumors in U.S. Data readout is expected in early 2022. Further, on September 16, the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) approved the Company’s IND application to advance to a phase 2 clinical trial of lemzoparlimab in combination with toripalimab (TUOYI) in patients with advanced solid tumors. The combined clinical results will potentially support a registrational trial later in China.

In all clinical trials conducted so far by the Company, including NHL, AML/MDS and solid tumors, lemzoparlimab have been evaluated without the need of a priming dose.

"Accumulative data from the ongoing lemzoparlimab clinical trials further increase our understanding of its safety, PK and efficacy profile," said Dr. Joan Shen, CEO of I-Mab. "We are encouraged by the clinical data of lemzoparlimab obtained so far and are rapidly advancing the clinical development of lemzoparlimab towards multiple registrational trials, with the goal of becoming the first CD47 antibody drug in China."

About CD47 and Lemzoparlimab

CD47 is a cell surface protein over-expressed in a wide variety of cancers and can act to protect tumors by delivering a "don’t eat me" signal to otherwise tumor-engulfing macrophages. CD47 antibody blocks this signal and enables macrophages to attack tumor cells. However, development of CD47 antibody as a cancer therapy is hampered by its hematologic side effects, such as severe anemia, caused by natural binding of CD47 antibody to red blood cells. Scientists at I-Mab have discovered a novel CD47 antibody, lemzoparlimab, that is designed to target tumor cells while exerting a minimal untoward effect on red blood cells.

I-Mab continues to advance a combination study of lemzoparlimab with Keytruda for solid tumors in the U.S. and with Rituxan for lymphoma in the U.S. and China, in addition to an on-going clinical trial in patients with AML in China.

In September 2020, I-Mab and AbbVie entered into a global strategic collaboration to develop and commercialize lemzoparlimab, including to design and conduct further clinical trials to evaluate lemzoparlimab in multiple cancers globally and in China. AbbVie has assumed sponsorship of the U.S. study as of April 2021.

On September 30, 2021 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of MasterKey therapies, reported the presentation of pre-clinical data for three pipeline programs in oral and poster sessions at the upcoming AACR (Free AACR Whitepaper)-NCI-EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) being held October 7-10, 2021 (Press release, Black Diamond Therapeutics, SEP 30, 2021, View Source [SID1234590573]).

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Oral presentation information is as follows:

Title: BDTX-1535, a CNS penetrant MasterKey inhibitor of common, uncommon and resistant EGFR mutations, demonstrates in vivo efficacy and has potential to treat osimertinib-resistant NSCLC with or without brain metastases
Session Title: Plenary Session 2: New Drugs on the Horizon I
Abstract Number: 5208
Presentation Date: Friday, October 8, 11:05-11:20 AM ET

Poster presentation information is as follows:

Title: Pre-clinical evaluation of next-generation inhibitor targeting a wide spectrum of oncogenic BRAF dimers
Poster Number: P229

Title: Discovery and characterization of selective, FGFR1 sparing, inhibitors of FGFR2/3 oncogenic mutations for the treatment of cancers
Poster Number: P246

Full abstracts will be available on the meeting platform at the start of the meeting on Thursday, October 7, 2021 at 9:00 AM ET.

On September 30, 2021 Susan G. Komen, the world’s leading breast cancer organization, reported that it is warning that decades of progress in lowering breast cancer mortality rates may be in jeopardy due to the ongoing COVID-19 pandemic and called for a united response to help save lives during this year’s National Breast Cancer Awareness month (Press release, Susan G Komen, SEP 30, 2021, View Source [SID1234590591]). Komen noted that in response to the growing need for financial support and overcoming barriers to care, the organization has increased its focus on providing care and support directly through its Patient Care Services Center, the demand for which has more than doubled over the past year.

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"Facing a breast cancer diagnosis is difficult in the best of times, but more so during the uncertainty of a pandemic," said Paula Schneider, a breast cancer survivor and Komen’s CEO. "More people than ever are encountering challenges in accessing and continuing needed care. Many have lost their jobs, health insurance and are facing new financial challenges. The pandemic has also highlighted persistent and tragic racial disparities, like the startling reality that Black women in the U.S. are about 40 percent more likely to die from breast cancer than white women. Our support is needed now, more than ever. Yet meeting those needs will only be possible thanks to the generosity and passion of our donors and fundraisers."

Komen noted that there are many ways that people can help support Komen’s advocacy, research and patient care programs, from fundraising through one of the organization’s local Race for the Cure or MORE THAN PINK Walk events, supporting someone walking in the Komen 3-Day, 60 mile walk, supporting one of Komen’s LIVE Pink partners, or by doing a personal fundraiser that is meaningful to you, such as hosting a Dress Up to Take Down Breast Cancer educational session or fundraiser at work.

The need for support is clear and growing more urgent by the day. Komen noted that while progress has been made in lowering mortality rates from breast cancer by 41 percent in the U.S. since 1989 thanks to more than three decades of increased access to early detection and more effective treatments, the trajectory of that progress is now in jeopardy due to COVID-19’s lingering impact on breast health care.

Without a renewed focus on early detection and efforts to maintain people in the continuum of care, as well as investments in improved treatments, we are likely to see more people die from the disease. Even without taking the impact of COVID-19 on screening and treatment into account, more than 44,000 people are expected to die this year from breast cancer in the U.S. alone. Now, due to the pandemic, which has caused people to become hesitant to get screened or see a doctor, suddenly become uninsured or face new financial challenges, people are facing new delays and barriers to care that are likely to have tragic consequences.

Initial reports from the National Cancer Institute in 2020 suggested there could be an excess of 10,000 deaths due to breast and colorectal cancer by 2030 due to the pandemic.
A newer model in July 2021, suggests about 2,500 excess deaths from breast cancer by 2030 are expected to occur due to reduced screening, delays in diagnosis and decreased chemotherapy use among women with estrogen receptor positive early breast cancer.
While screening rates are rebounding from the pandemic lows, we are still catching up for many people who should have already been screened and diagnosed. This may lead to a surge of new breast cancers, with later stage diagnoses and increased mortality.
While healthcare systems were able to adapt and adjust treatment regimens to better support patients during this challenging time, many people experienced a change or delay in treatment in the midst of the pandemic.
In response to the growing and evolving demand for direct support for those facing breast cancer today, Komen has developed a new national Patient Care Center to help people overcome barriers to care, no matter where they live. These services include a free Breast Care Helpline, where callers are connected to a trained oncology social worker who provides emotional support education, and access to resources such as financial assistance, patient navigation and more. The need for these care services continues to grow. For example, this year:

Demand for Komen’s free Breast Care Helpline has increased by 35 percent year-over-year.
Komen’s Treatment Assistance Program has provided financial support for thousands of patients and has seen a 155% increase in the number of patients served compared to last year.
Komen recently added eight patient navigators to its team to connect patients to support and resources that will help keep them in the continuum of care. The organization plans to add nine more navigators by the spring of 2022 to meet the growing need.
"In a single moment, a person’s life changes forever – there is life before breast cancer, and life after," noted Schneider. "This October, as part of National Breast Cancer Awareness Month, we are asking people to take a moment to make a difference in the lives of their neighbors. One action can help save a life."

On September 30, 2021 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, reported that Merck, known as MSD outside the United States and Canada, has extended the research term for the first cytokine derivative program under the 2018 Merck Agreement, for an additional two years (Press release, Sutro Biopharma, SEP 30, 2021, View Source [SID1234590607]). The research extension is intended to facilitate completion of preclinical research and development activities for a second candidate, which has a novel design and approach. As part of this extension, Sutro is eligible to receive up to $10 million.

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"We are encouraged by the strength of the continued research efforts in collaboration with Merck on the cytokine derivative programs," said Trevor Hallam, President of Research and Chief Scientific Officer of Sutro. "This research extension has the potential to produce an additional candidate using a different approach towards the same target. We believe that this productive research program underscores the potential of Sutro’s platform to engineer therapeutics with novel design and approach."

About the Merck Collaboration
Under the terms of the 2018 Merck collaboration agreement, Sutro and Merck are conducting preclinical research and development of cytokine derivatives utilizing Sutro’s proprietary cell-free protein synthesis and site-specific conjugation platforms, XpressCF and Xpress CF+. Merck has exclusive worldwide rights to therapeutic candidates derived from the collaboration. In March 2020, Merck exercised its option to extend the research term of the first collaboration program by one year, which generated a payment of $5 million to Sutro. In April 2021, Merck initiated IND-enabling toxicology studies for the first candidate under the first collaboration program for which Sutro earned a $15 million milestone payment. Additionally, research on a second cytokine derivative program on a separate target is ongoing.

On September 30, 2021 Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, reported that management will present at the following investment conferences in October (Press release, Celsion, SEP 30, 2021, https://investor.celsion.com/news-releases/news-release-details/celsion-present-three-investment-conferences-october [SID1234590548]):

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Chardan’s 5th Annual Genetic Medicines Conference. Michael H. Tardugno, Celsion’s chairman, president and chief executive officer, and Khursheed Anwer, Ph.D., Celsion’s chief scientific officer, will participate in a presentation and fireside chat on October 5, 2021 at 4:30 p.m. ET. Management will be available for 1×1 meetings on October 4 and 5, and investors should contact their Chardan representative to arrange a virtual meeting.
LD Micro Main Event. Jeffrey W. Church, chief financial officer, will present virtually at 9:00 a.m. ET on October 12, 2021.
Alliance Global Partners’ Virtual Healthcare Conference. Mr. Tardugno will participate in an oncology focused panel discussion moderated by James Molloy on October 13, 2021 at 9:00 a.m. ET.