On January 4, 2022- Alphamab Oncology and CSPC Pharmaceutical Group Co., Ltd. jointly reported that the IND application for the pivotal clinical trial (KN026-CSP-001) of the anti-HER2 bispecific antibody KN026 combined with chemotherapy was approved by the Center for Drug Evaluation (CDE) of NMPA (Press release, Alphamab, JAN 4, 2022, View Source [SID1234611313]).

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KN026-CSP-001 is a randomized, multi-center, phase II/III clinical study to evaluate the efficacy and safety of KN026 combined with chemotherapy in patients with HER2-positive gastric cancer (including gastroesophageal junction cancer) who have failed first-line treatment, with Professor Jianming Xu from the Chinese People’s Liberation Army General Hospital as principal investigator.

GC/GEJ is one of the common malignant tumors and there are more than 1 million new cases each year in the world. The incidence of gastric cancer is high in China, with about 410,000 new cases and 294,000 deaths each year, accounting for more than 40% of both new and death cases of GC/GEJ worldwide. Gastric cancer in China is characterized by low diagnosis rate of early gastric cancer, high proportion of metastatic stage (>80%) and low 5-year survival rate (about 35.1%), which seriously threatens the life and health of people. HER2 is overexpressed in many tumors, including about 15-20% in gastric cancer. HER2 overexpression is related to tumor aggressiveness and poor prognosis. With the development of targeted therapies, HER2-positive advanced gastric cancer patients have achieved better efficacy compared to traditional chemotherapy when treated with a combination of targeted drugs. However, for patients with HER2-positive gastric cancer who have progressed or recurred after first-line treatment, there is no effective drug approved in China, and there is a huge unmet clinical need.

KN026 is a HER2 bispecific antibody developed by Alphamab Oncology. Data from the Phase II clinical study of KN026, published at ASCO (Free ASCO Whitepaper) in 2021, demonstrated favorable safety and promising efficacy in Chinese HER2 overexpressing GC/GEJ patients, pretreated either with or without anti HER2 treatments. In patients with high expression, the ORR was 55.6% and the DCR was 72.2%, and the 9-month PFS rate was 60.4%. Among patients receiving prior-HER2 treatment, the ORR was 44.4%, and the DCR was 66.7%. The approval of the clinical trial application is a touchstone for the cooperation between Alphamab Oncology and CSPC to accelerate the clinical development and commercialization of KN026 in mainland China. We hope to see more positive data from the study, and bring hope to patients with advanced gastric cancer who are in urgent need of new treatment options.

About KN026
KN026 is an anti-HER2 bispecific antibody developed by Alphamab Oncology using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). KN026 can bind two non-overlapping epitopes of HER2 simultaneously, leading to a dual HER2 signal blockade. KN026 has demonstrated potentially equivalent efficacy compared with Trastuzumab and Pertuzumab in combination, and was superior to either single agent, such as increased binding affinity, as well as better tumor inhibition in HER2-positive tumor cell lines. Additionally, KN026 has also shown inhibitory effect on tumor cells with medium or low HER2 expression or Trastuzumab-resistant cell lines.

KN026 received IND approval from the National Medical Products Administration (NMPA) of China and U.S. Food and Drug Administration (FDA) in 2018. Currently, it is in multiple phase I/II clinical trials in China and phase I clinical trial in the United States. The results of Phase I clinical trials show KN026 has good safety, tolerance and potentially superior anti-tumor activity in HER2-positive breast cancer patients who progressed after multiple lines of anti-HER2 treatment.

In August 2021, the company entered an agreement with JMT-Bio, a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. (stock code: 1093.HK), for the development and commercialization of KN026 in Mainland China. According to the terms of the agreement, JMT-Bio will obtain the exclusive license rights of KN026 for the development and commercialization in the indications of breast cancer and gastric or gastroesophageal junction cancers (GC/GEJ) in Mainland China (excluding Hong Kong, Macau and Taiwan).

On January 4, 2022 Aileron Therapeutics (Nasdaq: ALRN), a chemoprotection oncology company focused on fundamentally transforming the experience of chemotherapy for cancer patients, reported that Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer, will provide a company overview and business update at the H.C. Wainwright BIOCONNECT Conference, which will be held virtually January 10th – 12th and the Emerging Growth Conference, which will be held virtually on January 5th (Press release, Aileron Therapeutics, JAN 4, 2022, View Source [SID1234598044]). Details of the upcoming Aileron presentations are as follows:

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H.C. Wainwright BIOCONNECT Conference
Date/Time: The presentation will be available on-demand beginning on Monday, January 10, 2022 at 7:00 a.m. ET.

A recorded webcast of the presentation will be archived under the Investors and Media section of Aileron’s website at View Source for 30 days following the event.

Emerging Growth Conference
Date: Wednesday, January 5, 2022
Time: 12:45 p.m. ET
An interactive question-and-answer session with Dr. Aivado will follow the presentation.

Register here to watch the presentation.

If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available on EmergingGrowth.com.

On January 4, 2022 Champions Oncology, Inc. (Nasdaq:CSBR), a leading global technology-enabled biotech that is transforming drug discovery through innovative pharmacology, biomarker, and data platforms, reported a therapeutic development partnership with Alloy Therapeutics (Press release, Champions Oncology, JAN 4, 2022, View Source [SID1234598061]). The partnership will combine novel therapeutic targets identified within Champions’ Lumin platform with Alloy’s fully-integrated in vivo and in vitro antibody discovery, optimization, and lead development services platform to develop antibodies used in the development of next generation Antibody Drug Conjugates (ADCs).

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ADCs engage tumor-specific therapeutic targets at a cell’s surface to deliver potent toxic payloads to the tumor, without affecting normal cells. The planned partnership will initiate with a single program focused on a previously unexplored target present in tumor indications such as Acute Myeloid Leukemia (AML), Multiple Myeloma (MM), Chronic Lymphocytic Leukemia (CLL), Lymphoma, and other hematologic tumors. This therapeutic target is the product of Champions’ newly expanded data-driven strategy to engage in drug discovery and development. The partnership will also leverage the unique experimental platforms available at Alloy and Champions to ensure rapid and efficient development towards clinical evaluation. Under the terms of this agreement, Champions will wholly own the therapeutic molecule, with milestones and royalty payments owed to Alloy.

Ronnie Morris, MD, President and CEO of Champions Oncology, said: "We have been particularly excited about this specific therapeutic program and partnership with Alloy. The advanced pheno-multiomic integration analytics within our Lumin platform revealed some exciting information about the target at the center of this program. Not only does it look to have strong potential as a classical ADC target, with high tumor-specific expression, but also has with a strong association with underlying biology linked to cancer progression and chemoresistance. This type of dual mechanism targeting with ADCs makes the use of such a platform very powerful. This development partnership with Alloy will ensure that we establish best in class antibodies in a quick timeframe. We’re excited to see this therapeutic program enter the pipeline."

Errik Anderson, CEO and Founder of Alloy Therapeutics, said: "We are proud to support antibody discovery in this promising ADC program with far-reaching therapeutic applications, made more powerful by the Lumin advanced analytics and target identification engine. This partnership with Champions represents Alloy’s approach to empowering drug developers in the pursuit of important treatments for patients. In 2022 we will increase our discovery services capacity to support a wider range of innovative programs and increase speed to the clinic for our community of partners."

On January 4, 2022 Inhibrx, Inc. (Nasdaq: INBX), a biotechnology company with four clinical programs in development and a strong emerging pipeline, reported initial results from Part 3 (combination dose escalation) of the 4-part Phase 1 trial of INBRX-106, a novel hexavalent OX40 agonist, in combination with Keytruda, in development for the treatment of patients with solid tumors (Press release, Inhibrx, JAN 4, 2022, View Source [SID1234598078]). Additionally, an update on single agent data from Part 1 (single agent dose escalation) and Part 2 (single agent dose expansion) of the trial was provided.

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In the all-comer Part 3 of this Phase 1 trial, the dose of INBRX-106 was escalated in combination with Keytruda in 21 patients with locally advanced or metastatic solid tumors. INBRX-106 in combination with Keytruda was observed to be well tolerated, with predominantly mild or moderate immune-related toxicities noted. The maximum administered dose of INBRX-106 was 0.3 mg/kg, at which dose-limiting, immune-related toxicities such as dermatitis were observed. Accordingly, 0.1 mg/kg dosed every three weeks was determined to be the maximum tolerated dose (MTD) of INBRX-106 in combination with Keytruda.

Out of five response evaluable patients with tumor types responsive to immunotherapy in the active dose range of INBRX-106 in combination with Keytruda, two durable partial responses were achieved in checkpoint inhibitor naïve nasopharyngeal carcinoma and uveal melanoma patients with duration greater than six months with treatment ongoing. Additionally, a third checkpoint inhibitor exposed cutaneous melanoma patient has a double-digit reduction in tumor volume and duration greater than four months with treatment ongoing.

Part 2, which was run in parallel with Part 3, is ongoing and aimed at investigating single agent INBRX-106 dosed at 0.03 mg/kg in two different dosing schedules in patients with tumor types responsive to checkpoint inhibitors. Four of ten response evaluable non-small cell lung cancer (NSCLC) and melanoma patients receiving INBRX-106 in either Part 1 or 2 of the trial have been on treatment with INBRX-106 for at least six months. Of those four patients, three had previous exposure to checkpoint inhibitors and the fourth, a uveal melanoma patient, was checkpoint inhibitor naïve. To date, the longest duration on treatment with single agent INBRX-106 is 90 weeks (approximately 21 months) and ongoing in a NSCLC patient refractory to Keytruda.

"We believe the early activity of single agent INBRX-106 and INBRX-106 in combination with Keytruda observed in patients who relapsed or are refractory to checkpoint inhibitors as well as in patients with tumor types responsive to immunotherapy that respond poorly to checkpoint inhibitors is very encouraging" said Mark Lappe, CEO of Inhibrx. "We are pleased to see that our preclinical data, which demonstrated that hexavalent valency is required to properly agonize OX40, appear to be translating clinically."

Part 4 (combination dose expansion) of the trial initiated in a NSCLC cohort and a basket cohort in patients who relapsed or were refractory to checkpoint inhibitors, as well as in selected checkpoint inhibitor naive patient cohorts including cutaneous melanoma, uveal melanoma, head and neck squamous cell carcinoma and nasopharyngeal carcinoma. We expect to have initial data from Part 4 of this trial late this year.

About INBRX-106
INBRX-106 is a hexavalent product candidate agonist of OX40. OX40 is a co-stimulatory receptor expressed on immune cells that is enriched in the tumor microenvironment. OX40 ligand is a trimeric protein that activates OX40 signaling through clustering. We engineered INBRX-106 to bind and cluster six OX40 receptors and has been shown preclinically to significantly outperform bivalent antibodies in co-stimulatory capacity and anti-tumor activity.

The trial for INBRX-106 is a first-in-human, multicenter, open-label, non-randomized, 4-part Phase 1 trial in patients with locally advanced or metastatic solid tumors designed to determine the safety profile and identify the MTD and/or recommended Phase 2 dose of INBRX-106 administered as a single agent or in combination with Keytruda (pembrolizumab), a programmed death receptor-1 (PD-1) checkpoint inhibitor.

About the Inhibrx sdAb Platform
Inhibrx utilizes diverse methods of protein engineering in the construction of therapeutic candidates that can address the specific requirements of complex target and disease biology. A key tool for this effort is the Inhibrx proprietary sdAb platform, which enables the development of therapeutic candidates with attributes superior to other monoclonal antibody and fusion protein approaches. This platform allows the combination of multiple binding units in a single molecule, enabling the creation of therapeutic candidates with defined valency or multiple specificities, potentially capable of enhanced cell signaling or conditional activation. An additional benefit of this platform, these optimized and/or multi-functional entities can be manufactured using the established processes that are commonly used to produce therapeutic proteins.

Inhibrx is pursuing targets with early validation where other therapeutics have demonstrated liabilities as well as a portfolio of sdAb based therapeutic candidates in a variety of indications for novel targets.

On January 4, 2022 Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed oncolytic immunotherapies, reported that Philip Astley-Sparke, Chief Executive Officer of Replimune, will present at the 40th Annual J.P. Morgan Healthcare Conference being held virtually on Monday, January 10, 2022 at 7:30 AM ET (Press release, Replimune, JAN 4, 2022, View Source [SID1234598094]).

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A simultaneous webcast will be available in the Investors section of Replimune’s website at www.replimune.com. A replay will be available for 30 days following the conference.