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Engine Biosciences Announces $43 Million Series A Round to Decipher Genetic Codes for New Medicines Through Machine Learning and Next-Generation Combinatorial Genetics

On May 26, 2021 Engine Biosciences ("Engine") reported the successful completion of an oversubscribed $43 million Series A funding round (Press release, Engine Biosciences, MAY 26, 2021, View Source [SID1234580638]). Engine identifies errors in the complex genetic codes of diseases, fixing them with precise therapeutic solutions. This round was led by Polaris Partners and also included new investors Invus and one of the world’s premier institutional investors, based in Singapore. Existing investors also participated in the Series A, which included 6 Dimensions Capital, WuXi AppTec, DHVC, EDBI, Baidu Ventures, Vectr Ventures, Goodman Capital, WI Harper, and Nest.Bio. Amy Schulman, Managing Partner at Polaris Partners, has joined the Engine Biosciences Board of Directors. Engine has now raised $53 million to date, including $10 million in a 2018 seed round.

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"The past year has reinforced the importance of rapid innovation and adaptation"

Located in Singapore and Silicon Valley, Engine has been operating at the intersection of data science, machine learning, high-throughput biology experimentation, combinatorial genetics, chemistry, and drug discovery. Engine’s technologies enable researchers and drug developers to uncover the gene interactions and biological networks underlying diseases orders-of-magnitude faster and more cost-effectively than conventional methods. Additionally, the company generates important insights for precision medicine applications.

"Many breakthrough tools to edit, program, and modulate biology have emerged and matured in recent years. The fundamental question continues to be whether we know the disease-driving errors in the genetic code of biology to direct these tools, including therapeutics," said Jeffrey Lu, Engine Biosciences’ Co-Founder and CEO. "We are honored that this preeminent group of life science and technology investors has recognized the progress our team has made and is supporting our mission to unleash new medicines by deciphering biology."

Engine has already been progressing its novel biology findings into drug discovery programs and proprietary small molecule inhibitors. It will utilize the new funds to expand its portfolio of precision oncology therapeutics, prepare for its first clinical programs, and scale its proprietary technology platform.

"The past year has reinforced the importance of rapid innovation and adaptation," said Polaris Partners’ Amy Schulman. "Engine’s distinct combination of biology, technology, and drug discovery, as well as its global perspective, may well enable the company to be particularly capable of realizing the promise of artificial intelligence in drug discovery and tackling a wide variety of diseases. We are excited to be part of this next step with the team."

Initial Disease Targets

Engine has performed several large-scale computational and experimental cycles with respect to genetic interactions and their relevance to multiple cancers, yielding new and subsequently validated discoveries. Engine’s growing and advancing pipeline of targeted therapies for genetically-defined patient populations has shown promise in treating liver, ovarian, colorectal, and breast cancers, representing major areas of unmet medical need and, in total, approximately 2.5 million deaths every year.

Through collaborations, Engine has also demonstrated its platform’s applicability in other disease areas and will continue to enable new therapeutics for more patients.

"We believe Engine’s AI-enabled technology platform has the potential to discover new biology targets and disease-causing links amongst known targets," said Leon Chen, CEO and Founding Partner of 6 Dimensions Capital. "Considering the field’s tremendous needs for the right drug targets for the right patients and Engine’s unique capabilities in finding those, we continue to be excited by Engine’s potential to power new medicines."

How It Works: NetMAPPR and CombiGEM

Two scientific innovations lie at the heart of Engine Biosciences: NetMAPPR and CombiGEM. NetMAPPR is Engine’s searchable biology platform, revealing gene combinations and drug targets integral to diseases. Employing combinatorial CRISPR, CombiGEM enables experimental confirmation of how genes and gene combinations relate to disease in supercharged fashion.

Engine has engineered NetMAPPR to operate in predict-test-learn cycles and scale for many research and drug discovery programs. Advanced computational tools leverage large patient and disease datasets and analyze the vast universe of millions-to-billions of gene interactions, making predictions on the most critical biologies for medicines. Engine uses its patented CombiGEM technology to test hundreds of thousands of gene interactions experimentally in diseased cells, thus breaking through bottlenecks in validation and data generation. The resulting data from well-controlled experiments improves Engine’s machine learning algorithms, while high-ranking genes are prioritized for drug discovery and development.

Compared to conventional approaches that are challenged by human limitations and less efficient and less precise experimental systems and hence cover tiny slices of biology, NetMAPPR searches much wider expanses of the complex architecture of biology at greater speeds, unleashing more new therapeutic opportunities.

NiKang Therapeutics Announces Completion of $200 Million Series C Financing to Advance Highly Differentiated Small Molecules Addressing Difficult-to-Drug Targets

On May 26, 2021 NiKang Therapeutics Inc. ("NiKang"), a clinical stage biotech company focused on developing innovative small molecule oncology medicines to help patients with unmet medical needs, reported the completion of an oversubscribed $200 million series C financing led by Cormorant Asset Management, HBM Healthcare Investments and Octagon Capital Advisors with participations from a premier syndicate of funds, including new investors EcoR1 Capital, Perceptive Advisors, Wellington Management, Ally Bridge Group, Pavilion Capital, funds and accounts managed by BlackRock, RA Capital Management, Surveyor Capital (a Citadel company), Samsara BioCapital, PFM Health Sciences, Invus, Janus Henderson Investors and Logos Capital (Press release, NiKang Therapeutics, MAY 26, 2021, View Source [SID1234580637]). All existing investors including CBC Group, RTW Investments, LP, Lilly Asia Ventures, Matrix Partners China, and Casdin Capital participated in the financing. In connection with the financing, Bing Yao, Ph.D., former CEO and chairman of Viela Bio, and Ting Jia, Ph.D., founder, and chief investment officer of Octagon Capital Advisors will join NiKang’s Board of Directors.

"We are thrilled to have such an outstanding group of investors as our shareholders," said Zhenhai Gao, Ph.D., co-founder, president, and chief executive officer of NiKang. "Their support of our vision allows us to build the world’s leading precision oncology company. We are now well positioned to rapidly advance our pipeline into clinic including our differentiated HIF-2 alpha inhibitor, and to bring our company to the next level of growth."

"This financing is a testament to the quality of our science and team," Kelsey Chen, Ph.D., MBA, chief finance officer, added. "Since joining NiKang, I have witnessed the passion and dedication by a group of talented scientists who are devoting their lives to advancing treatments for patients. We are grateful to be recognized by such a high caliber group of investors."

"NiKang has made remarkable progress over the last eight months since our initial investment," said Ting Jia, Ph.D., chief investment officer of Octagon. "We are impressed by the team’s accomplishment. We believe NiKang’s unique approach of attacking difficult-to-drug targets offers promising opportunities in developing breakthrough treatments for cancer patients. We are excited to co-lead the series C financing and partner with the NiKang team to accelerate its growth."

"We are proud of what NiKang has achieved since its inception," said Sean Cao, executive chairman of NiKang and managing director of CBC Group, which incubated the company. "The strength of this group of investors validates NiKang’s achievements and demonstrates their confidence in NiKang’s potential to grow into a leading innovative drug company."

Proceeds will be used to advance the company’s lead drug candidates into the clinic, expand the pipeline and fund internal drug discovery programs.

Repertoire Immune Medicines Enters Collaboration to Advance Novel Antigen Discovery and T Cell Receptor Research in Melanoma

On May 26, 2021 Repertoire Immune Medicines, a clinical-stage biotech company decoding the immune synapse to create novel immune therapies for cancer, immune disorders, infectious disease, and other serious diseases, reported a new collaboration with a Yale School of Medicine research team focused on identifying antigens expressed in patients with late-stage, advanced metastatic melanoma, and determining which of these antigens activate T cells in the tumor (Press release, Repertoire, MAY 26, 2021, View Source [SID1234580636]). The collaboration will seek to understand the specificity of various subsets of T cells with the goal of uncovering new antigens and their T cells, with potential for future incorporation into Repertoire’s cell therapy and other development programs.

The study will discover new immunodominant epitopes and determine the specificity of T cells obtained from patients with metastatic melanoma. The university research team will provide human T cell receptor (TCR) sequences to Repertoire, which will use its proprietary DECODE platform to determine the novel antigens that these TCRs identify. The team’s deep understanding of translational science in oncology, coupled with Repertoire’s platform technology, may generate unique insights leading to the development of novel immune medicines.

The research team will be led by David A. Hafler, MD, FANA, William S. and Lois Stiles Edgerly Professor of Neurology and Professor of Immunobiology, Yale School of Medicine; Chair, Department of Neurology and Neurologist-in-Chief, Yale New Haven Hospital.

"We’re pleased to initiate this collaboration with Dr. Hafler and his team at Yale University, particularly given their deep expertise in pioneering translational science in difficult disease areas, including advanced melanoma," said Anthony Coyle, Ph.D., President, Research and Development, Repertoire Immune Medicines. "Our hope is that this collaboration will unveil breakthrough science that we can apply to transformational drug discovery and development of novel immune therapies for melanoma patients in need."

Ikena Oncology to Participate in the 2021 Jefferies Virtual Healthcare Conference

On May 26, 2021 Ikena Oncology, Inc. (Nasdaq: IKNA), a targeted oncology company focused on developing therapies targeting key signaling pathways that drive the formation and spread of cancer, reported that management will participate in a fireside chat at the 2021 Jefferies Virtual Healthcare Conference on Wednesday, June 2, 2021 at 2:00 p.m. ET (Press release, Ikena Oncology, MAY 26, 2021, View Source [SID1234580635]).

The fireside chat will be webcast live and can be accessed by visiting the Investors & Media section of the company’s website at www.ikenaoncology.com. The webcast will be archived for a period of 30 days following the conclusion of the live event.

Aptevo Therapeutics Reports Positive Phase 1 Clinical Data for Its Lead Leukemia Drug Candidate APVO436 in Adults With Relapsed Acute Myeloid Leukemia

On May 26 2021 Aptevo Therapeutics Inc. ("Aptevo") (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported positive results from the Company’s Phase 1 dose escalation trial evaluating lead ADAPTIR candidate, APVO436, for the treatment of acute myeloid leukemia and myelodysplastic syndromes (AML/MDS) (Press release, Aptevo Therapeutics, MAY 26, 2021, View Source [SID1234580634]). APVO436 was generally well tolerated and demonstrated a favorable side effect profile, including the absence of severe or prolonged neutropenia, an often serious condition associated with CD123-targeting therapies. Further, APVO436 showed encouraging single agent activity and a promising benefit to risk profile in patients with relapsed, advanced stage AML.

The Phase 1 dose escalation study, conducted at leading cancer centers across the United States (US), as listed in www.clinicaltrials.gov as NCT03647800, enrolled 46 patients with AML or myelodysplastic syndromes, each of whom received escalated intravenous infusions of APVO436 ranging in dose from 0.3 micrograms to 60 micrograms. The long half-life of APVO436 enabled its administration over short infusion times. The study met its primary endpoint – identification of an active dose level for advanced studies. The Company plans to submit the data for publication later this year.

AML is the most common form of adult acute leukemia with >20,000 estimated new cases and >10,000 deaths in the United States (US) for 2021 (SEER Program, www.seer.cancer.gov).

The therapeutic landscape for leukemias is rapidly evolving in the era of personalized medicine but development of new drugs capable of killing chemotherapy resistant leukemia cells that can be used to improve the efficacy of standard of care induction and consolidation regimens remains an unmet medical need.

Unlike the potency of chemotherapy drugs, the clinical activity of bispecific antibodies in leukemia patients is often not "dose-linear," so a higher dose may potentially be less effective than a much lower dose. Likewise, the most effective concentrations are frequently not concentrations that are achieved at the highest tolerated dose levels. This is because these antibodies can be captured by normal cells, including T-cells that bind to the CD3 directed portion of the bispecific antibody. In order to avoid such a "sink effect", a dose level needs to be carefully identified at which the likelihood of excessive binding to normal cells in blood and bone marrow is very low. That is to say, an optimal dose needs to be identified at which leukemia cells are selectively killed without causing severe neutropenia, a complication reported for CD123-targeting drugs that can lead to life-threatening infections and sepsis. Therefore, the contemporary strategy in clinical development of bispecific antibodies is to identify a biologically optimal dose level, ideally a dose level much lower than the maximum tolerated dose level. Importantly, the APTEVO study 5001 has met the primary endpoint of its Part 1, identifying Cohort 6 dose as an active dose level for advanced studies of APVO436, also known as the recommended Phase 2 dose (RP2D).

"We observed, as preliminary signs of clinical activity both stabilization of leukemia as well as complete remissions," reported Dr. Fatih Uckun, leukemia expert and Chief Clinical Advisor, who is coordinating the APVO436 clinical development program. Of seven evaluable relapsed AML patients treated in Cohort 6, four showed stabilization of their leukemias. Of those four patients with disease stabilization, three patients lived 246+ days, 261+ days, and 281+ days, respectively and one progressed after a month. Two relapsed AML patients, who experienced stabilization of their leukemia, achieved a partial remission (PR) and subsequently a complete remission (CR). No partial or complete remissions have been observed at APVO436 dose levels either lower or higher than the Cohort 6 dose level. Therefore, APVO436 will be used at the Cohort 6 dose level in Part 2 of the study.

"We are very pleased to see lead ADAPTIR platform candidate, APVO436, progress in the clinic. APVO436 has demonstrated the potential to address a significant unmet need for patients with AML and provide the foundation for new and more effective multi-modality standard of care regimens that offer renewed hope for leukemia patients," said Jane Gross, PhD, the Chief Scientific Officer for Aptevo.

One of the most significant and frequent side effects associated with the use of bispecific, T-cell engaging antibodies are neurologic toxicities. Neurological toxicities may be severe, life-threatening, or fatal. Serious neurologic toxicity has not been a frequent complication associated with APVO436 treatments in this study. Another potential complication associated with treatment using bispecific, T-cell engaging antibodies is a systemic inflammatory syndrome known as Cytokine Release Syndrome (CRS). CRS has occurred in some patients and has been managed using the generally recommended standard CRS treatments. In Cohort 6, of 9 AML/MDS patients evaluable for toxicity, 2 patients developed a Grade 1 CRS and one patient developed a transient Grade 3 CRS related to APVO436 which resolved with routine clinical management.

CD123, although highly expressed on AML blasts, is also expressed on normal bone marrow hematopoietic stem cells and myeloid progenitor cells that give rise to the infection-fighting white blood cells. Therefore, treatment platforms targeting CD123 have been associated with a prolonged and profound decrease of white blood cell counts, known as severe neutropenia, and infections, especially pneumonias. This side effect caused by CD123 targeting overlaps with the blood count lowering side effects of standard chemotherapy drugs is among the main hurdles impeding the desired incorporation of CD123 targeting drugs into contemporary frontline as well as second-line standard of care treatment regimens. Notably, Aptevo researchers discovered that APVO436 does not cause severe or prolonged neutropenia at doses that resulted in complete remissions. None of the 46 patients treated with APVO436 developed severe or prolonged neutropenia as a side effect of the drug.

"This finding will inform the clinical development path for APVO436, as a novel drug candidate for blood cancers," stated Dr. Uckun. "AML patients are in urgent need of active new drugs capable of destroying leukemia cells without causing profound neutropenia. We will diligently advance the clinical development of APVO436 and evaluate its potential clinical impact for leukemia patients." Dr. Uckun added.

"We are pleased to report progress in the clinical development of our ADAPTIR platform candidate, APVO436," said Marvin White, President and CEO of Aptevo. "We remain confident about the breakthrough potential of APVO436 and look forward to sharing interim data from Part 2 of our study later this year. The scientific data from multiple studies so far suggest tremendous therapeutic potential for the APVO436 ADAPTIR platform and provides the foundation for our optimism regarding the potential commercialization of APVO436.",