Umoja Biopharma Launches with $53M Series A Financing to Develop Fully Integrated, Scalable, In Vivo Immunotherapy Platform

On November 18, 2020 Umoja Biopharma, a biotechnology company pioneering an integrated in vivo immunotherapy platform, reported the completion of its $53 million Series A financing led by MPM Capital and Qiming Venture Partners USA (Press release, Umoja Biopharma, NOV 18, 2020, View Source [SID1234575244]). Umoja was founded by a team of leading scientists and researchers with the vision of creating an entirely new approach to engineered immunotherapies. Umoja’s suite of innovations will re-engineer a patient’s own immune system to attack and destroy both hematologic and solid organ-based tumors with a simplicity and cost that enables widespread implementation.

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"Umoja has already made significant progress on its goal of delivering technologies that will address the limitations of current engineered immunotherapies," said Andy Scharenberg, M.D., co-founder and CEO of Umoja. "Our in vivo-based approach is scalable while also providing control, safety, and highly effective anti-tumor activity; our goal is to improve both access and outcomes."

Umoja’s platform incorporates three core components: the VivoVec delivery platform, RACR/CAR payload architecture, and the TumorTag platform. The VivoVec delivery platform acts in vivo to generate a population of cancer fighting cells, VivoCAR T cells, which can be exquisitely controlled by the RACR/CAR control system using exogenously administered, FDA approved drugs. TumorTag molecules can be used in combination with the VivoCAR T cells to direct cancer-killing T cells to the tumor and the critical supporting cells of the tumor. 2

"This represents an important step forward in delivering on a shared vision to develop transformational therapies for patients who need them, including the most vulnerable population affected by debilitating diseases – children," said Michael Jensen, M.D., co-founder, Umoja Biopharma, vice president, Seattle Children’s Therapeutics and chief therapeutics officer, Seattle Children’s. "We now have the opportunity to combine forces and move at light speed, eclipsing what could have been accomplished singularly or in a normal academic manner."

Umoja Biopharma was founded through an initial seed investment by MPM Capital and DCVC Bio, and its scientific founders from Seattle Children’s Research Institute and Purdue University, based on pioneering work in the laboratory of Philip Low, the Presidential Scholar for Drug Discovery and the Ralph C. Corley Distinguished Professor of Chemistry. The Series A financing will enable Umoja to advance its platform and therapeutic programs to early clinical development, attract talent and invest in research. "Umoja is comprised of a highly skilled and passionate team that brings together a unique complement of expertise with in vivo gene transfer, drug development and oncology," said Luke Evnin, Ph.D., co-founder and Managing Director of MPM Capital.

"We believe that Umoja’s approach represents the future of cancer treatment." "Umoja is working to create an entirely new approach to engineered immunotherapies that can pave the way for cancer therapies that are more accessible and effective for patients around the world," said John Hamer, Managing Partner, DCVC Bio. "We look forward to continuing to work with the exceptionally skilled Umoja team to support the development of their integrated and scalable VivoVec and TumorTag technology." "We believe that the combination of deep technical experience and integrated technology platform will put Umoja at the forefront of in vivo T cell engineering," said Anna French, Partner at Qiming Venture Partners USA. "Umoja’s universal CAR approach supports multi-antigen targeting which will be required for the development of solid tumor therapeutics."

Enosi Life Sciences Files Patent for TNF-Inhibiting Molecules EN1001, EN2001 and EN3001

On November 18, 2020 Enosi Life Sciences Corp. ("Enosi" or the "Company"), a drug research and development company focused on providing industry-leading therapeutics for autoimmune disease, cancer, and acute inflammation, reported it has filed a patent for its proprietary molecules (Press release, Enosi Life Sciences, NOV 18, 2020, View Source [SID1234572277]). These include EN1001 for autoimmune disease; EN2001 for autoimmune disease and cancer; and EN3001 for autoimmune disease and cancer.

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The EN1001 molecule blocks Tumor Necrosis Factor Receptor-1 (TNFR1), which is a principal culprit in autoimmune disease, acute inflammation and has a role in cancer. EN1001 will be a significant enhancement compared to existing TNF-blocking technologies which inhibit both TNFR1 and TNFR2, which have limited efficacy as a result of co-inhibition of the naturally anti-inflammatory TNFR2.

Enosi’s EN2001 molecule offers a completely different option for the treatment of rheumatoid arthritis. Inflammatory EGF-like growth factors stimulate the growth of the pannus, a tumor-like structure in a Rheumatoid Arthritis (RA) joint which contains cells that produce tumor necrosis factor (TNF) and other destructive cytokines. Enosi has shown that its lead molecule (EN2001), which traps these growth factors, can prevent tissue destruction by inhibiting the growth of cells that form the pannus. This is a new mechanism of action for autoimmune disease drugs. Since Enosi’s growth factor trap is not expected to have adverse immunosuppressive activity, it can be combined with other RA therapeutics without fear of increasing immunosuppression. This is important because all of the approved RA therapies are immunosuppressive and make the patient susceptible to infection, cancer and even cardiovascular problems. Its ability to inhibit the proliferation of diseased cells may allow Enosi’s growth factor trap EN2001 to also be useful in the treatment of solid tumors.

For cancer and fibrotic diseases where TNFR2 is a "bad actor" instead of a "good actor," Enosi’s proprietary EN3001 molecule will counter TNFR2 activation. The function of TNFR2 is to protect the body from the effects of inflammation, but too much TNFR2 occurs in tumors and leads to inactivation of immunity against cancer. TNFR2 does this by inducing the proliferation of regulatory T cells that suppress the immune response. Thus, EN3001 will act like a checkpoint inhibitor by increasing immunity, which will be particularly useful in the treatment of cancer.

Each Enosi therapeutic will offer use in multiple diseases. EN1001 will be tested in RA and a number of autoimmune diseases, however, research has shown that TNF-mediated inflammation is important in other diseases as well, ranging from acute inflammation associated with viral infections like COVID-19, to endometriosis and Alzheimer’s disease. These three therapeutics from Enosi; EN1001, EN2001 and EN3001 are still in development and are at least five years away from clinical trials.

The market for TNF inhibitor drugs is expected to reach $43 billion by 2023, and $115 billion by 2026. To capitalize on this high growth industry and meet a wide and unmet demand, Enosi Life Sciences recently announced its Regulation D offering, enabling investors the opportunity to invest in next generation therapeutics for autoimmune disease and cancer.

"The filing of this patent represents a key milestone for Enosi as we seek to firmly communicate our targeted therapeutic pipeline to potential partners, industry professionals and of course, the broader investment community," said Dr. H. Michael Shepard, President, CSO and CEO of Enosi Life Sciences. "Enosi is derived from the Greek word for combinations, and we are following that philosophy. The combination of Dr. Feldmann’s experience in autoimmune diseases and my experience with antibody therapies for cancer, together with Dr. Jim Woody’s experience in management and fundraising bring a depth of knowledge to our endeavor. In addition, the candidate therapeutics we discover will likely be useful for a combination of different diseases." We believe our unique, proprietary approach represents significant potential once commercialized, and we look forward to continued updates regarding its development."

Capital raised through the Regulation D 506(c) offering, and potentially a future Regulation A+ financing, will support Enosi’s efforts to progress the Company’s molecules that target autoimmune disease, cancer and acute inflammation toward clinical trials.

Olema Oncology Announces Pricing of Initial Public Offering

On November 18, 2020 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology"), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, reported the pricing of its initial public offering of 11,000,000 shares of its common stock at a price to the public of $19.00 per share (Press release, Olema Oncology, NOV 18, 2020, View Source [SID1234571463]). The gross proceeds to Olema Oncology from the offering, before deducting the underwriting discounts and commissions and offering expenses, are expected to be $209.0 million. All of the shares are being offered by Olema Oncology. In addition, Olema Oncology has granted the underwriters a 30-day option to purchase up to an additional 1,650,000 shares of its common stock at the initial public offering price, less the underwriting discounts and commissions.

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The shares are expected to begin trading on the Nasdaq Global Select Market on November 19, 2020, under the ticker symbol "OLMA." The offering is expected to close on November 23, 2020, subject to customary closing conditions.

J.P. Morgan Securities LLC, Jefferies LLC and Cowen and Company, LLC are acting as active joint book-running managers for the offering. Canaccord Genuity LLC is also acting as a book-running manager.

Registration statements relating to these securities were filed with the U.S. Securities and Exchange Commission (SEC) and became effective on November 18, 2020. Copies of the registration statements can be accessed through the SEC’s website at www.sec.gov. This offering is being made only by means of a written prospectus, forming a part of the effective registration statement. Copies of the final prospectus relating to the initial public offering can be obtained, when available, from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at (212) 834-4533 or by email at [email protected]; Jefferies LLC, Attn: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, by telephone at (877) 821-7388 or by email at [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at +1 (833) 297-2926 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

AUM Biosciences and Newsoara Biopharma Announce a 5-year Transformational Strategic Partnership to Co-develop and Co-discover Next-generation Cancer Therapeutics

On November 18, 2020 AUM Biosciences (AUM), a global, clinical stage healthcare company focused on discovering, acquiring and developing novel oncology therapeutics and Newsoara Biopharma reported that the companies have entered into a 5-year strategic partnership to co-develop up to 6 oncology drugs in AUM’s pipeline (Press release, AUM BioSciences, NOV 18, 2020, View Source [SID1234571396]).

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The partnership combines AUM’s world-class discovery and clinical development capabilities with Newsoara’s strong discovery, development, and manufacturing capabilities in China.

Under the terms of the Agreement, AUM will receive an undisclosed collaboration fee upon closing. AUM will license exclusive greater China rights of AUM001, AUM302 and AUM003 upon closing of this Agreement, and up to a further 3 candidates for a maximum of 6 oncology drugs.

AUM will receive up to $135 Million in near term development, regulatory, commercial milestones and up to double-digit royalty payments. Newsoara will be responsible for all development and commercialisation and will contribute for potential R&D funding for current and future investigational compounds in greater China.

AUM and Newsoara will co-discover and co-fund first-in-class therapeutics for mutually agreed novel targets. AUM retains worldwide rights ex-greater China and Newsoara retains greater China rights for these newly discovered compounds.

Newsoara’s CEO, Benny Li will join AUM’s Board of Directors.

"Newsoara is an ideal partner for AUM with its focus to provide novel and differentiated therapies for unmet medical needs in China ," said Vishal Doshi, CEO, AUM Biosciences. "This collaboration is foundational for AUM and will allow us to act as one team to maximize the clinical and commercial potential of AUM’s molecules, greatly amplifying and expediting the opportunities in our pipeline. This partnership accelerates AUM’s path to becoming an independent, fully integrated biopharmaceutical company."

AUM is building a diverse portfolio of small molecule therapeutics that target critical biological pathways. A core component of AUM’s strategy is mandating biomarkers and leveraging AI to systematically discover and develop targeted cancer therapies. Additionally, AUM has a strong focus on the development of intra-portfolio combinations that include small molecules. Through its "Asia to Global" Strategy, including this partnership, AUM will expedite drug development to meet unmet medical needs for patients globally.

"We are very pleased to build on Newsoara’s growing presence in China with this important new strategic collaboration with AUM," said Benny Li, CEO, Newsoara Biopharma. "Newsoara is committed to developing first-in-class programs for patients and our agreement with AUM further demonstrates that commitment. By gaining access to each other’s diverse pipeline and AUM’s clear strengths and world-class experts in discovery and development, we believe that our partnership with AUM will significantly accelerate our progress in developing next generation therapies for patients."

Elevation Oncology Announces $65M Series B Financing and Promotion of Founder Shawn M. Leland to Chief Executive Officer

On November 18, 2020 Elevation Oncology, a clinical-stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, reported a Series B financing of $65 million led by new investors, venBio Partners and Cormorant Asset Management, and the promotion of Shawn M. Leland, PharmD, RPh, the Company’s founder, to Chief Executive Officer (Press release, Elevation Oncology, NOV 18, 2020, View Source [SID1234571381]). Additional participants in the financing include Boxer Capital of Tavistock Group, Janus Henderson, Samsara Biocapital, and Vivo Capital, as well as all of Elevation Oncology’s existing investors: Aisling Capital, Vertex Ventures HC, Qiming Venture Partners USA, Driehaus Capital Management, and BVF Partners.

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Andrew Phillips, PhD from Cormorant Asset Management, and Richard Gaster, MD, PhD from venBio Partners, will join the Elevation Oncology Board of Directors in conjunction with the new financing.

"We welcome Andy and Rich to our Board of Directors and are encouraged by the support of a highly sophisticated investor group committed to helping us continue to pursue our mission," said Dr. Leland. "At the core of Elevation Oncology is the belief that patients deserve the right clinical team and the right genomic tests to match the right therapeutics to the unique genomic profile of each tumor. We look forward to continuing to work closely with our Board and Scientific Advisors to innovate and accelerate the development of precision oncology therapeutics to realize this vision."

Dr. Leland founded Elevation Oncology in July 2019, is a member of its Board of Directors, and previously served as the Company’s Chief Business Officer. He has over a decade of experience in medical affairs and business development for the pharmaceutical/biotech industry, with a focus on building collaborations to realize the full potential of targeted and personalized therapeutics. He has been involved in global transactions totaling more than $450 million in upfront payments and milestone payments at Eli Lilly, ARIAD Pharmaceuticals, Argos Therapeutics and Verastem Oncology. Steve Elms, Managing Partner of Aisling Capital, who was serving as Interim CEO of Elevation Oncology, will remain Chair of the Company’s Board of Directors.

"Shawn has been instrumental in the founding and success of Elevation Oncology to date," said Mr. Elms. "On behalf of the entire Board of Directors, I express our great confidence in the future of Elevation Oncology under Shawn’s leadership. The proceeds raised with the Series B positions the Company well to deliver on our mission of developing precision therapeutics for patients with genomically defined cancers."

Elevation Oncology’s lead development program, the Phase 2 CRESTONE study, is evaluating the HER3 monoclonal antibody seribantumab for the treatment of patients with tumors harboring an NRG1 gene fusion. The Company is actively evaluating opportunities for pipeline expansion, prioritizing targeted therapy approaches in tumor types defined by genomic driver alterations.

"The progress that Elevation Oncology has made in the short time since its founding to establish a strong scientific rationale and an accelerated development path for seribantumab in patients with tumors harboring an NRG1 gene fusion is quite impressive," said Dr. Gaster, Partner at venBio. "We see the progress to date as indicative of Elevation Oncology’s long-term potential. I look forward to serving on Elevation’s Board of Directors as the Company continues to advance its mission to match unique genomic test results with a purpose-built precision medicine approach to enable an individualized treatment plan for each patient."

"Elevation Oncology’s commitment to innovation across the drug development lifecycle has drawn a distinguished group of collaborators who are able to broadly conduct genomic testing across the US, rapidly open up clinical trial sites, and ensure exemplary execution of the CRESTONE study," said Dr. Phillips, Managing Director at Cormorant. "I am very pleased to be joining the Company’s Board of Directors to support the continued and expanded application of these efforts towards the efficient acquisition, development, and approval of new therapeutics for patients with genomically defined cancers."

Proceeds from the Series B financing will be used to fund the completion of enrollment in the CRESTONE study and other corporate development activities.