Mosaic ImmunoEngineering Inc. signs license-option to advance novel immunotherapy to treat cancer and infectious diseases

On August 31, 2020 Mosaic ImmunoEngineering Inc., a private biotechnology company based in Novato, California, reported that it has signed a two-year option agreement with Case Western Reserve University and Dartmouth College, granting the company the exclusive right to license technology for a novel platform technology using virus-like nanoparticles ("VLP") to treat and prevent cancer and infectious diseases in humans and for veterinary use (Press release, Case Western Reserve University, AUG 31, 2020, View Source [SID1234564178]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The technology has broad potential to treat many different types of cancer and is supported by numerous scientific publications and grant funding. The technology also has direct application as part of a vaccine platform, which has generated promising data in both cancer and infectious diseases, including COVID-19, through research funded by the National Science Foundation (NSF).

An option agreement provides Mosaic two years to obtain a full license agreement. A license option typically is granted to a company interested in further evaluation of the technology before entering into a full license agreement that allows the company to commercially market it. The two-year option to license agreement, is managed through Case Western Reserve’s Technology Transfer Office.

"Along with providing world-class research in many areas, Case Western Reserve University and Dartmouth College are striving to translate these exciting discoveries into products that can make a difference in the lives of patients with life threatening illnesses," said Wayne Hawthorne, senior licensing manager in the university’s Technology Transfer Office. "We encourage our faculty to conduct basic research which can become the basis of discoveries that have direct application to clinical needs such as the technology that Mosaic is seeking to advance. Considerable research and progress was made on the technology through internal awards and grants that funded early product development and clinical proof from organizations such Coulter Foundation, Council to Advance Human Health and Ohio Third Frontier Technology Validation and Start-Up Fund."

The inventors of the technology include Nicole Steinmetz, professor in the Department of NanoEngineering and director of the Center for Nano-ImmunoEngineering at the University of California San Diego (UCSD), and Jonathan Pokorski, associate professor in the Department of NanoEngineering at UCSD. During their tenure at Case Western Reserve, they worked in conjunction with Steven Fiering, a professor of microbiology and immunology at Dartmouth Geisel School of Medicine.

The researchers have collectively demonstrated that plant-derived, engineered VLP-based nanotechnologies stimulate a potent anti-tumor immune response in mouse models of metastatic melanoma, ovarian cancer, colon cancer, brain cancer and breast cancer, including companion dogs with metastatic melanoma. This data supports the potential to translate preclinical studies into veterinary applications, such as the treatment of cancer in companion animals, which has high relevance to human melanoma.

"We are pleased to have completed this agreement with CWRU and Dartmouth, and look forward to working closely with the university and Drs. Steinmetz, Pokorski and Fiering to rapidly advance the highly promising technology platforms into the clinic," said Steven King, co-founder and chief executive officer of Mosaic. "This technology platform includes many opportunities in oncology and infectious diseases, including both human and veterinary applications. This is a very important milestone for Mosaic, and we are very happy to have the opportunity to work with prestigious universities and an impressive team of scientists."

"This immuno-oncology approach provides a personalized treatment approach by relieving the patient’s tumor-mediated immunosuppression and potentiating anti-tumor immunity against antigens expressed by their own tumor," said Steinmetz, a co-inventor of the technology and a co-founder and chief scientific officer of Mosaic. "The vaccine platform is a natural extension of the immune-stimulating properties of the VLP, combined with directing the response to pre-defined targets. Instead of being a personal vaccine, the modular approach of linking disease specific targets to the VLP allows the potential to rapidly develop countermeasures for pandemics such as COVID-19."

Mosaic, through its founding team, has identified a lead oncology candidate for advancement into clinical trials and the ongoing NSF funded research is supporting the application of the technology toward the development of a SARS-CoV-2 vaccine for the prevention of COVID-19. Over the past 10 years, the technology has been funded through numerous research grants totaling more than $20 million.

Ligand Commences Previously Announced Cash Tender Offer to Acquire Pfenex Inc.

On August 31, 2020 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that its wholly-owned subsidiary, Pelican Acquisition Sub, Inc. (the "Purchaser"), is commencing a tender offer to purchase all outstanding shares of common stock of Pfenex, Inc. (NYSE American: PFNX) at an offer price of $12.00 per share in cash, plus one non-transferable contractual contingent value right per share representing the right to receive a contingent payment of $2.00 in cash, if a certain specified milestone is achieved (Press release, Ligand, AUG 31, 2020, View Source [SID1234564169]). The tender offer is being made pursuant to an Offer to Purchase, dated August 31, 2020 (the "Offer to Purchase"), and in connection with the Agreement and Plan of Merger, dated August 10, 2020, by and among Ligand, Purchaser and Pfenex (the "Merger Agreement"), which Ligand and Pfenex previously announced on August 10, 2020.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The tender offer will expire at midnight (New York City time) at the end of the day on Tuesday, September 29, 2020, (such date and time, the "Expiration Date"), unless (i) the Purchaser extends the period during which the tender offer is open pursuant to and in accordance with the terms of the Merger Agreement, in which case the term "Expiration Date" means the latest date and time at which the offer period, as so extended by the Purchaser, will expire or (ii) the Merger Agreement has been earlier terminated. Pursuant to the Merger Agreement, the Purchaser will extend the offer period for any period or periods required by any applicable law or applicable rules, regulations, interpretations or positions of the Securities and Exchange Commission ("SEC") or its staff or the NYSE American, and the Purchaser may (and if requested by Pfenex shall) extend the Offer for successive periods of up to 10 business days each (or such longer period as may be approved by Pfenex), if on or prior to any then scheduled Expiration Date, any of the conditions to the offer (other than the Minimum Condition (as defined below)) has not been satisfied or waived (where permitted by applicable law or the Merger Agreement). The Purchaser will also extend the offer period for successive periods of 10 business days each (or such longer period as may be approved by Pfenex), if on or prior to any then scheduled Expiration Date, all conditions to the offer (other than the Minimum Condition) have been satisfied or waived (where permitted by applicable law or the Merger Agreement); provided, in no event will the Purchaser be required to extend the tender offer on more than two occasions (but may elect to do so in its sole and absolute discretion).

The tender offer is not subject to any financing condition. The tender offer is conditioned upon (i) there being validly tendered in the tender offer and not properly withdrawn prior to the Expiration Date, a number of shares of common stock which, together with the number of shares of common stock then owned by Ligand or any of its wholly-owned direct or indirect subsidiaries, including the Purchaser (if any), represents at least a majority of the then outstanding shares of common stock (determined in accordance with the Merger Agreement) (excluding from the number of tendered shares, shares tendered pursuant to guaranteed delivery procedures that have not yet been "received" as such term is defined in Section 251(h) of the General Corporation Law of the State of Delaware, by the depositary for the tender offer pursuant to such procedures) (the "Minimum Condition"); (ii) the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, having expired or been terminated; (iii) the absence of legal restraints that has the effect of prohibiting or otherwise preventing the consummation of the Offer or the Merger; and (iv) the satisfaction or waiver by the Purchaser of the other conditions and requirements of the tender offer. As soon as practicable following the consummation of the tender offer, the Purchaser will merge with and into Pfenex with Pfenex continuing as the surviving corporation and as a wholly-owned subsidiary of Ligand.

D.F. King & Co., Inc. is acting as information agent and American Stock Transfer & Trust Company, LLC is acting as depositary in the tender offer. Requests for documents and questions regarding the tender offer may be directed to the information agent by telephone at (800) 821-8781.

New Preclinical GlycoMimetics Data Suggests Uproleselan With Venetoclax/HMA in AML May Prolong Survival

On August 31, 2020 GlycoMimetics, Inc. (Nasdaq: GLYC) reported new preclinical data providing the first evidence that an E-selectin targeting strategy with uproleselan may help patients with acute myeloid leukemia (AML) to overcome resistance to venetoclax and hypomethylating agent (HMA)-based therapy (Press release, GlycoMimetics, AUG 31, 2020, View Source [SID1234564168]). The poster (Abstract #AML-337) entitled "Targeting E-selectin with GMI-1271 Overcomes Microenvironment-mediated Resistance to Venetoclax/HMA Therapy," will be presented September 9 from 6:15-8:15 p.m. CDT on the virtual platform of the virtual meeting of the Society of Hematologic Oncology (SOHO).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The data presented are from an animal model created using tissue derived from a patient who had developed resistance to venetoclax/HMA. In this model, the addition of uproleselan to the treatment regimen demonstrated robust anti-leukemic activity and a statistically significant prolongation of survival. The research strongly supports the opportunity for additional clinical evaluation of the triple combination of uproleselan, venetoclax and HMA in the frontline, unfit AML patient population.

"We know that binding leukemic cells to E-selectin within the bone marrow niche up-regulates pro-survival mechanisms. This preclinical study shows that by blocking this activity with uproleselan, we can enhance the sensitivity to venetoclax/HMAs. This supports using this treatment regimen to potentially improve outcomes in patients whose duration of response is typically very short," said John Magnani, Ph.D., GlycoMimetics’ Senior Vice-President of Research and Chief Scientific Officer. "We are excited to share this encouraging data and hope that additional clinical evaluation will provide more insight on the potential of this combination-therapy approach."

Visit the meeting’s website for more information: View Source, The virtual meeting will be held September 9-12, 2020.

About Uproleselan (GMI-1271)

Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted inhibitor of E-selectin. Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy Designation from the U.S. FDA for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In a Phase 1/2 clinical trial, uproleselan was evaluated in both newly diagnosed elderly and relapsed or refractory patients with AML. In both populations, patients treated with uproleselan together with standard chemotherapy achieved better-than-expected remission rates and overall survival compared to historical controls, which have been derived from results from third-party clinical trials evaluating standard chemotherapy, as well as lower-than-expected induction-related mortality rates. Treatment in these patient populations was generally well-tolerated, with fewer than expected adverse effects.

Erasca Extends Series B Financing to $236 Million

On August 31, 2020 Erasca, a company whose mission is to erase cancer, reported the completion of a $36 million extension of its Series B financing round, which brings the total round to $236 million (Press release, Erasca, AUG 31, 2020, View Source [SID1234564167]). New investors include Partner Fund Management and OrbiMed.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This financing brings the total capital raised by the company to $300 million. Erasca will use the proceeds to finance the clinical development of multiple promising oncology programs, continue driving corporate development efforts and further advance the company’s in-house drug discovery pipeline.

"Erasca is honored to welcome Partner Fund Management and OrbiMed as partners in our bold mission of erasing cancer," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO and co-founder. "We are doing everything we can to help patients live longer and healthier lives. Because cancer is such a formidable foe, we are grateful to have the support of our new and existing investors to tackle this terrible disease."

The company has assembled a robust pipeline of precision therapies directed at undisclosed targets through in-house drug discovery as well as active pipeline expansion via collaborations with world-class academic and biopharmaceutical organizations.

"Erasca has demonstrated impressive progress in less than two years since its founding," said Mark Karvosky, a partner at Partner Fund Management. "The company’s portfolio of potentially first-in-class and best-in-class assets will target significant unmet medical needs across multiple cancer types. We are excited to support this team and its programs, as Erasca strives to deliver practice-changing precision oncology therapies."

Targovax ASA: Settlement of restricted stock units by primary insider and resolution to increase the share capital

On August 31, 2020 The board of directors of Targovax ASA (OSE:TRVX) ("Targovax" or the "Company") reported that it has resolved to increase the share capital of the Company following the completion of a settlement period for vested restricted stock units ("RSUs") (Press release, Targovax, AUG 31, 2020, View Source [SID1234564166]). The settlement period commenced on 21 August 2020 at 10:00 hours (CEST) and ended on 28 August 2020 at 10:00 hours (CEST).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In total were 88,272 RSUs settled, giving the RSU holders the right to subscribe for in total 88,272 shares, each with a par value of NOK 0.10, at a subscription price of NOK 0.10 per share.

1. Settlement of RSUs by primary insider

Bente-Lill Romøren, member of the board of directors and primary insider in the Company (the "Primary Insider"), settled 9,399 RSUs on 28 August 2020, which were granted at the AGM in 2017 and 2018, giving the Primary Insider the right to subscribe for an equal amount of shares in the Company at a price of NOK 0.10 per share.

The Primary Insider received the RSUs as part of her remuneration for her directorship at the board. The number of RSUs granted was calculated as the NOK amount of the RSU selected portion of the total remuneration to the board member, divided by the market price for the shares, calculated as the volume weighted average share price for the 10 trading days prior to the AGM, being NOK 23.88 per share in 2017 and NOK 14.33 per share in 2018.

2. Resolution to increase the share capital in Targovax ASA

The Company’s board of directors has on 30 August 2020, in accordance with the authorisation granted by the general meeting on 29 April 2020, resolved to increase the share capital of the Company with NOK 8,827.20 by issuance of 88,272 new shares, each with a par value of NOK 0.10, in order to facilitate the settlement of RSUs.

The share capital increase will be registered with the Norwegian Register of Business Enterprises (Nw. Foretaksregisteret) as soon as practically possible. The new share capital of the Company will be NOK 7,617,576.40, divided into 76,175,764 shares, each with a par value of NOK 0.10.

3. New shareholding for primary insider

Following the Primary Insider’s subscription of shares and registration of the Company’s new share capital, the Primary Insider and her close associates will hold 20,327 shares, 15,250 RSUs and nil options in the Company.