On March 2, 2020 Primmune Therapeutics reported that it has raised $7 million in seed financing to support the development of novel orally-administered, small molecule toll-like receptor 7 (TLR7) agonists for long-term systemic activation of innate immunity (Press release, Primmune Therapeutics, MAR 2, 2020, View Source [SID1234555043]). Investors in the seed financing were CAM Capital, Charlie McDermott, BioBrit and BioRock Ventures.

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In conjunction with the financing, Scott Morenstein, Managing Director at CAM Capital will join the board of directors. Ezra Cohen, M.D., Chief, Division of Hematology-Oncology and Associate Director, Translational Science, Moores Cancer Center at the University of California, San Diego and Isan Chen, M.D., Chief Medical and Development Officer at Mirati Therapeutics will join the company’s clinical advisory board.

"The recent advances in cancer immunotherapy have resulted in medicines that have had profound benefit for cancer patients; yet, a majority of those patients do not respond or relapse. There is a strong rationale for combining agents that activate systemic innate immunity, like a TLR7 agonist, with drugs that engage systemic adaptive immunity, like checkpoint inhibitors, to potentially address patients who have an inadequate response to approved treatments," said Charlie McDermott, Chief Executive Officer of Primmune Therapeutics. "We are pleased to have secured financial support from our investors and local biotech executives who are committed to supporting the advancement of our small molecule TLR7 agonists into human studies in oncology and virology."

Primmune is being led by an experienced and dedicated team, which includes:

• Charlie McDermott, Chairman, President & Chief Executive Officer
• James Appleman, Ph.D., Co-founder, Board Member, SVP, R&D and Chief Scientific Officer
• Paulo Rangel, President, Co-founder, Board Member, Chief Business Officer
• Stephen Webber, Ph.D., Co-founder and SVP Medicinal Chemistry
• Todd Harris, Ph.D., Board Member, CEO of Tyra Biosciences

Mr. McDermott is Chairman, President & CEO of Primmune. He brings more than 25 years of experience in the life sciences industry and has held roles of increasing responsibility in drug discovery, regulatory affairs, corporate development, commercial planning, and executive management. Most recently, Mr. McDermott was President, Chief Business Officer, and a member of the board of directors of Impact Biomedicines, Inc. While at Impact, Mr. McDermott raised more than $110 million in venture and non-dilutive royalty financing to fully fund the development and commercialization of fedratinib (INREBIC) for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF). Impact was acquired by Celgene in 2018 for $1.1 billion upfront and up to $7 billion overall, if all contingent payments are realized. Prior to joining Impact, Mr. McDermott was President and Chief Business Officer of Kala Pharmaceuticals, Inc., where he helped lead the transformation of Kala from a private pre-clinical stage company to a pre-commercial stage public company. To this end, Mr. McDermott helped raise approximately $190 million via private equity, debt, and an initial public offering. In August of 2018, Kala received NDA approval for Inveltys, an internally developed drug for ocular indications. Before joining Kala, Mr. McDermott worked at Allergan as Vice President, Global Business Development for the Eye Care and Drug Delivery business units. At Allergan, Mr. McDermott led efforts to license and acquire a variety of technologies and therapeutics including Lastacaft, Acuvail, Restasis MultiDose, Latisse, and Abicipar. Before joining Allergan, Mr. McDermott held positions as Associate Director of Business Development at deCODE genetics and before that, in drug discovery and regulatory affairs at Pfizer/Agouron. Mr. McDermott has an M.A. in molecular, cellular, and developmental biology from University of California, Santa Barbara, an MBA from the University of San Diego and a B.A. in biochemistry and molecular biology from the University of California, Santa Cruz.

Dr. Appleman is SVP, R&D and CSO, Co-founder, Director of Primmune. Dr. Appleman brings nearly 30 years of experience in building successful drug discovery organizations while having served as an advisor to biotech, hi-tech, and diagnostic firms. Dr. Appleman is a Co-founder of eFFECTOR Therapeutics where he established both the technology base and bioinformatics infrastructure to support eFFECTOR’s unique programs targeting dysregulated mRNA translation. He previously served as Senior Vice President, Research and Chief Scientific Officer at Anadys Pharmaceuticals, Inc. where he played a pivotal role in the business process culminating in the acquisition of Anadys for $230M (256% premium to market cap) by Roche. Additionally, he led the invention, characterization and clinical development of the Anadys’ internally discovered drug candidates setrobuvir and ANA773, a novel oral TLR7 agonist for the treatment of cancer and hepatic viral diseases. Prior to joining Anadys, Dr. Appleman held positions at Gensia, Inc. and its subsidiary Metabasis Therapeutics and was a faculty member at St. Jude Children’s Research Hospital. He received a Ph.D. in biochemistry from Oklahoma State University and completed his postdoctoral training at Dartmouth Medical School.

Mr. Rangel is Chief Business Officer, Co-founder, Director of Primmune. He brings 25 years of experience in the pharmaceutical and related industries in both small and large companies. Before Primmune, Mr. Rangel was President & CEO and Co-founder of Evince Biosciences, a precursor to Primmune Therapeutics. Before Evince, Mr. Rangel was a Partner at ProPharma Partners International, an international consulting group where he focused on working with biopharmaceutical and medical device companies on worldwide in- and out- licensing, valuations, business plans and market research. Before ProPharma, Mr. Rangel was Head of Global Business Development at Besins Healthcare, a global pharmaceutical company with products targeted at women’s and men’s health. Mr. Rangel was a founder of, and key executive in, two medical device start-ups, Lasercure Sciences and 5i Sciences (now Sommetrics). In those positions, he managed the financing, clinical studies and collaborations, and was responsible for all intellectual property. Mr. Rangel has filled key roles in a number of other biotechnology companies and worked at Amgen and Hybritech/Lilly early on in his career. Mr. Rangel received a B.A. in chemistry and biochemistry from the University of California, San Diego and an MBA from The Fuqua School of Business at Duke University.

Dr. Webber is Co-founder and SVP of Medicinal Chemistry at Primmune. He brings 33 years of experience in drug discovery in the biotech and pharmaceutical industry. Prior to Primmune, Dr. Webber was Executive Director of Medicinal Chemistry at Polaris Pharmaceuticals where he was responsible for the discovery and synthesis of small molecules against various oncology targets using structure-based drug design. Before joining Polaris, Dr. Webber was a Co-founder and Director of Medicinal Chemistry at eFFECTOR Therapeutics, a company devoted to the discovery and development of translation regulators for cancer. He is a Co-inventor of tomivosertib, an orally active MNK1/2 inhibitor. Previously, Dr. Webber led discovery chemistry efforts at Anadys Pharmaceuticals Inc. where he served at various senior levels until the company was acquired by Roche. His contributions include the discovery of anti-HCV clinical candidates setrobuvir, a non-nucleoside NS5B inhibitor and ANA-773, a second generation orally active TLR-7 agonist prodrug demonstrating antiviral and anticancer activity. Dr. Webber’s career extends back to the inception of Agouron Pharmaceuticals Inc. where he helped pioneer protein crystal structure- and computer-based drug design. Dr. Webber discovered and invented several PARP inhibitors, including Rucaparib (marketed as Rubraca), a FDA approved medicine to treat ovarian cancer in patients with the BRCA, or BRCA-like mutations. Dr. Webber also discovered and co-invented several clinical candidates including nolatrexed dihydrochloride (Thymitaq). He also made significant contributions to the rhinovirus protease project leading to the advancement of ruprintrivir as a clinical candidate. Dr. Webber received his Ph.D. from the University of Pennsylvania and his B.S. from Philadelphia University.

On March 2, 2020 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported financial results for the year ended December 31, 2019 (Press release, Zymeworks, MAR 2, 2020, View Source [SID1234555059]).

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"We’ve started the year off strong thanks to significant clinical progress in the second half of 2019 and a recent financing that has provided expanded resources to further advance global development of our clinical candidates, ZW25 and ZW49," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "We plan to initiate registration-enabling studies for ZW25 in both biliary tract and gastric cancer, as well as explore additional indications, with a vision toward establishing ZW25 as the new foundational HER2 therapy. We also remain confident in the potential of ZW49 to be transformative in refractory and low HER2-expressing cancers and expect to begin expansion cohorts later this year."

2019 Business Highlights and Recent Developments

Strengthened Balance Sheet

In January 2020, Zymeworks completed an upsized US$320.8 million public financing to accelerate and expand global development of its lead clinical candidates, ZW25 and ZW49, and support further advancement of its novel preclinical programs.

Robust ZW25 Clinical Data and Initiation of Two Phase 2 Clinical Trials Pave the Way for Upcoming Registration-Enabling Studies

ZW25 has been well tolerated and has demonstrated promising anti-tumor activity both as a single agent and in combination with chemotherapy, supporting the planned initiation of two registration-enabling trials in refractory HER2-positive biliary tract cancer and first-line HER2-positive gastroesophageal adenocarcinomas. In addition, Zymeworks recently initiated a Phase 2 trial and collaboration with Pfizer to evaluate ZW25 in combination with palbociclib and fulvestrant in HER2-positive, hormone receptor-positive breast cancer.

ZW49 Advancing Phase 1 Dose-Escalation and Interim Clinical Update

Zymeworks’ second product candidate, ZW49, began a Phase 1 clinical trial to evaluate safety and anti-tumor activity, and to establish a recommended dose and schedule for expansion cohorts. A recent update highlighted that there had been no dose-limiting toxicities observed and the maximum tolerated dose had not been reached. The majority of treatment-related adverse events were grade 1 or 2, and were reversible and manageable on an outpatient basis. Preliminary results from these initial dose cohorts included anti-tumor activity.

Partner Programs Progress into the Clinic

In 2019, Eli Lilly entered the clinic with a novel bispecific; Merck, Celgene (now BMS), and Daiichi Sankyo advanced bispecific candidates toward clinical testing; GSK expanded its Azymetric partnership; and the first ZymeLink ADC collaboration was signed with Iconic Therapeutics. Zymeworks currently has nine active collaborations that offer up to US$7.9 billion in potential milestone payments as well as royalties on potential product sales.

Financial Results for the Year Ended December 31, 2019

Revenue in 2019 was $29.5 million as compared to $53.0 million in 2018. Revenue for both years was primarily comprised of non-recurring upfront fees, expansion payments and milestone payments from Zymeworks’ licensing and collaboration agreements. Revenue for 2019 included $8.0 million received from Eli Lilly for achievement of a development milestone upon their submission of an IND application, $7.5 million received upon BMS’s exercise of its commercial license option, $3.5 million received upon Daiichi Sankyo’s exercise of a commercial license option, and $7.0 million received in other development milestones and research support and other payments from our partners. Revenue in 2019 also included recognition of $3.5 million from deferred revenue relating to the upfront payment received in the prior year from BeiGene under the 2018 licensing and collaboration agreement for development of ZW25.

Revenue for 2018 included recognition of $23.5 million of the $60.0 million upfront fee from BeiGene associated with a new licensing agreement, an $18.0 million upfront fee related to a second licensing agreement with Daiichi Sankyo, a $5.0 million upfront fee related to a new licensing agreement with LEO Pharma, a $4.0 million research program expansion fee from BMS and $2.5 million in other milestones and research support payments from our partners.

For the year ended December 31, 2019, research and development expenses were $115.9 million as compared to $56.9 million in the prior year. The change was primarily due to an increase in activities related to the progression and expansion of ZW25 clinical studies and the associated manufacturing costs, as well as development activities for ZW49 in 2019, and an increase in other research and development activities, which include an increase in salaries and benefits expense as a result of an increase in headcount and non-cash stock-based compensation expense compared to the same period in 2018. Research and development expense included non-cash stock-based compensation expense of $14.3 million, including expense of $8.4 million related to the mark-to-market revaluation of certain historical liability classified equity awards.

For the year ended December 31, 2019, general and administrative expenses were $64.2 million as compared to $29.5 million in the prior year. The change was due to an increase in headcount to support our expanding research and development activities and non-cash stock-based compensation expense. General and administrative expense included non-cash stock-based compensation expense of $34.2 million including $27.5 million expense related to the mark-to-market revaluation of certain historical liability classified equity awards.

Net loss for the year ended December 31, 2019 was $145.4 million as compared to $36.6 million in 2018. This increase in net loss was primarily due to the variances in revenue, research and development expenses and general and administration expenses noted above.

Zymeworks expects research and development expenditures to increase over time due to the ongoing development of our product candidates and other clinical, preclinical, and regulatory activities. Additionally, Zymeworks anticipates continuing to receive revenue from its existing and future strategic partnerships, including technology access fees, milestones and research support payments. However, Zymeworks’ ability to receive these payments is dependent upon either Zymeworks or its collaborators successfully completing specified research and development activities.

As of December 31, 2019, Zymeworks had $298.9 million in cash and cash equivalents and short-term investments.

On March 2, 2020 KIYATEC, Inc. reported that VA Portland Health Care System (VAPORHCS) has joined the growing roster of institutions participating in its 3D-PREDICT clinical study to validate the company’s test as a patient-specific predictor of response to cancer therapies for patients with glioblastoma, an aggressive form of brain cancer (Press release, KIYATEC, MAR 2, 2020, View Source [SID1234555075]).

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"Glioblastoma, one of the most common and deadly forms of brain cancer, is notoriously difficult to treat. Patients and clinicians do not have the luxury of time to experiment with drug therapies they don’t know will work, so we developed our investigational glioblastoma drug response profile to help clinicians optimize therapeutic decision-making for their patients over the course of their disease," said Matthew Gevaert, CEO of KIYATEC. "We are honored to welcome VAPORHCS to the 3D-PREDICT study and salute the important commitment to cancer clinical studies demonstrated by all VA hospitals."

3D-PREDICT is a prospective, open-label, non-interventional study to validate KIYATEC’s glioblastoma drug response profile, which leverages the company’s ex vivo 3D cell culture technology platform to assess pre-treatment, patient-specific response to a panel of 12 drugs most commonly used to treat patients with newly diagnosed or recurrent glioblastoma. Details on the study can be found at View Source

On March 2, 2020 Gilead Sciences, Inc. (Nasdaq: GILD) and Forty Seven, Inc. (Nasdaq: FTSV) reported that the companies have entered into a definitive agreement pursuant to which Gilead will acquire Forty Seven for $95.50 per share in cash (Press release, Gilead Sciences, MAR 2, 2020, View Source [SID1234555015]). The transaction, which values Forty Seven at approximately $4.9 billion, was unanimously approved by both the Gilead and Forty Seven Boards of Directors and is anticipated to close during the second quarter of 2020, subject to regulatory approvals and other customary closing conditions.

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Through the addition of Forty Seven’s investigational lead product candidate, magrolimab, the acquisition will strengthen Gilead’s immuno-oncology research and development portfolio. Magrolimab is a monoclonal antibody in clinical development for the treatment of several cancers for which new, transformative medicines are urgently needed, including myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) and diffuse large B-cell lymphoma (DLBCL). The investigational therapy targets CD47, a "do not eat me" signal that allows cancer cells to avoid destruction thereby permitting the patient’s own innate immune system to engulf and eradicate those cancer cells. Forty Seven presented promising results of a Phase 1b study of magrolimab in patients with MDS and AML at the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in December 2019. Magrolimab has the potential to be a first-in-class therapy.

"This agreement builds on Gilead’s presence in immuno-oncology and adds significant potential to our clinical pipeline," said Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences. "Magrolimab complements our existing work in hematology, adding a non-cell therapy program that complements Kite’s pipeline of cell therapies for hematological cancers. With a profile that lends itself to combination therapies, magrolimab could potentially have transformative benefits for a range of tumor types. We are looking forward to working with the highly experienced team at Forty Seven to help patients with some of the most challenging forms of cancer."

"This is an exciting day for patients who may one day benefit from future anti-CD47 therapies and other immuno-oncology treatments based on our research and an exciting time for Forty Seven as this allows us to achieve our vision of helping patients defeat their cancer," commented Mark McCamish, MD, PhD, President and Chief Executive Officer of Forty Seven. "We are pleased to join Gilead and believe that by combining our scientific expertise with Gilead’s strength in developing treatments that modify the immune system, we will be able to more rapidly advance our therapies."

Magrolimab

Forty Seven is initially studying magrolimab in patients with MDS and AML. Additional studies are ongoing in non-Hodgkin lymphoma (NHL) and solid tumors. Magrolimab has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of MDS and AML, and for the treatment of relapsed or refractory DLBCL and follicular lymphoma, two forms of B-cell NHL. Magrolimab has also been granted Orphan Drug designation by the FDA for the treatment of MDS and AML and by the European Medicines Agency for the treatment of AML.

More than 400 patients have received the compound to date through clinical trials.

Ongoing Phase 1b Clinical Trial

In December 2019, Forty Seven presented promising results of a Phase 1b trial evaluating magrolimab in combination with azacitidine in untreated patients with higher risk MDS and untreated patients with AML, who are ineligible for induction chemotherapy. This has led to the initiation of a potential registrational cohort in MDS. All patients received a 1 mg/kg priming dose of magrolimab, coupled with intrapatient dose escalation to mitigate on-target anemia. Patients were then treated with full doses of azacitidine and magrolimab maintenance doses of 30 mg/kg weekly.

As of the data cutoff of November 18, 2019, 62 patients had been treated with the combination in the Phase 1b portion of the trial, including 35 patients with MDS and 27 patients with AML.

Clinical Activity Data

As of the data cutoff, 46 patients were evaluable for response assessment, including 24 patients with untreated higher-risk MDS and 22 patients with untreated AML, who were ineligible for induction chemotherapy.

In higher-risk MDS, the overall response rate (ORR) was 92 percent, with 12 patients (50 percent) achieving a complete response (CR), eight patients (33 percent) achieving a marrow CR and two patients (8 percent) achieving hematologic improvement. Two patients (8 percent) had stable disease.
In untreated AML, the ORR was 64 percent, with nine patients (41 percent) achieving a CR, three patients (14 percent) achieving a CR with complete blood count recovery (CRi) and one patient (5 percent) achieving a morphologic leukemia-free state (MLFS). Seven patients (32 percent) had stable disease and one patient (5 percent) had progressive disease.
The median time to response among MDS and AML patients treated with the combination was 1.9 months.
Median duration of response and median overall survival have not been reached for either MDS or AML patients, with a median follow-up of 6.4 months (range 2.0 to 14.4 months) for MDS and 8.8 months (range 1.9 to 16.9 months) for AML.
Safety Data

As of the data cutoff, the combination of magrolimab and azacitidine was well-tolerated, with no evidence of increased toxicities compared to azacitidine alone. Adverse events (AEs) were consistent with prior clinical experience. No deaths were observed in the first 60 days on combination treatment and only one patient out of 62 (1.6 percent) discontinued treatment due to a treatment-related AE.

Additional Programs

Beyond magrolimab, Forty Seven is preparing to advance two additional investigational compounds into clinical testing. FSI-174, an anti-cKIT antibody, is being developed in combination with magrolimab as a novel, all-antibody conditioning regimen to address the limitations of current stem cell transplantation conditioning regimens. FSI-189, an anti-SIRPα antibody, is being developed for the treatment of cancer, as well as certain non-oncology settings, including transplantation conditioning.

Terms of the Transaction

Under the terms of the merger agreement, a wholly-owned subsidiary of Gilead will promptly commence a tender offer to acquire all of the outstanding shares of Forty Seven’s common stock at a price of $95.50 per share in cash. Following successful completion of the tender offer, Gilead will acquire all remaining shares not tendered in the offer through a second step merger at the same price as in the tender offer.

Consummation of the tender offer is subject to a minimum tender of at least a majority of outstanding Forty Seven shares plus Forty Seven shares underlying vested options, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions.

Gilead plans to pay all cash consideration for the transaction. The tender offer is not subject to a financing condition.

Citi and J.P. Morgan are acting as joint financial advisors to Gilead. Centerview Partners LLC is acting as the exclusive financial advisor to Forty Seven. Skadden, Arps, Slate, Meagher & Flom LLP is serving as legal counsel to Gilead and Cooley LLP is serving as legal counsel to Forty Seven.

Conference Call

At 8:00 a.m. Eastern Time today, Gilead’s management will host a conference call and a simultaneous webcast to discuss the transaction. A live webcast of the call can be accessed at Gilead’s Investors page at View Source Please connect to the website at least 15 minutes prior to the start of the call to allow adequate time for any software download that may be required. Alternatively, please call 877-359-9508 (U.S.) or 224-357-2393 (international) and dial the conference ID 8479332 to access the call.

Telephone replay will be available approximately two hours after the call through 8:30 a.m. Eastern Time, March 4, 2020. To access the replay, please call 855-859-2056 (U.S.) or 404-537-3406 (international) and dial the conference ID 8479332. The webcast will be archived on www.gilead.com for one year.

On March 2, 2020 Marker Therapeutics, Inc. (NASDAQ:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported that the Company has entered into a Common Stock Purchase Agreement (the "Agreement") of up to $30 million with Aspire Capital Fund, LLC ("Aspire"), a Chicago-based institutional investor and long-term Marker shareholder (Press release, TapImmune, MAR 2, 2020, View Source [SID1234555044]).

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Under the terms of the Agreement, Aspire has committed to purchase up to $30 million of the Company’s common stock at Marker’s discretion from time to time during a 30-month period at prices based on the market price at the time of each sale. Marker will retain full control as to the timing and amount of any sale of shares of common stock to Aspire, subject to certain limitations specified in the Agreement.

There are no warrants, options, financing swaps, derivatives or other securities associated with this Agreement. Additionally, there are no financial covenants or restrictions on future financings and there are no rights of first refusal, participation rights, penalties or liquidated damages. Lastly, Marker maintains the right to terminate the Agreement at any time, at its discretion, without any additional cost or penalty. Proceeds from the Agreement will be used to further advance the Company’s pipeline including its post-transplant acute myeloid leukemia (AML) Phase 2 trial, which is expected to begin in 2020, as well as for general corporate purposes.

"This Agreement with Aspire provides Marker with the opportunity to access capital in an efficient manner," stated Peter L. Hoang, President and CEO of Marker. "The financial flexibility provided by this transaction will further support the advancement of our clinical programs including the first Marker-sponsored clinical trial this year investigating our novel MultiTAA cell therapy."

As consideration for Aspire’s entering into the Agreement, Marker issued 345,357 shares to Aspire as a commitment fee. Additional detail regarding the Agreement is set forth in Marker’s Current Report on Form 8-K, filed today with the SEC.