SALE of Lycera Corp Asset Portfolio.
Gerbsman Partners (www.gerbsmanpartners.com) has been retained by Lycera Corp. (www.lycera.com) to solicit interest for the acquisition of all, or substantially all, the assets of Lycera Corp.
Lycera Corp (Lycera) is a privately held biotechnology company located in Plymouth Meeting, Pennsylvania. Since its founding in 2006, Lycera has focused on the development of novel small molecule immunomodulatory medicines for the treatment of autoimmune diseases and cancer. Lycera has been supported by leading venture capital companies comprising Arch Venture Partners, Blackstone Ventures and InterWest Partners, as well as, through a partnership with Celgene for a total investment of $180M. The Board of Directors has approved the search for a strategic partner to continue the development of the Lycera assets.
The acquisition of Lycera’s asset portfolio enables immediate access to clinical and preclinical drug candidates. Lycera has a patent portfolio comprising thirty-six (36) patent families, one hundred and twenty-one (121) patents and forty-four (44) provisional applications to protect the company’s preclinical and clinical assets.
Lycera has developed and owns the following core assets:
1.Cintrorogon (LYC-55716) an RORγ Agonist, completed development in a single agent phase 2 and a phase 1b in combination with pembrolizumab (KeytudaTM). In combination therapy with pembrolizumab, 64% of patients demonstrated reduction of tumor burden with one confirmed partial response (patient remains on-drug after 2 years). The company recommends conducting a larger combination study to fully determine utility and to further explore potential biomarkers for patient selection.
2.A portfolio of RORγ Agonists which have increased the potency and durability of adaptive cell therapy treatment approaches when applied ex vivo. Published preclinical studies further support use of cintirorgon drug in an adaptive cell therapy setting, e.g. as an adjunct to CAR-T.
3.ATPase Modulators for the treatment of various auto-immune diseases.
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- LYC-30397, a clinical drug candidate previously evaluated as a gut-directed oral therapy in a phase 2 double blind, placebo controlled study in ulcerative colitis and phase 2 clinical study in psoriasis. The company believes that LYC-30937 may offer its best potential as a topical formulation for the treatment of psoriasis and related skin conditions.
- YC-30824 a LYC-30937 backup that is poised to enter GLP toxicology studies.
4. A RORγ antagonist (LYC-56056) for treatment of autoimmune disease that with scale-up of chemistry and manufacture of supplies would be ready for preclinical toxicology stu
5. A collection of preclinical selective inhibitors of the kinase ROCK II.
6. A contingent revenue stream comprising clinical and regulatory milestones and royalties payable on net sales related to an out-licensed GCN2 program
7. A compound library: a collection of approximately 8,000 compounds comprising drug-like small molecule inhibitors of kinases, NLRP3, CD73 and histone deacetylases, modulators of the mitochondrial ATPase and nuclear receptor family members, as well as modulators of the STimulator of INterferon Genes (STING) pathway.
8. A large patent estate affording composition of matter protection across major markets
IMPORTANT LEGAL NOTICE:
The information in this memorandum does not constitute the whole or any part of an offer or a contract.
The information contained in this memorandum relating to Lycera’s assets has been supplied by Lycera. It has not been independently investigated or verified by Gerbsman Partners or its agents.
Potential purchasers should not rely on any information contained in this memorandum or provided by Lycera, or Gerbsman Partners (or their respective staff, agents, and attorneys) in connection herewith, whether transmitted orally or in writing as a statement, opinion, or representation of fact. Interested parties should satisfy themselves through independent investigations as they or their legal and financial advisors see fit.
Lycera, Gerbsman Partners, and their respective staff, agents, and attorneys, (i) disclaim any and all implied warranties concerning the truth, accuracy, and completeness of any information provided in connection herewith and (ii) do not accept liability for the information, including that contained in this memorandum, whether that liability arises by reasons of Lycera’s or Gerbsman Partners’ negligence or otherwise.
Any sale of the Lycera Assets will be made on an “as-is,” “where-is,” and “with all faults” basis, without any warranties, representations, or guarantees, either express or implied, of any kind, nature, or type whatsoever from, or on behalf of Lycera or Gerbsman Partners. Without limiting the generality of the foregoing, Lycera and Gerbsman Partners and their respective staff, agents, and attorneys, hereby expressly disclaim any and all implied warranties concerning the condition of the Lycera Assets and any portions thereof, including, but not limited to, environmental conditions, compliance with any government regulations or requirements, the implied warranties of habitability, merchantability, or fitness for a particular purpose.
This memorandum contains confidential information and is not to be supplied to any person without Gerbsman Partners’ prior consent. This memorandum and the information contained herein are subject to the non-disclosure agreement attached hereto as Exhibit A.
Historical Company Information
Lycera’s vision is to develop novel small molecule immunomodulatory medicines for the treatment of autoimmune diseases and cancer. Based on its world-class R&D engine, advancing clinical candidates from distinct, yet complementary, areas of research, including immune metabolism, cell signaling, and immune cell differentiation.
The Company has a leading position in the development of agonists of RORγ, a master transcription factor, or “master control switch,” with diverse applications in immuno-oncology. In 2019, Lycera completed a 2A study to explore single-agent activity of cintirorgon (LYC-55716) in 6 tumor types (n=86). Furthermore, in 2018 Lycera initiated a Phase 1B combination study combining cintirorgon with pembrolizumab in patients with metastatic Non-Small Cell Lung Cancer (NSCLC) who had previously relapsed on pembrolizumab therapy alone (n=17). One patient from this combination study achieved partial response and remains on therapy.
Lycera has also developed novel ATPase modulators, for the treatment of autoimmune disease. ATPase modulators have been shown to be beneficial in several widely-accepted preclinical models for autoimmune disease, as well as in human translational systems, acting through pathways directly involved in immune regulation. ATPase modulators represent a novel and targeted approach for down-regulating the immune system without incurring global systemic immune suppression. As a result, it is anticipated that this approach will lead to an improved safety profile when compared to existing immunosuppressive therapeutic agents.
The Board of Directors has approved the search for a strategic partner to continue the development of the Lycera assets.
Lycera’s Assets
- Cintirorgon
Lycera developed Cintirorgon (RORγ Agonist) for the oral treatment of solid tumors. RORγt (retinoic acid-related orphan receptor gamma_t) is a nuclear receptor transcription factor that controls the development of Th17 and Tc17 cells. As transcription factor activators, RORg agonists have pleotropic effects on the immune system that result in improved anti-tumor immunity including enhanced cytokine/chemokine production, increased CTL activity, and improved T cell survival and memory formation. RORg agonists have demonstrated robust, single agent anti-tumor efficacy in syngeneic tumor models. Further preclinical studies have demonstrated the potential to combine an RORg agonist with radiation, chemotherapy, or checkpoint inhibitor (CPI) antibodies for improved benefit. Cintirorgon is a clinical stage RORg agonist that has generated partial responses and extended stable disease in patients with a variety of late-stage, metastatic cancers.
- Cintirorgon is safe and well tolerated as a single agent and in combination with pembrolizumab
- Single agent: 2 confirmed partial responses in NSCLC and sarcomatoid breast cancers and 25% disease control Rate (stable disease > 4 months)
- Pembrolizumab combination (NSCLC resistant to CPI therapy n = 16): 64% patients demonstrated reduction of tumor burden; partial response (69% decrease) confirmed in one patient (remains on study drug for 2 years)
2.RORγ Agonists (ex-vivo) for enhancing Adoptive Cell Therapy treatments
Lycera has generated extensive preclinical data demonstrating that use of RORg Agonists during in vitro expansion cultures enhances effector function and persistence of T cells resulting in improved anti-tumor activity. This approach has the potential to significantly enhance the efficacy of Adoptive Cell Therapy
- Increased effector activity and recruitment of immune cells
- Decreased activation-induced cell death and exhaustion
- Improved T cell memory responses providing long-term protection
- Reduced immune suppression mechanisms
- ATPase Modulators (LYC-30937 AND LYC-30824) for AutoImmune Diseases
ATPase modulators have exhibited broad based potential across multiple pre-clinical models in autoimmune disease and have shown preclinical and clinical potential for targeted investment supporting rapid development in either autoimmune, oncology, or other indications. The company also believe that there is potential for systemic, ophthalmological, and topical delivery formulations.
3.1 LYC-30397
LYC-30397 is a GI directed ATPase modulator that was developed for the treatment of autoimmune disease. Lycera completed a double blind, placebo controlled multinational Phase 2 clinical trial in patients with ulcerative colitis, and a double blind, placebo controlled Phase 2 clinical trial in patients with moderate-to-severe psoriasis.
Ulcerative Colitis Phase 2
- 120 patients in an 8 week study.
- Drug was well tolerated and safe
- Drug levels over the cellular EC50 were detected in colon tissue biopsies
- No evidence of differentiating efficacy over placebo
Psoriasis Phase 2
- 30 patients enrolled in a 12 week study
- No SAEs
- LYC-30937 reduced PASI from baseline to end of study, but did not meet statistical significance
3.2 LYC-30824
LYC-30824 is structurally related to LYC-30937 while incorporating a number of specific changes that address CMC challenges associated with the lead molecule. LYC-30824 has been subjected to extensive preclinical evaluation by the Lycera team. It exhibits a physical chemistry and ADME profile consistent with oral delivery for preferential drug exposure in the GI tract and is efficacious in a mouse TNBS model of inflammatory bowel disease. Having met stringent go/no-go criteria, LYC-30824 was formally accepted as a back-up candidate to LYC-30937 by the Lycera senior leadership team and can be quickly prepared at scale for near-term GLP toxicology studies prior to filing an IND.
- RORγ Antagonist LYC-56056 for treatment of autoimmune disease
LYC-56056 is a novel, allosteric RORγt inverse agonist developed by Lycera in collaboration with Merck for the treatment of autoimmune disease. RORgt is the key transcription factor orchestrating the differentiation of Th17 CD4+ T cells, inducing transcription of IL-17, IL-22 and GM-CSF. IL-17 and related cytokines play an important role in the pathogenesis of a diverse group of diseases such as Multiple Sclerosis, Rheumatoid Arthritis, and Psoriasis.
LYC-56056 exhibits drug-like pharmaceutical properties, and is efficacious in animal multiple models of disease.
- ROCK II Inhibitors
Lycera has developed small molecule inhibitors of the Rho-dependent kinase ROCK II for the potential treatment of fibrosis and chronic graft-versus-host disease. Multiple chemical scaffolds were explored and two of the more selective scaffolds are protected by issued patents. The company believes that the ROCK II inhibitors that it has discovered offer unique advantages when compared to other ROCK II inhibitors currently known in the literature.
- GCN2 License Income Stream
Lycera out licensed the rights to GCN2 in May 2019. The license agreement has downstream clinical and regulatory that total up to $62M as well a royalty on commercial sales.
- Compound Library
Over the 12 year existence of Lycera its scientists worked on a variety of drug discovery targets and chemical series, producing a total of approximately 8,000 high quality, individually prepared and purified small molecule drug like compounds. Physical samples (powders) for many of these compounds remain in storage and available for purchase. These compounds offer an opportunity to start an internal compound collection or to expand an existing screening collection with structurally diverse chemical tool compounds. The compounds available were originally prepared as ligands for a variety of protein targets, including kinases, nuclear receptors, NLRP3, CD73, mtATPase, HDAC6 as well as modulators of the STimulator of INterferon Genes (STING) pathway. Thus, a variety of chemotypes are represented within the compound collection representing a wide range of potential biological activities.
- Patent Estate
Lycera has a patent portfolio that consists of thirty-six (36) families which include 121 patents and 44 provisional applications to protect the programs summarized above
- Clinical Trial Data
Both LYC-30937 and LYC-55716 capitalized on robust preclinical toxicology packages that supported long-term clinical trials. Specifically:
- LYC-30937: completed a Phase 1 SAD, MAD and food effect study that demonstrated that drug was safe and well tolerated in healthy volunteers. There was also demonstrated a predictable food effect with high fat meals which serves to inform future clinical trials. The two phase 2 trials (in ulcerative colitis and psoriasis) provide long term safety data as well as evidence for possible further development in psoriasis. Its lipophilic properties seen in its limited systemic absorption (unless given with a high fat meal) suggest ideal topical delivery on the skin.
- LYC-55716: completed a Phase 1 dose escalation as a single agent in a 3 + 3 study in all comers with refractory solid tumors. With 2 PRs, the drug was further tested as a single agent in a basket trial that included 6 specified solid tumors and in combination with pembrolizumab in Non-small cell lung carcinoma in patients who progressed on pembrolizumab. The data as a single agent and in combination strongly support clinical activity in solid tumors (partial responses in heavily pretreated NSCLC and sarcomatoid breast cancer and significant tumor reductions in patients with refractory and resistant NSCLC). The safety and tolerability demonstrated in > 100 patients with refractory solid tumors and the clinical activity demonstrated suggests the need for a method to select those patients most likely to respond.
The assets of Lycera will be sold in whole or in part (collectively, the “Lycera Assets”). The sale of these assets is being conducted with the cooperation of Lycera. Lycera and its consultants will be available to assist purchasers with due diligence and a prompt, efficient transition to new ownership.
Lycera Corp. Key Personnel Available for Consultation
- H. Jeffery Wilkins, MD – Former CMO
- Peter Toogood, PhD – Former SVP, Chemistry
- Marcus Abraitis – VP, Finance
Lycera Corp. Board of Directors
- Steve Gillis, PhD: Chairman of the Board & Acting CEO, Managing Director, ARCH Venture Partners.
- Doug Fisher MD: Partner, InterWest.
- Kristina Burow: Managing Director, ARCH Venture Partners
- Nicholas Simon: Managing Director, Blackstone Ventures
The Bidding Process for Interested Buyers
Interested and qualified parties will be expected to sign a nondisclosure agreement (attached hereto as Exhibit A) to have access to key members of the management and intellectual capital teams and the due diligence “war room” documentation (the “Due Diligence Access”). Each interested party, as a consequence of the Due Diligence Access granted to it, shall be deemed to acknowledge and represent (i) that it is bound by the bidding procedures described herein; (ii) that it has an opportunity to inspect and examine the Lycera Assets and to review all pertinent documents and information with respect thereto; (iii) that it is not relying upon any written or oral statements, representations, or warranties of Lycera, Inc., Gerbsman Partners, or their respective staff, agents, or attorneys; and (iv) all such documents and reports have been provided solely for the convenience of the interested party, and neither Lycera nor Gerbsman Partners (or their respective, staff, agents, or attorneys) makes any representations as to the accuracy or completeness of the same.
Following an initial round of due diligence, interested parties will be invited to participate with a sealed bid, for the acquisition of the Lycera Assets. Sealed bids must be submitted so that the bid is actually received by Gerbsman Partners no later than Friday, September 25, 2020 at 3:00 p.m. Pacific Time (the “Bid Deadline”) at Gerbsman’s office, located at 211 Laurel Grove Ave, Kentfield, CA 94904. Please also email steve@gerbsmanpartners.com with any bid.
Bids should identify those assets being tendered for in a specific and identifiable way. The attached Lycera fixed asset list may not be complete and Bidders interested in the Lycera’s Assets must submit a separate bid for such assets. Be specific as to the assets desired.
Any person or other entity making a bid must be prepared to provide independent confirmation that they possess the financial resources to complete the purchase where applicable. All bids must be accompanied by a refundable deposit check in the amount of $200,000 (payable to Lycera, Inc.). The winning bidder will be notified within 3 business days after the Bid Deadline. Non-successful bidders will have their deposit returned to them.
Lycera reserves the right to, in its sole discretion, accept or reject any bid, or withdraw any or all assets from sale. Interested parties should understand that it is expected that the highest bid will be chosen as the winning bidder and bidders may not have the opportunity to improve their bids after submission.
Lycera will require the successful bidder to close within 7 business days. Any or all of the assets of Lycera will be sold on an “as is, where is” basis, with no representation or warranties whatsoever.
All sales, transfer, and recording taxes, stamp taxes, or similar taxes, if any, relating to the sale of the Lycera Assets shall be the sole responsibility of the successful bidder and shall be paid to Lycera at the closing of each transaction.
For additional information, please see below and/or contact:
Steven R. Gerbsman
Kenneth Hardesty
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