Sanofi Takes Strategic Stake in AnaptysBio as Company Raises $100 Million in Equity Offering

Aug 15, 2024 14:07 CST Updated 14:07

Anaptysbio

Developer of Immunotherapy Products

Sanofi

Pharmaceutical R&D Developer

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丨Medicine Hunter Club Research Team Compiled

On August 14, 2024, AnaptysBio, Inc. (NASDAQ: ANAB), a clinical-stage biotechnology company focused on providing innovative immunotherapies, announced$36.50 per shareThe price underwrote its2,750,498 sharesCommon stock, at a premium of approximately Anaptysbio Inc. on August 13, 202410% of the closing price。Before deducting underwriting discounts, commissions, and other issuance expenses payable by Anaptys, the total proceeds from this offering are expected to be approximately$100 millionAll common shares are provided by Anaptysbio Inc. The offering is expected to be completed around August 15, 2024, subject to the satisfaction of customary closing conditions.

This offering was led by current investor EcoR1 Capital, with participation from both new and existing investors, including Cormorant Asset Management, Farallon Capital Management, First Light Asset Management, Woodline Partners LP, and several large investment management companies.Sanofi (Sanofi)。

It is worth noting that,Leerink Partners AnalystDavid Risinger said in a report,Sanofi's corporate segment (rather than its venture capital business) took the initiative to invest in AnaptysBio."This type of strategic investment is not common."”

AnaptysBio's Shares Soared to a Five-Year High on the News, but Closed Up 4% at $34.65 with a Smaller Gain.

Anaptysbio Inc. said,The funds raised will be mainly used to accelerate and support the BTLA agonist.ANB032In the Phase 2b development of atopic dermatitis and the launch of Phase 3 trials, as well as the PD-1 agonistrosnilimabIn Phase 2b development for rheumatoid arthritis and Phase 2 development for ulcerative colitis, Phase 3 trial initiation.

AnaptysBio: Collaboration for Value,

Anti-IL-36R Antagonist Program to Be Sold Within the Year

AnaptysBio, Inc., founded in 2005, is a clinical-stage biotechnology company focused on providing innovative immunotherapies (including immuno-oncology and autoimmune therapies),Listed on NASDAQ through an IPO in 2017It is developing immune cell modulators, including two checkpoint agonists, for the treatment of autoimmune and inflammatory diseases:

ANB032It isBTLA Agonist, which is currently in the phase 2b trial for the treatment of atopic dermatitis;
rosnilimabIt isPD-1 Agonist, which is currently in Phase 2b trials for the treatment of rheumatoid arthritis and in Phase 2 trials for the treatment of ulcerative colitis.

Its preclinical immunomodulatory cell product portfolio includesANB033, aAnti-CD122 Antagonist Antibody, andANB101, aBDCA2 Modulator Antibody, used to treat autoimmune and inflammatory diseases.

In addition, Anaptys has developed two licensable cytokine antagonists:imsidolimab, which has completed Phase 3 trialsAnti-IL-36R Antagonist, for the treatment of generalized pustular psoriasis;etokimab, one that is ready for Phase 2/3 trialsAnti-IL-33 Antagonist. In addition, Anaptysbio has discovered multiple therapeutic antibodies.

AnaptysBio is also collaborating with GSK on the development of other drugs, primarily Jemperli (dostarlimab) and Cobolimab (GSK4069889). According to the agreement, GSK is responsible for the ongoing research, development, commercialization, and production of these drugs.In February 2023, the FDA fully approved GSK's cancer immunotherapy Jemperli (dostarlimab), which also meansAAnaptysBio's Somatic Hypermutation (SHM) Antibody Platform Fully Validated.

Regarding this offering, Anaptys intends to use the net proceeds from this offering primarily for general corporate purposes, which may include funding the Phase 3 enabling activities for ANB032 and rosnilimab, working capital, and general corporate purposes. Sanofi did not acquire any project rights from Anaptys through its equity investment.

ANB032

ANB032Is AntiBTLAAgonist monoclonal antibody, with the potential to treat various systemic inflammatory diseases.Under normal physiological conditions, after BTLA binds to its ligand, the herpesvirus entry mediator, it can inhibit the over-activation of lymphocytes in the body, playing a negative regulatory role in the body's anti-tumor immune response and preventing damage to the body by the immune system. Studies show that the expression of BTLA (B and T lymphocyte attenuator) is higher in malignant tissues than in normal tissues, and higher BTLA expression correlates with higherHVEN(Herpesvirus Invasion Medium)Expression is positively correlated.

In April 2022, AnaptysBio reported the top-line data from the Phase 1 clinical trial of ANB032, which showed good safety and tolerability, as well as rapid and sustained pharmacokinetic and pharmacodynamic profiles.ANB032TargetingAD(Clinical Trials for Patients with Atopic Dermatitis)2bPhase Research From2023Starting from the second quarter of the year, it is expected2024Top-line data achieved in year.

Sanofi's OX40L AntibodyAmlitelimab is also a drug developed for the treatment of atopic dermatitis, and the data from its Phase 2b clinical trial showBiomarkers of both the Th2 pathway and the Th17/Th22 pathway were significantly decreased.ANB032 more broadly inhibits Th1, Th2, Th17, and Th22 cytokine secretion than anti-OX40L in AD patient-derived PBMCs (peripheral blood mononuclear cells).

Rosnilimab

RosnilimabIs a new typePD-1Checkpoint Agonist Antibodies Can Reduce OveractiveTCellular Inflammation.PD-1+ T cells are prevalent in inflamed tissues and peripheral areas of RA (rheumatoid arthritis) and UC (ulcerative colitis). The potent depletion and agonistic effects of Rosnilimab can reduce T cell proliferation and inflammatory cytokines that cause joint damage, primarily by optimizing PD-1+ T cell inhibitory signaling through the formation of tight immune synapses.

Phase 1 clinical trial studies show that monthly SC (subcutaneous) administration in 144 healthy volunteers from the SAD (Single Ascending Dose) and MAD (Multiple Ascending Dose) cohorts demonstrated good safety and tolerability.Phase 2a Clinical Trial for the Treatment of Alopecia Areata (AA) (Q4W SC Administration for 6 Months) Was Well-Tolerated with No Significant Safety Signals.

Rheumatoid Arthritis (RA) is an autoimmune disease characterized by erosive arthritis. The current research on Rosnilimab focuses on moderate to severe RA.In Phase 2b of clinical trials, the study began in the third quarter of 2023 and is expected to obtain top-line data by mid-2025. The trial is currently recruiting patients for a placebo-controlled study.

Ulcerative colitis (UC) is a common chronic non-infectious inflammatory bowel disease, mainly characterized by diarrhea, mucus purulent bloody stool, and abdominal pain. Research on Rosnilimab for moderate to severe UCIn Phase 2 clinical trials, the study began in the fourth quarter of 2023 and is expected to obtain topline data in the first half of 2026.

imsidolimab

Imsidolimab is an IgG4 antibody targeting the interleukin-36 receptor (IL-36R), which can bind to IL-36R and inhibit its mediated signaling pathway. Studies have shown that the signaling pathway mediated by IL-36R is closely related to the occurrence of inflammatory diseases such as GPP. GPP is a severe, rare, chronic systemic autoinflammatory disease that can be life-threatening if left untreated. The company recently reported positive results from the GEMINI-1 and GEMINI-2 Phase III trials of imsidolimab for the treatment of generalized pustular psoriasis (GPP):

Imsidolimab Was Well-Tolerated at the End of the Study:

Data from two trials showed that patients treated with imsidolimab consistently demonstrated good safety and tolerability, with no serious adverse events (SAEs) related to treatment reported or SAEs leading to discontinuation.

In addition, the data also showed that: the incidence of infection was low, with no increase compared to placebo; no cases of drug reaction with eosinophilia and systemic symptoms (DRESS) or Guillain-Barré syndrome (GBS) were reported; no infusion reactions were reported; the overall incidence of anti-drug antibodies (ADA) was low, and the detected ADA was determined to be non-neutralizing.

Next Steps for the GEMINI-1 and GEMINI-2 Trials:

Anaptysbio plans to submit a comprehensive data summary of the GEMINI-1 and GEMINI-2 results at a medical conference in the second quarter of 2024. With all patients having surpassed the 24-week mark, and the longest-treated patients reaching 92 weeks, the company is concluding the GEMINI-2 trial. Anaptysbio intends to out-license imsidolimab in 2024, and the future submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) will depend on the outcome of the out-licensing deal.

Sanofi:

Holding 9 Key Immunology Products, Continuously Investing in Autoimmune Field‍‍‍‍‍

Spontaneous immune diseases are one of the largest areas in the pharmaceutical market. Due to their characteristic of being difficult to cure, they usually require long-term medication, and the market prospects for related drugs are relatively optimistic.The market size has broken through the 100 billion US dollar mark, continuing to show huge growth potential and commercial value.。

Sanofi is committed to building a pipeline portfolio focused on "First-in-Class" (FIC) and "Best-in-Class" (BIC) in the field of immune prevention.Plan to push at least 10 innovative products into clinical trials by 2025.

In fact, the field of immunology and inflammation has always been one of Sanofi's strong suits. Its star product Dupilumab (Dupixent) has earned Sanofi a high reputation. However, with the approaching patent cliff, Sanofi must seek new sources of performance support.

In October 2023, Sanofi announced the launch of a new chapter in its "Play to Win" strategy, aiming to continuously increase R&D investment. This was followed by Sanofi's R&D Day in December.Outlined its ambition to increase the number of Phase III projects by 50% over the next two years, with a focus on immunology, neurology, and vaccines.

Sanofi CEO Paul Hudson made a bold statement: "By 2030, Sanofi aims to exceed €22 billion in sales from its immunology and vaccines divisions." This confidence stems from the 12 potential blockbuster products in Sanofi’s pipeline.

Notably, among these 12 potential blockbuster therapies, 9 are products targeting the fields of immunology and inflammation. Among themBTK InhibitorRilzabrutinibIs one of the potential blockbuster drugs in Sanofi's immunology pipeline. After achieving positive results in the LUNA 3 trial, Sanofi plans to submit the marketing application for Rilzabrutinib in the second half of this year. If approved,Rilzabrutinib will become the first BTK inhibitor approved for ITP indication.

In addition to Rilzabrutinib, there are treatments for multiple sclerosis.Tolebrutinib, for the treatment of asthmaLunsekimig, Treating Inflammatory Bowel DiseaseTL1A Monoclonal Antibody, Treating Atopic DermatitisIRAK4 DegraderAnd the treatment of COPDItepekimab, etc., each with a peak sales potential expected to reachEUR 2 billion to EUR 5 billionIn addition, there are three "self-developed pipeline products" -Amlitelimab、FrexalimabAndSAR441566, each with a promising peak sales potentialMore than 5 billion euros.

Summary

With income derived from collaborative research and development, the company is approaching its 20th anniversary.As of June 30, AnaptysBio Inc. had$394 million in cash and investments. The company expects to By the end of 2026Will still have cash reserves.

A series of favorable events have catalyzed a surge in AnaptysBio's stock price over the past year, reaching a high of $38.91, with a significant change of 72.07% within one year. This impressive performance highlights investors' confidence in AnaptysBio's product pipeline and strategic initiatives.

References:

[1] PharmaCircle:

MNC Potential M&A Target: Collaboration and Licensing, Innovative Immunotherapy AnaptysBio

[2] Cauchy CRO：

Anaptys Announces Positive Topline Results from Phase 3 Trial of Imsidolimab for Generalized Pustular Psoriasis | Cauchy International News

[3] Pharmaceutical Economy News:

BTK Inhibitor Rilzabrutinib Phase III Clinical Trial Finally Successful! After Repeated Failures, Is Sanofi’s All-in Bet on the Autoimmune Track Paying Off with a "Game-Changer"?

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