Immunome and Morphimmune Announce Definitive Merger Agreement and Simultaneous Private Placement Investment of $125 Million to Develop Targeted Cancer Therapies

On June 29, 2023 Immunome (Nasdaq: IMNM), a biopharmaceutical company utilizing a proprietary human memory B-cell platform to discover and develop antibody therapeutics to improve patient care, and Morphimmune, a private biotechnology company focused on developing targeted oncology therapeutics, reported that they have entered into a definitive merger agreement (Press release, Immunome, JUN 29, 2023, View Source [SID1234632974]).

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The Boards of Directors of both companies have approved the all-stock transaction. The combined company, which will operate as Immunome and retain the same ticker symbol, will be headquartered in Seattle, WA and will maintain cost-efficient research lab facilities in Exton, PA and West Lafayette, IN.

Clay B. Siegall, Ph.D., who was appointed CEO and President of Morphimmune earlier this year, will serve as the CEO, President, and Chairman of the Board of Directors of Immunome.

Dr. Siegall previously served as the CEO and President of Seagen, Inc., which he co-founded in July 1997. Under his nearly 25 years of leadership, Seagen became an industry leader in ADC therapeutics, earned FDA approvals for four cancer therapies, and grew to over $2 billion in annual revenue. During his tenure, he raised well over $1 billion of financing for Seagen from public and private markets and oversaw the company’s acquisition of Cascadian Therapeutics. In March of 2023, Pfizer, Inc. agreed to purchase Seagen for $43 billion.

"Clay Siegall’s track record of drug development and shareholder value creation is exceptional, and we are honored to have him serve as Chairman and CEO after the merger closes," said Michael Rapp, Immunome Board Chairman. "By building on the accomplishments of Purnanand Sarma and the Immunome team, Clay will be positioned to develop best-in-class targeted cancer therapies across multiple modalities."

The companies also announced an oversubscribed private placement investment of $125 million with participation from Enavate Sciences, EcoR1 Capital, Redmile Group, Janus Henderson Investors, Avidity Partners, Woodline Partners LP, and other leading institutional investors. In connection with the PIPE, James P. Boylan, Chief Executive Officer of Enavate Sciences, will be appointed to the Board of Directors of Immunome. Both the merger and private placement are expected to close by the end of Q4 2023.

The investment will be used to continue development of the lead assets in Immunome’s combined pipeline, to continue to advance the company’s platforms, and for general working capital purposes. The combined pipeline includes a novel anti-IL-38 mAb derived from Immunome’s discovery engine, as well as a folate receptor-targeted TLR7 agonist (FA-TLR7a) and FAP-targeted radioligand (177Lu-FAP). The company expects to submit three INDs within 18 months following the closing, including the anti-IL-38 program, which is now slated for submission in Q1 2024. Additionally, the company will be well-positioned to explore opportunities for strategic in-licensing and further acquisitions.

"This is the first step in establishing a preeminent oncology company," said Dr. Siegall. "Combining Morphimmune’s Targeted Effector Platform with Immunome’s Discovery Engine will enable us to pursue novel targets and modalities, unlocking substantial synergistic value."

"Given the quality of our science, the expertise of our combined leadership team, and the strengthened cash position, I am extremely enthusiastic about our potential to reduce the suffering and loss of life caused by cancer."

"We founded Morphimmune to realize the extraordinary potential of Professor Philip S. Low’s scientific vision, which builds on decades of work at Purdue University. Our subsequent investments in the company, our engagement with Clay Siegall as CEO and now the anticipated merger are evidence of that potential," said Isaac Barchas, Morphimmune Founding Board Chairman and Research Bridge Partners Co-Founder and CEO. Barchas will serve on Immunome’s Board of Directors following the merger.

About the Proposed Transaction

Immunome will acquire Morphimmune through a reverse subsidiary merger that is intended to be a tax-free reorganization. Stockholders of Morphimmune will receive common stock of Immunome based on a fixed exchange ratio applicable to the specific class and series of Morphimmune capital stock and outstanding options to acquire Morphimmune common stock will be assumed by Immunome. At the effective time of the merger, prior to giving effect to the private placement, securityholders of Immunome will own approximately 55% of the combined company and securityholders of Morphimmune will own approximately 45% of the combined company on a fully diluted basis, excluding out-of-the-money securities and the inducement grant to Dr. Siegall discussed below. The closing of the transaction is subject to customary closing conditions, including the effectiveness of the registration statement on Form S-4 to be filed by Immunome, and the receipt of required stockholder approvals from Immunome and Morphimmune stockholders. In conjunction with execution of the merger agreement, Dr. Siegall entered into an employment agreement with Immunome that will become effective upon closing. In connection with the entry into the employment agreement, the Immunome Board of Directors approved a stock option grant to Dr. Siegall as an inducement material to Dr. Siegall entering into employment with Immunome in accordance with Nasdaq Listing Rule 5635(c)(4). The stock option provides for the purchase of up to 2,137,080 shares of Immunome common stock at a price of $5.91 per share, the closing price per share of Immunome common stock as reported by Nasdaq on June 28, 2023, the date of grant, and vests over four years, with 25 percent of the shares vesting on the first anniversary of closing of the merger, and the remainder vesting ratably at the end of each subsequent month thereafter, subject to Dr. Siegall’s continued employment with Immunome through the applicable vesting dates.

Stockholders of Immunome holding approximately 20% of the voting stock of Immunome executed voting and support agreements pursuant to which they agreed to vote in favor of the issuance of shares in the merger and related matters and stockholders of Morphimmune holding approximately 70% of the voting stock of Morphimmune executed voting and support agreements pursuant to which they agreed to vote in favor of the adoption of the merger agreement and the merger and other related matters.

Following the proposed merger, the board of directors of the combined company will be comprised of seven members: two selected by Morphimmune, who will initially be Dr. Siegall and Mr. Barchas; one selected by Immunome, who will initially be Philip Wagenheim; and four additional independent directors, to be mutually agreed, one of whom will initially be Mr. Boylan.

Stifel is serving as financial advisor and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. is serving as legal counsel to Immunome. TD Cowen is serving as financial advisor and Cooley LLP is serving as legal counsel to Morphimmune.

In connection with the private placement, TD Cowen and SVB Securities are serving as placement agents, and Wedbush Securities Inc. is serving as a strategic advisor.

Geron Announces U.S. Expanded Access Protocol for Imetelstat in Lower Risk MDS

On June 29, 2023 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported that an Expanded Access Protocol (EAP) is available for imetelstat, the Company’s first-in-class telomerase inhibitor (Press release, Geron, JUN 29, 2023, http://ir.geron.com/investors/press-releases/press-release-details/2023/Geron-Announces-U.S.-Expanded-Access-Protocol-for-Imetelstat-in-Lower-Risk-MDS/default.aspx [SID1234632973]). As allowed under the U.S. Food and Drug Administration (FDA) policies, companies may offer an EAP, which permits an investigational medicinal product intended to treat a serious or life-threatening condition, such as lower risk myelodysplastic syndromes (MDS), to be used outside of a clinical trial.1

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"We have heard physicians in both academic and community settings express the need for new treatment options for their lower risk MDS patients, and they will now have an option to access imetelstat through the EAP," said Faye Feller, M.D., Executive Vice President, Chief Medical Officer of Geron. "With positive IMerge Phase 3 results submitted to the FDA, we now plan to be working with clinicians, patients and the MDS patient advocacy community to provide access to imetelstat for eligible patients through our EAP that was accepted by the FDA."

The imetelstat EAP is available for patients with transfusion dependent non-del(5q) lower risk MDS who are refractory to, relapsed after, or ineligible for erythropoiesis-stimulating agents (ESAs), and naïve to lenalidomide and hypomethylating agents (HMAs). Transfusion dependent is defined as requiring at least four units of packed red blood cells (RBCs) over any eight-week period during the 16 weeks prior to being considered for the EAP.

The Company recently announced the submission to the FDA of a New Drug Application (NDA) for imetelstat, which is based on results from the IMerge Phase 3 clinical trial. In that trial, the primary endpoint of 8-week transfusion independence (TI) was significantly higher with imetelstat vs. placebo (P<0.001), with median TI duration approaching one year for imetelstat 8-week TI responders. Mean hemoglobin levels in imetelstat-treated patients increased significantly (P<0.001) over time compared to placebo patients. Further, statistically significant and clinically meaningful efficacy results were achieved across key MDS subgroups: ring sideroblast (RS) status, baseline transfusion burden and IPSS risk category. Safety results were consistent with prior imetelstat clinical experience.

About the Imetelstat EAP

The imetelstat EAP is a U.S.-only protocol for eligible adult participants diagnosed with lower risk (very low, low, or intermediate risk by IPSS-R) myelodysplastic syndromes (MDS) who are red blood cell (RBC) transfusion dependent, have failed to respond or have lost response or are ineligible for erythropoiesis-stimulating agents (ESAs), had not received prior treatment with either a hypomethylating agent or lenalidomide and are non-del(5q). Additional information is planned to be available on www.clinicaltrials.gov.

U.S.-based healthcare professionals seeking more information about the imetelstat EAP can email [email protected].

Lower risk MDS patients who are interested in enrolling in the imetelstat EAP should speak with their physician to understand if imetelstat is an appropriate treatment option.

More information is available on Geron’s website under the Patients tab.

Imetelstat is an investigational therapy and is not approved for any indication in any markets.

About IMerge Phase 3

The Phase 3 portion of the IMerge Phase 2/3 study is a double-blind, 2:1 randomized, placebo-controlled clinical trial to evaluate imetelstat in patients with IPSS Low or Intermediate-1 risk (lower risk) transfusion dependent MDS who were relapsed after, refractory to, or ineligible for, erythropoiesis stimulating agent (ESA) treatment, had not received prior treatment with either a HMA or lenalidomide and were non-del(5q). To be eligible for IMerge Phase 3, patients were required to be transfusion dependent, defined as requiring at least four units of packed red blood cells (RBCs), over an eight-week period during the 16 weeks prior to entry into the trial. The primary efficacy endpoint of IMerge Phase 3 is the rate of red blood cell transfusion independence (RBC-TI) lasting at least eight weeks, defined as the proportion of patients without any RBC transfusion for at least eight consecutive weeks since entry to the trial (8-week TI). Key secondary endpoints include the rate of RBC-TI lasting at least 24 weeks (24-week TI), the duration of TI and the rate of hematologic improvement erythroid (HI-E), which is defined under 2006 IWG criteria as a rise in hemoglobin of at least 1.5 g/dL above the pretreatment level for at least eight weeks or a reduction of at least four units of RBC transfusions over eight weeks compared with the prior RBC transfusion burden. A total of 178 patients were enrolled in IMerge Phase 3 across North America, Europe, Middle East and Asia.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies. Data from non-clinical studies and clinical trials of imetelstat provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the U.S. Food and Drug Administration for both the treatment of adult patients with transfusion dependent anemia due to Low or Intermediate-1 risk MDS that is not associated with del(5q) who are refractory or resistant to an erythropoiesis stimulating agent, and for adult patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus associated kinase (JAK) inhibitor treatment. Geron submitted a New Drug Application (NDA) in the U.S. in June 2023 and expects to submit a Marketing Authorization Application (MAA) in the EU in the second half of 2023 in the lower risk MDS indication. Imetelstat is currently not approved by any regulatory authority.

Bexion Pharmaceuticals, Inc. to Present at the ESMO World Congress on Gastrointestinal Cancer 2023

On June 29, 2023 Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing a new generation of biologic therapy to treat solid tumor cancers and chemotherapy-induced peripheral neuropathy (CIPN), reported that the Company will be represented at the ESMO (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer 2023 taking place on June 28 – July 1, 2023, in Barcelona, Spain.

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Presentation Details:

Title: BXQ-350: A Phase 1b/2 placebo-controlled, double-blind study on the efficacy and safety of BXQ-350 in combination with mFOLFOX7 and bevacizumab in newly diagnosed metastatic colorectal carcinoma
Abstract Number: P-73
Presenter: Dr. Reema Patel
Date: Friday, June 30, 2023

About BXQ-350
Bexion’s lead drug candidate is BXQ-350, a first-in-class biologic containing the multifunctional, sphingolipid activator protein, Saposin C, and a phospholipid. BXQ-350 has pre-clinical antitumor effects in vitro and in vivo, particularly in colorectal, brain and other solid tumors. Two Phase 1 clinical trials, one in adults and one in pediatric DIPG patients, demonstrated a strong safety profile for BXQ-350 with evidence of single agent activity across multiple solid tumors. Additionally, other clinical and non-clinical data suggest BXQ-350 has activity in chemotherapy-induced peripheral neuropathy.

Domain Therapeutics announces nomination of best-in-class CCR8 antibody candidate, DT-7012, further strengthening its unique portfolio of GPCR-targeting immunotherapies

On June 29, 2023 Domain Therapeutics ("Domain" or "the Company"), a clinical-stage biopharmaceutical company developing innovative drug candidates in immuno-oncology targeting G Protein-Coupled Receptors (GPCRs), reported the nomination of a novel drug candidate, DT-7012, an anti-CCR8 monoclonal antibody depleting tumor-infiltrating regulatory T cells (Tregs), with best-in-class potential and an initial positioning that will enable fast-track development and accelerated market access (Press release, Domain Therapeutics, JUN 29, 2023, View Source [SID1234632960]).

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CCR8 is a GPCR target specifically expressed by Treg cells, one of the most important immunosuppressive immune cells responsible for the failure of several therapeutics in the clinic, including immune checkpoint inhibitors. Supported by pre-clinical data showing strong anti-tumor activity as a monotherapy, the CCR8 target is a highly strategic approach to derive efficient novel immunotherapies that aim to turn non-responder patients into responders.

Applying the Company’s precision research strategy and based on an in vitro benchmarking of competitor’s candidates, Domain has discovered a unique collection of anti-hCCR8 antibodies and nominated DT-7012 as a differentiated best-in-class Treg-depleting CCR8 antibody candidate. Unlike most competitors, DT-7012 is able to i) preserve CCR8-modulation capacity in presence of high concentrations of CCR8 in the tumor microenvironment and to ii) recognize different forms of CCR8 having different post-translational modifications. With cell line generation currently ongoing, the Company expects to start a Phase I study of DT-7012 by mid-2025.

Dr. Stephan Schann, VP Research at Domain Therapeutics, commented: "The nomination of our best-in-class Treg-depleting CCR8 monoclonal antibody candidate, DT-7012, following the recent nomination of our first-in-class PAR2 NAM candidate, DT-9045, further strengthens and continues to build Domain’s unique portfolio of GPCR-based immunotherapies. Our in vitro benchmark and comparative studies with competitor CCR8 antibodies, clearly demonstrated superiority of DT-7012 over other CCR8 clinical candidates, marking a key step in our efforts to increase the clinical success rate of treatments in non-responding patients with cancer."

The Company’s growing pipeline of GPCR-targeting immunotherapies is comprised of:

Anti-CCR8 antibody (DT-7012) – monoclonal antibody candidate
Phase I study to commence by mid-2025
PAR2 NAM antagonist (DT-9045) – small molecule candidate
Phase I study to commence by mid-2025
EP4 receptor antagonist (DT-9081) – small molecule candidate
Phase I ascending dose study dosing ongoing
A2a/A2b antagonist (M1069) – small molecule candidate in partnership with Merck KGaA
Phase I ascending dose study ongoing

Corvus Pharmaceuticals Presents New Ciforadenant Preclinical Data at the 2nd JCA-AACR Precision Cancer Medicine International Conference

On June 29, 2023 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported new preclinical data for ciforadenant, the Company’s adenosine 2A receptor inhibitor, highlighting its mechanism of action and synergy with immune checkpoint inhibitors via combination with anti-CTLA-4 and anti-PD-1 therapies (Press release, Corvus Pharmaceuticals, JUN 29, 2023, View Source [SID1234632959]). The data is being presented in a poster at the 2nd Japanese Cancer Association and American Association for Cancer Research (AACR) (Free AACR Whitepaper) (JCA-AACR) Precision Cancer Medicine International Conference, which is taking place June 28-30, 2023 in Kyoto, Japan.

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"Our presentation at the JCA-AACR conference further supports the rationale for the synergistic combination of ciforadenant with checkpoint inhibitors to leverage multiple components of the immune response to cancer," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We are exploring this combination in a Phase 1b/2 clinical trial that is being led by the Kidney Cancer Research Consortium. The clinical trial is exploring the potential of ciforadenant as a first line therapy for metastatic renal cell cancer in combination with anti-CTLA-4 and anti-PD-1 therapies, and is based on preclinical research published in 2018 demonstrating synergy when ciforadenant was combined with anti-CTLA-4 and anti-PD-1 therapies1. Enrollment in the clinical trial is ongoing and we plan to share initial data before the end of 2023."

Ciforadenant Data Presented at JCA-AACR Conference
The new ciforadenant preclinical data was presented by Dan Li, Ph.D., Senior Scientist at Corvus, in a poster session (abstract #12-1) today at the JCA-AACR conference. The poster is available to JCA-AACR attendees in the poster session and is also available on the Publications and Presentations page of the Corvus website. The poster presentation highlights preclinical data supporting the synergy between ciforadenant and immune checkpoint blockade (ICB), leading to a proinflammatory response:

Depletion of myeloid cells abolished the synergy of ciforadenant and ICB in a murine melanoma model.
The combination of ciforadenant with ICB upregulated the genes involved in the IL-12/STAT4 signaling axis, which leads to the development of CXCR3+ IFNγ-producing Th1 helper cells.
Ciforadenant treatment increased production of chemokine CXCL10, a ligand for recruitment of CXCR3+ Th1 helper cells into the tumor.
Ciforadenant modulated antitumor responses by turning the tumor microenvironment into the proinflammatory state.
The combination of ciforadenant with ICB promoted the production of several proinflammatory cytokines such as IL-6, TNFa, and IFNg.