On August 5, 2022 Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, reported financial results for the second quarter ended June 30, 2022 and provided a corporate update (Press release, Immunome, AUG 5, 2022, View Source [SID1234617667]).

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"The second quarter marked our transition into a clinical stage company, as we continue to dose patients in our Phase 1b study of our COVID-19 antibody cocktail, IMM-BCP-01," stated Purnanand Sarma, Ph.D., President and CEO of Immunome. "We also presented data in the second quarter that demonstrated the retention of neutralizing activity against the BA.4/.5, and BA.2.12.1 subvariants of SARS CoV-2. We look forward to reporting topline results from our Phase 1b study of IMM-BCP-01 in the second half of this year."

Dr. Sarma continued, "Additionally, we continue to make strides with our lead oncology candidate, IMM-ONC-01. Through an extensive profiling assessment of IL-38 mRNA using a database1 of over 60 cancer subtypes, we concluded that IL-38 is overexpressed in multiple cancers of high clinical unmet need. We are excited to continue advancing IMM-ONC-01 towards IND submission, as we believe IL-38 represents a promising target in multiple tumor types."

Highlights

IMM-BCP-01 Retains Neutralizing Activity Against Prevalent Omicron Subvariants, BA.4/.5 and BA.2.12.1. In July 2022, Immunome announced that its antibody cocktail retained activity against the BA.4/.5 and BA.2.12.1 subvariants in pseudovirus testing. Data recently published in the peer-reviewed journal Science Immunology provides a mechanistic basis for how IMM20253 binding, which is conserved across all variants to date including Omicron and its sub-lineages, neutralized SARS-CoV-2.
Initiation of Phase 1b Study of IMM-BCP-01 for the Treatment of COVID-19. In June 2022, Immunome announced the first patient had been enrolled in a clinical trial of IMM-BCP-01, a three-antibody cocktail for the treatment of SARS-CoV-2. Immunome currently expects to announce topline data in the second half of this year.
Research & Development Update on Lead Oncology Candidate Targeting IL-38. In May of 2022, Immunome announced updates to the ongoing development of its lead oncology program, IMM-ONC-01, specifically on mRNA expression profiling and collaboration with Fox Chase Cancer Center.
Financial Highlights

Research and development (R&D) expenses: R&D expenses for the three months ended June 30, 2022 were $5.7 million.
General and administrative (G&A) expenses: G&A expenses for the three months ended June 30, 2022 were $3.2 million.
Net loss: Net loss for the three months ended 2022 was $8.9 million.
Cash and cash equivalents: As of June 30, 2022, cash and cash equivalents totaled $34.6 million.
The investigational work related to IMM-BCP-01 was funded by the U.S. Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in collaboration with the Defense Health Agency (DHA) (Contract number: W911QY-20-9-0019).

[1] Tempus RealWorld Data

On August 5, 2022 BioNTech SE (Nasdaq: BNTX, "BioNTech") and Genmab A/S ("Genmab") reported an expansion of their global strategic collaboration to develop and commercialize novel immunotherapies for the treatment of cancer patients (Press release, BioNTech, AUG 5, 2022, View Source [SID1234617666]). Under this expansion, BioNTech and Genmab will jointly work to research, develop and commercialize novel monospecific antibody candidates for various cancer indications. Since 2015, the companies have been working on the joint development of bispecific cancer antibodies aimed at improving immunotherapy options for cancer patients.

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"The expansion of our collaboration with Genmab extends our antibody portfolio and will further strengthen our oncology pipeline in indications with high unmet medical needs," said Prof. Ugur Sahin, M.D., Chief Executive Officer and Co-Founder of BioNTech. "We are committed to working together with our colleagues at Genmab to develop new treatments for people affected by cancer."

"We are thrilled to expand our collaboration with BioNTech to include additional novel antibody therapies with the goal to deliver them to patients in need of innovative therapeutic options," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "Strategic partnerships, like our collaboration with BioNTech, are critical to developing differentiated antibody medicines with the aim of improving the lives of cancer patients."

Under the expanded collaboration, the companies will jointly develop and commercialize, subject to regulatory approval, monospecific antibodies leveraging Genmab’s proprietary HexaBody technology platform. The first monospecific antibody candidate, GEN1053/BNT313, is expected to enter clinical trials by the end of 2022. GEN1053/BNT313 is a CD27 antibody based on the HexaBody technology, specifically engineered to form an antibody hexamer (a formation of six antibodies) upon binding its target on the cell membrane of the T cells. Under the terms of the agreement, the companies will equally share the development costs and potential future profit deriving from GEN1053/BNT313.

The companies currently have two jointly developed investigational medicines in clinical testing since 2019, fusing BioNTech’s proprietary immunomodulatory antibodies and Genmab’s DuoBody technology platform: GEN1046/BNT311 is being evaluated in Phase 1/2 clinical trials for the treatment of advanced solid tumors (NCT04937153, NCT03917381), and in a Phase 2 study of patients with non-small cell lung cancer (NSCLC) (NCT05117242). GEN1042/BNT312 is being evaluated for the treatment of metastatic or locally advanced solid tumors in a Phase 1/2 study (NCT04083599).

On August 5, 2022 Ipsen S.A. (Euronext: IPN; ADR: IPSEY) reported that Hibernia Merger Sub, Inc. (Purchaser), its wholly owned indirect subsidiary, has extended the expiration time for the previously announced tender offer to purchase all of the issued and outstanding shares of common stock (the Shares) of Epizyme, Inc. (NASDAQ: EPZM) (Epizyme) at a price of $1.45 per share, to the holder in cash, without interest and less applicable withholding taxes, plus one non-transferable contingent value right (CVR) per Share, until 11:59 p.m., Eastern time on Thursday 11 August 2022, unless further extended (Press release, Ipsen, AUG 5, 2022, View Source [SID1234617646]). The tender offer was previously scheduled to expire at one minute after 11:59 p.m., Eastern time, on Monday 8 August 2022. All other terms and conditions of the tender offer remain unchanged.

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Each CVR represents the right to receive one or more payments in cash, of up to $1.00 per CVR, contingent upon the achievement of certain milestones upon the terms and subject to the conditions described in the Offer to Purchase dated 12 July 2022 (together with any amendments or supplements thereto, the ‘Offer to Purchase’) and in the related Letter of Transmittal.

The tender offer was extended to allow additional time for the condition relating to the expiration or termination of the waiting period (and any extension thereof) under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 as amended (the HSR Condition), to be satisfied.

Computershare Trust Company, N.A., the depositary and paying agent for the tender offer, has indicated that, as of 5:00 p.m., Eastern time, on 4 August 2022, approximately 42,256,760 Shares had been validly tendered into and not validly withdrawn from the tender offer, representing approximately 25% of the Shares outstanding as of 6 July 2022. Stockholders who have already tendered their Shares into the tender offer do not have to re-tender their Shares or take any other action as a result of the extension of the expiration time of the tender offer.

Completion of the tender offer remains subject to additional conditions described in the Tender Offer Statement on Schedule TO (as may be amended or supplemented) filed by Purchaser, Ipsen Biopharmaceuticals, Inc., Ipsen Pharma SAS and Ipsen S.A., with the United States Securities and Exchange Commission (SEC) on 12 July 2022. Such conditions include there having been validly tendered and not validly withdrawn Shares that, considered together with all other Shares (if any) beneficially owned by Ipsen Pharma SAS and its subsidiaries, represent at least one Share more than 50% of the total number of Shares outstanding immediately prior to the expiration of the Offer (including any extensions).

Requests for documents and questions regarding the tender offer may be directed to Georgeson LLC, the Information Agent for the tender offer, by telephone (toll-free) at (866) 203-9357 or by email at [email protected].

On August 4, 2022 Quince Therapeutics, Inc. (Nasdaq: QNCX), a biopharmaceutical company advancing innovative precision therapeutics targeting debilitating and rare diseases, reported that the company’s chief executive officer Dirk Thye, M.D., will present at the Canaccord Genuity 42nd Annual Growth Conference taking place on Thursday, August 11, 2022 beginning at 9:00 a.m. Eastern Time (Press release, Quince Therapeutics, AUG 4, 2022, View Source [SID1234619484]). A live webcast of the event will be accessible on the Investor Calendar page under the News & Events heading of Quince’s Investor Website. The webcast will be archived at that location for 90 days.

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On August 4, 2022 Portage Biotech reported An initial readout of an ongoing phase 1/2 study (ISRCTN80472712) from the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting indicated that treatment with IMM60 in patients with advanced melanoma and non–small cell lung cancer (NSCLC) yielded promising preliminary safety data, according to lead author Nick Coupe, MBBS, PhD (Press release, Portage Biotech, AUG 4, 2022, View Source [SID1234619258]).

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Aside from reporting that no adverse effects occurred in the 5 patients who were treated, Coupe, a consultant medical oncologist at Churchill Hospital, highlighted a notable reduction in tumor volume for 1 patient and a mixed response in another. Although the work is early, he explained how the research may lay the groundwork for further research.

"The hope is that we demonstrate yet another way of enhancing antitumor immune responses," Coupe explained. "There is obviously a lot of work in this field, [including] a lot of existing work looking at new targets. This is quite a novel approach. It’s not targeting a specific checkpoint; it’s targeting a component of the immune system that has a broad effect. It is quite a novel approach. By doing so, hopefully we can complement existing therapies with PD-1 [inhibitors]. There may be rationale to combine this with other treatments. Hopefully, it does lead to some excitement and yet another element of immunotherapy research in a clinical setting."

In an interview with CancerNetwork, Coupe highlighted the mechanism of action of the novel synthetically derived agonist of invariant natural killer cells formulated in the PORT-2 liposome and what future research efforts might look like.

CancerNetwork: Could you start off by telling me about the rationale for this study?
Coupe: The rationale stems from an unmet need in both tumor groups. We we’re looking at patients with metastatic melanoma and non–small cell lung cancer. It’s well known that there have been some big advances, particularly in the field of melanoma, in recent years. Despite that, close to 50% of patients with metastatic disease will eventually succumb. For those patients who require optimal treatments, combination immunotherapy has [a roughly] 60% grade 3 toxicity rate; it’s quite a toxic treatment.

In lung cancer, immunotherapy has been a big step forward with PD-1 inhibition, but in this group, the outcomes are still very poor, with only around 20% to 30% of people experiencing long-term survival. There’s a big unmet need, and the rationale for this study stems from some preclinical work that goes back a number of years. IMM60 is a molecule that was discovered Oxford. It has a broad impact upon the immune system targeting various components. The hope is that it can synergize with the therapies that are already in existence so that we may capitalize on the gains that are already made.

What is the mechanism of action of IMM60?
It’s an invariant, natural Killer T-cell agonist. Natural killer T cells are a subset of the T-cell population in the body. [They aren’t] as well studied as other subsidiaries, but they basically carry a very important function that affects multiple arms of the immune system. It has been known for some time that patients with high levels of invariant natural kill T-cell activation have more favorable cancer outcomes. PORT-2 is an activator of this population. It has direct impact against tumors in terms of upregulating PD-L1 expression, which we know is favorable because it can enhance the effectiveness of existing therapies. It is also a potent activator of not just natural killer cells, but also antigen-progenitor cells and CD8 T cells, which are the effector cells that drive antitumor responses. There is also some evidence that it helps create a favorable tumor microenvironment, potentially overcoming some of the resistance mechanisms that [lead to certain patients failing to derive] benefit from existing therapies.

At this year’s meeting, what findings read out from this study?
[Data were read-out from] two-thirds of the phase 1 study population, so it is very much in the in the early phases of development. We’re still in the dose-escalation phase. We presented the results of 5 patients who have been treated so far for dose level 3 and dose level 1, and 2 patients were in the in the second dose level. What we have seen so far for the 5 patients treated was 1 mixed response with the second dose and there was a quite impressive tumor reduction in a number of sites. In this particular case, as I just referenced, a mediastinum mass [went] from 4 cm down to 1.9 cm in a patient who was heavily pretreated with all existing standard therapies for melanoma. We also saw from a toxicity point of view that the treatment was safe. It only caused a very low number of grade 1 or grade 2 toxicities, so it’s very well tolerated. We’ve seen no SAEs [serious adverse effects] or AEs requiring any specific intervention.

Where do you see future efforts being focused here?
We aim to complete the dose-escalation study soon. We’re recruiting and hope to follow patients at their current dose level. Once we complete the dose-escalation phase, we’ll start our safety phase where we will be giving IMM60 PORT-2 alongside pembrolizumab [Keytruda]. Once we’ve completed the safety cohort, the next phase is to move into a phase 2 study. In this part of the study, we’re going to recruit over 80 patients from a number of different sites where we’ll be comparing a combination of PORT-2 and pembrolizumab vs pembrolizumab alone in patients with advanced melanoma and [NSCLC who] have not been pretreated.

Reference
Coupe N, Walters IB, Kramer RA, et al. A phase 1 first-in-human dose finding/randomized phase 2 study of IMM60 and pembrolizumab (PEM) in advanced melanoma and non–small cell lung cancer (NSCLC; IMP-MEL). J Clin Oncol. 2022;40(suppl 16):2582. doi:10.1200/JCO.2022.40.16_suppl.2582