Coherus Announces Clinical Collaboration with the Cancer Research Institute for a Novel Combination Evaluating LOQTORZI® (toripalimab-tpzi) with ENB Therapeutics’ ENB-003 for the Treatment of Ovarian Cancer

On May 8, 2024 Coherus BioSciences, Inc. (Coherus; Nasdaq: CHRS) reported that the Cancer Research Institute (CRI) and its Immunotherapy Platform Study in Platinum-Resistant High-Grade Serous Ovarian Cancer (IPROC) Drug Selection Committee (DSC) have selected LOQTORZI (toripalimab-tpzi), anti-PD-1 antibody, to explore in combination with ENB-003, a first-in-class small molecule inhibitor of endothelin B receptor (ETBR), for the treatment of drug-resistant cancers in the iPROC platform study (Press release, Coherus Biosciences, MAY 8, 2024, View Source [SID1234642869]). Endothelin B receptor is implicated in tumorigenesis and tumor immune suppression for several solid tumors, including melanoma, ovarian, and pancreatic cancers.

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"The iPROC DSC is pleased to have access to this next-generation PD-1 inhibitor and advance this combination supported by preclinical and clinical data in this study in ovarian cancer," said John Stagg, Ph.D., Professor, Faculty of Pharmacy at the University of Montreal and Principal Investigator, Centre Hospitalier de l’Université de Montréal (CHUM) and its affiliated Cancer Institute of Montreal.

Dr. Stagg continued, "The iPROC study DSC brings together a group of scientific experts within the CRI community to select promising combinations and rapidly advance them to clinical trials. Importantly, the DSC is not confined by a pipeline but looks to work with companies with drugs that have a strong data package. For this multiparty platform study to succeed, it requires science-driven, highly collaborative, and engaged companies. Coherus and ENB Therapeutics are two such partners, and we are excited to advance this clinical study."

"CRI is an established and preeminent organization leading immunotherapy discovery and advancement through its global network of scientific experts, and we are excited that the CRI network has selected LOQTORZI for this study to gain more insight into the potential clinical benefit that LOQTORZI might have when combined with novel mechanisms such as ENB Therapeutics’ ETBR blocker, particularly in this underserved patient population," said Rosh Dias, M.D., Chief Medical Officer at Coherus.

"There is a large body of clinical evidence for LOQTORZI, including positive phase 3 studies published in top-tier scientific journals, showing efficacy and safety in multiple tumor types," said Jay Campbell, Managing Director, Clinical Accelerator and Venture Fund at CRI. "This level of scientific evidence is what we are looking for when selecting immunotherapies to bring into our network, with the goal of advancing clinically meaningful solutions to patients. We are grateful to have the opportunity to collaborate with Coherus and ENB Therapeutics on this study and excited to be working with them on this novel combination that we hope will lead to improved outcomes in these patient populations."

Dr. Sumayah Jamal, CEO of ENB Therapeutics, added, "We are honored to be collaborating with CRI and Coherus to further accelerate the development of innovative immunotherapy solutions and expand the pool of patients benefitting from this approach to harness the immune system to fight cancer."

Under the terms of a clinical supply agreement with the Cancer Research Institute (CRI), Coherus will supply toripalimab-tpzi for combination treatment with ENB-003 to be investigated in the iPROC platform study.

About the IPROC Platform Trial
The IPROC clinical trial uses an adaptive platform study design that utilizes a single master protocol to evaluate multiple immunotherapy combinations. This allows multiple treatments to be evaluated in different groups of patients, or cohorts, from the same patient population. Such a study design offers flexibility in that different treatments can be evaluated in different cohorts, treatment regimens can be modified between cohorts, and treatment selection criteria can be customized for a specific cohort. The trial, titled Immunotherapy Platform Study in Platinum-Resistant High-Grade Serous Ovarian Cancer (IPROC) (NCT04918186), has two ongoing cohorts.

About LOQTORZI (toripalimab-tpzi)
LOQTORZI is an anti-PD-1 monoclonal antibody that blocks PD-L1 binding to the PD-1 receptor at a unique site with high affinity and activates anti-tumor immunity. LOQTORZI is indicated in the United States in combination with cisplatin and gemcitabine for first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC) and as a single agent for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after platinum-containing chemotherapy. For more information about LOQTORZI, including the U.S. Prescribing Information and important safety information, please visit www.loqtorzi.com.

About ENB-003
ENB-003, a small-molecule drug candidate targeting the ETBR, is expressed in solid tumors and plays a role in tumorigenesis and immune evasion. ETBR, a G-protein-coupled receptor, is overexpressed in a variety of tumor cell types and plays a key role in tumor cell proliferation, invasion, epithelial-mesenchymal transition (EMT), and angiogenesis. It also plays a role in tumor immunosuppression and blocks T-cell trafficking.

As reported in November 2023, preliminary results from the ENBOLDEN-101 demonstrated that ENB-003 in combination with KEYTRUDA (pembrolizumab) demonstrated encouraging objective responses, disease control, and progression-free survival in patients with metastatic platinum refractory/resistant ovarian cancer (PROC).

Cellectar Biosciences to Present at the Guggenheim Healthcare Talks Radiopharmaceuticals Day

On May 8, 2024 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of drugs for the treatment of cancer, reported that Jarrod Longcor, chief operating officer of Cellectar, will present an overview of the company in a fireside chat at the upcoming Guggenheim Healthcare Talks Radiopharmaceuticals Day being held on May 13, 2024 in New York City (Press release, Cellectar Biosciences, MAY 8, 2024, View Source [SID1234642868]). Details of the fireside chat are as follows:

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Date: Monday, May 13, 2024
Time: 1:00 pm Eastern Time
Webcast: Click HERE

A replay of the presentation will be available on the Events section of the company’s investor relations website.

C4 Therapeutics Reports First Quarter 2024 Financial Results and Recent Business Highlights

On May 8, 2024 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, reported financial results for the first quarter ended March 31, 2024, as well as recent business highlights (Press release, C4 Therapeutics, MAY 8, 2024, View Source [SID1234642867]).

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"We are off to a strong start in 2024 with enrollment progressing well in our ongoing Phase 1/2 trials of CFT7455, now known as cemsidomide, and CFT1946. We look forward to maintaining this momentum and are on track for clinical readouts from both trials in the second half of the year," said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. "During the first quarter, we continued to leverage our discovery expertise as we entered into a new license and collaboration agreement with Merck KGaA, Darmstadt, Germany and delivered our first development candidate to Biogen. Together, these accomplishments further validate the excitement around our TORPEDO platform and our ability to design innovative molecules for a range of diseases where degraders have the potential to become new therapeutic options for patients searching for treatments."

FIRST QUARTER 2024 AND RECENT ACHIEVEMENTS

Cemsidomide (CFT7455): Cemsidomide (CFT7455) is an oral degrader of IKZF1/3 for the potential treatment of relapsed/refractory (R/R) multiple myeloma (MM) and R/R non-Hodgkin’s lymphomas (NHL).

Advanced the Phase 1/2 Clinical Trial. The dose escalation portion of the Phase 1/2 trial evaluating cemsidomide (CFT7455) in combination with dexamethasone for R/R MM and as a monotherapy for R/R NHL continues to enroll patients. For the combination with dexamethasone MM arm, the 62.5 µg dose has been declared safe and patients are enrolling at a higher dose level. Simultaneously, additional patients are enrolling in the 62.5 µg expansion cohort. For the monotherapy NHL arm, the 62.5 µg cohort has been declared safe and patients are enrolling at a higher dose level.
CFT1946: CFT1946 is an oral degrader targeting BRAF V600X mutations for the potential treatment of solid tumors including non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and melanoma.

Advanced the Phase 1/2 Clinical Trial. The dose escalation portion of the CFT1946 Phase 1/2 trial for BRAF V600X mutations, including NSCLC, CRC and melanoma, continues to enroll patients. The 320 mg dose has been declared safe and patients are enrolling at a higher dose level. Simultaneously, additional patients are enrolling at the 160 mg and 320 mg dose levels for pharmacokinetic, pharmacodynamic and anti-tumor activity evaluation.
Presented New Preclinical Data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024. In April 2024, C4T presented preclinical data highlighting superior activity of CFT1946 compared to BRAF inhibitor standard of care combinations in models of BRAF V600X NSCLC, CRC, melanoma and brain metastasis.
Trial-in-Progress Poster Accepted at European Society for Medical Oncology Congress (ESMO) (Free ESMO Whitepaper) Gastrointestinal (GI) Cancers Congress 2024. C4T will present a trial-in-progress poster on the CRC opportunity within the ongoing CFT1946 Phase 1/2 trial at ESMO (Free ESMO Whitepaper) GI 2024, taking place from June 26 to June 29, 2024.
Collaborations:

Delivered development candidate to Biogen. In April 2024, C4T earned an $8 million payment after Biogen accepted delivery of a development candidate in an undisclosed indication. Biogen is responsible for all future clinical development and commercialization for this program.
License and collaboration agreement with Merck KGaA, Darmstadt, Germany (MKDG). In March 2024, C4T entered into a license and collaboration agreement with MKDG to exclusively discover two targeted protein degraders against critical oncogenic proteins that C4T has progressed within its internal discovery pipeline. Under the terms of the agreement, C4T received an upfront payment of $16 million. MKDG will fund C4T’s discovery research efforts. C4T has the potential to receive up to approximately $740 million in discovery, regulatory and commercial milestone payments across the collaboration. In addition, C4T is eligible for mid-single to low-double digit tiered royalties on future sales for each program.
CORPORATE UPDATES

In April 2024, Dan Powers, DO, was appointed as senior vice president, clinical development. Dr. Powers brings over 20 years of leadership experience in clinical development and medical affairs within the hematology and solid tumor space. Dr. Powers reports to C4T’s chief medical officer, Len Reyno, M.D., and is responsible for leading clinical development programs as well as supporting and executing our ongoing clinical studies.
KEY UPCOMING MILESTONES

Cemsidomide (CFT7455):

Present updated data from the ongoing Phase 1 dose escalation trial in R/R MM in 2H 2024.
Present data from the ongoing Phase 1 dose escalation trial in R/R NHL in 2H 2024.
Complete Phase 1 dose exploration in R/R MM and R/R NHL by year-end 2024.
CFT1946:

Present data from the ongoing Phase 1 monotherapy dose escalation trial in NSCLC, CRC, melanoma and other cancers with BRAF V600X mutations in 2H 2024.
FIRST QUARTER 2024 FINANCIAL RESULTS

Revenue: Total revenue for the first quarter of 2024 was $3.0 million, compared to $3.8 million for the first quarter of 2023. The decrease in revenue was primarily due to the Biogen and Calico research terms ending in 2023. In 2024, we commenced work on our new collaboration agreements with Merck Sharp & Dohme LLC (Merck) and MKDG, which were signed in December 2023 and March 2024, respectively. Total revenue for the first quarter of 2024 reflects revenue recognized under our collaborations with MKDG, Merck, Roche and Biogen, and total revenue recognized in the first quarter of 2023 reflects revenue recognized under collaboration agreements with Roche, Biogen and Calico.

Research and Development (R&D) Expense: R&D expense, net of a one-time $1.9 million restructuring charge, was $22.5 million for the first quarter of 2024. This is compared to $29.0 million for the first quarter of 2023. The reduction in R&D expense was primarily due to the prioritization of our internal discovery efforts and stopping clinical development for CFT8634, partially offset by increased clinical trial expense as cemsidomide (CFT7455) and CFT1946 continue to advance.

General and Administrative (G&A) Expense: G&A expense, net of a one-time $0.5 million restructuring charge, was $10.3 million for the first quarter of 2024. This is compared to $10.9 million for the first quarter of 2023. The decrease in G&A expense was primarily attributable to a reduction in external consulting spend.

Net Loss and Net Loss per Share: Net loss for the first quarter of 2024 was $28.4 million, compared to $34.8 million for the first quarter of 2023. Net loss per share for the first quarter of 2024 was $0.41 compared to $0.71 for the first quarter of 2023.

Cash Position and Financial Guidance: Cash, cash equivalents and marketable securities as of March 31, 2024 were $299.2 million, compared to $281.7 million as of December 31, 2023. The increase was primarily the result of proceeds received in January 2024 from the sale of shares of our common stock to a subsidiary of our partner Betta Pharmaceuticals and proceeds from settlement of shares under our at the market (ATM) offering arrangement, both of which were previously disclosed. These inflows were partially offset by cash used in operating activities. C4T expects that its cash, cash equivalents and marketable securities as of March 31, 2024 will be sufficient to fund planned operating expenses and capital expenditures into 2027.

BIO-TECHNE TO PRESENT AT THE BofA SECURITIES HEALTH CARE CONFERENCE 2024

On May 8, 2024 Bio-Techne Corporation (NASDAQ: TECH) reported that Kim Kelderman, President and Chief Executive Officer, will present at the BofA Securities Health Care Conference on Tuesday, May 14, 2024, at 2:20 p.m. PDT (Press release, Bio-Techne, MAY 8, 2024, View Source [SID1234642866]). A live webcast of the presentation can be accessed via the IR Calendar page of Bio-Techne’s Investor Relations website at View Source

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BeiGene Reports First Quarter 2024 Financial Results and Business Updates

On May 8, 2024 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, reported results from the first quarter 2024 and business highlights (Press release, BeiGene, MAY 8, 2024, View Source [SID1234642865]).

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"We are pleased to present another quarter of strong financial results. Supported by our tremendous global growth in revenue, we have now ascended into the top 15 of global oncology innovators based on total oncology sales. We also continue to make significant improvement in our operating leverage as we progress to sustainable profitability," said John V. Oyler, Co-Founder, Chairman and CEO at BeiGene. "We strengthened our hematology leadership with BRUKINSA, now the BTK inhibitor with the broadest label in the class, as we advance our innovative pipeline of therapies for hematologic malignancies. With TEVIMBRA now approved for use in the U.S. and Europe, we look forward to rapidly advancing our deep pipeline of solid tumor therapies to match our leadership in hematology and continue to solidify our reputation as a global oncology innovator."

Financial Highlights

(Amounts in thousands of U.S. dollars)

Three Months Ended March 31,

(in thousands, except percentages)

2024

2023

% Change

Net product revenues

$

746,918

$

410,291

82

%

Net revenue from collaborations

$

4,734

$

37,510

(87

)%

Total Revenue

$

751,652

$

447,801

68

%

GAAP loss from operations

$

(261,348

)

$

(371,258

)

(30

)%

Adjusted loss from operations*

$

(147,341

)

$

(275,859

)

(47

)%

* For an explanation of our use of non-GAAP financial measures refer to the "Use of Non-GAAP Financial Measures" section later in this press release and for a reconciliation of each non-GAAP financial measure to the most comparable GAAP measures, see the table at the end of this press release.

Key Business Updates

BRUKINSA (zanubrutinib)

U.S. sales of BRUKINSA totaled $351 million in the first quarter of 2024, representing growth of 153% over the prior-year period, as BRUKINSA gained share in treatment-naïve (TN) chronic lymphocytic leukemia (CLL), and emerged as the BTKi class leader in new-patient share in relapsed or refractory (R/R) CLL; BRUKINSA sales in Europe totaled $67 million in the first quarter of 2024, representing growth of 243%, driven by continued gains in market share and additional reimbursements including France, which implemented reimbursement for BRUKINSA within CLL, Waldenström’s macroglobulinemia (WM) and marginal zone lymphoma for the first time;
Presented a new matching adjusted indirect comparison of the efficacy of BRUKINSA versus acalabrutinib in R/R CLL based on data from the Phase 3 ALPINE and Phase 3 ASCEND trials demonstrating a progression-free survival and Complete Response (CR) advantage for BRUKINSA versus acalabrutinib, as well as potentially improved overall survival; and
Received U.S. Food and Drug Administration (FDA) approval for the treatment of adult patients with R/R follicular lymphoma, in combination with the anti-CD20 monoclonal antibody obinutuzumab, after two or more lines of systemic therapy.
TEVIMBRA (tislelizumab)

Sales of tislelizumab totaled $145 million in the first quarter of 2024, representing growth of 26% compared to the prior-year period;
Announced European Commission approval as a treatment for non-small cell lung cancer (NSCLC) across three indications, including first- and second-line use;
Received FDA approval for the treatment of second-line esophageal squamous cell carcinoma (ESCC) after prior chemotherapy;
Received FDA acceptance of BLA for the treatment of first-line gastric or gastroesophageal junction cancers; and
The pending FDA approval for tislelizumab in first-line unresectable, recurrent, locally advanced, or metastatic ESCC with a target PDUFA action date of July 2024 may be deferred on account of a potential delay in scheduling clinical site inspections.
Key Pipeline Highlights

Hematology

Sonrotoclax (BCL2 inhibitor)

Received FDA fast track designation for R/R mantle cell lymphoma (MCL); and
Continued enrollment in R/R MCL and WM with registrational intent as well as Phase 3 in TN CLL in combination with BRUKINSA; more than 850 patients enrolled to date across the program.
BGB-16673 (BTK CDAC)

Initiated expansion cohorts in R/R MCL (potential registrational intent) and R/R CLL; more than 220 patients enrolled to date across the program; and
Expect to initiate Phase 3 clinical trial in R/R CLL by the end of 2024.
Solid Tumors

Lung Cancer

Enrolled last subject in a Phase 3 clinical trial for ociperlimab (anti-TIGIT) for first-line PD-L1 high NSCLC;
Multiple tislelizumab lung cancer combination cohorts with BGB-A445 (anti-OX40), LBL-007 (anti-LAG3) and BGB-15025 (HPK1 inhibitor) expected to read out in 2024; and
Pan-KRAS and MTA-cooperative PRMT5 inhibitors and EGFR CDAC on track to enter the clinic in the second half of 2024.
Breast Cancer

BGB-43395 (CDK4 inhibitor): Initiated fourth dose level of monotherapy, which is in the efficacious dose range with no dose limiting toxicities observed; and initiated dosing of combination with fulvestrant just over four months from first monotherapy dose.
BG-68501 (CDK2 inhibitor): Initiated second dose level of monotherapy in first-in-human study, with clinical pharmacokinetics as expected and no dose limiting toxicities observed.
BG-C9074 (B7H4 ADC): First patient dosed in Australia in global first-in-human Phase 1 study.
Gastrointestinal Cancers

Multiple tislelizumab combination cohorts with LBL-007 (anti-LAG3) and BGB-A445 (anti-OX40) reading out in 2024;
Plan to submit a BLA with the NMPA for zanidatamab for the treatment of second-line biliary tract cancer; and
CEA-ADC and FGFR2b-ADC on track to enter the clinic in the second half of 2024.
Other Business Highlights

The U.S. Patent and Trademark Office (USPTO) granted the Company’s petition for post-grant review of the Pharmacyclics’ patent asserted against the Company in a patent infringement suit, stating that the Company has shown that it is more likely than not that the patent is invalid; The USPTO is expected to issue a final decision on the validity of the patent within 12 months;
Published the 2023 Responsible Business & Sustainability Report which details the Company’s commitment to providing equitable benefit to patients, business and society; and
Anticipate opening of state-of-the-art biologics manufacturing facility and clinical R&D center at the Princeton West Innovation Campus in Hopewell, New Jersey, in July.
First Quarter 2024 Financial Highlights

Revenue for the three months ended March 31, 2024, was $752 million, compared to $448 million in the same period of 2023, driven primarily by growth in BRUKINSA product sales in the U.S. and Europe of 153% and 243% respectively.

Product Revenue for the three months ended March 31, 2024, was $747 million, compared to $410 million in the same period of 2023, representing an increase of 82%. The increase in product revenue was attributable to increased sales of our internally developed products, BRUKINSA and tislelizumab. For the three months ended March 31, 2024, the U.S. was the Company’s largest market, with product revenue of $351 million, compared to $139 million in the prior year period.

Gross Margin as a percentage of global product revenue for the first quarter of 2024 was 83%, compared to 80% in the prior-year period. The gross margin percentage increased primarily due to proportionally higher sales mix of global BRUKINSA compared to other products in the portfolio.

Operating Expenses

GAAP

Non-GAAP

(in thousands, except percentages)

Q1 2024

Q1 2023

% Change

Q1 2024

Q1 2023

% Change

Research and development

$

460,638

$

408,584

13

%

$

405,440

$

361,696

12

%

Selling, general and administrative

$

427,427

$

328,499

30

%

$

372,146

$

283,154

31

%

Amortization

$

$

187

(100

)%

$

$

NM

Total operating expenses

$

888,065

$

737,270

20

%

$

777,586

$

644,850

21

%

Research and Development (R&D) Expenses increased for the first quarter of 2024 compared to the prior-year period on both a GAAP and adjusted basis primarily due to advancing preclinical programs into the clinic and early clinical programs into late stage. Upfront fees and milestone payments related to in-process R&D for in-licensed assets totaled $35 million in the first quarter of 2024, compared to nil in the prior-year period.

Selling, General and Administrative (SG&A) Expenses increased for the first quarter of 2024 compared to the prior-year period on both a GAAP and adjusted basis due to continued investment in the global commercial launch of BRUKINSA, primarily in the U.S. and Europe. SG&A expenses as a percentage of product sales were 57% for the first quarter of 2024 compared to 80% in the prior year period.

Loss from Operations in the first quarter of 2024 decreased 30% on a GAAP basis and 47% on an adjusted basis compared to the prior-year period. The decrease is driven by significantly improved operating leverage associated with substantial revenue growth and expense discipline as we make significant progress on the path to sustainable profitability.

GAAP Net Loss improved for the quarter ended March 31, 2024, compared to the prior-year period, as our product revenue growth and management of expenses is driving increased operating leverage.

For the quarter ended March 31, 2024, net loss per share was $(0.19) and $(2.41) per American Depositary Share (ADS), compared to $(0.26) per share and $(3.34) per ADS in the prior year period.

Cash Used in Operations for the quarter ended March 31, 2024, totaled $309 million compared to $564 million in the prior-year period, driven by improved operating leverage.

For further details on BeiGene’s First Quarter 2024 Financial Statements, please see BeiGene’s Quarterly Report on Form 10-Q for the first quarter of 2024 filed with the U.S. Securities and Exchange Commission.