On September 16, 2026 OncoC4 Inc., a late clinical-stage biopharmaceutical company developing novel medicines for cancer and neurodegenerative diseases, reported that the U.S. FDA has granted Fast Track Designation to its PD-1/VEGF bispecific antibody cesalatamig (also known as AI-081) for the treatment of patients with NSCLC whose disease has progressed following concurrent or sequential PD-(L)1-targeted immunotherapy and platinum-based chemotherapy.

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"This designation reflects the clinical safety and efficacy signals we have seen in our global Phase 1/2 trials, BiPAVE-001 US and BiPAVE-001 China," said Dr. Yang Liu, Co-founder, Chief Executive Officer and Chief Scientific Officer of OncoC4. "We are rapidly advancing to registrational phase 3 development in PD-(L)1-refractory or resistant NSCLC and other indications".

The global BiPAVE-001 Phase 1/2 trials are designed to evaluate the safety, efficacy and pharmacokinetics of cesalatamig in patients with advanced cancer. Part A is Phase 1 dose escalation and expansion study. Part B is the Phase 2 dose optimization studies consisting of multiple cohorts evaluating the safety and clinical activities of cesalatamig either as monotherapy or in combination therapy with standard of care or novel agents. The trials are being conducted at more than 50 clinical sites across the United States and China, with majority of the patients enrolled from the United States.

About cesalatamig

Cesalatamig is a differentiated PD-1/VEGF bispecific antibody with high affinity for PD-1 and more than 40-fold higher affinity for VEGF than bevacizumab-based bispecific PD-(L)1/VEGF inhibitors. As a result, cesalatamig shows best-in-class potential with a stronger cooperative interaction that favors its action in a PD-1 and VEGF-rich tumor microenvironment. Cesalatamig also has more effective Fc-silencing modifications to avoid the depletion of PD-1 positive effector T cells.

(Press release, OncoC4, SEP 16, 2026, View Source [SID1234670906])

On September 16, 2026 Phanes Therapeutics, Inc. (Phanes), a clinical-stage biotech company focused on innovative drug discovery and development in immuno-oncology (IO), reported that the U.S. Patent and Trademark Office (USPTO) has officially granted a patent (Patent No. US12,735,481) for its proprietary, core bispecific antibody technology platform, PACbody (PAC = Pairing of Alternative Cysteines). This patent grant marks a significant milestone for Phanes in its foundational bispecific technology and global intellectual property protection.

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PACbody is a proprietary bispecific antibody construction platform internally discovered and owned by Phanes. It enables the generation of bispecific antibodies that maintain native IgG structures with drug-like CMC characteristics. Bispecific antibodies built on this platform exhibit excellent manufacturability, including stability, high expression, and seamless compatibility with conventional monoclonal antibody commercial manufacturing processes, significantly reducing development, clinical, and manufacturing risks.

Innovative bispecific antibodies developed using the PACbody platform have demonstrated robust clinical potential. Most notably, Phanes’ core asset spevatamig (PT886) has advanced into Phase II clinical trials and showed positive results, as reported at the ASCO (Free ASCO Whitepaper) Annual Meeting in May 2026. Spevatamig is a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47. It was granted by the FDA orphan drug designation (ODD) for the treatment of pancreatic cancer in 2022, Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma in 2024, and recently, Fast Track designation for the treatment of advanced and metastatic biliary tract carcinoma. In 2023, Phanes entered into a clinical collaboration agreement with Merck (known as MSD outside the US and Canada) to study spevatamig in combination with pembrolizumab. Spevatamig is an innate immunity enhancer (I2E), an emerging class of immuno-oncology (IO) agents. It has the potential to become the first I2E for a solid tumor indication and is combinable with various anti-cancer therapies.

"We are thrilled that our PACbody platform has been granted this U.S. patent," said Dr. Ming Wang, Founder and CEO of Phanes Therapeutics. "PACbody is our core technology for overcoming the CMC challenges that typically hindered bispecific antibody development. This patent approval not only validates our top-tier innovative R&D capabilities but also significantly strengthens the protection of our core pipeline’s intellectual property. We will continue to leverage this platform to accelerate the delivery of safer and more effective breakthrough therapies to cancer patients worldwide."

(Press release, Phanes Therapeutics, SEP 16, 2026, View Source [SID1234670905])

On September 16, 2026 Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), reported that the Phase III CELESTIMO study evaluating Lunsumio (mosunetuzumab-axgb) in combination with lenalidomide versus Rituxan (rituximab) plus lenalidomide in people with relapsed or refractory follicular lymphoma (FL) who have received at least one prior line of treatment met its primary endpoint. Results demonstrated a statistically significant and clinically meaningful improvement in progression-free survival. Overall survival data were immature at the time of interim analysis. The safety profile of the Lunsumio and lenalidomide combination was consistent with the known profiles of the individual study medicines, with no new safety signals identified. Data from the study will be submitted to health authorities and presented at an upcoming medical meeting.

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"People living with relapsed or refractory follicular lymphoma need treatment options that provide meaningful clinical benefit and minimal disruptions to everyday care," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "The CELESTIMO results indicate that a two-drug outpatient Lunsumio regimen may offer these patients an effective new option earlier in their treatment journey."

CELESTIMO is a confirmatory study required to convert the accelerated approval/conditional marketing authorization of Lunsumio monotherapy for third-line or later (3L+) FL to full approval, as well as to secure an indication in second-line or later (2L+) FL.

Lunsumio is part of Genentech’s industry-leading CD20xCD3 bispecific antibody program. It is designed with the unique needs and preferences of patients in mind, offering the possibility of outpatient treatment and flexibility between intravenous and subcutaneous administration routes. Lunsumio is already approved for people with 3L+ FL in 60 countries worldwide and has been used to treat over 3,800 patients.

With the longest follow-up data of any bispecific antibody in lymphoma and a broad clinical development program spanning multiple disease settings, including both FL and diffuse large B-cell lymphoma (DLBCL), Lunsumio is helping redefine care across B-cell malignancies. The U.S. Food and Drug Administration recently accepted the supplemental Biologics License Application for Lunsumio in combination with Polivy (polatuzumab vedotin-piiq) for 2L+ DLBCL based on the SUNMO study, and results from CELESTIMO support continued expansion of Lunsumio and lenalidomide into earlier FL treatment, with the Phase III MorningLyte study ongoing in first-line FL.

About the CELESTIMO study

CELESTIMO [NCT04712097] is a Phase III trial evaluating the efficacy and safety of Lunsumio (mosunetuzumab-axgb) in combination with lenalidomide vs. Rituxan (rituximab) plus lenalidomide in people with relapsed or refractory follicular lymphoma (FL) who have received at least one line of prior systemic therapy. It is a confirmatory study required to convert the accelerated approval/conditional marketing authorization of Lunsumio monotherapy for third-line or later FL to full approval, as well as to secure an indication in second-line or later FL.

About follicular lymphoma (FL)

Follicular lymphoma (FL) is the most common slow-growing (indolent) form of non-Hodgkin lymphoma, accounting for about one in five cases. It typically responds well to treatment but is often characterized by periods of remission and relapse. The disease typically becomes harder to treat each time a patient relapses, and early progression can be associated with poor long-term prognosis. It is estimated that, in the United States, more than 15,000 new cases of FL will be diagnosed in 2026, and more than 110,000 people are diagnosed with FL each year worldwide.

About Lunsumio (mosunetuzumab-axgb)

Lunsumio is a first-in-class CD20xCD3 T-cell-engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual-targeting activates and redirects a patient’s existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells. A robust clinical development program for Lunsumio is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin lymphomas, including follicular lymphoma, diffuse large B-cell lymphoma, and other indications.

About Polivy (polatuzumab vedotin-piiq)

Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed specifically in the majority of B cells, an immune cell impacted in some types of non-Hodgkin lymphoma (NHL), making it a promising target for the development of new therapies. Polivy binds to cancer cells such as CD79b and destroys these B cells through the delivery of an anti-cancer agent, which is thought to minimize the effects on normal cells. Polivy is being developed by Genentech using Pfizer ADC technology and is currently being investigated for the treatment of several types of NHL.

Lunsumio and Lunsumio VELO U.S. Indication

LUNSUMIO (mosunetuzumab-axgb) or LUNSUMIO VELO is a prescription medicine used to treat adults with follicular lymphoma whose cancer has come back or did not respond to previous treatment, and who have already received two or more treatments.

It is not known if LUNSUMIO or LUNSUMIO VELO is safe and effective in children.

The conditional approval for this use is based on response rate. There are ongoing studies to establish how well the drug works.

Important Safety Information

What is the most important information I should know about LUNSUMIO or LUNSUMIO VELO?

LUNSUMIO or LUNSUMIO VELO can cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with LUNSUMIO or LUNSUMIO VELO, and can also be severe or life-threatening.

Get medical help right away if you develop any signs or symptoms of CRS at any time, including:

fever of 100.4°F (38°C) or higher
chills
low blood pressure
fast or irregular heartbeat
tiredness or weakness
difficulty breathing
headache
confusion
feeling anxious
dizziness or light-headedness
nausea
vomiting
Due to the risk of CRS, you will receive LUNSUMIO or LUNSUMIO VELO on a "step-up dosing schedule."

The step-up dosing schedule is when you receive smaller "step-up" doses before receiving higher doses of LUNSUMIO or LUNSUMIO VELO during your first cycle of treatment
If your dose of LUNSUMIO or LUNSUMIO VELO is delayed for any reason, you may need to repeat the "step-up dosing schedule"
You may receive medicines to help reduce your risk of CRS before your dose
Your healthcare provider will check you for CRS during treatment with LUNSUMIO or LUNSUMIO VELO and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment with LUNSUMIO or LUNSUMIO VELO, if you have severe side effects.

What are the possible side effects of LUNSUMIO or LUNSUMIO VELO?

LUNSUMIO or LUNSUMIO VELO can cause serious side effects, including:

Neurologic problems. LUNSUMIO or LUNSUMIO VELO can cause serious and life-threatening neurologic problems. Your healthcare provider will check you for neurologic problems during treatment with LUNSUMIO or LUNSUMIO VELO. Your healthcare provider may also refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems during or after treatment with LUNSUMIO or LUNSUMIO VELO, including:
headache
numbness and tingling of the arms, legs, hands, or feet
dizziness
confusion and disorientation
difficulty paying attention or understanding things
forgetting things or forgetting who or where you are
trouble speaking, reading or writing
sleepiness or trouble sleeping
tremors
loss of consciousness
seizures
muscle problems or muscle weakness
loss of balance or trouble walking
tiredness
Serious infections. LUNSUMIO or LUNSUMIO VELO can cause serious infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment. Tell your healthcare provider right away if you develop any signs or symptoms of infection during treatment with LUNSUMIO or LUNSUMIO VELO, including:
fever of 100.4°F (38°C) or higher
cough
chest pain
tiredness
shortness of breath
painful rash
sore throat
pain during urination
feeling weak or generally unwell
Hemophagocytic lymphohistiocytosis (HLH). LUNSUMIO or LUNSUMIO VELO can cause overactivity of the immune system, a condition called hemophagocytic lymphohistiocytosis. HLH can be life-threatening and has led to death in people treated with LUNSUMIO or LUNSUMIO VELO. Your healthcare provider will check you for HLH especially if your CRS lasts longer than expected. Signs and symptoms of HLH include:
fever
enlarged spleen
easy bruising
low blood cell counts
liver problems
Low blood cell counts. Low blood cell counts are common during treatment with LUNSUMIO or LUNSUMIO VELO and can also be serious or severe. Your healthcare provider will check your blood cell counts during treatment with LUNSUMIO or LUNSUMIO VELO. LUNSUMIO or LUNSUMIO VELO can cause the following low blood cell counts:
low white blood cell counts (lymphopenia [for LUNSUMIO VELO only] and neutropenia). Low white blood cells can increase your risk for infection
low red blood cell counts (anemia). Low red blood cells can cause tiredness and shortness of breath
low platelet counts (thrombocytopenia). Low platelet counts can cause bruising or bleeding problems
Growth in your tumor or worsening of tumor-related problems (tumor flare). LUNSUMIO or LUNSUMIO VELO can cause serious or severe worsening of your tumor. Tell your healthcare provider if you develop any of these signs or symptoms of tumor flare during your treatment with LUNSUMIO or LUNSUMIO VELO:
chest pain
cough
trouble breathing
tender or swollen lymph nodes
pain or swelling at the site of the tumor
Your healthcare provider may temporarily stop or permanently stop treatment with LUNSUMIO or LUNSUMIO VELO if you develop severe side effects.

The most common side effects of LUNSUMIO include: CRS, tiredness, rash, headache, fever, muscle pain, cough, itching, and numbness, tingling, or pain in the hands or feet (nerve damage).

The most common side effects of LUNSUMIO VELO include: injection site reactions, tiredness, rash, CRS, COVID-19, muscle and joint pain, and diarrhea.

The most common severe abnormal blood test results with LUNSUMIO include: decreased phosphate, increased glucose, and increased uric acid levels.

The most common severe abnormal blood test results with LUNSUMIO VELO include: decreased white blood cell counts and increased uric acid levels.

Before receiving LUNSUMIO or LUNSUMIO VELO, tell your healthcare provider about all of your medical conditions, including if you:

have ever had an infusion reaction after receiving LUNSUMIO
have an infection or have had an infection in the past which lasted a long time or keeps coming back
have or have had Epstein-Barr Virus
are pregnant or plan to become pregnant. LUNSUMIO or LUNSUMIO VELO may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LUNSUMIO or LUNSUMIO VELO
Females who are able to become pregnant:

your healthcare provider should do a pregnancy test before you start treatment with LUNSUMIO or LUNSUMIO VELO
use an effective method of birth control (contraception) during your treatment and for 3 months after the last dose of LUNSUMIO or LUNSUMIO VELO
are breastfeeding or plan to breastfeed. It is not known if LUNSUMIO or LUNSUMIO VELO passes into your breast milk. Do not breastfeed during treatment and for 3 months after the last dose of LUNSUMIO or LUNSUMIO VELO
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while receiving LUNSUMIO or LUNSUMIO VELO?

Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of CRS or neurologic problems.

These are not all of the possible side effects of LUNSUMIO or LUNSUMIO VELO. Talk to your healthcare provider for more information about the benefits and risks of LUNSUMIO or LUNSUMIO VELO.

You may report side effects to the FDA at (800) FDA-1088 or View Source You may also report side effects to Genentech at (888) 835-2555.

Please see Important Safety Information, including Serious Side Effects, as well as the LUNSUMIO full Prescribing Information and Medication Guide and LUNSUMIO VELO full Prescribing Information and Medication Guide and on View Source

Polivy U.S. Indication
Polivy is a prescription medicine used with other medicines (a rituximab product, cyclophosphamide, doxorubicin, and prednisone) as a first treatment for adults who have moderate to high risk diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL). Polivy is a prescription medicine used with other medicines, bendamustine and a rituximab product, to treat DLBCL in adults who have progressed after at least 2 prior therapies.

Important Safety Information

Possible serious side effects

Everyone reacts differently to Polivy therapy, so it’s important to know what the side effects are. Some people who have been treated with Polivy have experienced serious to fatal side effects. Your doctor may stop or adjust your treatment if any serious side effects occur. Be sure to contact your healthcare team if there are any signs of these side effects.

Nerve problems in your arms and legs: This may happen as early as after your first dose and may worsen with every dose. Your doctor will monitor for signs and symptoms, such as changes in your sense of touch, numbness or tingling in your hands or feet, nerve pain, burning sensation, any muscle weakness, or changes to your walking pattern
Infusion-related reactions: You may experience fever, chills, rash, breathing problems, low blood pressure, or hives within 24 hours of your infusion
Low blood cell counts: Treatment with Polivy can cause severe low blood cell counts. Your doctor will monitor your blood counts throughout treatment with Polivy
Infections: If you have a fever of 100.4°F (38°C) or higher, chills, cough, or pain during urination, contact your healthcare team. Your doctor may also give you medication before giving you Polivy, which may prevent some infections
Rare and serious brain infections: Your doctor will monitor closely for signs and symptoms of these types of infections. Contact your doctor if you experience confusion, dizziness or loss of balance, trouble talking or walking, or vision changes
Tumor lysis syndrome: Caused by the fast breakdown of cancer cells. Signs include nausea, vomiting, diarrhea, and lack of energy
Potential harm to liver: Some signs include tiredness, weight loss, pain in the abdomen, dark urine, and yellowing of your skin or the white part of your eyes. You may be at higher risk if you already had liver problems or you are taking other medication
Side effects seen most often

The most common side effects during treatment were

Nerve problems in arms and legs
Nausea
Tiredness or lack of energy
Diarrhea
Constipation
Hair loss
Redness and sores of the lining of the mouth, lips, throat, and digestive tract
Polivy may lower your red or white blood cell counts and increase uric acid levels.

Polivy may not be for everyone. Talk to your doctor if you are

Pregnant or think you are pregnant: Data have shown that Polivy may harm your unborn baby
Planning to become pregnant: Women should avoid getting pregnant while taking Polivy. Women should use effective contraception during treatment and for 3 months after their last Polivy treatment. Men taking Polivy should use effective contraception during treatment and for 5 months after their last Polivy treatment
Breastfeeding: Women should not breastfeed while taking Polivy and for 2 months after the last dose
These may not be all the side effects. Talk to your healthcare provider for more information about the benefits and risks of Polivy treatment.

(Press release, Genentech, SEP 16, 2026, View Source [SID1234670903])

On September 16, 2026 Halozyme Therapeutics, Inc. (Nasdaq: HALO) ("Halozyme" or the "Company"), reported that it intends to offer, subject to market conditions and other factors, $1.05 billion aggregate principal amount of convertible senior notes due 2033 (the "Convertible Notes"). The Company also expects to grant a 13-day option to the initial purchasers to purchase up to an additional $150 million aggregate principal amount of the Convertible Notes. The Convertible Notes are to be offered and sold only to persons reasonably believed to be "qualified institutional buyers" pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act").

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The Convertible Notes will be senior, unsecured obligations of the Company and will accrue interest payable semi-annually in arrears. The Convertible Notes will mature on October 1, 2033, unless earlier redeemed, repurchased or converted in accordance with their respective terms prior to such date. Prior to the close of business on the business day immediately preceding April 1, 2033, the Convertible Notes will be convertible only upon the satisfaction of certain conditions and during certain periods, and on and after April 1, 2033, at any time prior to the close of business on the second scheduled trading day immediately preceding the maturity date of the Convertible Notes, the Convertible Notes will be convertible regardless of these conditions. The Company will settle conversions in cash and, if applicable, shares of the Company’s common stock, at the Company’s election. The initial conversion rate, interest rate and other terms of the Convertible Notes will be determined at the time of pricing in negotiations with the initial purchasers of the Convertible Notes.

In connection with the pricing of the Convertible Notes, the Company intends to enter into privately negotiated capped call transactions relating to the Convertible Notes with one or more financial institutions, which may include one or more of the initial purchasers and/or their respective affiliates. The capped call transactions relating to the Convertible Notes will initially cover, subject to customary adjustments, the number of shares of our common stock that will initially underlie the Convertible Notes. If the initial purchasers exercise their option to purchase additional notes, the Company may enter into additional capped call transactions with the option counterparties.

The Company expects to use a portion of net proceeds of the offering to fund the cost of entering into the capped call transactions. The Company also expects to use a portion of the net proceeds of the offering to enter into privately negotiated agreements with certain holders of its outstanding 0.25% convertible senior notes due 2027 (the "2027 Notes") and 1.00% convertible senior notes due 2028 (the "2028 Notes" and, together with the 2027 Notes, the "Existing Convertible Notes") to repurchase their Existing Convertible Notes for cash through privately negotiated transactions entered into concurrently with or shortly after the pricing of the proposed offering (the "Note Repurchases").

The Company intends to use the remainder of the net proceeds from the offering for general corporate purposes, including working capital, capital expenditures, potential acquisitions and strategic transactions, and, potentially, future note repurchases including repurchases of the Existing Convertible Notes from time to time following the offering or for the repayment of the Notes at maturity or upon early optional redemption at the Company’s discretion. If the initial purchasers exercise their option to purchase additional notes, the Company intends to use a portion of the net proceeds from the sale of additional notes to fund the cost of entering into additional capped call transactions.

The Note Repurchases could increase (or reduce the size of any decrease in) the market price of the Company’s common stock or the Convertible Notes. We also expect that some existing noteholders may purchase or sell shares of the Company’s common stock in the market to hedge their exposure in connection with these transactions. The Note Repurchases and any associated hedging by holders could affect the market price of the Company’s common stock prior to, concurrently with or shortly after the pricing of the Convertible Notes and could also result in a higher effective conversion price for the Convertible Notes.

The capped call transactions relating to the Convertible Notes are generally expected to reduce potential dilution to the Company’s common stock upon conversion of the Convertible Notes and/or offset the amount of any potential cash payments the Company may be required to make in excess of the principal amount of converted Convertible Notes, as the case may be, in the event that the market price per share of our common stock, as measured under the terms of the capped call transactions, is greater than the strike price of the capped call transactions, which initially corresponds to the conversion price of the Convertible Notes and is subject to anti-dilution adjustments substantially similar to those applicable to the conversion rate of the Convertible Notes. If, however, the market price per share of our common stock, as measured under the terms of the capped call transactions, exceeds the cap price of the capped call transactions, there would nevertheless be dilution and/or there would not be an offset of such potential cash payments, in each case, to the extent that such market price exceeds the cap price of the capped call transactions.

The Company has been advised that, in connection with establishing their initial hedges of the capped call transactions, the option counterparties or their respective affiliates expect to enter into various derivative transactions with respect to our common stock and/or purchase shares of our common stock concurrently with or shortly after the pricing of the Convertible Notes. This activity could increase (or reduce the size of any decrease in) the market price of our common stock or the Convertible Notes at that time.

In addition, the Company has been advised that the option counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to our common stock and/or purchasing or selling our common stock or other securities of ours in secondary market transactions following the pricing of the Convertible Notes and from time to time prior to the maturity of the Convertible Notes (and (x) are likely to do so during any observation period related to a conversion of the Convertible Notes, following any redemption of the Convertible Notes by us, or following any repurchase of the Convertible Notes by us in connection with any fundamental change and (y) are likely to do so following any repurchase of Convertible Notes by us other than in connection with any such redemption or any fundamental change if we elect to unwind a corresponding portion of the capped call transactions in connection with such repurchase). This activity could also cause or avoid an increase or decrease in the market price of our common stock or the Convertible Notes, which could affect a holder’s ability to convert its Convertible Notes and, to the extent the activity occurs during any observation period related to a conversion of the Convertible Notes, it could affect the number of shares of our common stock and value of the consideration that a holder will receive upon conversion of its Convertible Notes.

This press release is neither an offer to sell nor a solicitation of an offer to buy the Convertible Notes or the shares of the Company’s common stock issuable upon conversion of the Convertible Notes, if any, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. Any offer of these securities will be made only by means of a private offering memorandum.

The offer and sale of the Convertible Notes and the shares of the Company’s common stock issuable upon conversion of the Convertible Notes, if any, have not been registered under the Securities Act, or the securities laws of any other jurisdiction, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

(Press release, Halozyme, SEP 16, 2026, View Source;Announces-Proposed-Offering-of-1-05-Billion-of-Convertible-Senior-Notes-due-2033/default.aspx [SID1234670902])

On September 16, 2026 Propanc Biopharma, Inc. (Nasdaq: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company focused on developing novel treatments for chronic diseases, including recurrent and metastatic cancer, reported a comparative analysis of its lead candidate PRP against recently announced clinical datasets from leading RAS-targeted programs, including Revolution Medicines’ daraxonrasib (RASONQUE; RMC-6236) and Erasca’s pan-RAS molecular glue ERAS-0015.

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The analysis is intended to clarify two distinct layers of tumor biology. RAS inhibitors block oncogenic RAS signaling and have produced practice-changing clinical results in RAS-mutant pancreatic ductal adenocarcinoma (PDAC) and encouraging activity in RAS-mutant non-small cell lung cancer (NSCLC). PRP, a proprietary fixed-ratio combination of the pancreatic proenzymes, trypsinogen and chymotrypsinogen, does not inhibit RAS. Instead, it promotes differentiation of malignant cells toward a more normal phenotype, reverses epithelial-mesenchymal transition (EMT), depletes cancer stem cells (CSCs), and remodels the fibrotic tumor microenvironment (TME).

Propanc believes these mechanisms address residual drivers of resistance, dormancy, and metastasis that can persist after RAS pathway blockade – creating a scientific rationale for combination or sequential use with RAS inhibitors.

A Landmark Moment for RAS-Targeted Therapy

RAS mutations drive approximately 90% of PDAC and roughly 30% of NSCLC. For decades the target was considered undruggable. That landscape has shifted rapidly.

Revolution Medicines – daraxonrasib: In the randomized Phase 3 RASolute 302 trial in previously treated metastatic PDAC, oral once-daily daraxonrasib produced median overall survival (OS) of 13.2 months versus 6.6–6.7 months with investigator’s-choice chemotherapy (hazard ratio 0.40; p < 0.0001), median progression-free survival (PFS) of 7.3 months versus 3.5 months, and an objective response rate (ORR) of approximately 33% versus 12%. The U.S. Food and Drug Administration approved daraxonrasib in August 2026 for pretreated metastatic pancreatic adenocarcinoma. In previously treated RAS-mutant NSCLC, a Phase 1/2 study published in The New England Journal of Medicine reported ORRs of 31–37% across evaluated dose bands; in a docetaxel-naïve subgroup treated at 160–220 mg, confirmed ORR was 42%, disease-control rate 89%, median PFS 8.3 months, and median OS 16.0 months.

Erasca – ERAS-0015: Preliminary Phase 1 monotherapy data from the U.S. AURORAS-1 and China JYP0015M101 trials showed unconfirmed overall response rates (uORR) of 62% in second-line or later KRAS G12X NSCLC at pharmacologically active doses of 16–32 mg once daily, and 75% in the post-checkpoint-inhibitor / platinum 2/3L NSCLC subset. In second-line KRAS G12X PDAC, uORR was 40% at 16–32 mg and 42% at recommended expansion doses of 24–32 mg; a July 2026 update reported a 57% uORR at 8 weeks at the 32 mg recommended expansion dose in 2L+ KRAS G12X PDAC. The program has been generally well tolerated to date, with mostly low-grade treatment-related adverse events and no dose-limiting toxicities reported at disclosed cutoffs. Erasca has described ERAS-0015 as a potentially best-in-class pan-RAS molecular glue and has outlined registration-enabling plans in pancreatic and lung cancers.

These datasets validate RAS as a therapeutically tractable node. They also leave an open clinical question: how to convert high response rates and doubled survival into durable, metastasis-free outcomes when residual mesenchymal and stem-like cells remain.

PRP Preclinical Profile in Advanced PDAC

In orthotopic and patient-derived xenograft (PDX) models of advanced PDAC, three-times-weekly intravenous PRP achieved:

Greater than 90%, mean, tumor-growth inhibition versus vehicle controls (p < 0.001).
Marked reduction in metastatic burden in liver and peritoneum.
Significant TME remodeling, including decreased cancer-associated fibroblast (CAF) activity, reduced fibrosis, and suppression of EMT markers.
Re-sensitization of chemo-resistant PDAC cells to gemcitabine/nab-paclitaxel, supporting lower chemotherapy doses with improved efficacy.
Median overall survival extension of more than 2.5-fold versus controls.
These findings are built on previously reported >85% tumor-growth inhibition, peer-reviewed work on PRP’s effects on PDAC fibroblasts and CSCs, and limited prior compassionate-use experience with related proenzyme formulations that showed signals of prolonged survival and a favorable safety profile with no severe treatment-related adverse events. PRP holds FDA Orphan Drug Designation for pancreatic cancer and is not restricted to a specific RAS genotype.

Important context: PRP efficacy cited here is preclinical. Daraxonrasib and ERAS-0015 data are from human clinical trials. Cross-modality numerical comparisons are directional only and are not head-to-head results.

Comparative Snapshot

Attribute PRP (PPCB) Daraxonrasib ERAS-0015
Modality IV proenzyme combo (trypsinogen + chymotrypsinogen, 1:6) Oral RAS(ON) multi-selective inhibitor Oral pan-RAS molecular glue
Primary node Differentiation / EMT reversal / CSCs / TME Oncogenic RAS(ON) signaling Pan-RAS (KRAS G12X and related)
Evidence stage Preclinical PDAC + limited compassionate use; Phase 1b planned Feb 2027 Phase 3 PDAC (approved Aug 2026); Phase 1/2 NSCLC in NEJM Phase 1 dose-escalation / expansion; registration path outlined
PDAC activity >90% TGI; >2.5× median OS in models; metastasis and fibrosis reduced Ph3 2L: mOS 13.2 vs 6.6–6.7 mo; mPFS 7.3 vs 3.5 mo; ORR ~33% vs ~12% Ph1 2L KRAS G12X: uORR 40–42%; 57% uORR8wk at 32 mg RDE (2L+)
NSCLC activity Not a primary disclosed indication to date Ph1/2 RAS-mutant: ORR 31–37%; docetaxel-naïve subset ORR 42%, mOS 16 mo Ph1 2L+ KRAS G12X: uORR 62%; post-ICI/platinum 2/3L uORR 75%
Genotype limit Not RAS-mutation restricted RAS-mutant tumors (multi-selective, non-G12C-only) RAS / KRAS G12X enriched populations
Resistance biology addressed EMT, CSCs, CAFs, fibrosis, metastasis, chemo-re-sensitization Oncogene-addicted proliferation; adaptive MAPK reactivation remains a known class issue RAS output; combinations (e.g., anti-EGFR) being explored
Sources: Company disclosures & peer-reviewed or conference reports for September 2026. Figures are not from a single comparative trial.

How Reversal of EMT Occurs — and Why It Matters After RAS Blockade

EMT is a developmental program co-opted by carcinomas. When it is activated, epithelial tumor cells lose polarity and adhesion, acquire a mesenchymal, invasive, and stem-like state, and become more resistant to apoptosis, chemotherapy, and targeted agents. In PDAC, EMT is tightly coupled to TGF-β signaling, a dense desmoplastic stroma, CAF activation, and a CSC reservoir that seeds metastasis and late relapse.

Oncogenic RAS feeds this program. KRAS signaling promotes MAPK- and PI3K-dependent transcriptional networks that stabilize EMT transcription factors, loosen cell–cell junctions, and maintain stemness. RAS inhibitors can collapse that upstream drive and produce rapid tumor shrinkage. They do not, by themselves, reliably extinguish cells that have already completed EMT or that reside in a fibrotic niche that limits drug penetration and immune access. Those residual populations are a leading hypothesized source of acquired resistance to RAS-targeted drugs.

PRP acts at a different biological layer:

Proenzyme activation and PAR signaling: After intravenous administration, trypsinogen and chymotrypsinogen are activated and engage proteinase-activated receptors (PAR-1 and PAR-2), which are frequently overexpressed on tumor cells. This cascade is associated with reduced TGF-β pathway output — a master inducer of EMT in late-stage cancer.
Restoration of an epithelial phenotype: Peer-reviewed studies show PRP increases epithelial adhesion proteins such as E-cadherin and β-catenin and decreases EMT transcription factors. Cells become less motile, more adherent, and more differentiated — the operational definition of EMT reversal (sometimes described as mesenchymal-to-epithelial transition, or MET).
Depletion of cancer stem cells: In pancreatic CSC models, PRP reduced ALDH-high cells and surface markers CD44, CD326, and CXCR4; suppressed primary and secondary sphere formation; down-regulated CSC and metastasis gene programs; and impaired tumor engraftment in vivo.
TME and fibroblast remodeling: PRP decreased CAF activity and fibrosis in PDAC models. A less desmoplastic stroma can improve drug delivery and reduce TGF-β-driven conversion of non-stem tumor cells into CSCs — a problem that pathway inhibitors alone do not solve.
Chemo- and pathway-sensitization: By pushing cells out of a mesenchymal, drug-tolerant state, PRP resensitized chemo-resistant PDAC cells to gemcitabine/nab-paclitaxel at lower doses. The same logic applies to RAS inhibitors: a smaller mesenchymal reservoir should theoretically reduce the probability of adaptive escape.
In short, RAS inhibitors turn the oncogenic engine off. PRP is designed to convert the remaining cells back toward a less dangerous epithelial identity and to dismantle the niche that protects them. The two approaches are biologically orthogonal.

Strategic Implication for RAS Inhibitor Developers

For companies such as Revolution Medicines and Erasca, durability — not only response rate — will define long-term competitive position as multiple RAS agents enter the same PDAC and NSCLC populations. Three practical implications follow from the EMT-reversal thesis:

Combination potential: A RAS inhibitor plus an EMT-reversing, CSC-targeting agent could pair rapid cytoreduction with suppression of the cells most likely to seed resistance. PRP’s non-cytotoxic differentiation mechanism and historically benign compassionate-use safety profile make it a candidate for add-on or maintenance designs that RAS companies are already exploring with chemotherapy, anti-EGFR antibodies, and RAS-doublet regimens (for example, zoldonrasib plus daraxonrasib).
Post-progression and maintenance use: When tumors adapt to RAS blockade, mesenchymal drift and fibrotic remodeling are common escape routes. An agent that reverses EMT and reduces CAFs could be sequenced after RAS-inhibitor response to lock in epithelial differentiation and limit metastatic outgrowth.
Broader eligible population: PRP is not genotype restricted. In mixed RAS-mutant / RAS-wild-type settings, or in tumors that lose RAS dependence after therapy, a differentiation backbone could extend benefit beyond the label of any single RAS agent.
Propanc is not announcing a partnership with Revolution Medicines or Erasca. The Company is putting the mechanistic case on record as it advances PRP into first-in-human development and as the RAS field looks beyond first-generation survival gains.

Clinical Path

Propanc plans to initiate a multicenter, open-label Phase 1b first-in-human study of PRP in February 2027 in up to 50 patients with advanced solid tumors, including pancreatic, ovarian, and refractory prostate cancers, at sites in Australia. The two-part design will use Bayesian optimal interval dose escalation with backfill, followed by tumor-specific expansion. PRP is planned as a weekly intravenous infusion on Days 1, 8, 15, and 22 of each 28-day cycle. GMP manufacture, pharmacokinetics assay validation, and ethics submissions are advancing in parallel.

"RAS inhibitors have rewritten what is possible in pancreatic and RAS-mutant lung cancer. That is a genuine inflection point for patients," said James Nathanielsz, Propanc’s Chief Executive Officer. "Our thesis is that turning RAS off is necessary but may not be sufficient. The cells that survive RAS blockade are often the mesenchymal, stem-like cells that PRP differentiate and disarm. If that biology holds in the clinic, PRP could help RAS-focused companies convert high response rates into longer, cleaner remissions."

"EMT is the program that lets a carcinoma leave home, hide, and return," said Dr. Ralf Brandt, Propanc’s Research & Development Director. "PRP does not compete with daraxonrasib or ERAS-0015 at the GTPase. It reverses the downstream identity change those tumors used to resist almost every class of drug. That is why we see suppression of EMT markers, loss of CSC phenotypes, less fibrosis, fewer metastases, and more than a two-and-a-half-fold survival extension in PDAC models. Those are the exact liabilities a RAS inhibitor leaves on the table."

(Press release, Propanc, SEP 16, 2026, View Source [SID1234670901])