Anixa to Get Additional Key Patent on Breast Cancer Vaccine Technology

  Anixa Biosciences, Inc. (NASDAQ: ANIX) ("Anixa"), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance broadening protection of Anixa's novel breast cancer vaccine technology.  This technology was invented and developed at Cleveland Clinic and Anixa is the exclusive worldwide licensee.

The patent is titled, "Vaccine Adjuvants and Formulations," and the lead inventor is the late Dr. Vincent Tuohy, of Cleveland Clinic.  This patent covers additional intellectual property related to the formulation of Anixa's breast cancer vaccine.

"We are pleased to receive this notice of allowance from the USPTO, confirming additional protection of our breast cancer vaccine technology," stated Dr. Amit Kumar, Chairman and CEO of Anixa.  "This breast cancer vaccine has the potential to prevent Triple Negative Breast Cancer ("TNBC"), the deadliest form of breast cancer, and perhaps other forms of breast cancer that express alpha-lactalbumin.  With our partners at Cleveland Clinic, we are currently performing clinical trials of this vaccine, and plan to present data from the trial at the annual meeting of the American Association for Cancer Research in April."

https://www.biospace.com/article/releases/anixa-biosciences-announces-notice-of-allowance-of-additional-key-patent-on-breast-cancer-vaccine-technology/

After Historic Hemophilia B Approval, uniQure Targets Huntington’s and ALS

 2022 was a big year for uniQure with the U.S. and European approval of world's first gene therapy for hemophilia B. In its 2022 financial report Monday, the Lexington, Mass. and Amsterdam-based company provided updates on the progress of its Huntington’s disease and ALS programs. 

uniQure, along with partner CSL Behring, made history in November 2022 when Hemgenix was approved in the U.S.

Hemgenix, now also conditionally approved in Europe, tops the charts as the most expensive medicine in the world. Under the terms of its partnership with CSL, uniQure supplies the therapy from its Lexington, Mass. manufacturing facility.

The company became eligible for a $100 million payment from CSL upon its first U.S. sale. Another $75 million will follow if a sale in one of five countries in Europe is seen by mid-summer.

The cash infusion should be well-spent on uniQure’s next big target – a gene therapy for Huntington’s disease.

Huntington’s has been a notoriously difficult indication for biopharma. Despite its absolute fatality and lack of therapies to treat or even slow progression, it remains thus far untouchable.

Earlier this month, Novartis dropped its program after neurotoxicity signals occurred in the majority of trial participants. A failure in the space led Triplet Therapeutics shut down last fall.

uniQure’s AAV gene therapy approach is currently being tested in a Phase I/II study. Twenty-six patients are currently enrolled in either a lower or higher dose cohort arm.

An AAV5 vector carries mRNA tailored to silence the huntingtin gene, inhibiting production of mutant protein mHTT. Preclinical studies showed a single dose of AMT-130 can lead to improvement in brain cell function, disease neuropathology reversal and a partial reversal of hippocampus volume loss.

AMT-130 has been granted Orphan Drug and medicinal designations from the FDA and EMA.

The biotech is also expanding its focus areas to include a new target. In Jan. the company picked up an ALS gene therapy hopeful from Apic Bio. The one-time therapy utilizes a recombinant AAVrh10 vector to reduce the expression of superoxide dismutase 1 (SOD1) to slow or reverse progression of the disease.

AMT-162 already has a cleared IND. uniQure expects to initiate a Phase I/II study of its new asset in the second half of 2023.

https://www.biospace.com/article/after-historic-hemophilia-b-approval-uniqure-targets-huntington-s-and-als-/

Seagen has a New Suitor as Pfizer Talks Begin

 Following its failed deal with Merck last year, Seagen has a new suitor. The Seattle-based company is in talks with Pfizer over a potential acquisition, The Wall Street Journal reported Sunday evening, citing people familiar with the matter.

Negotiations between Pfizer and Seagen are in the early stages, according to the WSJ report, and there is no guarantee both companies will reach an agreement.

If a deal does materialize, however, it could be one of biopharma’s biggest buyouts ever. Seagen currently has a market cap of $30.14 billion and any acquisition agreement is expected to carry a heftier price tag.

Any potential deal would also have to pass increasingly stringent antitrust scrutiny. In January, Sen. Elizabeth Warren (D-MA) sent a letter to FTC commissioners, citing the “rampant consolidation in the pharmaceutical industry” and the effects this could have on competition. A high-value deal between Pfizer and Seagen could attract similar attention.

BioSpace has reached out to both Seagen and Pfizer for comment.

Pfizer isn’t Seagen’s first high-profile suitor. In June 2022, Merck reportedly approached the cancer-focused biotech for a buyout. The negotiations, which were also first broken by the WSJ, progressed to advanced stages in July 2022, with both companies settling on a deal value of around $40 billion according to sources familiar with the matter.

In August 2022, however, negotiations hit a snag over pricing disagreements. There have been no major developments since.

ADC Alliance

If a deal with Pfizer does push through, it will bring two of the industry’s most influential antibody-drug conjugate (ADC) players together.

Pfizer owns Mylotarg (gemtuzumab ozogamicin), the first-ever ADC to make it to the U.S. market after it won FDA approval for acute myelogenous leukemia (AML) in 2010. Pfizer withdrew Mylotarg in this indication in 2010 due to potentially fatal side effects. The therapeutic regained its AML approval in 2017, at a lower dose and for patients with CD33-positive disease.

Seagen, meanwhile, owns Adcetris (brentuximab vedotin), which won FDA approval for Hodgkin lymphoma and systemic anaplastic large cell lymphoma in August 2011 and became the second ADC to pass regulatory muster. Adcetris has since picked up several other oncology approvals and Seagen expects it to hit blockbuster status in 2023.

Aside from Adcetris, the potential buyout could also give Pfizer access to Padcev (enfortumab vedotin-ejfv), which Seagen also sees blockbuster potential in, especially as the drug could grow into a strong bladder cancer franchise. Padcev is already approved for locally advanced or metastatic urothelial cancer.

Seagen is looking to expand Padcev’s use into earlier stages of the disease. The FDA has already granted priority review for its accelerated approval in first-line metastatic bladder cancer.

https://www.biospace.com/article/seagen-has-a-new-suitor-as-pfizer-talks-begin-wsj/

Supreme Court to review constitutionality of funding consumer protection bureau

 The Supreme Court will review the constitutionality of the Consumer Financial Protection Bureau’s (CFPB) funding mechanism.

Lower courts have split on the issue of whether the CFPB’s funding through annual transfers by the Federal Reserve violates the Constitution’s Appropriations Clause, which establishes Congress’s power of the purse.

In a brief, unsigned order on Monday, the court announced it will take up the case, indicating at least four justices agreed to do so.

The CFPB was created after the 2008 financial crisis to enforce consumer financial laws, and a coalition of 16 Republican attorneys general want the justices to affirm a lower court decision deeming the funding scheme from the Federal Reserve unconstitutional.

The Biden administration says that lower court decision calls into question virtually every action the CFPB has taken since it was created.

The administration is backed by 21 Democratic state attorneys general and Washington, D.C., who want to reverse the ruling and deem the CFPB’s funding a valid use of Congress’ appropriations power.

https://thehill.com/regulation/court-battles/3875570-supreme-court-to-review-constitutionality-of-funding-consumer-protection-bureau/

Avita: Skin Cellular Therapy Webinar

 AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative medicine company leading the development and commercialization of first-in-class devices and autologous cellular therapies for skin restoration, invites shareholders and prospective investors to attend its investor webinar briefing and presentation by Jim Corbett, CEO, and Sean Ekins, acting CFO, on February 28, 2023 at 4:00pm (PST) / March 1, 2023 at 11:00am (AEDT).

The webinar will cover highlights from AVITA Medical’s recent fourth quarter 2022 webcast with commercial revenue up 37% compared to the corresponding period in the prior year, business highlights, revenue guidance, and conclude with Q&A.

To register for the presentation, please follow this Zoom link: https://us02web.zoom.us/webinar/register/WN_lqqQRuMHRWW-WF0ZYUHGMg

Participants are invited to submit questions via the registration page or during the webinar via the chat function. A replay will be available on the AVITA Medical website, ir.avitamedical.com, following the presentation.

https://finance.yahoo.com/news/avita-medical-host-investor-webinar-130000541.html

EyePoint, Rallybio to Collaborate in Geographic Atrophy Research

 EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing therapeutics to improve the lives of patients with serious eye disorders, and Rallybio Corporation, a clinical-stage biotechnology company committed to identifying and accelerating the development of life-transforming therapies for patients with severe and rare diseases, today announced a research collaboration. The partnership will evaluate sustained delivery of Rallybio’s inhibitor of complement component 5 (C5) using EyePoint’s proprietary Durasert technology for sustained intraocular drug delivery. The initial focus will be on geographic atrophy, an advanced form of age-related macular degeneration that leads to irreversible vision loss.

https://finance.yahoo.com/news/eyepoint-rallybio-announce-research-collaboration-120000251.html

Rhythm to Acquire Xinvento B.V. and Portfolio of Investigational Therapeutics

 Rare disease company in preclinical development for congenital hyperinsulinism -

- Acquisition is strong strategic fit with Rhythm’s rare endocrinology focus and provides meaningful new development opportunity -

- Expect to initiate clinical development in 2024 -

Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with hyperphagia and severe obesity caused by rare melanocortin-4 receptor (MC4R) pathway diseases, today announced that Rhythm’s Netherlands subsidiary, Rhythm Pharmaceuticals Netherlands B.V. (“Rhythm BV”), acquired Xinvento B.V., a Netherlands-based biotech company focused on developing therapies for congenital hyperinsulinism (CHI). CHI is a rare genetic disease in which cells secrete excess insulin, causing hypoglycemia, which can result in serious health outcomes including seizures, coma, permanent brain damage and death.

Xinvento was founded in 2021 by Claudine van der Sande, an experienced biopharmaceutical leader who previously held positions at Roche and Sanofi, and whose first-hand experience as a caregiver to her son living with CHI inspired her mission to seek a more effective treatment for CHI patients. Ms. van der Sande partnered with Dr. Piet Wigerinck, a medicinal chemist who served as chief scientific officer of Galapagos for 10 years, to lead the scientific effort. Xinvento is developing novel investigational therapeutic candidates designed to improve the care of patients with CHI.

https://finance.yahoo.com/news/rhythm-pharmaceuticals-announces-acquisition-xinvento-134500730.html